| Methods |
Cross‐over randomised controlled trial. |
| Participants |
30 adults (8 women) with ileoanal pouches (16 handsewn and 14 stapled), performed for ulcerative colitis. Groups combined for analysis
Median age: 38 years (range 26 to 61)
Exclusion criteria: not specified |
| Interventions |
A: loperamide 4 mg three times a day
B: placebo
Duration of treatment: 8 day treatment periods with 7 day washout period.
Dose titration: no |
| Outcomes |
Number experiencing soiling, day: A: 3/28, B: 7/28; night: A: 1/28, B: 11/28
Number using pads, day: A: 1/28, B: 3/28; night: A: 1/28, B: 6/28
Defecation frequency (n, mean, SD): A: 28, 4.24 (1.86), B: 28, 6.43 (1.99)
Anal canal resting pressure, mm Hg (n, mean, SD): A: 28, 62 (16), B: 28, 55 (9)
Anal canal maximum squeeze pressure, mm Hg, (n, mean, SD): A: 28, 223 (82), B: 28, 219 (93)
Pouch volumetry and contractility.
Sensory threshold, rectal balloon distension, cm water, for 'sensation of filling' and 'defecation urge' (n, mean, SD): A: 28, 30 (12), B: 28, 27 (15)
Recto/pouch ‐ anal reflex inhibition on distension.
No adverse effects. |
| Notes |
Patients were asked to keep to usual meal times and diet.
Data from two groups combined, and converted from medians and 95% CIs to means and SDs. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not specified |
| Allocation concealment (selection bias) |
Unclear risk |
Not specified |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Reported as "double blinded" and used "identical capsule" therefore participants must be blinded. Not sure about personnel |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not reported |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No complete data |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available |
| Was use of a cross over design appropriate? |
Low risk |
Seems appropriate with seven days washout period in between. |
| Is it clear that the order of receiving treatment was randomised? |
Unclear risk |
Method of randomisation not specified |
| Can it be assumed that the trial was not biased from carry over effects? |
Low risk |
There was seven days washout period |
