Faried 2010.
| Methods | Study design: randomised controlled trial Total study duration: 1 year |
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| Participants | 60 patients seen during recruitment period (> 3 years) met Rome II criteria for functional constipation and unresponsive to laxatives Anismus diagnosed as non‐relaxing external anal sphincter, inability to expel water‐filled balloon, non‐relaxing puborectalis, prolonged evacuation time 17 male, 43 female Mean age 37.53 years (range 20 to 69 years) No difference between groups at baseline NB: demographic data for patients in two groups of this study are identical to the patients in Farid 2009 |
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| Interventions |
Intervention group: Biofeedback (n = 20) Two times per week for one month (8 sessions), expert therapist Each session 30 minutes as out‐patient Explanation of pelvic floor and own test results Pressure‐based biofeedback learning to expel 50 mL balloon and push down with abdominal muscles using 'trial and error' Continued periodic supervision for 6 months if successful Comparison groups: 1.Botulinum toxin (BTX‐A) (n = 20) into left and right sides of puborectalis and EAS as outpatient 2.Bilateral open partial division of puborectalis (n = 20) under GA |
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| Outcomes | Primary end point ‐ 'improvement in bowel habits' using symptom questionnaire (unspecified ‐ possibly Cleveland Clinic Score) at 1 month Success defined as bowel habits that 'returned to normal' Secondary endpoints: complications, satisfaction using visual analogue scale (change of at least 2 out of 10 score) post‐operative incontinence, anorectal manometry balloon expulsion test, defecography and EMG of anal sphincter |
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| Notes | It is noted that the authors report screening consecutive patients referred to the same unit over the same time period, with identical demographics, for both this study (biofeedback and botulinum toxin‐A arms) and for Farid 2009, suggesting that the two papers report the same study, however with major inconsistencies in reporting details This is a major concern |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated randomisation sequence |
| 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 | Low risk | No attrition |
| Selective reporting (reporting bias) | Unclear risk | Not registered on a clinical trials registry |
| Other bias | High risk | See comments in table above |