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POSSIBLY EFFECTIVE

• Diarrhea. Low-quality evidence shows that oral cooked green bananas might be helpful for the management of acute and persistent diarrhea due to various causes in children. Details: Many clinical studies in children aged 5 months to 5 years with acute diarrhea of various etiologies shows that consuming cooked green bananas with or without rice for up to 14 days increases recovery rates by 30% to 266% when compared with control (93451,93462,93463,106469). Consuming cooked green bananas also reduced the need for rehydration therapy and the incidence of dehydration (93462,93463,106469). Clinical trials used cooked green bananas 50-100 grams per day in children aged 6-12 months, 100-200 grams per day in children aged 12-24 months, and 300 grams per day aged 24 months to 5 years (93451,93462,93463,106469). A moderate size, open label clinical study among children aged 6-35 months hospitalized with persistent diarrhea in Bangladesh shows that consuming a diet of green banana mixed with rice suji increases the number of children who recover within 5 days when compared with a full-strength rice suji diet but is equivalent to the standard treatment (control) of 75% strength rice suji diet (112150). Duration of hospital stay is also similar with green banana and 75% strength rice suji and shorter than with full strength rice suji. There is also less relapse at home among children who had been given the green banana rice suji diet in hospital compared with the 75%-strength rice suji. The validity of the study is limited by the lack of blinding. Clinical research also shows that bananas might be beneficial for diarrhea associated with enteral feeding in adults with critical illness. Adding banana flakes (Kanana Banana, Corpak Co) 1-3 tablespoons every 8 hours to the feeding tube seems to be as effective as routine medical treatment involving feeding rate adjustments and use of antidiarrheal agents for reducing symptoms and duration of diarrhea. After 7 days of treatment, 57% of patients in the banana group were free of diarrhea compared with only 24% of patients in the group receiving routine treatment (93453).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). Although there has been interest in using oral banana flower for allergic rhinitis, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Athletic performance. It is unclear if oral banana is beneficial for athletic performance. Details: Preliminary clinical research in trained male cyclists shows that consuming 0.4 grams/kg carbohydrate orally from ripe bananas with water 10-20 minutes prior to a 75 km cycling time trial, and 0.15-0.2 grams/kg carbohydrate from bananas with water every 15 minutes during the trial, modestly improves cycling time and oxygen consumption when compared with water alone. This regimen is equally effective to the same dose of carbohydrate from a 6% carbohydrate beverage (Gatorade) (93459,93465). However, another study from the same group of researchers found conflicting results with the use of carbohydrates from banana for this purpose (100995). It is possible that the consumption of carbohydrates in general, not the use of bananas specifically, is beneficial for athletic performance. However, other preliminary clinical research in trained male runners shows that consuming a banana and drinking plain water does not improve the time to run 10 km on a treadmill when compared with plain water alone. No benefit was seen with the consumption of other carbohydrate drinks when compared with plain water; it is possible that the duration of exercise was too short to identify an improvement in performance (93457). Further research is needed to clarify the benefits of banana, if any, for athletic performance.
• Burns. It is unclear if topical banana leaf is beneficial in patients with burns. Details: Preliminary clinical research in adults and children with partial thickness burns shows that daily changes of a banana leaf dressing with povidone iodine reduces pain during dressing changes. Furthermore, wound healing is as effective as a boiled potato peel bandage with povidone iodine, with no increased need for skin grafting (93454). When compared with Vaseline gauze dressing for 8 days following skin graft treatment for burns in adults, banana leaf dressing increases speed of epithelization from 11.7 days to 8.7 days, and improves average pain, pain during dressing removal, and ease of dressing removal. By the 8th day, complete epithelization was present in 57% of the wounds dressed with banana leaves when compared with 0% of the wounds dressed with Vaseline gauze (93455).
• Cancer. Although there has been interest in using topical banana green fruit for cancer, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Constipation. It is unclear if oral green banana is beneficial in patients with constipation. Details: Preliminary clinical research in children with functional constipation shows that consuming cooked green bananas, 30 grams daily for 8 weeks, improves stool consistency and abdominal pain and reduces straining and pain during defecation when compared with baseline. Consuming cooked green bananas with a conventional laxative such as polyethylene glycol plus electrolytes or sodium picosulfate also appears to decrease the dose of laxative needed in these children when compared with baseline (100996). The validity of these findings is limited by the lack of a comparator group.
• Contraception. Although there has been interest in using oral banana root for contraception, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Cough. Although there has been interest in using oral banana flower for cough, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Depression. It is unclear if oral banana is beneficial in patients with depression. Details: A large cross-sectional study in the general Chinese adult population has found that moderate, but not high, banana consumption is associated with a lower likelihood of depressive symptoms in males. However, high banana consumption is associated with a higher likelihood of depressive symptoms in females (106471).
• Diabetes. It is unclear if oral banana starch is beneficial in patients with diabetes. Details: Two small clinical studies in adults with type 2 diabetes shows that taking banana starch 24-57.2 grams orally daily for 4-28 days does not improve serum glucose levels, glucose variability, glucose control scores, or insulin levels when compared with control starches (110619,93448).Other preliminary clinical research in obese patients with type 2 diabetes shows that taking banana starch 24 grams in 240 mL of water each day for 4 weeks reduces body weight when compared with a taking soymilk powder in water. However, banana starch did not improve lipid levels or body fat (93448). Other preliminary clinical research in patients with type 2 diabetes shows that taking desiccated banana 250 grams daily for 12 weeks does not improve lipid levels or glycemic response when compared to baseline (93452).
• Exercise-induced muscle soreness. It is unclear if oral banana is beneficial for exercise-induced muscle soreness. Details: Preliminary clinical research in trained cyclists shows that consuming 0.4 grams/kg of carbohydrates orally from mini-yellow bananas with water 20 minutes prior to a 75 km cycling time trial, and 0.2 grams/kg of carbohydrates from banana every 15 minutes during the trial, decreases muscle soreness ratings 1.5 hours after the time trial when compared with water alone. Consuming carbohydrates from Cavendish bananas in the same manner did not decrease delayed onset muscle soreness, although cyclists reported less muscle cramping with both types of bananas when compared with water (100995). It is unclear whether carbohydrates from banana are any more effective than other carbohydrate sources or whether these results are generalizable to other types of exercise.
• Gastroesophageal reflux disease (GERD). Although there has been interest in using oral banana fruit for GERD, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Hangover. Although there has been interest in using oral banana fruit for hangover, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Headache. Although there has been interest in using topical banana leaves for headache, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Hypercholesterolemia. It is unclear if oral banana is beneficial in patients with hypercholesterolemia. Details: Preliminary clinical research shows that taking desiccated banana 500 grams orally daily for 12 weeks reduces levels of total cholesterol by 7.5% when compared with baseline in patients with hypercholesterolemia. Taking 250 grams daily does not seem to reduce total cholesterol levels; however, high-density lipoprotein (HDL) cholesterol levels increase by 14.5% (93452). The validity of these findings is limited by the lack of a comparator group.
