Psyllium Husks 500 mg by Puritan's Pride

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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LIKELY EFFECTIVE

• Cystic fibrosis. Long-term nebulized hypertonic sodium chloride improves lung function and reduces pulmonary exacerbations in patients with cystic fibrosis. Details: Meta-analyses of clinical research in adults with cystic fibrosis show that, when taken along with a bronchodilator and other standard therapies, nebulized hypertonic sodium chloride in concentrations of 3% to 7%, up to 10 mL twice daily for 4 weeks, increases forced expiratory volume at one second (FEV1) when compared with isotonic saline (sodium chloride 0.9%) (26230,26230). This benefit was not seen at 48 weeks. Other clinical research in adults with cystic fibrosis shows that inhaling sodium chloride 7%, 4 mL twice daily for 48 weeks, does not improve FEV1 when compared with isotonic saline. However, chronic treatment with hypertonic saline does reduce the number of pulmonary exacerbations and increase the number of patients without pulmonary exacerbations when compared with isotonic saline (29402). It is not clear if this benefit occurs in children with cystic fibrosis. The Pulmonary Clinical Practice Guidelines Committee of the Cystic Fibrosis Foundation recommends that individuals with cystic fibrosis aged 6 years or older use nebulized hypertonic saline long-term to improve lung function, reduce the number of exacerbations, and improve quality of life (29403).

POSSIBLY EFFECTIVE

• Amphotericin B nephrotoxicity. Oral sodium chloride seems to prevent nephrotoxicity associated with use of amphotericin B. Details: Clinical research shows that administering oral or intravenous sodium chloride 150 mEq daily during treatment with amphotericin B can attenuate the rise in serum creatinine levels and preserve renal function when compared to treatment with amphotericin B alone (26226).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bipolar disorder. It is unclear if oral sodium is beneficial in preventing lithium level fluctuations in patients with bipolar disorder. Details: A moderate-sized open-label clinical study in adults with type I bipolar disorder receiving lithium carbonate shows that taking sodium chloride 1 gram daily for 12 weeks along with dietary salt restriction of 1 gram daily reduces the percentage of patients with lithium level fluctuations above 0.8 mEq/L, but does not significantly affect serum sodium, potassium, aldosterone, or creatinine levels when compared with controls who were not salt restricted, but were advised not to consume additional salt at the table (112909). However, the interpretation of these findings is limited by missing data in both groups.
• Canker sores. Although there is interest in using topical sodium chloride for canker sores, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Congestive heart failure. It is unclear if oral sodium is beneficial in patients with acute decompensated heart failure requiring decongestive therapy with diuretics. Details: A moderate-sized clinical study in adults hospitalized with acute decompensated heart failure requiring high-dose intravenous furosemide shows that taking sodium chloride 2 grams three times daily for up to 96 hours does not affect patient weight or serum creatinine levels when compared with placebo (112911). However, the clinical relevance of this study is unclear and it may have been inadequately powered to detect a difference between groups.
• Conjunctivitis. Although there is interest in using ophthalmic sodium chloride for conjunctivitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Hyponatremia. Although there is interest in using oral sodium chloride for hyponatremia, there is insufficient reliable information about the clinical effects of oral sodium chloride for this condition.
• Pharyngitis. Although there is interest in using topical sodium chloride for pharyngitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Prematurity. It is unclear if oral sodium is beneficial for premature infants. Details: Preliminary clinical research in infants born at less than 32 weeks' gestation shows that adding sodium 4 mEq/kg daily to enteral feedings, starting from the 7th day after birth and continuing through the 35th day, reduces the risk of developing hyponatremia and improves weight gain when compared with adding water (98180). A small, open-label clinical study in newborns less than 35 weeks gestation shows that high sodium intake, defined as an average of 0.25% sodium in maintenance fluids, for 48 hours on day 2 and 3 after birth results in less weight loss within the first 72 hours of life when compared with control, but does not improve mortality, length of hospital stay, or complications from prematurity (112908). However, interpretation of these findings is limited by varied concentrations of sodium as an intervention. More evidence is needed to rate sodium 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 and appropriately. Sodium is safe in amounts that do not exceed the Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams daily (100310). Higher doses can be safely used therapeutically with appropriate medical monitoring (26226,26227).

