CCF Tea Joyful Heart [Discontinued] by Banyan Botanicals

Anorexia. Although there has been interest in using oral coriander to stimulate appetite in patients with anorexia, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Anxiety. Although there has been interest in using oral coriander for anxiety, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Constipation. Oral coriander has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in nursing home residents with constipation shows that taking one cup of a specific tea (Smooth Move, Traditional Medicinals) containing senna leaf 1080 mg and 920 mg of a proprietary blend of coriander fruit, licorice root, fennel, orange peel, cassia cinnamon, and ginger daily for 28 days can increase the number of bowel movements when compared with placebo (46196). It is unclear if this effect is due to coriander, other ingredients, or the combination.
Diabetes. Although there has been interest in using oral coriander for diabetes, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Diarrhea. Although there has been interest in using oral coriander for diarrhea, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Dyspepsia. Although there has been interest in using oral coriander for dyspepsia, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Epilepsy. Although there has been interest in using oral coriander for epilepsy, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Flatulence. Although there has been interest in using oral coriander for flatulence, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Insomnia. Although there has been interest in using oral coriander for insomnia, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Intestinal parasite infection. Although there has been interest in using oral coriander for intestinal parasite infection, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Irritable bowel syndrome (IBS). Oral coriander 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 taking 30 drops of a combination product containing total extracts of coriander, lemon balm, and spearmint (Carmint, Pour Sina) three times daily after meals for 8 weeks, in addition to standard treatment with loperamide or psyllium, reduces abdominal pain and discomfort when compared with standard treatment alone (19535). It is unclear if these effects are due to coriander, other ingredients, or the combination.
Lactation. Although there has been interest in using oral coriander to stimulate lactation, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Osteoarthritis. Although there has been interest in using oral coriander for osteoarthritis, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Rheumatoid arthritis (RA). Although there has been interest in using oral coriander for RA, there is insufficient reliable information about the clinical effects of coriander for this purpose.
Skin irritation. It is unclear if oral coriander seed oil is beneficial in patients with skin irritation. Details: A small clinical study in Caucasian females aged 18-65 years with sensitive and reactive skin shows that taking a specific coriander seed oil product (Sepibliss, Seppic Inc.) 200 mg daily for 8 weeks reduces redness and itching after exposure to skin stress tests and improves patient-rated perceptions of skin sensitivity and reactivity when compared with placebo (111131).
Tinea pedis. It is unclear if topical coriander oil is beneficial in patients with tinea pedis. Details: A small clinical study in adults with tinea pedis shows that applying coriander oil 6% ointment (Oleum Coriandri e Semine; Caesar & Loretz GmbH) twice daily to affected areas for 28 days is approximately 20% more effective for eliminating clinical signs of infection, as rated by patients and clinicians, when compared with applying the ointment alone (97874). More information is needed to rate coriander for these uses.

CUMIN

Diabetes. It is unclear if oral cumin is beneficial in patients with diabetes. Details: Two small clinical studies in adults with type 2 diabetes show that taking cumin essential oil 25-100 mg by mouth daily for 8-12 weeks reduces fasting blood glucose, glycated hemoglobin (HbA1c), serum insulin, and diabetes-associated inflammatory markers when compared with placebo (111368,111370). However, meta-analyses of studies in patients with and without type 2 diabetes show conflicting results. One analysis of seven clinical trials shows that taking cumin essential oil 25-300 mg daily for up to 24 weeks does not improve fasting plasma glucose, HbA1c, or other markers of glycemic control when compared with a control group (106516). Another meta-analysis evaluating eight clinical trials, including all seven assessed in the previous analysis, shows that cumin essential oil has a large effect on both fasting plasma glucose and HbA1c when compared with control (106517). These discrepant findings may be due to the inclusion of an additional trial in the second analysis or different methods for pooling study results.
Dyslipidemia. It is unclear if oral cumin is beneficial in patients with dyslipidemia. Details: A meta-analysis of six clinical trials including 376 individuals with or without hyperlipidemia shows that taking cumin reduces levels of total cholesterol by around 11 mg/dL and low-density lipoprotein (LDL) cholesterol by around 7 mg/dL when compared with control or placebo. Cumin also increases high-density lipoprotein (HDL) cholesterol levels by around 3 mg/dL, but does not affect triglyceride levels. A sub-analysis of dosages and dosage forms shows that cumin essential oil 25-100 mg daily or cumin powder 3 grams daily were beneficial, while lower doses of the powder or essential oil and all doses of cumin extract did not affect lipid levels. Patients included in the available research were either overweight or obese or had been diagnosed with type 2 diabetes or non-alcoholic steatohepatitis (NASH) (100162). It is not clear what effect, if any, cumin has in patients with diagnosed dyslipidemia.
Hypertriglyceridemia. Small clinical studies suggest that oral cumin extract or essential oil does not seem to reduce triglyceride levels in patients with hypertriglyceridemia, although it may improve other lipid parameters. Details: A meta-analysis of two small clinical trials in adults with either type 2 diabetes or non-alcoholic steatohepatitis (NASH) who also have hypertriglyceridemia shows that taking cumin extract 225 mg daily for 6 months or cumin essential oil 25 mg daily for 3 months modestly reduces levels of total cholesterol and low-density lipoprotein (LDL) cholesterol and modestly increases levels of high-density lipoprotein (HDL) cholesterol when compared with placebo. However, taking cumin does not improve triglyceride levels (100162).
Impaired glucose tolerance (prediabetes). It is unclear if oral cumin is beneficial in patients with prediabetes. Details: A small clinical trial in adults with prediabetes shows that taking cumin essential oil 75 mg daily for 10 weeks does not improve fasting blood glucose, glycated hemoglobin (HbA1c), or measures of insulin resistance but does seem to reduce body weight, body mass index (BMI), and low-density lipoprotein (LDL) cholesterol and increase high-density lipoprotein (HDL) cholesterol when compared with placebo (111369).
Irritable bowel syndrome (IBS). Although there has been interest in using oral cumin for IBS, there is insufficient reliable information about the clinical effects of cumin for this purpose.
Metabolic syndrome. It is unclear if oral cumin essential oil is beneficial in patients with metabolic syndrome. Details: A small clinical trial in adults with metabolic syndrome shows that taking cumin essential oil 75 mg three times daily for 8 weeks does not improve body weight, blood pressure, glycemic control, or lipid levels when compared with placebo (104143).
Nonalcoholic steatohepatitis (NASH). Although there has been interest in using oral cumin for NASH, there is insufficient reliable information about the clinical effects of cumin for this purpose.
Obesity. Small clinical studies suggest that oral cumin essential oil or powder may reduce body weight and body mass index (BMI) in overweight or obese individuals. Details: One small clinical study in overweight and obese individuals maintaining their usual diet and physical activity shows that taking cumin essential oil 100 mg three times daily for 8 weeks reduces weight by 1.3 kg and BMI by 0.5 kg/m2 when compared with placebo. The effect of cumin was similar to that of orlistat 120 mg three times daily. Cumin, but not orlistat, improved plasma insulin levels and insulin sensitivity; however, it did not affect insulin resistance, thyroid function, or plasma glucose or lipid levels (100160). Another small clinical study in overweight or obese females shows that taking cumin powder 1.5 grams in 150 mL of low-fat yogurt twice daily with meals as part of a calorie-restrictive diet for 3 months increases weight loss by an additional 2 kg when compared with yogurt and a calorie-restrictive diet alone. Intake of cumin also improved BMI, fat mass, waist circumference, and blood lipid levels, but did not affect fasting blood glucose levels (100161). More evidence is needed to rate cumin for these uses.

