C-Cleanse Unflavored by Patient One MediNutritionals

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).

POSSIBLY EFFECTIVE

• 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).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• 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.

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POSSIBLY EFFECTIVE

• Constipation. Most clinical research shows that oral inulin modestly improves stool frequency, but may not improve discomfort, in adults and children with constipation. Details: A meta-analysis of clinical research in adults with constipation shows that consuming inulin improves stool frequency by approximately 0.7 stools per week. It also seems to improve stool transit time, consistency, and hardness, but does not reduce pain or bloating (93718). Additional clinical research shows that taking a specific type of inulin (OraftiGR, BENEO GmbH) 12 grams daily in three divided doses for 4 weeks increases stool frequency by approximately one stool per week when compared with a maltodextrin control. Taking inulin also reduces the number of patients experiencing hard and lumpy stools by 13%, but does not improve symptoms of bloating, distension, physical discomfort, or gas (96850). In children aged 2-5 years, one small clinical study shows that taking a specific combination of two inulin products (Orafti P95 oligofructose and Orafti GR inulin, BENEO GmbH), 2 grams twice daily in a dairy liquid for 6 weeks, improves the softness of stools, but not pain with stooling or stool frequency, when compared with a maltodextrin control (96848). Research in older adults is conflicting. One small study shows that taking inulin 20-40 grams daily for 19 days increases the number of stools from 1-2 per week to 8-9 per week (10415). However, other preliminary clinical research in this population shows that taking a specific inulin supplement (Fibruline Instant, Cosucra Groupe Warcoing) 15 grams daily in yogurt or stewed fruit for 4 weeks does not improve bowel symptoms, stool frequency, or stool consistency (93724).
• Diabetes. Short-term use of oral inulin along with antidiabetes drugs may improve glycemic control in some patients with type 2 diabetes; however, the benefits of long-term use are unclear. Details: Two meta-analyses of clinical research in normal weight and obese patients with type 2 diabetes show that taking inulin 0.8-10 grams orally daily for 6-12 weeks reduces glycated hemoglobin (HbA1c) by 0.65% and fasting plasma glucose by 16 mg/dL when compared with control. Taking inulin also improved HOMA-IR, a measure of insulin resistance, when compared with control. Researchers did not evaluate the most effective dose of inulin; however, most studies used 8.4-10 grams daily (103198,105533). In females treated with metformin and glyburide, taking inulin 10 grams daily for 8 weeks reduces fasting blood glucose by 15 mg/dL and HbA1c by 1% when compared with placebo (93719). Population research in adults has also found that high dietary intake of inulin over 8 years of follow up is associated with a 6% lower risk of type 2 diabetes when compared with low dietary intake (110515). Inulin has also been studied in combination with other supplements. Preliminary clinical research in elderly patients with diabetes shows that drinking a milk powder product supplemented with inulin and resistant dextrin 30 grams before breakfast and 15 grams before dinner for 12 weeks decreases fasting plasma glucose by 17 mg/dL, HbA1c by 0.38%, postprandial glucose by 27 mg/dL, body weight by 0.8 kg, and systolic and diastolic blood pressure by 5 mmHg when compared with placebo (99843). Other clinical research in adults with type 2 diabetes shows that taking a specific combination product (Orafti Synergy1, BENEO GmbH), containing 50% inulin and 50% fructo-oligosaccharides, 8 grams orally twice daily for 6 weeks does not reduce body weight or caloric intake or increase satiety scores when compared with placebo (107934).
• Obesity. Oral inulin might modestly improve short-term weight loss. Additional research is needed to determine the long-term effects of inulin on weight loss and weight maintenance in overweight or obese individuals. Details: Some clinical research in overweight and obese females with diabetes shows that taking inulin 10 grams daily for 8 weeks results in weight loss of 2.6 kg, compared with no weight loss in those taking placebo (93719). Preliminary clinical research in overweight or obese patients with prediabetes shows that taking a specific brand of inulin (Orafti Synergy 1, BENEO GmbH) 30 grams orally daily for 6 weeks reduces body weight by 0.4 kg, compared with a 0.4 kg increase in those in the control group (93721). Preliminary clinical research in adults with obesity shows that taking inulin 16 grams orally daily for 3 months moderately reduces body weight and body mass index (BMI) when compared with placebo. However, these effects were most prominent in subjects that also increased physical activity (110514). Additional preliminary clinical research in adults with overweight shows that adding 