• Hypertension. Although there has been interest in using oral banana fruit for hypertension, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Hypokalemia. Although there has been interest in using oral banana fruit for hypokalemia, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Inflammatory bowel disease (IBD). Although there has been interest in using oral banana fruit for IBD, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Joint pain. Although there has been interest in using oral banana flower for joint pain, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Kidney stones (nephrolithiasis). Oral banana stem has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with calculi of at least 5 mm shows that taking a specific Ayurvedic product (Herbmed) containing banana stem 250 mg and Crateva nurvala 250 mg orally daily for 3 months moderately improves symptoms associated with urinary calculi and reduces the size of the calculi by 11% to 33% when compared with baseline (93460). It is not clear if this is due to banana stem, Crateva nurvala, or the combination. Also, the validity of this finding is limited by the lack of a comparator group.
• Menorrhagia. Although there has been interest in using oral banana fruit for menorrhagia, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Obesity. It is unclear if oral banana is beneficial in patients with obesity. Details: Preliminary clinical research in obese patients with type 2 diabetes shows that taking banana starch 24 grams in 240 mL of water orally each day for 4 weeks reduces body weight by 1 kg more when compared to a control group consuming soymilk powder in water (93448).
• Peptic ulcers. Although there has been interest in using oral banana fruit for peptic ulcers, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Shigellosis. It is unclear if oral green banana is beneficial in patients with shigellosis. Details: Clinical research in children 6-60 months of age who are being treated with antibiotics for shigellosis shows that eating cooked green banana 250 grams per liter of a rice-based diet for 5 days improves symptoms of diarrhea, including the presence of fecal mucus and blood, when compared with a rice-based diet alone. Adding banana to the diet decreased the number of daily stools by 70% in those consuming banana compared to 50% in children consuming the rice diet alone (93461).
• Skin grafts. Although there has been interest in using topical banana leaves for skin grafts, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Smoking cessation. Although there has been interest in using oral banana fruit for smoking cessation, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Stroke. Although there has been interest in using oral banana fruit for stroke, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Tuberculosis. Although there has been interest in using oral banana flower for tuberculosis, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Vaginitis. Although there has been interest in using oral banana root for vaginitis, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Vitamin A deficiency. Although there has been interest in using oral banana fruit for vitamin A deficiency, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Warts. Although there has been interest in using topical banana leaves or peels for warts, there is insufficient reliable information about the clinical effects of banana for this purpose.
• Wound healing. Although there has been interest in using topical banana leaves, peels, or green fruit for wound healing, there is insufficient reliable information about the clinical effects of banana for this purpose. More evidence is needed to rate banana for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Breast cancer-related hot flashes. Oral chicory has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A moderate-sized clinical study of breast cancer survivors who use estrogen deprivation therapy shows that taking 5 mL of chicory and fumitory syrup 3 times daily for 4 weeks significantly decreases the frequency and severity of hot flashes when compared with placebo. Hot flash frequency and severity were both reduced by around 57% in the treatment group, as compared with a 10% reduction in the placebo group (110724). The use of a per-protocol analysis limits the validity of these findings. Additionally, it is unclear if these findings are due to chicory, fumitory, or the combination. Cancer. Although there has been interest in using oral chicory for the treatment or prevention of cancer, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Constipation. Although there has been interest in using oral chicory for constipation, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Diabetes. Although there has been interest in using oral chicory for diabetes, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Dyspepsia. Although there has been interest in using oral chicory for dyspepsia, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Hyperlipidemia. Although there has been interest in using oral chicory for hyperlipidemia, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Hypertension. Although there has been interest in using oral chicory for hypertension, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Neonatal jaundice. It is unclear if oral chicory solution is beneficial in neonates with jaundice. Details: A moderate-sized clinical study of nursing mothers shows that taking 50 mL of chicory 10% distillate every 12 hours for 3 days reduces bilirubin levels of breastfed neonates with jaundice by around 0.3 mg/dL when compared with placebo (110723). However, it is unlikely that these findings are clinically significant.
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral chicory seed is beneficial in patients with NAFLD. Details: A small clinical trial in patients with NAFLD shows that taking chicory seed 9 grams infused in hot water daily for 12 weeks reduces body mass index (BMI) by 0.66 kg/m2 when compared with placebo. When combined with turmeric 3 grams daily, serum alkaline phosphatase was decreased. Although levels of other liver enzymes decreased when compared to baseline, changes were not significant when compared with placebo. Also, taking chicory seed did not affect plasma lipid levels (102350).
• Osteoarthritis. It is unclear if oral chicory root extract is beneficial in patients with osteoarthritis. Details: A small clinical study in patients with knee or hip osteoarthritis shows that taking chicory root extract 600 mg three times daily for 3 months does not improve pain, stiffness, or functional ability when compared with placebo (93647). However, this small study was likely underpowered to detect differences between groups. More evidence is needed to rate the effectiveness of chicory for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Constipation. Although there has been interest in using oral dandelion for constipation, there is insufficient reliable information about the clinical effects of dandelion for this purpose.
• Dyspepsia. Although there has been interest in using oral dandelion for dyspepsia, there is insufficient reliable information about the clinical effects of dandelion for this purpose.
• Flatulence. Although there has been interest in using oral dandelion for flatulence, there is insufficient reliable information about the clinical effects of dandelion for this purpose.
• Heart failure. Although there has been interest in using oral dandelion for its diuretic effects in patients with heart failure, there is insufficient reliable information about the clinical effects of dandelion for this purpose.
• Joint pain. Although there has been interest in using oral or topical dandelion for joint pain, there is insufficient reliable information about the clinical effects of dandelion for this purpose.
• Tonsillitis. It is unclear if oral dandelion is beneficial in patients with tonsillitis. Details: One small clinical study in patients with acute purulent tonsillitis shows that eating soup containing dandelion (pugongying soup) daily for 3 days along with benzylpenicillin sodium 640,000 units daily improves recovery when compared with placebo plus benzylpenicillin sodium. Recovery rates were 36% with the dandelion-containing soup compared to 10% with placebo (18292).
• Urinary tract infections (UTIs). Oral dandelion has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in females with recurrent UTIs shows that taking a specific combination of dandelion root and uva ursi leaf extracts three times daily for 1 month reduces the risk of UTI recurrence when compared with placebo at 12-month's follow-up. For every 5 patients treated with this combination over placebo, one additional UTI was prevented (1932). In this combination, uva ursi is used for its antibacterial properties and dandelion is used to increase urination. However, this combination is not recommended for extended use because uva ursi may be unsafe when used long-term. Another small clinical study in premenopausal females with acute, uncomplicated lower UTIs shows that taking a combination product containing dandelion extract 50 mg, D-mannose, prebiotics, arabinogalactan, and astragalus root extract twice daily for five days, along with phenazopyridine and alkylating agents as conventional therapy, improves UTI symptoms and bacteriuria when compared with placebo plus conventional therapy (111757). It is unclear if these effects are due to dandelion, other ingredients, or the combination. More evidence is needed to rate dandelion for these uses.

