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. Author manuscript; available in PMC: 2016 May 1.
Published in final edited form as: Neurogastroenterol Motil. 2015 Apr 1;27(5):594–609. doi: 10.1111/nmo.12520

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
  1. Presence of dyssynergia

  2. Balloon expulsion time

  3. Number of complete spontaneous bowel movements

  4. Global satisfaction

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