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Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial.

Abstract

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.

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  • Authors+Show Affiliations

    ,

    Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, Netherlands. c.j.bijkerk-2@umcutrecht.nl

    , , , ,

    Source

    BMJ (Clinical research ed.) 339: 2009 Aug 27 pg b3154

    MeSH

    Abdominal Pain
    Adolescent
    Adult
    Aged
    Dietary Fiber
    Family Practice
    Female
    Humans
    Irritable Bowel Syndrome
    Male
    Middle Aged
    Plantago
    Treatment Outcome
    Young Adult

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    19713235

    Citation

    Bijkerk, C J., et al. "Soluble or Insoluble Fibre in Irritable Bowel Syndrome in Primary Care? Randomised Placebo Controlled Trial." BMJ (Clinical Research Ed.), vol. 339, 2009, pp. b3154.
    Bijkerk CJ, de Wit NJ, Muris JW, et al. Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial. BMJ. 2009;339:b3154.
    Bijkerk, C. J., de Wit, N. J., Muris, J. W., Whorwell, P. J., Knottnerus, J. A., & Hoes, A. W. (2009). Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial. BMJ (Clinical Research Ed.), 339, pp. b3154. doi:10.1136/bmj.b3154.
    Bijkerk CJ, et al. Soluble or Insoluble Fibre in Irritable Bowel Syndrome in Primary Care? Randomised Placebo Controlled Trial. BMJ. 2009 Aug 27;339:b3154. PubMed PMID: 19713235.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial. AU - Bijkerk,C J, AU - de Wit,N J, AU - Muris,J W M, AU - Whorwell,P J, AU - Knottnerus,J A, AU - Hoes,A W, Y1 - 2009/08/27/ PY - 2009/8/29/entrez PY - 2009/8/29/pubmed PY - 2009/9/11/medline SP - b3154 EP - b3154 JF - BMJ (Clinical research ed.) JO - BMJ VL - 339 N2 - 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. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/19713235/full_citation L2 - http://www.bmj.com/cgi/pmidlookup?view=long&pmid=19713235 DB - PRIME DP - Unbound Medicine ER -