Fiber Formula by CVS Health

POSSIBLY EFFECTIVE

• Constipation. Oral guar gum may improve symptoms and stool frequency in adults and children with constipation. Details: Several small clinical studies in adults show that taking partially hydrolyzed guar gum increases stool frequency and relieves straining and pain when compared to baseline. Studied doses include 4-12 grams daily for up to 8 weeks or 11 grams twice daily for up to 3 weeks (12548,25073,93619). Small clinical studies in children with constipation also show that taking guar gum 3-5 grams daily for 4 weeks or partially hydrolyzed guar gum 6 grams daily for 2-15 months moderately increases bowel movement frequency and decreases abdominal pain when compared to baseline (93605,101889). While these improvements appear to be similar to those reported in children treated with lactulose (93605), a direct comparison is lacking.
• Diarrhea. Oral guar gum may reduce the duration of diarrhea in adults and children. Details: Two small clinical studies in patients in the intensive care unit show that adding guar gum 2% or 22 grams/L to enteral feeding formula reduces the number of liquid stools and decreases the percentage of days with diarrhea by around 70% when compared with control enteral formula (10325,54239). A larger clinical trial in children with acute watery diarrhea due to infections also shows that taking guar gum reduces the duration of diarrhea by around 16 hours when compared with a control (54210). Another clinical study in children with persistent watery diarrhea also shows that adding guar gum 20 grams/L daily for 7 days to a comminuted chicken diet improves the odds of diarrhea resolution after 7 days by 3-fold when compared with the chicken diet alone (54243).
• Hypercholesterolemia. Oral guar gum, taken alone or with other dietary fibers, may reduce cholesterol levels in patients with hypercholesterolemia. Details: Several small clinical trials in patients with hypercholesterolemia show that taking guar gum 15-18 grams in single or divided doses daily for up to 24 months lowers cholesterol levels when compared with baseline levels or placebo (4971,10897,54314,54318,54333). Additionally, a meta-analysis of 25 small clinical studies in patients with hypercholesterolemia, diabetes, hypertension, or metabolic syndrome shows that guar gum reduces total cholesterol by around 20 mg/dL and low-density lipoprotein (LDL) cholesterol by around 17 mg/dL, but does not reduce triglyceride levels, when compared with controls. Subgroup analyses suggest that improvements in total and LDL cholesterol are greater in patients with hypercholesterolemia and in those taking at least 15 grams of guar gum daily (107930). Additional clinical evidence shows that taking guar gum along with other dietary fibers can reduce cholesterol levels. Taking 20 grams of a mixture containing guar gum, pectin, and a small amount of the insoluble fibers from soy, pea, and corn bran daily for 36 weeks lowers total and LDL cholesterol, but does not affect high-density lipoprotein (HDL) cholesterol or triglyceride levels (12547,54335). Also, taking a specific product containing guar gum and psyllium (Minolest) 16.5 grams daily for 3 months reduces total and LDL cholesterol when compared with placebo, but does not affect triglyceride levels (54206). Taking 15 grams of a combination of guar gum, psyllium, pectin, and carob gum daily for 6 months also appears to reduce total and LDL cholesterol when compared to baseline (8431).
• Hypertension. Oral guar gum may modestly reduce systolic and diastolic blood pressure, although these reductions may not be considered clinically significant. Details: Several small clinical trials in patients with hypertension show that taking guar gum 7-10 grams with each meal daily for up to 6 weeks modestly reduces systolic and diastolic blood pressure when compared with placebo (54232,54304,54320). However, guar gum does not appear to be as effective for reducing blood pressure as psyllium husk (54260). A meta-analysis of clinical trials in adults also shows that taking guar gum 1-30 grams daily for 6 weeks to 6 months reduces systolic and diastolic blood pressure by approximately 1 mmHg when compared with placebo or no intervention. However, many patients included in these trials did not have hypertension at baseline. Sub-analyses suggest that the effects of guar gum on blood pressure may be larger in patients with hypertension. The validity of this meta-analysis is limited by high heterogeneity (105507).
• Irritable bowel syndrome (IBS). Oral guar gum may improve bowel function and abdominal pain in adults and children with IBS. Details: Clinical trials in adults with IBS show that taking guar gum 5-10 grams daily for 12 weeks improves abdominal pain, bowel function, and quality of life when compared with baseline or wheat bran (10326,54245). A small clinical study in children 8-16 years of age with chronic abdominal pain and IBS shows that taking partially hydrolyzed guar gum 5 grams daily for 4 weeks decreases symptom frequency and normalizes bowel movements when compared with placebo. However, it does not improve abdominal pain (93615). Another small clinical trial in children 1-18 years of age with IBS shows that taking a specific guar gum product (Resource Optifibre, Nestle HealthCare Nutrition) for at least 6-8 weeks improves stool consistency and abdominal pain when compared to baseline (93621).

