Table 3.
Chiaironi et al (71) | Rao et al (68) | Chiaironi et al (67) | Heymen et al (69) | |
---|---|---|---|---|
Trial Design | Biofeedback vs PEG 14.6 gms | Biofeedback vs. standard vs. sham biofeedback | Biofeedback for slow transit vs Dyssynergia | Biofeedback vs Diazepam 5 mg vs placebo |
Subjects and Randomization | 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 & Number of biofeedback sessions | 3 months & 1 year, 5 weekly, 30 minute training sessions performed by physician investigator | 3 months, Biweekly, one hour, maximum of six sessions over three months, performed by biofeedback nurse therapist | 5 weekly 30 minute training sessions, performed by physician investigator | 6 bi-weekly, one hour sessions |
Primary outcomes | 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 4. Global satisfaction |
Symptom improvement
None=1 Mild=2 Fair=3 Major=4 |
Global Symptom relief |
Dyssynergia corrected or symptoms improved | 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 vs 4% sham and 6% in Standard group; CSBM= Biofeedback group vs 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 to 38% with placebo and 30 % with diazepam |
Conclusions | 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 |