Multi fibre by Good Health New Zealand

Alzheimer disease. It is unclear if apple juice consumption is beneficial in patients with Alzheimer disease. Details: A small clinical study in adults with moderate to severe Alzheimer disease shows that drinking 4 ounces of apple juice twice daily for one month does not improve cognitive function when compared with baseline. However, according to caregiver assessment, it seems to improve aspects of mood and behavior, such as anxiety, depression, apathy, delusion, and agitation, when compared with baseline (94422). The validity of this finding is limited by the lack of a comparator group.
Cancer. It is unclear if apple consumption is beneficial for preventing cancer. Details: Some population research has found that eating one or more apples daily may be associated with a decreased risk of esophageal, colorectal, larynx, or breast cancer when compared with eating less than 1 apple daily (31688). Also, a case-control study in adults with lung cancer has found that increased apple consumption may be associated with a reduced risk of lung cancer (3470).
Dental plaque. It is unclear if apple consumption is beneficial for reducing dental plaque. Details: A small clinical study in healthy patients shows that eating an apple is less effective for reducing plaque than brushing teeth. Eating an apple actually increases plaque when compared with baseline, although it decreases the measure of bacterial vitality (99447).
Diabetes. It is unclear if consumption of powdered, dehydrated apple is beneficial in patients with type 2 diabetes. Details: A small clinical study in patients with type 2 diabetes shows that substituting 26-52 grams of white wheat flour in bread with powdered, dehydrated apple and consuming the bread daily for up to 4 weeks does not improve fasting blood glucose or postprandial glucose levels when compared with a low-fiber white bread control (13141).
Diarrhea. It is unclear if apple juice consumption is beneficial in infants with severe diarrhea. Details: A clinical study in infants with severe diarrhea shows that drinking apple juice 15 mL/kg twice daily during episodes of diarrhea results in more fecal loss when compared with drinking water (31687).
Metabolic syndrome. Although there has been interest in using apple for metabolic syndrome, there is insufficient reliable information about the clinical effects of apple for this purpose.
Muscle strength. Oral apple extract has only been evaluated in combination with other ingredients; its effects when used alone is unclear. Details: Small clinical studies in resistance trained males show that taking a specific blend of ancient peat and apple extract (elevATP, VDF FutureCeuticals Inc.) 150 mg daily as a liquid with liposomes (QuSomes, BioZone Laboratories Inc.) for 12 weeks modestly increases lower body and total strength, improves lower body power output, and increases cross-sectional area of muscle when compared with placebo (94418,94419).
Obesity. It is unclear if apple consumption is beneficial in patients with overweight or obesity. Details: A small clinical study in females with hypercholesterolemia and overweight or obesity shows that eating apples three times daily for 12 weeks is associated with weight loss of 1.2 kg, compared with weight loss of 0.9 kg in those consuming oat cookies (17997). More evidence is needed to rate apple for these uses.

Athletic performance. Oral beet may improve athletic performance associated with aerobic activities. However, it is not clear who is most likely to benefit, for which type of competition it is most useful, or what dose or duration of use is most appropriate. Details: Several small clinical trials, most of which enrolled elite athletes, recreational athletes, and sedentary males, as well as meta-analyses of some of these and other studies, show that beet improves various measures of athletic performance, including ability, muscular endurance, power output, sprinting, and strength (93844,94464,94468,94469,100143,100150,100152,105761,113422). Clinical research also shows that drinking beetroot juice improves the use of oxygen during exercise testing in recreationally-trained athletes, especially with severe exercise testing (94460,94463,94467,100147,105762). Also, in obese adolescents, taking beetroot juice daily for 6 days increases the time to exhaustion from severe exercise, but does not improve moderate exercise (100145). Not all research shows that beet supplementation benefits athletic performance. Another meta-analysis of several small clinical studies, including some of the studies above, shows that taking beetroot does not improve performance in high-intensity or sprint interval training (111159). Additionally, the majority of research in elite athletes does not support the use of beetroot juice to decrease the time needed to complete a task, aid in some sort of graded exercise test, or improve the use of oxygen during exercise testing (94455,94458,94460,94461,94464,94465,94466,94469,94473,100142,100153,105763). The supposed lack of effect of beetroot juice in elite athletes might be related to the natural production of nitrates and nitrites in the body or the increased ability to use oxygen that comes from extensive training (94458,94463). Alternatively, any changes might be very small (<1%) and not identified with statistical comparisons, although even very small changes might be beneficial in competition (94464). The most commonly used doses in all studies, regardless of effect, have included an acute dose of beetroot juice 70-500 mL up to 3 hours prior to exercise (93844,94463,94464,94466,94467,94473,97726,100142,100143,105761)(105762,111159,113422) or chronic dosing of up to 500 mL daily for 3-6 days (94459,94464,94469,100145,100147,100153,111159,113422). Less commonly, beetroot juice 70-140 mL daily, betalain-rich concentrate 100 mg daily, or a beetroot-based nutritional gel 100 grams daily, have been taken for longer dosing schedules of 7-15 days (97720,100144,100148,100152,105763,113422). Benefits in elite athletes, most often related to time trials, are usually limited to studies using chronic dosing of 7-15 days, which is longer than the duration of 6 days used in the majority of studies (94473,97720,100144,100148). Brands of juice used in clinical trials have included Beet It Sport (James White Drinks Ltd.) (94455,94458,94465,100142,100143,100144,100148,105761,105763), Beet It Stamina Shot (James White Drinks Ltd.) (93844), Beet It (James White Drinks Ltd) (94457,94459,94460,94467,94469,97726,100145,100153,105762,111159), and Love Beets Beetroot Juice (Gs Fresh Ltd.) (94461,94462). Although plasma levels have not been analyzed in all studies, the majority of studies suggest that these doses are adequate to increase levels of nitrates or nitrites, which is thought to be essential for increasing athletic potential (93844,94455,94458,94459,94460,94465,94467,94469,94466,94473,97726). The evidence also suggests benefit in both normoxic and hypoxic environments (94465,100148,105763).
Exercise-induced muscle soreness. Drinking beetroot juice 7-8 times over 48 hours after strenuous exercise may reduce exercise-induced muscle soreness, but evidence is conflicting. Details: Some clinical research shows drinking beetroot juice (Love Beets Beetroot Juice, Gs Fresh Ltd.) 125 mL or 250 mL seven times over 48 hours after strenuous box jumps improves muscle soreness when compared with placebo and sodium nitrite (96964,97722). Other small clinical studies show that drinking beetroot juice 50-250 mL as eight separate doses over 48 hours after strenuous exerciseimproves muscle soreness and reduces tissue edema when compared with placebo (94461,113424). However, drinking beetroot juice 250 mL as seven separate doses over 48 hours after running a marathon does not appear to reduce muscle soreness when compared with placebo (94462). A meta-analysis of 4 small studies, mostly in healthy or physically active males, shows that drinking beetroot juice improves the pressure pain threshold, which is a measure of muscle soreness, at 48- and 72-hours post-exercise when compared with a fruit-flavored drink. However, beetroot juice does not improve subjective muscle soreness scores (111160). The validity of the findings from this meta-analysis is limited by the heterogeneity of the beetroot juice regimens among the included studies. Further, these results should not be generalized to elite athletes.

POSSIBLY INEFFECTIVE

Chronic obstructive pulmonary disease (COPD). Drinking beetroot juice for up to 14 days may not improve exercise capacity in patients with COPD. Details: A meta-analysis of eight small clinical trials in patients with COPD shows that taking nitrate-rich beetroot juice does not improve most measures of exercise capacity, including the 6-minute walk test, cycling ergometry endurance time, and maximum rate of oxygen consumption (VO2 max), when compared with placebo. Additionally, beetroot juice did not reduce blood pressure or heart rate. However, the analysis did show a significant improvement in scores on the Borg Rating of Perceived Exhaustion scale with beetroot juice over placebo. Nitrate-rich beetroot juice doses ranged from 70-140 mL daily for up to 14 days (104200).