(Read more about DANDELION)

POSSIBLY EFFECTIVE

• Constipation. Oral flaxseed is a bulk forming laxative that helps to relieve constipation. Details: Flaxseed is a source of dietary fiber and has a bulk forming laxative effect (6803,12910). One clinical study in healthy young adults shows that consuming muffins containing 25 grams of milled flaxseed twice daily for 4 weeks increases weekly bowel movements by 30% when compared to a control group (6803). Other clinical research in diabetic patients with constipation shows that taking flaxseed 10 grams twice daily for 12 weeks improves stool form and reduces constipation by a moderate amount when compared with placebo (101950). Furthermore, a small clinical study in patients in China with functional constipation shows that consuming brown flaxseed flour 50 grams in divided doses with meals daily for 4 weeks seems to modestly improve frequency of bowel movements and pain and reduce failure to evacuate when compared with taking lactulose 15 mL every morning (105474). Flaxseed has also been evaluated in combination with other natural ingredients. A preliminary clinical trial in elderly patients with mild constipation shows that eating yogurt containing galacto-oligosaccharide syrup (Elixor, Borculo Whey Products) 6 grams, prunes 6 grams, and flaxseed 3 grams twice daily for 3 weeks increases stool frequency when compared with a control yogurt (21191). It is unclear if the effects were due to flaxseed, other constituents, or the combination.
• Diabetes. Oral ground flaxseed modestly reduces blood glucose in patients with diabetes and pre-diabetes. It is unclear if oral whole flaxseed reduces blood glucose. Details: Most evidence from meta-analyses and clinical research in adults with prediabetes and diabetes shows that taking ground flaxseed reduces fasting blood glucose and insulin levels (21194,21196,26479,101950,111061). A meta-analysis of 7 small to moderate clinical trials shows that taking flaxseed, usually ground, 13 to 40 grams daily for 8-12 weeks has a small beneficial effect on fasting blood glucose, insulin, insulin resistance, and glycated hemoglobin (HbA1c), compared with no intervention or another fiber source. A sub-analysis shows that the benefit of flaxseed on fasting glucose levels remains in patients with type 2 diabetes (111061). Other research disagrees. A meta-analysis of three small clinical trials in patients with type 2 diabetes shows that taking flaxseed does not improve fasting blood glucose, insulin resistance, or HbA1c (111062). Another meta-analysis of 24 clinical studies involving 1,879 patients with and without diabetes shows that whole and ground flaxseed seem to reduce blood glucose levels by an average of 6 mg/dL and insulin levels by an average of 1 mIU/mL and modestly reduce insulin resistance when compared with control treatments such as wheat germ or raw rice. Whole and ground flaxseed were not shown to significantly reduce HbA1c when compared with control, although there was a non-significant trend towards a reduction (96428). Significant heterogeneity in study size and study population limit the validity of these findings. The effects of flaxseed lignan extract in patients with type 2 diabetes is unclear. A small clinical study in Chinese adults with type 2 diabetes show that using a specific standardized flaxseed lignan extract (Flax Essence, Jarrow Formulas) 600 mg three times daily, providing 360 mg secoisolariciresinol diglucoside, slightly reduces HbA1c when compared with placebo (16768). However, a small meta-analysis including this study shows that taking flaxseed lignans does not reduce fasting blood glucose or HbA1c (111062).
• Hypercholesterolemia. Oral whole and ground flaxseed modestly reduce lipid levels. Details: Most research shows that taking various flaxseed preparations 30-50 grams daily reduces total cholesterol by 5% to 15% and low-density lipoprotein (LDL) cholesterol by 8% to 18%, but does not seem to affect high-density lipoprotein (HDL) cholesterol, when compared with control (6808,10952,22179,26478,65866,101944,101947,101949,108044,108046)(111064). Apolipoprotein A-1 and apolipoprotein B may be reduced by 6% and 7.5%, respectively (10952). A meta-analysis of clinical studies shows reductions in apolipoprotein A and apolipoprotein B following whole flaxseed supplementation (108046). The cholesterol-lowering effect of flaxseed has been shown in various populations, including those with hypercholesterolemia with/or without diabetes, postmenopausal patients, and patients with chronic kidney disease or cardiovascular risk factors (6808,10952,10978,12910,22180,22181,26478,26480,26488,101944)(101949,101950,111064). One large meta-analysis suggests that the most consistent effect occurs in patients with hypercholesterolemia (101947). Another large meta-analysis suggests that patients with hypercholesterolemia and healthy patients with a body mass index greater than 25 kg/m2 may benefit the most from treatment (108044). Most research shows that flaxseed reduces triglyceride levels (101947,108046,111064). However, there are certain preparations, such as partially defatted flaxseed (which lacks alpha-linolenic acid content) or flaxseed incorporated into bread products, which might increase triglyceride levels by up to 26% (6808,26488).
• Hypertension. Daily oral flaxseed consumption, especially for longer than 12 weeks, seems to modestly reduce blood pressure. Details: Meta-analyses of mainly small clinical studies in patients with and without hypertension show that taking flaxseed reduces systolic and diastolic blood pressure by an average of 1.1 to 1.8 and 1.0 to 1.3 mmHg, respectively, when compared with control (96426,111063). The effect of flaxseed lignan is unclear. One meta-analysis shows that flaxseed lignan does not seem to reduce blood pressure when compared with control (96426). However, a more recent meta-analysis shows that taking flaxseed lignan has a small effect on systolic, but not diastolic, blood pressure (111063). The length of supplementation may play a role as studies lasting longer than 12 weeks seemed to lower blood pressure to a slightly greater degree than studies lasting less than 12 weeks (96426). The validity of these findings is limited due to the short duration of treatment, the variation in study size, the inclusion of patients with and without hypertension, and the range of doses used. Some clinical research also shows that taking flaxseed may be beneficial for blood pressure reduction in patients with hypertension (111063). One individual clinical study in adults with hypertension shows that taking flaxseed 10 grams or 30 grams daily affects blood pressure in a dose-dependent manner when compared with placebo. After 12 weeks of treatment, systolic and diastolic blood pressure decreased by 12 mmHg and 6 mmHg, respectively, in the high-dose group, compared with 10 mmHg and 7 mmHg, respectively, in the low-dose group (108043).
• Mastalgia. Oral flaxseed seems to reduce symptoms of cyclic mastalgia. Details: Clinical research in healthy Iranian women with cyclic mastalgia shows that taking flaxseed powder 25 grams daily for 2 months reduces breast pain intensity from moderate to mild and also reduces duration of pain when compared with placebo (96250). Other preliminary clinical research shows that eating a muffin containing ground flaxseed 25 grams daily for 3 months reduces symptoms of severe cyclic mastalgia (16766).
• Obesity. Oral flaxseed and flaxseed mucilage seem to modestly improve weight loss in patients who are obese or overweight. However, flaxseed lignan extract does not seem to be beneficial. Details: A meta-analysis of 45 clinical studies including 2,561 overweight or obese adults shows that flaxseed consumption reduces body weight by 1.8 kg, body mass index (BMI) by 0.6 kg/m2, and waist circumference by 1.2 cm when compared with control in adults. The most benefit is seen in adults with a baseline BMI greater than or equal to 27 (96427). Flaxseed consumption of at least 30 grams daily for durations of at least 12 weeks demonstrated the greatest efficacy (96427,101949). The soluble fiber, flaxseed mucilage, has also been studied. A clinical trial in overweight or obese adults shows that taking oral flaxseed mucilage 1280 or 2560 mg mixed in water twice daily with meals for 12 weeks decreases body weight, waist circumference, and BMI in a dose-dependent manner when compared with placebo. After 12 weeks, a 5 kg and 4 kg weight reduction was observed in the high- and low-dose groups, respectively, compared to a 1 kg reduction in the placebo group (108047). The validity of this finding is limited due to short duration of treatment and lack of follow-up. Conversely, flaxseed lignan extract does not appear to be effective in reducing weight, BMI, or waist circumference (96427). Some research has investigated whether variants in genes related to satiety and appetite play a role in any effect of flaxseed on weight loss and appetite. A small clinical trial in adults with overweight or obesity shows that taking defatted flaxseed flour in biscuits daily for 8 weeks modestly reduces body weight, BMI, triglycerides, or blood glucose only in those with specific gene variants when compared with control biscuits (111066). More information is needed to determine how these gene variants play a role in the connection between nutrition and obesity.
• Systemic lupus erythematosus (SLE) nephritis. Oral flaxseed might be beneficial for improving kidney function in SLE. Details: Some small clinical studies suggest that taking whole or ground flaxseed orally might improve serum creatinine levels in people with SLE nephritis (6802,8021).

