Gas & Bloating Phytosolution by Aboca USA, Inc

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Ingredients hide details

Two capsules contain: Vegetable Charcoal 174 mg • fennel fruit WPC (whole phytocomplex concentrate, foeniculum vulgare, standardized to contain minimum 2% essential oil) 116 mg • Proprietary Blend 290 mg: Cumin fruit powder (cuminum cyminum, standardized to contain 2% essential oil), Chamomile flower freeze-dried extract (matricaria recutita, standardized to contain minimum 1% flavonoids apigenin-like), Star Anise fruit powder (illicum verum, standardized to contain minimum 7% essential oil), Lemon Balm leaf freeze-dried extract (melissa officinalis, standardized to contain 14% rosmarinic acid), Caraway fruit powder (carum carvi, standardized to contain minimum 2.2% essential oil), fennel fruit essential oil (foeniculum vulgare). Other Ingredients: Natural Gelatin (capsule).

Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.

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Effectiveness view details

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

ACTIVATED CHARCOAL (Vegetable Charcoal)

POSSIBLY EFFECTIVE

Poisoning. Oral activated charcoal taken after ingestion of certain drugs reduces systemic drug exposure. However, it is unclear if it affects clinical endpoints such as morbidity or mortality. Details: Taking activated charcoal orally appears to be effective when used as part of standard treatment for some, but not all, acute poisonings (12392,12393,93198,93606,93607,93613,94730). Single doses of activated charcoal, 25-100 grams in adults (10-50 grams in children, depending on age), are effective for preventing absorption of some drugs, including acetaminophen, aminophylline, amiodarone, aspirin, atenolol, carbamazepine, digoxin, fluoxetine, indomethacin, phenytoin, valproate, and verapamil, especially if taken within one hour of ingestion (93602,93610,93612,93613,94730,108852). A single dose reduces drug exposure by 38% to 52% when given within 1 hour, by 21% to 35% when given 2-4 hours after ingestion, and by about 14% when given 6 hours after ingestion. These late effects, occurring after oral absorption is complete, are due to enhanced elimination via interruption of enterohepatic circulation and binding of drug that has been actively or passively transported back into the gastrointestinal tract (105543). Multiple-dose activated charcoal, 50-100 grams initially followed by doses of 25 grams every 2 hours or 50 grams every 4 hours, or 10-25 grams per dose in children, is recommended for patients who ingest life-threatening amounts of carbamazepine, dapsone, phenobarbital, quinine, or theophylline. This is based on clinical, animal, and in vitro research showing increased elimination of these drugs (12392,105543). This increased elimination can also reduce levels of drugs that have been given intravenously, with the median half-life being decreased by an average of 45% and the median area under the concentration/time curve (AUC) by an average of 47% (105543). Additional research suggests that multiple-dose activated charcoal may be useful for increasing the elimination of amitriptyline, digoxin, imipramine, moxifloxacin, nadolol, phenytoin, piroxicam, and sotalol. Evidence supporting the use of multiple-dose activated charcoal in aspirin, doxepin, tobramycin, valproate, or vancomycin overdose is limited or conflicting (12392,105543). While activated charcoal may reduce absorption of some toxic agents, there is contradictory evidence about whether it improves clinical outcomes (12392,93200,93601,93613,94730). Administering activated charcoal 50 grams every 6 hours for carbamazepine poisoning decreases the duration of coma by 9 hours, the duration of mechanical ventilation by 12 hours, and the length of hospital stay by 9 hours. However, activated charcoal does not reduce the duration of hospitalization, intensive care admission, vomiting, or mortality when compared with control after oral overdose of benzodiazepines, acetaminophen, or selective serotonin reuptake inhibitors (93200). Other preliminary clinical research in patients with phenytoin toxicity shows that taking activated charcoal 50 grams orally every 4 hours reduces the time to return to therapeutic levels by about 22 hours when compared with control, but without reducing symptoms (93609). In patients with pesticide or yellow oleander seed toxicity, neither single-dose nor multi-dose regimens of activated charcoal reduce mortality, seizures, or the need for intubation when compared with control (93601).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Celiac disease. Although there is interest in using activated charcoal for acute gluten exposure in those with celiac disease, there is insufficient reliable information about the clinical effects of activated charcoal for this purpose.
Chemotherapy-induced diarrhea. It is unclear if oral activated charcoal is beneficial in patients with chemotherapy-induced diarrhea. Details: Preliminary clinical research in children treated with irinotecan shows that taking activated charcoal 250 mg the night before the first infusion and every 8 hours thereafter until the end of the cycle reduces the risk of diarrhea by 60% when compared with no treatment. Activated charcoal also appears to reduce the risk of severe diarrhea by 92% and to decrease chemotherapy discontinuation by 87% in these patients (93608).
Cholestasis. It is unclear if oral activated charcoal is beneficial in patients with pregnancy-induced cholestasis. Details: Preliminary clinical research in pregnant patients with cholestasis shows that taking activated charcoal 50 grams orally three times daily for 8 days decreases bile acid levels by about 50%, compared with an increase in those not taking activated charcoal. However, itching was not significantly improved with activated charcoal when compared with control (126).
