Intestinal Drawing Formula by Healthforce Detox

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.

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POSSIBLY EFFECTIVE

• Diarrhea. Oral carob, when taken with oral rehydration solution (ORS) seems to reduce the duration of diarrhea in infants and children with acute diarrhea. Details: Clinical research in children with acute diarrhea shows that drinking 20 mL/kg of juice extracted from raw carob bean immediately prior to taking a World Health Organization ORS over 4-6 hours reduces the duration of diarrhea by 46% and the weight of stools by 44% when compared with ORS alone (40017). Other clinical research in infants with acute diarrhea shows that taking carob pod powder 1.5 gram/kg daily (up to a total of 15 grams) along with ORS for up to 6 days reduces the duration of diarrhea by approximately 47% when compared with ORS alone (39999).
• Hypercholesterolemia. Oral carob seems to reduce cholesterol in adults with moderate hypercholesterolemia. Details: Clinical research in adults with moderate hypercholesterolemia shows that taking a carob fiber containing 80% polyphenols (Exxenterol, Puleva Biotech SA) 4 grams twice daily for 4 weeks reduces total cholesterol and low-density lipoprotein (LDL) cholesterol by 18% and 23%, respectively, when compared with placebo (97846). Other clinical research in patients with moderate hypercholesterolemia shows that taking a specific carob product (Caromax, Nutrinova) 15 grams daily in bread and a fruit bar, along with a regular diet for 6 weeks, reduces total cholesterol and LDL cholesterol when compared with placebo (39986). Lower quality research in patients with moderate hypercholesterolemia shows that consuming carob pulp 15 grams daily in prepared food products also reduces total cholesterol and LDL cholesterol when compared to baseline (39975).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. It is unclear if oral carob is effective for improving athletic performance. Details: A very small clinical study in healthy professional taekwondo athletes shows that taking carob pod powder 40 grams, containing 208 mg of polyphenols, daily for 6 weeks improves total distance covered and maximal aerobic velocity when compared with placebo. Carob also moderately reduced weight and body mass index (BMI), but did not affect fat or muscle mass, heart rate, or rate of perceived exertion (104237). The validity of these findings is limited by the small size and short duration of the study.
• Celiac disease. Although there has been interest in using oral carob for celiac disease, there is insufficient reliable information about the clinical effects of carob for this purpose.
• Diabetes. Although there has been interest in using oral carob for diabetes, there is insufficient reliable information about the clinical effects of carob for this purpose.
• Dyspepsia. Although there has been interest in using oral carob for dyspepsia, there is insufficient reliable information about the clinical effects of carob for this purpose.
• Familial hypercholesterolemia. It is unclear if oral carob is beneficial in patients with familial hypercholesterolemia. Details: A small crossover study in children and adults with familial hypercholesterolemia shows that consuming food prepared with carob gum 8-30 grams daily for 4-8 weeks reduces total cholesterol by 10% to 17% and low-density lipoprotein (LDL) cholesterol by 11% to 19% when compared to baseline. Triglycerides and high-density lipoprotein (HDL) cholesterol levels do not appear to be affected (40008).
• Fibromyalgia. It is unclear if oral carob is beneficial in females with fibromyalgia. Details: A small clinical study in females with fibromyalgia shows that taking carob flour 3 grams dissolved in water twice daily for 6 weeks does not improve blood glucose, cholesterol, blood pressure, body weight, or other measures of body composition when compared to baseline (108309). It is unclear if carob improves symptoms or quality of life in patients with fibromyalgia, as these outcomes were not assessed.
• Impaired glucose tolerance (Prediabetes). It is unclear if oral carob is beneficial in adults with prediabetes. Details: A small clinical study in non-obese adults with prediabetes shows that taking a beverage made with carob pod extract (Fruit Up, Wild-Valencia SAU) 250 mL twice daily for 12 weeks reduces insulin levels and improves insulin resistance by approximately 15% and reduces fasting glucose levels by 10% when compared with a control sweetened beverage (97849).
• Male infertility. Small clinical studies suggest that oral carob might improve sperm motility in males with infertility, but its effect on sperm count and morphology is unclear. Details: A small clinical study in otherwise healthy males with infertility of various etiologies shows that taking a syrup containing 200 mg/mL of ground carob pods as 7.5 mL twice daily for 90 days increases sperm count, morphology, and motility parameters when compared with vitamin E 100 mg twice daily. The rate of pregnancy was higher in the carob group; however, the rates of live births were not different between the two groups (104236). Another small clinical study in males with idiopathic infertility shows that taking carob pod powder 500 mg three times daily for 90 days increases sperm motility but does not improve sperm count, sperm morphology, or sexual function scores when compared with vitamin E 100 mg three times daily (111127).
• Nausea and vomiting. It is unclear if oral formula thickened with carob gum is effective for preventing or treating vomiting in infants. Details: Observational research in formula-fed, full-term infants with moderate to severe regurgitation has found that using a carob gum-thickened formula for 1 month is associated with reduced frequency and volume of regurgitation, with resolution of regurgitation achieved in nearly half of all infants (111128). The validity of these findings is limited by a lack of control, blinding, and randomization.
• Obesity. It is unclear if oral carob is beneficial in adults with obesity. Details: One small clinical study in adults with overweight or obesity shows that taking carob and bean pod extract daily for 3 months modestly improves lipid profiles and the excretion of fat in the feces when compared with placebo (10633). It is unclear if carob improves weight loss.
• Ulcerative colitis. Although there has been interest in using oral carob for ulcerative colitis, there is insufficient reliable information about the clinical effects of carob for this purpose. More evidence is needed to rate carob for these uses.