POSSIBLY INEFFECTIVE

• Osteoporosis. Oral flaxseed does not seem to be beneficial in osteoporosis. Details: Clinical research shows that consuming ground flaxseed 40 grams daily for up to one year does not affect markers of bone metabolism or improve bone mineral density in healthy, postmenopausal adults (10952,12910). Similarly, taking flaxseed extract 550 mg three times daily for 6 months does not appear to improve bone mineral density when compared with placebo in older adults (21197).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using oral flaxseed for acne, there is insufficient reliable information about the clinical effects of flaxseed for this purpose.
• Benign prostatic hyperplasia (BPH). It is unclear if oral flaxseed lignan improves symptoms of BPH. Details: A small clinical study in patients with BPH shows that taking a specific flaxseed lignan extract (BeneFlax, Archer Daniels Midland Co.) 300 mg or 600 mg daily for 4 months improves lower urinary tract symptom scores when compared with placebo. Additionally, the 600 mg dose was associated with improved quality of life when compared with placebo (21193).
• Breast cancer. It is unclear if oral flaxseed reduces the risk for breast cancer or the progression of breast cancer. Details: A small clinical study in females newly diagnosed with breast cancer shows that consuming a muffin containing ground flaxseed 25 grams daily for about 40 days reduces markers of tumor cell proliferation when compared with baseline, but not when compared with placebo (16765). The effect of flaxseed intake on breast cancer outcomes was not assessed. Dietary lignans, which occur in flaxseed, have been linked with a lower risk of developing breast cancer. Most large-scale population studies have found that high intake of dietary lignans and serum levels of the lignan enterolactone are associated with a reduced risk of developing breast cancer (16775,16776,16777,16779,16781,16782,16783,16785). It is unclear if flaxseed lignan, specifically, is beneficial for reducing the risk of breast cancer.
• Burning mouth syndrome. Flaxseed has only been evaluated in a mouthwash in combination with German chamomile; its effect when used alone is unclear. Details: A small clinical study in female patients with burning mouth syndrome shows that using a homemade mouthwash containing boiled whole flaxseed 10 grams and German chamomile 1 gram in 200 mL of water 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.
• Cardiovascular disease (CVD). It is unclear if oral flaxseed or flaxseed lignans reduce the development or progression of CVD. Details: A small clinical study in older adults that were also given dietary advice shows that taking flaxseed 30 grams daily for 12 weeks, starting 4 weeks after percutaneous coronary intervention (PCI), more than doubles flow mediated dilation when compared with a group not taking flaxseed (101945). However, population research has found that total dietary intake of lignans, including flaxseed lignans, is not associated with a reduced risk of coronary heart disease or all-cause mortality (16787). This research did not specifically assess the effect of flaxseed intake on CVD.
• Chronic kidney disease (CKD). Although there is interest in using oral flaxseed for CKD, there is insufficient reliable information about the clinical effects of flaxseed for this condition.
• Colorectal cancer. It is unclear if oral flaxseed reduces the risk of colorectal cancer. Details: Flaxseed is one source of dietary lignans. Population research has found that serum levels of lignans are not associated with risk of developing colorectal cancer (16778). However, other population research has found that high dietary intake of lignans is associated with a reduced risk of colorectal cancer (16784), and that higher serum levels of dietary lignans are associated with a reduced risk of colorectal adenomas (16788). It is unclear if flaxseed lignan, specifically, is beneficial for reducing the risk of colorectal cancer.
• Endometrial cancer. It is unclear if oral flaxseed reduces the risk of endometrial cancer. Details: Flaxseed is one source of dietary lignans. A large-scale population study has found that serum levels of lignans are not associated with risk of developing endometrial cancer (16786).This research did not specifically assess the effect of flaxseed intake on endometrial cancer risk.
• Fatigue. It is unclear if oral ground flaxseed reduces fatigue in overweight children. Details: A small non-blinded clinical study in overweight healthy children ages 7-18 shows that consuming ground flaxseed 20 grams in divided doses with food daily for 4 weeks seems to modestly reduce mental fatigue but not physical fatigue when compared with puffed wheat 25 grams daily (105473).
• Impaired glucose tolerance (prediabetes). It is unclear if oral flaxseed is beneficial in prediabetes. Details: A small clinical study in adults with prediabetes shows that consuming milled flaxseed 20 grams or 40 grams daily for 12 weeks does not improve glycemic control, but modestly reduces systolic blood pressure, when compared with no intervention (96434).
• Irritable bowel syndrome (IBS). It is unclear if oral flaxseed improves IBS symptoms. Details: A small open-label clinical study in patients with IBS suggests that consuming whole or ground flaxseed 24 grams daily for 4 weeks does not improve quality of life, severity of IBS symptoms, or number of bowel movements when compared with no intervention (21198).
• Lung cancer. It is unclear if oral flaxseed reduces the risk of lung cancer. Details: Observational research has found that consuming a higher amount of dietary phytoestrogens, such as the lignan metabolites and precursors found in flaxseed, is associated with a lower risk of developing lung cancer when compared to those who consume smaller amounts (13190). It is unclear if flaxseed, specifically, is beneficial for reducing the risk of lung cancer.
• Menopausal symptoms. There is contradictory evidence about the effects of flaxseed for reducing menopausal symptoms. Details: Some preliminary clinical research in postmenopausal adults shows that taking either flaxseed meal 90 grams daily or a specific flaxseed extract (Biogalenica, Medicinal Compounding Pharmacy) 1000 mg daily for 6 months reduces menopausal symptoms and the frequency of hot flashes when compared to baseline (21200). Other small clinical studies in postmenopausal adults show that consuming ground flaxseed orally 40 grams daily reduces symptoms of hot flashes by about 35% and night sweats by about 44% when compared to baseline (10978,12910). However, similar reductions have been observed with placebos, such as wheat germ (12910,18224). Higher quality studies of flaxseed used in food products have yielded negative results. One clinical trial in postmenopausal adults shows that taking a specific flaxseed-containing bar (Glambia Nutritionals) providing 7 grams of flaxseed and 410 mg of lignans reduces hot flash frequency by 28% and hot flash scores by 50% when compared to baseline, but not when compared with placebo (18224). In another small clinical study, consuming muffins containing flaxseed 25 grams daily providing 50 mg lignans did not improve hot flashes or measures of quality of life when compared with placebo in a similar patient population (16762). Eating flaxseed-enriched bread providing 25 grams of flaxseed daily for 12 weeks also did not improve menopausal symptoms or reduce the frequency of hot flashes when compared to control (22176).
• Metabolic syndrome. Small studies suggest that oral flaxseed is beneficial for metabolic syndrome. Details: One small clinical study in older adults shows that taking a specific flaxseed lignan extract (BeneFlax, Archer Daniels Midland Co.) 550 mg three times daily for 6 months reduces metabolic syndrome risk scores when compared with placebo in males, but not females (21197). Another small open-label clinical trial in patients with metabolic syndrome suggests that taking flaxseed powder 30 grams daily for 12 weeks modestly reduces the number of people meeting the criteria for metabolic syndrome when compared with no supplementation (105276). However, food containing flaxseed does not seem to be as beneficial. Some clinical research in Asian Americans with metabolic syndrome shows that eating bread containing flaxseed 30 grams daily plus lifestyle counseling for 12 weeks does not improve markers of metabolic syndrome when compared with lifestyle counseling alone (21199).
• Nonalcoholic fatty liver disease (NAFLD). Small clinical studies suggest that oral flaxseed may modestly reduce markers of liver disease progression in patients with NAFLD. Details: A small clinical pilot study in adults with NAFLD shows that taking brown milled flaxseed 30 grams daily for 12 weeks along with lifestyle modification reduces fibrosis by 21% and steatosis by about 15.3%, compared with reductions of 9.7% and 5.5%, respectively, in those following lifestyle modifications alone (96249). A larger follow-up clinical study in patients with NAFLD shows that taking brown milled flaxseed 30 grams daily for 12 weeks in addition to lifestyle modification reduces steatosis by about 28%, compared with a 16% reduction in the lifestyle modification group (105275).
• Osteoarthritis. It is unclear if topical flaxseed is beneficial in patients with osteoarthritis. Details: A small clinical study in patients with hand osteoarthritis who are using routine treatments shows that using a flaxseed poultice compress once daily for 7 days improves pain by 63% and hand function by 66% when compared with a hot compress or no compress in combination with routine treatments. Some of the benefit was maintained for at least a week following treatment (101946).
• Peripheral arterial disease (PAD). It is unclear if oral flaxseed is beneficial in patients with PAD. Details: Clinical research in patients with PAD shows that taking milled flaxseed 30 grams daily mixed with a variety of foods for one year does not reduce the incidence of cardiac arrhythmias or improve the distance walked until claudication when compared with placebo (101942). This study may have been inadequately powered to detect differences between groups.
• Pharyngitis. Although there is interest in using oral flaxseed for pharyngitis, there is insufficient reliable information about the clinical effects of flaxseed for this purpose.
• Polycystic ovary syndrome (PCOS). It is unclear if oral flaxseed is beneficial in patients with PCOS. Details: A small open-label clinical study in patients with PCOS shows that taking flaxseed 30 grams daily for 12 weeks in conjunction with receiving lifestyle modification advice reduces triglyceride and insulin levels and improves insulin resistance when compared with lifestyle modification advice alone. About 69% of those in the treatment group who had irregular menstrual cycles at baseline had a regular cycle at the end of treatment, compared with no significant improvement in the control group. Flaxseed did not affect body weight, low-density lipoprotein (LDL) cholesterol, or blood glucose when compared with control (101943).
• Prostate cancer. Small clinical studies suggest that oral flaxseed may modestly improve biomarkers of prostate cancer. Details: A very small clinical trial in patients with prostatic intraepithelial neoplasia (PIN), a precancerous proliferation of prostatic epithelial cells, shows that adding ground flaxseed (Alena, Enreco) 30 grams daily to a fat-restricted diet for 6 months lowers prostate specific antigen (PSA) levels and slows prostate epithelium proliferation when compared with baseline (12908). This finding is limited by the lack of a placebo group. A clinical study in patients with prostate cancer awaiting prostatectomy shows that taking ground flaxseed (Alena, Enreco) 30 grams daily with or without a fat-restricted diet for about 30 days reduces tissue proliferation rate, but does not reduce PSA, when compared with control (16761).
• Radiation-induced pneumonitis. It is unclear if oral flaxseed is beneficial for preventing radiation-induced pneumonitis in patients with non-small cell lung cancer (NSCLC). Details: A very small, clinical trial in adults with locally advanced or metastatic NSCLC currently undergoing chemoradiation therapy shows that taking ground flaxseed (Golden Valley Flax; Hylden Farms) 40 grams daily, starting one week prior to radiotherapy and continuing until completion of treatment, may reduce the risk of radiation-induced pneumonitis when compared with baseline, with only 1 patient (5%) developing a grade ≥3 event and no cases of grade 2 events (108042). The validity of these findings is limited by the lack of a comparator group and a low adherence rate due to tolerability issues.
• Rheumatoid arthritis (RA). It is unclear if oral flaxseed is beneficial in patents with RA. Details: A clinical study in adults with RA shows that following either a regular or anti-inflammatory diet supplemented with oral flaxseed 30 grams daily for 12 weeks improves disease activity score 28-joint (DAS28-ESR), as well as pain and quality of life outcomes, such as emotional well-being and vitality, when compared with baseline (108048). The validity of these findings is limited by the lack of a comparator group.
• Ulcerative colitis. It is unclear if oral flaxseed is beneficial in patients with ulcerative colitis. Details: A small open-label clinical study in patients with ulcerative colitis shows that taking ground flaxseed 30 grams daily for 12 weeks seems to modestly reduce inflammatory markers and disease severity and improve quality of life when compared with control (101941). A nonblinded, clinical study in adults with mild to moderate ulcerative colitis shows that taking brown milled flaxseed 15 grams twice daily for 12 weeks improves disease severity scores when compared with placebo (108045). The validity of these findings is limited by the lack of blinding and short duration of treatment. More evidence is needed to rate flaxseed for these uses.