FENNEL

POSSIBLY EFFECTIVE

Dysmenorrhea. Taking fennel oil or extract by mouth may reduce pain in patients with primary dysmenorrhea. This benefit may be similar to ibuprofen or mefenamic acid. Details: Two separate meta-analyses in patients with primary dysmenorrhea show that taking fennel oil or fennel extract for 1-6 menstrual cycles reduces dysmenorrhea pain when compared with placebo. Improvement in pain was similar when compared with ibuprofen or mefenamic acid. In the included studies, doses of fennel oil ranged from 3-30 drops every 4-8 hours, and doses of fennel extract ranged from 30-230 mg daily (104196,108972). However, most studies included in these meta-analyses were small and low-quality, and all studies were conducted in Iran. Higher quality studies in other geographic locations are needed to confirm these findings.

Anxiety. Although there has been interest in using oral fennel for anxiety, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Bronchitis. Although there has been interest in using oral fennel for bronchitis, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Cancer. Although there has been interest in using oral fennel for cancer prevention, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Cholera. Although there has been interest in using oral fennel for cholera, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Colic. Small clinical studies suggest that oral fennel may reduce crying time in infants with colic. However, most research to date has evaluated fennel in combination with other ingredients. Details: A meta-analysis of three small clinical studies shows that giving fennel to infants with colic can reduce crying time by about 72 minutes daily when compared with placebo (97497). However, the studies included in this meta-analysis were at medium to high risk of bias, and the placebo response rate was high in all of the included studies. Additionally, two of the three studies evaluated combination products (16735,19715,49428). In the one study that used fennel alone, administering 5-20 mL of fennel seed oil 0.1% emulsion daily for one week led to colic relief in 65% of infants, compared with 24% of infants receiving placebo (49428). The other studies evaluated fennel in combination with lemon balm and German chamomile (ColiMil) or in combination with chamomile, vervain, licorice, and lemon balm (Calma-Bebi, Bonomelli). These combination products produced a response in 57% to 85% of infants, compared with 26% to 49% of infants receiving placebo (16735,19715).
Constipation. Oral fennel has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small crossover trial in patients with constipation shows that drinking an herbal tea containing 3 grams of a combination of fennel, anise, elderberry, and senna daily for 5 days can decrease colonic transit time, increase the number of daily evacuations, and improve the perception of bowel function when compared with placebo (49494). Another small clinical study in elderly patients with constipation shows that drinking a specific tea (Smooth Move, Traditional Medicinals) containing fennel, senna, licorice, orange peel, cassia cinnamon, coriander, and ginger for 28 days can increase the number of bowel movements when compared to baseline (46196). The validity of this finding is limited by the lack of a comparator group. Additionally, a small clinical study in patients aged 60-65 years with functional constipation shows that taking a traditional Iranian combination product containing 5 grams each of fennel seed and rose flower, dissolved in water twice daily before meals for 4 weeks, improves constipation severity and stool consistency when compared with polyethylene glycol 10 grams. Improvements in constipation severity persisted in both groups 4 weeks after treatment completion (108973). However, polyethylene glycol is usually taken at a higher dose of 17 grams daily, limiting the validity of these findings.
Cough. Although there has been interest in using oral fennel for cough, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Dementia. Although there has been interest in using oral fennel for dementia, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Diabetes. Although there has been interest in using oral fennel for diabetes, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Dyspepsia. Although there has been interest in using oral fennel for dyspepsia, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Flatulence. Although there has been interest in using oral fennel for flatulence, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Hirsutism. It is unclear if topical fennel is beneficial in patients with hirsutism. Details: A small clinical study in females with male pattern body hair due to unknown causes shows that applying a fennel 2% cream twice daily for 12 weeks can reduce hair diameter by approximately 19% when compared with placebo (49429).
Insomnia. Although there has been interest in using oral fennel for insomnia, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Irritable bowel syndrome (IBS). Oral fennel has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in adults with either diarrhea- or constipation-predominant IBS shows that taking two capsules containing fennel essential oil 25 mg and curcumin 42 mg per capsule (CU-FEO, Alfa Wassermann S.p.A.) twice daily for 30 days improves overall ratings of abdominal pain, abdominal distention, and quality of life by 24% when compared with placebo (97422).
Lactation. Although there has been interest in using oral fennel to stimulate breastmilk production, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Menopausal symptoms. Small clinical studies suggest that oral fennel oil or fennel seed powder may modestly improve menopausal symptoms. Details: One small clinical trial in adults with medium severity menopausal symptoms shows that taking fennel essential oil 60 mg daily for 8 weeks improves scores on the Menopause Rating Scale when compared with a sunflower oil placebo (97498). Another small clinical study in postmenopausal adults shows that taking fennel seed powder 2 grams daily for 8 weeks improves scores on the Kupperman Menopausal Index when compared with placebo (104198). Fennel has also been evaluated in combination with other ingredients. One small clinical study shows that taking a combination of fennel 120 mg, chamomile 1000 mg, and saffron 60 mg daily for 12 weeks reduces physical, psychological, and urogenital symptom scores on the Menopause Rating Scale when compared with placebo or lower doses of the combination (103628). Additionally, a moderate-sized clinical study in postmenopausal women conducted in Iran shows that taking combined fennel and valerian extract 500 mg twice daily for 8 weeks modestly improves self-reported scores for frequency and severity of hot flashes but does not improve sleep quality or duration of hot flashes when compared with placebo (112369). However, it is unclear if these benefits are due to fennel, other ingredients, or the combination.
Nausea and vomiting. Although there has been interest in using oral fennel for nausea and vomiting, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Nocturnal enuresis. Although there has been interest in using oral fennel for nocturnal enuresis, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Osteoarthritis. It is unclear if oral fennel extract is beneficial in patients with knee osteoarthritis. Details: A small clinical trial in females with osteoarthritis of the knee shows that taking powdered fennel extract 800 mg daily for 2 weeks reduces pain and disability scores, but not stiffness, when compared with placebo (104199).
Polycystic ovary syndrome (PCOS). It is unclear if oral fennel is beneficial in patients with PCOS. Details: A small clinical study in patients with PCOS shows that taking two fennel capsules, containing anethole 21-27 mg per capsule, daily along with a hypocaloric standard diet or a hypocaloric high-protein diet for 3 months does not reduce body weight or improve androgenic parameters such as testosterone levels, sex hormone-binding globulin levels, or free androgen index, when compared with these diets plus placebo (104197). Fennel has also been evaluated in combination with other ingredients. A clinical study in patients with oligomenorrhea due to PCOS shows that taking a traditional combination product (Aslagh) containing equivalent amounts of essential oils of fennel, wild carrot seeds, and Vitex agnus-castus fruit for 3 months, either alone or in combination with metformin, improves rates of menstrual bleeding and menstrual cyclicity similarly to metformin alone. All three groups experienced a significant improvement from baseline. Aslagh was taken as two, 500-mg capsules twice daily, except during menses; metformin was titrated over one week to a dose of 500 mg three times daily (108974). Additionally, a moderate-sized clinical study in patients with PCOS shows that taking fennel 60 mg and Elwendia persica 25 mg twice daily for 4 months modestly improves number of ovarian follicles and body mass index when compared with placebo; however, when compared to baseline, the combination also improves hirsutism scores and menstrual cycle duration and interval (112370). It is unclear if these effects are due to fennel, other ingredients, or the combination.
Rheumatoid arthritis (RA). Although there has been interest in using oral fennel for RA, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Sexual desire. It is unclear if oral fennel is beneficial for improving sexual desire. Details: A small clinical study in postmenopausal adults shows that taking fennel seed powder 2 grams daily for 8 weeks does not improve scores on the Hurlbert Index of Sexual Desire when compared with placebo (104198).
Sunburn. It is unclear if topical fennel emulsion is beneficial for preventing sunburn. Details: A small clinical study shows that applying a fennel 5% emulsion topically prior to ultraviolet (UV) exposure can reduce sunburn by 65% when compared with a control (49518).
Upper respiratory tract infection (URTI). Although there has been interest in using oral fennel for upper respiratory tract infections, there is insufficient reliable information about the clinical effects of fennel for this purpose.
Vaginal atrophy. It is unclear if intravaginal application of fennel cream is beneficial in patients with vaginal atrophy. Details: A small clinical study in postmenopausal adults shows that applying 5 grams of a fennel 5% cream to the vagina once daily for 8 weeks seems to reverse vaginal thinning, improve vaginal pH, and reduce symptoms of vaginal atrophy such as itching, dryness, and pain with intercourse when compared with placebo (92509). Patients in the fennel group also rated their sexual function to be improved when compared with those receiving placebo (97496). More evidence is needed to rate fennel for these uses.