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POSSIBLY INEFFECTIVE

• Hyperlipidemia. A meta-analysis of small clinical studies suggests that consuming chia seeds, flour, powder, or oil for 7-24 weeks does not improve lipid levels in patients with conditions associated with hyperlipidemia. Details: A meta-analysis of 10 small clinical trials in patients with various metabolic conditions, including diabetes, metabolic syndrome, nonalcoholic fatty liver disease, and obesity, shows that consuming chia seeds, flour, or powder 15-60 grams daily for 7-24 weeks, or taking chia oil 6 grams daily for 8 weeks, does not reduce total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglyceride levels or increase high-density lipoprotein (HDL) cholesterol levels when compared with control groups consuming wheat bran, oat bran, dietary fiber, poppy seeds, or soybean oil (106657). While the patient populations in the studies analyzed are more likely to develop hyperlipidemia, it is unclear if these findings can be generalized to patients diagnosed with hyperlipidemia.
• Obesity. Small clinical studies suggest that consuming chia seeds for up to 12 weeks does not reduce body weight in overweight or obese adults. Details: One small clinical study in overweight or obese individuals shows that ingesting chia seeds 25 grams mixed in 0.25 liters of water twice daily before meals for 12 weeks does not improve body composition or reduce blood pressure when compared with placebo (25533). Another small clinical study in overweight, postmenopausal females shows that ingesting milled or whole chia seeds 25 grams daily for 10 weeks does not improve body composition or blood pressure when compared to baseline (25532).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. It is unclear if oral chia is beneficial for improving athletic performance. Details: A small clinical study in trained athletes shows that drinking a beverage containing 50% of calories from chia seeds (Greens Plus Omega 3 Chia seeds) and 50% of calories from a carbohydrate-containing beverage (Gatorade) for 2 days prior to participating in an endurance exercise lasting more than 90 minutes leads to similar performance when compared with Gatorade alone (25531).
• Cardiovascular disease (CVD). Although there has been interest in using oral chia for CVD, there is insufficient reliable information about the clinical effects of chia for this purpose.
• Diabetes. Small clinical studies suggest that consuming chia for 4-6 months might reduce systolic blood pressure (SBP) in patients with type 2 diabetes, although it does not appear to improve glycemic control or lipid levels and has shown mixed effects on body weight and inflammatory markers. Details: One small clinical trial in patients with type 2 diabetes shows that consuming bread containing a specific, selectively bred type of chia (Salba, Salba Smart Natural Products LLC), providing 37 grams of chia daily for 12 weeks reduces SBP, C-reactive protein, and vonWillebrand factor, but not lipid levels, when compared with consuming bread containing wheat bran. This form of chia also significantly reduced glycated hemoglobin (HbA1c) when compared to baseline, but not when compared with a wheat bran control (16124). Another small clinical study in adults with type 2 diabetes and obesity shows that consuming Salba chia 40 grams daily, either baked into bread or as a powder, in conjunction with a restricted calorie diet for 6 months reduces weight by 1.6 kg and waist circumference by 2.8 cm when compared with an oat bran control. However, consuming chia had no effect on body fat percentage, HbA1c, or fasting glucose levels (97940). Also, a small clinical study in adults with type 2 diabetes shows that consuming chia seeds 40 grams daily for 12 weeks reduces SBP, but does not improve body weight, HbA1c, or levels of fasting glucose, lipids, or C-reactive protein, when compared with those not consuming chia (106658).