(Read more about FLAXSEED)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Constipation. Small clinical studies suggest that oral FOS may modestly improve symptoms in patients with constipation when used in combination with probiotics. The benefits of FOS when used alone are unclear. Details: Most clinical research has evaluated the use of FOS for constipation in conjunction with probiotics. Preliminary clinical research in adults with chronic functional constipation shows that taking an unspecified dose of a specific product (Hexbio) consisting of FOS, Lactobacillus acidophilus, Lacticaseibacillus casei, Lactococcus lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Bifidobacterium infantis orally twice daily for 7 days increases defecation frequency by 3-fold when compared with placebo. Taking this product also improved patient reported symptoms of straining, lumpy hard stools, and incomplete evacuation sensations (90266). Other clinical research in adult females with constipation shows that taking a different product (Lactofos, SKL Functional Nutrition Ltda.) containing FOS 6 grams and Lacticaseibacillus paracasei, Lacticaseibacillus rhamnosus, Lactobacillus acidophilus, and Bifidobacterium lactis 0.1-1 billion colony-forming units each, orally twice daily for 30 days, modestly increases the frequency of evacuation and decreases constipation severity when compared with placebo (90300). It is unclear if these effects are due to FOS, other ingredients, or the combination. In children aged 4-8 years with functional constipation, preliminary clinical research shows that taking a mixture of FOS 0.45 grams and polydextrose 4.17 grams orally daily for 45 days improves the weekly frequency of bowel movements, clinical manifestations of constipation, and quality of stool type when compared with baseline (106482). It is unclear if these effects are due to FOS, polydextrose, or the combination. Additionally, the validity of these findings is limited by the lack of a comparator group. Clinical research evaluating the use of FOS alone is limited. Preliminary clinical research in elderly males shows that taking FOS alone 3-10 grams daily for 30 days increases the frequency of defecation by 1.5-fold when compared with baseline (8505). The validity of this study is limited by the lack of a comparator group. In non-breastfeeding infants 6-24 months of age with constipation, preliminary clinical research shows that fortifying formula or milk with FOS daily for 4 weeks increases the frequency of soft stools by 33% and decreases the frequency of straining by 55% when compared with placebo. However, the use of FOS did not increase the percentage of infants who achieved normal bowel pattern. The daily dose of FOS was 6 grams for infants 6-8.9 kg, 9 grams for infants 9-11.9 kg, and 12 grams for infants over 12 kg (98651).
• Diabetes. Oral FOS has only been evaluated in combination with probiotics; its effect when used alone is unclear. Details: Preliminary clinical research in adults with type 2 diabetes shows that taking a combination product containing FOS 500 mg, Bacillus coagulans 100 billion spores, Lacticaseibacillus rhamnosus 10 billion colony-forming units (CFUs), and Lactobacillus acidophilus 1 billion CFUs once daily for 12 weeks reduces fasting blood glucose by 17 mg/dL, compared with an increase of 3 mg/dL with placebo. However, taking this product did not affect body weight, waist circumference, or cholesterol levels. It is unclear if this effect is due to FOS, other ingredients, or the combination (107731).
• Hematopoietic stem cell transplant (HSCT). It is unclear if oral FOS is beneficial in patients undergoing HSCT. Details: Preliminary clinical research in patients undergoing an allogeneic HSCT shows that taking a specific oral FOS supplement, (Fibrulose F97, Cosucra Groupe) 5-15 grams daily for 21 days, beginning 5 days before transplant, does not reduce acute graft-versus-host disease, blood stream infections, or Clostridioides difficile infections or improve overall survival when compared with control (107931). However, this study may have been inadequately powered to detect a difference between groups.
• Hypercholesterolemia. Although there has been interest in using oral FOS for hypercholesterolemia, there is insufficient reliable information about the clinical effects of FOS for this purpose.
• Obesity. Although there has been interest in using oral FOS for obesity, there is insufficient reliable information about the clinical effects of FOS for this purpose.
• Osteoporosis. Oral FOS has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in postmenopausal adults shows that taking a specific FOS product (NutraFlora, Ingredion Inc.) 3.2 grams plus calcium 800 mg daily for 24 months reduces the decline in total-body bone mineral density (BMD) when compared with calcium alone, but not when compared with a maltodextrin control. In a subgroup of patients with osteopenia, this combination reduced the decline in BMD in the lumbar vertebrae when compared with calcium alone or a maltodextrin control (94931).
• Travelers' diarrhea. It is unclear if oral FOS is beneficial for preventing traveler's' diarrhea. Details: Preliminary clinical research shows that taking FOS 10 grams orally daily for 4 weeks, starting 2 weeks before traveling to a medium- to high-risk destination, does not reduce the incidence of travelers' diarrhea when compared with placebo (10373). However, the study may have been inadequately powered to detect a difference between groups. More evidence is needed to rate FOS for these uses.

