| Methods |
Cross‐over randomised controlled trial |
| Participants |
26 patients (16 women) with chronic diarrhoea and FI
Heterogeneous group of patients with diarrhoea due to irritable bowel syndrome (n = 11), Crohn's disease (n = 2), ulcerative colitis (n = 1), diabetes mellitus (n = 2) and others including a group who were undiagnosed despite extensive tests
Mean age 45 years (range 24 to 82)
Exclusion criteria: none specified |
| Interventions |
A: loperamide 4 mg three times a day
B: placebo
Length of treatment: two one‐week treatment periods
Washout period: not specified
Dose titration: no |
| Outcomes |
Episodes of FI per week (n, mean number, range): A: 26, 0.6 (0 to 6), B: 26, 0.9 (0 to 6), P < 0.01
Improvement (number having fewer incontinence episodes): A: 7/26, B: 2/26
Episodes of faecal urgency per week (n, mean number, range): A: 26, 1.52 (0 to 7), B: 26, 5.3 (0 to 27), P < 0.001
Improvement (number having fewer episodes of faecal urgency): A: 19/26, B: 3/26
Bowel movements per week (n, mean, range): A: 26, 11 (1 to 44), B: 26, 17 (0 to 54), P < 0.001
24‐hour stool weight (n, mean g, range): A: 26, 102 (0 to 467), B: 26, 186 (0 to 466), P < 0.001
Per cent unformed stool per week (mean %, range): A: 40% (0 to 100), B: 57% (0 to 100), P < 0.001
Adverse effects (all mild): A: 18/26, B: 1/26 (constipation 11; abdominal pain 2; nausea and vomiting 3; exacerbation of diarrhoea 4)
Anal canal resting pressure (n, mean cm water, SD): A: 26, 84 (31), B: 26, 73 (31), P < 0.05
Anal canal maximum squeeze pressures: increased (but still below normal range) by loperamide only in the 17 participants who could not retain rectal saline. Within normal range in the 9 participants who could retain saline
Saline continence test (volume (mL water) at which first leak occurs, n, mean, SEM): A: 17, 950 (110), B: 17, 510 (100), P < 0.005
Recovery of rectoanal inhibitory reflex improved by loperamide (P < 0.05)
Rectal compliance enhanced by loperamide |
| Notes |
Some data only presented graphically, data calculated by approximate measurement
Data analysed using Wilcoxon's rank sum test for paired data, and Student's t test for paired data |
| 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 |
It is stated that "Neither the patient, physician, or technician was aware of the preparation taken during the week. Finally, the technician who performed the objective tests was, in most instances, unaware of the subjective improvement of the patient during the previous week" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
It is stated that "Neither the patient, physician, or technician was aware of the preparation taken during the week. Finally, the technician who performed the objective tests was, in most instances, unaware of the subjective improvement of the patient during the previous week" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No incomplete data |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available however, all the outcomes mentioned in the method section were reported |
| Was use of a cross over design appropriate? |
Low risk |
Seems appropriate |
| Is it clear that the order of receiving treatment was randomised? |
Unclear risk |
Not stated |
| Can it be assumed that the trial was not biased from carry over effects? |
High risk |
No washout period |