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 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.

POSSIBLY EFFECTIVE

Hypertension. Oral Hibiscus sabdariffa seems to lower blood pressure by a small amount in patients with mild to moderate hypertension. Details: Most research shows that drinking Hibiscus sabdariffa tea daily can modestly lower blood pressure in patients with pre-hypertension or mild hypertension after 2-6 weeks of treatment (16894,54985,54995,90159,93817,101730,108867). In addition, some research shows that drinking Hibiscus sabdariffa tea daily can modestly lower blood pressure in patients with either untreated or insufficiently treated mild to moderate hypertension (54989,93815,101733,108867). These studies have used tea made from 1.25-10 grams or 150 mg/kg, brewed in 150 mL to 500 mL of water and taken one to three times daily for 2-6 weeks (16894,54985,54989,54995,90159,93815,93817,101730,101733,108867). The dose has been increased to 15 or 20 grams, brewed in 1000 mL for daily consumption for 2-3 weeks if needed (101733,108867). In this population, research shows that drinking Hibiscus sabdariffa tea or infusions is more effective than hydrochlorothiazide 25 mg daily and as effective as captopril 25 mg twice daily for lowering systolic and diastolic blood pressure (54989,93815). Pooled analyses of results from clinical research shows that drinking Hibiscus sabdariffa tea or taking Hibiscus sabdariffa extract lowers systolic blood pressure by 5-8 mmHg and diastolic blood pressure by about 4 mmHg in patients with or without mild hypertension (93817,105304). The clinical relevance of these results is uncertain due to the small size and low quality of the included studies. Some researchers suggest that there is insufficient reliable evidence to determine if the effects of Hibiscus sabdariffa are clinically relevant (17114). Taking Hibiscus sabdariffa in combination with other ingredients has also showed beneficial effects on blood pressure in clinical research. In one study, a specific product containing Hibiscus sabdariffa extract in combination with olive leaf extract (NW Roselle) for 8 weeks was found to be as effective as captopril 25 mg twice daily for reducing systolic and diastolic blood pressure (105302). In another study, a specific product (MetabolAid, Monteloeder S.L.) providing Hibiscus sabdariffa and lemon verbena extracts for 12 weeks reduced systolic, but not diastolic, blood pressure. However, these effects were limited to daytime ambulatory readings (105303).

Cancer. Although there has been interest in using oral Hibiscus sabdariffa for cancer, there is insufficient reliable information about the clinical effects of Hibiscus sabdariffa for this condition.
Constipation. Although there has been interest in using oral Hibiscus sabdariffa for constipation, there is insufficient reliable information about the clinical effects of Hibiscus sabdariffa for this purpose.
Diabetes. It is unclear if oral Hibiscus sabdariffa is beneficial for diabetes. Details: Pooled analyses of results from clinical research show that taking Hibiscus sabdariffa lowers fasting blood glucose levels by approximately 4 mg/dL (105304,105305). However, only one low-quality study included in one of these analyses examined the effects of Hibiscus sabdariffa on fasting blood glucose levels in patients with type 2 diabetes (105305). Therefore, any benefit specific to this population is unclear.
Dry mouth. Topical Hibiscus sabdariffa has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with dry mouth shows that taking a specific mucoadhesive tablet (Aqualief, Helsinn Healthcare SA), containing a combination of Hibiscus sabdariffa and carnosine, 400 mg three times daily after meals for 6 days increases saliva production and improves symptoms of dry mouth when compared to baseline. While saliva production was also increased in patients taking placebo, the increase was 3-fold greater with the combination product, and significant improvements in dry mouth symptoms were lacking in the placebo group (103288). It is unclear if these findings are due to Hibiscus sabdariffa, carnosine, or the combination.
Dry skin. It is unclear if oral Hibiscus sabdariffa is beneficial for dry skin. Details: A crossover clinical study in healthy adults shows that drinking Hibiscus sabdariffa 100 mL twice daily for 6 months improves skin moisture but does not improve skin surface water loss or sebum secretion when compared to baseline (112426). However, it is unclear whether any improvements are clinically significant or apply to patients with dry skin.
Dyslipidemia. It is unclear if oral Hibiscus sabdariffa is beneficial for dyslipidemia. Details: Some preliminary clinical research shows that drinking Hibiscus sabdariffa tea or taking Hibiscus sabdariffa extract can decrease total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, and can increase high-density lipoprotein (HDL) cholesterol, in patients with metabolic disorders (54997,54999). These studies used Hibiscus sabdariffa 2 grams in 240 mL boiling water, steeping for 20-30 minutes, twice daily and Hibiscus sabdariffa extract 100 mg daily, each for 4 weeks (54997,54999). Clinical research also shows that taking powdered dried Hibiscus sabdariffa 6 grams daily reduces LDL cholesterol by approximately 8% in obese adolescents with dyslipidemia (93816). Additionally, two meta-analyses shows that taking Hibiscus sabdariffa extract modestly reduces LDL cholesterol levels (105305,105306). However, other preliminary clinical research shows that taking Hibiscus sabdariffa extract does not improve cholesterol or triglyceride levels in patients with hypercholesterolemia (17415,55000). Two pooled analyses of clinical data show that Hibiscus sabdariffa does not improve total cholesterol, HDL cholesterol, LDL cholesterol, or triglycerides when compared with placebo, a change in diet, or black tea in patients with hyperlipidemia, metabolic disorders, or obesity (93805,105304). The differing conclusions of these trials and meta-analyses are related to their inclusion and exclusion criteria with respect to age and populations of focus.
Kidney stones (nephrolithiasis). Although there has been interest in using oral Hibiscus sabdariffa for kidney stones, there is insufficient reliable information about the clinical effects of Hibiscus sabdariffa for this condition.
Metabolic syndrome. Some small clinical studies suggest that oral Hibiscus sabdariffa may be beneficial for metabolic syndrome. Details: In adults with metabolic syndrome, a small clinical trial shows that taking Hibiscus sabdariffa powder 500 mg daily for 4 weeks modestly reduces systolic blood pressure and triglyceride levels by 5% and 15%, respectively, when compared with baseline. These changes were significant when compared with placebo. However, there was no effect on diastolic blood pressure, fasting glucose or insulin levels, cholesterol levels, or body mass index (105307). Other preliminary clinical research in adults with metabolic syndrome shows that taking Hibiscus sabdariffa extract 100 mg daily for one month modestly reduces fasting glucose and low-density lipoprotein (LDL) cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels when compared with baseline. When taken in combination with recommendations to follow the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) diet, triglyceride levels and blood pressure were also modestly reduced (54999).
Obesity. Oral Hibiscus sabdariffa has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Two small clinical trials in overweight and obese females show that taking a combination product (MetabolAid, Monteloeder SL) containing Hibiscus sabdariffa and lemon verbena extracts as 500 mg per capsule daily for 2 months modestly increases weight loss when compared with placebo (97290,101731). This combination also reduces hunger and increases satiety, and has small to moderate beneficial effects on low-density lipoprotein (LDL) cholesterol, heart rate, and blood pressure (97290). The effects in obese individuals seem to be less than those seen in overweight individuals, with no overall change in abdominal circumference or percent body fat in obese individuals (101731). A meta-analysis of these two studies and several others in overweight or obese individuals shows that taking Hibiscus sabdariffa in combination with other ingredients daily for 6-12 weeks modestly improves body mass index, weight, and body fat percentage when compared with control (112427). However, the validity of these results is limited by the heterogeneity of the included studies. Additionally, it is unknown if these effects are due to Hibiscus sabdariffa, other ingredients, or the combination.
Urinary tract infections (UTIs). It is unclear if oral Hibiscus sabdariffa is beneficial for UTIs. Details: Population research in patients with urinary catheters living in long-term care facilities has found that drinking Hibiscus sabdariffa tea is associated with a 36% lower risk of UTIs when compared with not drinking tea (93807). Some small clinical studies that have evaluated the use of Hibiscus sabdariffa in combination with other ingredients suggest that they might reduce the occurrence of symptomatic UTIs in females with recurrent UTIs. One study used a product containing Hibiscus sabdariffa 200 mg, D-mannose 1000 mg, and Lactobacillus plantarum Lp-115 (1 billion colony forming units) daily for 15 days each month for 6 months (101734); the other study used a specific product (Monurelle Plus, Zambon Italia) containing Hibiscus sabdariffa 100 mg, xyloglucan 100 mg, gelatin 50 mg, and propolis 100 mg twice daily for 14 days (101735). Also, a small observational study in patients with an uncomplicated UTI has found that taking two tablets of a specific combination product (Acidif plus) containing Hibiscus sabdariffa extract 100 mg, boswellia gummy dry extract 100 mg, and L-methionine 400 mg daily for 7 days is associated with reduced UTI symptoms and reduced bacteriuria when compared with taking an unreported dose of fosfomycin for two days (103783). However, due to the poor quality of these studies, the magnitude of benefit is unclear. Also, it is unknown whether these effects are due to Hibiscus sabdariffa, other ingredients, or the combination.
Wound healing. Although there has been interest in using topical Hibiscus sabdariffa for wound healing, there is insufficient reliable information about the clinical effects of Hibiscus sabdariffa for this purpose.
More evidence is needed to rate Hibiscus sabdariffa for these uses.

