Jay Luther, MD; William D. Chey, MD
In primary care patients with the irritable bowel syndrome (IBS), what is the effectiveness of soluble fiber (psyllium) or insoluble fiber (bran)?
Randomized placebo-controlled trial. ClinicalTrials.gov NCT00189033.
Blinded (patients, physicians, and research personnel).*
1, 2, and 3 months.
Primary care practices in Utrecht and Maastricht, The Netherlands.
275 patients 18 to 65 years of age (mean age 34 y, 78% women) who had symptoms of IBS in the past 4 weeks, with either a definite diagnosis based on Rome II criteria or probable IBS pragmatically diagnosed by the general practitioner. Exclusion criteria were organic bowel disease, use of fiber treatments in past 4 weeks, severe psychosocial or psychiatric disorder, specialist treatment of IBS in the past 2 years, and inability to understand Dutch.
Psyllium, 10 g (n = 85); bran, 10 g (n = 97); or rice flour (placebo) (n = 93), twice daily (mixed with food, preferably yogurt) for 12 weeks.
Primary outcome was treatment response (adequate symptom relief for ≥ 2 of the previous 4 wk). Secondary outcomes included moderately severe adverse events.
85% at 1 month (intention-to-treat analysis).
Only the results at 1 month are reported here because < 80% of patients completed 2- and 3-month follow-ups. At 1 month, more patients in the psyllium group had a treatment response than did those in the bran or placebo groups; bran and placebo did not differ (Table). Groups did not differ for patients reporting ≥ 1 moderately severe adverse event.
In patients with the irritable bowel syndrome, soluble fiber (psyllium) increased symptom relief more than insoluble fiber (bran) or placebo at 1 month.
Psyllium vs bran vs placebo in patients with the irritable bowel syndrome†
†Abbreviations defined in Glossary. RBI, NNT, and CI calculated from data in article.
‡Adequate symptom relief for ≥ 2 of the previous 4 wk.
Luther J, Chey WD. Psyllium increased symptom relief in patients with the irritable bowel syndrome more than bran or placebo. Ann Intern Med. ;152:JC1–11. doi: 10.7326/0003-4819-152-2-201001190-02011
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Published: Ann Intern Med. 2010;152(2):JC1-11.
Gastroenterology/Hepatology, Irritable Bowel Syndrome.
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