Chang 2003.
Methods | Study design: randomised controlled trial Total study duration: 10 to 12 days ‐ no long‐term follow‐up beyond end of treatment |
|
Participants | 22 patients selected from 130 consecutive referrals who met Rome II criteria for functional constipation and were thought to have 'impaired rectal sensation' defined as rectal sensory threshold volume for desire to defecate of > 90 mL Electrical stimulation: n = 12 (5 male, 7 female) (Age ‐ mean 41 years (range 18 to 71 years) Electromyograph (EMG) biofeedback: n = 10 (6 male 4 female) (Age ‐ mean 53 years (range 28 to 74 years) Duration of symptoms not reported Baseline comparability‐ reported 'no significant difference', but no P values were reported |
|
Interventions |
Intervention group: Electrical stimulation using anal plug with pulse generator introduced into the anal canal 'Variant stimulation' parameters scheduled individually within pre‐specified range Performed for 20 minutes daily for 10 to 12 sessions Comparison group: EMG biofeedback with visual changes in pressure activity displayed on monitor 10 to 14 sessions lasting 60 to 90 minutes (frequency not reported) |
|
Outcomes | Symptom questionnaire (bowel frequency and urge, satisfaction with bowel habit, straining, sensation of incomplete evacuation, anal obstruction scored on VAS) Anorectal manometry immediately before and after each treatment Rectal sensation measured using balloon distention |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
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 | Unclear risk | Disproportionate number of male participants compared with usual biofeedback population |