HOLY BASIL

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

SPEARMINT

Age-related cognitive decline. It is unclear if oral spearmint extract is beneficial for age-related cognitive decline. Details: A small clinical study in older adults with age-related cognitive decline shows that taking a specific spearmint extract 900 mg daily for 90 days modestly improves quality of working memory, as well as time to sleep, overall mood, and feelings of vigor, when compared with placebo. However, no improvements were seen in attention, overall quality of memory, speed of memory, quality of sleep, or feelings of anxiety, depression, or confusion. Additionally, taking 600 mg daily does not seem to provide benefit (98523).
Cognitive function. Small clinical studies suggest that oral spearmint extract or spearmint-flavored gum may not improve most measures of cognitive function. Details: One small clinical study in healthy young adults shows that taking a proprietary spearmint extract (Neumentix Phenolic Complex K110-42, Kemin Foods, LC.) 900 mg daily for 90 days modestly improves attention, but not working memory, executive function, speed, reasoning, or other measures of cognitive function, when compared with placebo (101713). Other small clinical studies in healthy adults shows that chewing spearmint-flavored gum during memory testing does not improve memory or attention when compared with chewing unflavored gum (75725,75754).
Flatulence. Although there has been interest in using oral spearmint for flatulence, there is insufficient reliable information about the clinical effects of spearmint for this purpose.
Hirsutism. Small clinical studies suggest that drinking spearmint tea may modestly reduce testosterone levels in patients with hirsutism; any effects on hair growth are unclear. Details: A small clinical study in patients with hirsutism associated with polycystic ovary syndrome (PCOS) shows that drinking spearmint tea twice daily for one month can reduce the subjective severity of hirsutism when compared to pretreatment; however, it does not seem to reduce the amount or location of hair based on objective assessment when compared with placebo tea (68500). Any effect of spearmint tea in patients with hirsutism is believed to be related to its antiandrogenic properties. Two small clinical studies in patients with idiopathic hirsutism or hirsutism associated with PCOS show that drinking spearmint tea twice daily for 5-30 days can decrease free testosterone levels and increase levels of luteinizing hormone, estradiol, and follicle-stimulating hormone when compared to baseline (68451,68500).
Irritable bowel syndrome (IBS). Oral spearmint 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 containing lemon balm, spearmint, and coriander (Carmint) three times daily after meals for 8 weeks along with conventional therapy with loperamide or psyllium reduces abdominal pain and discomfort by approximately 81% when compared with conventional therapy alone (19535). It is unclear if these findings are due to spearmint, other ingredients, or the combination.
Osteoarthritis. It is unclear if drinking spearmint tea is beneficial in patients with knee osteoarthritis. Details: A small clinical study in patients with knee osteoarthritis shows that drinking 2 cups of spearmint tea daily for 16 weeks reduces pain and stiffness when compared to baseline (94923). The validity of these findings is limited by a lack of control group.
Postoperative nausea and vomiting (PONV). Aromatherapy with spearmint oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical study in patients reporting nausea after surgery shows that inhaling vapors from a mixture of spearmint, peppermint, ginger, and cardamom essential oils reduces symptoms of postoperative nausea in approximately 15% more patients when compared with inhaling ginger essential oils alone, and in about 43% more patients when compared with inhaling saline (89888). It is unclear if these findings are due to spearmint oil, other ingredients, or the combination. More evidence is needed to rate spearmint for these uses.

