Bran Buds® cereal, Effersyllium®, Fiberall®, flea seed, Fybogel®, Heartwise® cereal, Hydrocil®, I-so-gel®, ispaghula, ispaghula husk, ispaghula seed, isphagula, Konsyl®, Lunelax®, Metamucil®, Minolest®, natural vegetable laxative, Perdiem®, Plantago arenaria, Plantago psyllium, Prodiem Plain®, psyllion, psyllios, psyllium husk, psyllium seed, Regulan®, Serutan®, Vi-Siblin®, Yerba Prima® psyllium husk powder.
Psyllium, also referred to as ispaghula (or isphagula), is derived from the husks of the seeds of Plantago ovata. Psyllium contains a high level of soluble dietary fiber, and is the chief ingredient in many commonly used bulk laxatives, including products such as Metamucil® and Serutan®.
Psyllium has been studied as a "non-systemic" cholesterol-lowering agent, with generally modest effects seen on total cholesterol and low-density lipoprotein levels. Several psyllium-containing cereals such as Heartwise® and Bran Buds® have appeared in the U.S. marketplace during the last 15 years and have been touted for their potential lipid-lowering and "heart health promoting" effects.
Allergic reactions, including anaphylaxis, have been reported, particularly in healthcare workers with previous experience preparing psyllium-containing bulk laxatives. Obstruction of the gastrointestinal tract by such laxatives has also been reported, particularly in patients with prior bowel surgeries or anatomic abnormalities, or when mixed with inadequate amounts of water.
Psyllium is well studied as a lipid-lowering agent with generally modest reductions seen in blood levels of total cholesterol and low-density lipoprotein ("bad cholesterol"). Effects have been observed following eight weeks of regular use. Psyllium does not appear to have significant effects on high-density lipoprotein ("good cholesterol") or triglyceride levels. Because only small reductions have been observed, people with high cholesterol should discuss the use of more potent agents with their healthcare provider. Effects have been observed in adults and children, although long-term safety in children is not established.
Psyllium has long been used as a chief ingredient in "bulk laxatives." Generally, an increase in stool weight, an increase in bowel movements per day, and a decrease in total gut transit time has been observed in most studies.
Psyllium has been studied for the treatment of diarrhea, particularly in patients undergoing tube feeding. It has also been studied in addition to orlistat therapy in hopes of decreasing gastrointestinal effects (diarrhea and oily discharge) of this weight loss agent. An effective stool bulking effect has generally been found in scientific studies.
Anal fissures (tears or cracks in the anus):
Psyllium may help to prevent or relieve anal fissures, which can result from constipation, diarrhea, inflammatory bowel disease, or irritable bowel syndrome. However, further research is necessary before psyllium can be recommended.
According to early research, diets that include psyllium may reduce the risk for colon cancer. More studies are needed to determine whether psyllium can help prevent colon cancer.
Patients with new onset constipation or presumed hemorrhoid bleeding frequently require the use of both fiber supplements and diagnostic colonoscopy. Researchers have concluded that in non-constipated patients, psyllium-based fiber supplementation should not be initiated in the few days prior to endoscopy using a polyethylene glycol preparation. Instructions given by the appropriate healthcare professional and pharmacist should be followed when preparing for colonoscopy.
Fat excretion in stool:
Early research shows that dietary psyllium and chitosan supplementation may help to increase the excretion of fat in the stool.
Early research suggests that diets high in fiber (such as psyllium) will increase gas production, yet promote gas retention. The effect of psyllium on gas needs to be explored further.
Psyllium may reduce the symptoms of hemorrhoids, which can result from constipation. Further research is needed to determine whether psyllium can help relieve or prevent the symptoms of hemorrhoids.
Hyperglycemia (high blood sugar levels):
Several studies have examined the administration of psyllium with meals or just prior to meals in order to measure effects on blood sugar levels. Better evidence is necessary before a firm conclusion can be drawn.
Induction of labor/abortion (cervical dilator):
An early study examined whether a preparation made from psyllium could help dilate the cervix when labor or abortion is induced. Further research is needed to determine whether psyllium can help to open the cervix.
Inflammatory bowel disease (Crohn's disease, ulcerative colitis):
There is limited and unclear evidence regarding the use of psyllium in patients with inflammatory bowel disease.