18 grams of inulin powder to green tea daily increases weight loss when compared with green tea alone. Over six weeks, individuals taking inulin lost 2 kg, compared with no weight loss in those taking green tea. Weight loss was maintained for at least 2 weeks (93726). Clinical trials in children show conflicting results. In children aged 7-12 years, a small clinical study shows that taking a specific oligofructose-enriched inulin product (Orafti Synergy1, BENEO GmbH) 8 grams orally in water before one meal daily for 16 weeks decreases weight gain by 2.4-fold and attenuates an increase in BMI when compared with placebo (96847). However, other preliminary clinical research in children with obesity aged 7-15 years shows that taking inulin extract 13 grams orally daily for 6 months does not reduce body weight or BMI when compared with placebo (110598). However, other clinical research shows that taking inulin orally in combination with other ingredients might not improve weight loss. Combining inulin, chromium picolinate, capsicum, L-phenylalanine, and other nutrients with caloric reduction and exercise doesn't seem to reduce weight in moderately obese patients when compared to caloric reduction and exercise alone (7607). Another preliminary clinical trial shows that taking inulin 10 grams with maltodextrin 10 grams daily for 12 weeks does not reduce body weight or improve body composition when compared with placebo in adults with overweight or obesity following a calorie-restricted diet (103202). Preliminary clinical research in adults with obesity also shows that consuming a seafood-based dietary product fortified with inulin 1.7 grams, fish oil 370 mg (containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and bifidobacterium animalis daily for 12 weeks does not lower body weight, waist circumference, abdominal fat, serum cholesterol levels, or blood pressure when compared with placebo. However, consuming the product modestly improved some markers of insulin resistance (110600).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alcohol use disorder. It is unclear if oral inulin is beneficial in patients with alcohol use disorder. Details: Preliminary clinical research in adults with alcohol use disorder who were recently admitted to the hospital shows that taking a specific inulin product (Fibruline, Cosucra) 4-16 grams orally daily for 17 days does not improve liver function tests when compared with placebo. Some liver function tests were also worse in those treated with inulin (110601).
• Antibiotic-associated diarrhea. Oral inulin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children aged 6 months to 14 years receiving antibiotics for common infections shows that taking a combination of inulin and fructo-oligosaccharides, up to 5 grams daily depending on age, does not reduce the rate of antibiotic-associated diarrhea (93720).
• Celiac disease. Small clinical studies suggest that patients with celiac disease who take oral inulin may have a lower risk of vitamin and mineral deficiency. Details: Preliminary clinical research in a small number of children and adolescents with vitamin and mineral malabsorption due to celiac disease shows that taking a specific oligofructose-enriched inulin product (Orafti Synergy 1, BENEO GmbH) 10 grams daily for 3 months improves the absorption of vitamin D, vitamin E, and iron, but not vitamin A (99841,99842). Levels of 25-hydroxy vitamin D and vitamin E increased by 42% and 19%, respectively, compared with no significant improvements in those taking placebo (99842). Although taking inulin did not improve serum ferritin levels, it did decrease serum hepcidin concentrations by 61% when compared with baseline, while no significant improvement was reported with placebo. Hepcidin is a regulator of iron homeostasis, and increased levels are associated with iron-deficiency anemia (99841).
• Child growth. Oral inulin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in healthy, exclusively formula-fed, infants less than 4 months of age shows that supplementing formula with 0.8 grams/dL of a specific combination product (Orafti Synergy1, Beneo-Orafti) containing 50% inulin and 50% fructo-oligosaccharide until 12 months of age does not improve markers of child growth, including body weight, length, and head circumference, when compared with placebo. The combination product was associated with a reduced duration of fever during infectious episodes, but not with a reduction in the number of infections. It is unclear if any potential effects are due to inulin, fructo-oligosaccharide, or the combination (107937).
• Chronic kidney disease (CKD). It is unclear if oral inulin is beneficial in patients with CKD. Details: In adults with CKD, adding inulin 19 grams daily for 6 months to a low-protein diet reduces serum insulin, fasting plasma glucose, total serum cholesterol, triglycerides, and markers of systemic inflammation, while increasing serum high density lipoprotein (HDL) cholesterol, when compared with baseline (105534). However, it is unclear if similar changes occur with a low-protein diet alone, or if the rate of progression of CKD is reduced. Population research in adults has found that high dietary intake of inulin over 8 years of follow up is not associated with a lower risk of CKD when compared with low dietary intake (110515).
