- C J Bijkerk, general practitioner1,
- N J de Wit, associate professor of general practice1,
- J W M Muris, associate professor of general practice2,
- P J Whorwell, professor of medicine and gastroenterology3,
- J A Knottnerus, professor of general practice2,
- A W Hoes, professor of clinical epidemiology and general practice1
- 1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, Netherlands
- 2Department of General Practice, Care and Public Health Research Institute (CAPHRI), Maastricht University, 6200 MD Maastricht, Netherlands
- 3Department of Medicine and Gastroenterology, University of Manchester, Manchester, M23 9LT
- Correspondence to: C J Bijkerk
- Accepted 21 April 2009
Objective To determine the effectiveness of increasing the dietary content of soluble fibre (psyllium) or insoluble fibre (bran) in patients with irritable bowel syndrome.
Design Randomised controlled trial.
Setting General practice.
Participants 275 patients aged 18-65 years with irritable bowel syndrome.
Interventions 12 weeks of treatment with 10 g psyllium (n=85), 10 g bran (n=97), or 10 g placebo (rice flour) (n=93).
Main outcome measures The primary end point was adequate symptom relief during at least two weeks in the previous month, analysed after one, two, and three months of treatment to assess both short term and sustained effectiveness. Secondary end points included irritable bowel syndrome symptom severity score, severity of abdominal pain, and irritable bowel syndrome quality of life scale.
Results The proportion of responders was significantly greater in the psyllium group than in the placebo group during the first month (57% v 35%; relative risk 1.60, 95% confidence interval 1.13 to 2.26) and the second month of treatment (59% v 41%; 1.44, 1.02 to 2.06). Bran was more effective than placebo during the third month of treatment only (57% v 32%; 1.70, 1.12 to 2.57), but this was not statistically significant in the worst case analysis (1.45, 0.97 to 2.16). After three months of treatment, symptom severity in the psyllium group was reduced by 90 points, compared with 49 points in the placebo group (P=0.03) and 58 points in the bran group (P=0.61 versus placebo). No differences were found with respect to quality of life. Fifty four (64%) of the patients allocated to psyllium, 54 (56%) in the bran group, and 56 (60%) in the placebo group completed the three month treatment period. Early dropout was most common in the bran group; the main reason was that the symptoms of irritable bowel syndrome worsened.
Conclusions Psyllium offers benefits in patients with irritable bowel syndrome in primary care.
Trial registration Clinical trials NCT00189033.
We thank all participating patients and the general practitioners, assistants, and nurses in the participating practices. We thank B Slotboom for his valuable assistance in constructing the data file and P Zuithoff for statistical advice.
Contributors: All authors contributed to the design of the trial, interpretation of the results, and writing of the manuscript. CJB contributed to the recruitment of general practitioners and patients, data collection, management of the trial, and statistical analysis. NJdW recruited general practitioners and co-coordinated the trial. JWMM recruited general practitioners. PJW and JAK contributed to the statistical analysis. AWH co-coordinated the trial and contributed to the statistical analysis. All authors met regularly as a steering group. CJB is the guarantor.
Funding: The Netherlands Organisation for Health Research and Development provided peer-reviewed funding for this study. The psyllium for this study was delivered by Pfizer BV, the Netherlands. The sponsors of this study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
Competing interests: None declared.
Ethical approval: The medical ethics committee of the University Medical Center Utrecht approved the study protocol. All patients gave written informed consent.
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