Calm Surfer by Remedys Nutrition

Anxiety. Small clinical studies suggest that oral ashwagandha might reduce anxiety. Details: A meta-analysis of small randomized controlled trials in adults with anxiety and/or insomnia shows that taking ashwagandha 600-12,000 mg orally daily for 6-10 weeks moderately improves anxiety scores when compared with placebo. However, the validity of this study is limited by high heterogeneity (114787). One small clinical study in postal workers reporting moderate or severe anxiety shows that taking ashwagandha root (Swiss Herbals) 300 mg twice daily for 12 weeks, in combination with standard psychotherapy interventions, including dietary counseling, deep breathing exercise instruction, and a multivitamin, reduces anxiety scores when compared with standard psychotherapy interventions and placebo (19271). Additionally, two small clinical studies in adults with mild to moderate anxiety, depression, or stress show that taking a specific ashwagandha root extract standardized to contain 2.5% withanolides (Shagandha, Sabinsa Corp.) 500 mg with piperine 5 mg daily for 60-90 days reduces anxiety symptoms and perceived stress and improves sleep and quality of life when compared with placebo (113608,113609). However, another clinical study in young adults shows that taking a specific ashwagandha root and leaf extract (NooGandha, Specnova LLC) 225 mg or 400 mg daily for 30 days does not improve anxiety, stress, and depression scores when compared with placebo (107370).
Generalized anxiety disorder (GAD). Oral ashwagandha may modestly improve symptoms of anxiety in patients with GAD. Details: Clinical practice guidelines from the World Federation of Societies of Biological Psychiatry (WFSBP) and the Canadian Network for Mood and Anxiety Treatments (CANMAT) provisionally recommend ashwagandha root extract at doses of 300-600 mg, standardized to 5% withanolides, daily as monotherapy or adjunctive therapy in patients with GAD. This recommendation is based on a review of three preliminary clinical trials with consistent results (110318). Two of these studies are described below. A small clinical trial in patients with GAD who are taking selective serotonin reuptake inhibitors (SSRIs) shows that taking ashwagandha 1 gram daily for 6 weeks reduces symptoms of anxiety by 48%, compared with a 27% reduction in patients taking placebo. Furthermore, by the end of treatment, 72% of patients taking ashwagandha were determined to have mild symptoms of GAD, compared with only 32% of those taking placebo (102687). Another preliminary clinical trial in patients aged 16 years and older with GAD shows that taking ashwagandha root powder granules 4 grams three times daily for 60 days moderately improves anxious mood in 58% of patients, compared with no moderate improvement in the placebo group. Mild improvement occurred in 82% of patients in the placebo group and 40% of patients in the ashwagandha group (90654). Another small clinical trial in adults with general anxiety disorder shows that taking ashwagandha, standardized to 35% withanolides, 60-120 mg orally daily for 60 days improves anxiety scores by about 60% when compared with placebo (114792).
Insomnia. Oral ashwagandha may modestly improve sleep in patients with insomnia or non-restorative sleep. Details: A small meta-analysis in patients with insomnia and healthy patients shows that taking a specific ashwagandha root extract (KSM-66, Ixoreal Biomed) 250-600 mg daily or a specific root and leaf extract (Shoden, Arjuna Natural) 120 mg daily for 6-12 weeks modestly improves overall sleep, as well as sleep quality, sleep latency, total sleep time, wake time after sleep onset, and sleep efficiency, when compared with placebo. Effects were more pronounced in those with insomnia, with doses of at least 600 mg daily, and with treatment durations of at least 8 weeks (106784). These findings may be limited by heterogeneity of the included studies. A meta-analysis of 2 small randomized controlled trials in adults with anxiety and/or insomnia shows that taking ashwagandha 600 mg orally daily for 8-10 weeks modestly improves sleep onset latency, total sleep time, sleep efficiency, and sleep quality scores, but not wake after sleep onset or total time in bed, when compared with placebo. However, the validity of this study is limited by moderate heterogeneity (114787). In patients with non-restorative sleep, clinical research shows that taking a specific ashwagandha extract (Shoden, Arjuna Natural Private Ltd) 125 mg daily for 6 weeks increases sleep quality by 72%, compared with an improvement of 29% in patients taking placebo. Small to moderate improvements also occurred in total sleep time, sleep latency, and number of times awake (103476). Ashwagandha has also been evaluated as part of a combination treatment. A very small clinical trial in adults with poor quality sleep shows that taking milk fortified with ashwagandha 250-600 mg, or ashwagandha 250 mg and tryptophan, orally daily for 90 days moderately improves sleep quality scores when compared with placebo (114791). Additional data are needed to determine if the addition of tryptophan improves results more than ashwagandha alone.
Stress. Oral ashwagandha seems to help reduce stress and may also reduce stress-related weight gain. Details: A meta-analysis of seven small clinical studies in healthy adults, patients with chronic stress, or patients with psychiatric conditions shows that taking ashwagandha 240-1000 mg daily for 8-12 weeks improves stress when compared with placebo (109587). Clinical studies, some of which are included in the meta-analysis mentioned above, evaluating adults with chronic stress show that taking specific ashwagandha root extracts 240 mg daily (Shoden, Arjuna Natural Ltd.), 300 mg twice daily (KSM-66, Ixoreal Biomed), or 500 mg daily (Shagandha, Sabinsa Corp.) with piperine 5 mg for 60 days, or a specific slow-release capsule containing ashwagandha root extract (Prolanza) 300 mg daily for 90 days reduces perceived stress and cortisol levels when compared with baseline and placebo (90652,95617,101816,102682,107371,113608). Additionally, a small clinical study in adults with stress and a related comorbidity, such as anxiety or depression, shows that taking ashwagandha root and leaf extract (Sensoril, Kerry Group) 125-500 mg orally daily for 8 weeks improves stress scores in a dose-dependent manner when compared with placebo (114112). In contrast, a moderate-sized study in adults with overweight or mild obesity with moderate-to-high levels of stress and fatigue shows that taking ashwagandha root extract (Witholytin, Verdure Sciences Inc) 200 mg twice daily for 12 weeks reduces stress when compared to baseline, but not when compared with placebo (113611).In healthy college students, clinical research also shows that taking ashwagandha root extract 350 mg twice daily for 30 days improves qualitative perceptions of stress management, but not stress scores, when compared with placebo (109589,109590). Other clinical research shows that taking ashwagandha root extract 500 mg twice daily may prevent stress-related weight gain when compared with placebo (95617).

Aging. A small clinical study suggests that oral ashwagandha may modestly improve well-being, sleep, and alertness in elderly patients. Details: A small clinical trial in individuals aged 65-80 years shows that taking ashwagandha root extract (KSM-66, Ixoreal Biomed) 600 mg daily for 12 weeks improves overall well-being, sleep quality, and mental alertness by small to moderate amounts when compared with placebo (102684).
Androgenic alopecia. It is unclear if topical ashwagandha is beneficial for androgenic alopecia. Details: A small clinical study in adults with mild to moderate hair loss, including androgenic alopecia, shows that applying ashwagandha root extract serum (KSM-66, Ixoreal Biomed) 1-2 drops to the scalp daily for 75 days reduces hair shedding and increases hair density, growth, and thickness when compared with placebo (113613).
Antipsychotic-induced metabolic side effects. It is unclear if ashwagandha is beneficial for attenuating the metabolic side effects of antipsychotic agents. Details: One preliminary clinical trial shows that taking a specific ashwagandha extract (Cap Strelaxin, M/s Pharmanza Herbal Pvt. Ltd.) 400 mg three times daily for one month reduces serum triglycerides by 12% and fasting blood glucose by 15% when compared with baseline levels. Patients were taking atypical antipsychotics and had modestly elevated triglycerides and fasting blood glucose levels at baseline (90649). The validity of these findings is limited by the lack of a comparator group.
Asthma. Although there has been interest in using oral ashwagandha for asthma, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
Athletic performance. It is unclear if ashwagandha is beneficial for improving athletic performance. Details: A meta-analysis of four small clinical trials shows that taking ashwagandha increases aerobic capacity in athletes and non-athletes based on the measurement of maximum oxygen consumption. Effective doses ranged from 500-1000 mg daily for up to 12 weeks (102683). Another meta-analysis shows that taking ashwagandha in doses of 120-1250 mg daily, as a single dose or divided twice daily, for up to 6 months seems to improve muscle strength, speed, time to exhaustion, recovery time, and cardiorespiratory fitness in athletes and non-athletes (105824). However, the validity of this analysis is reduced by the lack of a control group, the varied training levels of the subjects, and the wide range of outcomes assessed. A moderate-sized clinical trial in active adults shows that taking a specific ashwagandha root extract (KSM-66, Ixoreal Biomed) 300 mg orally twice daily, in addition to resistance training, for 8 weeks improves the maximum rate of oxygen consumption (VO2 max) as a measure of cardiorespiratory endurance, but not muscle strength when compared with placebo (114788). More research is needed to determine whether taking ashwagandha can improve athletic performance.
Attention deficit-hyperactivity disorder (ADHD). Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In a preliminary clinical trial, children with ADHD were given a combination herbal extract formula (Nurture & Clarity), containing ashwagandha, white peony root, gotu kola, blue-green algae, bacopa, and sage, 3 mL three times daily for 4 months. Measures of attention, cognition, and impulse control improved significantly in children receiving ashwagandha when compared with placebo (19272). The dose of ashwagandha in the combination product was not reported, and the effect of ashwagandha alone in ADHD is unclear. Back pain.Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in adults with back pain shows that taking a specific combination product (Berelief, Monteloeder S.L.) containing ashwagandha 66%, rosemary, and sesame seed, 200-400 mg orally daily for 12 weeks moderately improves pain scores and reduces the need for adjunct pain medication when compared with placebo (114793). It is unclear if this effect is due to ashwagandha, other ingredients, or the combination.
Bipolar disorder. It is unclear if oral ashwagandha is beneficial for improving cognitive function in adults with bipolar disorder. Details: Clinical research shows that taking ashwagandha extract (Sensoril, Natreon, Inc.) 250 mg daily for 1 week and then 250 mg twice daily for 7 weeks, improves some, but not all, measures of cognition by a small-to-moderate amount when compared with placebo (90653).
Bronchitis. Although there has been interest in using oral ashwagandha for bronchitis, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
Cerebellar ataxia. It is unclear if oral ashwagandha is beneficial for improving balance in patients with cerebellar ataxia. Details: A small, open-label study evaluating ashwagandha 500 mg three times daily in combination with Ayurvedic therapy for one month showed improvement in balance indices in subjects with cerebellar ataxia when compared with baseline (19273). The validity of this finding is limited by the lack of a comparator group. Additionally, it is unclear if this effect is due to ashwagandha, other ingredients, or the combination.
Chemotherapy-related fatigue. Evidence is limited to one small clinical study in patients with breast cancer. Details: In preliminary clinical research in patients with breast cancer, taking ashwagandha powdered root extract 2 grams (Himalaya Drug Co) three times daily through six cycles of chemotherapy decreases chemotherapy-related fatigue when compared with no treatment. Fatigue scores were 16% to 52% higher in the control group when compared to the ashwagandha group (90651).
Chronic obstructive pulmonary disease (COPD). It is unclear if oral ashwagandha is beneficial in patients with COPD. Details: A small clinical study in patients with stable COPD shows that taking ashwagandha root extract 250 mg twice daily for 12 weeks, along with conventional therapy, improves measures of lung function and exercise tolerance, but not quality of life, when compared with conventional therapy alone (109588).
Cognitive function. Although there has been interest in using oral ashwagandha for cognitive function, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
Constipation. Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A very small clinical study in adults with constipation shows that taking a combination product containing ashwagandha root and ambrette fruit extracts 300 mg or 500 mg daily for 14 days improves bowel movement frequency and abdominal, rectal, and stool symptoms when compared with placebo (112114). Additionally, a moderate-sized clinical study in adults with functional constipation shows that using the same combination of ashwagandha and ambrette 300 mg or 500 mg daily for 60 days moderately improves constipation symptom scores and bowel movement scores when compared with placebo (114115). It is unclear if these effects are due to ashwagandha, ambrette, or the combination.
Coronavirus disease 2019 (COVID-19). Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults hospitalized with COVID-19 shows that taking a specific combination product, (Artovid-20, Bioved Pharmaceuticals) containing ashwagandha, ginger, turmeric, and Boswellia, 1,776 mg orally twice daily for 14 days shortens the duration of symptoms by 0.9 days when compared with placebo. Taking the combination product also modestly reduced the severity ratings of some symptoms, such as sore throat and cough, however, these improvements are unlikely to be clinically relevant (109899). Another small clinical study in adults with mild to moderate COVID-19 shows that taking ashwagandha 500 mg and ginger 1000 mg twice daily for 15 days reduces time to recovery by around 6 days and increases the rate of clinical cure 14-fold and 2.6-fold at days 5 and 7, respectively, when compared with a control. However, taking this combination does not appear to improve the proportion of patients with a negative COVID-19 test, viral clearance, serum antibodies, chest findings, or disease progression when compared with control (112094). The validity of these findings is limited by a lack of blinding, and the study may have been inadequately powered to detect a difference between groups. Other clinical research in adults hospitalized with mild to moderate COVID-19 shows that taking a specific combination product (Coroprotect) containing ashwagandha, pomegranate, turmeric, bacopa, licorice, and other ingredients, twice daily for 10 days improved cough, breathlessness, and fatigue symptoms when compared with placebo (114114). It is unclear if any effects are due to ashwagandha, other ingredients, or the combination.
Depression. It is unclear if oral ashwagandha is beneficial for depression. Details: A small clinical study in adults with mild to moderate depression, anxiety, or stress shows that taking a specific ashwagandha root extract standardized to contain 2.5% withanolides (Shagandha, Sabinsa) 500 mg with piperine 5 mg daily for 90 days reduces the severity of depressive symptoms, improves sleep and quality of life, and increases serum serotonin levels when compared with placebo (113609).
Diabetes. It is unclear if oral ashwagandha is beneficial for type 2 diabetes. Details: In patients with type 2 diabetes, preliminary clinical research shows that ashwagandha 3 grams daily for 30 days decreases blood glucose to a degree similar to oral hypoglycemic drugs (19274). However, this study did not compare ashwagandha directly to a group taking oral hypoglycemic drugs.
Fatigue. It is unclear if oral ashwagandha is beneficial for fatigue. Details: A moderate-sized clinical study in adults with overweight or obesity and moderate-to-high levels of fatigue and stress shows that taking ashwagandha root extract (Witholytin, Verdure Sciences Inc.) 200 mg twice daily for 12 weeks reduces self-reported fatigue when compared with placebo (113611).
Fibromyalgia. Although there has been interest in using oral ashwagandha for fibromyalgia, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
Hiccups. Although there has been interest in using oral ashwagandha for hiccups, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
Hypercholesterolemia. It is unclear if ashwagandha is beneficial for hypercholesterolemia. Details: A very small clinical study in subjects with hypercholesterolemia shows that ashwagandha 3 grams daily for 30 days decreases serum cholesterol, triglyceride, low-density lipoprotein (LDL) cholesterol, and very low-density lipoprotein (VLDL) cholesterol levels when compared with baseline (19274). The validity of these findings is limited by the lack of a comparator group.
Hypothyroidism. It is unclear if ashwagandha is beneficial for hypothyroidism. Details: Preliminary clinical research in adults with subclinical hypothyroidism shows that taking a specific ashwagandha root extract (KSM-66, Ixoreal Biomed) 300 mg twice daily for 8 weeks increases triiodothyronine (T3) and thyroxine (T4) levels by 42% and 20%, respectively, and reduces serum TSH levels by 17% from baseline. These changes are significant when compared with placebo (97292). However, the effects of ashwagandha on thyroid hormone levels in patients with overt hypothyroidism, or in patients taking prescription thyroid hormones, is unknown.
Infertility. Although there has been interest in using oral ashwagandha for infertility in females, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
Male infertility. It is unclear if oral ashwagandha is beneficial for male infertility. Details: Preliminary clinical research in males with infertility shows that taking ashwagandha root powder for approximately 3 months modestly improves hormone levels, as well as sperm count and motility, when compared with baseline (19275,90650). The validity of these findings is limited by the lack of a comparator group. One study used a specific ashwagandha root extract (KSM-66 Ashwagandha, Ixoreal Biomed) 225 mg three times daily; another study provided doses of 5 grams daily (19275,90650).
Menopausal symptoms. Oral ashwagandha may be beneficial for menopausal symptoms. Details: A small clinical study in healthy adults in perimenopause shows that taking a specific ashwagandha root extract (KSM-66, Ixoreal Biomed) 300 mg twice daily for 8 weeks improves menopausal symptom severity by 24%, compared with 11% in those receiving placebo. Quality of life and hot flashes also were improved in those taking ashwagandha (106785).
Obsessive-compulsive disorder (OCD). It is unclear if ashwagandha is beneficial for OCD. Details: Preliminary clinical research shows that taking ashwagandha root extract 120 mg after meals for 6 weeks, in conjunction with prescribed selective-serotonin reuptake inhibitors (SSRIs), might reduce OCD symptom severity when compared with prescribed SSRIs alone. The dose was initiated at 30 mg daily and increased by 30 mg every 4 days. Although OCD scores were significantly reduced when compared with placebo, it should be noted that scores were already significantly lower in the placebo group at baseline (95618).
Osteoarthritis. Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with osteoarthritis, taking a specific combination supplement, containing ashwagandha 450 mg, Ayurvedic zinc complex 50 mg, guggul 100 mg, and turmeric 50 mg (Articulin-F) two capsules three times daily for 3 months reduces symptoms of pain and swelling when compared with placebo. However, there were no radiological improvements (19276). It is unclear if this effect is due to ashwagandha, other ingredients, or the combination.
Parkinson disease. Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with Parkinson disease, a small clinical study shows that taking a product containing ashwagandha 14.5 grams, cowhage 4.5 grams, Hyoscyamus reticulantus 0.75 grams, and Sida cordifolia 14.5 grams in lukewarm milk twice daily for 56 days improves symptoms like tremor, stiffness, and cramps when compared with baseline. The therapy followed 28 days of cleansing or eliminative therapy using Ayurvedic remedies (6899). The validity of these findings is limited by the lack of a comparator group. Also, it is unclear if these effects are due to ashwagandha, other ingredients, or the combination. Cowhage contains levodopa, which may contribute to any benefit seen with this combination product.
Psychological well-being. It is unclear if oral ashwagandha is beneficial for improving psychological well-being in college students. Details: A small clinical study in healthy college students shows that taking ashwagandha root extract 350 mg twice daily for 30 days improves perceptions of well-being, including improvements in energy, mental clarity, food cravings, and sleep quality, when compared with placebo. Qualitative analysis also suggests these students had improvements in stress management, but stress scores were not reduced when compared with placebo (109589,109590).
Rheumatoid arthritis (RA). It is unclear if oral ashwagandha is beneficial for improving symptoms of RA. Details: Preliminary clinical research shows that taking ashwagandha powder 5 grams twice daily for 3 weeks, followed by 4 weeks of sidh makardhwaj (a mixture of gold, mercury, and sulfur) 100 mg with honey daily, modestly improves symptoms in about 50% of males and 60% of females with RA when compared with baseline (95620). The lack of a control group limits the validity of this finding. Additionally, the effect of ashwagandha powder alone is unclear. Another small study in adults with RA shows that taking a combination product containing ashwagandha, ginger, black pepper, and colchicum luteum orally twice daily for 4 weeks does not improve RA disease scores when compared with celecoxib 100 mg orally twice daily (114785). However, the interpretation of these results is limited by poor methodology, and the study may have been inadequately powered to detect a difference between groups.
Sexual dysfunction. Small clinical studies suggest that oral ashwagandha root extract may help improve sexual arousal and sexual desire in some females and males with sexual dysfunction. Details: Two, small clinical studies in adult females with sexual dysfunction show that taking ashwagandha root extract (KSM-66, Ixoreal Biomed) 300 mg twice daily with food for 8 weeks in conjunction with or without counseling increases the number of successful sexual encounters and improves orgasms, satisfaction, lubrication, and arousal when compared with placebo or counseling alone (95619,110492). Also, a small clinical study in adult males with low sexual desire shows that taking the same ashwagandha root extract 300 mg twice daily after meals for 8 weeks improves subjective sexual functioning scores, including measures of sexual arousal, sexual desire, sexual behavior, and orgasm, when compared with placebo (109586).
Smoking cessation. Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A moderate-sized clinical study in adults with a history of smoking 5 or more cigarettes daily for at least 3 years shows that taking a specific combination product containing ashwagandha 100 mg, Indian gooseberry, tribulus, bacopa, Albizia lebbeck, licorice, clove, ginger, cowhage, holy basil, and turmeric (Smotect, Smotect India) daily for 3 months reduces the number of cigarettes smoked daily and levels of alveolar carbon monoxide and carboxyhemoglobin but does not improve lung capacity when compared with placebo (112115). It is unclear if these effects are due to ashwagandha, other ingredients, or the combination.
Tuberculosis. Although there has been interest in using oral ashwagandha for tuberculosis, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
Vitiligo. Although there has been interest in using oral ashwagandha for vitiligo, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
Wrinkled skin. It is unclear if topical ashwagandha is beneficial in individuals with wrinkled skin. Details: A small clinical study in healthy adults with photoaged skin shows that applying ashwagandha root extract 8% lotion daily for 60 days improves physician-rated scores for skin wrinkles, hydration, brightness, tone, and pigmentation and improves other measures of skin elasticity and hydration when compared with placebo. However, changes in melanin content did not differ between treatment groups (111538).
Wound healing. Although there has been interest in using topical ashwagandha for healing of skin ulcers and skin sores, there is insufficient reliable information about the clinical effects of ashwagandha for this condition. More evidence is needed to rate ashwagandha for these uses.