Constipation. Oral activated charcoal has only been evaluated in combination with other ingredients; its effects when used alone are unclear. Details: A clinical study in patients with chronic constipation shows that a specific combination product (Nucarb; Wilshire Laboratories Ltd) containing activated charcoal 180 mg, calcium sennosides 50 mg, peppermint oil 0.5 mg, fennel oil 0.5 mg, rhubarb extract 250 mg, and sulfur 50 mg, taken as two tablets at bedtime for one week, followed by 1 tablet at bedtime for 1 week, reduces passing gas, abdominal pain, and sensation of bloating by 81%, 73%, and 72% respectively, when compared with baseline. Sensation of straining, severity of constipation, and feeling of incomplete evacuation were reduced by 69%, 67%, and 54% respectively, when compared with baseline (108853). The validity of this finding is limited by the lack of a comparator group.
Dyspepsia. Oral activated charcoal has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with functional dyspepsia shows that taking a specific combination product containing activated charcoal 280 mg, simethicone 90 mg, and magnesium oxide 180 mg (Carbosymag, Laboratoires Grimberg) three times daily for one month reduces symptoms of dyspepsia, such as postprandial fullness, epigastric pain, and abdominal bloating, when compared with placebo (93199). Other preliminary clinical research in patients with dyspepsia shows that taking another specific combination product containing activated charcoal 280 mg and simethicone 90 mg (Carbosylane, Laboratoires Grimberg) three times daily for 3 months does not improve overall symptoms of dyspepsia or nausea, but does improve abdominal fullness by 20%, bloating by 20%, and slow digestion by 30%, when compared with placebo (93604).
Flatulence. It is unclear if oral activated charcoal is beneficial for reducing the occurrence of flatulence. Details: Some preliminary clinical research shows that taking activated charcoal (Requa Charcocaps) 582 mg after a gas-producing meal significantly decreases the number of flatus events when compared with placebo. On average, subjects taking activated charcoal reported less than 3 flatus events over 8 hours, compared with more than 14 flatus events in those taking placebo (12395). However, other preliminary clinical research shows that taking activated charcoal 520 mg at breakfast, lunch, dinner, and bedtime for 7 days does not significantly reduce excessive gas or total flatus events when compared with baseline (12396).
Hangover. There is no reliable evidence that activated charcoal prevents or treats hangover. Details: Activated charcoal is included in some hangover remedies. However, ethanol adsorbs poorly to activated charcoal (12400).
Hypercholesterolemia. It is unclear if oral activated charcoal is beneficial in patients with hypercholesterolemia. Details: Some preliminary clinical research in patients with hypercholesterolemia shows that taking activated charcoal 4-32 grams daily for 3 weeks decreases total cholesterol by up to 29% and low-density lipoprotein (LDL) cholesterol by up to 41% when compared with control. The effects of activated charcoal appear to be dose-dependent. Additional clinical research shows that taking activated charcoal 20 grams twice daily for 3 weeks is as effective as cholestyramine 8 grams twice daily for treating hypercholesterolemia (12398), but the combined use of activated charcoal and cholestyramine does not appear to confer additional benefit when compared with either agent alone (12397). However, other research suggests that activated charcoal is not effective for treating hypercholesterolemia (12399). Reasons for the discrepancies are unclear but may relate to the small size of the latter study, and the inclusion of some patients without hyperlipidemia.
Hyperphosphatemia. Oral activated charcoal might reduce the incidence of hyperphosphatemia in patients with kidney disease. Details: Preliminary clinical research in a small number of patients with stage 3 or 4 chronic kidney disease (CKD) shows that taking activated charcoal 0.6-1.2 grams three times daily for 12 months reduces the risk of hyperphosphatemia by 64% when compared with placebo. Additionally, in CKD patients who develop hyperphosphatemia, use of activated charcoal at the same dose for up to 24 months seems to delay the development of vascular calcification when compared with calcium carbonate, but not when compared with lanthanum carbonate (103193). Other preliminary clinical research in patients on hemodialysis shows that taking activated charcoal for 24 weeks, at a starting dose of 600 mg three times daily, increasing by 300 mg three times daily every 4 weeks until the goal phosphate level is reached, reduces phosphate levels to the goal in over 90% of patients when compared with baseline (93611). The lack of a control group limits the validity of these findings.
Tooth whitening. It is unclear if toothpaste containing activated charcoal is beneficial for tooth whitening. Details: A small clinical study in adults with dental stains due to factors such as coffee or tobacco use shows that using a toothpaste containing activated charcoal (Blanx Black, Coswell SpA) twice daily for 3 months reduces visible staining, dental plaque, and bleeding when compared to baseline, but not when compared with a micro-cleaning crystal toothpaste (Sensation White, Colgate) (111718).
Wound healing. Research on the use of activated charcoal-containing dressings for wound healing is limited and conflicting. Details: One preliminary clinical study shows that treating chronic venous leg ulcers with activated charcoal-containing dressings (Actisorb, Systagenix) for 6 weeks reduces ulcer size by 17% when compared with control occlusive or semi-occlusive dressings containing antibacterial or antiseptic agents (94731). However, other preliminary clinical research shows that treating pressure ulcers or venous leg ulcers with activated charcoal-containing dressings (Actisorb and Actisorb Silver 220, Systagenix) for 4 weeks does not significantly improve wound healing when compared with a hydrocolloid dressing (93603). More evidence is needed to rate activated charcoal for these uses.