POSSIBLY INEFFECTIVE

• Obesity. Oral guar gum may not improve body weight in patients with obesity. Details: Several small clinical trials in overweight or obese adults show that taking guar gum 10.5-20 grams in divided doses daily for up to 14 months does not reduce body weight or improve satiety when compared with placebo or other controls (54212,54260,54353,54360). Additionally, a meta-analysis of 11 small clinical studies of various patient populations, including postmenopausal adults and those with hyperlipidemia or diabetes, shows that taking guar gum 7.5-21 grams daily for 3 weeks to 6 months does not reduce body weight when compared with placebo (8305).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anal fissures. It is unclear if oral guar gum is beneficial in patients with anal fissures. Details: A small clinical study in patients with chronic anal fissures treated with topical application of glyceryl trinitrate shows that taking partially hydrolyzed guar gum 5 grams daily as maintenance therapy for a total of 10 months increases success rate by 53% and decreases the risk for recurrence of anal fissures by 52% when compared with control (93617).
• Autism spectrum disorder. It is unclear if oral guar gum is beneficial in children with autism spectrum disorder. Details: A very small clinical study in children 4-9 years of age with autism and constipation shows that taking partially hydrolyzed guar gum (Sunfiber, Taiyo Kagaku Co. Ltd.) 6 grams daily for 2-15 months moderately improves irritability, but not other measures of behavior, when compared to baseline (101889). The validity of this finding is limited by the lack of a comparator group.
• Chemotherapy-induced diarrhea. It is unclear if oral guar gum is beneficial for the prevention or treatment of chemotherapy-induced diarrhea. Details: A clinical study in patients receiving 5-fluorouracil chemotherapy for colorectal cancer shows that adding guar gum (Novasource GI control, Novartis Nutrition) 11 grams daily on cycle days 7-14 for 24 weeks to treatment with Lacticaseibacillus rhamnosus GG does not reduce the rate of severe diarrhea or other abdominal complaints when compared with no treatment or L. rhamnosus GG alone (16736).
• Cholera. It is unclear if oral guar gum is beneficial for improving diarrhea in patients with cholera. Details: A small clinical study in adults with cholera treated with doxycycline shows that adding guar gum 25-50 grams to oral rehydration solution for 2 days does not reduce the duration of diarrhea, but might reduce stool weight over the first 24 hours, when compared with oral rehydration solution alone (54262).
• Cholestasis. Small clinical studies suggest that oral guar gum may not improve symptoms of cholestasis during pregnancy. Details: Two small clinical studies in patients with cholestasis during pregnancy show that taking a specific granulated guar gum product (Guarem, Orion Pharmaceutical) 5-15 grams daily until delivery does not reduce the intensity of pruritus or improve liver function when compared with placebo (54209,54356).
• Diabetes. Small clinical studies suggest that oral guar gum might improve postprandial glucose levels in patients with type 1 diabetes; whether guar gum is effective for improving glycemic control in patients with type 2 diabetes is unclear. Details: Two small clinical studies in patients with type 1 diabetes show that taking guar gum 5 grams with meals four times daily for 4-6 weeks lowers postprandial glucose levels when compared with placebo (10896,12545). However, clinical trials in patients with type 2 diabetes show conflicting results. Several very small clinical studies suggest that taking guar gum 5-7.6 grams with each meal daily for up to 48 weeks lowers blood glucose when compared with baseline levels or placebo in patients with type 2 diabetes (12540,12541,12542,12543,12544). However, other small clinical trials in these patients show that taking guar gum 5-7 grams with each meal for up to 3 months does not improve glycemic control (54270,54275,54320,54326). The reasons for these discrepant findings are unclear; however, all of the studies in patients with type 2 diabetes were very small and likely underpowered to identify significant treatment effects. In addition to glycemic control, the effect of guar gum on serum lipids in patients with diabetes has also been evaluated. A meta-analysis of 11 small clinical studies in patients with type 2 diabetes with or without hypercholesterolemia shows that taking guar gum 5-30 grams daily for up to 6 months reduces total cholesterol by around 20 mg/dL and low-density lipoprotein (LDL) cholesterol by around 15 mg/dL. Doses of guar gum 20 grams daily or greater also appear to reduce triglyceride levels by around 13 mg/dL, while lower doses have no effect (107929).
• Influenza. It is unclear if oral guar gum is beneficial for the prevention of influenza. Details: Observational research in hospitalized patients has found that taking partially hydrolyzed guar gum 5.2 grams daily for the duration of a hospital stay is associated with a lower risk of influenza when compared with those not taking guar gum. One additional case of influenza appears to be prevented for every 14 patients taking guar gum over placebo (107928).
• Malnourishment-related diarrhea. It is unclear if oral guar gum is beneficial in children with malnourishment-related diarrhea. Details: A small clinical study in children aged 6-36 months with acute watery diarrhea related to malnutrition shows that adding guar gum 15 grams/L to oral rehydration solution reduces the duration of diarrhea by around 18 hours when compared with oral rehydration solution alone (93616).
• Postprandial hypotension. Small clinical studies suggest that oral guar gum may be beneficial for the prevention of postprandial hypotension in older females and patients with type 2 diabetes. Details: A small clinical study in older females with postprandial hypotension shows that taking guar gum 9 grams along with a meal decreases the risk of postprandial hypotension by 75% when compared with placebo (93618). Another small clinical study in patients with type 2 diabetes shows that taking guar gum 9 grams prior to a meal reduces the risk of postprandial decreases in blood pressure when compared to baseline (12540).
• Small intestinal bacterial overgrowth (SIBO). It is unclear if oral guar gum is beneficial in patients with SIBO. Details: A small clinical study in patients with SIBO shows that taking guar gum 5 grams daily along with rifaximin 1200 mg daily for 10 days increases the chance for eradication of SIBO by 37% to 40% when compared with rifaximin alone. However, overall clinical improvement appears to be similar for guar gum plus rifaximin and rifaximin alone (93622). More evidence is needed to rate guar gum for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

