Table 1.
Summary of the randomized controlled trials of biofeedback therapy for dyssynergic defecation
| Rao et al (35) | Chiarioni et al (32) | Rao et al (86) | Chiarioni et al (34) |
Heymen et al (33) | |
|---|---|---|---|---|---|
| Trial Design | Biofeedback versus standard | Biofeedback versus polyethylene glycol, 14.6 g | Biofeedback versus standard versus sham biofeedback | Biofeedback for slow transit versus dyssynergia | Biofeedback versus diazepam, 5 mg, versus placebo |
| Subjects and randomization | 26 (23 women) 13 Biofeedback 13 standard |
104 women 54 biofeedback 55 polyethylene glycol |
77 (69 women) 1:1:1 distribution |
52 (49 women) 34 dyssynergia 12 slow transit 6 mixed |
84 (71 women) 30 biofeedback 30 diazepam 24 placebo |
| Duration and number of biofeedback sessions | 3 months 6,9,12, months reinforcement sessions |
3 months and 1 year, 5 weekly, 30-minute training sessions performed by physician investigator | 3 months, biweekly, 1 hour, maximum of six sessions over 3 months, performed by biofeedback nurse therapist | Five weekly 30-minute training sessions, performed by physician investigator | Six biweekly, 1-hour sessions |
| Primary outcomes | Number of complete spontaneous bowel movements (CSBM) | Global improvement of symptoms Worse=0 No improvement=1 Mild=2 Fair=3 Major improvement=4 |
1. Presence of dyssynergia 2. Balloon expulsion time 3. Number of complete spontaneous bowel movements (CSBM) 4. Global satisfaction |
Symptom improvement None=1 Mild=2 Fair=3 Major=4 |
Global symptom relief |
| Dyssynergia corrected or symptoms improved | The number of CSBMs per week increased significantly (P<0.001) in the biofeedback group | 79.6% reported major improvement at 6 and 12 months, 81.5% reported major improvement at 24 months |
Dyssynergia corrected at 3 months in 79% with biofeedback versus 4% sham and 6% in standard group; CSBM=biofeedback group versus sham or standard, p<0.05 | 71% with dyssynergia and 8% with slow transit alone reported fair improvement in symptoms | 70% improved with biofeedback compared with 38% with placebo and 30% with diazepam |
| Conclusions | Biofeedback provided sustained improvement compared to standard therapy | Biofeedback was superior to laxatives | Biofeedback was superior to sham feedback and standard therapy | Biofeedback benefits dyssynergia and not slow transit constipation | Biofeedback is superior to placebo and diazepam |