CARAWAY

POSSIBLY EFFECTIVE

Dyspepsia. Oral caraway in combination with peppermint and possibly other ingredients, seems to reduce symptoms of dyspepsia. It is unclear if oral caraway alone is beneficial. Details: Several small, low-quality clinical studies and a meta-analysis of this research show that taking proprietary combinations of caraway oil 50 mg and peppermint oil 90 mg (Enteroplant or Menthacarin, Dr Willmar Schwabe GmbH & Co.), 1-3 times daily for 4 weeks, improves quality of life and reduces symptoms of dyspepsia, including feelings of fullness, pain, and mild gastrointestinal (GI) spasms, when compared with placebo (6740,6741,10075,96344,102600). A meta-analysis of three of these clinical studies shows that taking this combination product 2-3 times daily for 4 weeks modestly reduces abdominal pain when compared with placebo (110091). This combination appears to be comparable to cisapride for relieving dyspepsia (6740,6741,10075). It also improves postprandial distress syndrome and epigastric pain syndrome, two subtypes of dyspepsia, when compared with placebo (96344). Another small clinical study in patients with functional dyspepsia shows that taking a combination of caraway oil 50 mg and L-menthol 41.4 mg (equivalent to 100 mg peppermint oil), in a microsphere formulation that releases the oils in the duodenum (FDgard, IM HealthScience LLC), twice daily for 28 days reduces symptoms of postprandial distress syndrome within 24 hours and reduces severe symptoms of epigastric pain syndrome at 28 days when compared with placebo. However, when all patients with functional dyspepsia are considered, symptom scores are not significantly different than placebo at 28 days (103161). Another specific combination product containing caraway, peppermint leaf, clown's mustard plant, German chamomile, licorice root, milk thistle, angelica, celandine, and lemon balm (Iberogast, Steigerwald Arzneimittelwerk GmbH) has also been evaluated in patients with dyspepsia, with promising results (7049). A meta-analysis of three small clinical studies using this combination product shows that taking 1 mL three times daily for 4 weeks reduces severity of acid reflux, epigastric pain, cramping, nausea, and vomiting when compared with placebo (13089). Other clinical research in patients with dyspepsia shows that taking a similar combination product (STW 5-II, Steigerwald Arzneimittelwerk GmbH) that does not contain milk thistle, angelica, or celandine as 1 mL three times daily for up to 8 weeks eliminates gastrointestinal symptoms in 40% more patients when compared with placebo (12724). It is unclear if these findings are due to caraway, other ingredients, or the combination.

