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. 2014 Mar 26;2014(3):CD008486. doi: 10.1002/14651858.CD008486.pub2

Glia 1997.

Methods Study design: randomised controlled trial
Total study duration: six month follow‐up following five week intervention
Participants 26 consecutive patients with functional constipation ‐ based on Rome I criteria ‐ organic lesions excluded
Proportion of females or males not reported. Age ‐ mean 55 years (range 28 to 78 years); duration of symptoms ‐ mean 11 years (range 1 to 35 years)
10 patients had rectocele, 1 had enterocele, 11 had intussusception and 4 had rectal prolapse
Baseline comparability between groups not reported
Interventions Intervention group:
Manometry Biofeedback 1 to 2 sessions per week for maximum of 10 sessions
Pressure‐based training using four‐lumen catheter ‐ patients were allowed to view manometric recordings of pressure and encouraged to relax anal sphincter during balloon expulsion
Comparison group:
EMG biofeedback using bilateral surface electrodes, same frequency as manometry
Outcomes Balloon expulsion test of 60 mL water filled balloon.
Whole gut transit
Anorectal manometry and EMG
Bowel symptom diary daily for 1 week
Global rating of treatment effect: worse or unaltered or better
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer randomised sequence generation
Allocation concealment (selection bias) Low risk Sealed opaque envelopes
Blinding (performance bias and detection bias) 
 All outcomes High risk Not blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk High attrition (six participants from 26, but three from each group) and no intention‐to‐treat analysis
Selective reporting (reporting bias) Unclear risk Not registered on a clinical trials registry
Other bias Unclear risk Recruitment bias and power unclear