• Hypertension. It is unclear if oral chia is beneficial in patients with hypertension. Details: A very small clinical study in patients with mild hypertension shows that consuming chia flour 35 grams daily for 12 weeks reduces systolic blood pressure (SBP) by around 10 mm Hg and diastolic blood pressure (DBP) by almost 9 mm Hg when compared to baseline. In patients already taking antihypertensive drugs, chia seems to have an even greater impact on SBP and DBP. However, in patients not being treated with antihypertensive drugs, chia flour modestly reduces SBP by 6.5%, but does not significantly reduce DBP. No improvements in blood pressure were reported in patients consuming a wheat bran control (91516).
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral chia is beneficial in patients with NAFLD. Details: Small, uncontrolled clinical studies in patients with NAFLD show that consuming milled chia seeds 25 grams daily for 8 weeks may reduce hepatic steatosis, as measured by the liver: spleen attenuation ratio, in up to 43% of subjects with prediabetes and 100% of subjects with diabetes when compared to baseline. Chia seed supplementation may also modestly reduce visceral fat, body mass index, and waist circumference in patients with prediabetes when compared to baseline, but does not seem to improve lipid levels (104530,110438). The validity of these findings is limited by the lack of a comparator group in both studies.
• Metabolic syndrome. Oral chia has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with metabolic syndrome shows that reducing daily caloric intake by 500 kcal and drinking a beverage containing chia seed 4 grams, soy protein 32 grams, dehydrated nopal 7 grams, and oat 22 grams daily for 2 months reduces body weight, body mass index, and waist circumference when compared to baseline, but not when compared with following a reduced calorie diet alone. However, following the reduced calorie diet and drinking this beverage appears to lower serum triglycerides and C-reactive protein and improve glucose tolerance when compared with a reduced calorie diet alone (25534). It is unclear if these findings are due to chia, other ingredients, or the combination.
• Muscle strength. It is unclear if oral chia is beneficial for increasing muscle strength and muscle mass during resistance training. Details: A very small clinical trial in healthy, non-resistance trained males shows that drinking a supplemental beverage containing chia flour 50 grams, providing 20 grams of protein and 3 grams of omega-3 fatty acids, is no more effective than whey protein 20 grams or placebo for augmenting the increases in muscle strength and fat-free mass that occur with an 8-week whole body resistance training program (112385). The habitual baseline diet of the study participants already contained dietary protein intakes recommended for strength training, and the beverage was only consumed three times per week immediately after training sessions.
• Pruritus. It is unclear if topical chia seed oil is beneficial in patients with pruritus. Details: One very small, uncontrolled clinical study in patients with xerotic pruritus or pruritus caused by kidney failure or diabetes shows that applying lotion containing chia seed oil 4% for 8 weeks improves skin hydration and reduces the severity of lichen simplex chronicus and prurigo nodularis when compared to baseline (25537). The validity of these findings is limited by the small study size and lack of a comparator group. More evidence is needed to rate chia for these uses.

