Glia 1997.
Methods | Study design: randomised controlled trial Total study duration: six month follow‐up following five week intervention |
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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 |
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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 |
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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 |
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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 |