HOLY BASIL

Aging. Although there has been interest in using oral holy basil for aging, there is insufficient reliable information about the clinical effects of holy basil for this purpose.
Asthma. Although there has been interest in using oral holy basil for asthma, there is insufficient reliable information about the clinical effects of holy basil for this condition.
Dental plaque. Small clinical studies suggest that topical use of holy basil mouthwash, gel, or toothpaste may modestly reduce the severity of dental plaque. Details: Small clinical studies in patients with mild to moderate dental plaque or gingivitis shows that using 10 mL of a mouthwash containing holy basil leaf extract 4% twice daily for 30 days reduces plaque severity by about 17% to 28% when compared with baseline (91570,103621). In one study, this effect was significant when compared with a placebo mouthwash and similar to a mouthwash containing chlorhexidine 0.12% (91570), whereas the other study did not conduct comparisons between study groups (103621). A small clinical study in patients with chronic gingivitis shows that applying holy basil extract 2% gel as a gingival massage twice daily for 30 days reduces plaque severity when compared with baseline (110030). The validity of this finding is limited by the lack of statistical comparison to the other study groups. Also, a small clinical trial in children 14-15 years of age shows that brushing with toothpaste containing holy basil leaf extract 4% twice daily for 3 weeks reduces plaque severity when compared with placebo, with similar improvements when compared with a fluorinated toothpaste (104183). Holy basil has also been evaluated in combination with other ingredients. A small study shows that rinsing with 10 mL of a solution containing tea tree oil, clove, and holy basil (0.2% to 0.3% of each), for 30 seconds twice daily for 21 days, reduces plaque formation by 64%. This reduction is similar to a 72% reduction seen in the active control group using a mouth rinse containing thymol, eucalyptol, menthol, and methyl salicylate (91446).
Diabetes. Small clinical studies suggest that oral holy basil may modestly improve glycemic control in patients with diabetes. Details: One small clinical trial in adults with type 2 diabetes shows that taking holy basil dried leaf powder 2.5 grams daily for 4 weeks decreases fasting and postprandial blood glucose by 18%, compared with a 7% reduction in those taking placebo (12242). Another small clinical study in patients with type 2 diabetes shows that taking holy basil 250 mg twice daily in combination with glyburide 5 mg daily for 3 months reduces fasting blood glucose by 16%, postprandial blood glucose by 13%, and glycated hemoglobin (HbA1c) levels by 18% when compared with glyburide alone (91571).
Dyspepsia. Although there has been interest in using oral holy basil for dyspepsia, there is insufficient reliable information about the clinical effects of holy basil for this purpose.
Generalized anxiety disorder (GAD). It is unclear if oral holy basil is beneficial in patients with GAD. Details: One small, uncontrolled clinical study in patients with GAD shows that taking holy basil leaf extract 500 mg twice daily following meals for 60 days reduces anxiety and associated symptoms of stress and depression when compared to baseline (19575). The validity of these findings is limited by a lack of control group.
Gingivitis. Small clinical studies suggest that topical use of holy basil mouthwash or toothpaste may modestly improve gingivitis. Details: Small clinical studies in patients with mild to moderate dental plaque or gingivitis shows that using 10 mL of a mouthwash containing holy basil leaf extract 4% twice daily for 30 days reduces gingivitis by about 23% to 40% when compared with baseline (91570,103621). In one study, these effects were significant when compared with placebo mouthwash and similar to those of a mouthwash containing chlorhexidine 0.12% (91570), whereas the other study did not conduct statistical comparisons between study groups (103621). A small clinical trial in children 14-15 years of age shows that brushing with toothpaste containing holy basil leaf extract 4% twice daily for 3 weeks reduces the severity of gingivitis when compared with placebo, with similar improvements when compared with a fluorinated toothpaste (104183). However, a small clinical study in patients with chronic gingivitis shows that applying holy basil leaf extract 2% gel as a gingival massage twice daily for 30 days does not reduce gingivitis severity when compared with baseline (110030). Holy basil has also been evaluated in combination with other ingredients. A small clinical study shows that rinsing with 10 mL of a solution containing tea tree oil, clove, and holy basil (0.2% to 0.3% of each), for 30 seconds twice daily for 21 days, reduces gum inflammation by 76%. This reduction is similar to a 70% reduction seen in the active control group using a mouth rinse containing thymol, eucalyptol, menthol, and methyl salicylate (91446).
Headache. Although there has been interest in using oral holy basil for headache, there is insufficient reliable information about the clinical effects of holy basil for this purpose.
Hepatitis. Although there has been interest in using oral holy basil for hepatitis, there is insufficient reliable information about the clinical effects of holy basil for this condition.
Hypercholesterolemia. Although there has been interest in using oral holy basil for hypercholesterolemia, there is insufficient reliable information about the clinical effects of holy basil for this purpose.
Hypertension. Although there has been interest in using oral holy basil for hypertension, there is insufficient reliable information about the clinical effects of holy basil for this purpose.
Insect repellent. Although there has been interest in using topical holy basil as an insect repellent, there is insufficient reliable information about the clinical effects of holy basil for this purpose.
Insomnia. It is unclear if oral holy basil is beneficial for sleep problems. Details: A moderate-sized clinical study in adults with stress and sleep problems (i.e., unrefreshing sleep or difficulty falling or staying asleep) shows that taking holy basil 125 mg twice daily for 8 weeks does not improve patient-reported or wearable tracker scores related to sleep when compared with placebo (112416). However, the interpretation of these results is limited by self-reported outcomes and use of a non-validated measurement tool for sleep (i.e., Fitbit device).
Obesity. It is unclear if oral holy basil is beneficial in overweight or obese patients. Details: One small clinical study in individuals with overweight or obesity shows that taking holy basil extract 250 mg twice daily for 8 weeks slightly reduces body weight and improves levels of triglycerides or low-density lipoprotein (LDL) cholesterol and certain glycemic indices when compared to baseline, but not when compared with no treatment. Holy basil extract also did not improve liver enzymes when compared to baseline or with no treatment (96944).
Oral submucous fibrosis. It is unclear if topical holy basil paste is beneficial for oral submucous fibrosis. Details: A moderate-sized clinical study in adults with oral submucous fibrosis conducted in India shows that applying a paste containing holy basil extract 250 mg intraorally twice daily for 1 month modestly improves mouth opening scores and patient-reported burning sensation at the 3 month follow up when compared to baseline (112424). However, the validity of these findings is limited by poor methodology and lack of a comparator group.
Respiratory tract infections. Although there has been interest in using oral holy basil for respiratory tract infections, including bronchitis, common cold, influenza, and tuberculosis, there is insufficient reliable information about the clinical effects of holy basil for these conditions.
Stress. It is unclear if oral holy basil is beneficial in patients with stress. Details: One small clinical trial in patients experiencing various symptoms of stress shows that taking a specific holy basil extract (OciBest, Natural Remedies Pvt. Ltd.) 400 mg in the morning and 800 mg at night for 6 weeks decreases self-reported symptoms of stress, including forgetfulness, sexual problems and sleep problems of recent origin, and frequency of exhaustion, when compared with placebo (18107). A moderate-sized clinical study in adults with stress and sleep problems shows that taking holy basil 125 mg twice daily for 8 weeks modestly improves stress scores but does not improve individual symptoms related to stress including anxiety, mood disturbance, physical function, depression, fatigue, or sleep disturbance when compared with placebo (112416). However, the interpretation of these findings is limited by self-reported outcome measures and unclear clinical significance.
Tinea corporis. Although there has been interest in using topical holy basil for tinea corporis, there is insufficient reliable information about the clinical effects of holy basil for this purpose. More evidence is needed to rate holy basil for these uses.

Anxiety. Oral kava seems to improve anxiety when taken for at least 5 weeks. Details: Most clinical research shows that kava extracts 150-400 mg, standardized to 70% kavalactones, daily are superior to placebo for relieving symptoms of non-psychotic anxiety (2094,2095,11372,18315,18316,18317,18320,98980), and are possibly comparable to buspirone 10 mg or low-dose benzodiazepines such as oxazepam 30 mg (18314). However, kava may not be effective for improving subthreshold anxiety. A meta-analysis of 3 small clinical studies in patients with subthreshold anxiety shows that taking kava does not improve anxiety symptoms when compared with placebo (110711). Overall, kava's effects appear to be dose-dependent and duration-dependent. One meta-analysis suggests that taking more than 200 mg kavalactones daily tends to be more beneficial for anxiety than taking less than 200 mg kavalactones daily (98980). Some clinical research also suggests that kava extract must be taken for at least 5 weeks to provide a benefit (2094,15046,18314,98980), while single-dose treatments may not be beneficial for acute anxiety (18319). Most studies have used a specific standardized extract (WS 1490, Dr. Willmar Schwabe Pharmaceuticals) 150-300 mg daily. Another specific kava extract (LI 150, Lichtwer Pharma) 400 mg daily has also been used (18314,98980). Clinical practice guidelines from a joint taskforce of the World Federation of Societies of Biological Psychiatry (WFSBP) and the Canadian Network for Mood and Anxiety Treatments (CANMAT) conclude that there is evidence supporting the use of kava for acute or short-term management of general anxiety symptoms but that only products standardized to a sufficient level of kavalactones should be recommended (110318).

POSSIBLY INEFFECTIVE

Generalized anxiety disorder (GAD). Oral kava doesn't seem to be effective for treating GAD. Details: A meta-analysis of 3 small, low-quality clinical studies in adults with GAD shows that kava extract standardized to 70% kavalactones, providing 140-280 mg kavalactones daily, is no more effective than placebo when used for 4-8 weeks (15130). Additionally, a more recent meta-analysis of 3 moderate-sized clinical trials in patients diagnosed with GAD shows that taking kava does not reduce anxiety when compared with placebo or conventional therapy (110711). While a small clinical trial in adults with GAD shows that taking kava rootstock extract, standardized to provide 120-240 mg of kavalactones daily, for 6 weeks reduces clinician rated anxiety scores when compared with placebo (29663), a large, multi-center clinical trial from the same research group shows that taking kava root extract standardized to 120 mg of kavalactones twice daily for 16 weeks does not reduce anxiety scores when compared with placebo in adults diagnosed with GAD (102086). Clinical practice guidelines from a joint taskforce of the World Federation of Societies of Biological Psychiatry (WFSBP) and the Canadian Network for Mood and Anxiety Treatments (CANMAT) recommends against the use of kava rootstock extracts (standardized to 60-250 mg kavalactones) as either monotherapy or adjunctive therapy in patients with GAD (110318). This recommendation against kava for GAD is based on high quality evidence from a meta-analysis and two additional clinical trials, along with a meta-review of two meta-analyses on the use of kava for GAD (110318,112133).

Benzodiazepine withdrawal. It is unclear if oral kava is beneficial for reducing benzodiazepine withdrawal symptoms. Details: One small clinical study in patients with non-psychotic anxiety shows that titrating a specific kava extract (WS1490, Dr. Willmar Schwabe Pharmaceuticals) up to 300 mg daily over one week while tapering the benzodiazepine over 2 weeks is no more effective than placebo for decreasing benzodiazepine withdrawal symptoms (7325).
Cancer. It is unclear if oral kava is beneficial in patients with cancer. Details: Epidemiological evidence has found that increasing kava consumption is associated with a lower incidence of cancer (8175).
Epilepsy. Although there is interest in using oral kava for epilepsy, there is insufficient reliable information about the clinical effects of kava for this condition.
Insomnia. It is unclear if oral kava is beneficial in patients with insomnia. Details: One small clinical study shows that taking a specific kava extract (WS1490, Dr. Willmar Schwabe Pharmaceuticals) 200 mg standardized to 70% kavalactones daily for 4 weeks reduces sleep disturbances associated with non-psychotic anxiety disorders (18321). However, another internet-based clinical trial in patients with self-reported insomnia associated with anxiety suggests that taking kava in a dose equivalent to 100 mg kavalactones three times daily for 4 weeks does not improve sleep when compared with placebo (15046).
Menopausal symptoms. It is unclear if oral kava is beneficial for menopausal symptoms. Details: One small clinical study shows that taking kava 100-200 mg standardized to contain 55% kavaina daily for 3 months reduces depression, anxiety, and hot flashes when compared to baseline in perimenopausal patients. However, the changes in depression and hot flashes were not better when compared with the control group that took calcium (18318).
Myalgia. Although there is interest in using oral kava for myalgia, there is insufficient reliable information about the clinical effects of kava for this condition.
Premenstrual syndrome (PMS). Although there is interest in using oral kava for PMS, there is insufficient reliable information about the clinical effects of kava for this condition.
Sexual arousal. Although there is interest in using oral kava for sexual arousal, there is insufficient reliable information about the clinical effects of kava for this condition.
Stress. It is unclear if oral kava reduces reactivity to experimental stress. Details: A small study in healthy volunteers shows that taking a single dose of kava (LI 150, Lichtwer Pharma) 120 mg orally might reduce the physiological changes associated with mentally stressful tasks when compared to baseline (9893). More evidence is needed to rate kava for these uses.

KUDZU

Alcohol use disorder. Oral kudzu seems to be beneficial for reducing alcohol consumption in heavy drinkers; however, it may not be beneficial in those with chronic alcohol use disorder. Details: Some research shows that heavy drinkers who take a specific kudzu root extract (Alkontrol-Herbal; NPI-031; Natural Pharmacia International, Inc.) 0.5-1 grams three times daily for 1-4 weeks consume less beer when given an opportunity to drink and may have more abstinent days (13085,92257). Other research shows that binge drinkers who take kudzu extract 2 grams as a single dose 2.5 hours prior to a 90-minute binge drinking episode consume 37% fewer beers than those taking placebo (92258). However, kudzu does not seem to decrease the craving for alcohol (10386,13085,57948,92257). Kudzu extract also does not seem to improve sobriety in people with chronic alcohol use disorder (10386).