(Read more about FRUCTO-OLIGOSACCHARIDES (FOS))

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dental plaque. It is unclear if oral or topical gum arabic is beneficial for preventing or treating dental plaque. Details: Preliminary clinical research shows that chewing gum arabic for 10 minutes, five times daily for 7 days, reduces dental plaque when compared with chewing sugar-free gum (30220). Another small clinical study in adults with mild or moderate plaque-induced gingivitis shows that applying half a teaspoon of gum arabic powder to the buccal surface of dentogingivial areas for 5 minutes then rinsing with tap water twice daily for 60 days reduces dental plaque in patients with moderate, but not high, plaque accumulation when compared with placebo (111508). Gum arabic has also been evaluated in combination with other ingredients for this purpose. A small clinical study shows that applying a pea-size amount of gel containing gum arabic, barleria, medlar, terminalia, and melia (Gum Tone Gel, Charak Pharma Pvt Ltd.) after brushing for 6 weeks decreases plaque severity when compared with placebo. The gel is similar in effectiveness to chlorhexidine 1% gel (92887). However, it's unclear if these findings are due to gum arabic, other ingredients, or the combination.
• Diabetes. It is unclear if oral gum arabic is beneficial in patients with diabetes. Details: Clinical research in adults with type 2 diabetes who are taking oral antidiabetes medications shows that taking gum arabic powder 30 grams daily in the morning for 3 months modestly reduces fasting blood glucose and glycated hemoglobin (HbA1c) when compared with baseline. Gum arabic also modestly reduces low-density lipoprotein (LDL) cholesterol levels, body mass index, and hip circumference, but not waist circumference or blood pressure, when compared with baseline (98700,99098). The validity of these findings is limited by the lack of a comparison to the placebo group.
• Gingivitis. It is unclear if topical gum arabic is beneficial in patients with gingivitis. Details: A small clinical study in adults with mild or moderate plaque-induced gingivitis shows that applying half a teaspoon of gum arabic powder to the buccal surface of dentogingivial areas for 5 minutes then rinsing with tap water twice daily for 60 days reduces gingival inflammation in patients with mild, but not moderate, gingivitis when compared with placebo (111508). Another small clinical study in patients with chronic gingivitis shows that applying a pea-size amount of gel containing a mixture of ingredients including gum arabic, barleria, medlar, terminalia, and melia (Gum Tone Gel, Charak Pharma Pvt Ltd.) after brushing for 6 weeks decreases gingivitis severity when compared with placebo. The gel was no better than using chlorhexidine 1% gel (92887). However, it's unclear if these findings are due to gum arabic, other ingredients, or the combination.
• Hypercholesterolemia. It is unclear if oral gum arabic helps to reduce high cholesterol levels. Details: One small clinical study in patients with hypercholesterolemia shows that taking gum arabic 5 grams twice daily for 4 weeks does not seem to affect plasma lipid levels when compared with baseline (8072).
• Irritable bowel syndrome (IBS). Although there is interest in using oral gum arabic for IBS, there is insufficient reliable information about the clinical effects of gum arabic for this condition.
• Kidney failure. Although there is interest in using oral gum arabic for kidney failure, there is insufficient reliable information about the clinical effects of gum arabic for this condition.
• Metabolic syndrome. It is unclear if oral gum arabic is beneficial for preventing metabolic syndrome. Details: One small clinical study in healthy adults at risk for metabolic syndrome shows that taking gum arabic 20 grams daily for 12 weeks modestly reduces blood pressure and increases fat-free mass when compared with baseline, but not when compared with taking pectin 1 gram. There were no changes in weight, glycated hemoglobin, or cholesterol levels (105039).
• Obesity. It is unclear if oral gum arabic is beneficial for promoting weight loss. Details: One small clinical study in healthy adults shows that taking powdered gum arabic 18 grams in the morning and 12 grams in the evening for 6 weeks reduces body mass index by 0.32 kg/m2 and body fat percentage by about 2% when compared with placebo. Body weight was also reduced by 1.2%, but this was not significant when compared with placebo (18237). It is unclear if gum arabic is beneficial in individuals with obesity.
• Peristomal lesions. It is unclear if topical gum arabic is beneficial for preventing peristomal lesions in patients with a colostomy bag. Details: Preliminary clinical research in infants shows that applying a thick layer of gum arabic gel to peristomal skin before attaching a colostomy bag twice daily for 4 weeks decreases the incidence of postoperative peristomal dermatitis by about 78% when compared with zinc sulfate ointment (92886).
• Sickle cell disease. It is unclear if oral gum arabic is beneficial in patients with sickle cell disease. Details: Preliminary clinical research in patients with sickle cell disease shows that taking gum arabic powder 30 grams daily for 12 weeks does not improve most markers of liver and kidney function in these patients. While an improvement in direct bilirubin levels was observed when compared to baseline, no significant changes in serum levels of total bilirubin, albumin, protein, liver enzymes, urea, or creatinine were reported (102087). However, in this same group of patients, gum arabic did reduce levels of total cholesterol by 8 mg/dL, low-density lipoprotein (LDL) cholesterol by 5 mg/dL, and triglycerides by 12 mg/dL when compared with baseline. Significant improvements in high-density lipoprotein (HDL) cholesterol were lacking (102088). This research is limited by the lack of a control group, Also, it is unclear whether gum arabic can improve clinical outcomes in patients with sickle cell disease. More evidence is needed to rate the effectiveness of gum arabic for these uses.

(Read more about GUM ARABIC)

LIKELY SAFE ...when used in the amounts commonly found in food.

POSSIBLY SAFE ...when the leaves are applied topically and appropriately (93456). There is insufficient reliable information available about the safety of the other parts of the banana plant when used orally or topically as a medicine.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using amounts greater than those found in food.

(Read more about BANANA)

LIKELY SAFE ...when consumed in amounts commonly found in food. Chicory and chicory extract have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally in medicinal amounts, short-term. Chicory root extract has been used with apparent safety at doses of 600 mg three times daily for one month (93647). Chicory seed has been used with apparent safety as a hot water infusion of 4.5 grams twice daily for 12 weeks (102350). There is insufficient reliable information available about the safety of chicory when used orally, long-term, or when used topically.

PREGNANCY: POSSIBLY UNSAFE
when used orally in excessive amounts. Chicory may induce menstruation or miscarriage (19).

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about CHICORY)

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

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (12).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using amounts greater than those in foods.

