Chiarioni, G., Whitehead, W.E., Pezza, V., Morelli, A., & Bassotti, G. (2006). Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. Gastroenterology, 130, 657–664.

DOI Link

Study Purpose

To assess long-term (24-month) efficacy of biofeedback versus laxatives and bowel education.

Intervention Characteristics/Basic Study Process

Biofeedback training was provided in five 30-minute classes over five weeks. Similarly, laxative plus bowel education was provided in five 30-minute bowel training classes over five weeks. Those patients also took 14.6 to 22.9 g/kg of polyethylene glycol for the first six months; after six months, patients took the dose BID.

Sample Characteristics

  • The study reported on a sample of 109 men and women who had a history of chronic or severe pelvic floor dyssynergia (PFD) and were nonresponders to previous therapy.
  • The sample comprised 54 patients in the biofeedback arm and 55 patients in the laxative arm; 53 patients per group were needed to validate significance.

Setting

Tertiary gastroenterology clinic in Verona, Italy

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

  • Straining
  • Sensation of incomplete evacuation
  • Anorectal blockage
  • Use of enemas or suppositories
  • Abdominal pain
  • Balloon defecation test

Results

  • At six months, major improvement was reported by 43 of 54 patients (80%) in the biofeedback group versus 12 of 55 patients (22%) in the laxative group (p < 0.001).
  • Biofeedback benefits were sustained at 12 and 24 months in all measures, but not significantly.
  • Patients in the biofeedback group showed greater reductions in straining, sensations of incomplete evacuation and anorectal blockage, use of enemas and suppositories, and abdominal pain (p ≤ 0.01). Stool frequency also increased in the laxative group.

Conclusions

Biofeedback should be the treatment of choice for PFD-induced constipation.

Limitations

  • The study design was not blinded.
  • The sample was restricted to patients with normal whole-gut transit times; patients with delayed whole-gut transit times were excluded.
  • The authors insisted the success of biofeedback greatly depends on the instructor's skill.