Allergic rhinitis (hay fever). Although there is interest in using oral kudzu for allergic rhinitis, there is insufficient reliable information about the clinical effects of kudzu for this condition.
Angina. Although there is interest in using the injectable kudzu constituent puerarin for angina, there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
Angioplasty. Although there is interest in using the injectable kudzu constituent puerarin in patients undergoing percutaneous transluminal coronary angioplasty (PTCA), there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
Athletic performance. Oral kudzu has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in healthy males shows that taking capsules containing kudzu isoflavone extract 180 mg, soybean peptides 600 mg, taurine 200 mg, and ginseng saponins 120 mg daily in two divided doses for 15 days can significantly increase time to exhaustion during exercise when compared with placebo (57945).
Back pain. Although there is interest in using the injectable kudzu constituent puerarin for back pain, there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
Cluster headache. Although there is interest in using oral kudzu for cluster headache, there is insufficient reliable information about the clinical effects of kudzu for this condition.
Coronary heart disease (CHD). Although there is interest in using the injectable kudzu constituent puerarin for CHD, there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
Diabetes. It is unclear if oral kudzu is beneficial for diabetes. Details: Preliminary clinical research in adults with type 2 diabetes shows that taking oral puerarin, a kudzu constituent, 250 mg three times daily in addition to rosiglitazone 4 mg daily for 12 weeks reduces blood glucose levels and glycated hemoglobin (HbA1c) when compared to baseline (57951). The effect of kudzu alone is unclear. Additionally, the lack of a comparator group limits the validity of this finding.
Diabetic nephropathy. It is unclear if oral kudzu is beneficial for diabetic nephropathy. Details: Preliminary clinical research in patients with diabetic nephropathy shows that taking puerarin, a kudzu constituent, 250 mg three times daily in addition to rosiglitazone 4 mg daily for 12 weeks improves laboratory measurements of kidney function, including serum creatinine, blood urea nitrogen, and urinary albumin, when compared to baseline (57951). The effect of kudzu alone is unclear. Additionally, the lack of a comparator group limits the validity of this finding.
Hangover. Although there is interest in using oral kudzu for hangover, there is insufficient reliable information about the clinical effects of kudzu for this condition.
Heart failure. Although there is interest in using the kudzu constituent puerarin for heart failure, there is insufficient reliable information about the clinical effects of kudzu for this condition.
Hypertension. It is unclear if oral kudzu is beneficial for hypertension. Details: Preliminary clinical research in adults with hypertension shows that taking kudzu powder 1.5 grams twice daily for 12 weeks decreases systolic blood pressure by 16% and diastolic blood pressure by 12% when compared to baseline (92261). The validity of this finding is limited by the lack of a comparator group.
Menopausal symptoms. Small clinical studies suggest that oral kudzu may modestly improve menopausal symptoms. Details: Preliminary clinical research shows that taking kudzu 25 mg, 50 mg, or 100 mg daily for 6 months during perimenopause improves climacteric symptoms based on a modified Green climacteric scale when compared with baseline (57890,57942). Other preliminary clinical research in patients with menopausal symptoms shows that taking kudzu extract 0.84-2.52 grams daily for 4 weeks, providing puerarin 113-338 mg daily, modestly reduces overall menopausal symptoms when compared with baseline (108154). The validity of the findings from these studies is limited by the lack of a comparator group. Other clinical research shows that taking kudzu 50 mg daily for 6 months during perimenopause reduces vasomotor symptoms similarly to taking conjugated equine estrogen 0.625 mg with or without medroxyprogesterone acetate 2.5 mg daily (57927).
Migraine headache. It is unclear if oral kudzu is beneficial for migraine headache. Details: Preliminary clinical research in adults with migraine shows that taking one capsule of kudzu (Kuzik) daily, providing an unspecified dose of kudzu, for 90 days reduces the number of headache attacks per month by about 3, with approximately 50% of patients achieving a 50% reduction in monthly headache days when compared with baseline. There were also modest improvements in disability and medication use (108155). The validity of these findings is limited by the lack of a comparator group.
Myocardial infarction (MI). Although there is interest in using the injectable kudzu constituent puerarin for MI, there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
Obesity. It is unclear if oral kudzu is beneficial for obesity. Details: Preliminary clinical research in adults with obesity shows that taking a kudzu extract 300 mg daily for 12 weeks reduces visceral fat and body mass index (BMI) when compared with placebo. However, doses of 200 mg do not seem to be as effective (57954).
Postmenopausal conditions. It is unclear if oral or intravaginal kudzu is beneficial for postmenopausal conditions. Details: A small clinical study in postmenopausal individuals shows that taking kudzu containing isoflavones 100 mg orally once daily for 3 months improves flexible thinking and attention when compared with control. However, it does not appear to improve total cholesterol, low-density lipoprotein (LDL) cholesterol, or sex hormone levels (11386). Another small clinical study in postmenopausal individuals shows that taking kudzu 20 mg, 30 mg, or 50 mg daily for 24 weeks improves vaginal dryness and pH when compared with baseline, but not when compared with placebo. It also decreases a specific biomarker of bone turnover, called bone alkaline phosphatase, when compared with placebo (57924,57929). It is unclear if this correlates with improved bone density or with a reduced risk of osteoporosis. Kudzu has also been evaluated as an intravaginal gel. One small clinical study shows that applying 0.5 grams of kudzu 6% gel into the vagina every night for 2 weeks, followed by 3 nights each week for 9 weeks, improves vaginal symptoms of dryness, soreness, irritation, and abnormal discharge similarly to conjugated estrogen cream applied on the same schedule. However, kudzu gel is less effective than conjugated estrogen cream for improving overall vaginal health (96740). Another small clinical study of postmenopausal patients shows that applying 0.5 grams of kudzu 6% gel intravaginally every night for 3 weeks increases vaginal arterial blood flow and restores atrophic vaginal tissue when compared with placebo after 12 weeks (110702). In contrast, a similar study shows that applying 0.5 grams of kudzu 5% gel into the vagina every night for 2 weeks, followed by 3 nights each week for 10 weeks, does not improve vaginal symptoms when compared with placebo gel (105521). However, the study may have been inadequately powered to detect a difference between groups.
Rhinosinusitis. Although there is interest in using oral kudzu for rhinosinusitis, there is insufficient reliable information about the clinical effects of kudzu for this condition.
Stroke. Although there is interest in using the injectable kudzu constituent puerarin for stroke, there is insufficient reliable information about the clinical effects of oral kudzu for this condition. More evidence is needed to rate kudzu for these uses.

LAVENDER

Anxiety. Orally, lavender seems to improve anxiety in some patients. Lavender oil aromatherapy and aromatherapy massage also seem to improve chronic and situational anxiety in some patients. Details: Guidelines from The World Federation of Societies of Biological Psychiatry (WFSBP) and Canadian Network for Mood and Anxiety Treatments (CANMAT) Taskforce state that lavender essential oil at doses of 80-160 mg daily or dried lavender flower at doses of 500-1500 mg twice daily is provisionally recommended for monotherapy or adjunctive use in the treatment of generalized anxiety disorder. Essential oil capsules and standardized dried flower formulations are preferred over tea preparations (110318). Most meta-analyses and clinical trials in patients with subthreshold anxiety, mixed anxiety and depressive disorder, generalized anxiety disorder, and mild to severe anxiety show that taking capsules containing a specific lavender oil ingredient (Silexan, Dr Willmar Schwabe GmbH & Co. KG) 80-160 mg orally daily for 6-10 weeks improves objective and subjective measures of anxiety and increases response rates and complete remission rates when compared with placebo. However, heterogeneity and small sample sizes limit the validity of these findings (58077,58080,58098,95640,97257,103061,103069,112255). Subgroup analysis of a meta-analysis of 5 clinical studies suggests that Silexan is more effective in older adults with higher somatic symptom burden and those with anxiety-related difficulties in concentration and poor memory at baseline (112255). Limited research compares Silexan to the conventional medications paroxetine and lorazepam. One clinical study shows that taking Silexan 80 mg daily for 6 weeks improves anxiety and quality of sleep similarly to low-dose lorazepam 0.5 mg in adults with generalized anxiety disorder (58077). Another clinical study in adults with generalized anxiety disorder shows that taking Silexan 80-160 mg daily for 10 weeks reduces symptom severity similar to paroxetine 20 mg daily (93004). A network meta-analysis suggests that the higher dose of Silexan (160 mg) might be more effective when compared with paroxetine 20 mg or lorazepam 0.5 mg (103069). Limited research has assessed other oral formulations of lavender. A small clinical study in postmenopausal adults with mild to moderate anxiety shows that taking a dried lavender flower powder 500 mg twice daily for 8 weeks reduces anxiety by about 6% when compared with placebo, as measured on the State-Trait Anxiety Inventory Scale (97256). The clinical significance of this improvement is not clear. Meta-analyses of clinical trials in patients with chronic or situational anxiety show that inhalation aromatherapy or aromatherapy massage using lavender oil moderately reduces anxiety when compared with control. Most often, the control group received no intervention although occasionally they received standard or routine care. In some studies, plain water or diluted lemon juice were used as controls. Most treatments with lavender aromatherapy were given as single sessions of 1-30 minutes. However, occasionally multiple sessions were used (101720,103061,109974). Most other individual clinical trials of aromatherapy with lavender, alone or in combination with bergamot, are in agreement with these findings (58103,95637,97258,99713,101722,101724,108752,109854,109981), although some research does not support the use of lavender aromatherapy for anxiety (29504,58053,97258,101724,109853). The poor quality of most of the available research makes it difficult to determine which patients, if any, are most likely to benefit.
Depression. Oral lavender, in the form of tea, tincture, powder, or a specific oil (Silexan), seems to reduce depressive symptoms in some patients. Early research also shows that lavender oil aromatherapy seems to improve symptoms of depression. Details: Guidelines from The World Federation of Societies of Biological Psychiatry (WFSBP) and Canadian Network for Mood and Anxiety Treatments (CANMAT) Taskforce state that lavender essential oil at doses of 80-160 mg daily or dried lavender flower at doses of 500-1500 mg twice daily is weakly recommended for monotherapy or adjunctive use in the treatment of major depressive disorder (110318). Essential oil capsules and standardized dried flower formulations are preferred over tea preparations. A meta-analysis of five clinical trials shows that oral lavender is moderately more beneficial than a control group for reducing symptoms of depression (109860). Most studies included in the analysis were low- to moderate-quality with variation in patient demographics. Studies in the analysis investigated the effects of oral lavender oil or powder in menopausal or postpartum patients, or in patients with major depression, and compared lavender with routine care, placebo, medication, or no intervention. Doses have included powdered lavender leaves 1-2 grams daily for 8 weeks, lavender tea made from 2 grams powder per teabag once or twice daily for 2 weeks, and a specific oral capsule containing lavender oil (Silexan, Dr. Willmar Schwabe GmbH & Co. KG) 80 mg daily for 70 days (103060,104433,109860). Other preliminary clinical research in patients with depressed mood shows that taking Silexan 80 mg daily for 6 weeks can improve depression scores by about 33% when compared to baseline (58098). Also, a small clinical study in patients with mild to moderate depression shows that drinking a tincture of lavender appears to be slightly less effective than imipramine; however, lavender might have some additive antidepressant effects when used in combination with imipramine (9792). The validity of these findings is limited by the lack of a placebo group and small study size. Lavender has also been taken in combination with other products. A small clinical study in patients with depression and anxious distress shows that taking 5 mL of a syrup containing lavender flower extract and Chinese dodder extract twice daily for 6 weeks seems to reduce depression to a similar degree as citalopram 20 mg daily (104437). It is unclear if the benefit is due to lavender, Chinese dodder, or the combination. Lavender oil aromatherapy has also been evaluated. A meta-analysis of nine clinical trials shows that lavender oil aromatherapy is moderately more beneficial than control for reducing symptoms of depression. Most studies included in the analysis were low- to moderate-quality with variation in patient demographics. Studies in the analysis investigated the effects of lavender oil aromatherapy in a variety of patient populations, and no studies were specific to patients with depression. Lavender aromatherapy was compared with no intervention, routine care, other aromatherapy oils, or distilled water (109860). However, in hospitalized patients undergoing microvascular breast reconstruction, lavender oil aromatherapy does not improve symptoms of perioperative depression when compared with coconut oil (109853). Lavender oil has also been studied in combination with other oils as aromatherapy. A small clinical study in community-dwelling older adults shows that inhalation or massage with lavender, sweet orange, and bergamot oils twice weekly for 8 weeks improves depressive symptoms in 55% to 65% of patients when compared with a control (98474). Another small clinical study in postmenopausal adults shows that a combination of aromatherapy with lavender and bergamot oils three times daily for 8 weeks along with routine care modestly improves symptoms of depression when compared with routine care alone (109981). It is unclear if any benefit is due to lavender, other ingredients, or the combination.
Dysmenorrhea. Limited clinical research suggests that lavender oil aromatherapy might reduce dysmenorrhea symptoms. Details: A clinical study in young adults with dysmenorrhea shows that applying 3 drops of lavender oil to a piece of cotton and inhaling for 30 minutes daily for the first 3 days of menstruation modestly reduces pain when compared to inhaling the scent of diluted milk (95635). Another small clinical study in patients with dysmenorrhea shows that applying 3 drops of lavender oil to the hands and inhaling for 5 minutes every 6 hours for the first 3 days of menstruation seems to reduce abdominal pain and backache when compared with inhaling the scent of sesame oil (90510). Lavender oil has also been added to abdominal massage. A clinical crossover study in young females with dysmenorrhea shows that administering a gentle abdominal massage with lavender essential oil for 15 minutes moderately reduces pain immediately after treatment when compared with a massage with petrolatum (58106). It is unclear if the benefit persists after the end of the treatment. Additionally, because all available research has been conducted in the Middle East, it is unclear if these results can be extrapolated to other geographic locations.

POSSIBLY INEFFECTIVE

Cancer-related pain. Using lavender oil for massage or as an aromatherapy diffusion does not seem to provide any additional pain relief in patients with advanced or terminal cancer. Details: Clinical research in patients with advanced or terminal cancer shows that diffusing lavender oil as aromatherapy or using lavender oil for massage does not improve pain scores when compared with control treatments without lavender oil (29504,58053).