Cognitive function. It is unclear if drinking beetroot juice is beneficial for cognitive function. Details: A small clinical study in adults with overweight or obesity on a calorie-restricted diet shows that drinking 70 mL of concentrated beetroot juice daily for 14 days improves the time to complete part B of the trail making test, which is a test of cognitive function, but not part A, when compared with controls (111158). However, the duration and size of this study limits its validity. Further, it is unclear whether any improvement is clinically significant. The effect of acute beet administration on cognitive function has also been studied. A very small clinical study in healthy adults shows that taking beet extract (RedNite, Enovate Biolife) chewable tablets 3 grams 90 minutes prior to neuropsychological testing improves immediate and delayed memory capacity, frontal lobe function, and lexical flexibility but does not improve working memory, information processing speed, or subjective reports of memory performance when compared with placebo (113427).
Coronary heart disease (CHD). It is unclear if oral beetroot extract is beneficial in patients with CHD. Details: A small clinical trial in patients with CHD shows that taking red beetroot extract 500 mg, containing around 25 mg betalains, twice daily for 2 weeks reduces total cholesterol and low-density lipoprotein (LDL) cholesterol by 15 mg/dL and reduces triglycerides by 8 mg/dL when compared to baseline. Slight improvements in blood pressure and blood glucose were also reported, but these changes were not clinically significant (103883). The validity of these findings is limited by the lack of a comparator group. Also, it is unclear whether beetroot can reduce the risk of cardiovascular events in patients with CHD.
Dyslipidemia. It is unclear if oral beetroot is beneficial in patients with dyslipidemia. Details: A meta-analysis of small clinical studies in healthy individuals or patients with dyslipidemia, cardiovascular disease, or overweight or obesity, shows that consuming beetroot juice or leaves does not improve levels of triglycerides or total, low-density lipoprotein, or high-density lipoprotein cholesterol when compared with controls (111163). However, the validity of the findings from this meta-analysis is limited by the heterogeneity of the enrolled patients and beetroot regimens.
Exercise-induced muscle damage. It is unclear if oral beetroot juice improves recovery from muscle damage after exercise. Details: A meta-analysis of 4 small clinical studies in healthy or physically active individuals, most of which enrolled males only, shows that drinking beetroot juice improves measures of muscle recovery at 72 hours post-exercise when compared with a fruit-flavored drink. However, beetroot juice does not consistently improve recovery at earlier time points post-exercise, nor does it reduce levels of creatine kinase or markers of inflammation (i.e., interleukin-6, interleukin-8, c-reactive protein, or tumor necrosis factor-alpha) (111160). However, the validity of the findings from this meta-analysis is limited by the heterogeneity of the beetroot juice regimens among the included studies, which usually varied from 210-250 mg of nitrate in 7-11 servings over 3-7 days. Further, these results should not be generalized to elite athletes. Another very small clinical study in semi-professional female athletes shows that ingesting beetroot juice 50 mL 8 times over 48 hours after exercise-induced muscle damage enhances the recovery of some functional parameters such as muscle endurance but not others such as flexibility and vertical jump performance when compared with placebo (113424).
Hypertension. Oral beet may slightly reduce blood pressure in healthy individuals, but it is unclear if it is beneficial in patients with hypertension. Details: Meta-analyses of small studies show the potential for a minor reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in healthy adults taking beetroot juice (94470,97718,97728). The average reduction in SBP and DBP with beetroot juice consumption is about 4 mmHg and 1 mmHg, respectively, which is greater than the effect seen with consuming blackcurrant juice or nitrate-depleted beetroot juice. The most benefit is seen when beetroot juice is taken for at least 2 weeks or at doses of 500 mL daily (97728). The effect of acute beet supplementation on blood pressure is conflicting. A small clinical study in healthy adults shows that drinking beet juice (Beet It, James White Company) 140 mL two hours prior to cardiovascular measurements reduces resting SBP by about 4 mmHg but does not improve resting or post-exercise DBP, central blood pressure, or arterial stiffness nor does it improve post-exercise SBP when compared with placebo. Subgroup analysis suggests that the reductions in resting SBP were only observed in males, not females (113423). Another small clinical study shows that consuming beet 100 grams baked into bread modestly decreases DBP over a 6-hour period when compared with white bread (97725). It is possible that genetics might play a role in the magnitude of effect seen with beetroot consumption. Adults with a specific gene polymorphism, eNOS Glu298Asp, experienced a greater reduction in DBP after consuming beet-containing bread (97724). Despite positive findings in studies of healthy individuals, research on the use of beetroot juice in patients with hypertension is unclear. A small clinical study in adults with hypertension who were taking antihypertensive medications shows that drinking nitrate-rich beetroot juice (Beet it; James White Drinks Ltd.) 70 mL twice daily for one week does not lower blood pressure when compared with nitrate-depleted beetroot juice (94457). Also, in patients with mild to moderate hypertension, clinical research shows that taking a combination of beetroot powder (Sensient) 300 mg, olive leaf extract 1000 mg, and green coffee bean extract 200 mg daily for 6 weeks does not lower blood pressure when compared with placebo (97723). However, some evidence suggests that at least part of the blood pressure lowering effects of beet might be independent of nitrate (97728). Furthermore, some research suggests that identifying effects on blood pressure might be dependent on the method of measurement, including clinic resting measurements, 24-hour monitoring, or morning/evening home resting measurements (97729).
Hypertriglyceridemia. It is unclear if oral beet is beneficial in patients with hypertriglyceridemia. Details: A small clinical study in overweight or obese individuals with dyslipidemia shows that taking freeze-dried beet leaf 2.8 grams daily for 4 weeks in addition to nutritional guidance does not lower triglyceride levels when compared with nutritional guidance alone (100146). Beet has also been evaluated in combination with other ingredients. A small clinical trial in patients at risk for heart disease shows that a specific combination of beet and hawthorn berry (Neo40-Daily, Neogenis Labs), taken twice daily for 30 days, can modestly reduce blood triglyceride levels when compared to baseline (18222). It is unclear if these findings are due to beet, hawthorn berry, or the combination.
Liver disease. Although there has been interest in using oral beet for liver disease, there is insufficient reliable information about the clinical effects of beet for this purpose.
Muscle strength. It is unclear if oral beetroot juice is beneficial for muscle strength. Details: A meta-analysis of 18 clinical studies in healthy males shows that taking beetroot juice or beetroot gel 2-3 hours before exercise improves muscular strength when compared with placebo. Subgroup analysis suggests that beetroot-based supplements improve muscular strength in a fatigued but not resting state (113422). A small clinical study in adults with overweight or obesity on a calorie-restricted diet shows that drinking 70 mL of concentrated beetroot juice daily for 14 days improves handgrip strength by approximately 18% compared with 4% in controls (111158). However, it is unclear whether any improvement is clinically significant.
Obesity. It is unclear if oral beet leaf or beetroot juice is beneficial for weight loss. Details: A small clinical study in patients with overweight or obesity and dyslipidemia shows that taking freeze-dried beet leaf 2.8 grams daily for 4 weeks in addition to nutritional guidance does not reduce body weight or body mass index (BMI) when compared with nutritional guidance alone (100146). Similarly, a small clinical study in adults with overweight or obesity on a calorie-restricted diet shows that drinking 70 mL of concentrated beetroot juice daily for 14 days does not improve weight loss when compared with controls (111158). However, the size and duration of this study may have been inadequate to detect differences between groups.
Pregnancy-induced hypertension. It is unclear if oral beetroot juice is beneficial in patients with pregnancy-induced hypertension. Details: A small clinical trial in pregnant patients with hypertension who are at approximately 22-35 weeks gestation shows that taking beetroot juice (James White Drinks Ltd) 70 mL daily for 8 days does not reduce blood pressure when compared with a nitrate-depleted beetroot juice (100151). However, the study was small and designed to investigate the feasibility of using beetroot juice in this population.
Pulmonary hypertension. It is unclear if oral beetroot juice is beneficial in patients with pulmonary hypertension. Details: A small clinical study shows that taking beetroot juice (Beet-It Sport; James White Drinks Ltd) 70 mL twice daily for 7 days does not improve right ventricular systolic function when compared with nitrate-depleted beetroot juice in patients with pulmonary hypertension (100149). However, this study was small and not adequately powered to detect differences between groups.
Raynaud syndrome. It is unclear if oral beetroot juice is beneficial in patients with Raynaud syndrome. Details: A small clinical study in patients with Raynaud syndrome undergoing cold sensitivity tests shows that drinking beetroot juice (Beet-It, James White Drinks Ltd) 70 mL daily for 13 days, followed by 140 mL prior to testing, does not reduce pain in the hands or feet, but might improve thermal comfort in the feet, when compared to baseline (103884). The validity of this finding is limited by the lack of a comparator group. More evidence is needed to rate beet for these uses.

