Advertisement

Diseases of the Colon & Rectum

, Volume 50, Issue 4, pp 428–441 | Cite as

Randomized, Controlled Trial Shows Biofeedback to be Superior to Alternative Treatments for Patients with Pelvic Floor Dyssynergia-Type Constipation

  • Steve HeymenEmail author
  • Yolanda Scarlett
  • Kenneth Jones
  • Yehuda Ringel
  • Douglas Drossman
  • William E. Whitehead
Article

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.

Key words

Biofeedback Constipation Dyssynergia Dyssynergic defecation Electromyography 

References

  1. 1.
    Harari, D, Gurwitz, JH, Avom, J, Bohn, R, Minaker, KL 1996Bowel habit in relation to age and gender. Findings from the National Health Interview Survey and clinical implicationsArch Int Med56315320CrossRefGoogle Scholar
  2. 2.
    Higgins, PD, Johanson, JF 2004Epidemiology of constipation in North America: a systematic reviewAm J Gastroenterol99750759PubMedCrossRefGoogle Scholar
  3. 3.
    Glia, A, Lindberg, G 1997Quality of life in patients with different types of functional constipationScand J Gastroenterol3210831089PubMedGoogle Scholar
  4. 4.
    Koloski, NA, Talley, NJ, Boyce, PM 2000The impact of functional gastrointestinal disorders on quality of lifeAm J Gastroenterol956771PubMedCrossRefGoogle Scholar
  5. 5.
    Drossman, DA, Li, Z, Andruzzi, E,  et al. 1993U.S. householder survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impactDig Dis Sci3815691580PubMedCrossRefGoogle Scholar
  6. 6.
    Rantis, PC,Jr, Vernava, AM,3rd, Daniel, GL, Longo, WE 1997Chronic constipation: is the work-up worth the cost?Dis Colon Rectum40280286PubMedCrossRefGoogle Scholar
  7. 7.
    Singh, G, Kahler, K, Bharathi, V, Mithal, A, Omar, M, Triadafilopoulos, G 2004Adults with chronic constipation have significant health care resource utilization and costs of careAm J Gastroenterol99S227Google Scholar
  8. 8.
    Lahr, CJ 1988Evaluation and treatment of incontinencePract Gastroenterol122735Google Scholar
  9. 9.
    Talley, NJ, Weaver, AL, Zinsmeister, AR,  et al. 1992Onset and disappearance of gastrointestinal symptoms and functional gastrointestinal disordersAm J Epidemiol136165177PubMedGoogle Scholar
  10. 10.
    Levitt, MA, Penn, A 2005Surgery and constipation: when, how, yes, or no?J Pediatr Gastroenterol Nutr41S58S60PubMedGoogle Scholar
  11. 11.
    Whitehead, WE, Wald, A, Diamant, NE, Enck, P, Pemberton, JH, Rao, SS 2000Functional disorders of the anus and rectumDrossman, DACorazziari, ETalley, NJThompson, WGWhitehead, WE eds. Rome II: the functional gastrointestinal disorders2Degnon AssociatesMcLean, VA483532Google Scholar
  12. 12.
    Preston, DM, Lennard-Jones, JE 1985Anismus in chronic constipationDig Dis Sci30413418PubMedCrossRefGoogle Scholar
  13. 13.
    Wald, A, Caruana, BJ, Freimanis, MG, Bauman, DH, Hinds, JP 1990Contributions of evacuation proctography and anorectal manometry to the evaluation of adults with constipation and defecatory difficultyDig Dis Sci35481487PubMedCrossRefGoogle Scholar
  14. 14.
    Heymen, S, Jones, KR, Scarlett, Y, Whitehead, WE 2003Biofeedback treatment of constipation: a critical reviewDis Colon Rectum4612081217PubMedCrossRefGoogle Scholar
  15. 15.
    Basmajian, JV 1981Biofeedback in rehabilitation: a review of principles and practicesArch Phys Med Rehabil62469475PubMedGoogle Scholar
  16. 16.
    Chiarioni, G, Salandini, L, Whitehead, WE 2005Biofeedback benefits only patients with outlet dysfunction, not patients with isolated slow transit constipationGastroenterology1298697PubMedCrossRefGoogle Scholar
  17. 17.
    Chiarioni, G, Whitehead, WE, Pezza, V, Morelli, A, Bassotti, G 2006Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergiaGastroenterology130657664PubMedCrossRefGoogle Scholar
  18. 18.
    Norton, C, Chelvanayagam, S, Wilson-Barnett, J, Redfern, S, Kamm, MA 2003Randomized controlled trial of biofeedback for fecal incontinenceGastroenterology12513201329PubMedCrossRefGoogle Scholar
