Serenity [Discontinued] by doTERRA

NatMed Pro Brand Evidence-based Rating (NMBER)

Product Information hide details

Serving Size 2 Softgel(s)

Ingredients	Amount Per Serving
Lavender flowering tops Oil (flowering tops)	160 mg
L-Theanine	100 mg
Proprietary Extract Blend	50 mg
Lemon Balm (leaf & stem)
Passionflower (flowering tops & aerial parts)
German Chamomile (petal)

Other Ingredients

extra virgin Olive Oil, Food Starch, Glycerin, purified Water, Maltitol, Carrageenan, Sunflower Lecithin, Silica

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Editor's Comments hide details

This product has been discontinued by the manufacturer.

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Effectiveness view details

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

GERMAN CHAMOMILE

INSUFFICIENT RELIABLE EVIDENCE to RATE

Allergic rhinitis (hay fever). Although there has been interest in using oral German chamomile for allergic rhinitis, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
Anxiety. It is unclear if inhaled German chamomile essential oil, as aromatherapy, is beneficial in patients with anxiety. Details: A large clinical study in adults in Iran hospitalized with acute coronary syndrome shows that placing 7 drops of German chamomile essential oil 10% on a cotton ball and inhaling for 12 hours nightly for 2 nights modestly lowers anxiety scores when compared with a control group (114528). The validity of this finding is limited by the potential for inadequate blinding and the short study duration. However, a small clinical study in adults with gastrointestinal, neuroendocrine, and skin cancers receiving intravenous infusion therapy shows that inhaling German chamomile essential oil 3 times daily for 7 days does not reduce self-reported anxiety when compared with a control group (111379). German chamomile has also been studied in combination with other ingredients. A small, open-label study in critically ill children in the pediatric intensive care unit shows that aromatherapy massage with an essential oil 1% blend of lavender, German chamomile, and neroli in grapeseed oil reduces distress, anxiety, and heart rate when compared to baseline (111378). However, the validity of these findings is limited by a lack of blinding and control group. It is unclear if these effects are due to German chamomile, other ingredients, or the combination.
Atopic dermatitis (eczema). It is unclear if topical German chamomile is beneficial in patients with atopic dermatitis. Details: Clinical research in patients with atopic dermatitis shows that applying a specific cream containing a 2% ethanolic extract of German chamomile flowers (Kamillosan, Asta Medica AG) up to three times daily for up to 4 weeks improves pruritus, erythema, and desquamation when compared with placebo or hydrocortisone 0.5% cream (19707).
Attention deficit-hyperactivity disorder (ADHD). Although there has been interest in using oral German chamomile for ADHD, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
Burning mouth syndrome. German chamomile has only been evaluated as a mouthwash in combination with flaxseed; its effect when used alone is unclear. Details: Preliminary clinical research in female patients with burning mouth syndrome shows that using a mouthwash containing German chamomile and flaxseed 3-4 times daily for 3 months decreases subjective burning and dry mouth symptoms, increases salivary flow rate, and decreases saliva viscosity when compared with baseline (104807). However, the validity of these results is limited by the lack of a control group and product standardization, as the mouthwash was prepared by each patient from ingredients they purchased.
Cancer-related anorexia. It is unclear if inhaled German chamomile essential oil, as aromatherapy, is beneficial in patients with cancer-related anorexia. Details: A small clinical study in adults with gastrointestinal, neuroendocrine, and skin cancers receiving intravenous infusion therapy shows that inhaling German chamomile essential oil 3 times daily for 7 days does not increase self-reported appetite when compared with a control group (111379).
Chemotherapy-induced fatigue. It is unclear if inhaled German chamomile essential oil, as aromatherapy, is beneficial in patients with chemotherapy-induced fatigue. Details: A small clinical study in adults with gastrointestinal, neuroendocrine, and skin cancers receiving intravenous infusion therapy shows that inhaling German chamomile essential oil 3 times daily for 7 days does not reduce self-reported fatigue when compared with a control group (111379).
Chemotherapy-induced nausea and vomiting (CINV). It is unclear if inhaled German chamomile essential oil, as aromatherapy, is beneficial in patients with CINV. Details: A small clinical study in adults treated for gastrointestinal, neuroendocrine, and skin cancers with intravenous infusion therapy shows that inhaling German chamomile essential oil 3 times daily for 7 days does not improve self-reported nausea when compared with a control group. (111379).
Colic. Oral German chamomile has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical studies in infants with colic show that two multi-ingredient products given orally twice daily for 1-4 weeks reduce crying times when compared with placebo or simethicone 60 mg twice daily. The products studied contained German chamomile 178 mg with fennel and lemon balm (ColiMil, Milte Italia SPA) and German chamomile 9 mg with lemon balm and Lactobacillus acidophilus (ColiMil Plus, Milte Italia SPA) (16735,96278). Other clinical research in infants shows that taking 150 mL of a specific herbal tea preparation (Calma-Bebi, Bonomelli) containing extracts of German chamomile, vervain, licorice, fennel, and lemon balm up to three times daily after each episode of colic for 7 days increases the percentage of infants with relief by 31% when compared with placebo, although there was no effect on the number of night awakenings (19715).
Common cold. It is unclear if inhaling the steam from a solution of German chamomile in hot water is beneficial in patients with a common cold. Details: Preliminary clinical research shows that inhaling the steam from a solution containing 13-39 mL of German chamomile alcoholic extract (Kneipp Kamillen-Konzentrat, Kneipp Werke) dissolved in 1000 mL of hot water for 10 minutes reduces symptoms when compared to baseline in patients suffering from an uncomplicated common cold (19360).
Diarrhea. Oral German chamomile has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children aged 6 months to 6 years with acute diarrhea, using a specific combination product (Diarrhoesan, Dr. Loges + Co. GmbH) containing apple pectin and German chamomile extract for 1-3 days reduces stool frequency and improves symptom relief when compared with placebo (19705).
Dysmenorrhea. Although there has been interest in using oral German chamomile for dysmenorrhea, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
Dyspepsia. Oral German chamomile has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Two specific combination products containing German chamomile (Iberogast, Steigerwald Arzneimittelwerk GmbH; STW-5-S, Steigerwald Arzneimittelwerk GmbH), 1 mL three times daily for 4 weeks, seem to improve symptoms of dyspepsia. The combinations include German chamomile plus milk thistle, peppermint leaf, licorice, caraway, celandine, angelica, and lemon balm, with (Iberogast) or without (STW-5-S) clown's mustard plant (19532). A meta-analysis of studies using Iberogast product suggests that taking 1 mL orally three times daily for 4 weeks reduces severity of acid reflux, epigastric pain, cramping, nausea, and vomiting when compared with placebo (13089). Also, using a preparation containing clown's mustard plant, German chamomile, peppermint, caraway, licorice, and lemon balm (STW 5-II, Steigerwald Arzneimittelwerk GmbH), 1 mL three times daily for up to 12 weeks, improves symptoms in 40% more patients than placebo (12724).
Fibromyalgia. Although there has been interest in using oral German chamomile for fibromyalgia, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
Flatulence. It is unclear if oral German chamomile is beneficial in adults with flatulence post-laparoscopic cholecystectomy. Details: A moderate-sized clinical study in adults undergoing laparoscopic cholecystectomy conducted in Iran shows that German chamomile extract 20 drops given once orally 1 hour before surgery mitigates the severity and incidence of flatulence 2 hours postoperatively when compared with placebo (112364). The interpretation of these findings is limited by the use of self-reported outcomes. In addition, providers had influence on who received German chamomile, raising concerns about selection bias.
Generalized anxiety disorder (GAD). It is unclear if oral German chamomile is beneficial in adults with GAD. Details: Small clinical studies in adults with GAD show that taking German chamomile extract 220-1500 mg daily for 8-26 weeks improves anxiety rating scores but does not reduce the risk of relapse when compared with placebo (19377,111380). Clinical practice guidelines from the World Federation of Societies of Biological Psychiatry and the Canadian Network for Mood and Anxiety Treatments do not currently recommend German chamomile as monotherapy or adjunctive therapy in patients with GAD (110318).
