Biofeedback

Biofeedback

PEP Topic 
Constipation
Description 

Biofeedback is a treatment method that uses monitoring devices and information to help people consciously control physical processes such as heart rate, blood pressure, temperature, sweating, and muscle tension that are usually controlled automatically. Biofeedback therapy for constipation focuses on training the person to relax the pelvic floor and anal sphincter. Different types of equipment can be used, such as balloons inserted into the rectum and electrical devices to determine muscle contraction. Biofeedback for constipation has not been specifically studied in patients with cancer.

Effectiveness Not Established

Research Evidence Summaries

Chiarioni, G., Salandini, L., & Whitehead, W.E. (2005). Biofeedback benefits only patients with outlet dysfunction, not patients with isolated slow transit constipation. Gastroenterology, 129, 86–97.

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Study Purpose:

To compare the efficacy of biofeedback in pelvic function dyssynergia–induced constipation (PFD) versus slow transit constipation (STC).

Intervention Characteristics/Basic Study Process:

All subjects received five weekly biofeedback lessons and were assessed at 1, 6, 12, and 24 months.

Sample Characteristics:

  • The study reported on a sample of 75 consecutive patients who were referred to a gastroenterology clinic hospital for refractory, long-standing constipation and met inclusion criteria.
  • Fifty-two patients had delayed whole-gut transit issues, 34 had PFD, and 12 had STC.

Setting:

Gastroenterology Clinic of the Division of Gastrointestinal Rehabilitation of the University of Verona in Valeggio sul Mincio, Italy

Study Design:

This was a quasi-experimental study.

Measurement Instruments/Methods:

  • Anorectal manometry at one and six months
  • Questionnaire and balloon defecation test at 1, 6, 12, and 24 months

Results:

At six months, greater improvements were seen in patients with PFD compared to those with STC: 71% versus 8% reported improved satisfaction (p = 0.001), and 76% versus 8% reported three or more bowel movements per week (p ≤ 0.001).

Conclusions:

Patients with PFD received greater benefit from biofeedback than those with STC.

Limitations:

  • The sample size was small (less than 100).
  • The study design was not randomized and used a two-group comparison without controls.

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: 10.1053/j.gastro.2005.11.014
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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.

Systematic Review/Meta-Analysis

Koh, C.E., Young, C.J., Young, J.M., & Solomon, M.J. (2008). Systematic review of randomized controlled trials of the effectiveness of biofeedback for pelvic floor dysfunction. British Journal of Surgery, 95, 1079–1087.

doi: 10.1002/bjs.6303
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Purpose:

To determine whether biofeedback improves outcomes for patients with pelvic floor dysfunction (PFD), and to assess the relative effectiveness of different types of biofeedback therapy.

Search Strategy:

Databases searched were CINAHL, Embase, Medline, PsycINFO, Evidence-Based Medicine Reviews (EBMR), and the Cochrane Database. References of retrieved articles also were hand searched.

Search keywords were constipation, anismus, dyssynergia, obstructive defecation, rectocele, rectal intussusception, rectal prolapse, ​and biofeedback.

Studies were included in the review if they

  • Were randomized controlled trials (RCTs)
  • Reported on adults with PFD
  • Included biofeedback as at least one of the treatments studied.

Studies were excluded from the review if they reported on pediatric cases.

Literature Evaluated:

The initial searching provided 5,028 references. Study selection and screening for inclusion criteria provided a final set of seven studies. Study quality was evaluated by two reviewers.

Sample Characteristics:

  • The final sample of seven RCTs included 413 patients.
  • Sample sizes ranged from 26 to 109.
  • Medical diagnostic information across studies was not provided.

Results:

  • Three trials compared biofeedback with other interventions such as laxatives, diazepam, and placebo. Meta-analysis showed an odds ratio (OR) of 5.861 (95% confidence interval [CI] [2.175, 15.794], p < 0.001) in favor of biofeedback.
  • Four trials compared differences in biofeedback techniques. A meta-analysis of the most widely used technique, electromyogram biofeedback, showed an OR of 6.738 (95% CI [2.194, 15.58], p < 0.001) in favor of biofeedback.

Limitations:

  • Results suggest biofeedback is associated with symptomatic relief of constipation; however, the number of studies included was very small and substantial heterogeneity existed across studies.
  • Study quality overall was poor.
  • Findings are not specific to the oncology population, and whether any of the studies included patients with cancer is not known.

Nursing Implications:

Additional, better-designed studies are needed in this area to determine efficacy. Future studies should compare different biofeedback modalities to identify the most effective approaches.


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