  19. 19.
    Palsson, OS, Heymen, S, Whitehead, WE 2004Biofeedback treatment for functional anorectal disorders: a comprehensive efficacy reviewAppl Psychophysiol Biofeedback29153174PubMedCrossRefGoogle Scholar
  20. 20.
    Kamm, MA, Hawley, PR, Lennard-Jones, JE 1988Lateral division of the puborectalis muscle in the management of severe constipationBr J Surg75661663PubMedCrossRefGoogle Scholar
  21. 21.
    Ron, Y, Avni, Y, Lukovetski, A,  et al. 2001Botulinum toxin type-A in therapy of patients with animusDis Colon Rectum4418211826PubMedCrossRefGoogle Scholar
  22. 22.
    Mathew, A, Mathew, MC, Thomas, M, Antonisamy, B 2005The efficacy of diazepam in enhancing motor function in children with spastic cerebral palsyJ Trop Pediatr51109113PubMedCrossRefGoogle Scholar
  23. 23.
    Ordia, JI, Fischer, E, Adamski, E, Spatz, EL 1996Chronic intrathecal delivery of baclofen by a programmable pump for the treatment of severe spasticityJ Neurosurg85452457PubMedCrossRefGoogle Scholar
  24. 24.
    Irvine, EJ, Whitehead, WE, Chey, WD,  et al. 2006Design of treatment trials for functional gastrointestinal disordersGastroenterology13015381551PubMedCrossRefGoogle Scholar
  25. 25.
    Svedlund, J, Sjodin, I 1985A psychosomatic approach to treatment in the irritable bowel syndrome and peptic ulcer disease with aspects of the design of clinical trialsScand J Gastroenterol Suppl109147151PubMedGoogle Scholar
  26. 26.
    Creed, F, Fernandez, L, Guthrie, E,  et al. 2003The cost-effectiveness of psychotherapy and paroxetine for severe irritable bowel syndromeGastroenterology124303317PubMedCrossRefGoogle Scholar
  27. 27.
    Lewis, SJ, Heaton, KW 1997Stool form scale as a useful guide to intestinal transit timeScand J Gastroenterol32920924PubMedCrossRefGoogle Scholar
  28. 28.
    Borkovec, TD, Nau, SD 1972Credibility of analogue therapy rationalesJ Behav Ther Exp Psychiatry3257260CrossRefGoogle Scholar
  29. 29.
    Frank L, Farup C, Jones R, Miner P, Taylor L, Kleinman L. Evaluation of a patient symptom measure for constipation. Gastroenterology 1998;114:A14CrossRefGoogle Scholar
  30. 30.
    Dubois D. PAC-QOL-Patient Assessment of Constipation: International Psychometric Analysis. Jansen Research Foundation Internal Report, 1998Google Scholar
  31. 31.
    Ware, JE, Sherbourne, CD 1992The MOS 36-item short form Health Survey (SF-36): I. Conceptual framework and item selectionMed Care30473483PubMedCrossRefGoogle Scholar
  32. 32.
    Spielberger, CD, Gorsuch, RL, Lushene, R, Vagg, PR, Jacobs, GA 1983Manual for the state-trait anxiety inventoryConsulting Psychologists PressPalo AltoGoogle Scholar
  33. 33.
    Beck, A, Steer, R, Brown, G 1996The Beck depression inventoryHarcourt BraceSan AntonioGoogle Scholar
  34. 34.
    Drossman, DA, Talley, NJ, Leserman, J, Olden, KW, Barreiro, MA 1995Sexual and physical abuse and gastrointestinal illness: review and recommendationsAnn Intern Med123782794PubMedGoogle Scholar
  35. 35.
    CONSORT: Strength in science, sound ethics. Available at: http://www.consort-statement.org.
  36. 36.
    Rao, SS, Kincade, KJ, Shulze, S,  et al. 2005Biofeedback therapy (BT) for dyssenergic constipation: randomized controlled trial [abstract]Gastroenterology128A–269Google Scholar
  37. 37.
    Whitehead, WE, Wald, A, Norton, NJ 2004Priorities for treatment research from different professional perspectivesGastroenterology126S180S185PubMedCrossRefGoogle Scholar

Copyright information

© The American Society of Colon and Rectal Surgeons 2007

Authors and Affiliations

  • Steve Heymen
    • 1
    Email author
  • Yolanda Scarlett
    • 1
  • Kenneth Jones
    • 2
  • Yehuda Ringel
    • 1
  • Douglas Drossman
    • 1
  • William E. Whitehead
    • 1
  1. 1.UNC Center for Functional GI and Motility DisordersUniversity of North Carolina at Chapel HillChapel HillUSA
  2. 2.VA - National Center for Health Promotion and Disease PreventionDurhamUSA

Personalised recommendations