POSSIBLY UNSAFE ...when used orally in high doses. Tell patients to avoid exceeding the CDRR intake level of 2.3 grams daily (100310). Higher intake can cause hypertension and increase the risk of cardiovascular disease (26229,98176,98177,98178,98181,98183,98184,100310,109395,109396,109398,109399). There is insufficient reliable information available about the safety of sodium when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately (26229,100310). Sodium is safe in amounts that do not exceed the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310).

CHILDREN: POSSIBLY UNSAFE
when used orally in high doses. Tell patients to avoid prolonged use of doses exceeding the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310). Higher intake can cause hypertension (26229).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately. Sodium is safe in amounts that do not exceed the CDRR intake level of 2.3 grams daily (100310).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in higher doses. Higher intake can cause hypertension (100310). Also, both the highest and the lowest pre-pregnancy sodium quintile intakes are associated with an increased risk of hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia, and the delivery of small for gestational age (SGA) infants when compared to the middle intake quintile (106264).

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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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ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = A Theoretically, a high intake of dietary sodium might reduce the effectiveness of antihypertensive drugs.  Details High intake of dietary sodium can increase systolic and diastolic blood pressure (26222). Also, high intake of sodium may necessitate increased use of antihypertensive medications to achieve blood pressure control in some patients, such as those with chronic kidney disease (26223).

CORTICOSTEROIDS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of mineralocorticoids and some glucocorticoids with sodium supplements might increase the risk of hypernatremia.  Details Mineralocorticoids and some glucocorticoids (corticosteroids) cause sodium retention. This effect is dose-related and depends on mineralocorticoid potency. It is most common with hydrocortisone, cortisone, and fludrocortisone, followed by prednisone and prednisolone (4425).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Altering dietary intake of sodium might alter the levels and clinical effects of lithium.  Details High sodium intake can reduce plasma concentrations of lithium by increasing lithium excretion (26225). Reducing sodium intake can significantly increase plasma concentrations of lithium and cause lithium toxicity in patients being treated with lithium carbonate (26224,26225). Stabilizing sodium intake is shown to reduce the percentage of patients with lithium level fluctuations above 0.8 mEq/L (112909). Patients taking lithium should avoid significant alterations in their dietary intake of sodium.

SODIUM-CONTAINING DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of sodium-containing drugs with additional sodium from dietary or supplemental sources may increase the risk of hypernatremia and long-term sodium-related complications.  Details The Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams of sodium daily indicates the intake at which it is believed that chronic disease risk increases for the apparently healthy population (100310). Some medications contain high quantities of sodium. When used in conjunction with sodium supplements or high-sodium diets, the CDRR may be exceeded. Additionally, concomitant use may increase the risk for hypernatremia; this risk is highest in the elderly and people with other risk factors for electrolyte disturbances.

TOLVAPTAN (Samsca) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = C Theoretically, concomitant use of tolvaptan with sodium might increase the risk of hypernatremia.  Details Tolvaptan is a vasopressin receptor 2 antagonist that is used to increase sodium levels in patients with hyponatremia (29406). Patients taking tolvaptan should use caution with the use of sodium salts such as sodium chloride.

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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, sodium is well tolerated when used in moderation at intakes up to the Chronic Disease Risk Reduction (CDRR) intake level. Topically, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Worsened cardiovascular disease, hypertension, kidney disease.