EFFECTIVE

Constipation. Oral blond psyllium is effective as a bulk laxative for reducing constipation and for softening stools. Details: Blond psyllium, in doses of 7 grams to 24 grams daily in single or divided doses for up to 8 weeks, has been used for the treatment or prevention of constipation (8424,9423,10092,22969,22970,22972,22973,99501). Some evidence suggests that blond psyllium alone for 7 days can relieve constipation and improve stool consistency as effectively as preparations containing blond psyllium 6.5 grams plus senna 1.5 grams daily (8424) or docusate sodium (10088). However, some preliminary evidence suggests that taking blond psyllium is less effective than prunes for increasing stool frequency in patients with constipation (22973). Taking blond psyllium-containing combination products also seems to reduce constipation. Some clinical evidence suggests that taking a combination product containing blond psyllium, aloe vera, and celandine daily for 28 days can improve stool frequency and stool softness and decrease laxative dependence when compared with placebo in people with chronic constipation (22974). Other clinical research suggests that taking a combination containing blond psyllium 17.3%, acacia fiber 67.7%, and fructose at a total daily dose of 16.8-22.4 grams daily for 8 weeks can improve symptoms of constipation in 78% of children with chronic functional constipation (22975).

LIKELY EFFECTIVE

Coronary heart disease (CHD). Consuming products containing soluble fiber, such as blond psyllium, may reduce the risk of CHD when used as part of a diet low in saturated fat and cholesterol. Details: In 1998, the FDA authorized a health claim stating that the addition of soluble fiber, such as that from blond psyllium, to a diet low in saturated fat and cholesterol might reduce the risk of CHD. The daily dietary intake of psyllium husk must be 7 grams or more (93216).
Hyperlipidemia. Oral blond psyllium reduces levels of low-density lipoprotein (LDL) cholesterol in most patients with mild to moderate hypercholesterolemia. It is unclear if blond psyllium is beneficial in older adults. Details: Blond psyllium seed husk or seed, added to food or as a separate supplement in a dose of 3-20 grams daily, in combination with a low-fat or a high-fat diet, can reduce levels of total cholesterol by 3% to 14%, LDL cholesterol by 5% to 11%, and apolipoprotein B by 8.8% after 7 weeks or more of treatment. It also reduces the LDL to high-density lipoprotein (HDL) ratio after 6 months of treatment (1376,2324,2327,4971,6261,6262,8060,8061,8066,10095) (22984,22986,22987,22988,22989,22990,22992,22993,22994,22995)(22996). There is evidence the LDL:HDL ratio can be reduced further when blond psyllium is consumed with a diet containing approximately 12% of energy as monounsaturated fatty acids and 29% as total fat (8067). However, taking blond psyllium 6 grams or less daily may not be effective for lowering cholesterol (22998). Also, there is some evidence that it lowers LDL cholesterol levels to a lesser degree in patients 60 years or older when compared with younger patients (2326). Blond psyllium does not significantly increase HDL levels and may actually lower HDL cholesterol levels in some patients. However, the magnitude of change in the HDL level is much less than changes in total and LDL cholesterol levels (1376,8433,10095). While some evidence suggests that blond psyllium reduces triglycerides (22993), other evidence shows no benefit (13102). Blond psyllium has also been used in cereal or cookies or in mixtures of soluble fibers, such as pectin, guar gum, carob gum, and/or oats, providing up to 15 grams of soluble fiber daily for up to 8 weeks (1584,6263,8060,8061,8431,8432,22988,22992). In fact, blond psyllium seems to be most effective when consumed with foods at mealtime (8062). Breakfast cereal containing blond psyllium can modestly decrease total cholesterol and LDL cholesterol by 5% and 9%, respectively (1584,6263,8060,8061). When used in conjunction with guar gum, carob gum, or oats for 56 months, it reduces total cholesterol by 6.4% and LDL cholesterol by 10.5% (8431). Some evidence suggests that blond psyllium seed might be more effective than the seed husk for lowering cholesterol (8069) and increasing levels of HDL cholesterol (92198). Blond psyllium has also been studied in combination with cholesterol-lowering medications. In one study, patients taking a combination of simvastatin 10 mg and blond psyllium (Metamucil) daily had similar reductions in cholesterol as those taking only simvastatin 20 mg daily (13102). Also, a combination of blond psyllium with colestipol, at half the usual doses, seems to be as effective as colestipol alone (8432). Blond psyllium also seems to reduce colestipol and cholestyramine side effects such as constipation and abdominal pain (8432,9424). In children with hypercholesterolemia, psyllium supplementation can further decrease LDL cholesterol levels by 7% to 15% when added to the low-fat, low-cholesterol, National Cholesterol Education Program (NCEP) Step 1 diet. However, psyllium supplementation added to the more stringent NCEP Step 2 diet may have less of an additional effect on LDL cholesterol (8073,8074,8075,8076). Blond psyllium 3.2-10 grams daily in cereal for up to 12 weeks has been used in children aged 2-18 years, in combination with a low-fat, low-cholesterol diet. Younger children aged 2-5 years used lower amounts of 3.2 grams daily while children aged 6-18 years used up to 10 grams daily (8075,8076). However, a small study in obese school children 15-19 years old shows that taking a specific psyllium powder (Natural Psyllium Fiber, Kirkland Signature) orally 10 grams daily for 7 weeks does not reduce LDL cholesterol, HDL cholesterol, or triglyceride levels when compared with placebo (106859).