Gingivitis. Topical German chamomile has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in people with gingivitis shows that using a toothpaste containing German chamomile, sage, myrrh, eucalyptus, calcium carbonate, and sodium monofluorophosphate twice daily for 30 days reduces gingivitis scores when compared with baseline, but not when compared with standard toothpaste (19702).
Hemorrhoids. Topical German chamomile might improve symptoms after anal surgery for hemorrhoids. Details: Preliminary clinical research in patients with hemorrhoids shows that German chamomile ointment (Kamillosan, Asta Medica AG) applied twice daily for 6 weeks, in combination with band ligation plus anal dilation surgery, improves anal bleeding, itching, burning, and oozing when compared with surgery alone (19714).
Hyperprolactinemia. Oral German chamomile might lower prolactin levels, but is not likely to work as well as conventional medications. Details: Preliminary clinical research in female patients with idiopathic hyperprolactinemia shows that taking a syrup containing 10% of a German chamomile dried flower extract 5 mL twice daily for 4 weeks produces a significant decline in serum prolactin levels when compared with baseline. However, the decrease is less than that associated with taking cabergoline 0.25 mg twice weekly for 4 weeks. Serum prolactin levels normalized in 96% of patients taking cabergoline, and 72% of patients taking German chamomile (104806).
Inflammatory bowel disease (IBD). Although there has been interest in using oral German chamomile for IBD, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
Insomnia. Oral German chamomile does not seem to be beneficial in patients with primary insomnia. Details: Preliminary clinical research in patients with primary insomnia shows that taking German chamomile 270 mg twice daily for 28 days does not improve total sleep time, sleep efficiency, sleep latency, sleep quality, waking after sleep onset, or number of awakenings when compared with placebo (19716).
Leukemia. It is unclear if oral German chamomile is beneficial in children with leukemia. Details: One small clinical study in children aged 2-18 years with acute lymphoblastic leukemia suggests that taking German chamomile flower extract 125 mg in 2.5 mL syrup daily for 30 days during induction chemotherapy is associated with a more rapid recovery in absolute neutrophil counts, but not white blood cell counts, when compared with placebo (103180). However, statistical methods used are unclear, and it is not known if German chamomile altered the effectiveness of chemotherapy.
Mastalgia. Preliminary research suggests that German chamomile might be effective for reducing the pain of premenstrual mastalgia. Details: Preliminary clinical research in patients with cyclic (premenstrual) mastalgia shows that taking 5 drops of German chamomile extract orally three times daily for 2 months reduces the severity of mastalgia when compared with placebo (104811).
Nocturnal enuresis. Topical German chamomile has only been evaluated in combination with almond oil; its effect when used alone is unclear. Details: Preliminary clinical research in children with enuresis shows that applying 6 drops of almond oil infused with German chamomile flower to the perineal and suprapubic areas nightly for 6 weeks reduces the frequency of enuresis by about 3 episodes per week when compared with placebo (98621).
Oral mucositis. Small clinical studies suggest that oral rinses containing German chamomile might help to prevent or treat oral mucositis associated with radiation therapy, chemotherapy, or hematopoietic stem cell transplantation (HSCT). Details: Clinical research shows that using an oral rinse containing German chamomile extract (Kamillosan Liquidum, Asta Media AG) three times daily might help prevent or treat mucositis associated with radiation therapy and several chemotherapy drugs, but not 5-fluorouracil (6655,6656). Other clinical research in patients undergoing HSCT shows that using German chamomile 1% oral rinse twice daily along with standard care reduces the risk of oral mucositis by 67% when compared with standard care alone. However, 0.5% and 2% rinses did not decrease the risk, suggesting that the study may have been underpowered to detect differences (99853). German chamomile has also been studied in combination with other herbal ingredients. One clinical study shows that using an oral rinse containing 1% peppermint oil and 1% German chamomile extract, diluted in water, three times daily starting 1 week before HSCT might help to reduce the severity and duration of oral mucositis induced by high-dose pre-HSCT chemotherapy when compared with placebo. However, the oral rinse does not prevent oral mucositis or reduce the duration of hospitalization when compared with placebo (95622). Another small clinical study in adults with head and neck cancer receiving radiotherapy shows that rinsing with 5 mL of a mouthwash containing German chamomile, peppermint oil, aloe vera, and honey 3 times daily for 60 seconds for 6 weeks starting on the first day of radiotherapy reduces oral mucositis incidence, severity, and pain compared with chlorhexidine and placebo (111291). It is unclear if these findings are due to German chamomile, other ingredients, or the combination.
Peptic ulcers. Although there has been interest in using oral German chamomile for peptic ulcers, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
Periodontitis. German chamomile 1% mouthwash may be similarly effective to chlorhexidine 0.12% mouthwash. Details: Preliminary clinical research shows that using 15 mL of a 1% German chamomile flower mouthwash twice daily for 30 days reduces symptoms and severity of periodontitis by a similar amount when compared with chlorhexidine 0.12% mouthwash (104808).
Pressure ulcers. Although there has been interest in using oral German chamomile for pressure ulcers, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
Radiation dermatitis. It is unclear if topical German chamomile is beneficial for preventing dermatitis caused by radiotherapy. Details: A small clinical study in adults with head and neck cancer undergoing radiotherapy who developed dry desquamation shows that applying a German chamomile 2.5% compress, 20 minutes 3 times daily, results in complete or partial regression of the dry desquamation in 65% and 35% of patients, respectively, and delays the development of moist desquamation by 5-10 days (111376). The validity of these findings is limited by a lack of a comparator group. Another small clinical study in females with breast cancer shows that using a lotion containing a microencapsulated German chamomile extract 0.2%, applied daily after radiation therapy, starting on the first day and continued until the end of treatment, does not improve the incidence or time to onset of any grade of radiation dermatitis on day 35, although it may delay the time to onset of grades 2 or greater, when compared with an identical lotion vehicle control. German chamomile may modestly improve the rate of skin recovery in those with more severe dermatitis over the 15 days following therapy completion (108993). However, due to the small size of the study and short follow-up duration, the validity of these findings is unclear.
Rhinosinusitis. Using German chamomile nose drops might improve symptoms of rhinosinusitis. Details: Preliminary clinical research in patients with rhinosinusitis shows that using 3 drops of an ethanolic German chamomile extract in each nostril three times daily for 3 weeks reduces symptom scores and improves quality of life when compared with a sesame seed oil placebo (104810).
Sexual dysfunction. A 5% German chamomile vaginal gel may have similar efficacy to conjugated estrogen vaginal cream in postmenopausal patients. Details: Preliminary clinical research in postmenopausal patients with sexual dysfunction shows that using a 5% German chamomile vaginal gel, 1 gram nightly for 2 weeks then twice weekly for 10 weeks, decreases dyspareunia and increases sexual satisfaction to a similar extent as conjugated estrogen vaginal cream used in the same dosage (104809).
Vaginitis. Although there has been interest in using oral German chamomile for vaginitis, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
Venous leg ulcers. Although there has been interest in using oral German chamomile for venous leg ulcers, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
Wound healing. It is unclear if topical German chamomile is beneficial for wound healing. Details: Preliminary clinical research in adults undergoing abrasive tattoo removal shows that applying a topical German chamomile product (Kamille Spitzner, W. Spitzner Arzneimittelfabrik GmbH) three times daily for 14 days reduces wound size by day 4 of treatment when compared with placebo (19718). However, no significant differences in wound healing were observed after 18 days. More information is needed to rate German chamomile for these uses.