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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

• ACE inhibitor-induced cough. It is unclear if oral marshmallow root is beneficial in patients with cough due to ACE inhibitors. Details: A small clinical study in patients with ACE inhibitor-induced cough shows that taking marshmallow root 40 mg (20 drops) three times daily for 4 weeks improves cough when compared to baseline (62027). The validity of this finding is limited by the lack of a control group.
• Atopic dermatitis (eczema). It is unclear if topical marshmallow is beneficial in children with eczema. Details: A very small clinical study in children ages 3 months to 12 years with a recent diagnosis of mild to moderate eczema shows that applying a marshmallow 1% ointment twice daily for 1 week and then three times weekly for 3 weeks seems to reduce symptoms, as measured on the SCORing Atopic Dermatitis (SCORAD) scale, when compared with applying hydrocortisone 1% ointment (105437). This finding is limited by the large number of drop-outs due to non-compliance, most of which were in the marshmallow group.
• Breast engorgement. It is unclear if topical marshmallow is beneficial in women with this condition. Details: A small clinical study in breastfeeding women with breast engorgement shows that applying a compress containing 40-50 mL of a solution made from marshmallow leaves and stems 3 times daily for 2 days in conjunction with standard treatment improves patient-reported breast engorgement scores when compared with standard treatment alone. Standard treatment consisted of massage and alternating warm and cold compresses before and after breastfeeding (92845).
• Constipation. Although there is interest in using oral marshmallow for constipation, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Cough. Although there is interest in using oral marshmallow for cough, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Diarrhea. Although there is interest in using oral marshmallow for diarrhea, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Fever. It is unclear if topical marshmallow is beneficial for pediatric fever. Details: A moderate-sized clinical study in children aged 6 months-10 years with fever receiving rectal acetaminophen shows that applying marshmallow extract body wash and lukewarm water reduces the time to defervescence by 8 minutes when compared with lukewarm water alone, but does not improve the change in body temperature, number of acetaminophen doses given, or incidence of fever recurrence (112375). However, the interpretation of these findings is limited to patients without fevers greater than 40 degrees Celsius or history of febrile seizures since these patients were not studied.
• Leishmania lesions. Topical marshmallow has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research suggests that the topical application of an herbal extract containing a combination of marshmallow and Althaea rosa to affected areas for 5 days can help promote curing of Leishmania lesions (62020).
• Respiratory tract infections. Although there is interest in using oral marshmallow for respiratory tract infections, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Vaginal candidiasis. It is unclear if vaginal marshmallow is beneficial for vulvovaginal candidiasis. Details: A small clinical study in adults with vulvovaginal candidiasis shows that applying a vaginal cream comprised of marshmallow extract 4% and clotrimazole 1% daily for 7 days improves itching, dyspareunia, and dysuria at 7 days when compared with clotrimazole 1% alone. At 30 days, the marshmallow intervention also results in fewer positive yeast cultures and sustained reduction in itching (112371). However, the validity of these results is limited by significant differences between groups at baseline for dyspareunia and dysuria, and lack of adjustment for multiple comparisons which can increase false positive findings. Additionally, all primary outcomes were patient-reported.
• Venous leg ulcers. Although there is interest in using topical marshmallow for venous leg ulcers, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Wounds. Although there is interest in using topical marshmallow for wounds, there is insufficient reliable information about the clinical effects of marshmallow for this condition. More evidence is needed to rate marshmallow for these uses.

(Read more about MARSHMALLOW)