Diabetes. Oral blond psyllium seems to be beneficial for improving glycemic control in people with type 1 or type 2 diabetes. It is unclear if blond psyllium is beneficial for the prevention of type 2 diabetes. Details: Taking blond psyllium seed husk 10.2-22 grams daily in divided doses for 8-20 weeks reduces postprandial serum glucose, insulin levels, serum total cholesterol, and low-density lipoprotein (LDL) cholesterol levels in patients with type 2 diabetes and hypercholesterolemia (1405,8058,8064,10091,10099,12552,22963,22964). Blond psyllium reduces postprandial blood glucose levels by about 14% to 20%, total cholesterol by about 9%, and LDL cholesterol by 13% (1405,8058). In a meta-analysis of 8 studies in people with type 2 diabetes, blond psyllium 3.4-15 grams daily for 8-20 weeks was associated with significant reductions in fasting blood glucose, glycated hemoglobin (HbA1c), LDL cholesterol, and triglycerides; however, it did not affect body weight, body mass index, total cholesterol, or high-density lipoprotein (HDL) cholesterol (102828). Blond psyllium also seems to lower postprandial glucose levels in patients with type 1 diabetes (12553,12554). The maximum effect of blond psyllium on glucose levels occurs when psyllium is mixed and consumed with foods (8064,10091). Evidence is mixed over whether blond psyllium lowers postprandial glucose in people who do not have diabetes (9249,22965,110762). The FDA has allowed a qualified health claim stating that psyllium husk may reduce the risk of developing type 2 diabetes. However, the FDA has concluded that there is very little scientific evidence supporting this claim (102827).
Diarrhea. Oral blond psyllium seems to be beneficial for the treatment of most types of diarrhea. However, it is unclear if blond psyllium is beneficial for tube feed-related diarrhea. Details: Taking blond psyllium orally seems to delay gastric emptying, slow colonic transit, increase fecal viscosity, and improve fecal consistency in patients with diarrhea (5246,8419,8420,8421). Clinical research shows that taking psyllium 7-18 grams daily in divided doses for up to 7 days, alone or in combination with calcium carbonate and calcium phosphate 1 gram each daily in a weight ratio of 4:1:1, seems to be as effective as loperamide in reducing the frequency and urgency associated with diarrhea (5246,8419,8420,8421,8422). Also, preliminary clinical research shows that blond psyllium 6.5 grams three times daily might also be useful in treating post-cholecystectomy diarrhea (10097). Additionally, taking blond psyllium orally seems to reduce diarrhea associated with the use of misoprostol. There is preliminary evidence that blond psyllium 3.4 grams twice daily relieves diarrhea associated with misoprostol use and prevents its reoccurrence when used throughout misoprostol therapy (8429). However, the research for tube feed-related diarrhea is mixed (8423,9422,102829). In patients receiving enteral tube feedings, psyllium does not decrease the frequency of stools (8423,9422). Other preliminary clinical research shows that adding a specific blond psyllium product (Mucilin SF, Paradigm Pharmaceuticals Inc.), as 15.2 grams per liter of an enteral nutrition formula does not reduce the number of days of diarrhea (102829). Conversely, some research suggests blond psyllium 14 grams daily in divided doses for 7 days may decrease the number of liquid stools (8423,9422).
Hemorrhoids. Oral blond psyllium seems to be beneficial for hemorrhoid symptoms. Details: Taking blond psyllium orally seems to help relieve bleeding and pain in people with hemorrhoids (8077,22961,22962). One clinical trial suggests that taking blond psyllium seed fiber (Vi-Siblin) 6.6 grams before each meal daily for 6 weeks can decrease bleeding and pain upon defecation when compared with placebo in people with symptomatic hemorrhoids (22961). Another clinical trial suggests that taking blond psyllium (Metamucil) 3.9 grams three times daily for 40 days can decrease bleeding when compared with a B vitamin control supplement in people with internal bleeding hemorrhoids (22962). Additionally, a preliminary clinical trial suggests that psyllium husk 3.5 grams twice daily used with micronized purified flavonoid fraction (MPFF, Daflon) 1500 mg twice daily for 5 days, followed by 1000 mg twice daily for 3 weeks can relieve bleeding more rapidly than psyllium husk used alone or psyllium husk used with rubber band ligation in patients with non-prolapsed hemorrhoids (8077).
Irritable bowel syndrome (IBS). Oral blond psyllium seems to be beneficial for reducing symptoms in adults and children with IBS. Details: While some evidence shows no benefit (8425,22981), the majority of evidence shows that blond psyllium seed husk can relieve constipation and improve abdominal pain, diarrhea, and overall well-being in patients with IBS (2316,8426,8427,8428,22976,22977,22978,22979,22980). One meta-analysis of clinical trials suggests that blond psyllium can reduce the risk of persistent IBS symptoms by 22% when compared with placebo (22982). These studies have used blond psyllium 6.4-30 grams daily in divided doses for up to 4 months (2316,8426,8427,22976,22978,22979,22982). There is also some evidence that a combination of blond psyllium 10 grams twice daily and propantheline (Pro-Banthine) 15 mg three times daily relieves constipation, incomplete bowel evacuation, abdominal pain, constipation, and straining associated with IBS. Patients typically experience relief after four weeks of treatment (8428). However, taking blond psyllium with mebeverine does not seem to improve symptoms of IBS when compared to mebeverine taken with a high fiber diet (22983). There is also evidence that blond psyllium may benefit children with IBS. A moderate-size clinical study in pediatric patients in India with IBS shows that taking blond psyllium husk 3-6 grams twice daily for 4 weeks leads to symptom remission in about 44% of patients compared with 10% of patients who took placebo (110763). However, it is unclear if these benefits can be extrapolated to patients in other geographic locations.
Orlistat (Xenical, Alli) side effects. Oral blond psyllium seems to be beneficial for reducing orlistat side effects. Details: Taking blond psyllium 18 grams daily with each dose of orlistat for 30 days seems to relieve orlistat side effects such as flatulence, stomach rumbling (borborygmi), abdominal cramps, oily spotting, and fecal incontinence without decreasing the weight-reducing effect of orlistat (5245).

POSSIBLY INEFFECTIVE

Colorectal adenoma. Oral blond psyllium does not seem to be beneficial for preventing colorectal adenoma recurrence. Details: Taking blond psyllium orally 3.5 grams per day does not seem to reduce the risk of colorectal adenoma recurrence. There is some evidence that it might actually increase the risk of adenoma recurrence, particularly in people with high dietary calcium intake. However, more evidence is needed to determine the relationship of psyllium and calcium to colorectal adenoma (7585).