Asthma. It is unclear if dietary citrus fruits are beneficial in patients with asthma. Details: There is some evidence that consumption of vitamin C-rich citrus fruits, including sweet orange and others, might improve lung function in people with asthma. However, this is controversial. Some studies show that intake of citrus fruits 1-2 times per week produces significant benefit (6049,6055,6056), while other studies have not found this benefit (6057,6058).
Common cold. It is unclear if drinking sweet orange juice prevents the common cold. Details: Preliminary clinical research in healthy individuals ages 17 to 25 years suggests that drinking sweet orange juice 180 mL daily for 72 days might decrease the risk of developing common cold-related symptoms (15328).
Depression. It is unclear if drinking sweet orange juice or using sweet orange essential oil as aromatherapy is beneficial for depression. Details: Preliminary clinical research in adults with depression shows that drinking flavonoid-rich sweet orange juice 190 mL three times daily for 8 weeks modestly improves depression scores when compared to baseline, but not when compared with a low-flavonoid orange drink (110045). Sweet orange has also been studied as part of a combination aromatherapy. A very small clinical study in community-dwelling older adults shows that massage therapy to the upper body with sweet orange, lavender, and bergamot oils twice weekly for 8 weeks improves symptoms of depression in 65% of patients when compared with no intervention. Twice weekly inhalation of the same essential oils via nebulizer, without massage, also improves symptoms of depression in 55% of patients when compared with no intervention (98474).
Hypercholesterolemia. It is unclear if drinking sweet orange juice improves blood lipid levels. Details: A very small clinical study in hypercholesterolemic patients shows that drinking large amounts of sweet orange juice (750 mL daily for four weeks) seems to increase high-density lipoprotein (HDL) cholesterol by 21% and reduce the ratio of low-density lipoprotein (LDL) to HDL cholesterol by 16% when compared to baseline. This effect was not seen with 250-500 mL of sweet orange juice. Because consumption of this large amount of juice daily provides approximately 20% of the daily energy requirement, this regimen may not be practical (3340).
Insomnia. Sweet orange essential oil as aromatherapy has only been evaluated in combination with other essential oils; its effect when used alone is unclear. Details: Preliminary clinical research in adults undergoing hemodialysis shows that inhaling aromatherapy with sweet orange and lavender oil nightly before bed for one month improves overall sleep quality by 72% and fatigue by about 78% when compared with no treatment (98508).
Kidney failure. It is unclear if sweet orange oil massage can improve fatigue or symptoms of restless leg syndrome (RLS) in adults receiving hemodialysis. Details: A small clinical study shows that receiving an 18-minute foot massage with sweet orange oil 1.5% for 3 weeks during hemodialysis sessions modestly improves sleep quality and symptoms of RLS when compared with routine care. However, it does not seem to be more effective than using lavender oil (109859).
Kidney stones (nephrolithiasis). It is unclear if drinking sweet orange juice is beneficial for preventing kidney stones. Details: Consuming 400 mL of sweet orange juice three times a day, providing a total of 100 mEq of citrate daily, increases urinary pH and urinary citrate levels (15171). Theoretically, this might reduce kidney stone formation in patients with calcium nephrolithiasis. However, this outcome has not been evaluated in clinical research.
Obesity. It is unclear if drinking sweet orange juice or taking oral sweet orange extract improves weight loss or other metabolic parameters in adults with overweight or obesity. Most studies suggest that any effects are unlikely to be considered clinically relevant. Details: Some preliminary clinical research in adults with overweight or obesity shows that taking a specific sweet orange extract (Morosil, Bionap S.R.L.) 400 mg orally once daily for six months reduces waist circumference, body weight, fat mass, and body mass index (BMI) by 2% to 5% when compared with placebo (110046). However, other preliminary clinical research in this population shows that drinking red sweet orange juice 750 mL daily for 8 weeks does not reduce body weight or BMI when compared with baseline (92309). A meta-analysis of clinical research in adults, most of whom were overweight or obese at baseline, shows that drinking 250-750 mL of various types of sweet orange juice daily for 2-12 weeks does not reduce body weight, BMI, waist circumference, or body fat percentage (BFP) when compared with control groups, which included either no supplementation, pomegranate juice, or exercise (107853). The validity of this meta-analysis is limited due to the population heterogeneity and variety of orange juice formulations and controls utilized. Some clinical studies have also evaluated sweet orange juice for improving cardiovascular risk factors in overweight and obese adults. Although some research has shown benefit, not all research agrees (110046,110047). A meta-analysis of randomized clinical trials in adults with overweight or obesity shows that drinking sweet orange juice 250-600 mL daily for 2-13 weeks modestly increases high-density lipoprotein cholesterol levels and decrease average systolic blood pressure by 1 mmHg when compared with control. However, drinking sweet orange juice does not affect other blood lipid levels, blood glucose levels, or markers of insulin resistance (110048). The validity of this study is limited by high heterogeneity and a small sample size. In addition, these improvements are unlikely to be considered clinically relevant. Sweet orange extract has also been studied in combination with other ingredients. Some clinical research in overweight adults shows that taking a specific combination product (Sinetrol, Fytexia) 450-700 mg twice daily containing sweet orange, blood orange, and grapefruit extracts for 12 weeks reduces body weight, BFP, and BMI when compared with placebo or baseline (95517,95518). It is unclear if these effects are due to sweet orange, other ingredients, or the combination.
Pre-procedural anxiety. It is unclear if inhaling sweet orange essential oil as aromatherapy reduces anxiety before surgeries or invasive procedures. Details: A small, low-quality study suggests that inhaling the scent from 3 drops of sweet orange essential oil applied to a cotton ball for 5 minutes modesty reduces anxiety and pain scores in patients undergoing needle insertion for hemodialysis when compared with performing a breathing exercise for 3 minutes (105455).
Prostate cancer. It is unclear if drinking sweet orange juice reduces prostate cancer risk. Details: Observational research has found that increasing dietary intake of sweet orange or sweet orange juice is not associated with a reduced risk of developing prostate cancer (15172).
Stress. It is unclear if inhaling sweet orange essential oil as aromatherapy is beneficial for stress. Details: Preliminary clinical research shows that using up to 10 drops of sweet orange essential oil as aromatherapy helps prevent some anxiety and tension associated with stressful tasks when compared with control (90505). More evidence is needed to rate sweet orange for these uses.

Safety view details

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

CORIANDER

LIKELY SAFE ...when used orally in amounts commonly found in foods. Coriander and coriander oil have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately for medicinal purposes (12). ...when used topically and appropriately. Coriander oil 6% ointment has been used with apparent safety twice daily for up to 28 days (97874).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid amounts in excess of those found in foods.

CUMIN

LIKELY SAFE ...when used orally in amounts commonly found in foods. Cumin and cumin oil have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when the powder or essential oil is used orally and appropriately in medicinal amounts, short-term (12). Cumin essential oil has been used with apparent safety in doses up to 225 mg daily for up to 8 weeks or 100 mg daily for up to 6 months (100160,100162,104143). Cumin powder has been used with apparent safety in doses up to 3 grams daily for up to 6 months (100161,100162). There is insufficient reliable information available about the safety of cumin powder or essential oil when used orally, long-term.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in excess of food amounts.

FENNEL

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

POSSIBLY SAFE ...when fennel essential oil or extract is used orally and appropriately, short-term. Twenty-five drops (about 1.25 mL) of fennel fruit extract standardized to fennel 2% essential oil has been safely used four times daily for 5 days (49422). Also, two 100 mg capsules each containing fennel 30% essential oil standardized to 71-90 mg of anethole has been safely used daily for 8 weeks (97498). Powdered fennel extract has been used with apparent safety at a dose of 800 mg daily for 2 weeks (104199). ...when creams containing fennel 2% to 5% are applied topically (49429,92509).

CHILDREN: POSSIBLY SAFE
when combination products containing fennel are used to treat colic in infants for up to one week. Studied products include up to 20 mL of a fennel seed oil emulsion; a specific product (ColiMil) containing fennel 164 mg, lemon balm 97 mg, and German chamomile 178 mg; and up to 450 mL of a specific tea (Calma-Bebi, Bonomelli) containing fennel, chamomile, vervain, licorice, and lemon balm (16735,19715,49428).

PREGNANCY: POSSIBLY UNSAFE
when used orally. Observational research has found that regular use of fennel during pregnancy is associated with shortened gestation (100513).