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

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LIKELY EFFECTIVE

• Coronary heart disease (CHD). A diet high in soluble fiber, such as that found in oats, reduces the risk of CHD. Details: Clinical research shows that a diet containing foods high in fiber, such as oats, oat bran, or whole oat flour, reduces the risk of CHD (2737,4960,4962,4963,4964,4965,4966,4967,4968). In 1993, the US Food and Drug Administration (FDA) approved a health claim stating that consuming at least 3 grams of soluble fiber per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD (102336). However, clinical studies show that at least 3.6 grams of soluble fiber daily is needed to reduce the risk of CHD (5786,5787,5788,5794,5795,5796).
• Dyslipidemia. A diet rich in soluble fiber, such as that found in oats, can reduce cholesterol by a moderate amount. Details: Oats, oat bran, and other soluble fibers can modestly reduce total and low-density lipoprotein (LDL) cholesterol, especially when consumed as part of a diet low in saturated fat. Consuming 56-150 grams of whole oat products such as oatmeal and oat bran, containing 3.6-10 grams of soluble fiber daily, can significantly lower total and LDL cholesterol levels. For each gram of soluble fiber consumed, total cholesterol decreases by about 1.4 mg/dL and LDL by about 1.2 mg/dL. Eating 3-10 grams of soluble fiber daily can reduce total cholesterol by about 4-14 mg/dL (4976,4977,5786,5788,5792,5794,5795,8521,107749,113488,113495). For example, eating 3 bowls of oatmeal (28 gram servings) daily, providing a total of 3 grams of soluble fiber daily, can decrease total cholesterol by about 5 mg/dL (5788). However, consuming more than 10 grams of soluble fiber daily doesn't seem to increase effectiveness (5788). A meta-analysis comparing the effects of oats and isolated beta-glucans shows that both products similarly impact lipid profiles, suggesting that the bioactive component of oats are beta-glucans (113488). Oat bran products, such as oat bran muffins and oat bran flakes, may vary in their ability to lower cholesterol, depending on the total soluble fiber content and other dietary variables (6188). Whole oat products might be more effective for lowering LDL and total cholesterol than foods containing oat bran plus soluble fiber (10145). Although oats are shown to lower total and LDL cholesterol, a meta-analysis and a small clinical study in adults with and without dyslipidemia shows that consuming oatmeal or oat products does not reduce triglycerides or increase high-density lipoprotein (HDL) cholesterol when compared with controls (113488,113495).