Colorectal cancer. It is unclear if dietary blond psyllium is beneficial for colorectal cancer. Details: Population research suggests that higher dietary intake of blond psyllium is associated with reduced mortality from colorectal cancer (92197).
Crohn disease. Oral blond psyllium has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with Crohn disease shows that taking blond psyllium 9.9 grams daily along with Lactobacillus- and Bifidobacterium-containing probiotics 75 billion colony forming units daily for an average of 13 months can decrease disease activity and symptom scores when compared to baseline. Overall, 70% of subjects in the study showed an improvement in clinical symptoms (22968). However, the validity of these findings is limited by the lack of a control group.
Dry eye. It is unclear if blond psyllium eye drops are beneficial for dry eye. Details: In patients with dry eye, clinical research shows that use of eye drops providing blond psyllium mucilage polysaccharides 0.35 mcg/mL four times daily for 6 weeks improves subjective symptoms of dry eye by 62%, compared with a 15% improvement in those using placebo drops. There were also improvements in light sensitivity, grittiness, burning, and blurred vision, but the eye drops did not affect objective symptoms including tear film break up time, tear production, or tear osmolarity (105274).
Fecal incontinence. It is unclear if blond psyllium is beneficial for patients with this condition. Details: A small clinical study in adults with fecal incontinence and loose stools suggests that taking blond psyllium 6 grams daily for 4 weeks does not improve the proportion of patients with at least 50% reduction in incontinence episodes when compared with a dietician-led low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diet (110761).
Gastroesophageal reflux disease (GERD). It is unclear if oral blond psyllium is beneficial for GERD. Details: Preliminary clinical research shows that taking a specific blond psyllium supplement (Mucofalk, Dr. Falk PharmaGmbH) 5 grams three times daily mixed in 150 mL of water for 10 days may help control symptoms in some patients with GERD. About 60% of patients achieved at least 7 consecutive days of no reflux after taking blond psyllium (99500). The validity of these results is limited by the lack of a control group.
Hypertension. It is unclear if oral blond psyllium is beneficial for hypertension. Details: Preliminary clinical research shows that blond psyllium 3.5 grams taken three times daily for 6 months can reduce both systolic and diastolic blood pressure when compared with pretreatment in overweight patients with hypertension (54260). A small clinical study shows that taking blond psyllium 15 grams with soy protein 66 grams daily for 8 weeks can help reduce systolic and diastolic blood pressure by about 6 mmHg and 2 mmHg, respectively, in hypertensive adults (10458). In a meta-analysis of 11 trials using psyllium 3.7-15 grams daily for 1-6 months, the overall weighted mean reduction in systolic blood pressure was 2 mmHg, with only 3 trials reporting a significant reduction. Only one trial reported a significant reduction in diastolic blood pressure (102826). This improvement in systolic blood pressure appears to only occur with a study duration of 8 weeks or longer, and the level of effect seems to be related to baseline blood pressure. It is not clear if any reduction in blood pressure achieved with psyllium would be considered clinically significant. Additionally, it is unclear if the studies included in this meta-analysis used blond psyllium or black psyllium supplements.
Kidney failure. Although there has been interest in using oral blond psyllium to improve outcomes in kidney failure, there is insufficient reliable information about the clinical effects of blond psyllium for this purpose.
Obesity. It is unclear if oral blond psyllium can improve weight loss in overweight or obese adolescents and adults; the available research is conflicting. Details: Some preliminary clinical research shows that blond psyllium might reduce body weight and appetite in adults who are overweight or obese. In one clinical trial, taking blond psyllium 12 grams three times daily for 12 weeks reduced body weight, body mass index (BMI), and body fat percentage when compared with placebo in overweight and obese individuals (23402). In obese individuals, another clinical trial shows that taking psyllium along with a specific diet reduces body weight and appetite when compared with the specific diet alone (23403). However, a meta-analysis of 22 trials using psyllium 1.7-21 grams daily for 2-36 weeks shows that psyllium does not have a significant effect on body weight, BMI, or waist circumference in overweight or obese adults, although several sources of heterogeneity are present in the trials (102825). A small clinical study in school children 15-19 years old with obesity and at least 1 other cardiovascular risk factor shows that taking a specific psyllium powder (Natural Psyllium Fiber, Kirkland Signature) orally 10 grams daily for 7 weeks reduces body mass index (BMI) and waist circumference by 2% and 0.5%, respectively, when compared with baseline, but not when compared with placebo (106859).
Oral mucositis. It is unclear if rinsing the mouth with blond psyllium is beneficial for oral mucositis prevention. Details: In patients with breast cancer who had developed oral mucositis during the previous chemotherapy cycle, a small clinical trial shows that using a mouthwash containing a mixture of blond psyllium husk 500 mg in 30 mL water with three drops of vinegar three times daily, starting during a later chemotherapy cycle and continuing for 2 weeks, modestly reduces the degree of mucositis, severity of pain, and xerostomia grade when compared with a placebo mouthwash (105273).
Postoperative bowel function. It is unclear if taking oral blond psyllium preoperatively reduces the time to the first bowel movement after surgery. Details: A moderate-size clinical study in patients undergoing surgery for pelvic organ prolapse shows that taking blond psyllium (Metamucil) 3.4 g twice daily for 7 days prior to surgery, followed by a usual postoperative bowel regimen, does not reduce the time to the first bowel movement after surgery or pain due to the first postoperative bowel movement when compared with usual care (110764).
Ulcerative colitis. It is unclear if oral blond psyllium is beneficial for ulcerative colitis. Details: One small clinical study shows that taking blond psyllium seeds 10 grams twice daily might be as effective as mesalamine 500 mg three times daily for 12 months in preventing the relapse of ulcerative colitis (2385). However, this dose of mesalamine is much lower than what is typically used for this indication. Another small clinical trial shows that blond psyllium 3.5 grams twice daily for 4 months also appears to relieve gastrointestinal symptoms in adult patients with ulcerative colitis in remission, including abdominal pain, diarrhea, loose stools, urgency, bloating, incomplete evacuation, mucus discharge, and constipation (10086). However, the authors were unable to rule out the presence of irritable bowel syndrome (IBS) this population. A small clinical study in patients with juvenile ulcerative colitis in remission shows that blond psyllium does not appear to have an effect on fecal bile acid excretion, an indicator of disease progression (10090). More evidence is needed to rate the effectiveness of blond psyllium for these uses.

CHLORELLA

Pregnancy-related iron deficiency. Oral chlorella, which contains iron, can help to prevent iron deficiency and anemia in pregnancy. Details: A small clinical study in Japanese patients in their first trimester of pregnancy shows that taking chlorella (Sun Chlorella A, Sun Chlorella Corp.) 2 grams three times daily, providing 7.2 mg iron daily, starting at the 12-18th week of gestation and continuing until delivery, reduces the incidence of maternal anemia, defined as a hemoglobin level less than 11 g/dL, to about 30%, compared with about 60% in patients receiving no intervention (95013).