• Hypercholesterolemia. It is unclear if oral inulin reduces cholesterol levels in patients with hypercholesterolemia. Details: Research in patients with hypercholesterolemia has shown mixed results, with some studies showing a small decrease and others showing no improvement in serum cholesterol levels (7604,8450,10412,10413,96849). A typical dose of inulin used is 6 grams orally three times daily for up to 6 weeks (10412). A meta-analysis of healthy, dyslipidemic, overweight or diabetic patients shows that inulin reduces levels of low-density lipoprotein (LDL) cholesterol by approximately 5% (96849). Another meta-analysis of randomized clinical trials in the same population shows that taking inulin 1.5-30 grams daily for 2-12 weeks reduces LDL cholesterol levels by 7 mg/dL and increases high-density lipoprotein cholesterol levels by 2 mg/mL when compared with control. However, this meta-analysis also included data from patients treated with fructo-oligosaccharides instead of inulin (107940).
• Hypertension. It is unclear if oral inulin is beneficial in patients with hypertension. Details: Population research in adults has found that high dietary intake of inulin over 8 years of follow up is associated with a 21% lower risk of hypertension when compared with low dietary intake (110515).
• Hypertriglyceridemia. It is unclear if oral inulin is beneficial in patients with hypertriglyceridemia. Details: A meta-analysis of clinical trials in normal and moderately hyperlipidemic patients suggests that taking inulin-type fructans at an approximate average dose of 14 grams daily reduces triglyceride levels by about 15 mg/dL when compared with control (93737). However, other research, including a meta-analysis of healthy, dyslipidemic, overweight or diabetic patients shows that taking inulin 1.5-30 grams daily for 2-12 weeks does not reduce triglyceride levels when compared with control. However, these negative studies are limited by small sample sizes and inclusion of data from patients treated with fructo-oligosaccharides instead of inulin (7604,107940).
• Impaired glucose tolerance (prediabetes). Several small clinical studies suggest that oral inulin is not beneficial in patients with prediabetes. Details: Preliminary clinical research in adults with prediabetes shows that taking inulin 15 grams orally daily for 24 weeks does not improve fasting blood glucose, glycated hemoglobin (HbA1c), or lipid levels when compared with placebo. However, taking inulin modestly improved markers of insulin resistance (107938). Two other, small, clinical trials show that taking specific inulin products (Orafti Synergy 1, BENEO GmbH or Frutafit IQ, Sensus American) 10-30 grams daily for 6 weeks does not improve blood glucose, insulin resistance, glucose homeostasis, or insulin sensitivity when compared with placebo (93721,107936). However, these studies may have been inadequately powered to detect a difference between groups.
• Iron deficiency anemia. Oral inulin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in young adult females with iron deficiency anemia shows that taking inulin 963 mg/kg and iron supplementation orally daily for 3 months modestly improves serum hemoglobin, hematocrit, and iron levels when compared with a control group consuming iron-fortified flour (110599).
• Menopausal symptoms. It is unclear if oral inulin is beneficial in patients with hypertriglyceridemia. Details: Preliminary clinical research in adults experiencing menopause shows that consuming yogurt enriched with a specific inulin (Frutafit TEX, Sensus Company) 1.5% daily for 6 weeks moderately improves menopausal symptom scores, including depression, anxiety, and vasomotor symptoms, when compared with yogurt alone (107659).
• Nonalcoholic fatty liver disease (NAFLD). Taking oral inulin alone does not seem to improve liver transaminase levels in patients with NAFLD. Details: Preliminary clinical research in patients with NAFLD shows that taking metronidazole 400 mg twice daily for one week plus inulin 4 grams twice daily for 12 weeks reduces levels of alanine aminotransferase and aspartate aminotransferase when compared with placebo. However, when inulin is taken without metronidazole, these measures are not improved (103200).
• Polycystic ovary syndrome (PCOS). It is unclear if oral inulin is beneficial in patients with PCOS. Details: Preliminary clinical research in overweight or obese females with PCOS shows that taking specific products containing inulin (FrutaFit TEX, Sensus American) or inulin and fructo-oligosaccharides (FrutaFit IQ, Sensus American) 10 grams orally once daily for 12 weeks does not reduce systolic or diastolic blood pressure when compared with placebo. However, the validity of this study is limited by the inclusion of subjects with and without hypertension at baseline (107941). More evidence is needed to rate inulin for these uses.