LACTATION: POSSIBLY UNSAFE
when used orally. Case reports have linked consumption of an herbal tea containing extracts of fennel, licorice, anise, and goat's rue to neurotoxicity in two breast-feeding infants. The adverse effect was attributed to anethole, a constituent of fennel and anise (16744). However, levels of anethole were not measured in breastmilk, and the herbal tea was not tested for contaminants. Furthermore, other adverse effects related to use of fennel during lactation have not been reported. However, until more is known, avoid using.

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.

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

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Hibiscus sabdariffa tea has been safely consumed in amounts of up to 720 mL daily for up to 6 weeks (16894,93805,93814). Hibiscus sabdariffa extracts, including a specific Hibiscus sabdariffa leaf extract (Green Chem), have also been safely used in doses of up to 1000 mg daily for up to 90 days (17415,54989,93805,93809,105307).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately. Hibiscus sabdariffa calyx powder has been used with apparent safety at a dose of 2 grams three times daily for 4 weeks by adolescents aged 12-18 years (93816).

PREGNANCY: POSSIBLY UNSAFE
when used orally. Hibiscus sabdariffa is thought to be a menstrual stimulant, and might have abortifacient effects (19).

LACTATION: POSSIBLY UNSAFE
when used orally in large amounts. Animal research found that administering large doses of Hibiscus sabdariffa during lactation decreases food and water intake during pregnancy and delays puberty in offspring (93810); however, this has not been assessed in humans.

HOLY BASIL

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

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

SPEARMINT

LIKELY SAFE ...when used in amounts commonly found in foods. Spearmint and spearmint oil have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally or topically for medicinal reasons (11,12). Spearmint extract up to 900 mg daily has been used safely for up to 90 days (94925,101713,101714). Spearmint tea has been consumed safely twice daily for up to 16 weeks (68500,94923).

PREGNANCY: LIKELY SAFE
when used in the amounts commonly found in foods (4912).

PREGNANCY: POSSIBLY UNSAFE
when used orally during pregnancy in excessive amounts. Animal research suggests that spearmint tea may cause uterine damage (68448). Avoid using in amounts greater than those typically found in foods during pregnancy.

LACTATION: LIKELY SAFE
when used in the amounts commonly found in foods (4912). There is insufficient reliable information available about the safety of spearmint during lactation. Avoid using in amounts greater than those typically found in foods.

LIKELY SAFE ...when sweet orange juice or fruit is used orally in amounts commonly found in foods (1310,3340,15171,92309).

POSSIBLY SAFE ...when the essential oil of sweet orange is inhaled as aromatherapy, short-term (35735,58060,90505,105455). There is insufficient reliable information available about the safety of sweet orange peel when used orally.

CHILDREN: LIKELY SAFE
when sweet orange juice or fruit is used orally in amounts commonly found in foods.

CHILDREN: POSSIBLY UNSAFE
when the sweet orange peel is used orally in excessive amounts. There have been reports of intestinal colic, convulsions, and death in children given large amounts of sweet orange peel (11).

PREGNANCY AND LACTATION: LIKELY SAFE
when sweet orange juice or fruit is used orally in amounts commonly found in foods (1310,3340).

Interactions with Drugs view details

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

CORIANDER

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

Evidence from animal research suggests that coriander fruit and coriander extract can reduce blood glucose levels (14907,46153,46216). Monitor blood glucose levels closely. Dose adjustments might be necessary.

ANTIHYPERTENSIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, coriander might increase the risk of hypotension when taken with antihypertensive drugs.

Details

Evidence from animal research suggests that coriander fruit can lower blood pressure (46221).

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, coriander might cause additive sedative effects when taken with CNS depressants.

Details

Evidence from animal research suggests that coriander fruit extract has sedative effects (46184).

PHOTOSENSITIZING DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, coriander might increase the risk of photosensitivity when taken with photosensitizing drugs.

Details

Evidence from in vitro research suggests that coriandrin, a constituent of coriander, has photosensitizing effects (46228).

CUMIN

ANTICOAGULANT/ANTIPLATELET DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, cumin might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.

Details

In vitro evidence suggests that cumin can inhibit platelet aggregation (46897). Theoretically, cumin might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

Animal research suggests that cumin can lower blood sugar in diabetic animals (19,46857,46895). However, research in humans with and without diabetes has found conflicting results (106516,106517).

RIFAMPIN (Rifadin)

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, cumin might increase the effects and adverse effects of rifampin.

Details

Animal research suggests that an aqueous extract of cumin containing a specific flavonoid glycoside can increase the bioavailability and plasma levels of rifampin (46876).

FENNEL

ANTICOAGULANT/ANTIPLATELET DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, fennel might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.

Details

Animal research suggests that fennel oil has antithrombotic and antiplatelet effects (31415,49445).

CIPROFLOXACIN (Cipro)

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, fennel might decrease the levels and clinical effects of ciprofloxacin.

Details

Animal research shows that fennel reduces ciprofloxacin bioavailability by nearly 50%, possibly due to the metal cations such as calcium, iron, and magnesium contained in fennel. This study also found that fennel increased tissue distribution and slowed elimination of ciprofloxacin (6135).

CONTRACEPTIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, taking large amounts of fennel might decrease the effects of contraceptive drugs due to competition for estrogen receptors.

Details

Some constituents of fennel have estrogenic activity (11).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, fennel might increase levels of drugs metabolized by CYP3A4.

Details

In vitro research suggests that fennel inhibits CYP3A4 enzyme activity (38375,49468). This effect has not been reported in humans.

ESTROGENS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, taking large amounts of fennel might interfere with hormone replacement therapy due to competition for estrogen receptors.

Details

Some constituents of fennel have estrogenic activity (11).

TAMOXIFEN (Nolvadex)

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, taking large amounts of fennel might decrease the antiestrogenic effect of tamoxifen.

Details

Some constituents of fennel have estrogenic activity (11), which may interfere with the antiestrogenic activity of tamoxifen.

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).

ACETAMINOPHEN (Tylenol, others)

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, taking Hibiscus sabdariffa with acetaminophen might decrease the clinical effects of acetaminophen.

Details

There is some evidence that consuming a Hibiscus sabdariffa beverage (Zobo drink) before taking acetaminophen can decrease the elimination half-life of acetaminophen. Hibiscus sabdariffa does not seem to decrease maximum concentration or area under the curve of acetaminophen (12184). The clinical significance of this is unknown.

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

Most clinical research shows that Hibiscus sabdariffa can reduce blood glucose levels (54999,105304,105305).

ANTIHYPERTENSIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

Most clinical evidence suggests that taking Hibiscus sabdariffa reduces systolic and diastolic blood pressure (16894,54985,54995,105304). In animal research, Hibiscus sabdariffa increased the hypotensive effects of single doses of losartan and amlodipine (102459,107901).

CHLOROQUINE (Aralen)

Interaction Rating = Major Do not take this combination.

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

Taking Hibiscus sabdariffa tea along with chloroquine seems to reduce levels of chloroquine.

Details

When taken together, Hibiscus sabdariffa tea significantly reduces the bioavailability of chloroquine (55004). This may reduce its clinical effects. People taking chloroquine for the treatment or prevention of malaria should avoid Hibiscus sabdariffa tea.

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP1A2 substrates.

Details

In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP1A2 (93811). This interaction has not been reported in humans.

CYTOCHROME P450 2A6 (CYP2A6) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2A6 substrates.

Details

In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2A6 (93811). This interaction has not been reported in humans.

CYTOCHROME P450 2B6 (CYP2B6) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2B6 substrates.