Brain tumor. It is unclear if oral chlorella is beneficial in patients with glioma. Details: A small clinical study in patients with glioma shows that taking chlorella tablets plus chlorella liquid extract over 2 years might improve tolerability of chemotherapy and radiotherapy, but does not seem to affect tumor progression or survival, when compared to baseline (6804). The validity of this finding is limited by the lack of a comparator group.
Depression. It is unclear if oral chlorella is beneficial as an adjunct to conventional antidepressant therapy in patients with major depressive disorder. Details: One open-label clinical trial in patients with major depressive disorder shows that taking chlorella extract tablets (ALGOMED, Bioprodukte Prof. Steinberg Produktions-und Vertreibs GmbH & Co.) 600 mg three times daily in addition to standard antidepressant therapy for 6 weeks improves subjective symptoms of depression and anxiety, measured on the Beck Depression Inventory II and the Hospital Anxiety and Depression Scale, when compared with standard antidepressant therapy alone (92132). The validity of this finding is limited by the large number of patients lost to follow-up and a lack of blinding.
Dysmenorrhea. It is unclear if oral chlorella improves symptoms of dysmenorrhea. Details: A small clinical study in females 18-35 years of age with primary dysmenorrhea shows that taking chlorella (American Super Golden Med) 1500 mg daily for 8 weeks modestly decreases the severity and duration of painful menstrual cramps when compared with placebo (99882). This study is limited by small sample size and unclear allocation concealment.
Exercise-induced respiratory infections. It is unclear if oral chlorella can prevent respiratory infections related to exercise. Details: A small clinical trial in physically active adults shows that taking chlorella (Sun Chlorella A, Sun Chlorella Corp.) 3 grams twice daily for 6 weeks increases salivary IgA, a marker of immune response, but doesn't improve the duration or severity of upper respiratory symptoms or reduce the risk for upper respiratory tract infections when compared with placebo (99881). However, this study was likely underpowered to detect differences in these outcomes.
Fatigue. It is unclear if oral chlorella improves fatigue from exercise. Details: A small clinical trial in healthy males shows that taking chlorella (Chlorella Kogyo Co., Ltd) 2 grams three times daily for 4 weeks does not decrease exercise-induced fatigue or fatigue at rest when compared with placebo (99880).
Fibromyalgia. It is unclear if oral chlorella improves symptoms of fibromyalgia. Details: A small open-label clinical trial in people with fibromyalgia shows that taking chlorella tablets (Sun Chlorella) 10 grams plus a liquid chlorella extract (Wakasa Gold) 100 mL daily for 2 months improves general symptoms and pain scores when compared with baseline (5890). The validity of this finding is limited by the lack of a comparator group.
Halitosis. Although there is interest in using oral chlorella for halitosis, there is insufficient reliable information about the clinical effects of chlorella for this purpose.
Hepatitis C. It is unclear if oral chlorella improves outcomes in patients with chronic hepatitis C infection. Details: A small clinical trial in patients with chronic hepatitis C virus (HCV) genotype 1 infection shows that taking chlorella tablets (Sun Chlorella A, Sun Chlorella Corp) 1500 mg twice daily for one week, then 1500 mg three times daily for 11 weeks, in addition to an extract containing 82 mg/mL of chlorella (Wakasa Gold, Sun Chlorella Corp) 30 mL twice daily for 12 weeks, decreases alanine aminotransferase (ALT) levels, but not aspartate aminotransferase (AST) or HCV RNA levels, when compared to baseline (92130). The validity of this finding is limited by the lack of a comparator group.
Hyperlipidemia. It is unclear if oral chlorella reduces lipid levels. Details: A meta-analysis of mostly low-quality clinical studies in healthy adults and those with metabolic disorders shows that taking chlorella 900-5000 mg daily for 3-8 weeks reduces both total cholesterol and low-density lipoprotein (LDL) cholesterol by about 8 mg/dL but does not reduce triglycerides or increase high-density lipoprotein cholesterol when compared with placebo (113623). Additionally, a small clinical trial in patients with mild hypercholesterolemia, defined as total cholesterol between 200-250 mg/dL, who are not using lipid-lowering medications, suggests that taking chlorella (Daesang Corp.) 1664 mg three times daily for 4 weeks reduces total cholesterol by 1.6% and triglycerides by 10.3%, but does not affect low-density lipoprotein cholesterol or high-density lipoprotein cholesterol, when compared with placebo (92131). This study was limited by its short duration and small size.
Hypertension. It is unclear if oral chlorella is beneficial in patients with hypertension. Details: Preliminary clinical research in patients with mild to moderate hypertension shows that taking chlorella 10 grams and chlorella extract 100 mL daily for 1-2 months does not reduce blood pressure when compared to baseline (41811).
Metabolic syndrome. Although there is interest in using oral chlorella for metabolic syndrome, there is insufficient reliable information about the clinical effects of chlorella for this condition.
Nonalcoholic fatty liver disease (NAFLD). Oral chlorella has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small open-label clinical trial in patients with NAFLD shows that taking chlorella extract 1200 mg with metformin 750 mg and vitamin E 200 mg daily for 3 months decreases alanine aminotransferase (ALT), aspartate aminotransferase (AST), and triglyceride levels when compared to baseline. Treatment with metformin 1250 mg and vitamin E 200 mg daily without chlorella does not appear to improve these outcome measures (99878). This study is limited by the lack of statistical comparison between groups.
Peptic ulcers. Although there is interest in using oral chlorella for peptic ulcers, there is insufficient reliable information about the clinical effects of chlorella for this purpose.
Pregnancy-induced hypertension. It is unclear if oral chlorella is beneficial for preventing pregnancy-induced hypertension. Details: A small clinical study in healthy Japanese patients in their first trimester of pregnancy shows that taking chlorella (Sun Chlorella A, Sun Chlorella Corp.) 2 grams three times daily, starting at the 12-18th week of gestation and continuing until delivery, reduces proteinuria and leg edema, but does not affect blood pressure, when compared with no intervention (95013). It is unclear if chlorella is beneficial in patients who are at risk for hypertension during pregnancy.
Ulcerative colitis. Although there is interest in using oral chlorella for ulcerative colitis, there is insufficient reliable information about the clinical effects of chlorella for this condition. More evidence is needed to rate chlorella for these uses.

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).

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.

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.

Safety view details

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

APPLE

LIKELY SAFE ...when used orally in food amounts. Eating apples and consuming apple juice is safe for most people. Apples are a common food source (3470,3472). However, eating apple seeds should be avoided because they can be toxic (6).

CHILDREN: LIKELY SAFE
when used orally in food amounts. Eating apples and consuming apple juice is safe for most people. Apples are a common food source (3470,3472).

CHILDREN: POSSIBLY SAFE
when apple pectin is used orally and appropriately, short-term. Preliminary clinical research suggests that combination products containing apple pectin and German chamomile (Diarrhoesan) are safe when used in infants for up to one week (19705,19706).

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of apple in amounts greater than those found in foods during pregnancy and lactation; avoid using.

LIKELY SAFE ...when used in amounts commonly found in foods.

POSSIBLY SAFE ...when used orally and appropriately for medicinal purposes, short term. Beetroot juice has been safely used in clinical trials in doses of up to 500 mL daily for up to 7 days and a beetroot-based nutritional gel has been used safely in doses of up to 100 grams daily for 8 days (94461,94462,94464,100149,100152,100153).

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of beets used medicinally during pregnancy and breast-feeding.

LIKELY SAFE ...when used orally with appropriate fluid intake (93216). Blond psyllium preparations have been safely used in doses up to 20 grams per day for up to 6 months (1376,2324,2327,6261,6262,8060,8061,8066,8423,9422) (10095,13102,22961,22962,22963,22964,22966,54260,22968,22969) (22970,22972,22973,22976,22977,22978,22979,22980,22981,22986) (22987,22988,22989,22990,22992,22993,22994,22995,22996,22998) (23402,23403,23404,23405,92198,106859). The U.S. Food and Drug Administration (FDA) requires over-the-counter medicines that contain dry or incompletely hydrated psyllium to carry a warning that they should be taken with at a least a full glass of liquid to reduce the risk of choking. This labeling also applies to foods containing psyllium that are marketed with a health claim regarding coronary heart disease (93217,93218).

POSSIBLY SAFE ...when used in eye drops. Blond psyllium mucilage has been used with apparent safety in eye drops four times daily for 6 weeks (105274). There is insufficient reliable information available about the safety of blond psyllium when used topically.

LIKELY UNSAFE ...when used orally without adequate fluid intake due to the risk for choking and gastrointestinal obstruction (93218). ...when granular dosage forms containing blond psyllium are used as over the counter (OTC) laxatives. The U.S. Food and Drug Administration (FDA) states that these granular dosage forms are not generally recognized as safe and effective as OTC laxatives due to an increased risk of choking and gastrointestinal obstruction (93219).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. Blond psyllium husk has been used with apparent safety in doses up to 12 grams daily for 4 weeks (110763).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately (272).

CHLORELLA

LIKELY SAFE ...when used orally and appropriately, short-term. Tablets and liquids containing chlorella 3-10 grams or 60-100 mL daily have been safely used in clinical studies lasting 2-3 months (5890,92130,92131). Also, chlorella extract 200-1800 mg daily has been safely used in clinical research for 4-6 weeks (10388,92132). There is insufficient reliable information available about the safety of chlorella when used topically.

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts for up to approximately 28 weeks. A commercially available chlorella supplement (Sun Chlorella A, Sun Chlorella Corp.) has been safely used in doses of 6 grams daily, starting during the 12-18th week of gestation and continuing until delivery (95013).

LACTATION:
Insufficient reliable information available; avoid using.

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.

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.

Interactions with Drugs view details

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

APPLE

ALISKIREN (Tekturna, Rasilez)

Interaction Rating = Moderate Be cautious with this combination.

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

Concomitant consumption of apple juice can significantly decrease oral absorption and blood levels of aliskiren.