(Read more about GERMAN CHAMOMILE)

LAVENDER (Lavender flowering tops Oil)

POSSIBLY EFFECTIVE

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). Additionally, guidelines from the American Society of Clinical Oncology and the Society for Integrative Oncology provide a weak recommendation for the use of lavender essential oil inhalation in people with cancer procedure-related anxiety. The recommendation is based on low-quality evidence (114626,114642). 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 (58077,58080,58098,95640,97257,103061,103069,112255,114628). Subgroup analyses of 5 clinical studies suggest 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). Additionally, an individual patient-level analysis of 5 clinical studies shows that while Silexan is beneficial in mild to severe anxiety, treatment effects may be more pronounced in those with greater severity at baseline (114628). Limited research has compared Silexan to some conventional prescription medications. 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 similarly 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. Lavender aromatherapy has also been evaluated. Meta-analyses of clinical trials in adults 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). A meta-analysis of 5 clinical studies in adults undergoing hemodialysis shows that aromatherapy with 2% to 100% lavender oil reduces anxiety when compared with control groups receiving no intervention (114625). 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 adults. Clinical research also shows that lavender oil aromatherapy may 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 (MDD) (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 adults, or in adults with MDD, 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). Some research has compared lavender with traditional antidepressants. A large clinical study in adults with mild to moderate MDD shows that taking Silexan 80 mg daily for 8 weeks reduces symptoms of depression as measured on the Montgomery-Asberg Depression Rating Scale (MADRS), and also improves functional impairment, when compared with placebo. These improvements were similar to those seen in a control group taking sertraline 50 mg daily (114631). Conversely, a small clinical study in adults with mild to moderate MDD shows that drinking 60 drops per day of a 1:5 tincture of lavender appears to be slightly less effective than imipramine 100 mg daily; however, lavender might have some additive antidepressant effects when used in combination with imipramine (9792). The validity of these findings is limited by the small study size. Lavender has also been taken in combination with other products. A small clinical study in adults 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 populations, and no studies were specific to adults with MDD. Lavender aromatherapy was compared with no intervention, routine care, other aromatherapy oils, or distilled water (109860). A small clinical study in adults with post-stroke depression shows that lavender aromatherapy via microcapsules placed inside of a nonwoven bag under the pillow each night for 4 weeks reduces symptoms of depression when compared with control (114627). 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.
Pain (acute). Most clinical research suggests that lavender aromatherapy modestly reduces acute pain from needle insertion or other procedures in infants and adults. The benefit of oral lavender or lavender aromatherapy for other forms of acute pain is unclear. Details: Lavender oil aromatherapy has shown modest benefit for limiting acute pain in adults undergoing a variety of medical procedures. A meta-analysis of 6 small clinical studies shows that lavender aromatherapy, inhaled or as topical application, reduces the severity of pain experienced with arteriovenous fistula catheter insertion for hemodialysis when compared with control (114632). A clinical study in adults with diabetes shows that topical lavender oil sprayed 3 times on the arm five minutes before insulin injection reduces injection site pain when compared with placebo (112254). Additionally, a clinical study in adults undergoing surgical drain removal shows that administering lavender aromatherapy as 2 drops of lavender oil in the oxygen mask reduces pain similarly to a cold compress and to a greater extent than oxygen alone or a control group receiving no intervention (114633). Clinical research also shows that inhaling 10% lavender oil from a heat lamp for 10-15 minutes prior to gynecological exams reduces pain experienced during the exam when compared with no treatment (95639). However, lavender aromatherapy may not reduce pain related to extracorporeal shockwave lithotripsy (ESWL). A clinical study in adults with kidney stones shows that inhaling 4 drops of diffused lavender oil does not reduce pain or the use of self-administered opioids after ESWL when compared with standard care. These results were unchanged when lavender aromatherapy was combined with music (112258). The validity of these findings is limited by a lack of blinding and the high variability in kidney stone size between groups. Lavender oil aromatherapy also seems to modestly reduce pain in infants undergoing various medical procedures. One clinical study in term infants shows that aromatherapy with lavender oil 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 to a similar extent as 2 mL of 30% glucose solution and to a greater extent than no intervention (103066). A small clinical study in preterm 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 reduces pain scores when compared with exposure to an unscented cotton ball (104442). Another small clinical study in preterm infants shows that placing cotton soaked with lavender oil in front of the infant's nose for 5 minutes before and 2 minutes after venipuncture reduces pain intensity during and after venipuncture to a similar extent as cotton soaked in breastmilk but to a greater extent than cotton soaked with distilled water (114638). A small clinical study also shows that applying a gauze pad containing one drop of lavender oil under the nose, starting 2 minutes before 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 for this purpose (109810).

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).

INSUFFICIENT RELIABLE EVIDENCE to RATE

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 improving the symptoms of mild to moderate COVID-19. Details: A small clinical trial in adults 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 participants 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). A clinical study in adults with mild to moderate respiratory symptoms, suspected by not confirmed to be caused by COVID-19, shows that taking lavender syrup 9 mL twice daily for 3 weeks with standard care reduces severity of cough and anosmia, but not anxiety or any other respiratory symptoms, when compared with standard care alone (114635). The interpretation of these results is limited by the lack of a placebo group and the lack of confirmation of COVID-19 infection.
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, but not all, 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 (95642,98524,109867). A meta-analysis of 5 clinical studies in patients undergoing hemodialysis shows that aromatherapy with 5% to 100% lavender essential oil reduces fatigue when compared with control groups inhaling almond oil or receiving no intervention (114625). 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. Lavender has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with mild hypertension shows that aromatherapy with lavender oil 0.3% and ylang ylang oil 0.7%, provided via a fabric sticker placed on participant shirt collars, modestly reduces systolic blood pressure after 3 days of use and heart rate after 14 days of use when compared with control stickers containing no essential oils (114641).
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 small 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. Additionally, a small clinical study in adults with post-stroke depression shows that lavender aromatherapy via microcapsules placed inside of a nonwoven bag under the pillow each night for 4 weeks improves sleep quality, latency, and duration when compared with control (114627). 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. Small studies suggest that lavender oil aromatherapy may help to modestly reduce pain during childbirth. Details: A meta-analysis of clinical trials 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 included studies were 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 either lavender aromatherapy or oral lavender reduce menopausal symptoms such as hot flashes. 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 flashes 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). Oral lavender has also been evaluated for improving menopausal symptoms. A small clinical study in postmenopausal adults shows that taking lavender essential oil 80 mg daily by mouth for 2 months does not improve overall menopausal symptom scores when compared with placebo. Although it modestly improved symptoms of sexual dysfunction, it did not improve other vasomotor, physical, or psychological menopausal symptoms when compared with placebo (114629).
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 or lavender aromatherapy is beneficial for reducing fatigue in adults with multiple sclerosis (MS). Details: A small clinical trial in adults 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). Another small clinical study in adults with MS living in Turkey shows that lavender aromatherapy, provided as 3 drops of lavender oil on cotton pads placed 15-20 cm from the bed pillow nightly for 30 days, reduces fatigue severity and improves sleep quality when compared with no intervention (114630).
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).
Perioperative anxiety. It is unclear if lavender aromatherapy is beneficial for perioperative anxiety. Details: A 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). Conversely, a 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 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 and the high variability in kidney stone size between groups. Lavender has also been evaluated in combination with other ingredients. A clinical study in adults undergoing port catheter placement under modified anesthesia shows that preoperative and intraoperative placement of an aromatherapy patch containing lavender and peppermint essential oils (Elequil Aromatabs, Beekley Corporation) near the head does not reduce benzodiazepine or opioid requirements or time to discharge when compared with a placebo patch (114623). It is unclear if the use of an oxygen mask during the procedure resulted in inadequate exposure to the aromatherapy oils.
Polycystic ovary syndrome (PCOS). It is unclear if lavender is beneficial for PCOS. Details: A small clinical study in adults with PCOS between the ages of 18-45 who had not received any prior treatment for the condition shows that taking lavender 250 mg twice daily for 90 days increases serum progesterone levels and reduces menstrual cycle length similarly to metformin 500 mg three times daily (114634).
Postdural puncture headache. It is unclear if lavender aromatherapy improves postdural puncture headache severity. Details: A small clinical study in adults 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).
Postherpetic neuralgia. It is unclear if lavender aromatherapy is beneficial for alleviating pain in postherpetic neuralgia. Details: A small clinical study in adults with postherpetic neuralgia shows that aromatherapy with either lavender oil 1% or oils containing two of its major constituents (linalool 1% or linalyl acetate 1%), placed on gauze and then inhaled with natural breathing for 5 minutes, reduces the intensity and severity of pain when compared with almond oil control (114624). The validity of this finding is limited by the short-term nature of the study; any benefit beyond 5 minutes was not evaluated.
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). A specific combination patch providing both lavender and peppermint essential oils (Elequil Aromatabs, Beekley Corporation) has also been evaluated, with conflicting findings. A clinical study in adults undergoing port catheter placement under modified anesthesia shows that preoperative and intraoperative placement of this patch near the head does not reduce antiemetic requirements, the proportion of patients requiring antiemetics, or average PONV scores when compared with a placebo patch (114623). It is unclear if the use of an oxygen mask during the procedure resulted in inadequate exposure to the essential oils. Conversely, a small clinical study in patients with anxiety prior to primary unilateral total hip arthroplasty shows that placement of this patch on the gown at least 1 hour before surgery, with re-application every 12 hours postoperatively for 2 days, reduces PONV on postoperative day 2 when compared with a placebo patch (114622). It is unclear if this effect is due to lavender, peppermint, or the combination.
Postoperative pain. The evidence for the use of lavender aromatherapy for pain after various types of surgical procedures is conflicting. Details: Some small clinical studies 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 modestly reduces postoperative pain when compared with control (58093,101724). A small clinical study in adults 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). 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). Additionally, a clinical study in adults hospitalized after abdominal surgery shows that a lavender oil-infused warm water foot bath for 20 minutes each night for 3 nights after surgery does not reduce postoperative pain when compared with a standard warm water foot bath (114637). Likewise, a clinical study in adults hospitalized after total knee or hip arthroplasty shows that lavender aromatherapy administered via inhalers and used as needed does not reduce pain or analgesic use when compared with control (114639). Lavender oil aromatherapy has also been evaluated in children. 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 acetaminophen use when compared with control (90513). A specific combination patch providing both lavender and peppermint essential oils (Elequil Aromatabs, Beekley Corporation) has also been evaluated, with conflicting findings. A clinical study in adults undergoing port catheter placement under modified anesthesia shows that preoperative and intraoperative placement of the patch near the head does not reduce time to readiness for discharge, opioid requirements, or pain intensity scores when compared with a placebo patch (114623). It is unclear if the use of an oxygen mask during the procedure resulted in inadequate exposure to the essential oils. Conversely, a small clinical study in patients with anxiety prior to primary unilateral total hip arthroplasty shows that placing the patch on the gown at least 1 hour before surgery, with re-application every 12 hours postoperatively for 2 days, reduces opioid use on postoperative day 2, as well as pain scores and acetaminophen use on postoperative day 7, when compared with a placebo patch (114622). It is unclear if any effect is due to lavender, peppermint, or the combination.
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). Similarly, a meta-analysis of 19 small to moderate-sized clinical studies in adults undergoing various types of surgical procedures shows that lavender aromatherapy modestly reduces preoperative anxiety when compared with routine care or placebo (114636). However, most of the studies included in these meta-analyses 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 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.
Pruritus. Topical lavender has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in older females with pruritus shows that aromatherapy massage utilizing a 4:1:1 mixture of lavender, Roman chamomile, and sandalwood oils diluted to 1.5% in sweet almond oil, three times weekly for 1 month, modestly improves pruritus and reduces pruritus-related stress when compared with sandalwood oil alone. However, it does not improve skin pH or level of hydration (112365). It is unclear if these findings are due to lavender, other ingredients, or the combination.
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 small clinical studies suggest that lavender oil aromatherapy massage may be beneficial for RLS in patients undergoing hemodialysis. Its benefits in other patient populations are unclear. Details: A meta-analysis of 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 (95638,103064,109865,114632). 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 10-45 minutes during hemodialysis sessions for 3-4 weeks (95638,103064,109859,109865).
Stress. Some clinical studies suggest that inhaling lavender oil as aromatherapy may reduce stress. However, overall research is conflicting. 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, a clinical study in pharmacy students shows that 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, when compared with inhaling an odorless oil, although both were more effective than no intervention (101723). Lavender oil aromatherapy has shown conflicting results when evaluated for reducing stress in 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.

