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

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.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    UNC Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. steve_heymen@med.unc.edu

    , , , ,

    Source

    Diseases of the colon and rectum 50:4 2007 Apr pg 428-41

    MeSH

    Ataxia
    Biofeedback, Psychology
    Constipation
    Diazepam
    Electromyography
    Female
    Follow-Up Studies
    Humans
    Male
    Middle Aged
    Muscle Relaxants, Central
    Pelvic Floor
    Quality of Life
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    17294322

    Citation

    Heymen, Steve, et al. "Randomized, Controlled Trial Shows Biofeedback to Be Superior to Alternative Treatments for Patients With Pelvic Floor Dyssynergia-type Constipation." Diseases of the Colon and Rectum, vol. 50, no. 4, 2007, pp. 428-41.
    Heymen S, Scarlett Y, Jones K, et al. Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. Dis Colon Rectum. 2007;50(4):428-41.
    Heymen, S., Scarlett, Y., Jones, K., Ringel, Y., Drossman, D., & Whitehead, W. E. (2007). Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. Diseases of the Colon and Rectum, 50(4), pp. 428-41.
    Heymen S, et al. Randomized, Controlled Trial Shows Biofeedback to Be Superior to Alternative Treatments for Patients With Pelvic Floor Dyssynergia-type Constipation. Dis Colon Rectum. 2007;50(4):428-41. PubMed PMID: 17294322.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. AU - Heymen,Steve, AU - Scarlett,Yolanda, AU - Jones,Kenneth, AU - Ringel,Yehuda, AU - Drossman,Douglas, AU - Whitehead,William E, PY - 2007/2/13/pubmed PY - 2007/5/26/medline PY - 2007/2/13/entrez SP - 428 EP - 41 JF - Diseases of the colon and rectum JO - Dis. Colon Rectum VL - 50 IS - 4 N2 - 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. SN - 0012-3706 UR - https://www.unboundmedicine.com/medline/citation/17294322/Randomized_controlled_trial_shows_biofeedback_to_be_superior_to_alternative_treatments_for_patients_with_pelvic_floor_dyssynergia_type_constipation_ L2 - http://link.springer.com/article/10.1007/s10350-006-0814-9 DB - PRIME DP - Unbound Medicine ER -