Alopecia areata. Topical lavender oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with alopecia areata shows that applying lavender oil in combination with essential oils from thyme, rosemary, and cedarwood daily for 7 months seems to improve hair growth in 44% of participants when compared with 15% of those using only carrier oils (5177). It is unclear if this effect is due to lavender oil, other oils, or the combination.
Atopic dermatitis (eczema). Although there is interest in using topical lavender oil for eczema, there is insufficient reliable information about the clinical effects of lavender oil for this condition.
Burns. It is unclear whether lavender oil aromatherapy is beneficial as adjunct treatment for reducing pain associated with dressing changes in children with burns. Details: Preliminary clinical research in young children with second-degree burns shows that lavender oil aromatherapy, provided as 0.5 mL dripped onto a gauze pad and placed 20 cm away from the child's nose for 15 minutes before a dressing change, modestly reduces pain severity at 1 and 30 minutes after the dressing change when compared with placebo aromatherapy with jojoba oil. Use of lavender oil aromatherapy also attenuated increases in heart and respiratory rates after the dressing change (109857).
Canker sores. Topical lavender oil might improve canker sore healing and reduce swelling and pain. Details: A clinical study shows that applying 2 drops of lavender oil to canker sores three times daily might reduce redness, swelling, and pain when compared with placebo (58099).
Colic. Two clinical studies suggest that lavender oil, applied topically during massage of the belly or inhaled as aromatherapy, might modestly reduce duration of crying in infants with colic. Details: A small clinical trial shows that using lavender oil diluted with almond oil to massage the belly of infants for 5-15 minutes beginning at the onset of colic reduces average weekly crying times by about 7 hours when compared with infants not receiving aromatherapy massages (58096). It is unclear if this effect is due to lavender oil, massage, or the combination. Another moderate-sized clinical study in infants 4-8 weeks old with colic shows that inhaling lavender oil as aromatherapy for 4-6 hours daily for 7 days reduces the duration of night crying when compared with placebo (112260).
Coronary artery bypass graft (CABG) surgery. Small clinical studies suggest that lavender aromatherapy might modestly improve sleep and reduce pain in patients who have undergone CABG surgery. Details: One small clinical study shows that placing three drops of lavender oil (Barich Essence Company) on the pillow every night for 5 nights modestly improves sleep quality, but not sleep latency, duration, or efficiency, when compared with placebo (109861). Another small clinical study shows that placing 2 drops of lavender oil on a cotton ball for overnight aromatherapy starting on the second evening after surgery modestly improves sleep quality on the second and third nights of use, but not the first night, when compared with distilled water (109856). Also, a small clinical study shows that applying 5 drops of lavender oil 20% to a gauze which is worn around the neck for 30 minutes after CABG surgery modestly reduces postoperative pain on the day of surgery and the day after surgery when compared with pre-aromatherapy pain levels. These changes were greater than those seen in patients inhaling distilled water (109850). However, one small clinical study shows that inhaling 2 drops of lavender oil 2% for 20 minutes on postoperative days 2 and 3 does not reduce mental stress when compared with placebo (93009).
Coronavirus disease 2019 (COVID-19). It is unclear if oral lavender is beneficial for olfactory dysfunction in patients with COVID-19. Details: A small preliminary clinical trial in patients with olfactory dysfunction related to COVID-19 shows that taking lavender syrup 9 mL twice daily for 3 weeks in combination with routine treatments modestly reduces symptoms when compared with routine treatments alone. However, there was no change in symptom scores or the percentage of patients with complete improvement in olfactory or taste dysfunction. The lavender syrup was made by preparing a water extract of the dried aerial parts and mixing with honey and water (109864).
Dementia. Small clinical studies suggest that diffused aromatherapy with lavender oil may modestly improve agitation symptoms in patients with dementia; however, lavender oil applied to the patient or the patient's clothes might not be beneficial. Details: Some small and heterogeneous clinical studies in patients with dementia show that applying lavender oil aromatherapy via a diffuser for either 20 minutes twice daily, 2 hours daily, or once nightly for up to 3 weeks seems to improve agitation when compared with baseline, water, or a sunflower oil placebo (16393,58052,95632). However, using aromatherapy that is applied to the person's clothes or arms does not seem to help. Small clinical studies in patients with moderate or advanced dementia show that applying lavender oil to a pad attached to a patient's shirt does not reduce agitation when compared with placebo (12213,99710). Another clinical study in nursing home residents with dementia and frequent agitated behavior shows that applying 1 mL of 30% lavender oil to each forearm does not reduce agitation or improve mood when compared with applying placebo oil (93014).
Diabetic neuropathy. It is unclear if lavender aromatherapy massage is beneficial for diabetic neuropathy. Details: Preliminary clinical research in patients with neuropathic pain related to diabetes shows that a gentle foot massage with lavender essential oil 3% in sunflower oil for 10 minutes nightly for 1 month reduces neuropathic pain and improves quality of life when compared with a placebo sunflower oil massage or routine care alone (109858).
Fall prevention. It is unclear if lavender aromatherapy prevents falls in elderly patients. Details: A clinical study in nursing home residents aged 65 years or older shows that attaching a patch with lavender oil (Aromaseal Lavender, Hakujuji Co.) onto the neckline of clothing once daily for one year seems to have a non-significant trend toward reduced fall incidence when compared with placebo (58101).
Fatigue. Small clinical studies suggest that lavender aromatherapy may modestly reduce fatigue in patients with underlying medical conditions, such as kidney failure or heart disease. The effects of lavender for fatigue in otherwise healthy adults is unclear. Details: Most small clinical studies in adults with kidney failure show that receiving aromatherapy with lavender essential oil during hemodialysis sessions for 4 weeks reduces fatigue when compared with baseline, a control group, or a placebo group (98524,109867). However, one small clinical study in these patients shows that applying lavender oil for inhalation for 10 minutes during dialysis sessions for 4 weeks does not reduce fatigue when compared with control (95642). Lavender aromatherapy has also been tried in patients hospitalized with various forms of cardiac disease. A small clinical trial shows that placing 3 drops of lavender oil on a cotton ball and inhaling for 20 minutes nightly for 7 days improves fatigue scores by 21 points, compared with a 2-point improvement in those receiving placebo (107959). The validity of these findings is limited due to the short duration of treatment.
Hypertension. Although there is interest in using lavender aromatherapy for hypertension, there is insufficient reliable information about the clinical effects of lavender for this condition.
Insect repellent. Although there is interest in using topical lavender to repel insects, there is insufficient reliable information about the clinical effects of lavender for this condition.
Insomnia. Inhalation aromatherapy or aromatherapy massage with lavender oil may improve some subjective measures of sleep, but results are conflicting and improvements appear minimal at best. Additionally, most small clinical studies suggest it does not improve sleep in hospitalized patients. Details: Lavender oil aromatherapy seems to improve sleep quality in some patients, although it is unclear which patient populations may be most likely to be benefit. A clinical study in healthy college students with self-reported sleep problems shows that wearing a patch containing lavender oil 55 mcL on the chest, in addition to practicing sleep hygiene, improves self-reported sleep quality, but not sleep quantity, when compared with wearing a placebo patch (93012). Another small clinical study in elderly patients that have trouble sleeping in nursing homes shows that placing 2 drops of lavender oil to a cotton pad on a nightstand at bedtime for 4 weeks moderately improves sleep quality and reduces fatigue when compared with control (103062). A meta-analysis of three clinical trials shows that lavender modestly improves postpartum sleep quality when compared with control, including placebo or no intervention. However, each trial used a different form of lavender, including a topical cream, a tea, and aromatherapy. Also, the individual trials included in the analysis show that only the cream and aromatherapy resulted in statistically significant improvements in sleep quality (109866). Conversely, a small clinical study in postmenopausal adults with insomnia who received sleep hygiene guidance shows that inhaling lavender oil 6% before bed nightly for 1 month does not improve sleep quality when compared with sunflower oil. The oil was inhaled from the bottle for two, two-minute sessions and then poured on a cotton ball and placed near the head while sleeping (109852). Lavender aromatherapy has also been evaluated for insomnia in patients with comorbid disease states. A clinical study in patients with insomnia and type 2 diabetes shows that lavender oil aromatherapy for 5 minutes at bedtime nightly for 4 weeks improves sleep when compared with almond oil (103065). Preliminary clinical research in adults with kidney failure shows that foot massage with lavender oil 1.5% for 3 weeks during hemodialysis modestly improves sleep quality when compared with routine care, but is no more effective than sweet orange oil (109859). Another preliminary clinical study in cancer patients shows that receiving aromatherapy as two drops of pure lavender oil applied to a cotton ball and attached to the collar for 20 minutes at bedtime for one week improves sleep when compared with baseline, but seems to be no better than using peppermint oil or a lavender oil 1% control (103063). The validity of this finding is limited because the lavender oil 1% control resulted in notable benefit and might have been an inadequate control treatment. Aromatherapy with lavender oil does not seem to improve sleep in most hospitalized patients, including patients in intermediate care units, hospitalized cardiac patients, and in patients undergoing microvascular breast reconstruction. Aromatherapy treatments have included lavender aromatherapy throughout hospitalization, placing 3 mL of lavender oil 3 feet away from the bed during sleep, and hand and lower leg massage with lavender essential oil 1.5% in sweet almond oil at bedtime (93013,101727,109853). However, studies have generally been small and did not use proper controls. Also, some small clinical studies suggest that lavender aromatherapy might have modest beneficial effects in patients undergoing coronary artery bypass graft (CABG) surgery (109856,109861).
Kidney failure. Small clinical studies suggest that lavender aromatherapy may modestly reduce fatigue and improve sleep quality in adults receiving hemodialysis. Lavender oil massage may also modestly improve symptoms of restless leg syndrome (RLS) in these patients. Details: Multiple small studies have evaluated lavender aromatherapy, provided during hemodialysis sessions, for reducing fatigue. A small clinical study shows that applying 5% lavender essential oil (Barij Essence Pharmaceutical Company) to a cotton ball on the patient's collar for inhalation for 15-20 minutes twice daily during each session for 1 month reduces fatigue by an additional 44% and 40% when compared with baseline and control, respectively (98524). Another preliminary clinical trial shows that applying lavender oil 7% in sweet almond oil to a gauze pad placed 20 cm from the patient's nose for 2 minutes improves fatigue when compared with placebo aromatherapy. By the third week of four total weeks of treatment, most patients given lavender oil aromatherapy had only mild fatigue, compared with moderate or severe fatigue in the control group (109867). Also, a small clinical trial shows that aromatherapy or aromatherapy foot massage with lavender and sweet orange oil for 10-20 minutes during each session for 2 months reduces fatigue when compared with no treatment. Aromatherapy massage seems to be more effective than aromatherapy alone (103068). However, one small clinical study shows that applying the oil for inhalation for 10 minutes during each session for 1 month does not reduce fatigue when compared with control (95642). The difference in these findings might be due to study size, lavender oil concentration, or the frequency and duration of aromatherapy sessions. Lavender aromatherapy has also been evaluated for reducing insomnia in adults on hemodialysis. A small clinical study shows that foot massage with lavender oil 1.5% for 3 weeks during hemodialysis sessions modestly improves sleep quality when compared with routine care. However, it does not seem to be more effective than using sweet orange oil (109859). Some small clinical studies in patients undergoing hemodialysis show that massaging the feet or lower legs with lavender oil reduces the severity of RLS by up to 45% when compared with routine care, massage only, or baby oil as placebo (95638,103064,109865). However, massage with lavender oil does not seem to be more beneficial than glycerin oil 2% or sweet orange oil 1.5% for reducing RLS severity (103064,109859). Doses have included 10-15 mL of 1.5% or 5% lavender oil for 10- to 45-minutes during hemodialysis sessions for 3-4 weeks (95638,103064,109859,109865).
Labor pain. Lavender aromatherapy may help to reduce pain during childbirth. Details: A meta-analysis of clinical trials in pregnant patients in Iran shows that lavender oil aromatherapy applied by various means, such as mask or massage, reduces labor pain when compared with control (104440). All available research has been conducted in Iran, so it is unclear if the benefit can be extrapolated to other geographic locations.
Lice. Topical lavender oil has only been evaluated in combination with other essential oils; its effect when used alone is unclear. Details: Clinical studies in patients with head lice shows that applying lavender oil in combination with tea tree oil reduces the number of hatched and unhatched live lice when compared with control (19188,19189). When applied with tea tree oil three times weekly, lavender oils seems to improve lice eradication when compared with two weekly treatments of pyrethrin and piperonyl butoxide (19189). It is not known if these effects are due to tea tree oil, lavender, or the combination.
Menopausal symptoms. It is unclear if lavender aromatherapy reduces menopausal symptoms such as hot flushes. Details: A meta-analysis and individual clinical studies in postmenopausal adults show that lavender aromatherapy for 4-12 weeks, alone or in combination with other essential oils, reduces menopausal symptoms such as hot flushes when compared with placebo (95634,99711,103067). However, heterogeneity and small sample sizes limit the validity of these findings. A small clinical study in postmenopausal adults shows that aromatherapy with lavender 2% oil for 20 minutes at bedtime every day for 1 month improves quality of life scores when compared to baseline (99711). Another small clinical study in menopausal adults shows that receiving aromatherapy with lavender oil and lemon oil for 5 minutes daily for 30 days seems to improve sleep and quality of life when compared with placebo (104439). However, a small clinical study in postmenopausal adults shows that a combination of lavender and bergamot oils administered via inhalation three times daily for 8 weeks with routine care does not improve sexual function when compared with routine care alone (109981).
Migraine headache. It is unclear if lavender aromatherapy improves migraine symptoms. Details: A small clinical study in patients with migraine headaches shows that rubbing 2-3 drops of lavender oil on the upper lip for inhalation might reduce headache pain and associated symptoms such as nausea and photophobia. Of 129 headaches treated with lavender oil, 92 responded completely or partially, compared with 32 of 68 headaches in the placebo group (18209).
Multiple sclerosis (MS). It is unclear if lavender aromatherapy can improve memory in patients with MS. Details: A small preliminary clinical trial in patients with MS shows that dripping 2 drops of lavender oil (Barij Essence Pharmaceutical Company) on a cotton ball for inhalation for 10 minutes twice daily for 2 weeks improves working memory by a small amount when compared with inhaling distilled water (109855).
Multiple sclerosis-related fatigue. It is unclear if oral lavender is beneficial for reducing fatigue in adults with multiple sclerosis (MS). Details: A small clinical trial in patients with MS shows that taking lavender 600 mg three times daily for 60 days improves fatigue by a large amount when compared with placebo (109851).
Neuropathic pain. Although there is interest in using topical lavender oil for neuropathic pain, there is insufficient reliable information about the clinical effects of lavender for this condition.
Osteoarthritis. It is unclear if lavender aromatherapy with massage reduces osteoarthritis pain. Details: A small clinical study in patients with osteoarthritis shows that applying 5 mL of 3% lavender oil (Barij Essence Pharmaceutical Company) to the knee through self-administered massage three times weekly for 3 weeks can reduce pain by 23% when compared to massage with placebo oil and by 36% when compared with no treatment. However, any benefits of treatment begin to wear off after treatment completion (95645).
Otitis media. Topical lavender oil has only been evaluated in combination with other essential oils; its effect when used alone is unclear. Details: A clinical study in children ages 5-18 years with otitis media and otalgia shows that administering ear drops containing lavender and other herbal extracts, alone or in combination with a topical anesthetic, improves ear pain when compared with baseline. However, it is possible that the pain is self-limited and any pain reduction is due to natural resolution (39500).
Pain (acute). Small clinical studies suggest that lavender aromatherapy may modestly reduce acute pain from needle insertion or other procedures in infants and adults. Details: Lavender has been evaluated for treating acute pain in infants and adults prior to a variety of procedures. Two small clinical studies in patients having a needle inserted for hemodialysis shows that inhaling 10% lavender essence for 5 minutes or topically applying 0.3 mL of 100% lavender oil for 5 minutes prior to needle insertion modestly reduces pain when compared with using placebo oil or water (93008,93010). A moderate-sized clinical study in adults with diabetes on insulin shows that topical lavender aromatherapy (Talya, Talya Herbal LLC) sprayed 3 times on the arm five minutes before insulin injection reduces injection-site pain when compared with placebo (112254). Lavender aromatherapy has also been used for gynecological exam pain. A clinical study shows that inhaling 10% lavender oil from a heat lamp for 10-15 minutes prior to gynecological exams reduces pain experienced during the exam up to three-fold when compared with no treatment (95639). However, not all research shows that lavender reduces acute pain. A moderate-sized clinical study in adults undergoing extracorporeal shockwave lithotripsy (ESWL) to treat kidney stones shows that inhaling 4 drops of diffused lavender oil does not reduce pain or the use of self-administered opioids when compared with standard control opioid analgesia. These results were unchanged when lavender aromatherapy was combined with music (112258). The validity of these effects is limited by a lack of blinding. Additionally, the kidney stones in the groups studied were different sizes at baseline. Lavender oil aromatherapy may also reduce pain in infants undergoing various medical procedures. One clinical study shows that aromatherapy with lavender oil (Barij Essence Pharmaceutical Company) 0.5% for one minute before vaccination modestly reduces pain and decreases crying time by about 20 seconds when compared with sweet almond oil (109869). Another small clinical study in term infants shows that being placed in an incubator with lavender essential oil scent overnight before receiving a blood draw modestly reduces overall pain scores when compared with no intervention, but seems to be no different than giving 2 mL of 30% glucose solution (103066). Another small clinical study in premature infants shows that inhaling the scent of 6 lavender oil drops on a cotton ball for 3 minutes before and 30 seconds after a heel-lancing procedure seems to reduce pain scores when compared with exposure to an unscented cotton ball (104442). Lavender oil aromatherapy may also reduce pain due to frenotomy in infants. Preliminary clinical research shows that applying a gauze pad containing one drop of lavender oil under the nose, starting 2 minutes before the frenotomy and continuing throughout the procedure, modestly reduces pain when compared with routine care, which includes swaddling, oral sucrose, and pre-frenotomy sucking. Post-frenotomy crying was also reduced by about 50%, or 10 seconds (109868). Lavender oil seems to be similarly effective to vanilla oil (109810).
Perioperative anxiety. It is unclear if lavender aromatherapy is beneficial for perioperative anxiety. Details: A moderate-sized clinical study in adults with kidney stones undergoing extracorporeal shockwave lithotripsy (ESWL) shows that inhaling 4 drops of diffused lavender oil does not reduce anxiety when compared with standard control opioid analgesia. These results were unchanged when lavender aromatherapy was combined with music (112258). The validity of these effects is limited by a lack of blinding. Additionally, the kidney stones in the groups studied were different sizes at baseline. Another large clinical study in adults shows that inhaling lavender 2% before, during, and after dental procedures reduces dental pain intensity and perioperative dental anxiety when compared with control. Inhaled lavender seems to have the greatest effect on perioperative anxiety when used in the waiting room (112250).
Postdural puncture headache. It is unclear if lavender aromatherapy improves postdural puncture headache severity. Details: A small clinical study in patients with postdural puncture headache shows that receiving lavender oil aromatherapy for 15 minutes modestly improves pain immediately after treatment when compared with placebo. However, the pain relief is not maintained at 30 minutes after treatment (104441).
Postoperative nausea and vomiting (PONV). It is unclear if lavender aromatherapy reduces PONV. Details: A small clinical study in postoperative patients shows that inhaling the scent of 2 drops of lavender oil from a cotton pad for 5 minutes improves nausea scores in 83% of people, compared with 44% of those inhaling a placebo. There was no difference in vomiting scores between groups (99712). Another small clinical study in patients after percutaneous nephrolithotomy shows that inhaling the scent of 3 drops of lavender essential oil from a gauze for 5 minutes immediately after the operation, and again 3 and 6 hours later, does not improve nausea or vomiting when compared with a control group that was not receiving aromatherapy (103872).
Postoperative pain. The evidence for the use of lavender aromatherapy for pain after various types of surgical procedures is preliminary and conflicting. Details: Some preliminary clinical research in patients post-Cesarean section shows that, when used in conjunction with standard analgesic therapy, applying 2 drops of lavender oil 2% to a face mask or applying 3 drops of lavender to a cotton ball for inhalation seems to reduce postoperative pain when compared with control (58093,101724). Additionally, preliminary clinical research in patients undergoing coronary artery bypass graft (CABG) surgery shows that applying lavender oil to a gauze which is worn around the neck may modestly reduce postoperative pain on the day of surgery and the day after surgery when compared with distilled water (109850). Also, a small clinical study in children aged 6-12 years post-tonsillectomy shows that rubbing lavender oil onto the palms and inhaling for 3 minutes every 6 hours as needed reduces the use of acetaminophen when compared with control (90513). However, aromatherapy with lavender throughout hospitalization does not seem to improve postoperative pain in patients undergoing microvascular breast reconstruction when compared with coconut oil (109853).
Postpartum complications. It is unclear if topical or inhaled lavender reduces postpartum complications such as pain and swelling. Details: Some clinical research in patients receiving an episiotomy during childbirth shows that adding lavender oil to water or sitz baths for up to 10 days might reduce episiotomy redness and discomfort when compared with using no lavender and standard treatment, such as povidone-iodine. However, findings are mixed as to whether adding lavender oil to baths helps to reduce edema and analgesic use (58085,58092,58116,58121). Lavender aromatherapy has also been studied to improve wellbeing in postpartum patients. A small clinical study in postpartum patients immediately following a natural birth shows that inhaling lavender oil from a cotton ball for 10-15 minutes in the morning, 6 hours later, and at bedtime, improves perceived pain, fatigue, distress, and mood within 1 hour of treatment and also the next morning when compared with placebo (95631).
Postpartum depression. Small clinical studies suggest that aromatherapy with lavender oil may modestly improve or prevent depressive symptoms in postpartum patients. Details: A clinical study in healthy postpartum patients shows that placing 3 drops of lavender essential oil on the palms three times daily for 4 weeks after delivery moderately reduces depressive symptoms and anxiety when compared with usual care only (95637). There is limited research on the benefits of lavender aromatherapy in patients diagnosed with postpartum depression. A small clinical trial in these patients shows that a combination of lavender and rose essential oils, administered via inhalation or aromatherapy massage using hand "M" technique for 15-minute sessions, twice weekly for 4 weeks, reduces depression scores when compared with no intervention (58103).
Pre-procedural anxiety. It is unclear if lavender aromatherapy can reduce preoperative or preprocedural anxiety; results from clinical research are generally of low-quality and benefits are modest at best. Details: A meta-analysis of four small clinical studies in patients undergoing cardiac surgery shows that lavender aromatherapy modestly reduces preoperative anxiety when compared with control (103058). However, the included studies were conducted in the Middle East, and it is unknown if these results are generalizable to other geographic areas. There is conflicting clinical evidence regarding the effect of lavender aromatherapy on anxiety prior to a dental procedure (58078,101725,103059). Small clinical studies also show mixed results as to whether lavender oil aromatherapy applied to a gauze bandage or oxygen mask improves anxiety in patients waiting for breast surgery when compared with usual care. (95641,101729). Lavender aromatherapy might reduce anxiety prior to less risky and extensive procedures such as needle injections. Small clinical studies in adults receiving botulinum toxin type A injections or children receiving dental injections show that lavender oil aromatherapy reduces heart rate and cortisol levels when compared with placebo (58089,104438). Another clinical study in preoperative patients undergoing insertion of a peripheral venous cannula shows that inhalation of 1% lavender oil (Talya Herbal Products) from a gauze pad for 5 minutes modestly reduces pain and anxiety scores and improves patient satisfaction when compared with control (95636). However, a clinical study in patients undergoing a colonoscopy or esophagogastroduodenoscopy shows that inhaling lavender oil does not reduce anxiety, although it does improve patient satisfaction, when compared with placebo (58066). Reasons for conflicting findings are unclear but may relate to the severity of anxiety, the specific outcomes measured, and cultural differences occurring in different geographic locations.
Psychological well-being. It is unclear if topical or inhaled lavender improves well-being. Details: A small clinical study in healthy females shows that adding 3 mL of a mixture containing 20% lavender oil and 80% grapeseed oil to daily baths modestly improves mood when compared with baths containing grapeseed oil alone (15534). However, lavender may not impact well-being in patients with cancer. Clinical research shows that that adding lavender oil for an aromatherapy massage in patients with advanced or terminal cancer does not improve well-being or quality of life when compared with no massage treatment or massage with inert oil (29504,58053).
Restless legs syndrome (RLS). Most preliminary clinical research suggests that lavender oil aromatherapy massage is beneficial for RLS in patients undergoing hemodialysis. Its effect in other patient populations is unclear. Details: Some small clinical studies in patients undergoing hemodialysis show that massaging the feet or lower legs with lavender oil reduces the severity of RLS by up to 45% when compared with routine care, massage only, or baby oil as placebo (95638,103064,109865). However, massage with lavender oil does not seem to be more beneficial than glycerin oil 2% or sweet orange oil 1.5% for reducing RLS severity (103064,109859). Doses have included 10-15 mL of 1.5% or 5% lavender oil for 10 to 45 minutes during hemodialysis sessions for 3-4 weeks (95638,103064,109859,109865).
Stress. Small studies suggest that inhaled lavender oil does not reduce stress in students under academic stress. Details: A meta-analysis of 21 moderate- to high-quality, small- to medium-sized studies shows that inhaling lavender oil modestly reduces stress when compared with control. Most studies included in the analysis have used lavender oil as aromatherapy; other studies have used a cream (109863). In contrast, inhaling lavender oil 3% in almond oil twice daily for 30 minutes during the exam period does not reduce academic stress or associated symptoms, including headache, blood pressure, or heart rate, in pharmacy students when compared with inhaling an odorless oil, although both were more effective than no intervention (101723). Lavender oil has also been evaluated for reducing stress for healthcare professionals. A small study in hospital nurses with work-related stress shows that inhaling lavender oil as aromatherapy for 2 hours daily for 4 weeks does not reduce job-related stress when compared with placebo or rose oil aromatherapy (112256). However, another small clinical study in healthcare professionals at an outpatient clinic shows that inhaling lavender oil through a diffuser during work shifts reduces work stress and increases job satisfaction when compared with placebo (112251).
Toothache. Although there is interest in using topical lavender oil for toothache, there is insufficient reliable information about the clinical effects of lavender oil for this purpose. More evidence is needed to rate lavender for these uses.