(Read more about LAVENDER)

LEMON BALM

POSSIBLY EFFECTIVE

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 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. Although studies have assessed oral lemon balm as monotherapy, its use in combination with other ingredients has also been explored. 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). Additionally, a single-center clinical study in Iranian adults with constipation-predominate irritable bowel syndrome (IBS-C) shows that taking a lemon balm, anise, and rose hip extract supplement twice daily for 4 weeks reduces anxiety and depression scores,on a patient-reported survey, when compared with placebo (115636). The validity of these results is limited by the lack of data regarding history or diagnosis of anxiety or depression. It is not clear if this effect is due to lemon balm, the other ingredients, or the combination.
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).

INSUFFICIENT RELIABLE EVIDENCE to RATE

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). Although studies have assessed oral lemon balm as monotherapy, its use in combination with other ingredients has also been explored. A single-center clinical study in Iranian adults with constipation-predominate irritable bowel syndrome (IBS-C) shows that taking a lemon balm, anise, and rose hip extract supplement twice daily for 4 weeks reduces anxiety and depression scores, on a patient-reported survey, when compared with placebo (115636). The validity of these results is limited by the lack of data regarding history or diagnosis of anxiety or depression. It is not clear if this effect is due to lemon balm, the other ingredients, or the combination.
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).
Dyslipidemia. It is unclear if oral lemon balm is beneficial in patients with dyslipidemia. Details: A meta-analysis of 5 small clinical studies in adults shows that oral lemon balm extract, leaf powder, or tea in doses ranging from 700-4000 mg daily for 8-24 weeks reduces low-density lipoprotein (LDL), total cholesterol (TC), and triglycerides (TG) when compared with placebo; however, the clinical significance of these findings is unclear (115638). The validity of these results is limited by the heterogenous methods between clinical trials, including population, dose, and study duration.
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. It is unclear if oral lemon balm is beneficial for insomnia. Details: A small, cross-over clinical study in Italy in adults with self-reported poor sleep quality shows that taking a specific lemon balm phytosome (Meloff, Pharmextracta SpA) 400 mg 30 minutes prior to bed for 2 weeks improves some, but not all, measures of sleep quality when compared with placebo . (115637). However, it is unclear if these improvements are clinically significant. Additionally, lemon balm has been evaluated in combination with other ingredients. 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.

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PASSION FLOWER (Passionflower)

