Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation.

Full Abstract

PURPOSE:
This study was designed to determine whether biofeedback is more effective than diazepam or placebo in a randomized, controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented biofeedback is necessary for successful training.

METHODS:
A total of 117 patients participated in a four-week run-in (education and medical management). The 84 who remained constipated were randomized to biofeedback (n=30), diazepam (n=30), or placebo (n=24). All patients were trained to do pelvic floor muscle exercises to correct pelvic floor dyssynergia during six biweekly one-hour sessions, but only biofeedback patients received electromyography feedback. All other patients received pills one to two hours before attempting defecation. Diary data on cathartic use, straining, incomplete bowel movements, Bristol stool scores, and compliance with homework were reviewed biweekly.

RESULTS:
Before treatment, the groups did not differ on demographic (average age, 50 years; 85 percent females), physiologic or psychologic characteristics, severity of constipation, or expectation of benefit. Biofeedback was superior to diazepam by intention-to-treat analysis (70 vs. 23 percent reported adequate relief of constipation 3 months after treatment, chi-squared=13.1, P<0.001), and also superior to placebo (38 percent successful, chi-squared=5.7, P=0.017). Biofeedback patients had significantly more unassisted bowel movements at follow-up compared with placebo (P=0.005), with a trend favoring biofeedback over diazepam (P=0.067). Biofeedback patients reduced pelvic floor electromyography during straining significantly more than diazepam patients (P<0.001).

CONCLUSIONS:
This investigation provides definitive support for the efficacy of biofeedback for pelvic floor dyssynergia and shows that instrumented biofeedback is essential to successful treatment.

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Author information

Author/s: Heymen, Steve (S); Scarlett, Yolanda (Y); Jones, Kenneth (K); Ringel, Yehuda (Y); Drossman, Douglas (D); Whitehead, William E (WE);

Affiliation: UNC Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. steve_heymen(-atsign-)med.unc.edu

Grants: R01DK57048 (Agency:NIDDK NIH HHS) ; RR00046 (Agency:NCRR NIH HHS)

Journal and publication information

Publication Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

Journal: Diseases of the colon and rectum (Dis Colon Rectum), published in United States. (Language: eng)

Reference: 2007-Apr; vol 50 (issue 4) : pp 428-41

Dates: Created 2007/05/03; Completed 2007/05/25; Revised 2007/12/03;

PMID: 17294322, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Ataxia - complications
Biofeedback (Psychology)
Constipation - etiology; therapy
Diazepam - therapeutic use
Electromyography
Female
Follow-Up Studies

Humans
Male
Middle Aged
Muscle Relaxants, Central - therapeutic use
Pelvic Floor
Quality of Life
Treatment Outcome

Associated Chemicals: Muscle Relaxants, Central (0) ; Diazepam (439-14-5)

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