INSUFFICIENT RELIABLE EVIDENCE to RATE

Amenorrhea. Although there has been interest in using oral caraway for amenorrhea, there is insufficient reliable information about the clinical effects of caraway for this purpose.
Asthma. Oral caraway has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with allergic asthma shows that drinking one cup of tea containing caraway along with anise, black seed, saffron, cardamom, chamomile, fennel, and licorice twice daily for 6 months reduces sleep discomfort, cough frequency, and cough intensity when compared with placebo (19056). It is unclear if these findings are due to caraway, other ingredients, or the combination.
Constipation. Although there has been interest in using oral caraway for constipation, there is insufficient reliable information about the clinical effects of caraway for this purpose.
Dysmenorrhea. Although there has been interest in using oral caraway for dysmenorrhea, there is insufficient reliable information about the clinical effects of caraway for this purpose.
Flatulence. Although there has been interest in using oral caraway for flatulence, there is insufficient reliable information about the clinical effects of caraway for this purpose.
Irritable bowel syndrome (IBS). It is unclear if topical caraway oil is beneficial in patients with IBS. Details: A small, open-label study in patients with IBS shows that applying a heated poultice of caraway oil 2% to the abdomen for 20-30 minutes at least once daily for 3 weeks modestly improves the severity of IBS symptoms when compared with applying a nonheated, olive oil poultice. However, the improvement may not be clinically meaningful. Also, the heated caraway oil poultice is not more effective than a heated olive oil poultice. This suggests that any possible benefit might relate to the application of heat rather than caraway oil (94085).
Obesity. It is unclear if oral caraway seed extract is beneficial in patients with obesity. Details: A small clinical study in physically active overweight and obese females shows that taking 30 mL of an aqueous extract providing about 3 grams of caraway seed once daily prior to lunch for 3 months decreases body weight by about 2 kg, body mass index by 0.84 kg/m², percent body fat by 0.7%, and waist circumference by 6 cm, and increases percent muscle mass by 0.19%, when compared to baseline (94088). These improvements are significant when compared with placebo; however, they might not be considered clinically meaningful. Taking caraway seed aqueous extract does not appear to improve blood pressure or lipid levels in these patients (94086). More evidence is needed to rate caraway for these uses.

(Read more about CARAWAY)

CUMIN

INSUFFICIENT RELIABLE EVIDENCE to RATE

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.

(Read more about CUMIN)

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.

INSUFFICIENT RELIABLE EVIDENCE to RATE

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.

(Read more about FENNEL)

GERMAN CHAMOMILE (Chamomile)

INSUFFICIENT RELIABLE EVIDENCE to RATE

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

(Read more about GERMAN CHAMOMILE)

LEMON BALM

POSSIBLY EFFECTIVE

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

INSUFFICIENT RELIABLE EVIDENCE to RATE

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

(Read more about LEMON BALM)

STAR ANISE

There is insufficient reliable information available about the effectiveness of star anise.

(Read more about STAR ANISE)

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Safety view details

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

ACTIVATED CHARCOAL (Vegetable Charcoal)

LIKELY SAFE ...when used orally, short-term (12392,12393,93200,93609,93610,93611,93613). ...when activated charcoal-containing wound dressings are used topically (93603,94731).

POSSIBLY SAFE ...when used orally, long-term. Activated charcoal has been used with apparent safety in doses up to 1.2 grams three times daily for up to 3 years (103193).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally short-term. Activated charcoal 50 grams three times daily for 8 days has been used with apparent safety in pregnancy (126).

CARAWAY

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

POSSIBLY SAFE ...when caraway oil is used orally in medicinal amounts. Caraway oil has been used with apparent safety at a dose of up to 150 mg daily for up to 4 weeks, in combination with peppermint oil (6740,6741,6742,10075,96344). ...when caraway seed is used orally, short-term. An aqueous caraway seed extract has been used with apparent safety at a dose of 3 grams daily for up to 3 months (94086,94087,94088). ...when used topically and appropriately. A heated poultice containing caraway oil 2% has been used with apparent safety for up to 3 weeks (94085).

PREGNANCY: POSSIBLY UNSAFE
when used in medicinal amounts (4912,6746). Caraway oil has been used to stimulate menstruation (6746); avoid using.

LACTATION:
Insufficient reliable information available; avoid using.

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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.

(Read more about CUMIN)

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.

(Read more about FENNEL)

GERMAN CHAMOMILE (Chamomile)

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

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

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

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

(Read more about GERMAN CHAMOMILE)

LEMON BALM

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

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

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

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

(Read more about LEMON BALM)

STAR ANISE

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

POSSIBLY UNSAFE ...when star anise is used orally as a tea. In 2003, the US Food and Drug Administration (FDA) issued an advisory to the public not to consume teas brewed from star anise. They have been associated with adverse neurological and gastrointestinal effects, including jitteriness, irritability, tachycardia, nystagmus, vomiting, diarrhea, and seizures. Star anise products associated with these symptoms are often found to be contaminated with Japanese star anise (Illicium anisatum), which has known toxicity (11384,13058,76290,76293,100159,108932). However, large doses of star anise can also cause neurotoxicity (108932).