POSSIBLY EFFECTIVE

Anxiety. Oral passion flower has a long history of use as a sedative and may improve symptoms of anxiety in some patients. Details: Preliminary clinical research shows that taking a specific dried alcoholic extract of passion flower (Sedanxio, Tilman SA) 400 mg orally twice daily for 2-8 weeks reduces the severity of non-specific anxiety when compared to baseline (88198). The validity of this finding is limited by the lack of a placebo group. Passionflower has also been evaluated as an adjunct to conventional medication. One clinical small study in patients with generalized anxiety disorder shows that taking a specific passion flower extract (Pasipay, Iran Darouk Pharmaceutical Company) 15 drops three times daily along with sertraline 50-100 mg daily for one month reduces anxiety when compared with taking sertraline alone (95036). Passion flower has also been compared to conventional treatments. One preliminary clinical study shows that taking passion flower extract 90-180 mg daily reduces symptoms of non-specific anxiety when compared to baseline, and seems to be comparable to taking mexazolam (15391). A small clinical study in patients with generalized anxiety disorder shows that taking a specific passion flower extract (Pasipay, Iran Darouk Pharmaceutical Company) 45 drops orally once daily for 28 days reduces anxiety similarly to oxazepam 30 mg daily. However, passion flower appears to have a slower onset of action than oxazepam (8007). This finding is limited because it did not utilize a therapeutic dosing regimen for oxazepam, which is given 3-4 times daily to account for its short half-life. Passion flower has also been studied in combination with other ingredients. A small clinical study in healthy adults shows that taking a combination of herbal extracts containing passion flower 40 mg, valerian root, black horehound, and hawthorn (Euphytose, Bayer HealthCare) 6 times daily with meals for 14 days reduces anxiety and 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.
Insomnia. Moderate-sized clinical studies suggest that oral passion flower may modestly improve total sleep time in patients with insomnia; however, its effects on sleep latency and maintenance are mixed. Details: A moderate-sized clinical study in adults in India with insomnia and stress shows that taking passion flower extract 600 mg daily at bedtime for 30 days increases total sleep time by about 30 minutes and reduces both the time to fall asleep and wake time after sleep onset by about 10 minutes when compared with placebo (114529). The validity of these findings is limited by lack of reporting on baseline use of medications or other substances which may impact sleep and exclusion of patients with severe insomnia. Another moderate-sized clinical study in adults with insomnia shows that taking passion flower extract 60 mg every evening before bedtime for 2 weeks increases total sleep time by around 23 minutes, but doesn't seem to improve sleep efficiency, sleep latency, or awakening after sleep onset, when compared with placebo (102866). Additionally, a smaller clinical study in young adults with mild fluctuations in sleep quality shows that drinking tea prepared by steeping passion flower aerial parts 2 grams in 250 mL of boiling water for 10 minutes every evening, about an hour before bedtime for 7 nights, improves subjective ratings of sleep quality, but not other sleep parameters, when compared with placebo (parsley tea) (17374). Passion flower has also been studied in combination with other ingredients. One small clinical study in adults with primary insomnia shows that taking a specific combination product containing passion flower 80 mg, valerian 300 mg, and hops 30 mg (NSF-3, M/s Tablets India) orally at bedtime for 2 weeks yields similar effects on subjective measures of sleep as zolpidem 10 mg nightly (88193).
Pre-procedural anxiety. Oral passion flower modestly reduces preoperative anxiety. Details: Two small clinical studies in adults awaiting dental surgery or inguinal hernia repair surgery shows that taking a specific passion flower extract (Pasipay, Iran Darouk Pharmaceutical Company) reduces preoperative anxiety when compared with placebo. Passion flower extract was given as 20 drops or 500 mg 90 minutes prior to surgery, with or without another dose on the evening before surgery (88195,88196). Another small clinical study shows that drinking 5 mL of syrup containing passion flower aqueous extract (Passiflora syrup, Sandoz) 700 mg orally 30 minutes before epidural catheter insertion for inguinal hernia repair surgery seems to attenuate anxiety; the placebo group experienced a significant increase in anxiety (88194). This finding is limited because there were no statistical comparisons conducted between groups. Passion flower has also been compared with conventional medications. Three clinical studies show that taking passion flower prior to dental surgery decreases preoperative anxiety similarly to oral midazolam 15 mg. One study used passion flower 260 mg, administered 30 minutes prior to the surgery (95038), the second used 500 mg, administered 60 minutes prior (104206), and the third used 600 mg, administered 45 minutes prior (110014). Of the two studies that evaluated patient preference, patients in one study preferred midazolam, possibly due to its ability to cause perioperative amnesia (95038), whereas there was no preference in the other study (110014). Another clinical study shows that taking passion flower 1000 mg one hour prior to elective minor or moderate surgery reduces preoperative anxiety similarly to melatonin 6 mg; however, passion flower seems to cause more cognitive impairment than melatonin (95037).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Adjustment disorders. Oral passion flower has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical study in patients with adjustment disorder with anxious mood shows that taking two tablets of a specific combination product (Euphytose, Bayer Healthcare) three times daily seems to decrease anxiety symptoms when compared with placebo. One tablet contains the dry extracts of passion flower 40 mg, valerian 40 mg, hawthorn 10 mg, and black horehound 10 mg, as well as the caffeine-containing stimulant herbs kola nut 15 mg and guarana 15 mg (6250). It is unclear if this effect is due to passion flower, other ingredients, or the combination.
Alcohol use disorder. Oral passion flower has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults experiencing alcohol withdrawal symptoms shows that taking one capsule of a combination product (Relief) three times daily for 15 days reduces the frequency of excessive sweating, reduces serum liver enzyme levels, and improves appetite and quality of life when compared to baseline. One capsule contains passion flower extract 30 mg, black seed extract 100 mg, cocoa extract 90 mg, radish extract 165 mg, and saffron extract 15 mg (97280). The validity of these findings is limited by the lack of a comparator group.
Attention deficit-hyperactivity disorder (ADHD). It is unclear if oral passion flower is beneficial in patients with ADHD. Details: A small clinical trial in children aged 6-13 years with ADHD shows that taking tablets of passion flower (Pasipay, Iran Darouk Pharmaceutical Company) 0.02 mg/kg orally twice daily for 8 weeks reduces parent and teacher ratings of ADHD symptoms no better than taking methylphenidate (0.5 mg/kg twice daily) (88197).
Benzodiazepine withdrawal. It is unclear if oral passion flower is beneficial for benzodiazepine withdrawal. Details: A moderate-sized observational study in adults with depression or anxiety on antidepressants undergoing a benzodiazepine taper after chronic benzodiazepine use suggests that taking a specific dry extract of passion flower (Tractana, Baldacci) 200-600 mg daily for 3 months is associated with a faster benzodiazepine dose reduction and greater percentage of patients with at least 50% reduction or complete benzodiazepine discontinuation after 1 and 3 months from taper initiation when compared with control (111651). The validity of these effects is limited by a lack of placebo group and the retrospective observational study design.
Congestive heart failure (CHF). Oral passion flower has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with mild CHF shows that taking a combination of passion flower and hawthorn extracts 2 mL three times daily for 6 weeks increases six-minute walking distance when compared with placebo. However, it does not appear to improve exercise capacity on a bicycle ergometer test (19201). It is unclear if this effect is due to passion flower, hawthorn, or the combination. Additionally, hawthorn has been evaluated alone for the management of CHF, with some research suggesting that although it may improve symptoms, it may also be associated with worsened clinical outcomes.
Fibromyalgia. Although there is interest in using oral passion flower for fibromyalgia, there is insufficient reliable information about the clinical effects of passion flower for this condition.
Menopausal symptoms. Although there is interest in using oral passion flower for menopausal symptoms, there is insufficient reliable information about the clinical effects of passion flower for this purpose.
Muscle cramps. Although there is interest in using oral passion flower for muscle cramps, there is insufficient reliable information about the clinical effects of passion flower for this purpose.
Neuropathic pain. Although there is interest in using oral passion flower for neuropathic pain, there is insufficient reliable information about the clinical effects of passion flower for this condition.
Opioid withdrawal. It is unclear if oral passion flower helps to prevent opioid withdrawal. Details: A small preliminary clinical study in adults who are completing an inpatient withdrawal program for opioid addiction shows that taking passion flower liquid extract 60 drops, in combination with clonidine 0.8 mg daily, is better than clonidine alone when used for reducing symptoms such as anxiety, irritability, insomnia, and agitation. However, the combination is no better than clonidine alone for reducing physical symptoms such as tremor and nausea (2303).
Seizures. Although there is interest in using oral passion flower for seizures, there is insufficient reliable information about the clinical effects of passion flower for this condition.
Stress. It is unclear if oral passion flower reduces stress. Details: A moderate-sized clinical study in adults in India with stress and insomnia shows that taking passion flower 600 mg daily at bedtime for 30 days modestly reduces stress when compared with placebo (114529). It is unclear how changes in stressors over the course of the study may have affected results. Additionally, a small clinical study in healthy adults shows that taking a specific combination product (Relaxane, Max Zeller Söhne AG) containing passion flower 90 mg, lemon balm 50 mg, valerian 90 mg, and butterbur 90 mg three times daily for 3 days modestly reduces subjective anxiety scores during social stress testing when compared with placebo or no treatment (97276). It is unclear if this effect is due to passion flower, other ingredients, or the combination. More evidence is needed to rate passion flower for these uses.