Irritable bowel syndrome:
Psyllium preparations have been studied for more than 20 years in the treatment of irritable bowel syndrome symptoms. Results of these trials have been conflicting. In some cases, insoluble fiber may worsen the clinical outcome.
The reviewed evidence seems to show that psyllium may improve blood sugar and lipid levels, which can be related to obesity in some children. However, further studies are needed to clarify its effects and the mechanisms involved. Body weight reduction has not been proven to be associated with psyllium use in adults.
Recommendations for dietary fiber intake for adults fall within the range of 20 to 35 grams per day, or 10 to 13 grams per 1,000 kilocalories ingested.
It is important to take laxatives such as psyllium with sufficient amounts of water or liquid in order to reduce the risk of bowel obstruction. Doses ranging from 2.2 to 45 grams by mouth daily in divided doses, often administered just prior to meals, have been used in studies.
3.4 to 16 grams by mouth daily has been studied, although more research is needed to establish benefits and long-term safety.
Serious allergic reactions including anaphylaxis, difficulty breathing/wheezing, skin rash, and hives have been reported after ingestion of psyllium products. Less severe hypersensitivity reactions have also been noted. Cross-sensitivity may occur in people with allergy to English plantain pollen (Plantago lanceolata), grass pollen, or melon.
Psyllium-containing laxatives, cereals, and other products are generally believed to be safe. Important exceptions include those with repeated psyllium exposure (such as healthcare workers frequently handling bulk laxatives who are at risk for hypersensitivity reactions) and patients with significant pre-existing bowel abnormalities (such as gastrointestinal strictures or impaired motility) or prior bowel surgery.
Obstruction of the gastrointestinal tract has been noted in numerous case reports of patients taking psyllium-containing laxatives, particularly in individuals with previous bowel surgery or problems and/or when the laxatives are mixed with inadequate amounts of water. Psyllium should be avoided by people who have throat problems or difficulty swallowing.
Gastrointestinal side effects are generally mild and have not prompted discontinuation of psyllium in most clinical trials. Esophageal obstruction has been reported in a patient with Parkinson's disease.
Immediate medical attention should be sought if any of these symptoms appear after taking psyllium: chest pain, vomiting, or difficulty swallowing or breathing.
Psyllium-containing laxatives are considered class C-2 drugs in pregnancy, meaning that they appear to be safe in all three trimesters, although studies in pregnant humans and animals have not been done. Psyllium-containing products are considered class 1 (apparently safe) during breastfeeding.
Psyllium-containing products may delay gastric emptying time and reduce the absorption of some drugs. It is advised that drugs be taken at separate administration times from psyllium to minimize potential interactions (for example, one hour before or a few hours after taking psyllium).
Although no effect on warfarin (Coumadin®) levels with co-administration of psyllium was reported in one study, administration of these agents should be separated until better research is available.
Due to potential reductions in blood sugar levels caused by psyllium, requirements for insulin or other diabetes drugs in diabetic patients may be reduced. Blood glucose levels should be closely monitored, and dosing adjustments may be necessary.
Other drugs may be affected by psyllium, including anticoagulants, antidepressants, anti-gout agents, anti-inflammatory agents, diuretics, salicylates, tetracyclines, nitrofurantoin, insulin, lithium (Lithobid®, Eskalith®), and digoxin (Lanoxin®). People should speak with their healthcare providers before taking psyllium. Dosing adjustments may be necessary.
Psyllium-containing products may delay gastric emptying time and reduce the absorption of some herbs, supplements, vitamins, or minerals. Absorption of calcium, iron, zinc, and vitamin B12 may also be affected. Other agents should be taken one hour before or a few hours after psyllium to avoid potential interactions.
Psyllium should be used cautiously with other laxatives, such as senna, because effects may be increased.
Psyllium and chitosan together may increase fat excretion in the stool.
Theoretically, psyllium may reduce the absorption of anticoagulant herbs and supplements. However, no effect on warfarin levels by co-administered psyllium was found in one study.
Taking psyllium with herbs and supplements that alter blood sugar may increase the risk of hypoglycemia (lowered blood sugar). People using other herbs or supplements that may alter blood sugar levels, such as bitter melon (Momordica charantia), should be monitored closely by their healthcare provider while using psyllium. Dosing adjustments may be necessary.
