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. Author manuscript; available in PMC: 2012 Feb 1.
Published in final edited form as: Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):159–166. doi: 10.1016/j.bpg.2011.01.004

Table 2.

Summary of the randomized controlled trials of biofeedback therapy for Dyssynergic Defecation

Chiaironi et al (18) Rao et al (11) Chiaironi et al (10) Heymen et al (13) Rao et al 912)
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
Biofeedback vs Standard
therapy
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
52; Short term therapy
26= long term study
12= biofeedback
13= standard therapy
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 One year;
6 active therapy sessions and 3
reinforcement sessions at 3
month intervals
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  Number of complete
spontaneous bowel
movements

Secondary Outcome;
 Presence of dyssynergia
 Balloon expulsion time
 Global satisfaction
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
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)
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
Biofeedback is superior to
standard therapy
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