Details

In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2B6 (93811). This interaction has not been reported in humans.

CYTOCHROME P450 2C19 (CYP2C19) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2C19 substrates.

Details

In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2C19 (93811). This interaction has not been reported in humans.

CYTOCHROME P450 2C8 (CYP2C8) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, Hibiscus sabdariffa might reduce the metabolism of CYP2C8 substrates.

Details

In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2C8 (93811). This interaction has not been reported in humans.

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2C9 substrates.

Details

In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2C9 (93811). This interaction has not been reported in humans.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2D6 substrates.

Details

In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2D6 (93811). This interaction has not been reported in humans.

CYTOCHROME P450 2E1 (CYP2E1) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2E1 substrates.

Details

In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2E1 (93811). This interaction has not been reported in humans.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP3A4 substrates.

Details

In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP3A4 (93811). This interaction has not been reported in humans.

DICLOFENAC (Voltaren, others)

Interaction Rating = Moderate Be cautious with this combination.

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

Taking Hibiscus sabdariffa with diclofenac may increase the levels and adverse effects of diclofenac.

Details

Pharmacokinetic research in humans shows that drinking a beverage made with Hibiscus sabdariffa flowers reduces the excretion of diclofenac by approximately 38% when compared with water. The clinical significance of this is unknown (101726).

LOSARTAN (Cozaar)

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, Hibiscus sabdariffa might increase the levels and clinical effects of losartan.

Details

Animal research in rats with laboratory-induced hypertension shows that providing Hibiscus sabdariffa for 14-17 days prior to a single administration with losartan modestly increases losartan concentrations and increases hypotensive effects when compared with a single administration of losartan alone (102459). It is not clear if Hibiscus sabdariffa alters the concentration or effects of losartan when taken continuously. Additionally, this interaction has not been shown in humans.

SIMVASTATIN (Zocor)

Interaction Rating = Moderate Be cautious with this combination.

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

Taking Hibiscus sabdariffa with simvastatin might reduce the levels and clinical effects of simvastatin.

Details

A pharmacokinetic study in humans shows that taking a beverage prepared with dried Hibiscus sabdariffa flower 300 grams concurrently with a single dose of simvastatin 40 mg increases the clearance of simvastatin by about 45% and reduces peak levels of simvastatin by 18% (96270).

HOLY BASIL

ANTICOAGULANT/ANTIPLATELET DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

PENTOBARBITAL (Nembutal)

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

SPEARMINT

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, spearmint might alter the sedative effects of CNS depressants.

Details

Animal research suggests that (-)-carvone, a major constituent of spearmint, has sedative effects (39800,75758). However, in humans, chewing spearmint-flavored gum induced arousal effects (75699).

HEPATOTOXIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, high doses of spearmint might increase the risk of liver damage when taken with hepatotoxic drugs.

Details

Animal research suggests that drinking spearmint tea for 30 days can increase markers of liver damage, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT), and cause liver degeneration and necrosis, in a dose-dependent manner (12731). This effect has not been reported in humans.

CELIPROLOL (Celicard)

Interaction Rating = Major Do not take this combination.

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

Consuming sweet orange with celiprolol can decrease oral absorption of celiprolol.

Details

A pharmacokinetic study in healthy volunteers shows that celiprolol levels, after a single dose of 100 mg, are decreased by up to 90% in people who drink sweet orange juice 200 mL three times daily. It's not known if lower consumption of sweet orange juice will have the same effect. Theoretically, this occurs due to short-term inhibition of organic anion transporting polypeptide (OATP) (12115,17603,17604). Recommend separating drug administration and consumption of sweet orange by at least 4 hours (17603,17604).

FEXOFENADINE (Allegra)

Interaction Rating = Moderate Be cautious with this combination.

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

Consuming sweet orange juice with fexofenadine can decrease oral absorption of fexofenadine.

Details

Clinical research shows that coadministration of sweet orange juice 1200 mL decreases bioavailability of fexofenadine by about 72% (7046,17604). In an animal model, sweet orange juice decreased bioavailability of fexofenadine by 31% (17605). Fexofenadine manufacturer data indicates that concomitant administration of sweet orange juice and fexofenadine results in larger wheal and flare sizes in research models. This suggests that sweet orange reduces the clinical response to fexofenadine (17603). Theoretically, this occurs due to short-term inhibition of organic anion transporting polypeptide (OATP) (7046). Recommend separating drug administration and consumption of sweet orange by at least 4 hours (17603,17604).

IVERMECTIN (Stromectol, others)

Interaction Rating = Major Do not take this combination.

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

Consuming sweet orange juice with ivermectin can decrease the oral absorption of ivermectin.

Details

A pharmacokinetic study in healthy volunteers shows that taking ivermectin orally with sweet orange juice 750 mL over 4 hours reduces the bioavailability of ivermectin. This effect does not seem to be related to effects on P-glycoprotein. The effect on ivermectin is more pronounced in males compared to females (12154).

ORGANIC ANION-TRANSPORTING POLYPEPTIDE SUBSTRATES (OATP)

Interaction Rating = Major Do not take this combination.

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

Consuming sweet orange juice can decrease oral absorption of OATP substrates. Separate administration by at least 4 hours.

Details

Clinical research shows that consuming sweet orange juice inhibits OATP, which reduces bioavailability of oral drugs that are substrates of OATP (17603,17604). For example, sweet orange juice decreases bioavailability of fexofenadine, a substrate of OATP, by about 72% and of celiprolol, another OATP substrate, by up to 90% (7046,12115). Since sweet orange juice seems to affect OATP for a short time, recommend separating drug administration and consumption of sweet orange juice by at least 4 hours (17603,17604).

P-GLYCOPROTEIN SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

Sweet orange juice seems to modulate P-glycoprotein (P-gp), which might affect the blood levels of P-gp substrates.

Details

Animal and in vitro research suggest that orange juice extract inhibits drug efflux by P-gp, increasing absorption and levels of P-gp substrates (12116,15327). In contrast, pharmacokinetic research in humans shows that drinking large amounts of sweet orange juice decreases absorption and levels of the P-gp substrate celiprolol. This suggests that orange juice actually induces drug efflux by P-gp or affects drug levels by another mechanism such as inhibiting the gut drug transporter called organic anion transporting polypeptide (OATP) (7046,12115). Until more is known, sweet orange juice should be used cautiously in people taking P-gp substrates.

PRAVASTATIN (Pravachol)

Interaction Rating = Major Do not take this combination.

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

Consuming sweet orange juice with pravastatin can increase the absorption of pravastatin.

Details

A small pharmacokinetic study in healthy volunteers shows that consuming sweet orange juice 800 mL over 3 hours, including before, during, and after taking pravastatin 10 mg, increases pravastatin levels by about 149%, without affecting pravastatin elimination. Theoretically this effect might be due to modulation of organic anion transporting polypeptides (OATPs) by sweet orange juice (14348). Sweet orange juice does not seem to affect simvastatin levels, but it is not known if sweet orange affects any of the other statins.

QUINOLONE ANTIBIOTICS

Interaction Rating = Moderate Be cautious with this combination.

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

Calcium-fortified sweet orange juice might reduce quinolone absorption.

Details

Calcium binds to quinolones in the gut. Theoretically, the calcium in certain fortified orange juices can also bind to quinolone antibiotics and reduce their absorption and levels (4412,10339,13714,21638,38570).