POSSIBLY EFFECTIVE

• Diabetes. Oral prickly pear cactus might help reduce postprandial blood glucose in patients with diabetes. Details: Some preliminary clinical research shows that prickly pear cactus decreases blood glucose levels in patients with type 2 diabetes. Single doses can decrease blood glucose levels by 17% to 48% in some patients (14807,65322,65326). For example, one small clinical study in adults with diabetes shows that adding prickly pear cactus to breakfast meals decreases postprandial glucose when compared with the equicaloric breakfast meals without prickly pear cactus (14807). However, it is not known if long-term use consistently lowers blood glucose levels and decreases glycated hemoglobin (HbA1c) levels.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if oral prickly pear cactus prevents age-related cognitive decline in older adults. Details: A small clinical study in healthy adults 55 years and older living in Korea shows that taking ethanolic prickly pear pad extract 960 mg (containing about 0.5 mg dihydrokaempferol) daily for 12 weeks does not affect performance on cognitive tests when compared with placebo. However, in a subgroup of patients 70 years or younger, there was a small improvement on certain cognitive tests when compared with placebo (105903).
• Benign prostatic hyperplasia (BPH). It is unclear if oral prickly pear cactus is beneficial in patients with BPH. Details: Preliminary clinical research shows that some patients with BPH who take powdered prickly pear cactus flowers 500 mg three times daily for 2-8 months have subjective improvements in symptoms such as urgency and feelings of fullness in the bladder (12175).
• Familial hypercholesterolemia. It is unclear if oral prickly pear cactus is beneficial in patients with BPH. Details: One very small clinical study in patients with familial hypercholesterolemia shows that consuming prickly pear cactus pulp 250 grams daily for 4 weeks, in combination with dietary intervention, reduces total cholesterol by 30 mg/dL and low-density lipoprotein (LDL) cholesterol by 34 mg/dL when compared to baseline. However, taking prickly pear cactus does not improve high-density lipoprotein (HDL) cholesterol or triglyceride levels in these patients (65274). The validity of this finding is limited by the lack of a comparator group.
• Dyspepsia. Oral prickly pear cactus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in healthy adults shows that taking a specific combination product containing prickly pear cactus and olive extract (Mucosave, Bionap S.R.L.) 400 mg daily for 8 weeks seems to improve dyspepsia and other gastrointestinal symptoms when compared with placebo (105904). It is unclear if the benefit is from prickly pear cactus, olive, or the combination. It is also unclear if this benefit would occur in patients with clinically diagnosed dyspepsia.
• Hangover. It is unclear if oral prickly pear cactus is beneficial in patients with hangover. Details: A small clinical study in healthy adults shows that taking 1600 IU of a specific prickly pear cactus fruit extract (Tex-OE, Extracts Plus Inc.) as a single dose 5 hours prior to binge alcohol consumption does not reduce overall hangover symptoms when compared with placebo. However, it may help to reduce specific symptoms such as nausea, anorexia, and dry mouth when compared with placebo. Furthermore, there was a 62% lower odds of severe hangover in the prickly pear cactus group when compared with placebo (12085).
• Hypercholesterolemia. It is unclear if oral prickly pear cactus lowers cholesterol levels. Details: A small clinical study in patients with primary isolated hypercholesterolemia or combined hyperlipidemia shows that, when used in combination with a Step 1 diet, taking prickly pear cactus pulp 250 grams daily can reduce total cholesterol by 12%, low-density lipoprotein (LDL) cholesterol by 15%, and triglycerides by 12%; however, levels of high-density lipoprotein (HDL) cholesterol do not seem to be affected (65263). It is unclear how these results compare to the control group.
• Metabolic syndrome. It is unclear if oral prickly pear cactus is beneficial in patients with metabolic syndrome. Details: One small clinical study in females with metabolic syndrome shows that taking a specific dehydrated prickly pear cactus pad product (NeOpuntia, Bio Serae) 4.8 grams in 3 divided doses daily for 6 weeks does not affect blood lipid levels when compared with placebo (65293). Another small study in adults with 1-2 risk factors for metabolic syndrome shows that consuming durum wheat pasta 500 mg, containing prickly pear cactus pad extract 3%, weekly for 1 month modestly reduces waist circumference, blood glucose, and triglycerides, but not other lipid parameters or weight, when compared with baseline (105902). The validity of these findings is limited by the lack of a comparator group.
• Obesity. It is unclear if oral prickly pear cactus is beneficial for weight loss. Details: A meta-analysis of 4 clinical trials shows that taking prickly pear cactus orally for 8 weeks to 2 years does not improve weight loss when compared with placebo. However, the results of this analysis are limited by the low methodological quality and small sample sizes of many of the included studies (92146). Studies in the meta-analysis used prickly pear cactus pads 3-15 grams daily for up to 2 years or prickly pear cactus fruit skin extract 400 mg daily for 16 weeks. Specific prickly pear cactus pad products included NeOpuntia (Bio Serae) 4.8 grams daily and Litramine (InQpharm North America LLC) 3 grams daily (92146). More evidence is needed to rate prickly pear cactus for these uses.