POSSIBLY EFFECTIVE

• Diabetes. A diet rich in whole grains, such as oats, may help prevent diabetes or improve blood glucose control in patients with type 1, type 2, or gestational diabetes. Details: Population research shows that for every 16 gram daily serving of whole grains, including oats, there is a 7% to 11% lower risk of developing type 2 diabetes (100622). There is also evidence that consuming oats can decrease blood glucose and insulin levels, as well as lipid levels, in patients with diabetes. The glycemic effects of oats depend on the level of processing of the oat products. Consuming intact oat kernels or thick-cut oats (>0.6 mm) reduces postprandial blood glucose and insulin, but consuming thin-cut, or "quick", oats has no effect (105536). Clinical research shows that consuming oats and oat bran for 4-8 weeks decreases pre-prandial blood glucose, 24-hour plasma glucose, glycated hemoglobin (HbA1c), insulin levels, and low-density lipoprotein (LDL) cholesterol in people with type 2 diabetes (4980,4982,6266,103345). Various doses have been used, including 3 grams of soluble fiber daily, or bread providing 34 grams of total fiber daily (9 grams of soluble fiber) (4961,4980). Additional clinical research in obese adults with type 2 diabetes shows that eating whole grain oats 50-100 grams daily in place of other carbohydrates reduces postprandial blood glucose by 19-27 mg/dL when compared with other carbohydrates in a healthy diet. After 1 year, the groups consuming 50 grams and 100 grams of oats had an additional 0.48% and 0.64% reduction in HbA1c, respectively, when compared with the regular healthy diet group (97520). There is also some evidence that consuming oats 50 grams daily, containing 25 grams of soluble fiber, might be more effective for improving glycemic control and decreasing hyperinsulinemia than the standard moderate fiber diet recommended by the American Diabetes Association (ADA) (6266). Oats have also been evaluated in adolescents with type 1 diabetes. One very small clinical study shows that taking 50 grams of a specific oat product (Betaglucare), providing beta-glucans 6 grams, in three divided doses daily for one week is beneficial for glycemic control and variability when compared with a standard diet without beta-glucans or with taking only 25 grams of the product daily. Maximal, mean, and pre- and post-meal blood glucose levels were modestly lower, and minimal blood glucose levels were modestly higher. Most measures of glycemic variability were statistically different, although there were no differences in the duration of hypoglycemia or hyperglycemia between groups (105261). Oats have also been evaluated in patients with gestational diabetes. A randomized, controlled trial shows that taking 30 grams of a specific oat bran product (OAB; Golden Light Cup Company) orally twice daily at lunch and dinner for 4 weeks improves mean fasting blood glucose and two-hour postprandial glucose when compared with a control group. After 4 weeks, the mean fasting blood glucose and 2-hour postprandial glucose in the treatment group were 85 mg/dL and 104 mg/dL, respectively, compared with 93 mg/dL and 117 mg/dL, respectively, in the control group (107751). The validity of this study is limited by the short treatment duration and lack of follow-up.
• Gastric cancer. A diet rich in soluble fiber, such as that found in oats, might reduce the risk of gastric cancer. Details: Observational research has found that consuming a diet that includes cereal fiber, such as oats and oat bran, might reduce the incidence of gastric cancer (10435).