Psyllium may interact with herbs and supplements with antidepressant, anti-gout, anti-inflammatory, and diuretic activities.
This information is based on a full professional monograph edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com): Ethan Basch, MD (Memorial-Sloan-Kettering Cancer Center); Wendy Chao, PhD (Natural Standard Research Collaboration); Dawn Costa, BA, BS (Natural Standard Research Collaboration); Chi Dam, PharmD (Northeastern University); Nicole Giese, MS (Natural Standard Research Collaboration); Dana A. Hackman, BS (Northeastern University); Erica Seamon, PharmD (Nova Southeastern University); Scott W. Shurmur, MD (University of Nebraska Medical Center); Shaina Tanguay-Colucci, BS (Natural Standard Research Collaboration); Catherine Ulbricht, PharmD (Massachusetts General Hospital); Wendy Weissner, BA (Natural Standard Research Collaboration); Jen Woods, BS (Natural Standard Research Collaboration).
Anderson JW, Allgood LD, Turner J, et al. Effects of psyllium on glucose and serum lipid responses in men with type 2 diabetes and hypercholesterolemia. Am J Clin Nutr 1999;70(4):466-473.
Barroso Aranda J, Contreras F, Bagchi D, et al. Efficacy of a novel chitosan formulation on fecal fat excretion: a double-blind, crossover, placebo-controlled study. J Med 2002;33(1-4):209-225.
Davidson MH, Dugan LD, Burns JH, et al. A psyllium-enriched cereal for the treatment of hypercholesterolemia in children: a controlled, double-blind, crossover study. Am J Clin Nutr 1996;63(1):96-102.
Davidson MH, Maki KC, Kong JC, et al. Long-term effects of consuming foods containing psyllium seed husk on serum lipids in subjects with hypercholesterolemia. Am J Clin Nutr 1998;67(3):367-376.
Dennison BA, Levine DM. Randomized, double-blind, placebo-controlled, two-period crossover clinical trial of psyllium fiber in children with hypercholesterolemia. J Pediatr 1993;123(1):24-29.
Fernandez-Banares F, Hinojosa J, Sanchez-Lombrana JL, et al. Randomized clinical trial of Plantago ovata seeds (dietary fiber) as compared with mesalamine in maintaining remission in ulcerative colitis. Spanish Group for the Study of Crohn's Disease and Ulcerative Colitis (GETECCU). Am J Gastroenterol 1999;94(2):427-433.
Food and Drug Administration, HHS. Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule. Fed Regist 2007 Mar 29;72(60):14669-74.
Jenkins DJ, Kendall CW, Vuksan V, et al. Soluble fiber intake at a dose approved by the US Food and Drug Administration for a claim of health benefits: serum lipid risk factors for cardiovascular disease assessed in a randomized controlled crossover trial. Am J Clin Nutr 2002;75(5):834-839.
Juarranz M, Calle-Puron ME, Gonzalez-Navarro A, et al. Physical exercise, use of Plantago ovata and aspirin, and reduced risk of colon cancer. Eur J Cancer Prev 2002;11(5):465-472.
MacMahon M, Carless J. Ispaghula husk in the treatment of hypercholesterolaemia: a double- blind controlled study. J Cardiovasc Risk 1998;5(3):167-172.
McRorie JW, Daggy BP, Morel JG, et al. Psyllium is superior to docusate sodium for treatment of chronic constipation. Aliment Pharmacol Ther 1998;12(5):491-497.
Murai M, Tamayama Y, Nishibe S. Phenylethanoids in the herb of Plantago lanceolata and inhibitory effect on arachidonic acid-induced mouse ear edema. Planta Med 1995 Oct;61(5):479-80.
Reid R, Fodor G, Lydon-Hassen K, et al. Dietary counselling for dyslipidemia in primary care: results of a randomized trial. Can J Diet Pract Res 2002;63(4):169-175.
Sierra M, Garcia JJ, Fernandez N, et al. Therapeutic effects of psyllium in type 2 diabetic patients. Eur J Clin Nutr 2002;56(9):830-842.
van Rosendaal GM, Shaffer EA, Edwards AL, et al. Issues raised by psyllium meta-analysis. Am J Clin Nutr 2001;73(3):653-654.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.