(Read more about DANDELION)

LIKELY SAFE ...when ground flaxseed is used orally and appropriately. Ground flaxseed has been safely used in numerous clinical trials in doses up to 30-60 grams daily for up to 1 year (6803,6808,8020,10952,10978,12908,12910) (16760,16761,16762,16765,16766,18224,21191,21194,21196,21198) (21199,21200,22176,22179,22180,22181,65866,66065) (101943,101949,101950).

POSSIBLY SAFE ...when flaxseed lignan extract or mucilage is used orally and appropriately. Some clinical research shows that a specific flaxseed lignan extract (Flax Essence, Jarrow Formulas) 600 mg daily can be used with apparent safety for up to 12 weeks (16768). Additional clinical research shows that other flaxseed lignin extracts can be used with apparent safety for up to 6 months (21193,21197,21200). In one clinical trial, flaxseed mucilage was used with apparent safety at a dose of up to 5120 mg daily for up to 12 weeks (108047)....when flaxseed is used topically in a warm poultice (101946).

POSSIBLY UNSAFE ...when raw or unripe flaxseed is used orally. Raw flaxseed contains potentially toxic cyanogenic glycosides (linustatin, neolinustatin, and linamarin); however, these glycosides have not been detected after flaxseed is baked (5899). Unripe flaxseeds are also thought to be poisonous when consumed due to cyanide content.

PREGNANCY: POSSIBLY UNSAFE
when used orally. Flaxseed can have mild estrogenic effects. Theoretically, this might adversely affect pregnancy (9592,12907); however, there is no reliable clinical evidence about the effects of flaxseed on pregnancy outcomes.

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about FLAXSEED)

POSSIBLY SAFE ...when used orally and appropriately, alone or in combination with probiotics, in doses up to 30 grams daily for up to 4 weeks (741,745,8505,90266,107729,107931). ...when a specific FOS product (NutraFlora, Ingredion Inc.) is used orally in combination with calcium at doses up to 3.2 grams daily for up to 24 months (94931).

CHILDREN: POSSIBLY SAFE
when short-chain FOS are included in approved infant formulas for healthy term infants at a level of up to 4 grams/L or 1 gram/kg daily (94929,94930,98651).

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

(Read more about FRUCTO-OLIGOSACCHARIDES (FOS))

LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods. Gum arabic has Generally Recognized As Safe (GRAS) status for use in foods in the US. It is also considered to be safe for use as a food additive by the European Food Safety Authority (4912,105040).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (8072). Up to 30 grams daily of powdered gum arabic has been used with apparent safety for 3 months (18237,99098,105040).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in amounts greater than those found in foods (4912,105040).

(Read more about GUM ARABIC)

LEVODOPA Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Taking banana may reduce the effectiveness of levodopa.  Details A case report describes apparent wearing off in a patient with Parkinson disease after eating a banana every day. The wearing off subsided after removing dietary bananas (110618).

(Read more about BANANA)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, chicory might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Animal and in vitro research shows that chicory extracts have antidiabetic effects (93650,108543).

(Read more about CHICORY)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking dandelion root along with anticoagulant or antiplatelet drugs might increase the risk of bruising and bleeding.  Details In vitro research suggests that dandelion root inhibits platelet aggregation (18291).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, dandelion might increase the risk for hypoglycemia when used with antidiabetes drugs.  Details Laboratory research suggests that dandelion extract may have moderate alpha-glucosidase inhibitor activity and might also increase insulin secretion (13474,90926). Also, in a case report, a 58-year-old woman with type 2 diabetes who was being treated with insulin developed hypoglycemia 2 weeks after beginning to eat salads containing dandelion (46960).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, dandelion might increase levels of drugs metabolized by CYP1A2.  Details Laboratory research suggests that dandelion might inhibit CYP1A2 (12734). So far, this interaction has not been reported in humans. However, until more is known, watch for an increase in the levels of drugs metabolized by CYP1A2 in patients taking dandelion.

GLUCURONIDATED DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, dandelion might increase the clearance of drugs that are UDP-glucuronosyltransferase substrates.  Details There is some preliminary evidence that dandelion might induce UDP-glucuronosyltransferase, a phase II enzyme (12734).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, through diuretic effects, dandelion might reduce excretion and increase levels of lithium.  Details Animal research suggests that dandelion has diuretic properties (13475). As diuretics can increase serum lithium levels, the dose of lithium might need to be decreased when taken with dandelion.

POTASSIUM-SPARING DIURETICS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, dandelion might increase the risk of hyperkalemia when taken with potassium-sparing diuretics.  Details Dandelion contains significant amounts of potassium (13465).

QUINOLONE ANTIBIOTICS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, dandelion might lower fluoroquinolone levels.  Details Animal research shows that dandelion reduces absorption of ciprofloxacin and can lower levels by 73% (13477). However, this effect has not been reported in humans.

(Read more about DANDELION)

ANTIBIOTIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, antibiotics might interfere with the metabolism of flaxseed constituents, which could potentially alter the effects of flaxseed.  Details Some potential benefits of flaxseed are thought to be due to its lignan content. Secoisolariciresinol diglucoside (SDG), a major lignan precursor, is found in high concentrations in flaxseed. SDG is converted by bacteria in the colon to the lignans enterolactone and enterodiol (5897,8022,8023,9592). Antibiotics alter the flora of the colon, which could theoretically alter the metabolism of flaxseed.

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, using flaxseed in combination with anticoagulant or antiplatelet drugs might have additive effects and increase the risk of bleeding.  Details Some clinical evidence suggests that the oil contained in flaxseed can decrease platelet aggregation (5898,21912).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Theoretically, flaxseed might have additive effects when used with antidiabetes drugs and increase the risk for hypoglycemia.  Details Some clinical research suggests that flaxseed can lower blood glucose levels (5899,10978,21194,21196,111061).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, flaxseed might have additive effects when used with antihypertensive drugs and increase the risk of hypotension.  Details Clinical research shows that daily flaxseed consumption, especially for longer than 12 weeks, modestly reduces blood pressure (21197,26487,96426,96428,111063).

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking flaxseed might decrease the effects of estrogens.  Details Flaxseed contains lignans with mild estrogenic and possible antiestrogenic effects. The lignans seem to compete with circulating endogenous estrogen and might reduce estrogen binding to estrogen receptors, resulting in an anti-estrogen effect (8868,9593). It is unclear if this effect transfers to exogenously administered estrogens.

(Read more about FLAXSEED)

(Read more about FRUCTO-OLIGOSACCHARIDES (FOS))

AMOXICILLIN (Amoxil, Trimox) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Gum arabic can reduce the absorption of amoxicillin.  Details A small study in healthy volunteers shows that taking amoxicillin and gum arabic concurrently significantly reduces the absorption of amoxicillin. Separate doses of amoxicillin from gum arabic by at least 2 hours (12654).

ORAL DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, gum arabic can alter the absorption of oral drugs due to its fiber content.  Details Gum arabic has been used as a suspending osmotic agent in drug formulations. It might improve bioavailability of water-insoluble drugs like naproxen, but reduce absorption of polar drugs like amoxicillin (12654,104058). To avoid changes in absorption, take gum arabic 30-60 minutes after oral medications.

(Read more about GUM ARABIC)

General ...Orally, bananas are well tolerated when consumed as food.
Most Common Adverse Effects:
Orally: Bloating, cramping, gas.
Topically: Urticaria.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis, intestinal obstruction.

Endocrine ...In one case report, an adolescent girl who consumed nothing other than 20 bananas daily developed hyperkalemia and hyperdopaminemia. These changes in the blood resulted in pseudoaldosteronism and dysthymia (93780).

Gastrointestinal ...Orally, banana starch isolated from green bananas has resulted in bloating, gas, cramping, and softer feces (93448,93449,110619). When consumed prior to exercise, fullness and bloating during exercise have been reported (93459). In children, nausea, vomiting, and abdominal distension have been reported when banana is used in the treatment of diarrhea (93461). Cases of intestinal obstruction due to banana seeds have been reported (93777).
In one case report, food protein-induced enterocolitis syndrome (FPIES) has been associated with banana consumption (93778).