POSSIBLY INEFFECTIVE

• Colorectal cancer. Regular consumption of oats does not seem to reduce the risk of colorectal cancer. Details: Observational research has found that consuming oat bran or oats orally doesn't seem to reduce the risk of colon cancer. Additionally, consuming fiber, including oat-bran fiber, is not associated with a reduction in the risk for recurrence of colorectal adenomas (4820,5104).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical oats for acne, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Anxiety. Although there is interest in using oral oats for anxiety, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Atopic dermatitis (eczema). Topical colloidal oatmeal cream may be beneficial in patients with atopic dermatitis. Details: Preliminary clinical research shows that applying a cream containing colloidal oatmeal 1% daily for 2 weeks moderately reduces the severity of atopic dermatitis when compared with baseline (103344). The validity of this finding is limited by the lack of a comparator group. Other research suggests that colloidal oatmeal may be beneficial when used in combination with topical steroids. Clinical research shows that the benefits obtained from applying an ointment containing fluocinolone 0.025% to the hands for 2 weeks were better maintained in the patients who also used a cream containing colloidal oatmeal 1% during this time period and for an additional 4 weeks when compared with patients using fluocinolone and the cream base without colloidal oatmeal. Quality of life was also improved in the patients using colloidal oatmeal (103340).
• Breast cancer. Observational research suggests that regular oatmeal intake may be associated with reduced mortality from breast cancer. Details: Population research in postmenopausal patients has found that those who have eaten 50 grams of oatmeal daily prior to a breast cancer diagnosis have a 20% reduced risk of all-cause mortality in the 7 years following the diagnosis when compared with patients who have not eaten oatmeal. However, no benefit was seen when post-diagnostic oatmeal intakes were examined (103343).
• Burns. Although there is interest in using topical oats for burns, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Chronic fatigue syndrome (CFS). Although there is interest in using oral oats for CFS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Cognitive function. It is unclear if oral oats are beneficial in healthy adults with mild memory impairment. Details: Preliminary clinical research in healthy middle-aged adults with self-reported memory decline shows that consuming a specific wild green-oats extract (Neuravena, Frutarom) 800 mg as a single dose improves overall speed, but not overall accuracy, of cognitive performance when compared with placebo. However, a higher dose of 1600 mg was ineffective (97519).
• Dry skin. It is unclear if applying lotion containing colloidal oat extract improves dry skin to a greater extent than other lotion products. Details: Preliminary clinical research shows that applying a lotion containing colloidal oat extract (Aveeno Active Naturals Skin Relief 24Hr Moisturizing Lotion, Johnson & Johnson) twice daily for 2 weeks improves itchiness, cracking, scaling, dryness, and roughness when compared to baseline in females with dry skin (91458). Additional preliminary clinical research shows that applying a colloidal oatmeal lotion to the legs twice daily for three weeks reduces skin dryness and improves skin integrity when compared to baseline in adults with dry skin (97518). The validity of these findings is limited by the lack of a comparator group.
• Exercise-induced muscle soreness. It is unclear if oral oats are beneficial for exercise-induced muscle soreness. Details: A small clinical trial shows that eating two cookies containing oat flour 60 grams daily for 8 weeks reduces muscle soreness 48 or 72 hours after downhill running when compared with baseline (103341).
• Fat redistribution syndrome. It is unclear if oral oats are beneficial for fat redistribution syndrome. Details: Consumption of a high fiber diet, including oats, with adequate energy and protein might prevent fat deposition in patients with HIV. A one-gram increase in total dietary fiber may decrease the risk of fat deposition by 7% (12517).
• Gallbladder disease. Although there is interest in using oral oats for gallbladder disease, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Hypertension. It is unclear if oral oats are beneficial for hypertension. Details: A meta-analysis of 21 clinical studies in healthy adults and those with a variety of metabolic conditions including hypertension shows that consumption of oat products reduces systolic blood pressure (SBP) by 3 mmHg but has no effect on diastolic blood pressure (DBP) when compared with control. Subgroup analysis suggests that consuming oat products reduces SBP by 10 mmHg in patients with hypertension at baseline. An additional subgroup analysis suggests that consuming at least 5 grams of beta-glucan-enriched oats daily or consuming oats for a duration at least 8 weeks reduces SBP and DBP (113494). Observational research has found that consumption of oats as oatmeal or oat cereal does not seem to reduce DBPor SBP in males with minor elevations in blood pressure or patients with dyslipidemia (2956,113495). A randomized, controlled trial in patients with stage 1 hypertension receiving dietary guidance shows that taking 30 grams of oat bran, providing 8.9 grams of dietary fiber, once daily with breakfast or in between meals for 3 months improves various blood pressure measures when compared with dietary guidance alone. After 3 months of treatment, 24-hour maximum SBP and DBP decreased by 14 mmHg and 11 mmHg, respectively, and office SBP and DBP decreased by 15 mmHg and 10 mmHg, respectively. Oat consumption may also have impacted antihypertensive medication use. Two patients in the control group increased doses of antihypertensive medications, whereas 6 patients in the treatment group decreased doses and 1 patient discontinued use (107750). The effect of oral oat bran on patients with stage 2 hypertension or pre-hypertension is unknown.
• Irritable bowel syndrome (IBS). Although there is interest in using oral oats for IBS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Metabolic syndrome. Limited research suggests that oats may not be beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome shows that adding oat bran 40 grams daily for 6 weeks to a low-calorie diet does not reduce the incidence of metabolic syndrome. Oat bran also does not improve body weight, blood pressure, low-density lipoprotein (LDL) cholesterol, triglycerides, or blood glucose levels when compared with a low-calorie diet alone in patients with metabolic syndrome (103342).
• Osteoarthritis. Although there is interest in using oral oats for osteoarthritis, there is insufficient reliable information about the clinical effects of oats for this condition.
• Pruritus. Applying oat lotion topically may improve some types of pruritus. Details: Preliminary clinical research shows that applying an oat lotion (Espanol) twice daily for up to 2 weeks can decrease itching intensity by about 20% when compared to baseline in patients with pruritus associated with chronic kidney disease (uremic pruritus). This decrease is similar to the effects of applying vinegar 5% solution or taking hydroxyzine 10 mg orally. However, applying the oat lotion does not appear to decrease the frequency of itching (91457).
• Psoriasis. Although there is interest in using topical oats for psoriasis, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Rheumatoid arthritis (RA). Although there is interest in using oral oats for RA, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Stroke. It is unclear if oral oats are beneficial for reducing the risk of stroke. Details: Population research suggests that consuming oatmeal for breakfast once weekly might reduce the incidence of stroke by a small amount when compared with consuming white bread or eggs for breakfast (103337).
• Ulcerative colitis. Oral oats have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking a specific oat-based product (Profermin, Nordisk Rebalance) containing fermented oat flour, Lactobacillus plantarum, barley malt flour, and lecithin, 250 mL orally twice daily for 8 weeks, reduces disease activity and increases remission in about two-fold more patients with relapsing ulcerative colitis, when compared with treatment with a specific nutritional beverage (Fresubin Original, Fresenius Kabi) (90271).
• Wound healing. Although there is interest in using topical oats for wound healing, there is insufficient reliable information about the clinical effects of oats for this purpose. More evidence is needed to rate oats 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.