(Read more about PRICKLY PEAR CACTUS)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. Oral slippery elm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Retrospective population research has found that taking a specific product containing burdock root, Indian rhubarb, sheep sorrel, and slippery elm bark (Essiac, Resperin Canada Limited) does not improve quality of life in breast cancer patients and may have a negative effect on physical well-being (37419).
• Constipation. Although there has been interest in using oral slippery elm for constipation, there is insufficient reliable information about the clinical effects of slippery elm for this purpose.
• Cough. Although there has been interest in using lozenges containing slippery elm for cough, there is insufficient reliable information about the clinical effects of slippery elm for this purpose.
• Diarrhea. Although there has been interest in using oral slippery elm for diarrhea, there is insufficient reliable information about the clinical effects of slippery elm for this purpose.
• Inflammatory bowel disease (IBD). Although there has been interest in using oral slippery elm for IBD, including Crohn disease and ulcerative colitis, there is insufficient reliable information about the clinical effects of slippery elm for this purpose.
• Irritable bowel syndrome (IBS). Oral slippery elm has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a specific formulation containing slippery elm inner bark, lactulose, oat bran, and licorice root can improve stool frequency by 20% and reduce abdominal pain and bloating in people with constipation-predominant IBS when compared to baseline. Also, taking a different formulation containing slippery elm inner bark, bilberry fruit, cinnamon quilts, and agrimony aerial parts can reduce abdominal pain, bloating, and flatulence in people with diarrhea-predominant IBS when compared to baseline, although stool frequency is increased in these individuals as well (35462). It is unclear if these findings are due to slippery elm, other ingredients, or the combination.
• Peptic ulcers. Although there has been interest in using oral slippery elm for peptic ulcers, there is insufficient reliable information about the clinical effects of slippery elm for this purpose.
• Pharyngitis. It is unclear if lozenges containing slippery elm are beneficial in patients with sore throat. Details: Slippery elm has demulcent properties and, when added to lozenges, may soothe sore throats (272,512,1740). However, clinical research is lacking. More evidence is needed to rate slippery elm for these uses.

(Read more about SLIPPERY ELM)

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).

(Read more about ACTIVATED CHARCOAL)

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

POSSIBLY SAFE ...when used orally in medicinal amounts, short-term. Carob fiber containing 80% polyphenols (Exxenterol, Puleva Biotech SA) has been used with apparent safety in doses of up to 8 grams daily for up to 12 weeks (97846). A beverage made with carob pod extract (Fruit Up, Wild-Valencia SAU) has been used with apparent safety at a dose of 500 mL daily for up to 12 weeks (97849). Carob pod powder has been safely used in doses up to 1500 mg daily for up to 90 days (111127).

CHILDREN: POSSIBLY SAFE
when used in full-term infants. Carob-based milk thickeners have been used with apparent safety in full-term infants as an additive in infant formula (39972,39991,104239,111128).

CHILDREN: POSSIBLY UNSAFE
when used in preterm infants. A carob-based milk thickener (Carobel) has been associated with necrotizing enterocolitis leading to death in two low birth-weight infants (39991).

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

(Read more about CAROB)

LIKELY SAFE ...when used orally in amounts commonly found in foods (104531,104532).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Chia has been used safely at doses up to 40 grams daily for up to 6 months (16124,97940). ...when used topically, short-term. A product containing chia seed oil 4% has been applied to the skin safely for up to 8 weeks (25537).

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

(Read more about CHIA)

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)

LIKELY SAFE ...when marshmallow root and leaf are used in amounts commonly found in foods. Marshmallow root has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).