Immunologic ...Orally, banana has been reported to cause allergic reaction, including urticaria and redness, abdominal pain and nausea, dyspnea (93779,93781,93782,93797,93798,93803), and anaphylaxis (93783,93793,93802,93803). Topically, contact urticara has also been reported (93784). Skin testing is not always accurate, even for patients with severe banana allergy (93793).

Psychiatric ...Orally, high banana consumption has been associated with a higher likelihood of depressive symptoms in females, but not males, in a cross-sectional study of the general Chinese adult population (106471).

(Read more about BANANA)

General ...Orally, chicory seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, belching, bloating, and flatulence.

Dermatologic ...Occupational exposure to chicory may cause skin rash, contact dermatitis, or generalized pruritus (41609,93649). The sesquiterpene lactones of the plant may be the allergens (41609). Chicory may cause an allergic reaction in individuals sensitive to the Asterceae/Compositae family (25416). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.

Gastrointestinal ...Orally, fructo-oligosaccharides, such as those extracted from chicory, can cause flatulence, belching, abdominal pains, intestinal sounds and bloating, which occur commonly, but are mild at doses of 10 grams daily (740,745,750,8509,93716).

Immunologic ...Occupational exposure to chicory may cause allergic reactions. Dyspnea and anaphylaxis have also been reported in a patient with regular occupational exposure to chicory. This patient also experienced contact dermatitis and generalized pruritus (93649).

Pulmonary/Respiratory ...Occupational exposure to chicory may cause asthma and rhinoconjunctivitis (41617,93648). Dyspnea and anaphylaxis have also been reported in a patient with regular occupational exposure to chicory. This patient also experienced contact dermatitis and generalized pruritus (93649).

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General ...Orally, dandelion seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, heartburn, and stomach discomfort.
Topically: Dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.

Cardiovascular ...In one report, a 39-year-old obese woman developed palpitations and syncope after taking a weight loss supplement containing a combination of dandelion, bladderwrack, and boldo for 3 weeks. The patient was found to have prolonged QT-interval on ECG and frequent episodes of sustained polymorphic ventricular tachycardia (14321). It is not clear whether dandelion, another ingredient, or the combination of ingredients is responsible for this adverse effect. The product was not analyzed to determine the presence of any potential toxic contaminants.

Dermatologic ...Topically, dandelion can cause contact dermatitis and erythema multiforme in sensitive individuals. Dandelion can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family (13478,13481,42893,46945,46977). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.

Endocrine ...In one report, a 56-year-old man with renal impairment developed hyperoxalaemia and peripheral gangrene after ingesting large amounts of dandelion tea (10 to 15 cups daily for 6 months). The adverse effect was attributed to the high oxalate content of dandelion tea (258 mcmol/L) and reduced renal oxalate clearance caused by renal impairment (90639). In another report, a 58-year-old woman with type 2 diabetes who was being treated with insulin developed hypoglycemic symptoms 2 weeks after beginning to eat salads containing dandelion (46960). The hypoglycemic effect was attributed to the potential alpha-glucosidase inhibitory activity of dandelion.

Gastrointestinal ...Gastrointestinal symptoms, including stomach discomfort, diarrhea, and heartburn, have been reported following oral use of dandelion (19146,36931). A case of intestinal blockage has been reported for a patient who ingested a large amount of dandelion greens three weeks after undergoing a stomach operation (46981). Also, a case of hemorrhagic cystitis has been reported for a 33-year-old woman who took a specific herbal product (Slim-Kombu, Balestra and Mech, Vicenza, Italy) containing 20 herbal extracts, including dandelion extract. Symptoms resolved after the patient discontinued using the product, and symptoms resumed when the patient began taking the supplement again four months later. While various ingredients in the supplement may have contributed to the symptoms, it is possible that dandelion extract may have contributed to the effect due to its diurectic, laxative, cholagogue, and antirheumatic properties (46959).

Other ...Orally, products containing dandelion pollen can cause allergic reactions, including anaphylaxis (13479,13480). Also, rhinoconjunctivitis and asthma have been reported after handling products such as bird feed containing dandelion and other herbs, with reported positive skin tests for dandelion hypersensitivity (46948). Dandelion pollen may cause pollinosis, such as allergic rhinitis and conjunctivitis (18065,46951,46964,46966,46972).

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General ...Orally, flaxseed is usually well-tolerated.
Most Common Adverse Effects:
Orally: Bloating, diarrhea, gastrointestinal complaints.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions such as and anaphylaxis.

Gastrointestinal ...Integrating flaxseed in the diet can cause digestive symptoms similar to other sources of dietary fiber including bloating, fullness, flatulence, abdominal pain, diarrhea, constipation, dyspepsia, and nausea (12910,16761,16765,21198,21200,22176,22179,65866,101943). Higher doses are likely to cause more gastrointestinal side effects. Flaxseed can significantly increase the number of bowel movements and the risk for diarrhea (6803,8021,16765). Doses greater than 45 grams per day may not be tolerated for this reason (6802). Metallic aftertaste and bowel habit deterioration have also been reported in a clinical trial (21198).
There is some concern that taking large amounts of flaxseed could result in bowel obstruction due to the bulk forming laxative effects of flaxseed. Bowel obstruction occurred in one patient in a clinical trial (65866). However, this is not likely to occur if flaxseed is consumed with an adequate amount of fluids.

Immunologic ...Occasionally, allergic and anaphylactic reactions have been reported after ingestion of flaxseed (16761). Handling and processing flaxseed products might increase the risk of developing a positive antigen test to flaxseed and hypersensitivity (6809,12911,26471,26482).

Oncologic ...Flaxseed contains alpha-linolenic acid (ALA). High dietary intake of ALA has been associated with increased risk for prostate cancer (1337,2558,7823,7147,12978). However, ALA from plant sources, such as flaxseed, does not seem to increase this risk (12909).

Other ...Orally, partially defatted flaxseed, which is flaxseed with less alpha-linolenic acid, might increase triglyceride levels (6808). Raw or unripe flaxseed contains potentially toxic cyanogenic glycosides (linustatin, neolinustatin, and linamarin). These chemicals can increase blood levels and urinary excretion of thiocyanate in humans. However, these glycosides have not been detected after flaxseed is baked (5899).

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General ...Orally, FOS are generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, bloating, flatulence.

Gastrointestinal ...Orally, FOS may cause flatulence, belching, abdominal pain, intestinal sounds, constipation, and bloating. These symptoms can occur commonly in some patients, but are generally mild at doses under 10 grams per day (745,750,8509,98651,107931). However, a meta-analysis of 8 small clinical studies shows that taking FOS at doses ranging from 2.5 grams to 15 grams daily for up to 8 weeks does not increase the rate of abdominal pain, bloating, flatulence, or intestinal sounds when compared with control groups (110710).

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General ...Orally, gum arabic seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal bloating, flatulence, mild diarrhea, nausea, and vomiting.

Gastrointestinal ...Orally, gum arabic can cause minor gastrointestinal disturbances such as abdominal bloating, flatulence, nausea, vomiting, cramping, and mild diarrhea (8072,18237,99098,105038,105040,108051). These effects occurred in 15%, 82%, and 90% of subjects respectively in one study (18237). They may subside with continued use within 2 weeks (8072,18237,99098,105038).

Immunologic ...Gum arabic might cause allergic reactions. In one case report, a patient had an immunoglobulin E response after exposure to gum arabic. However, there have been no identified case reports of allergic reactions after oral exposure to gum arabic (19636,105040).

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