Details

Pharmacokinetic research shows that coadministration of apple juice 200 mL along with aliskiren 150 mg decreases the bioavailability of aliskiren by 63% (17670). Apple juice seems to inhibit organic anion transporting polypeptide (OATP), which is involved in drug uptake in the gut, liver, and kidney (7046,94413). It is thought that apple juice might affect OATP for only a short time. Therefore, separating drug administration and consumption of apple juice by at least 4 hours might avoid this interaction (17603,17604).

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, consuming apple juice with antidiabetes drugs might interfere with blood glucose control.

Details

Clinical research suggests that consuming apples or drinking apple juice can raise blood glucose levels, with the effects of drinking apple juice being more significant than consuming apples (31699).

ANTIHYPERTENSIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Consuming apple juice with antihypertensive drugs might interfere with blood pressure control.

Details

Some clinical evidence suggests that consuming apple and cherry juice can increase blood pressure in elderly patients (31680).

ATENOLOL (Tenormin)

Interaction Rating = Moderate Be cautious with this combination.

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

Concomitant consumption of apple juice can significantly decrease oral absorption and blood levels of atenolol.

Details

Pharmacokinetic research shows that coadministration of apple juice 600-1200 mL decreases levels of atenolol by 58% to 82% in a dose-dependent manner (17999). Apple juice seems to inhibit organic anion transporting polypeptide (OATP), which is involved in drug uptake in the gut, liver, and kidney (7046). It is thought that apple juice might affect OATP for only a short time. Therefore, separating drug administration and consumption of apple juice by at least 4 hours might avoid this interaction (17603,17604).

FEXOFENADINE (Allegra)

Interaction Rating = Moderate Be cautious with this combination.

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

Concomitant consumption of apple juice can significantly decrease oral absorption and blood levels of fexofenadine.

Details

Pharmacokinetic research shows that coadministration of apple juice 400-1200 mL along with fexofenadine 60-120 mg decreases bioavailability of fexofenadine by up to 78% (7046,94413). Coadministration with smaller quantities of apple juice (150 mL or less) does not appear to affect the bioavailability of fexofenadine (94421). Apple juice seems to inhibit organic anion transporting polypeptide (OATP), which is involved in drug uptake in the gut, liver, and kidney (7046,94413). It is thought that apple juice might affect OATP for only a short time. Therefore, separating drug administration and consumption of apple juice by at least 4 hours might avoid this interaction (17603,17604).

LITHIUM

Interaction Rating = Moderate Be cautious with this combination.

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

There is some concern that concomitant consumption of apple juice might decrease oral absorption and blood levels of lithium.

Details

In one case report, a patient had an undetectable serum lithium level when lithium citrate was administered with apple juice. When lithium was administered with an alternative beverage, the lithium level became detectable and the patient demonstrated clinical improvement (105342).

ORGANIC ANION-TRANSPORTING POLYPEPTIDE SUBSTRATES (OATP)

Interaction Rating = Major Do not take this combination.

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

Concomitant consumption of apple juice can significantly decrease oral absorption and blood levels of OATP substrates.

Details

Research shows that consuming apple juice inhibits OATP, which reduces bioavailability of oral drugs that are substrates of OATP (7046,17605). Fexofenadine, atenolol, and aliskiren are substrates of OATP. Clinical research shows that coadministration of apple juice decreases bioavailability of fexofenadine by up to 78% (7046,94413), aliskiren by 63% (17670), and atenolol by up to 82% (17999). These effects appear to increase with larger quantities of apple juice. It is thought that apple juice might affect OATP for only a short time. Therefore, separating drug administration and consumption of apple juice by at least 4 hours might avoid this interaction (17603,17604).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, beet might decrease the levels and clinical effects of CYP1A2 substrates.

Details

In vitro research suggests that beet induces CYP1A2 enzymes (111404).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, beet might increase the levels of CYP3A4 substrates.

Details

In vitro research suggests that betanin, the major pigment in beet, competitively inhibits CYP3A4 in a dose-dependent manner similarly to strong CYP3A4 inhibitor ketoconazole (113425).

CARBAMAZEPINE (Tegretol)

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, blond psyllium might reduce the effects of carbamazepine and increase the risk for convulsions.

Details

Blond psyllium might reduce carbamazepine absorption and serum levels (539,92194). A preliminary study using blond psyllium reported decreased carbamazepine bioavailability due to binding of the drug to psyllium, as well as reduction of available fluid in the gut for dissolution of the drug (539).

DIGOXIN (Lanoxin)

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, taking blond psyllium at the same time as digoxin might reduce digoxin absorption.

Details

Psyllium might bind digoxin in the gut (12). However, some clinical evidence suggests that psyllium does not impact digoxin absorption (10098).

ETHINYL ESTRADIOL

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, taking blond psyllium at the same time as ethinyl estradiol might alter levels of estradiol.

Details

Concurrent use of blond psyllium with ethinyl estradiol results in a slight increase in the extent of ethinyl estradiol absorption and a slower rate of absorption. However, this is unlikely to be clinically significant (12421).

LITHIUM

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, taking blond psyllium at the same time as lithium might reduce lithium absorption.

Details

The fiber in blond psyllium might decrease the absorption of lithium. Some case reports describe a reduction in plasma lithium levels with concomitant administration of blond psyllium. This was reversed when psyllium was stopped (540,92194).

METFORMIN (Glucophage)

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, blond psyllium might increase the therapeutic and adverse effects of metformin.

Details

Concurrent use of blond psyllium with metformin slows and increases metformin absorption (99433). To avoid changes in absorption, take psyllium 30-60 minutes after metformin.

OLANZAPINE (Zyprexa)

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, taking blond psyllium at the same time as olanzapine might reduce olanzapine absorption.

Details

The fiber in blond psyllium might decrease the absorption of olanzapine. A single case report describes a reduction in the effectiveness of olanzapine when it was taken concomitantly with an unspecified type of psyllium 3 grams orally twice daily. This effect was reversed when psyllium was stopped (106858).

ORAL DRUGS

Interaction Rating = Minor Be watchful with this combination.

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

Theoretically, psyllium might increase, decrease, or have no effect on the absorption of oral drugs.

Details

Psyllium seems to have variable effects on drug absorption. To avoid changes in absorption, take psyllium 30-60 minutes after oral medications. Animal research shows that blond psyllium delays and increases the absorption of metformin and ethinyl estradiol (12421,99433). Conversely, case reports and animal research suggest that blond psyllium might reduce absorption of lithium, digoxin, olanzapine, and carbamazepine (12,18,272,93214,106858). Finally, some pharmacokinetic studies show that psyllium does not affect the absorption of levothyroxine or warfarin (12420,103940).

CHLORELLA

PHOTOSENSITIZING DRUGS

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, chlorella might have additive effects with photosensitizing drugs.

Details

Chlorella has been reported to cause photosensitization (3900,5852). In five case reports, patients who had ingested chlorella exhibited swelling followed by erythematopurpuric lesions on sun-exposed areas of the body (5852). Theoretically, concomitant use with photosensitizing drugs may exacerbate effects.

WARFARIN (Coumadin)

Interaction Rating = Moderate Be cautious with this combination.

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

Theoretically, chlorella might reduce the clinical effects of warfarin.

Details

Chlorella contains significant amounts of vitamin K. There is at least one case report of warfarin therapy becoming sub-therapeutic after initiation of chlorella supplements (3900,41830).

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.

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).

