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
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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.
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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
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Straining
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Sensation of incomplete evacuation
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Anorectal blockage
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Use of enemas or suppositories
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Abdominal pain
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Balloon defecation test
Results
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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).
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Biofeedback benefits were sustained at 12 and 24 months in all measures, but not significantly.
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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
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The study design was not blinded.
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The sample was restricted to patients with normal whole-gut transit times; patients with delayed whole-gut transit times were excluded.
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The authors insisted the success of biofeedback greatly depends on the instructor's skill.