(Read more about PECTIN)

LIKELY SAFE ...when used orally and appropriately. Guar gum has been safely used in doses up to 15 grams daily for up to two years (10326,10897,12541,12543,12544,12548,54212,54245,54260,54275)(54333,93617,93619,93622,101888). Doses up to 20 grams daily have been safely used for up to 51 weeks (10896,12545,12547,54314). Guar gum has Generally Recognized as Safe (GRAS) status as a food additive in the US (4912).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately. Guar gum has been safely used in doses of 4-5 grams daily for 4 weeks in children 6-16 years of age (93605,93615). Guar gum 3 grams daily for 4 weeks has been safely used in children 4-6 years of age (93605).

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts. Guar gum has been safely used at doses of 5-15 grams daily for up to 4 weeks during pregnancy (54209,54356).

LACTATION:
There is insufficient reliable information available about the safety of using medicinal amounts of guar gum during lactation; avoid using.

(Read more about GUAR GUM)

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

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

PREGNANCY AND LACTATION:
Insufficient reliable information available.

(Read more about MARSHMALLOW)

LIKELY SAFE ...when used orally and appropriately in food amounts (4960,4969,5792,5797). Oat bran has Generally Recognized as Safe (GRAS) status in the US (4912). Whole grain oats 50-100 grams daily have been used for up to 1 year without serious adverse effects (97520).

POSSIBLY SAFE ...when used topically and appropriately (12). Lotion containing colloidal oat 1% has been used topically without adverse effects for up to 6 weeks (97518,103340). There is insufficient reliable information available about the safety of oats when used orally in medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts (5792,5797).

(Read more about OATS)

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).