Report an Adverse Reaction to Multi fibre

Adverse Effects view details

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

APPLE

General ...Orally, apple fruit is well tolerated. Apple seeds, which contain cyanide, may cause serious adverse effects when consumed in large amounts.
Most Common Adverse Effects:
Orally: Bloating, flatulence.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, including anaphylaxis. Ingestion of large amounts of apple seeds may cause cyanide poisoning, leading to death.

Gastrointestinal ...Orally, apple products, including whole apples, apple puree, and apple juice, may cause bloating and flatulence in some people (104184).

Immunologic ...Patients allergic to other fruits in the Rosaceae family, including apricot, almond, plum, peach, pear, and strawberry, can also be allergic to apples (7129). Rarely, the allergy has resulted in anaphylaxis (94425).

Other ...Orally, ingestion of large amounts of apple seeds, which contain hydrogen cyanide (HCN), may cause cyanide poisoning, leading to death. One death is attributed to ingestion of a cupful of apple seeds. To release cyanide, seeds must be hydrolyzed in the stomach, and several hours may elapse before poisoning symptoms occur (6).

General ...Orally, beet seems to be well tolerated when used for medicinal purposes, short term.
Most Common Adverse Effects:
Orally: Red stools and red urine.
Serious Adverse Effects (Rare):
Orally: Hypocalcemia and kidney damage when ingested in large amounts.

Endocrine ...Theoretically, ingestion of large quantities of beets could lead to hypocalcemia because of the oxaluric acid content (18).

Gastrointestinal ...Orally, beet juice may cause red stools (94470,97726,100142,100145,105762). This red coloring of the stools is not harmful. Additionally, beet supplementation has been reported to cause black stools. In one case, a 79-year-old male on apixaban and clopidogrel presented with black stools, nausea, and vomiting after taking beet pills 2-3 days prior. The likelihood of upper gastrointestinal bleed was determined to be low based on factors such as normal vital signs and lack of severe anemia. The patient was diagnosed with beet-induced pseudo-hematochezia which was successfully treated with fluids and discontinuation of the beet supplement (113426).
Other less common gastrointestinal side effects include loose stools, constipation, and nausea (100149).

Genitourinary ...Orally, beet is known to produce red or pink urine (beeturia) in some people (32569,34134,94464,94470,97725,97726,100142,100145,100152,105762,113422). However, this red coloring of the urine is not harmful and dissipates after about 12 hours (113422).

Neurologic/CNS ...Orally, vivid dreams and worsening headaches have each occurred in one person in a clinical trial, although it is not clear if this is due to beet (97723).

Renal ...Theoretically, ingestion of large quantities of beets could lead to kidney damage due to its oxaluric acid content (18).

General ...Orally, blond psyllium is generally well tolerated. When used as eye drops, blond psyllium seems to be well tolerated.
Most Common Adverse Effects:
Oral: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, and nausea.
Serious Adverse Effects (Rare):
Oral: Bowel obstruction, esophageal obstruction.

Gastrointestinal ...Orally, blond psyllium can cause transient flatulence, abdominal pain, diarrhea, constipation, dyspepsia, and nausea (1376). Starting with a low dose and slowly titrating to the desired dose can often minimize gastrointestinal side effects. There is some concern that blond psyllium can cause esophageal or bowel obstruction when consumed without water or in patients with swallowing disorders (604,8080,8081,110760). Tell patients to consume plenty of water when taking blond psyllium. Suggest at least 240 mL of fluid for every 3.5-5 grams of seed husk or 7 grams of seed (1376,8080,8081).

Musculoskeletal ...Orally, backache has been reported with the use of psyllium (1376).

Neurologic/CNS ...Orally, headache has been reported with the use of psyllium (1376).

Ocular/Otic ...Ophthalmically, blurred vision or burning haven been reported rarely in patients using eye drops containing blond psyllium mucilage (105274).

Pulmonary/Respiratory ...Orally, rhinitis, increased cough, and sinusitis have been reported with the use of psyllium (1376).

Other ...Some patients can have an allergic response to blond psyllium. Allergy symptoms include allergic rhinitis, sneezing, conjunctivitis, urticarial rash, itching, flushing, and dyspnea. More serious symptoms include wheezing, facial and body swelling, chest congestion, chest and throat tightness, cough, diarrhea, hypotension, loss of consciousness, and anaphylactic shock. Occupational exposure or repeated ingestion of psyllium can cause sensitization, which can lead to serious allergic reactions (2328,2329,2330,8079,9246,92193). Severe allergic reactions may occur after eating a small quantity of cereal that contains blond psyllium. At least one cereal (Heartwise, Kellogg Co.) has increased the purity of the psyllium it contains, which has decreased the incidence of allergic reactions (9244). A warning of the potential for allergic reactions is on the label of all cereals that contain psyllium (9247). Patients hypersensitive to psyllium usually have marked eosinophilia and an elevated psyllium-specific IgE antibody serum level (2328,2329,92193).
There is concern that individuals allergic to pollen from English plantain weed (Plantain lanceolate) might also react to psyllium husk dust; however, it appears that there is little cross-allergenicity between these plants and is probably mild and of no clinical significance (8057,9244,92193).
Blond psyllium has a tendency to plug feeding tubes. This can be avoided if blond psyllium is mixed with water and pushed through the feeding tube in less than 5 minutes (8423).

CHLORELLA

General ...Orally, chlorella is generally well-tolerated.
Most Common Adverse Effects:
Orally: Allergic reactions, abdominal cramping, constipation, diarrhea, fatigue, flatus, nausea, photosensitivity, and stool discoloration.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis.

Dermatologic ...Orally, photosensitivity reactions have occurred following ingestion of chlorella (3900,5852). According to case reports, five patients who had ingested chlorella exhibited swelling followed by erythematopurpuric lesions on sun-exposed areas of the body (5852). The photosensitizing agent in the chlorella tablets was identified as pheophorbide-a and its ester.

Gastrointestinal ...Orally, chlorella can cause diarrhea, abdominal cramping, flatus, and nausea, especially during the first two weeks of treatment (5890,6804,92130,92132). In one clinical trial, one out of 42 patients reported nausea and one reported diarrhea (92132). In another trial, taking chlorella tablets (Sun Chlorella A, Sun Chlorella Corp) and a chlorella extract (Wakasa Gold, Sun Chlorella Corp) resulted in transient worsening of constipation in 4 of 13 patients and transient mild diarrhea in 2 of 13 patients (92130).
Green discoloration of the feces has also been reported, due to the chlorophyll content of chlorella (6804,95013).

Hematologic ...Orally, chlorella has been linked to one case of thrombocytopenia; however, causality has not been determined. A 49-year-old female living in Turkey presented with thrombocytopenia (a platelet count of 27,000/mm³) after taking chlorella 1080 mg daily for 20 days. Platelet counts had been normal one month earlier, and returned to normal two weeks after discontinuing the chlorella supplement (99879).

Immunologic ...Allergic reactions, including asthma and anaphylaxis, have been reported in people taking chlorella and in those preparing chlorella tablets (3900,5847,41827,105645).

Neurologic/CNS ...Orally, manganese (Mn)-induced parkinsonism has been reported after long-term consumption of chlorella extract. In this case, a patient on maintenance hemodialysis reported gait disturbance, dysarthria, elevated serum and cerebrospinal fluid manganese levels, and abnormal magnetic resonance imaging (MRI) findings of the brain. The authors identified the condition as a rare case of Mn-induced parkinsonism, which may have been due to long-term ingestion of a chlorella extract containing 1.7 mg of Mn in the usual daily dose. The patient underwent edetic acid infusion therapy, which improved the MRI abnormalities and the other symptoms improved four months later (41817).
In one study, fatigue was reported in 18 of 41 patients receiving chlorella 200 mg (10388).

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).

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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