LEMON BALM

Depression. Small clinical trials show that oral lemon balm may improve depression when used short-term; the long-term effects are unclear. It is also unclear if lemon balm aromatherapy is beneficial for depression. Details: A meta-analysis of randomized controlled trials in adults with depression and/or anxiety shows that using lemon balm, usually orally, daily for 3-56 days moderately improves depression scores when compared with control. Lemon balm was used orally as 1200-3000 mg daily or as aromatherapy for 30 minutes daily (110136). Other individual studies also show that oral lemon balm may modestly improve depression. A small clinical study in patients with mild or moderate depression shows that taking lemon balm 600 mg with fertilized egg powder (Young Tissue Extract) 1,680 mg daily for 12 weeks improves symptoms when compared with placebo, but not when compared with taking fertilized egg powder alone (19534). Another small clinical study in adults with mostly mild depression shows that taking lemon balm 2 grams daily for 8 weeks moderately improves depressive symptoms when compared with baseline. The improvement appears to be similar to taking lavender powder 2 grams daily or fluoxetine 20 mg daily (104433). However, this study was inadequately powered to detect differences between groups. A small clinical study in adults with type 2 diabetes and mild to moderate depression conducted in Iran shows that taking lemon balm extract capsules 350 mg twice daily for 12 weeks modestly reduces the severity of depression and anxiety based on validated patient-reported questionnaires when compared with placebo (111741). However, the interpretation of these findings is limited by methodological flaws in outcome analysis.
Herpes labialis (cold sores). Topical lemon balm 1% lotion seems to be beneficial for the healing of recurrent cold sores. Details: Clinical research in patients with recurring cold sores shows that applying a cream containing 1% lemon balm dried leaf extract (LomaHerpan, Infectopharm) at the early stages seems to shorten healing time and reduce symptoms of recurring cold sores when compared with placebo (790,9995).
Stress. Oral lemon balm seems to be beneficial for improving experimentally-induced stress in some patients. Details: A small study in healthy adults suggests that a single dose of lemon balm extract 600 mg increases calmness and alertness during laboratory-induced psychological stress when compared with placebo (19524). Another small study in healthy adults shows that a single dose of lemon balm extract (Bluenesse, Vital Solutions) 300 mg added to food or drink reduces anxiety and improves memory and alertness during multi-task cognitive testing when compared with placebo (91733). Lemon balm has also shown benefit when used in combination with other ingredients for stress. Lemon balm 240 mg has been used in combination with valerian 360 mg (Songha Night, Pharmaton Natural Health Products) (19405). Lemon balm 50 mg has been used in combination with valerian root 90 mg, passion flower 90 mg, and butterbur 90 mg (Relaxane, Max Zeller Sӧhne AG) (97276).

Age-related cognitive decline. It is unclear if oral lemon balm is beneficial for improving cognitive function. Details: Preliminary clinical research in adults with age-related cognitive impairment shows that taking lemon balm leaf extract, standardized to contain 500 mg rosmarinic acid, orally daily for 96 weeks does not improve cognitive function scores when compared with placebo (110142).
Alzheimer disease. It is unclear if oral lemon balm is beneficial for improving cognitive function. Details: A small clinical study in elderly patients with mild to moderate Alzheimer disease shows that taking a leaf extract of lemon balm (standardized to citral 500 mcg/mL) 60 drops daily for 4 months seems to reduce agitation and improve cognitive function when compared with placebo (9993). This study was limited by a large number of drop-outs in the placebo group. An even smaller clinical study in patients with mild Alzheimer disease shows that taking lemon balm extract containing 500 mg rosmarinic acid daily for 24 weeks does not seem to improve cognition, but might modestly improve neuropsychiatric symptoms, when compared with placebo (104435). The validity of these findings is limited because the study was not powered to evaluate cognition and neuropsychiatric symptoms.
Anxiety. It is unclear if oral lemon balm or lemon balm aromatherapy is beneficial for reducing anxiety in most patients. Details: A meta-analysis of randomized controlled trials in adults with depression and/or anxiety shows that using lemon balm daily for 3-56 days moderately improves anxiety scores when compared with control. Lemon balm was used orally as 1200-3000 mg daily or as aromatherapy for 30 minutes daily (110136). The validity of this result is limited by high heterogeneity. Also, a small clinical study in patients with mild or moderate anxiety disorders shows that taking a specific standardized lemon balm extract (Cyracos, Naturex SA) 300 mg twice daily reduces anxiety-associated symptoms and improves sleep when compared with baseline (104425). The validity of this finding is limited by the lack of a comparator group. Another small clinical study in adults with type 2 diabetes and mild to moderate depression conducted in Iran shows that taking lemon balm extract capsules 350 mg twice daily for 12 weeks modestly reduces the severity of depression and anxiety based on validated patient-reported questionnaires when compared with placebo (111741).
Attention deficit-hyperactivity disorder (ADHD). Although there is interest in using oral lemon balm for ADHD, there is insufficient reliable information about the clinical effects of lemon balm for this condition.
Chronic bronchitis. Although there is interest in using oral lemon balm for bronchitis, there is insufficient reliable information about the clinical effects of lemon balm for this condition.
Cognitive function. It is unclear if oral lemon balm is beneficial for improving memory and response time in healthy patients. Details: A small study in healthy young adults shows that taking a single dose of lemon balm 1600 mg increases memory accuracy, but may slow performance on timed memory tasks, when compared with placebo (19530). Another small study shows that taking a combination product containing equal parts lemon balm, sage, and rosemary, 5 grams of plant material per 10 mL solution, twice daily for 2 weeks might modestly improve delayed, but not immediate, word recall when compared with placebo in healthy adults 62 years of age or younger. No benefits were seen in adults 63 years of age and older (97277). It is not clear if this effect is due to lemon balm, the other ingredients, or the combination.
Colic. Oral lemon balm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical studies in breast-fed or formula-fed infants with colic show that giving specific multi-ingredient products containing lemon balm 65-97 mg and German chamomile 9-178 mg, with or without fennel 164 mg and inactivated Lactobacillus acidophilus (ColiMil; ColiMil Plus, Milte Italia SPA), orally twice daily for 1-4 weeks reduces crying times when compared with either placebo or simethicone (16735,96278). Another small clinical study in infants shows that giving 150 mL of a specific herbal tea preparation (Calma-Bebi, Bonomelli), containing German chamomile, vervain, licorice, fennel, and lemon balm, up to three times daily after an episode of colic for one week, modestly reduces colic when compared with placebo water without herbs (19715). It is not known if the benefits of these multi-ingredient preparations are due to lemon balm, other ingredients, or the combination.
Delirium. Oral lemon balm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults in the intensive care unit with agitation and delirium who are receiving quetiapine 50-200 mg every 12 hours shows that taking 5 mL of a syrup containing lemon balm leaf extract 50 mg and valerian root 625 mg orally every 12 hours improves agitation when compared to baseline. Although the improvement appeared to similar to that seen in those taking placebo, no statistical comparison was conducted between groups (106627).
Dementia. It is unclear if oral lemon balm is beneficial for reducing neuropsychiatric symptoms of dementia, such as agitation. Details: A small clinical study in patients with severe dementia and agitation shows that applying a lotion containing essential oil of lemon balm to the faces and hands of patients for 4 weeks reduces agitation based on the Cohen-Mansfield Agitation Inventory (CMAI) scale when compared with applying a placebo lotion (19523). However, another small clinical study in patients with Alzheimer disease and prolonged agitation shows that applying lemon balm oil by gentle massage for 1-2 minutes twice daily for 12 weeks does not reduce agitation when compared with applying placebo oil (19522). The validity of these results is limited by the notable improvement observed in the placebo group, which may have been due to the regular physical touch and increased social interaction that occurred in this group. A small clinical study in patients with dementia shows that inhaling lemon balm oil from a small pad attached to the collar of clothing for 2 hours once daily for 2 weeks does not reduce agitation based on the Neuropsychiatric Inventory (NPI) and CMAI scales when compared with placebo (99710).
Dysmenorrhea. Although there is interest in using oral lemon balm for dysmenorrhea, there is insufficient reliable information about the clinical effects of lemon balm for this condition.
Dyspepsia. Oral lemon balm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of four small clinical studies in patients with IBS shows that using a specific combination product containing lemon balm (Iberogast, Steigerwald Arzneimittelwerk GmbH) 1 mL orally three times daily over a period of 4 weeks reduces severity of acid reflux, epigastric pain, cramping, nausea, and vomiting when compared with placebo. The combination includes lemon balm, peppermint leaf, German chamomile, caraway, licorice, clown's mustard plant, celandine, angelica, and milk thistle (13089). In another clinical study, taking a similar combination product containing extracts from peppermint leaf, clown's mustard plant, German chamomile flower, caraway, licorice root, and lemon balm (STW 5-II, Steigerwald Arzneimittelwerk GmbH), 1 mL orally three times daily for up to 8 weeks eliminates gastrointestinal symptoms in 40% more dyspepsia patients when compared with placebo (12724).
Headache. Although there is interest in using oral lemon balm for headache, there is insufficient reliable information about the clinical effects of lemon balm for this condition.
Hypertension. It is unclear if oral lemon balm is beneficial for hypertension. Details: Preliminary clinical research in adults with uncontrolled hypertension while on 1-3 active treatments shows that taking lemon balm extract 400 mg, standardized to contain 8 mg rosmarinic acid, orally daily for 4 weeks reduces systolic and diastolic blood pressure by 8% to 14% and 11% to 16%, respectively, when compared with baseline. These improvements were significant when compared with placebo (110138).
Hyperthyroidism. Although there is interest in using oral lemon balm for hyperthyroidism, there is insufficient reliable information about the clinical effects of lemon balm for this condition.
Insect repellent. Although there is interest in using topical lemon balm as insect repellant, there is insufficient reliable information about the clinical effects of lemon balm for this condition.
Insomnia. Oral lemon balm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Taking a specific combination product providing lemon balm leaf extract 80 mg and valerian root extract 160 mg (Euvegal forte, Dr. Willmar Schwabe Pharmaceuticals) 2-3 times daily appears to improve the quality and quantity of sleep in healthy people and those diagnosed with insomnia or sleeping disorders (10423,19528,19536). However, lower daily doses may not improve sleep (10421). Other clinical research in healthy adults with insomnia shows that using a combination product containing ground lemon balm herb 1000 mg and aqueous extract of Nepeta menthoides 400 mg at bedtime for 4 weeks improves sleep quality and sleep duration and reduces sleep disturbance, sleep latency, and daytime dysfunction when compared with placebo (97278). A clinical study in children 12 years and younger shows that a specific combination product containing lemon balm leaf extract 80 mg and valerian root extract 160 mg (Euvegal forte, Dr. Willmar Schwabe Pharmaceuticals) 1-2 tablets once or twice daily might decrease symptoms of restlessness and dyssomnia when compared to baseline (14416). It is unclear if these effects are due to lemon balm, other ingredients, or the combinations.
Irritable bowel syndrome (IBS). Oral lemon balm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with IBS shows that using 30 drops of a combination product providing lemon balm, spearmint, and coriander (Carmint, PurSina Pharmacy) three times daily after meals for 8 weeks reduces abdominal pain and discomfort when added to standard treatment with loperamide or psyllium, compared to standard treatment alone (19535). It is not known if the effect is due to lemon balm, the other ingredients, or the combination.
Menopausal symptoms. Oral lemon balm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in postmenopausal adults with sleep disturbances shows that taking lemon balm leaf 250 mg and fennel fruit 250 mg orally once daily for 8 weeks improves menopausal symptoms including vasomotor, psychomotor-social, physical, and sexual symptoms, by 24% to 38% when compared with baseline. These improvements were significant when compared with placebo (110137).
Pain (acute). It is unclear if lemon balm aromatherapy is beneficial for reducing pain in patients with acute coronary syndrome. Details: A small clinical study in patients with acute coronary syndrome presenting to the emergency department shows that aromatherapy with lemon balm leaf and stem essential oil 1% for 10 minutes twice on the day of presentation modestly reduces chest pain scores when compared with placebo. However, pain was no longer different between groups within 15 minutes after the second aromatherapy session (110139).
Postpartum complications. Oral lemon balm might reduce postpartum pain in some patients; however, it's not clear if it is beneficial for other postpartum complications. Details: A small clinical study shows that taking lemon balm leaf extract 395 mg every 6 hours for 24 hours following childbirth is slightly more effective for reducing postpartum pain when compared with taking mefenamic acid 250 mg using the same dosing schedule (101763).
Psoriasis. Oral lemon balm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with mild to moderate psoriasis shows that taking an oral combination product containing lemon balm, rose hip, and fennel as 10 mL three times daily for 12 weeks improves pruritus and psoriasis scores by 45% and 49%, respectively, when compared with baseline. In contrast, these scores worsened in the placebo group (110141). The validity of this finding is limited by the lack of statistical comparison between groups.
Somatic symptom disorder. Oral lemon balm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A clinical study in individuals with somatic symptom disorder shows that taking one tablet of a combination product three times daily for 2 weeks seems to improve symptoms of depression and anxiety when compared with placebo. Each tablet of this product contains lemon balm leaf extract 60 mg, valerian root extract 90 mg, and passionflower herb extract 90 mg (19701). It is not known if the effect is due to lemon balm, other ingredients, or the combination.
Ventricular arrhythmias. It is unclear if oral lemon balm leaf tea is beneficial for patients with premature ventricular contraction (PVC). Details: Preliminary clinical research in adults with low to moderate PVCs shows that drinking lemon balm leaf tea twice daily for 12 weeks reduces the frequency of PVCs by 32% when compared with baseline. This improvement was significant when compared with no treatment. Lemon balm tea also modestly improved heart rate, but not left ventricular ejection fraction, when compared with no treatment. The tea was prepared by steeping lemon balm leaf 2 grams in 250 mL of boiling water (110140). More evidence is needed to rate lemon balm for these uses.