(Read more about PECTIN)

DIGOXIN (Lanoxin) Interaction Rating = Minor Be watchful with this combination. Severity = Insignificant •  Occurrence = Possible •  Level of Evidence = B Guar gum might slow digoxin absorption, but it does not seem to impact how much digoxin is absorbed overall.  Details Two small studies in healthy volunteers show no change in the overall extent of digoxin absorption, although early absorption was slowed, when taken with guar gum (533,25074).

ETHINYL ESTRADIOL Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, guar gum might reduce the absorption of ethinyl estradiol, potentially decreasing its effectiveness.  Details Animal research shows that taking guar gum with ethinyl estradiol decreases ethinyl estradiol absorption (12421). However, this effect has not been reported in humans.

METFORMIN (Glucophage) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Guar gum might reduce the absorption of metformin, potentially decreasing its effectiveness.  Details A small study in healthy volunteers shows that guar gum reduces the absorption rate of metformin (532,12546).

ORAL DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Guar gum might reduce the absorption of some oral drugs, potentially decreasing their effectiveness.  Details Clinical research shows that guar gum reduces or slows absorption of medications such as penicillin and metformin (532,533). To avoid changes in absorption, take guar gum 30-60 minutes after oral medications.

PENICILLIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Guar gum might reduce the absorption of penicillin, potentially decreasing its effectiveness.  Details A small clinical study in healthy volunteers shows that taking guar gum with penicillin results in decreased penicillin absorption and reduced penicillin levels (533).

(Read more about GUAR GUM)

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

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

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

(Read more about MARSHMALLOW)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, oats may have additive effects with antidiabetic agents and might increase the risk of hypoglycemia.  Details Consuming oats can decrease blood glucose in patients with diabetes (4980,4982,6266,103345). In those who require insulin, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

INSULIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Concomitant use of oats and insulin might increase the risk of hypoglycemia.  Details In patients with insulin-dependent type 2 diabetes, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

(Read more about OATS)

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.

(Read more about PECTIN)

General ...Orally, guar gum is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, bloating, diarrhea, flatulence, heartburn, gas, and loose stools.
Serious Adverse Effects (Rare):
Orally: Severe esophageal and small bowel obstruction when taken with an inadequate amount of fluid.

Gastrointestinal ...Orally, guar gum may cause gastrointestinal adverse effects such as abdominal cramps, abdominal pain, bloating, diarrhea, flatulence, heartburn, gas, and loose stools (10896,10897,12541,12543,12545,12547,12548,54209,54212,54232)(54260,54314,54333,93617,93619). Gastrointestinal side effects can be minimized by starting with small doses and titrating up. In one clinical study, taste aversion to guar gum leading to withdrawal from the study has been reported (16736).
When guar gum is consumed with inadequate amounts of fluids, it can cause severe esophageal and small bowel obstruction. Tell patients to take guar gum with at least 8 ounces (250 mL) of water (602,54230).

Pulmonary/Respiratory ...Occupational exposure to guar gum may cause asthma (600,601).

(Read more about GUAR GUM)

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

(Read more about MARSHMALLOW)

General ...Orally, oats are well tolerated.
Most Common Adverse Effects:
Orally: Abdominal distension, bloating, flatulence, and unpleasant taste.
Topically: Burning, contact dermatitis, itching, and redness.

Dermatologic ...Topically, oat-containing preparations can cause contact dermatitis (12515). Redness, burning, and itchiness have also been reported (103340).

Gastrointestinal ...When consumed orally, oats provide fiber. Increasing fiber in the diet can cause flatulence, bloating, abdominal distention, and unpleasant taste. To minimize side effects, doses should be slowly titrated to the desired level. These adverse effects usually subside with continued use (12514).
In patients who have difficulty chewing food, or those with conditions that decrease small bowel motility, oat bran may cause bezoars (concretions) and intestinal obstruction. Oats and oat bran are unlikely to cause obstruction without other causative factors (4979,4985).

Immunologic ...In a case report, a 45-year-old male developed acute generalized urticaria, facial angioedema, and dyspnea immediately after consuming oat flour. The reaction resolved after emergency care for anaphylaxis. Further investigation revealed an IgE-mediated hypersensitivity reaction to oat proteins (113490).

(Read more about OATS)

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).

(Read more about PECTIN)