CHILDREN: POSSIBLY UNSAFE
when used orally. Star anise tea is a traditional remedy for infant colic, but has been associated with adverse neurological and gastrointestinal effects, including jitteriness, irritability, tachycardia, nystagmus, vomiting, diarrhea, and seizures. Star anise products associated with these symptoms are often found to be contaminated with Japanese star anise (Illicium anisatum), which has known toxicity (11384,13058,76290,76293,100159,108932). However, large doses of star anise can also cause neurotoxicity (108932).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (4912).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when star anise is used orally as a tea. In 2003, the US Food and Drug Administration (FDA) issued an advisory to the public not to consume teas brewed from star anise, as they have been associated with adverse neurological and gastrointestinal effects (11384,13058,76290,76293,100159,108932).

(Read more about STAR ANISE)

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Interactions with Drugs view details

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

ACTIVATED CHARCOAL (Vegetable Charcoal)

ALCOHOL (Ethanol)

Interaction Rating = Moderate Be cautious with this combination.

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

The binding action of activated charcoal may be reduced by alcohol.

Details

Alcohol may lower the adsorptive capacity of activated charcoal (12400).

CONTRACEPTIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Activated charcoal may reduce the clinical effects of oral contraceptives.

Details

Activated charcoal, taken in a dose of 5 grams four times daily for 3 days, may bind to, and reduce the absorption of, oral contraceptives, thereby limiting their effectiveness and increasing the risk of contraceptive failure. However, some clinical research shows that the risk for this interaction is minimal when activated charcoal is taken either 3 hours after or at least 12 hours before oral contraceptives (103192).

ORAL DRUGS

Interaction Rating = Major Do not take this combination.

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

Activated charcoal reduces systemic exposure to many drugs, including those that undergo enterohepatic recirculation, regardless of the route of administration.

Details

Activated charcoal adsorbs various drugs and may reduce their absorption and/or half-life. Examples of affected drugs include acetaminophen, aminophylline, amiodarone, atenolol, carbamazepine, dapsone, digoxin, disopyramide, fluoxetine, indomethacin, moxifloxacin, nadolol, phenytoin, phenobarbital, piroxicam, quinine, sotalol, theophylline, tricyclic antidepressants, valproate, and verapamil (12392,12400,93198,93602,93610,93612,93613,94730,105543). Avoid co-administration, except after drug overdose.

SYRUP OF IPECAC

Interaction Rating = Moderate Be cautious with this combination.

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

Syrup of ipecac is inactivated by activated charcoal.

Details

Activated charcoal adsorbs and inactivates syrup of ipecac (12394). Avoid co-administration.

CARAWAY

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, caraway might increase the risk of hypoglycemia when used with antidiabetes drugs.

Details

Animal research suggests that caraway can reduce blood glucose levels (12736,39844). Monitor blood glucose levels closely. Medication dose adjustments may be necessary.

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, caraway might increase the effects and adverse effects of CNS depressants.

Details

Animal research suggests that (S)-(+)-carvone, a major constituent of caraway seed extract, has sedative effects (39800).

CYTOCHROME P450 1A1 (CYP1A1) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, caraway might increase the levels and clinical effects of CYP1A1 substrates.

Details

In vitro evidence suggests that caraway extract can inhibit the activity of CYP1A1 in a dose-dependent manner (39780). This interaction has not been reported in humans.

DIURETIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, caraway might increase the risk of hypokalemia when used with diuretics that deplete potassium.

Details

Animal research suggests that a single dose of caraway fruit extract can promote diuresis and increase the urinary excretion of sodium and potassium. However, sub-chronic use of caraway fruit extract does not seem to significantly increase potassium excretion, although urine output continues to be increased for up to 6 days (39797).

ISONIAZID

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, caraway might increase the effects and adverse effects of isoniazid.

Details

Animal research suggests that a specific fraction of caraway seed extract (CC-1a) can increase plasma levels of isoniazid when administered concomitantly (25529). This interaction has not been reported in humans.

LITHIUM

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, caraway might reduce excretion and increase levels of lithium due to diuretic effects.

Details

Animal research suggests that caraway fruit extract has diuretic properties (39797).

PYRAZINAMIDE

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, caraway might increase the effects and adverse effects of pyrazinamide.