VALERIAN

Insomnia. Most research shows that taking valerian whole root extract 300-600 mg daily modestly improves subjective sleep quality, although it might take up to 4 weeks to provide benefit. Valerian does not seem to improve sleep latency, sleep duration, or insomnia severity. Details: Although there is a great deal of conflicting research, overall, taking valerian 300-600 mg before bedtime seems to improve sleep quality when compared with placebo. In contrast, no consistent benefit has been seen for sleep latency, sleep duration, or insomnia severity (15046,17577,19406,19409,104010). Older meta-analyses show that valerian root improves sleep quality regardless of its formulation. However, the most recent meta-analysis shows that valerian whole root extract improves sleep quality, while it's unclear whether an unspecified valerian extract is effective (17577,19406,104010). These analyses are limited by significant heterogeneity in valerian dosage and formulation, treatment duration, and included patient populations. Some experts claim that valerian does not work acutely for sleep, and it can take up to 4 weeks for a benefit to be seen (10209,104010). Indeed, most short-term studies assessing valerian as a single dose, or used daily for up to one week, show no benefit for sleep quality when compared with placebo (19407,19408,19411,19414). However, a meta-analysis of studies lasting 4 weeks or longer also did not find a consistent benefit (104010). The benefits of valerian for sleep might vary in different patient populations. A large post-marketing surveillance study in children with restlessness or dyssomnia under the age of 12 has found that taking a specific combination product (Euvegal Forte, Dr. Willmar Schwabe Pharmaceuticals) containing valerian root extract 160 mg and lemon balm extract 80 mg 1-2 tablets once or twice daily is associated with moderate sleep improvement (14416). Also, one clinical study in postmenopausal adults shows that taking valerian root extract 530 mg (Sadamine) twice daily for 28 days moderately improves sleep quality when compared with placebo (19425). Another clinical study in patients undergoing treatment for cancer shows that taking valerian 450 mg 1 hour before bedtime for 8 weeks does not improve objective sleep measures, but might improve subjective sleep ratings and mood, when compared with placebo (19424). Small clinical studies in adults on hemodialysis show that taking valerian 530 mg before bedtime for 1 month improves sleep quality when compared with baseline or placebo. (105718,110712). In one of these studies, improvements in sleep quality were similar when compared with gabapentin (110712). Research also shows that taking specific combination products containing valerian and other ingredients can improve sleep quality. These combination products have combined valerian with hops; lemon balm (Euvegal Forte); lemon balm and hops (Valerina Natt); or passionflower and hops (NSF-3, M/s Tablets India) (10423,15018,19413,19417,19418,19419,88193,89408). Finally, limited research has compared valerian to benzodiazepines. A small clinical study in patients with non-organic insomnia shows that taking valerian extract (LI 156, Sedonium) 600 mg daily for 6 weeks seems to be no different for improving sleep quality when compared with taking low-dose oxazepam 10 mg (19416). Valerian might also improve sleep quality in patients who are resistant to chronic benzodiazepine therapy. In one small study, after tapering the benzodiazepine over two weeks, valerian extract 100 mg three times daily for 15 days improves sleep quality when compared with placebo (8006).

Anxiety. It is unclear if valerian is beneficial for anxiety. Details: Meta-analyses of heterogeneous clinical research show that there is insufficient and contradictory evidence on the use of valerian root for anxiety (104010,110711). However, one analysis suggests that using whole root preparations seems to have greater efficacy than valerian extracts (104010). These meta-analyses are limited by significant heterogeneity in valerian dosage and formulation, treatment duration, and patient populations and concerns related to publication bias (104010,110711). One small clinical study in patients with generalized anxiety disorder (GAD) shows that taking valerian extract containing 81.3 mg valepotriates daily for 4 weeks is no different for reducing anxiety scores when compared with diazepam 6.5 mg or placebo (9896). This study was not adequately powered to detect a difference between groups. Also, a small, quasi-randomized trial in adults with poor sleep quality who are undergoing hemodialysis shows that taking a specific valerian root product (Sedamin, Goldaru Company) 530 mg daily for 1 month improves anxiety scores by 2-3.9 times when compared with placebo. However, not all patients reported anxiety at baseline (105718). In contrast, a small clinical study in healthy adults shows that taking a combination of herbal extracts containing valerian root, passionflower, ballota, and hawthorn (Euphytose) daily for 14 days reduces subjective anxiety and objective sympathetic and autonomic nervous system activation in response to a psychosocial stressor when compared with placebo (111222). It is unclear if these effects are due to valerian, other ingredients, or the combination.
Delirium. Oral valerian has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adult intensive care unit (ICU) patients with agitation and delirium receiving quetiapine 50-200 mg every 12 hours shows that taking 5 mL of syrup containing valerian root 625 mg and an extract of lemon balm leaf 50 mg every 12 hours improves agitation from baseline similarly to placebo. It is unclear if the improvement from baseline differed between groups (106627).
Depression. It is unclear if valerian is beneficial in patients with depression. Details: A retrospective case series in patients with mild to moderate depression and reports of anxiety has found that taking high-dose valerian 1000 mg with St. John's wort is associated with more rapidly improved depressive symptoms than low-dose valerian 500 mg with St. John's wort (19402). The validity of this study is limited by its retrospective nature and small size. Also, it is unclear if this effect is due to valerian, St. John's wort, or the combination. One small, quasi-randomized trial in adults with poor sleep quality who are undergoing hemodialysis shows that taking a specific valerian root product (Sedamin, Goldaru Company) 530 mg daily for 1 month improves depression scores by 2-3.9 times when compared with placebo. However, not all patients reported depression at baseline (105718).
Dysmenorrhea. One small study suggests that oral valerian may reduce symptoms of dysmenorrhea. Details: A small clinical study shows that taking powdered valerian root 255 mg three times daily for two menstrual cycles reduces pain severity associated with menstruation when compared with placebo (19342).
Menopausal symptoms. Small studies suggest that oral valerian may reduce menopausal symptoms. Details: Two small clinical studies in postmenopausal adults show that taking valerian root (Zardband or Goldaroo Co.) 225 mg three times daily or 530 mg twice daily for 2 months moderately reduces hot flash frequency and severity when compared with placebo (89407,96243). Another small study in adults with menopausal symptoms shows that taking a combination of valerian and fennel extracts 500 mg twice daily for 8 weeks reduces the severity of hot flashes and improves sleep quality but does not reduce the duration or frequency of hot flashes when compared with control (112369). It is unclear if these effects are due to valerian, fennel, or the combination. All 3 studies were conducted in Iran, so it is unclear if these results are generalizable to other geographic locations.
Premenstrual syndrome (PMS). One small study suggests that oral valerian may reduce PMS symptoms. Details: A small clinical study in young adults with PMS shows that taking valerian root extract (Goldaroo Co.) 530 mg twice daily on the last 7 days of the menstrual cycle for 3 cycles moderately reduces the severity of self-reported PMS symptoms when compared with placebo (96239).
Pre-procedural anxiety. One small study suggests that oral valerian may reduce anxiety during wisdom tooth extraction. Details: A small crossover clinical study in patients undergoing impacted mandibular molar extraction shows that taking valerian extract (Dermatologica Ltda.) 100 mg one hour prior to the extraction reduces physiological responses to anxiety to a satisfactory but lesser degree than midazolam 15 mg. Patients expressed no clear preference for either valerian or midazolam for reducing perioperative anxiety (102242). The validity of these findings is limited by the use of subjective outcome measures.
Restless legs syndrome (RLS). It is unclear if oral valerian is beneficial in patients with RLS. Details: A small clinical study in patients with RLS shows that taking valerian (Pharmavite, LLC) 800 mg daily for 8 weeks does not improve RLS symptoms or sleep latency when compared with placebo (19422). However, this study was not adequately powered to detect a difference in RLS symptoms between groups. Conversely, another small clinical study in adults with RLS on hemodialysis shows that taking valerian 530 mg nightly before bed for 1 month reduces symptoms of RLS when compared to baseline; however, valerian's effects were weaker when compared with gabapentin 100 mg nightly (110712). The validity of this study is limited by a lack of a placebo group and a small sample size.
Stress. Two small studies suggest that oral valerian may reduce the stress response in healthy adults who are performing a stressful mental task or a verbal presentation. Details: Two small clinical studies in healthy volunteers shows that taking valerian 100 mg once or 600 mg daily for 7 days prior to participating in a mental stress task or public verbal test reduces physiologic responses to stress and feelings of anxiety when compared to baseline (9893,9895). The validity of these findings is limited by the lack of statistical comparison to the control group. Another small study in healthy volunteers shows that taking a specific combination product containing valerian 360 mg and lemon balm 240 mg (Songha Night, Pharmaton Natural Health Products) reduces anxiety associated with laboratory-induced stress. However increasing the dose to valerian 1080 mg and lemon balm 720 mg seems to increase anxiety (19405).
Tension headache. One small study suggests that oral valerian may reduce tension headache. Details: A small clinical study in patients with frequent tension headaches shows that taking valerian root extract (Sedamin, Goldaru Pharmaceutical Company) 1060 mg daily after dinner for one month modestly reduces headache severity and disability when compared with placebo (103221). More evidence is needed to rate valerian for these uses.

Safety view details

Below is general information about the safety of the known ingredients contained in the product Calm Surfer. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

ASHWAGANDHA

POSSIBLY SAFE ...when used orally and appropriately, short-term. Ashwagandha has been used with apparent safety in doses of up to 1250 mg daily for up to 6 months (3710,11301,19271,90649,90652,90653,97292,101816,102682,102683) (102684,102685,102687,103476,105824,109586,109588,109589,109590). ...when used topically. Ashwagandha lotion has been used with apparent safety in concentrations up to 8% for up to 2 months (111538).

PREGNANCY: LIKELY UNSAFE
when used orally. Ashwagandha has abortifacient effects (12).

LACTATION:
Insufficient reliable information available; avoid using.

HOLY BASIL

POSSIBLY SAFE ...when used orally, short-term. Holy basil leaf extract has been used with apparent safety at a dose of 500 mg daily for 60-90 days (12242,18107,19575,91571,96944). ...when used topically in the mouth, short-term. Holy basil has been used with apparent safety as a 4% mouthwash solution for up to 30 days (91570,103621).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used in high doses during pregnancy or when trying to conceive. Animal research suggests that relatively high doses of holy basil extract (200 mg/kg) may reduce implantation rate when used for one week, while long-term use of higher doses (2-4 grams/kg) may decrease the number of full-term pregnancies (55040,91569). There is insufficient reliable information available regarding the safety of holy basil during lactation; avoid using.

POSSIBLY SAFE ...when used orally, short-term. Kava extracts have been used safely in clinical trials under medical supervision for up to 6 months (2093,2094,2095,4032,7325,15046,15130,18314,18316,18318)(18320,29663,29671,98980,102086,112642). Historically, there has been some concern that kava preparations could induce hepatotoxicity and liver failure in patients taking relatively normal doses, short-term. At least 100 cases of liver toxicity following kava use have been reported. Although liver toxicity is more frequently associated with prolonged use of very high doses (6401,57346), in some cases the use of kava for as little as 1-3 months has been associated with the need for liver transplants, and even death (390,7024,7068,7086,7096,17086,57252)(57254,57297). However, some experts question the clinical validity of several of these cases (11369,11371).

PREGNANCY: POSSIBLY UNSAFE
when used orally. There is some concern that pyrone constituents in kava can cause loss of uterine tone (19); avoid using.

LACTATION: POSSIBLY UNSAFE
when used orally. There is concern that the toxic pyrone constituents of kava can pass into breast milk (19); avoid using.

KUDZU

POSSIBLY SAFE ...when used orally and appropriately. Kudzu appears to be safe for up to 4 months (10386,11386,92257). ...when used intravaginally and appropriately. Kudzu 5% to 6% gel has been used with apparent safety for up to 12 weeks (96740,105521,110702).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

LAVENDER

LIKELY SAFE ...when used orally in amounts commonly found in foods. Lavender has Generally Recognized as Safe (GRAS) status for food use in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (9792). In clinical research, a specific product containing lavender oil (Silexan, Dr Willmar Schwabe GmbH & Co. KG) has been used safely at doses of 80-160 mg daily for up to 10 weeks (58077,58080,58098,97257,112255). Powdered dried lavender flowers 500 mg twice daily has also been used with apparent safety for up to 8 weeks (97256). ...when used topically and appropriately. Lavender oil has been used safely for up to 7 months in adults (5177,109858,109865). ...when the essential oil is inhaled as a part of aromatherapy. Clinical studies have used lavender oil aromatherapy with apparent safety for up to 12 weeks (7107,12213,16393,16394,95634,103062,103063,103065,103068).

CHILDREN: POSSIBLY SAFE
when the essential oil is inhaled as a part of aromatherapy. Clinical studies have used lavender oil aromatherapy with apparent safety in single doses for up to 2 hours (109868,112260).

CHILDREN: POSSIBLY UNSAFE
when applied topically in males. Anecdotal reports suggest that applying topical products containing lavender oil to prepubertal males may result in gynecomastia in some cases (15254,95643). Products with a higher concentration of lavender oil and more frequent applications might be more likely to result in gynecomastia.

PREGNANCY AND LACTATION:
Insufficient reliable evidence available. Preliminary clinical research shows that lavender essential oil can be inhaled during labor, with no apparent adverse outcomes in the infants (95633). Although this study suggests safety, high quality assessment of safety has not been conducted.

LEMON BALM

LIKELY SAFE ...when used orally in amounts commonly found in foods. Lemon balm has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately, short-term. Lemon balm extract has been used with apparent safety at a dose of 500 mg daily for 6 months or at a dose of 3000 mg daily for 2 months (9993,9994,104435,104435,110136). ...when used topically and appropriately, short-term. Lemon balm 1% dried leaf extract has been used up to 4 times daily with apparent safety for a few days (790,9995).

CHILDREN: POSSIBLY SAFE
when used orally and appropriate, short-term. A single dose of lemon balm extract 3-6 mg/kg has been safely used in children aged 6-7 years (19525). A specific combination product providing lemon balm leaf extract 80 mg and valerian root extract 160 mg (Euvegal forte, Dr. Willmar Schwabe Pharmaceuticals) 1-2 tablets once or twice daily has been safely used in children under 12 years of age for 30 days (14416). In infants up to 4 weeks old, multi-ingredient products (ColiMil, ColiMil Plus) containing lemon balm 64-97 mg daily have been used with apparent safety for up to 7 days (16735,96278).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

VALERIAN

LIKELY SAFE ...when used orally and appropriately, short-term. Valerian 300-600 mg daily has been safely used in clinical studies in over 12,000 patients for up to 6 weeks (2074,3484,3485,4032,15018,17577,17578,19409,96242,103221)(104010,105718). There is insufficient reliable information available about the safety of valerian when used orally for longer than 6 weeks.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. Valerian 160-320 mg has been used with apparent safety in children under 12 years of age for 4-8 weeks (14416).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

Interactions with Drugs view details

Below is general information about the interactions of the known ingredients contained in the product Calm Surfer. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

ASHWAGANDHA

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = B

Theoretically, taking ashwagandha with antidiabetes drugs might increase the risk of hypoglycemia.

Details

There is preliminary clinical evidence suggesting that ashwagandha might lower blood glucose levels. Theoretically, ashwagandha might have additive effects when used with antidiabetes drugs and increase the risk of hypoglycemia (19274,90649,102685).

ANTIHYPERTENSIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Theoretically, taking ashwagandha with antihypertensive drugs might increase the risk of hypotension.

Details

Animal research suggests that ashwagandha might lower systolic and diastolic blood pressure (19279). Theoretically, ashwagandha might have additive effects when used with antihypertensive drugs and increase the risk of hypotension.

BENZODIAZEPINES

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, taking ashwagandha might increase the sedative effects of benzodiazepines.

Details

There is preliminary evidence that ashwagandha might have an additive effect with diazepam (Valium) and clonazepam (Klonopin) (3710). This may also occur with other benzodiazepines.

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, taking ashwagandha might increase the sedative effects of CNS depressants.

Details

Ashwagandha seems to have sedative effects. Theoretically, this may potentiate the effects of barbiturates, other sedatives, and anxiolytics (3710).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

Severity = Mild • Occurrence = Possible • Level of Evidence = D

Theoretically, ashwagandha might decrease the levels and clinical effects of CYP1A2 substrates.

Details

In vitro research shows that ashwagandha extract induces CYP1A2 enzymes (111404).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

Severity = Mild • Occurrence = Possible • Level of Evidence = D

Theoretically, ashwagandha might decrease the levels and clinical effects of CYP3A4 substrates.

Details

In vitro research shows that ashwagandha extract induces CYP3A4 enzymes (111404).

HEPATOTOXIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, taking ashwagandha with hepatotoxic drugs might increase the risk of liver damage.

Details

Ashwagandha has been linked to cases of acute hepatitis, liver failure, hepatic encephalopathy, autoimmune hepatitis, the need for liver transplantation, and death due to liver failure (102686,107372,110490,110491,111533,111535,112111,113610).

IMMUNOSUPPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, taking ashwagandha might decrease the effects of immunosuppressants.

Details

Ashwagandha has demonstrated immunostimulant effects in humans (3710,3711,4114,11301,106786). Animal research has shown that ashwagandha can attenuate the immunosuppression caused by cyclophosphamide (3711,4114).

THYROID HORMONE

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = B

Ashwagandha might increase the effects and adverse effects of thyroid hormone.

Details

Concomitant use of ashwagandha with thyroid hormones may cause additive therapeutic and adverse effects. Preliminary clinical research and animal studies suggest that ashwagandha boosts thyroid hormone synthesis and secretion (19281,19282,97292). In one clinical study, ashwagandha increased triiodothyronine (T3) and thyroxine (T4) levels by 41.5% and 19.6%, respectively, and reduced serum TSH levels by 17.4% from baseline in adults with subclinical hypothyroidism (97292).

HOLY BASIL

ANTICOAGULANT/ANTIPLATELET DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, holy basil seed oil might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.

Details

Animal research shows that holy basil seed oil can prolong bleeding time, possibly due to inhibition of platelet aggregation (13251). However, it is not known if this occurs in humans.

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = B

Theoretically, holy basil might increase the risk of hypoglycemia when taken with antidiabetes drugs.

Details

Small clinical studies show that taking holy basil can decrease fasting blood glucose and other measures of glycemic control in patients with type 2 diabetes (12242,91571).

PENTOBARBITAL (Nembutal)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, holy basil seed oil might increase the sedative effects of pentobarbital.