(Read more about PASSION FLOWER)

THEANINE (L-Theanine)

POSSIBLY EFFECTIVE

Cognitive function. Oral L-theanine may improve some aspects of cognitive function. It is unclear if using L-theanine in conjunction with caffeine can enhance the effects of either ingredient. Details: A single dose of L-theanine 100 mg seems to improve vigilant attention, reducing error rates in cognitive tests when compared with placebo (91747). However, taking L-theanine (Suntheanine, Taiyo Kagaku) 200 mg daily for 4 weeks does not improve verbal fluency, memory, motor speed, or executive function in an adult population, although it may moderately improve verbal fluency in a subgroup of people with lower cognitive function at baseline (101986). When L-theanine is combined with caffeine, a meta-analysis and multiple individual clinical studies show that the combination improves alertness, as well as accuracy during a test that requires switching attention between different tasks, but does not improve reaction time (38116,91750,96335,96336). Some research also shows that L-theanine plus caffeine improves cognitive performance and reduces task-induced fatigue when compared with baseline and placebo. However, it is unclear if this is due to the individual ingredients or the combination (38116,96335,96336). Some research suggests that the combination is no better than either individual ingredient alone (91747,96335,96336).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Age-related cognitive decline. It is unclear if oral L-theanine, taken continuously or as a single dose, improves cognition in older adults. Details: A small clinical study in healthy, Japanese adults aged 50-69 years shows that taking a specific product (Suntheanine; Taiyo International.) containing L-theanine 101 mg daily after breakfast for 12 weeks does not improve mini-mental state exam (MMSE) scores when compared with placebo. However, a single-dose analysis from this study shows that administration of L-theanine 101 mg may improve the quality of working memory and reaction times during a cognitive function test when compared with placebo (108553). Patients were permitted to consume polyphenol-rich beverages during the study period; however, consumption was not documented, limiting the validity of this finding.
Alzheimer disease. Although there is interest in using oral theanine for Alzheimer disease, there is insufficient reliable information about the clinical effects of theanine for this condition.
Anxiety. It is unclear if oral L-theanine is beneficial in patients with anxiety. Results of clinical research are conflicting. Details: A preliminary clinical study shows that taking a single dose of a specific L-theanine product (Suntheanine, Taiyo Kagaku) 200 mg does not reduce experimentally-induced anticipatory anxiety when compared with placebo (12188). However, another preliminary clinical study in healthy adults with stress-related anxiety shows that taking L-theanine 200 mg daily for 4 weeks reduces anxiety scale scores and sleep disturbance when compared with placebo (101986).
Attention. It is unclear if oral theanine improves attention. Details: A small clinical study in healthy males shows that taking a single dose of L-theanine 200 mg improves selective attention similar to a single dose of caffeine 160 mg (96337). However, other small clinical studies in adults show that taking L-theanine 100-400 mg does not improve most measures of attention, especially sustained attention or attention in executive control tasks, but doses of 100-200 mg may improve performance in simple attentional tasks when compared with placebo (96338,111396). Some of these studies suggest that taking L-theanine with caffeine appears to provide more benefit than either individual ingredient alone (96337,96338).
Attention deficit-hyperactivity disorder (ADHD). Oral L-theanine seems to improve some aspects of ADHD, including cognition and sleep. Details: Some preliminary clinical research in children with ADHD shows that taking a one-time dose of L-theanine 2.5 mg/kg increases cognition scores, but does not improve results on sustained attention or inhibitory control tests, when compared with placebo. Taking L-theanine with caffeine 2 mg/kg also increases cognition scores and improves performance on a sustained attention test, but does not improve inhibitory control, when compared with placebo (104141). Other preliminary clinical research in males aged 8-12 years with ADHD shows that taking a specific L-theanine product (Suntheanine, Taiyo Kagaku) 200 mg orally twice daily for 6 weeks increases the percent of time spent in restful sleep by about 5% and decreases the number of bouts of nocturnal activity by about 6 when compared with placebo (91744).
Cancer. Although there is interest in using oral theanine for cancer, there is insufficient reliable information about the clinical effects of theanine for this condition.
Chemotherapy-induced diarrhea. Oral L-theanine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with colon cancer shows that taking L-cystine 700 mg and L-theanine 280 mg (Ajinomoto Co. Inc.) orally once daily, starting one week before chemotherapy with TS-1 (Taiho Pharmaceutical) and continuing for 28 days, increases the rate of therapy completion by 49%, reduces the incidence of diarrhea by 37%, reduces appetite loss by 33%, and improves the reported tolerability of chemotherapy when compared with chemotherapy alone (96334). However, this combination does not appear to be beneficial in patients with gastric cancer, or in those with colorectal cancer receiving 4 courses of capecitabine-based adjuvant chemotherapy. (96334,101985).
Cognitive impairment. Oral L-theanine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One very small clinical study in adults with mild cognitive impairment shows that taking a product containing L-theanine 120 mg and green tea extract 720 mg (LGNC-07, LG Household & Health Care, Ltd) orally twice daily after meals for 16 weeks modestly improves memory and attention when compared with baseline. However, taking this product does not appear to improve memory and attention when patients with self-reported memory problems, but without mild cognitive impairment, are also considered (96339).
Depression. It is unclear if oral L-theanine is beneficial in patients with depression. Details: A small clinical study shows that taking a specific L-theanine product (Suntheanine, Taiyo Kagaku Co. Ltd.) 250 mg at bedtime for 8 weeks reduces symptoms and improves sleep quality when compared to baseline in individuals with mild major depressive disorder (MDD) (96331). The validity of these findings is limited by the lack of a comparator group. Another small clinical study in adults with MDD shows that taking L-theanine 200 mg daily with sertraline for 6 weeks reduces depression symptoms and increases remission rates but does not improve treatment response rates when compared with sertraline and placebo (112278). The validity of these effects is limited by the small sample size and short study duration. Additionally, it is unclear if the reduction in depressive symptoms is clinically significant.
Erythema. Oral L-theanine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in healthy females with self-perceived skin sensitivity shows that taking a specific supplement containing L-theanine, ashwagandha, and saffron (InnerCalm, Arbonne) daily for 8 weeks reduces facial pigmentation when compared to baseline (111399). The validity of this finding is limited by a lack of a placebo group. It is unclear if these effects are due to L-theanine, other ingredients, or the combination.
Generalized anxiety disorder (GAD). It is unclear if oral L-theanine is beneficial for reducing anxiety in people with GAD. Details: One small clinical study in adults with GAD shows that taking L-theanine 225 mg twice daily for 4 weeks, then 450 mg twice daily for 4 weeks, in conjunction with prescribed antidepressants, does not reduce anxiety scores when compared with antidepressants and placebo (104976).
Hypertension. Although there is interest in using oral theanine for hypertension, there is insufficient reliable information about the clinical effects of theanine for this condition.
Influenza. Oral L-theanine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination of green tea catechins (THEA-FLAN 90S, Ito-en Co.) 378 mg, standardized to contain epigallocatechin gallate 270 mg and L-theanine (Suntheanine, Taiyo Kagaku) 210 mg daily for 5 months reduces the risk of developing clinically diagnosed influenza when compared with placebo. However, the combination does not seem to prevent laboratory-confirmed influenza infection (54021).
Insomnia. It is unclear if oral L-theanine is beneficial for insomnia. Details: A very small clinical study in young healthy adults with sleep quality worsened by caffeine intake shows that taking L-theanine 50 mg (Suntheanine, Taiyo Kagaku Co. Ltd) once 10 minutes before bedtime suppresses caffeine-induced elevations in wake after sleep onset time but does not improve parameters of sleep quality including sleep onset latency, sleep time, or number of times waking after sleep onset when compared with placebo (112275). L-theanine has also been studied in combination with other ingredients. A small clinical study in adults with insomnia or disturbed sleep patterns shows that a specific product (RLX2; LiveLife Biosciences AG) containing L-theanine 50 mg and a specific casein peptide, alpha-s1-casein tryptic hydrolysate, 150 mg, taken one hour before bedtime for 4 weeks, increases sleep duration by 45 minutes and improves habitual sleep efficiency and daytime dysfunction when compared with baseline (108556). Another very small clinical study in healthy adults shows that taking a combination product containing tryptophan, glycine, magnesium, tart cherry powder, and L-theanine 2 hours before bedtime decreases sleep onset latency and increases total sleep duration, leading to better sleep efficiency and reduced morning sleepiness, when compared with placebo (111184). Another combination product containing L-theanine, ashwagandha, and saffron (InnerCalm, Arbonne), taken daily for 8 weeks, seems to improve sleep quality when compared to baseline (111399). However, the validity of this finding is limited by a lack of a control group. It is unclear if the effects described above are due to L-theanine, other ingredients, or the combination.
Obsessive-compulsive disorder (OCD). It is unclear if oral L-theanine is beneficial for OCD. Details: A small clinical study in adults with OCD shows that taking L-theanine 100 mg twice daily for 10 weeks with fluvoxamine reduces OCD symptoms, particularly obsessive symptoms, and increases the proportion of patients with a complete response to treatment but does not improve compulsive symptoms, partial response rates, or remission rates when compared with placebo and fluvoxamine (112276).
Postoperative recovery. Oral theanine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study of adults with esophageal cancer undergoing esophagectomy shows that taking theanine 280 mg and cystine 700 mg daily, staring 4 days before surgery and continued for 13 days after surgery, does not improve measures of physical activity but does improve exercise tolerance and some measures of quality of life when compared with placebo (111400). It is unclear if these findings are due to theanine, cystine, or the combination.
Schizophrenia. It is unclear if oral L-theanine is beneficial in patients with schizophrenia; the available evidence is limited and conflicting. Details: One small preliminary clinical study in adults with schizophrenia or schizoaffective disorder shows that taking L-theanine (Biosynergy) 200 mg orally twice daily for 8 weeks along with antipsychotic medications improves positive symptoms, anxiety, and general psychopathology symptoms, such as poor impulse control and disorientation, when compared with placebo. However, theanine does not improve general disease severity, negative symptoms, depression, cognitive function, extrapyramidal side effects, or quality of life (96341). In contrast, two small clinical studies show that taking L-theanine 400 mg (Suntheanine, BioSynergy Health Alternatives) with antipsychotics and with or without pregnenolone 50 mg daily for 8 weeks reduces negative symptoms, general psychopathology symptoms, and anxiety when compared with placebo in patients with schizophrenia or schizoaffective disorder. However, there were no improvements in positive schizophrenia symptoms, extrapyramidal side effects, or symptoms of depression (97923,112277). The inconsistency of results might be due to the small study sizes and the subjectivity of the outcomes measured.
Stress. It is unclear if oral L-theanine is beneficial in patients with stress. Details: One very small clinical study shows that taking L-theanine 200 mg prior to a stress-inducing exam reduces tension-anxiety and may prevent blood pressure increases caused by psychological stress when compared with placebo (91746). Other preliminary clinical research in pharmacy students shows that taking theanine 200 mg twice daily for one week prior, and then for the first 10 days of a pharmacy practice period, decreases subjective stress scores when compared with placebo (91745). Another small clinical study in healthy young adults shows that drinking a beverage containing L-theanine 200 mg alone or combined with L-arginine 50 mg after a psychological stressor reduces stress, as measured by salivary alpha-amylase activity, when compared with placebo. The combination of L-arginine and L-theanine did not differ from L-theanine alone, suggesting that the combination does not act synergistically to reduce markers of stress (110393). However, not all research has been positive. A small clinical study shows that taking a specific L-theanine product (Suntheanine, Taiyo Kagaku) 200 mg induces subjective feelings of tranquility in relaxed people, but not those with experimentally-induced anticipatory anxiety, when compared with placebo (12188). Also, a small, clinical crossover study in healthy, moderately stressed adults shows that taking a single dose of a specific product (Alphawave; Ethical Naturals) containing L-theanine 200 mg prior to a stress-inducing exam does not improve anxiety at any time point when compared with placebo (108554). Due to the single-dose nature of this study, the effects of continued administration of this product are unclear. L-theanine has also been evaluated in combination with other ingredients. A small clinical study in adults with stress shows that taking a specific combination product (Mg-Teadiola, Sanofi-Aventis Group), containing green tea extract 125 mg (providing 50 mg L-theanine), magnesium 150 mg, vitamin B6 0.2 mg, vitamin B9 0.1 mg, vitamin B12 1.25 mcg, and rhodiola 222 mg, orally once daily for 28 days modestly improves stress and anxiety scores when compared with placebo. Improvements in stress scores, but not anxiety scores, appear to persist at 28 days after treatment completion (108672). It is unclear if any effects are due to L-theanine, other ingredients, or the combination.
Tourette syndrome. It is unclear if oral L-theanine is beneficial in children with Tourette syndrome. Details: A small, nonblinded clinical study in children aged 4-17 years with untreated Tourette syndrome or with chronic tic disorder and associated symptoms of anxiety shows that taking a liquid nutritional supplement providing L-theanine 200 mg and vitamin B6 2.8 mg daily for 2 months improves scores on the Yale Global Tic Severity Scale, but does not reduce anxiety, when compared with patients receiving psychoeducation (108555). This study may have been inadequately powered to detect a difference between groups. More evidence is needed to rate theanine for these uses.