Details

Animal research suggests that a specific fraction of caraway seed extract (CC-1a) can increase plasma levels of pyrazinamide when administered concomitantly (25529). This interaction has not been reported in humans.

RIFAMPIN (Rifadin)

Interaction Rating = Minor Be watchful with this combination.

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

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

Details

Animal research suggests that a specific fraction of caraway seed extract (CC-1a) can increase plasma levels of rifampin when administered concomitantly (25529). This interaction has not been reported in humans.

(Read more about CARAWAY)

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).

(Read more about CUMIN)

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.

(Read more about FENNEL)

GERMAN CHAMOMILE (Chamomile)

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

CONTRACEPTIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

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

Details

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

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

ESTROGENS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

TAMOXIFEN (Nolvadex)

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

WARFARIN (Coumadin)

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

(Read more about GERMAN CHAMOMILE)

LEMON BALM

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

THYROID HORMONE

Interaction Rating = Moderate Be cautious with this combination.

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

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

Details

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

(Read more about LEMON BALM)

STAR ANISE

None known.

(Read more about STAR ANISE)

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Adverse Effects view details

Report an Adverse Reaction to Gas & Bloating Phytosolution

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

ACTIVATED CHARCOAL (Vegetable Charcoal)

General ...Orally, activated charcoal is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, black stools, bloating, constipation, and flatulence.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal obstruction and pulmonary aspiration.

Gastrointestinal ...The most common adverse reactions reported with activated charcoal are gastrointestinal in nature. Constipation appears to be the most frequent complaint, but is typically transient. Black stools, abdominal pain, bloating, and flatulence have also been reported (12392,12398,93611,103193). Rarely, activated charcoal may lead to gastrointestinal obstruction (12392).

Pulmonary/Respiratory ...Rarely, pulmonary aspiration has been reported in patients taking activated charcoal orally. This may happen if activated charcoal is regurgitated or if a misplaced nasogastric tube delivers activated charcoal to the lungs rather than the stomach (12392).

CARAWAY

General ...Orally, caraway oil seems to be well tolerated.

Gastrointestinal ...Orally, caraway oil, when used in combination with peppermint oil, may cause a substernal burning sensation, belching, nausea, and vomiting (6741,6742,10075,96344). It is unclear if these adverse effects are due to caraway oil, peppermint oil, or the combination. Peppermint oil, when used alone, has been reported to cause similar adverse effects.

Immunologic ...Orally, an allergic reaction has been reported after use of caraway oil in combination with peppermint oil in a patient with a history of bronchial asthma (96344). It is unclear if this adverse effect is due to caraway oil, peppermint oil, or the combination.

(Read more about CARAWAY)

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).

(Read more about CUMIN)

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).

(Read more about FENNEL)

GERMAN CHAMOMILE (Chamomile)

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

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

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

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

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

(Read more about GERMAN CHAMOMILE)

LEMON BALM

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

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

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

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

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

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

(Read more about LEMON BALM)

STAR ANISE

General ...Orally, star anise is generally well tolerated when consumed in the amounts commonly found in food. However, star anise tea is associated with serious neurological adverse effects which may or may not be related to contamination with Japanese star anise (Illicium apisatum).
Serious Adverse Effects (Rare):
Orally: Tea made from star anise has been associated with increased deep tendon reflexes, irritability, jitteriness, rapid eye movements, seizures, and vomiting. However, it is unclear if these effects are due to star anise or contamination with Japanese star anise (Illicium apisatum), which is known to be toxic due to its anisatin constituents.

Dermatologic ...Topically, the anethole constituent of star anise can cause dermatitis, including erythema, scaling, and vesiculation (13668,13669).

Gastrointestinal ...Orally, star anise tea has been reported to cause vomiting, diarrhea, and abdominal distension. The teas consumed in these reports may or may not have been contaminated with Japanese star anise (Illicum apisatum) (10407,13058,100159,108932).

Immunologic ...Topically, star anise and the constituents anethole, alpha-pinene, limonene, and safrole can cause allergic reactions in sensitive individuals (13669,76299).

Neurologic/CNS ...Orally, star anise tea has been reported to cause acute onset of irritability, jitteriness, hyperexcitability, clonus or myoclonus, increased deep tendon reflexes, rapid eye movements, nystagmus, and seizures. The teas consumed in these reports may or may not have been contaminated with Japanese star anise (Illicum apisatum) (10407,11384,13058,100159,108932).

(Read more about STAR ANISE)

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