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POSSIBLY EFFECTIVE

• Hypercholesterolemia. Most clinical research shows that oral pectin at a dose of 15 grams daily can slightly lower total cholesterol and low-density lipoprotein (LDL) cholesterol levels in patients with hypercholesterolemia. Details: While some small studies in patients with or without hypercholesterolemia suggest that pectin 1-12 grams daily for up to 12 weeks does not reduce lipid levels (2215,2217), other research in patients with hypercholesterolemia shows that taking pectin 15 grams daily for 4 weeks consistently reduces total cholesterol and LDL cholesterol by around 7% to 10% when compared with baseline or placebo (2214,2216,92473). Some forms of pectin might lower cholesterol levels better than others. Pectin with a higher molecular weight and higher degree of esterification appears to be the most effective (92473). A larger clinical study also shows that taking 20 grams of pectin and guar gum, along with small amounts of insoluble fiber, reduces total cholesterol by nearly 8% and LDL cholesterol by nearly 11%, but does not improve high-density lipoprotein (HDL) cholesterol or triglycerides, when compared with placebo (12547).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Colorectal cancer. Although there has been interest in using oral pectin for the prevention of colorectal cancer, there is insufficient reliable information about the clinical effects of pectin for this purpose.
• Diarrhea. It is unclear if oral pectin is beneficial in children with persistent diarrhea. Details: A small clinical study in children aged 5-12 months in developing nations with persistent diarrhea shows that taking pectin 4 grams/kg reduces the duration of diarrhea and vomiting, and reduces the need for oral rehydration solution and intravenous fluid, when compared with a rice-diet control (12575). Pectin has also been evaluated in combination with other ingredients. One clinical study in children aged 6 months to 6 years with acute diarrhea shows that taking a combination of apple pectin and chamomile (Diarrhoesan, Dr. Loges + Co. GmbH) for up to 5 days reduces the frequency of stools by day 3 by about 1.36-fold when compared with placebo, with improvements maintained through day 5. This combination product was given hourly up to a maximum dose of 50 mL in children 6-12 months of age, 60 mL in children 1-3 years of age, and 80 mL in children 4-6 years of age (19705). It is unclear if these findings are due to pectin, chamomile, or the combination.
• Gastroesophageal reflux disease (GERD). It is unclear if oral pectin is beneficial in children with GERD. Details: A small clinical study in children with GERD and cerebral palsy shows that adding pectin to enteral nutrition in a 1:2 ratio for 4 weeks might reduce some symptoms of GERD. The number of vomiting episodes per week was reduced by 60% and the frequency of coughing/wheezing was reduced by 76% for children given the pectin diet when compared with those given a non-pectin diet (92476).
• Impaired glucose tolerance (Prediabetes). It is unclear if oral pectin is beneficial in patients with impaired glucose tolerance. Details: A small clinical study in middle-aged patients with impaired glucose tolerance or impaired fasting glucose shows that drinking 400 mL of a beverage containing 40 grams/L of sugar beet pectin in two divided doses daily for 12 weeks does not improve fasting or postprandial plasma glucose concentrations or serum lipid levels when compared to baseline (34118).
• Irritable bowel syndrome (IBS). Although there has been interest in using oral pectin for IBS, there is insufficient reliable information about the clinical effects of pectin for this purpose.
• Mercury toxicity. It is unclear if oral pectin is beneficial in patients with mercury toxicity. Details: A small clinical study in children with mercury poisoning shows that taking pectin 2.5 grams daily for 21 days and then 5 grams daily for 39 days increases mercury excretion in the urine, decreases the duration of mercury toxicity, and improves psychological symptoms when compared to baseline (31657). The validity of these findings is limited by the lack of a comparator group.
• Niacin-induced flushing. It is unclear if oral pectin is beneficial for the prevention or management of niacin-induced flushing. Details: A small clinical study shows that taking apple pectin 2 grams 30 minutes prior to taking niacin extended-release 1000 mg reduces the duration of flushing by about 35 minutes when compared with placebo. However, apple pectin does not reduce the incidence of flushing, the time to flush, or the maximum severity of flushing (92477).
• Peptic ulcers. It is unclear if oral pectin is beneficial for the prevention of peptic ulcers. Details: A small clinical study in patients with recently healed duodenal ulcers shows that taking apple pectin 10 grams twice daily for 6 months does not reduce the recurrence of duodenal ulcers when compared with placebo (31697).
• Prostate cancer. It is unclear if oral pectin is beneficial in patients with prostate cancer. Details: Two small clinical studies in patients with prostate cancer show that taking a specific modified citrus pectin product (Pectasol, Econugenics) 4.8 grams three times daily following prostatectomy, radiation, or cryosurgery for up to one year slows disease progression and increases the time to prostate specific antigen (PSA) doubling when compared to baseline (15020,108525). The validity of these findings is limited by the lack of a comparator group.
• Radiation exposure. Although there has been interest in using oral pectin to minimize exposure to environmental radiation, there is insufficient reliable information about the clinical effects of pectin for this purpose. More evidence is needed to rate pectin for these uses.

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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).

