| Methods |
Cross‐over randomised controlled trial |
| Participants |
36 adults (22 women) with passive FI and structurally intact anal sphincters
Mean age 58 years (range 28 to 81)
Mean duration of faecal incontinence: 5 years (SD 4)
Characteristics of patients were comparable at baseline
Exclusion criteria: disruption of anal sphincter muscle on endoanal ultrasound examination, concomitant use of tricyclic or mono‐amine oxidase inhibitors, hypertension, aortic aneurysm or ischaemic heart disease, pregnancy, inflammatory bowel disease and surgically repairable sphincter damage. |
| Interventions |
A: 10% phenylephrine gel
B: placebo gel (0.5 mL), both used anally twice a day
Length of treatment: 4 weeks (two four‐week treatment periods with a one‐week washout period)
Dose titration: the choice of 10% phenylephrine gel was based on previous pilot studies on healthy volunteers |
| Outcomes |
Subjective cure: A: 0/36, B: 0/36
Subjective improvement in symptoms: A: 6/36, B: 2/36 [A: 28% versus B: 9% at the end of the first trial period]
Incontinence score (n, mean, SD): A: 18, 12.5 (3.4), B: 18, 12.6 (4.2) (no difference)
Adverse effects: A: 3/36, B: 0/36 (localised mild dermatitis, settled when drug stopped)
Maximum anal resting pressure (n, mean, SD): A: 18, 65 (21), B: 18, 54 (21) (no difference)
Anodermal blood flow (no change) |
| Notes |
15 patients continued with loperamide during the study
Sample size calculation pre‐stated (16 patients required)
Suggestion of an interaction between treatment and placebo periods, possibly reflecting an insufficient washout period |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Randomisation was carried out by a pharmacist by means of computer generated random numbers" |
| Allocation concealment (selection bias) |
Low risk |
"The randomization code was kept in the hospital pharmacy and made known to the investigators only after analysis of the completed study." |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Repored as "double‐blind" trial but it is not specified who was blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Repored as "double‐blind" trial but it is not specified who was blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No incomplete data |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available |
| Was use of a cross over design appropriate? |
Low risk |
Yes |
| Is it clear that the order of receiving treatment was randomised? |
Low risk |
Used computer‐generated random numbers. |
| Can it be assumed that the trial was not biased from carry over effects? |
Unclear risk |
"4 weeks treatment periods separated by a 1 week washout period" |