Details

Animal research shows that holy basil seed oil increases pentobarbitone-induced sleeping time (13056,13251). However, it is not known if this occurs in humans or if this applies to other barbiturates or sedatives.

ALCOHOL (ETHANOL)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = A

Combining kava with alcohol may increase the risk of sedation and/or hepatotoxicity.

Details

Kava has CNS depressant effects (11373,18316). Concomitant use of kava with other CNS depressants can increase the risk of drowsiness and motor reflex depression (2093,2098). Additionally, kava has been associated with over 100 cases of hepatotoxicity. There is some concern that kava can adversely affect the liver, especially when used in combination with hepatotoxic drugs (7024,7068,7086,7096,17086,57346). Clinical practice guidelines from a joint taskforce of the World Federation of Societies of Biological Psychiatry (WFSBP) and the Canadian Network for Mood and Anxiety Treatments (CANMAT) recommend that alcohol not be used with kava (110318).

CNS DEPRESSANTS

Interaction Rating = Major Do not take this combination.

Severity = High • Occurrence = Probable • Level of Evidence = A

Combining kava with CNS depressants can have additive sedative effects.

Details

Kava has CNS depressant effects (11373,18316). Concomitant use of kava with other CNS depressants can increase the risk of drowsiness and motor reflex depression (2093,2098). Clinical practice guidelines from a joint taskforce of the World Federation of Societies of Biological Psychiatry (WFSBP) and the Canadian Network for Mood and Anxiety Treatments (CANMAT) recommend that CNS depressants, including alcohol and benzodiazepines, not be used with kava (110318).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

Severity = Moderate • Occurrence = Unlikely • Level of Evidence = B

It is unclear if kava inhibits CYP1A2; research is conflicting.

Details

Although in vitro research and a case report suggest that kava inhibits CYP1A2 (8743,12479,88593), more robust clinical evidence shows that kava has no effect on CYP1A2. In a clinical study in healthy volunteers, taking kava 1000 mg twice daily (containing a daily dose of 138 mg kavalactones) for 28 days had no effect on CYP1A2 activity (13536,98979).

CYTOCHROME P450 2C19 (CYP2C19) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Theoretically, kava might increase levels of CYP2C19 substrates.

Details

In vitro research shows that kava significantly inhibits CYP2C19 enzymes (8743,12479). This effect has not yet been reported in humans.

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Theoretically, kava might increase levels of CYP2C9 substrates.

Details

In vitro research shows that kava significantly inhibits CYP2C9 enzymes (8743,12479). This effect has not yet been reported in humans.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

Severity = Moderate • Occurrence = Unlikely • Level of Evidence = B

It is unclear if kava inhibits CYP1A2; research is conflicting.

Details

In vitro research shows that kava extract significantly inhibits CYP2D6 (8743,12479). However, clinical research shows that kava does not affect the metabolism of CYP2D6 substrates in humans (13536,16848,98979).

CYTOCHROME P450 2E1 (CYP2E1) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = B

Kava might increase levels of CYP2E1 substrates.

Details

In a clinical study in healthy volunteers, taking kava 1000 mg twice daily (containing a daily dose of 138 mg kavalactones) for 28 days inhibited the metabolism of CYP2E1 substrates (13536).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

Severity = Moderate • Occurrence = Unlikely • Level of Evidence = B

It is unclear if kava inhibits CYP3AA; research is conflicting.

Details

Although in vitro research suggests that kava inhibits CYP3A4 (8743,12479), more robust clinical evidence shows that kava has no effect on CYP3A4. In a clinical study in healthy volunteers, taking kava 1000 mg twice daily (containing a daily dose of 138 mg kavalactones) for 28 days had no effect on CYP3A4 activity (13536,98979).

HALOPERIDOL (Haldol)

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Combining kava and haloperidol might increase the risk of cardiovascular adverse effects and hypoxia.

Details

Atrial flutter and hypoxia has been reported for a patient who received intramuscular injections of haloperidol and lorazepam after using kava orally. The side effects were attributed to kava-induced inhibition of CYP2D6, but might also have been related to additive adverse effects with the concomitant use of haloperidol, lorazepam, and kava (88593).

HEPATOTOXIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, using kava with hepatotoxic drugs might increase the risk of liver damage.

Details

Kava has been linked with over 100 cases of hepatotoxicity. Most cases occur with excessive and prolonged use. There is some concern that kava can adversely affect the liver, especially when used in combination with hepatotoxic drugs (7024,7068,7086,7096,17086,57346).

P-GLYCOPROTEIN SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

It is unclear if kava inhibits P-glycoprotein (P-gp); research is conflicting.

Details

In vitro research shows that kava can inhibit P-gp efflux (15131). However, a clinical study in healthy volunteers shows that taking kava standardized to provide 225 mg kavalactones daily for 14 days does not affect the pharmacokinetics of digoxin, a P-gp substrate (15132,98979). It is possible that the use of other P-gp substrates or higher doses of kava might still inhibit P-gp.

ROPINIROLE (Requip)

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Taking kava with ropinirole might increase the risk for dopaminergic toxicity.

Details

A case of visual hallucinations and paranoid delusions has been reported for a patient who used kava in combination with ropinirole. The adverse effects were attributed to kava-induced inhibition of CYP1A2, which may have reduced the metabolism of ropinirole, resulting in excessive dopaminergic stimulation (88593).

KUDZU

ANTICOAGULANT/ANTIPLATELET DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, kudzu may increase the risk of bleeding if used with antiplatelet or anticoagulant drugs.

Details

Kudzu isoflavones are reported to have antiplatelet activity (13278,13291).

ANTIDIABETES DRUGS

Interaction Rating = Minor Be watchful with this combination.

Severity = Moderate • Occurrence = Unlikely • Level of Evidence = D

Theoretically, taking kudzu with antidiabetes drugs might increase the risk of hypoglycemia.

Details

Kudzu might lower blood glucose levels and have additive effects in patients treated with antidiabetic agents (13285,13292,57868,57951). The dose of diabetes medications might need to be adjusted.

CAFFEINE

Interaction Rating = Moderate Be cautious with this combination.

Severity = Mild • Occurrence = Probable • Level of Evidence = D

Theoretically, taking kudzu with caffeine might increase levels of caffeine.

Details

In healthy males injected with the kudzu constituent puerarin, caffeine clearance and metabolism is inhibited (23583). This effect has been attributed to inhibition of cytochrome P450 1A2 (CYP1A2) enzyme, which is involved in caffeine metabolism. It is unclear if taking kudzu orally would have this same effect.

ESTROGENS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = B

Theoretically, kudzu might alter the effects of estrogen therapy.

Details

Some research suggests that kudzu has estrogenic effects (11386,57874,57877). This may enhance or inhibit the effects of estrogen therapy.

HEPATOTOXIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, concomitant use might have additive hepatotoxic effects.

Details

There is some concern that kudzu can adversely affect the liver (88777,92259,92260,92262).

METHOTREXATE (Trexall, others)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, taking kudzu with methotrexate might increase the risk of methotrexate toxicity.

Details

Preclinical research suggests that kudzu extract greatly reduces the elimination and increases the toxicity of methotrexate. Kudzu might inhibit organic anion transporters (OATs) that are responsible for hepatobiliary and renal excretion of anions, similar to the interaction between methotrexate and non-steroidal anti-inflammatory drugs (NSAIDs) (13296).

TAMOXIFEN (Nolvadex)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = B

Theoretically, kudzu might interfere with tamoxifen activity.

Details

Some research suggests that kudzu may have estrogenic effects (11386,110702).

LAVENDER

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Unlikely • Level of Evidence = D

Theoretically, lavender might potentiate the therapeutic effects and adverse effects of CNS depressants.

Details

Laboratory research suggests that lavender has sedative effects (7). However, clinical studies in patients taking oral lavender oil (Silexan) 160 mg for 10 weeks or taking lavender flower powder 1 gram daily for 2 months have not reported side effects of drowsiness, sedation, or sleepiness (97256,103061). There is still some concern that higher doses or different preparations of lavender might have additive effects with CNS depressant medications.

LEMON BALM

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = B

Theoretically, concomitant use of lemon balm might have additive effects with CNS depressant drugs.

Details

Lemon balm seems to have CNS depressant activity in animals and in humans (9994,19725).

THYROID HORMONE

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Theoretically, lemon balm might interfere with thyroid hormone replacement therapy.

Details

In vitro, constituents of lemon balm extract bind to thyroid stimulating hormone (TSH), preventing TSH receptor-binding and leading to the inhibition of TSH-stimulated adenylate cyclase activity (19727,19728). In animals, lemon balm extract has been shown to decrease levels of circulating TSH and inhibit thyroid secretion (19726).

VALERIAN

ALCOHOL (Ethanol)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = B

Valerian can have additive sedative effects when used concomitantly with alcohol.

Details

Valerian has sedative effects (9894). Theoretically, valerian might have an additive sedative effect when combined with alcohol. Excessive sedation has been reported in an alcohol-abusing individual who took valerian and Gingko biloba (19426). However, the potential interaction between valerian and alcohol has been disputed in other research. Limited evidence suggests that a combination of valerian 160 mg and lemon balm 80 mg (Euvegal) does not cause further deterioration in reaction ability and reaction rate when taken with alcohol as compared to the effects of alcohol alone (19427).

ALPRAZOLAM (Xanax)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = B

Valerian can have additive sedative effects when used with alprazolam. Also, valerian in high doses might modestly increase alprazolam levels, though this is not likely to be clinically significant.

Details

Valerian has sedative effects (9894). Theoretically, valerian might cause additive sedation when combined with alprazolam. Also, a small pharmacokinetic study shows that taking valerian extract 1000 mg daily (providing 11 mg valerenic acid) might increase alprazolam levels by about 19%. This might be due to valerian's mild inhibition of cytochrome P450 3A4 (CYP3A4) (13014). Despite being statistically significant, this increase is not likely to be clinically significant.

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Valerian can have additive sedative effects when used concomitantly with CNS depressant drugs.

Details

Theoretically, concomitant use of valerian and drugs with sedative and anesthetic properties may cause additive therapeutic and adverse effects (3486,12720,19429).

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

Severity = Mild • Occurrence = Unlikely • Level of Evidence = B

Valerian does not seem to have a clinically relevant effect on levels of drugs metabolized by CYP2D6.

Details

Although some in vitro evidence suggests that valerian affects CYP2D6, clinical pharmacokinetic (PK) studies show that valerian is unlikely to affect the CYP2D6 enzyme (13014,13536,19430,19431). In one PK study, taking valerian 1000 mg (providing about 11 mg valerenic acid) nightly for 14 days did not affect the metabolism of dextromethorphan, a CYP2D6 substrate. In another PK study, taking valerian 125 mg three times daily for 28 days did not affect metabolism of debrisoquine, an accepted CYP2D6 probe-substrate (13014,13536).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

Severity = Mild • Occurrence = Possible • Level of Evidence = B

Valerian does not seem to have a clinically relevant effect on levels of drugs metabolized by CYP3A4.

Details

Although some in vitro evidence suggests that valerian extract might inhibit or induce CYP3A4, clinical pharmacokinetic (PK) studies show that valerian does not have a clinically significant effect on the CYP3A4 enzyme (6450,12214,13014,13536,19431). In one PK study, taking valerian 125 mg three times daily for 28 days did not affect metabolism of midazolam, an accepted CYP3A4 probe-substrate. In another PK study, taking valerian 1000 mg (providing about 11 mg valerenic acid) nightly for 14 days modestly increases levels of alprazolam, a CYP3A4 substrate, suggesting mild inhibition of CYP3A4 (13014,13536). However, this mild inhibition is unlikely to be clinically relevant.

GLUCURONIDATED DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Valerian might weakly inhibit glucuronidation and increase concentrations of drugs metabolized by UGT1A1 and UGT2B7.

Details

In vitro research shows that methanolic valerian extract and valerenic acid might competitively inhibit UDP-glucuronosyltransferase (UGT) 1A1 (UGT1A1) and UGT2B7 (81685).

Report an Adverse Reaction to Calm Surfer

Adverse Effects view details

Below is general information about the adverse effects of the known ingredients contained in the product Calm Surfer. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

ASHWAGANDHA

General ...Orally, ashwagandha seems to be well-tolerated. Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal upset, nausea, and vomiting. However, these adverse effects do not commonly occur with typical doses.
Serious Adverse Effects (Rare):
Orally: Some case reports raise concerns about acute hepatitis, acute liver failure, hepatic encephalopathy, the need for liver transplantation, and death due to liver failure with ashwagandha treatment.

Dermatologic ...Orally, dermatitis has been reported in three of 42 patients in a clinical trial (19276).

Endocrine ...A case report describes a 73-year-old female who had taken an ashwagandha root extract (unspecified dose) for 2 years to treat hypothyroidism which had been previously managed with levothyroxine. The patient was diagnosed with hyperthyroidism after presenting with supraventricular tachycardia, chest pain, tremor, dizziness, fatigue, irritability, hair thinning, and low thyroid stimulating hormone (TSH) levels. Hyperthyroidism resolved after discontinuing ashwagandha (108745). Additionally, an otherwise healthy adult who was taking ashwagandha extract orally for 2 months experienced clinical and laboratory-confirmed thyrotoxicosis. Thyrotoxicosis resolved 50 days after discontinuing ashwagandha, without other treatment (114111). Another case report describes a 37-year-old female who presented with moderate symptomatic hyponatremia secondary to adrenal insufficiency after chronic consumption of ashwagandha for 2 years. This subject was effectively managed with oral hydrocortisone (114790).

Gastrointestinal ...Orally, large doses may cause gastrointestinal upset, diarrhea, and vomiting secondary to irritation of the mucous and serous membranes (3710). When taken orally, nausea and abdominal pain (19276,110490,113609) and gastritis and flatulence (90651) have been reported.

Genitourinary ...In one case report, a 28-year-old male with a decrease in libido who was taking ashwagandha 5 grams daily over 10 days subsequently experienced burning, itching, and skin and mucous membrane discoloration of the penis, as well as an oval, dusky, eroded plaque (3 cm) with erythema on the glans penis and prepuce (32537).

Hepatic ...Orally, ashwagandha in doses of 154 mg to 20 grams daily has played a role in several case reports of cholestatic, hepatocellular, and mixed liver injuries. In most of these cases, other causes of liver injury were excluded, and liver failure did not occur. Symptoms included jaundice, pruritus, malaise, fatigue, lethargy, weight loss, nausea, diarrhea, abdominal pain and distension, stool discoloration, and dark urine. Symptom onset was typically 5-180 days from first intake, although in some cases onset occurred after more than 12 months of use (102686,107372,110490,110491,111533,111535,112111,113610,114113). Laboratory findings include elevated aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, serum bilirubin, and international normalized ratio (INR) (112111,113610,114113). In most cases, liver enzymes normalized within 1-5 months after discontinuation of ashwagandha (102686,107372,110491,111535,112111,114113). However, treatment with corticosteroids, lactulose, ornithine, ursodeoxycholic acid, and plasmapheresis, among other interventions, was required in one case (111533). Rarely, use of oral ashwagandha has been reported to cause hepatic encephalopathy, liver failure requiring liver transplantation, and acute-on-chronic liver failure resulting in death (110490,113610).

Neurologic/CNS ...Orally, ashwagandha has been reported to cause drowsiness (110492,113609). Headache, neck pain, and blurry vision have been reported in a 47-year-old female taking ashwagandha, cannabis, and venlafaxine. Imaging over the course of multiple years and hospital admissions indicated numerous instances of intracranial hemorrhage and multifocal stenosis of intracranial arteries, likely secondary to reversible cerebral vasoconstriction syndrome (RCVS) (112113). It is unclear whether the RCVS and subsequent intracranial hemorrhages were precipitated by ashwagandha, cannabis, or venlafaxine.

HOLY BASIL

General ...Orally and topically, holy basil extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Loose stools and nausea.
Topically: Bitter taste with oral application.

Gastrointestinal ...Orally, two out of 24 participants taking capsules containing holy basil extract in one clinical study experienced nausea or loose stools (55037).
Topically, holy basil mouthwash has been reported to cause a bitter taste in clinical trials (55038).

General ...Orally, kava seems to be well tolerated.
Most Common Adverse Effects:
Orally: Drowsiness, dry mouth, dizziness, gastrointestinal upset, headache, memory problems, tremor.
Serious Adverse Effects (Rare):
Orally: There have been over 100 reported cases of hepatotoxicity and a few reported cases of rhabdomyolysis.

Cardiovascular ...Long-term use of very large amounts of kava, especially in high doses (400 mg kava pyrones daily), has been associated with overall poor health including symptoms of low body weight, reduced protein levels, puffy face, hematuria, increased red blood cell volume, decreased platelets and lymphocytes, and possibly pulmonary hypertension (4032,6402). Tachycardia and electrocardiogram (ECG) abnormalities (tall P waves) have been reported in heavy kava users (6402).

Dermatologic ...Orally, kava can cause allergic skin reactions, including sebotropic eruptions, delayed-type hypersensitivity, or urticarial eruption (4032,11370,28489,57277,57325,57343,114683). In one case of kava-associated urticarial eruption, biopsy revealed neutrophilic sebaceous glands with lymphocytic infiltrate (114683). Chronic use of high doses of kava has also been associated with kava dermopathy, which consists of reddened eyes; dry, scaly, flaky skin; and temporary yellow discoloration of the skin, hair, and nails (6240,6401,8414,8417,11370,28485,57342). This pellagra-like syndrome is unresponsive to niacinamide treatment (6240,7728,11370). The cause is unknown, but may relate to interference with cholesterol metabolism (6240). Kava's adverse effects on liver function might also contribute to kava dermopathy (6401,8417). Kava dermopathy usually occurs within three months to one year of regular kava use, and resolves when the kava dose is decreased or discontinued (6401,8414). Kava dose should be decreased or discontinued if kava dermopathy occurs (6401). In addition to kava cessation, oral or topical corticosteroids have been described as treatment options in some cases of kava associated dermatitis (114683).

Gastrointestinal ...Orally, kava may cause gastrointestinal upset, nausea, or dry mouth (2093,2094,4032,11370,18316,57228,57343).

