| Methods |
Cross‐over randomised controlled trial |
| Participants |
15 people (14 women) with chronic diarrhoea and FI
Range of severity of FI: once a day to once a month
Mixed aetiology of diarrhoea
Age: 31 to 70 years
Exclusion criteria: none specified |
| Interventions |
A: diphenoxylate (2.5 mg) plus atropine sulfate (25 mcg)
B: placebo
Length of treatment: 3 days, with one day of washout
Dose: 1 or 2 tablets, four times a day
Dose titration: not clearly reported. The first four patients were treated with two tablets every six hours (standard treatment). However, the 4th patient experienced abdominal pain and the dose was reduced in subsequent patients from 2 to 1 tablet every six hours. |
| Outcomes |
Failure rate (number not continent): A: 0/15, B: 3/15
Failure to improve (in stool weight and frequency): A: 3/15, B: 3/15
Stool frequency (n, mean, SD): A: 15, 2.6 (2.7), B: 15, 4.9 (3.1)
Stool weight (n, mean, SD): A: 15, 256 (333), B: 460 (150)
Anal canal resting pressure, mm Hg (n, mean, SD): A: 15, 41 (23), B: 15, 39 (19)
Anal canal maximum squeeze pressure, mm Hg, (n, mean, SD): A: 15, 94 (68), B: 15, 96 (68)
Duration of squeeze, seconds, (n, mean, SD): A: 15, 87 (128), B: 15, 86 (128)
Sensory threshold, rectal balloon distension, cm water: 15, 12 (12), B: 15, 31 (62)
Saline retention (continence) test, mL water: A: 15, 492 (461), B: 15, 486 (445)
Adverse effects: not reported. |
| Notes |
Patients were admitted to hospital and given a standardised diet |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Reported as "patients were randomized in a double‐blind fashion", however method of sequence generation not specified. |
| Allocation concealment (selection bias) |
Unclear risk |
Not specified. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
"Neither the patients, the laboratory personnel, nor the physicians in charge knew when the patients were lomotil or when they were on placebo until the code was broken after the experiment was completed". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
"Neither the patients, the laboratory personnel, nor the physicians in charge knew when the patients were lomotil or when they were on placebo until the code was broken after the experiment was completed". |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
reported data of only those participants who completed the trial as reported "data on this 4th patient are not included ion this paper...........". The excluded patient had "severe abdominal discomfort" the cause of which is not specified. |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available |
| 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 specified |
| Can it be assumed that the trial was not biased from carry over effects? |
High risk |
No washout period |