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Inulin has Generally Recognized As Safe status (GRAS) in the US (93728).

POSSIBLY SAFE ...when used orally and appropriately in supplemental doses, short-term. Doses of 8-18 grams daily have been used safely for up to 24 weeks (7604,7605,7606,7607,8451,93716,93719,93726,103200,107936,107935,107938). Also, 20 grams daily has been used with apparent safety for up to 3 weeks (96836,96850). There is insufficient reliable information available about the safety of inulin when used long-term.

CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods. Inulin has Generally Recognized As Safe status (GRAS) in the US (93728).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in supplemental doses, short-term. Clinical studies have used doses of 3-6 grams daily for 10 days in children 3-6 years of age and 5-13 grams daily for up to 6 months in children 7-15 years of age with apparent safety (96847,110598,110602). ...when used in infant formula. A formula containing chicory fructans (Orafti Synergy1, BENEO GmbH), approximately 50% of which were inulin, has been used with apparent safety in infants for 8-12 months (93717,107937).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (93728). There is insufficient reliable information available about using inulin in medicinal amounts during pregnancy or lactation; avoid use.

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

POSSIBLY SAFE ...when used orally in amounts greater than those typically found in food. Pectin 4.8 grams three times daily has been used for up to one year without serious adverse effects (12547,15019,15020,92481,108525).

CHILDREN: POSSIBLY SAFE
when used orally in amounts greater than those found in food, short-term. Pectin 4 grams/kg has been used daily for up to 7 days without reports of serious adverse effects (12575,19705).

PREGNANCY AND LACTATION: LIKELY SAFE
when used in amounts commonly found in foods. Pectin has Generally Recognized as Safe (GRAS) status in the US (4912).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally in medicinal amounts (12577).

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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).

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ANTIDIABETES DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, inulin might increase the risk of hypoglycemia with antidiabetes drugs.  Details Some clinical research shows that inulin improves glycemic control in patients with diabetes; however, it is unclear if it has hypoglycemic effects (93719,99843,103198).

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DIGOXIN (Lanoxin) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, pectin might reduce the absorption of digoxin, potentially decreasing its effectiveness.  Details A small clinical study shows that taking digoxin with a kaolin-pectin suspension reduces the absorption of digoxin by about 62% (2212). It is unclear if these effects are due to pectin, kaolin, or the combination.

LOVASTATIN (Mevacor) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, pectin might reduce the absorption of lovastatin, potentially decreasing its effectiveness.  Details Case reports suggest that concomitant use of pectin and lovastatin might reduce the cholesterol-lowering effect of lovastatin, possibly due to reduced intestinal absorption of lovastatin (615).

TETRACYCLINE ANTIBIOTICS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, pectin might reduce the absorption of tetracycline antibiotics, potentially decreasing their effectiveness.  Details A small clinical study shows that taking tetracycline with bismuth subsalicylate in a kaolin-pectin suspension reduces the absorption of tetracycline by about 34% (2213). It is unclear if these effects are due to pectin, kaolin, bismuth subsalicylate, or the combination.

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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).

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General ...Orally, inulin is well tolerated.
Most Common Adverse Effects:
Orally: Bloating, constipation, diarrhea, flatulence, and gastrointestinal cramps.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis has occurred following consumption of foods high in inulin.

Gastrointestinal ...Orally, inulin may cause flatulence, bloating, diarrhea, constipation, and gastrointestinal cramps, especially at doses over 30 grams (7604,8450,8509,93716,93721,93724,96836,96850,96851,99843)(107936,107940,107941,110602).

Immunologic ...Severe allergic reactions to inulin-containing foods have been reported. There is one report of anaphylaxis following consumption of foods with a high concentration of inulin including salsify, artichoke leaves, and margarine (7608).

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General ...Orally, pectin seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, gas, loose stools, and mild cramps.
Serious Adverse Effects (Rare):
All routes of administration: Allergic reactions, including anaphylaxis, in sensitive individuals.

Gastrointestinal ...Orally, pectin alone or in combination with guar gum and insoluble fiber can cause gastrointestinal adverse effects such as mild cramps, diarrhea, gas, and loose stools (12547,15020,92473).

Immunologic ...Orally and topically, pectin may cause allergic reactions in sensitive individuals. In one case, a 7-year-old boy with a history of oral allergy syndrome after consuming a pectin-containing beverage experienced anaphylaxis after taking a citrus bath containing pectin. Allergy testing confirmed sensitivity to pectin (106928).

Pulmonary/Respiratory ...The occupational inhalation of pectin dust can cause asthma (580,581,582,583,584).

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