Hematologic ...Orally, chronic use of very high doses of kava has been associated with increased red blood cell volume, reduced platelet volume, reduced lymphocyte counts, and reduced serum albumin (6402,57258). Hematuria has also been reported anecdotally (6402).

Hepatic ...Since the early 2000's, hepatotoxicity has been a particular concern with kava. Worldwide, there have been at least 100 reported cases of hepatotoxicity following use of kava products (7024,7068,7086,7096,11795,17086)(57252,57254,57297). However, some experts question the clinical validity of several of these cases (11369,11371). Some cases were reported multiple times and in some cases it was unlikely that kava was the causative agent (7068,57253).
In susceptible patients, symptoms can show up after as little as 3-4 weeks of kava use. Symptoms include yellowed skin (jaundice), fatigue, and dark urine (7024,7068). Liver function tests can be elevated after 3-8 weeks of use, possibly followed by hepatomegaly and onset of encephalopathy (7024). Kava has also been reported to exacerbate hepatitis in patients with a history of recurrent hepatitis (390). However, in many cases, symptoms seem to resolve spontaneously, and liver function tests usually normalize within eight weeks (390,7068).
Liver toxicity is more frequently associated with prolonged use of very high doses (6401,57346). But there is some concern that even short-term use of kava in typical doses might cause acute hepatitis in some patients, including severe hepatocellular necrosis. The use of kava for as little as 1-3 months has resulted in need for liver transplant and death, although these events are rare (7024,7068,7086,7096,17086).
There is some speculation that the type of extraction method could be responsible for these rare cases of hepatotoxicity (17086). The "Pacific kava paradox" holds that while the alcohol and acetone extracts of kava used for commercial products cause liver toxicity, the traditional kava rhizome preparation mixed with water might not be toxic (11794,17086). However, a more recent analysis reports cases of hepatotoxicity from the aqueous kava extract and suggests that kava's hepatotoxic effects may be due to contaminants such as mold (29676). Other suggested causes of hepatotoxicity include quality of the kava plant, concomitant medications, large doses and prolonged use, and toxic constituents and metabolites of kava (57300,88532).
Some commercial kava extracts contain parts of the stems and other aerial parts in addition to the rhizome, and it has been suggested that a constituent called pipermethysine, which is only found in these aerial parts, might be partly responsible for hepatotoxicity (17086). Other constituents of kava which might contribute to hepatotoxicity are kavalactones, which are metabolized by cytochrome P450 (CYP450) enzymes in the liver. Reactive metabolites are produced which conjugate with glutathione, and might deplete glutathione in a similar manner to acetaminophen (17086). Increased levels of gamma-glutamyl transferase, involved in the production of glutathione, have been reported in chronic kava users (17086). One of the enzymes involved in production of reactive metabolites from kavalactones is cytochrome P450 2E1 (CYP2E1), which is induced by chronic alcohol intake. Alcohol may also compete for other enzymes which clear kavalactone metabolites from the body. This might explain the observation that alcohol ingestion seems to increase the risk of hepatotoxicity with kava (7068,17086).
There is also speculation that "poor metabolizers" or those patients with deficiency in the cytochrome P450 2D6 (CYP2D6) isoenzyme, which occurs in up to 10% of people of European descent, may be at increased risk for hepatotoxic effects from kava (7068). This deficiency has not been found in Pacific Islanders. However, this theory has not been confirmed.
Due to the concerns regarding the potential hepatotoxicity of kava, kava supplements were withdrawn from European and Canadian markets in 2002 (7086). However, many of the market withdrawals of kava have been lifted after re-evaluation of kava suggested that the risk of hepatotoxicity was minimal (91593,91594,91615). Still, clinical practice guidelines from a joint taskforce of the World Federation of Societies of Biological Psychiatry (WFSBP) and the Canadian Network for Mood and Anxiety Treatments (CANMAT) recommend exercising caution when using kava in patients with preexisting liver issues (110318). Until more is known, tell patients to use kava cautiously and recommend liver function tests for routine users or those with underlying liver disease.

Immunologic ...Sjögren syndrome has been associated with an herbal supplement containing kava, echinacea, and St. John's wort. Echinacea may have been the primary cause, because Sjögren syndrome is an autoimmune disorder. The role of kava in this syndrome is unclear (10319).

Musculoskeletal ...Kava has been linked with reports of rhabdomyolysis. A 34-year-old man who consumed kava tea several times a week developed rhabdomyolysis with a peak creatine kinase level of 32,500 units/liter (18212). However, there is speculation that this might have been due to product impurities rather than kava itself. Another case report describes rhabdomyolysis with myoglobinuria and a creatine kinase level of 100,500 units/liter in a 29-year-old man who had taken kava in combination with guarana and ginkgo biloba (18213).
Cases of ataxia and tremors have been reported in patients taking single doses of kava powder 205 grams (11373).

Neurologic/CNS ...Orally, kava may cause headache, dizziness, and drowsiness (4032,6402,11370,11372,11373,18316,112642). It might also cause extrapyramidal side effects such as involuntary oral and lingual reflexes, twisting movements of the head and trunk, tremors, and other parkinsonian-like symptoms possibly due to dopamine antagonism (534,4055,7727,8415,102086). In one clinical trial, patients taking a kava supplement providing 120 mg of kavalactones twice daily for 16 weeks had a 3.2-fold greater risk of experiencing tremors when compared with patients taking placebo (102086). Theoretically, kava may worsen symptoms in patients with Parkinson disease or precipitate Parkinson-like symptoms in certain patients (4055,7727). Unlike benzodiazepines, kava is not thought to be associated with impaired cognitive function (2097,2098,11373,57332,57333). However, one clinical trial shows that taking a kava supplement providing 120 mg of kavalactones twice daily for 16 weeks increases the risk for memory impairment by 55% when compared with placebo (102086).
Orally, kava may reduce alertness and impair motor coordination in a dose-dependent manner. Some preliminary reports have noted a decline in accuracy of visual attention and slower reaction times after kava ingestion, particularly at higher doses and in combination with alcohol (11373,95926). Population research has also found that ingesting large amounts of kava tea (typically 50 times higher than what is used medicinally in the US) within a 12-hour period before driving increases the odds of being involved in a serious motor vehicle crash resulting in death or serious injury by almost 5-fold when compared to not drinking kava tea (95927). Use of normal doses of kava may also affect the ability to drive or operate machinery, and driving under the influence (DUI) citations have been issued to individuals observed driving erratically after drinking large amounts of kava tea (535). However, in computer-based driving simulator tests, there are no reported adverse effects of kava on performance (95926). Additionally, other research shows that consuming over 4400 mg of kavalactones over a 6-hour kava session does not seem to impair alertness or attention when compared with non-kava drinkers (103867). Similar research using a specific psychometric tool (Brain Gauge) shows that consuming approximately 3680 mg of kavalactones in a 6-hour kava session seems to impair temporal order judgment, which is associated with the brain's ability to track the order of events, when compared with non-kava drinkers. However, it does not seem to impact cognitive domains related to focus, accuracy, timing perception, plasticity, or fatigue when compared with non-kava drinkers (110435).

Ocular/Otic ...Orally, high doses of kava may cause eye irritation (7728). There is one case report of impaired accommodation and convergence, increased pupil diameter, and oculomotor disturbance following a single dose of kava (9920).

Psychiatric ...Apathy has been associated with traditional use of kava at high doses (57313).

Pulmonary/Respiratory ...Orally, kava may cause shortness of breath, possibly due to pulmonary hypertension (6402).

Renal ...Orally, kava may cause acute urinary retention (57349).

KUDZU

General ...Orally and intravaginally, kudzu seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Elevated liver transaminases.

Cardiovascular ...Orally, side effects of kudzu reported in clinical trials have included palpitations and chest discomfort; however, these effects did not occur more frequently than with placebo (57924,57927).

Dermatologic ...Orally, a side effect of kudzu reported in one clinical trial has included urticaria; however, this effect did not occur more frequently than with placebo (57924). There is one case report of allergic reaction following use of a combination herbal product (Kakkonto) containing kudzu involving a maculopapular eruption starting on the thighs and spreading over the entire body (13111,57886).

Gastrointestinal ...Orally, some side effects of kudzu reported in clinical trials have included nausea, dyspepsia, and bloating; however, these effects did not occur more frequently than with placebo (57927,57942).

Genitourinary ...Intravaginally, irritation of the vulva has been reported with kudzu gel. These cases were generally mild and transient (110702).

Hematologic ...Intravenously, the kudzu derivative, puerarin, has caused intravascular hemolysis (13298,15025,57947).

Hepatic ...Orally, there are several cases reports of liver injury following use of kudzu involving elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels (88777,92260).

Neurologic/CNS ...Orally, a side effect of kudzu reported in one clinical trial has included dizziness; however, this effect did not occur more frequently than with placebo (57924).

Other ...Orally, a side effect of kudzu reported in one clinical trial has included mastodynia; however, this effect did not occur more frequently than with placebo (57942).

LAVENDER

General ...Orally, lavender is well tolerated in food amounts and seems to be well tolerated in larger amounts. Topically, lavender oil seems to be well tolerated.
Most Common Adverse Effects:
Orally: Breath odor, constipation, diarrhea, dyspepsia, eructation, headache, and nausea.
Topically: Allergic contact dermatitis (with lavender oil).
Serious Adverse Effects (Rare):
Topically: Cases of gynecomastia have been reported in prepubertal males using lavender oil.

Cardiovascular ...Orally, a specific lavender oil ingredient (Silexan) has been associated with palpitations (103061).

Endocrine ...Topical products containing lavender oil alone, including a product referred to as agua de violetas, or in combination with tea tree oil have been linked to at least six cases of gynecomastia when used in prepubertal males. In each case, gynecomastia resolved when the lavender oil products were discontinued. It is thought that the estrogenic and antiandrogenic activity of lavender oil and tea tree oil resulted in gynecomastia in these cases (15254,95643).

Gastrointestinal ...Orally, lavender oil, including a specific lavender oil ingredient KG), may cause gastrointestinal disturbance, including dyspepsia, diarrhea, breath odor, eructation, and nausea (58077,58080,58098,93004,103061). Tincture of lavender has been linked to cases of constipation and increased appetite; however, it is unknown if this occurred at a greater rate than with placebo (9792).

Immunologic ...Topically, use of lavender oil, such as in personal care products, might cause allergic contact dermatitis in some patients (6,101728). There have been numerous case reports of allergic contact dermatitis and eczema linked to lavender oil exposure from shampoos, lotions, fragrances, or direct application of oil to pillows (10031,58043,58109,58120,101728,112253). In one case series, only 4 out of 15 cases of allergic contact dermatitis due to lavender had positive patch tests for lavender. Oxidation products of lavender essential oils such as linalool, linalyl acetate, limonene, cineol, geraniol, eugenol, and isoeugenol may be more allergenic than un-oxidized lavender essential oil, which may result in a false negative patch test (112253).

Neurologic/CNS ...Orally, lavender flower powder, tincture of lavender containing 50% alcohol, and a specific lavender oil ingredient (Silexan) have been linked to headache (9792,103061,109860). Headache has also been reported rarely following lavender oil aromatherapy (109860).

Pulmonary/Respiratory ...In one case report, a 34-year-old Japanese female presented with complaints of dyspnea, cough, and fever 2 weeks after initiating lavender essential oil therapy via humidifier. The patient had an oxygen saturation of 88% and was diagnosed with acute eosinophilic pneumonia. Symptoms improved after a course of corticosteroids and discontinuation of aromatherapy (109979).

Renal ...In one case report, a 24-year-old male presented with shortness of breath, weakness, nausea, and decreased urine output following the intake of Spanish lavender tea twice daily for 5 days. After presenting to the hospital, the patient was diagnosed with acute kidney failure secondary to acute interstitial nephritis likely due to lavender consumption (112259).

LEMON BALM

General ...Orally, lemon balm seems to be well tolerated in food amounts and larger, medicinal amounts. Topically, lemon balm seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Wheezing has been rarely reported.

Cardiovascular ...Orally, a case of transient complete atrioventricular block and QT prolongation is reported in a 25-year-old female following the post-workout use of a specific product (Muscle Eze Advanced) containing lemon balm and several other ingredients. Symptoms of fatigue and lightheadedness started 1 week into use of the product. Product discontinuation led to restoration of normal sinus rhythm within 24 hours and normalization of the electrocardiogram within 2 weeks (112556). It is unclear whether this occurrence is due to lemon balm, other ingredients, or the combination.

Dermatologic ...Topically, lemon balm 1% cream applied 5 times daily to cold sores has been associated with two cases of irritation and one case of cold sore exacerbation. However, these effects do not appear to occur more often with lemon balm than with placebo (790).

Gastrointestinal ...Orally, lemon balm might increase appetite in some patients (91732,104433). Nausea, vomiting, and abdominal pain have been reported rarely and do not seem to occur more often than in patients taking placebo (9993).

Neurologic/CNS ...Orally, lemon balm has been reported to cause dizziness and sedation; however, it does not seem to occur more often with lemon balm than placebo (9993,104433). Additionally, other clinical research shows that using lemon balm in conjunction with alcohol does not affect reaction time or influence cognitive performance (19427,19723).

Pulmonary/Respiratory ...Orally, lemon balm has been associated with rare cases of wheezing (9993).

VALERIAN

General ...Orally, valerian is generally well-tolerated.
Most Common Adverse Effects:
Orally: Dizziness, drowsiness, and mental slowness. Other reported side effects include headache, gastrointestinal upset, excitability, and vivid dreams. When used chronically and abruptly stopped, symptoms of withdrawal such as tachycardia, anxiety, irritability, and insomnia might occur. Advise patients to taper doses slowly after extended use.
Serious Adverse Effects (Rare):
Orally: Several case reports raise concerns about hepatotoxicity after the use of valerian and valerian-containing multi-ingredient dietary supplements. Withdrawal from chronic valerian use has been associated with cases of cardiac failure and hallucinations.

Cardiovascular ...When used orally in high doses for an extended period of time, valerian withdrawal has been associated with tachycardia and high output cardiac failure in one patient with a history of coronary artery disease (3487). Chest tightness has been reported for an 18-year-old female who took 40-50 capsules containing valerian 470 mg/capsule (659). A case of severe hypotension, suspected to be due to vasodilation, hypocalcemia, and hypokalemia, has been reported for a patient who injected an unknown quantity of a crude tap water extract of raw valerian root (81734).

Dermatologic ...Orally, valerian might rarely cause a rash. A case of valerian-related rash that resolved after valerian root discontinuation was reported in clinical research (19422).

Gastrointestinal ...Orally, valerian has been associated with increased incidence of gastrointestinal problems including diarrhea, nausea, vomiting, and stomach pain (15046,19406,19407,19422,110712). In one individual, taking 20 times the normal dose caused abdominal cramping (659).

Hepatic ...There have been several case reports of hepatotoxicity associated with the use of multi-ingredient oral preparations containing valerian (8243,96241). In one case report, a 57-year-old man presented with acute hepatitis after consuming a cold and flu remedy containing valerian 2 grams for 3 days; the remedy also contained white willow, elderberry, and horseradish. Although the use of the cold and flu remedy was discontinued one month prior to symptom presentation, the acute hepatitis was attributed to valerian root and treated with steroids (96241). It is possible, however, that some of these preparations may have been adulterated with hepatotoxic agents (8243).
Hepatotoxicity involving long-term use of single-ingredient valerian preparations has also been reported (3484,17578). Also, a case of a 38-year-old female with liver insufficiency and cirrhosis of a vascular parenchymal nature who developed hepatotoxic symptoms following valerian and ethyl-alcohol abuse has been reported (81697). Symptoms resolved and laboratory values normalized following intense plasmapheresis treatment. Another case of acute hepatitis characterized by elevated aminotransferases, mild fibrosis, and liver inflammation has been reported for a 50-year-old female who consumed valerian root extract 5 mL three times weekly along with 10 tablets of viamine, a product containing dry valerian extract 125 mg/tablet, for 2 months (81696). Because a variety of doses were used in these cases, and many people have used higher doses safely, these hepatotoxic reactions might have been idiosyncratic. Tell patients the long-term effect of valerian on liver function is unknown.

Musculoskeletal ...In a case report, combined intake of valerian and passionflower caused throbbing and muscular fatigue when taken concomitantly with lorazepam (19429).

Neurologic/CNS ...Orally, valerian might cause dizziness, headaches, fatigue, sleepiness, and mental dullness (3484,17578,19411,19422,81723,89407). The severity of adverse effects appears to increase with higher doses (19411). However, taking valerian extracts in doses up to 1800 mg does not appear to significantly affect mood or psychomotor performance (10424,15044). Valerian does not usually have a negative impact on reaction time, alertness, and concentration the morning after intake (2074,8296). Clinical research shows that a single dose of valerian root 1600 mg is not associated with any changes in sleepiness, reaction time, or driving performance within 1-4 hours after intake (96240). More serious side effects may occur when valerian is taken at higher doses. In one individual, 20 times the normal dose caused tremor of the hand and foot and lightheadedness (659). In a case report, combined intake of valerian and passionflower caused shaking of the hands and dizziness when taken concomitantly with lorazepam (19429).

Psychiatric ...Orally, valerian has been associate with reports of restlessness, excitability, uneasiness, agitation, and vivid dreams (3484,17578,19411,19422). Chronic use and rapid cessation can lead to withdrawal syndrome with symptoms of agitation, insomnia, and hallucinations (104003). There appears to be a trend towards increased severity of adverse effects with higher doses (19411). A case of acute hypomania has been reported for a 21-year-old female patient who took a valerian decoction in water each night for one month to treat subclinical anxiety. Symptoms included euphoric mood, rapid speech, and increased sociability and sexual interest. Following cessation of valerian use and treatment with quetiapine 100 mg daily for two weeks, the patient recovered (89405). In another case report, an 85-year-old male with mild cognitive impairment, major depression, anxiety, and chronic kidney disease presented to the emergency department with hallucinations, confusion, and agitation thought to be due to abrupt cessation after taking valerian 600 mg daily for about 6 months. The symptoms resolved in about 5 days (104003).

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