M Lauti1, D Scott, M W Thompson-Fawcett. 1. Department of Surgery, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
Abstract
BACKGROUND AND AIMS: Many patients with faecal incontinence (FI) are prescribed a constipating agent concurrently with either fibre supplementation or a low-residue diet. Clinician opinion varies as to which initial approach is best. This study compared these treatments in routine clinical practice. DESIGN: Double-blind randomized cross-over trial. PARTICIPANTS: Patients referred for FI. INTERVENTION: Six weeks of low-residue diet, placebo fibre supplement and loperamide followed by 6 weeks of fibre supplement, neutral diet and loperamide or the reverse order. RESULTS:Sixty-three patients were randomized. At baseline the mean Faecal Incontinence Severity Index (FISI) was 31. After low-residue diet, placebo fibre supplement and loperamide the FISI was 18.4 (standard deviation, SD 13.2). After fibre supplementation and loperamide the FISI was 18.8 (SD 14.1). The mean difference between the treatment arms was not significant (-0.8; 95% CI: -4.9 to 3.3). There was also no difference between the treatments for the SF-36 and the Faecal Incontinence Quality of Life scale. There was marked variability in individual responses, some favouring more fibre and some less. CONCLUSIONS: This study provides evidence that treatment with more or less fibre in addition to loperamide has similar clinical effectiveness overall, however individual tailoring of treatment seems important to achieve the best outcome.
RCT Entities:
BACKGROUND AND AIMS: Many patients with faecal incontinence (FI) are prescribed a constipating agent concurrently with either fibre supplementation or a low-residue diet. Clinician opinion varies as to which initial approach is best. This study compared these treatments in routine clinical practice. DESIGN: Double-blind randomized cross-over trial. PARTICIPANTS: Patients referred for FI. INTERVENTION: Six weeks of low-residue diet, placebo fibre supplement and loperamide followed by 6 weeks of fibre supplement, neutral diet and loperamide or the reverse order. RESULTS: Sixty-three patients were randomized. At baseline the mean Faecal Incontinence Severity Index (FISI) was 31. After low-residue diet, placebo fibre supplement and loperamide the FISI was 18.4 (standard deviation, SD 13.2). After fibre supplementation and loperamide the FISI was 18.8 (SD 14.1). The mean difference between the treatment arms was not significant (-0.8; 95% CI: -4.9 to 3.3). There was also no difference between the treatments for the SF-36 and the Faecal Incontinence Quality of Life scale. There was marked variability in individual responses, some favouring more fibre and some less. CONCLUSIONS: This study provides evidence that treatment with more or less fibre in addition to loperamide has similar clinical effectiveness overall, however individual tailoring of treatment seems important to achieve the best outcome.
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