POSSIBLY SAFE ...when marshmallow root and leaf are used orally in medicinal amounts (4,12). ...when used topically (4,62020). There is insufficient reliable information available about the safety of marshmallow flower.

PREGNANCY AND LACTATION:
Insufficient reliable information available.

(Read more about MARSHMALLOW)

LIKELY SAFE ...when prickly pear cactus fruit and pads are used orally as a food (5969).

POSSIBLY SAFE ...when prickly pear cactus fruit and pads are used orally and appropriately in supplemental amounts, short-term. Prickly pear cactus fruit pulp 250 grams twice daily has been used with apparent safety for up to 2 weeks (12086) and prickly pear cactus pads 3-15 grams daily have been used with apparent safety for up to 2 years (92146). Extracts of prickly pear fruit skin 400 mg daily or prickly pear pads 960 mg daily have been used with apparent safety for 12-16 weeks (92146,105903).

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

(Read more about PRICKLY PEAR CACTUS)

POSSIBLY SAFE ...when used orally and appropriately (4,12,272,512,1740).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using. Slippery elm bark has historically been inserted into the cervix to induce abortion. As a result, slippery elm has been reported in some sources to have abortifacient activity. However, there is no reliable information available about whether slippery elm has abortifacient activity when taken orally.

(Read more about SLIPPERY ELM)

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.

(Read more about ACTIVATED CHARCOAL)

ORAL DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, carob might also impair the absorption of oral drugs.  Details Laboratory research shows that carob, when consumed as part of the diet or used as a thickening agent in infant formula, reduces the absorption of certain minerals (39972,40007,103719). Take carob 30-60 minutes after oral medications.

(Read more about CAROB)

(Read more about CHIA)

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.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, marshmallow flower might have antiplatelet effects.  Details Animal research suggests that marshmallow flower extract has antiplatelet effects (92846). However, the root and leaf of marshmallow, not the flower, are the plant parts most commonly found in dietary supplements. Theoretically, use of marshmallow flower with anticoagulant/antiplatelet drugs can have additive effects, and might increase the risk for bleeding in some patients.

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, due to potential diuretic effects, marshmallow might reduce excretion and increase levels of lithium.  Details Marshmallow is thought to have diuretic properties. To avoid lithium toxicity, the dose of lithium might need to be decreased when used with marshmallow.

ORAL DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, mucilage in marshmallow might impair absorption of oral drugs.  Details Marshmallow contains mucilage which can affect oral drug absorption (1,11,12,19). To avoid changes in absorption, take marshmallow 30-60 minutes after oral medications.

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Combining prickly pear cactus with antidiabetes drugs might increase the risk of hypoglycemia.  Details Case reports show that combining prickly pear cactus with antidiabetes drugs such as chlorpropamide, glyburide, glipizide, and metformin can increase the risk of hypoglycemia in patients with type 2 diabetes (5968,14806,17226,65319,92146). Advise patients to monitor glucose levels closely. Dose adjustments may be necessary.

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ORAL DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, slippery elm may slow the absorption and reduce serum levels of oral drugs.  Details Slippery elm inner bark contains mucilage, which may interfere with the absorption of orally administered drugs (19).

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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).

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General ...Orally, carob seems to be generally well tolerated when eaten as food or when added to food.
Serious Adverse Effects (Rare):
Orally: Serious allergic reactions in sensitive individuals.

Gastrointestinal ...Orally, the addition of a carob milk thickener (Carobel) to preterm infant feeds has been associated with necrotizing enterocolitis leading to death in two low birth-weight infants (39991). This adverse effect has not been reported in term infants.

Immunologic ...A five month-old child who was allergic to an anti-regurgitation milk formula containing carob gum experienced urticaria, rash, and explosive vomiting within 30 minutes of administration of the formula (39969). In a separate case, an 11-week-old infant with Down syndrome presented with persistent vomiting, watery diarrhea, and lethargy requiring IV hydration. The infant had previously been diagnosed with food protein-induced enterocolitis syndrome (FPIES), likely due to cow's milk. He had consumed formula containing a carob gum thickener; the reaction resolved upon discontinuation of the carob gum additive. An oral challenge test to carob produced a reaction, confirming this as the likely causative agent (104235). In another case, a 52-year-old man experienced chest tightness, throat discomfort, and burning sensations related to an oral allergy to carob pods (97850).
Occupational exposure to carob flour has been reported to cause allergic asthma and rhinitis (39987,40015).

