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. 2016 Jun 28;22(3):423–435. doi: 10.5056/jnm16060

Table.

Summary of the Randomized Controlled Trials of Biofeedback Therapy for Dyssynergic Defecation

Chiarioni et al73 Heymen et al74 Rao et al75 Rao et al76
Trial design BT vs PEG 14.6 g/day BT vs diazepam 5 mg vs placebo BT vs standard vs sham biofeedback BT vs standard therapy
Subjects, randomization, and interventions

  • - 109 (65 females)

  • - 54 BT, 55 PEG

  • - 84 (71 females)

  • - 30 BT, 30 diazepam, 24 placebo

  • - 77 (69 females)

  • - 1:1:1 distribution

Standard = diet, exercise, titrated laxatives
Sham = progressive muscle relaxation with anorectal probe

  • - 52 (47 females) short term study then 26 (23 females) participated long term study

  • - 13 BT, 13 standard treatment
BT technique

  • - EMG-based, 5 weekly, 30 minutes/sessions

  • - performed by one physician

  • - EMG-based, 6 bi-weekly, 1 hour/sessions

  • - Manometry-based, bi-weekly, 1 hour/session, maximum of 6 sessions

  • - performed by nurse therapist

  • - Manometry-based, bi-weekly, 1 hour/ session, maximum of 6 sessions then 3 reinforcement sessions at 3-month intervals

  • - performed by nurse therapist
Primary outcomes Global improvement of symptoms (worse = 0, no improvement = 1, mild = 2, fair = 3, major improvement = 4) Adequate relief of constipation Global bowel satisfaction, CSBM, presence of dyssynergia, BET Number of CSBM/week
Follow-up duration 6th, 12th, 24th month 3rd, 6th, 12th month 3rd month 3rd, 12th month
Results (ITT analysis) Favor BT

  • - more major improvement of global symptom, 82% vs 22% at 24th month (P < 0.05)

  • - improved straining, in- complete bowel movement, blocked bowel movement, abdominal pain at 6th and 12th month (P < 0.05)

  • - more dyssynergia correction 83.3% vs 3.6% at 6th and 12th month (P < 0.05)

  • - decreased BET and urge threshold (P < 0.05) vs PEG

 Favor BT

  • - more adequate relief of constipation, 70% vs 23% vs 38% (P < 0.05, BT vs diazepam and. placebo)

  • - more SBM at 3rd month (P < 0.05, BT vs placebo)

  • - similar quality of life

  • - more pelvic floor relaxation at 3rd month (P < 0.05, BT vs diazepam)

 Favor BT

  • - improved global bowel satisfaction (≥ 20 mm VAS improved) 75% vs 63% vs 48% (P < 0.05, BT vs sham)

  • - more CSBMs (P < 0.05, BT vs standard and sham)

  • - more dyssynergia correction 79% vs 8.3% vs 4% (P < 0.05, BT vs standard and sham)

  • - decreased BET (P < 0.05, BT vs standard and sham)

 Favor BT

  • - Number of CSBM/week after treatment increased significantly in BT compared to baseline and standard treatment (P < 0.05)

  • - Significantly more dyssynergia pattern normalized, decreased BET (P < 0.05 BT vs standard treatment)

BT, biofeedback therapy; PEG, polyethylene glycol; EMG, electromyography; CSBM, complete spontaneous bowel movement; ITT, intention to treat; BET, balloon expulsion time; SBM, spontaneous bowel movement; VAS, visual analog scale.