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Safety view details

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

GERMAN CHAMOMILE

LIKELY SAFE ...when used orally in amounts commonly found in foods. German chamomile has Generally Recognized as Safe (GRAS) status in the US (4912,110318).

POSSIBLY SAFE ...when used orally, for medicinal purposes, short-term. German chamomile has been used with apparent safety at doses of up to 1500 mg daily for up to 26 weeks (6655,12724,12729,13089,19377,19716,104806,111380). ...when applied topically. A lotion containing 0.2% microencapsulated German chamomile extract has been applied to the skin with apparent safety for up to 35 days (108993). ...when used topically as an oral rinse (99853).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. Preliminary clinical research suggests that several multi-ingredient products containing German chamomile are safe in infants when used for up to 4 weeks (16735,19705,19715,96278). ...when used topically and appropriately, short-term. Six drops of oil infused with German chamomile flower has been applied nightly with apparent safety for up to 6 weeks in children 6-18 years old (98621).

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

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LAVENDER (Lavender flowering tops Oil)

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, lavender essential oil, including 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 (58077,58080,58098,97257,112255,114629). 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 (7107,12213,16393,16394,95634,103062,103063,103065,103068,114627)(114636,114641).

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.

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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.

(Read more about LEMON BALM)

PASSION FLOWER (Passionflower)

LIKELY SAFE ...when used orally as a flavoring in foods. The US Food and Drug Administration (FDA) lists passion flower as a permitted food flavoring additive, to be used in the minimum quantity necessary (91203).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Passion flower extract has been used with apparent safety at doses up to 800 mg daily for up to 8 weeks (88198,102866). A specific passion flower extract (Pasipay, Iran Darouk Pharmaceutical Company) has been safely used at a dose of 45 drops daily for up to one month (8007,95036). Also, a tea prepared by steeping 2 grams of the dried aerial parts of passion flower in 250 mL of boiling water for 10 minutes has been used nightly for 7 nights (17374). There is insufficient reliable information available about the safety of passion flower when used topically.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. A specific passion flower product (Pasipay, Iran Darouk Pharmaceutical Company) has been used safely in children aged 6-13 years at a dose of 0.04 mg/ kg daily for 8 weeks (88197).

PREGNANCY: POSSIBLY UNSAFE
when used orally. Some case reports suggest that passion flower use during the first and second trimesters of pregnancy may be associated with an increased risk for premature rupture of membranes and meconium aspiration syndrome; however, causality has not been confirmed (97279). The alkaloids harman and harmaline, which are sometimes found in passion flower, have been reported to have uterine stimulant activity (4,11020,95037). It is not known whether these constituents are present in sufficient quantities to have an effect.

LACTATION:
Insufficient reliable information available; avoid using.

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THEANINE (L-Theanine)

POSSIBLY SAFE ...when used orally and appropriately, short-term. L-theanine has been used safely in clinical research in doses of up to 900 mg daily for 8 weeks (12188,36439,96331,96332,96334,96341,97923,101986,104976). There is insufficient reliable information available about the safety of L-theanine when used long-term.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. A specific L-theanine product (Suntheanine, Taiyo Kagaku) 200 mg twice daily has been used safely in males aged 8-12 years for up to 6 weeks (91744).

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

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Interactions with Drugs view details

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

GERMAN CHAMOMILE

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, German chamomile might have additive effects when used with CNS depressants.

Details

German chamomile has mild sedative effects. Theoretically, concomitant use with drugs with sedative properties can cause additive effects and side effects (9765,12725,19719).

CONTRACEPTIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, large amounts of German chamomile might reduce the effectiveness of oral contraceptives.

Details

In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, concomitant use of large amounts of German chamomile might interfere with contraceptive drugs through competition for estrogen receptors.

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, German chamomile might inhibit CYP1A2 and increase levels of drugs metabolized by these enzymes.

Details

In vitro and animal research shows that German chamomile might inhibit CYP1A2 (12734,19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP1A2 in patients taking German chamomile.

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, German chamomile might inhibit CYP2C9 and increase levels of drugs metabolized by these enzymes.

Details

In vitro evidence shows that German chamomile might inhibit CYP2C9 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2C9 in patients taking German chamomile.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, German chamomile might inhibit CYP2D6 and increase levels of drugs metabolized by these enzymes.

Details

In vitro evidence shows that German chamomile might inhibit CYP2D6 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2D6 in patients taking German chamomile.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, German chamomile might inhibit CYP3A4 and increase levels of drugs metabolized by these enzymes.

Details

In vitro evidence shows that German chamomile might inhibit CYP3A4 (6450,19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP3A4 in patients taking German chamomile.

ESTROGENS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, large amounts of German chamomile might reduce the effectiveness of estrogens.

Details

In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, large amounts of German chamomile might interfere with hormone replacement therapy through competition for estrogen receptors.

TAMOXIFEN (Nolvadex)

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, large amounts of German chamomile might interfere with the activity of tamoxifen.

Details

In vitro, German chamomile has demonstrated antiestrogenic activity (12728).

WARFARIN (Coumadin)

Interaction Rating = Moderate Be cautious with this combination.

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

German chamomile might increase the effects of warfarin and increase the risk of bleeding.

Details

In one case, a 70-year-old female taking warfarin developed retroperitoneal hematoma and bilateral recti muscle bleeding along with an INR of 7.9 following ingestion of German chamomile tea 4-5 cups daily and use of a topical chamomile-based lotion applied 4-5 times daily (14309).

(Read more about GERMAN CHAMOMILE)

LAVENDER (Lavender flowering tops Oil)

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.

(Read more about LAVENDER)

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).

(Read more about LEMON BALM)

PASSION FLOWER (Passionflower)

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

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

Concomitant use of passion flower with sedative drugs might cause additive effects and side effects.

Details

Research in animals and humans shows that passion flower has sedative effects which can be additive when used with sedative medications like lorazepam (8007,19235,19236,19429,68309,104206).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, passion flower might decrease the effects of CYP3A4 substrates.

Details

In vitro research suggests that passion flower can induce CYP3A4 enzymes, albeit to a much lower degree than rifampin, a known CYP3A4 inducer (110704).

ORGANIC ANION-TRANSPORTING POLYPEPTIDE SUBSTRATES (OATP)

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, passion flower might reduce the bioavailability of OATP2B1 and OATP1A2 substrates.

Details

In vitro research shows that the passion flower constituents apigenin and vitexin inhibit OATP2B1 and OATP1A2. This inhibition may be dose-dependent. One specific high-flavonoid passion flower extract (Valverde) seems to inhibit OATP2B1 and OATP1A2, while another extract with a lower flavonoid concentration (Arkocaps) shows less potent inhibition (105095). OATPs are responsible for the uptake of drugs and other compounds into the body; however, the specific activities of OATP2B1 and OATP1A2 are not well characterized.

(Read more about PASSION FLOWER)

THEANINE (L-Theanine)

ANTIHYPERTENSIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theanine might lower blood pressure, potentiating the effects of antihypertensive drugs.

Details

Animal research shows that theanine can lower blood pressure in spontaneously hypertensive animals (7687,77354). Theoretically, concomitant use of theanine and antihypertensive drugs might potentiate the antihypertensive activity.

CNS DEPRESSANTS

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, theanine might have additive sedative effects when used in conjunction with CNS depressants. However, it is unclear if this concern is clinically relevant.

Details

Theoretically, theanine may compete with glutamate and/or increase plasma gamma-aminobutyric acid (GABA) levels, which could cause CNS depression (96334). In one clinical study, some subjects taking oral theanine reported drowsiness (96331).

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Adverse Effects view details

Report an Adverse Reaction to Serenity

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

GERMAN CHAMOMILE

General ...Orally and topically, German chamomile is well tolerated.
Most Common Adverse Effects:
Orally and topically: Allergic reactions and irritation.

Dermatologic ...Topically, German chamomile may cause allergic dermatitis and eczema (9766,9768,10377,110318).

Gastrointestinal ...When used topically as an oral rinse, German chamomile has been reported to cause nausea and burning in the mouth in some patients (99853).

Immunologic ...Orally, German chamomile tea can cause allergic reactions including severe hypersensitivity reactions and anaphylaxis in some patients (567). In one case report, a 47-year-old female who tolerated drinking chamomile tea, reported sneezing, nasal and ocular itching, red and watery eyes, and severe rhinorrhea after 10 years of occupational exposure to German chamomile dust (90542).

Ocular/Otic ...If used near the eyes, German chamomile can cause irritation (10377).

(Read more about GERMAN CHAMOMILE)

LAVENDER (Lavender flowering tops Oil)

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 (58077,58080,58098,93004,103061,114631). 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). Orally, taking lavender was associated with itching and rash in one clinical study participant (114634).

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).

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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).

(Read more about LEMON BALM)

PASSION FLOWER (Passionflower)

General ...Orally, passion flower is well tolerated.
Most Common Adverse Effects:
Orally: Confusion, dizziness, hypersensitivity, and sedation.

Cardiovascular ...There is a case report involving a 34-year-old female who was hospitalized with severe nausea, vomiting, drowsiness, prolonged QT interval, and episodes of nonsustained ventricular tachycardia following use of passion flower extract tablets (Sedacalm, Bioplus Healthcare), 1500 mg on day 1 and 2000 mg on day 2 to relieve stress. All symptoms resolved within one week after passion flower was discontinued (6251).

Genitourinary ...The alkaloids harman and harmaline, which are sometimes found in small amounts in passion flower, have been reported to have uterine stimulant activity (4,11020,95037).

Hematologic ...Orally, passion flower has been reported to cause epistaxis in one clinical trial (95038). Vasculitis has also been reported with use of a specific herbal product (Relaxir) produced mainly from the fruits of passion flower (6).

Hepatic ...There is debate about whether passion flower contains cyanogenic glycosides. Several related Passiflora species do contain these constituents (3), including Passiflora edulis, which is associated with liver and pancreatic toxicity (7).

Immunologic ...An idiosyncratic hypersensitivity reaction characterized by urticaria and cutaneous vasculitis has been reported in a 77-year-old male with rheumatoid arthritis after taking a specific combination product that included passion flower extract (Naturest) (68308). It is unclear if these effects were caused by passion flower or other ingredients.
In clinical trials, passion flower has been reported to cause allergy symptoms including sinus irritation; however, the frequency of these events was statistically nonsignificant when compared to treatment with midazolam 15 mg (95038).

Musculoskeletal ...Orally, passion flower has been reported to cause muscle relaxation in a clinical trial (95038).

Neurologic/CNS ...Orally, sedation, dizziness, ataxia, and confusion have been reported in clinical trials. However, these events generally do not necessitate discontinuation (8007,15391,15392,95036,95038). Altered consciousness has been reported with use of a specific herbal product (Relaxir) produced mainly from the fruits of passion flower (6).

(Read more about PASSION FLOWER)

THEANINE (L-Theanine)

General ...Orally, L-theanine seems to be well tolerated.
Most Common Adverse Effects:
Orally: Drowsiness, headaches.

Neurologic/CNS ...Orally, L-theanine may cause headaches (36439). Patients have also reported drowsiness, increased duration of sleep, and increased dream activity after oral L-theanine use (96331).
A case of subtle facial tic starting within 4 days of taking L-theanine 400 mg daily has been reported for a pediatric patient. Although the tics reportedly ceased once theanine was discontinued, the child had exhibited tics in the past. Therefore, the adverse effect was not thought to be related to L-theanine (91744).

(Read more about THEANINE)

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