Table 2.
Summary of randomized controlled trials of biofeedback therapy for Dyssynergic Defecation
| Rao et al (11) | Rao et al (12) | Chiarioni et al (13) | Heymen et al (14) | Chiarioni et al (15) | |
|---|---|---|---|---|---|
| Trial Design | Biofeedback (manometry pressure) vs. Standard treatment vs. Sham biofeedback |
Biofeedback (Manometry pressure) vs Standard therapy |
EMG Biofeedback for slow transit vs Dyssynergia |
EMG Biofeedback vs Diazepam 5 mg vs placebo |
EMG Biofeedback vs PEG 14.6 gms |
| Subjects and Randomization and Intervention(s) |
77 (69 women) 1:1:1 distribution Standard: diet, exercise, laxatives Sham: Progressive muscle relaxation with anorectal probe |
52; Short term therapy 26= long term study 12= biofeedback 13= standard therapy Standard: diet, exercise, laxatives (titrated) |
52 (49 women) 34 dyssynergia 12 slow transit 6 mixed |
84 (71 women) 30 biofeedback 30 diazepam 24 placebo |
109 (104 women) 54 biofeedback 55 polyethylene glycol |
| Duration & Number of biofeedback sessions |
3 months, Biweekly, one hour, maximum of six sessions over three months, performed by biofeedback nurse therapist |
One year; 6 active therapy sessions and 3 reinforcement sessions at 3 month intervals |
5 weekly 30 minute training sessions, performed by physician investigator |
6 bi-weekly, one hour sessions |
3 months & 1 year, 5 weekly, 30 minute training sessions performed by physician investigator |
| Primary outcomes |
|
Number of complete spontaneous bowel movements Secondary Outcome; Presence of dyssynergia Balloon expulsion time Global satisfaction |
Symptom improvement None=1 Mild=2 Fair=3 Major=4 |
Global Symptom relief | Global Improvement of symptoms Worse=0 No improvement=1 Mild=2 Fair=3 Major improvement=4 |
| Dyssynergia corrected or symptoms improved |
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 |
No of CSBM/week increased significantly in biofeedback 9p<0.001 Dyssynergia pattern normalized 9p<0.0010 Balloon expulsion improved (p<0.001) Colonic transit normalized (p<0.01) |
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, (p<0.01) |
79.6% reported major improvement at 6 and 12 months 81.5% reported major improvement at 24 months |
| Conclusions | Biofeedback was superior to sham feedback and standard therapy |
Biofeedback is superior to standard therapy |
Biofeedback benefits dyssynergia and not slow transit constipation |
Biofeedback is superior to placebo and diazepam |
Biofeedback was superior to laxatives |