Report an Adverse Reaction to CCF Tea Joyful Heart

Adverse Effects view details

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

CORIANDER

General ...Orally and topically, coriander seems to be well tolerated.
Most Common Adverse Effects:
Topically: Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.

Dermatologic ...Topically, coriander can cause pruritus and a burning sensation (97874).

Immunologic ...A case of anaphylactic reaction characterized by generalized urticaria, conjunctivitis, oropharyngeal angioedema, and bronchospasms has been reported in a 25-year-old spice worker who consumed food containing coriander fruit. The digestive spice allergy was attributed to sensitization to coriander caused by occupational exposure to coriander fruit, powder, and dust (46192). Also, cases of rhinitis and symptoms of asthma have been reported for patients exposed to dust from coriander spice, particularly people working with spices in the food industry (46226,46245). Like other members of the Apiaceae/Umbelliferae (carrot family), coriander can cause contact dermatitis (19). A case of occupational protein contact dermatitis has been reported for an individual exposed to coriander fruit (46168).

CUMIN

General ...Orally, cumin powder and essential oil seem to be well tolerated, short-term.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Topically: Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.

Dermatologic ...Topically, undiluted cumin oil has been reported to cause phototoxic effects (6).

Gastrointestinal ...Orally, gastrointestinal upset has been reported in some patients taking cumin essential oil (104143).

Immunologic ...Orally, cumin may cause allergic reactions, including anaphylaxis, in sensitive individuals. One case report of anaphylaxis associated with cumin consumption has been reported (46905).
Topically, cumin may cause allergic contact dermatitis in sensitive individuals (31341,46902,46905).

FENNEL

General ...Orally and topically, fennel seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal discomfort, photosensitivity, and allergic reactions in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Seizures.

Dermatologic ...Advise patients to avoid excessive sunlight or ultraviolet light exposure while using fennel (19). Allergic reactions affecting the skin such as atopic dermatitis and photosensitivity may occur in patients who consume fennel (6178,49507).

Gastrointestinal ...Orally, fennel may cause gastrointestinal complaints, including nausea and vomiting (19146,104196).

Hematologic ...Methemoglobinemia has been reported in four infants following intoxication related to ingestion of a homemade fennel puree that may have been made from improperly stored fennel (49444).

Immunologic ...A case report describes an 11-year-old male who developed an allergy to fennel-containing toothpaste. Immediately after using the toothpaste, the patient experienced sneezing, coughing, itchy mouth, rhinorrhea, nasal congestion, wheezing, difficulty breathing, and palpitations, which resolved within 10 minutes of spitting out the toothpaste and rinsing the mouth. In challenge tests, the patient reacted to chewing fresh fennel root, but not ground fennel seeds (103822).

Neurologic/CNS ...Orally, fennel oil has been associated with tonic clonic and generalized seizures (12868). New-onset cluster headaches are reported in a 24-year-old female while using a toothpaste containing fennel and camphor for 3 months. The headaches resolved upon stopping the toothpaste (112368). It is unclear if this adverse effect can be attributed to fennel, camphor, or the combination.

Pulmonary/Respiratory ...Orally, fennel and fennel seed have been reported to cause bronchial asthma (49478).

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).

General ...Orally, Hibiscus sabdariffa is generally well tolerated.

Gastrointestinal ...Orally, taking a specific Hibiscus sabdariffa leaf extract (Green Chem) 1 gram daily has been associated with reports of transient gastrointestinal symptoms such as abdominal distention, flatulence, and epigastric pain in one clinical trial. However, the overall rate of these adverse effects was similar to placebo (17415). Taking Hibiscus sabdariffa calyx extract 6 grams daily has been associated with single cases of nausea in one clinical trial (55000). Taking Hibiscus sabdariffa calyx powder 6 grams daily has been associated with reports of mild and transient constipation in one clinical trial (93816). Taking 0.5-1 liters of tea daily, made by steeping 10-15 grams of dried Hibiscus sabdariffa calyces, has been associated with one report of stomach pain in one clinical trial (101733).

Genitourinary ...Orally, taking Hibiscus sabdariffa calyx extract 6 grams daily has been associated with one report of dysuria in one clinical trial (55000).

Neurologic/CNS ...Orally, taking Hibiscus sabdariffa calyx extract 3 grams daily has been associated with one report of tremor and headache in one clinical trial (55000).

Ocular/Otic ...Orally, taking Hibiscus sabdariffa calyx extract 3 grams daily has been associated with one report of tinnitus in one clinical trial (55000).

Pulmonary/Respiratory ...Taking 0. 5-1 liters of tea daily, made by steeping 10, 15, or 20 grams of dried Hibiscus sabdariffa calyces, has been associated with two reports of dyspnea in one clinical trial. A clear association with Hibiscus sabdariffa could not be made (101733).

HOLY BASIL

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

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

SPEARMINT

General ...Orally, spearmint is well tolerated.
Most Common Adverse Effects:
Topically: Allergic contact dermatitis or cheilitis in sensitive individuals.

Cardiovascular ...Orally, taking spearmint extract 600 mg daily has been associated with one report of tachycardia in one clinical trial. However, it is not certain that this adverse event was caused by spearmint extract (94925).

Dermatologic ...Orally, drinking 2 cups of spearmint tea with normal amounts of rosmarinic acid has been associated with one report of itchy skin in clinical research (94923).

Gastrointestinal ...Orally, taking spearmint extract 600 mg daily has been associated with dyspepsia in one clinical trial (94925). Taking a higher dose of 900 mg daily has been associated with diarrhea and belching (94925). Drinking 2 cups of spearmint tea with normal amounts of rosmarinic acid has been associated with one report of dry mouth in clinical research. Drinking 2 cups of spearmint tea containing high amounts of rosmarinic acid has been associated with three reports of constipation and one report of loose bowel movements (94923). Taking 1 mL of spearmint oil equivalent to 500 mg of spearmint has been associated with reports of regurgitation in clinical research (75700).

Immunologic ...Topically, spearmint oil and leaves have caused allergic dermatitis (75711,75731,75737). Allergic contact cheilitis has also occurred from spearmint oil in toothpaste or chewing gum (31403,31528,75706,75739,75777,75790). Spearmint oil inhalation has also caused allergic dermatitis (56955). Orally, spearmint leaves have caused allergy-associated swelling of the soft palate. A specific 50 KDa protein in the spearmint was found to be the responsible allergen (94922). In some cases, spearmint allergy was associated with oral lichen planus of the tongue, lips, palate, buccal mucosa, and gingivae. Observational studies suggest that exposure to spearmint is associated with exacerbation of oral lichen planus as confirmed by patch testing (94924,112844).

Neurologic/CNS ...Orally, drinking 2 cups of spearmint tea containing high amounts of rosmarinic acid has been associated with two reports of headache in clinical research (94923).

Psychiatric ...Orally, taking spearmint extract 600 mg daily has been associated with one report of anxiety in one clinical trial. However, it is not certain that this adverse event was caused by spearmint extract (94925).

Other ...Orally, taking spearmint extract 600 mg daily has been associated with one report of increased appetite and weight gain in one clinical trial. However, it is not certain that these adverse events were caused by spearmint extract (94925).

General ...Orally, sweet orange juice or fruit seem to be well tolerated. Large amounts of sweet orange peel may be unsafe, especially for children. When inhaled, sweet orange essential oil seems to be generally well tolerated.

Gastrointestinal ...There have been reports of intestinal colic in children following ingestion of large amounts of sweet orange peel (11).

Neurologic/CNS ...There have been reports of convulsions in children following ingestion of large amounts of sweet orange peel (11).

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