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General ...Orally and topically, chia seems to be well tolerated.
Most Common Adverse Effects:
Orally: Flatulence and soft stools.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.

Cardiovascular ...Chia contains a high concentration of alpha-linolenic acid (ALA). There is some concern that ALA might increase triglyceride levels more than other omega-3 fatty acids (12918); however, clinical research with a specific variety of chia called Salba shows that it does not significantly increase triglyceride levels (16124).

Gastrointestinal ...Orally, chia might cause mild gastrointestinal adverse effects. Some patients consuming chia 40 grams daily for up to 6 months reported mild and transient gastrointestinal adverse effects such as flatulence and soft stools; however, the frequency of these adverse effects was similar to patients consuming an oat bran control (97940). Bloating and flatulence have been reported with a chia flour-based sports beverage (112385).

Immunologic ...Orally, chia might cause anaphylaxis in sensitive individuals. A single case of IgE-mediated anaphylactic reaction has been reported for a patient who consumed chia seeds. Symptoms, including pruritus in the mouth, urticaria, facial angioedema, shortness of breath, and dizziness, developed a few days after consuming chia seeds. The reaction was attributed to sensitivity to proteins in chia seeds (91517).

Oncologic ...Chia seeds contain a high concentration of alpha-linolenic acid (ALA). Epidemiologic research suggests that high dietary intake of ALA might increase risk for prostate cancer (1337,2558,7823,7147,12978). Other research suggests high intake or serum levels of ALA does not increase the overall risk of prostate cancer (12961,15736); however, it might increase the risk of advanced prostate cancer (12961). Association with prostate cancer appears to depend on the sources of ALA. Dairy and meat sources have been positively associated with prostate cancer, whereas plant sources, such as chia seed, don't seem to affect prostate cancer risk (12909). According to a clinical trial, intake of ALA does not appear to increase levels of prostate specific antigen (PSA) (91402).

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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 and topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.

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General ...Orally, prickly pear cactus is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal fullness, dyspepsia, mild diarrhea, nausea.

Dermatologic ...Orally, prickly pear cactus has been linked to rare cases of urticaria and pruritus. In a clinical study of 41 patients taking prickly pear cactus pad ethanolic extract, three patients experienced pruritus and one patient experienced urticaria (105903).

Gastrointestinal ...Orally, prickly pear cactus may cause mild diarrhea, dyspepsia, nausea, increased stool volume and frequency, and abdominal fullness (7028,65266,105903). Cases of low colonic obstruction and rectal phytobezoars resulting in rectal perforation have been reported for patients who ingested prickly pear cactus fruit seeds (65260,65266). However, these events are extremely rare and attributed to the ingestion of a large number of fruits. Because dried prickly pear cactus swells into a mass much larger than its original size, it may potentially cause dangerous blockages of the esophagus or intestines. Similar products have been associated with serious or even fatal blockages, but cases of such blockages from prickly pear cactus are lacking in the scientific literature.

Neurologic/CNS ...Orally, prickly pear cactus has been linked to rare cases of headache, insomnia, and dizziness (65266,105903). In a clinical study of 41 patients taking prickly pear cactus pad ethanolic extract, two patients experienced headache, one patient experienced dizziness, and one patient experienced insomnia (105903).

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General ...Orally, slippery elm seems to be well tolerated. A thorough evaluation of safety outcomes with topical use of slippery elm has not been conducted.

Dermatologic ...Topically, slippery elm extracts can cause contact dermatitis. The pollen is an allergen (6). Contact dermatitis and urticaria have been reported after exposure to slippery elm or an oleoresin contained in the slippery elm bark (75131).

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