Cardiovascular ...Orally, intake of sodium above the CDRR intake level can exacerbate hypertension and hypertension-related cardiovascular disease (CVD) (26229,98176,100310,106263). A meta-analysis of observational research has found a linear association between increased sodium intake and increased hypertension risk (109398). Observational research has also found an association between increased sodium salt intake and increased risk of CVD, mortality, and cardiovascular mortality (98177,98178,98181,98183,98184,109395,109396,109399). However, the existing research is unable to confirm a causal relationship between sodium intake and increased cardiovascular morbidity and mortality; high-quality, prospective research is needed to clarify this relationship (100312). As there is no known benefit with increased salt intake that would outweigh the potential increased risk of CVD, advise patients to limit salt intake to no more than the CDRR intake level (100310).
A reduction in sodium intake can lower systolic blood pressure by a small amount in most individuals, and diastolic blood pressure in patients with hypertension (100310,100311,106261). However, post hoc analysis of a small crossover clinical study in White patients suggests that 24-hour blood pressure variability is not affected by high-salt intake compared with low-salt intake (112910). Additionally, the available research is insufficient to confirm that a further reduction in sodium intake below the CDRR intake level will lower the risk for chronic disease (100310,100311). A meta-analysis of clinical research shows that reducing sodium intake increases levels of total cholesterol and triglycerides, but not low-density lipoprotein (LDL) cholesterol, by a small amount (106261).
It is unclear whether there are safety concerns when sodium is consumed in amounts lower than the adequate intake (AI) levels. Some observational research has found that the lowest levels of sodium intake might be associated with increased risk of death and cardiovascular events (98181,98183). However, this finding has been criticized because some of the studies used inaccurate measures of sodium intake, such as the Kawasaki formula (98177,98178,101259). Some observational research has found that sodium intake based on a single 24-hour urinary measurement is inversely correlated with all-cause mortality (106260). The National Academies Consensus Study Report states that there is insufficient evidence from observational studies to conclude that there are harmful effects from low sodium intake (100310).

Endocrine ...Orally, a meta-analysis of observational research has found that higher sodium intake is associated with an average increase in body mass index (BMI) of 1. 24 kg/m2 and an approximate 5 cm increase in waist circumference (98182). It has been hypothesized that the increase in BMI is related to an increased thirst, resulting in an increased intake of sugary beverages and/or consumption of foods that are high in salt and also high in fat and energy (98182). One large observational study has found that the highest sodium intake is not associated with overweight or obesity when compared to the lowest intake in adolescents aged 12-19 years when intake of energy and sugar-sweetened beverages are considered (106265). However, in children aged 6-11 years, usual sodium intake is positively associated with increased weight and central obesity independently of the intake of energy and/or sugar-sweetened beverages (106265).

Gastrointestinal ...In one case report, severe gastritis and a deep antral ulcer occurred in a patient who consumed 16 grams of sodium chloride in one sitting (25759). Chronic use of high to moderately high amounts of sodium chloride has been associated with an increased risk of gastric cancer (29405).

Musculoskeletal ...Observational research has found that low sodium levels can increase the risk for osteoporosis. One study has found that low plasma sodium levels are associated with an increased risk for osteoporosis. Low levels, which are typically caused by certain disease states or chronic medications, are associated with a more than 2-fold increased odds for osteoporosis and bone fractures (101260).
Conversely, in healthy males on forced bed rest, a high intake of sodium chloride (7.7 mEq/kg daily) seems to exacerbate disuse-induced bone and muscle loss (25760,25761).

Oncologic ...Population research has found that high or moderately high intake of sodium chloride is associated with an increased risk of gastric cancer when compared with low sodium chloride intake (29405). Other population research in patients with gastric cancer has found that a high intake of sodium is associated with an approximate 65% increased risk of gastric cancer mortality when compared with a low intake. When zinc intake is taken into consideration, the increased risk of mortality only occurred in those with low zinc intake, but the risk was increased to approximately 2-fold in this sub-population (109400).

Pulmonary/Respiratory ...In patients with hypertension, population research has found that sodium excretion is modestly and positively associated with having moderate or severe obstructive sleep apnea. This association was not found in normotensive patients (106262).

Renal ...Increased sodium intake has been associated with impaired kidney function in healthy adults. This effect seems to be independent of blood pressure. Observational research has found that a high salt intake over approximately 5 years is associated with a 29% increased risk of developing impaired kidney function when compared with a lower salt intake. In this study, high salt intake was about 2-fold higher than low salt intake (101261).

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