| Methods |
Cross‐over randomised controlled trial |
| Participants |
17 patients (4 women) with 'J' configuration ileoanal pouches 1 to 4 months after closure of diverting ileostomy (8 patients with ulcerative colitis and 9 with familial adenomatous polyposis)
Mean age 34 years (range 21 to 45, SD 6.51)
Exclusion criteria: none specified |
| Interventions |
A: sodium valproate 400 mg
B: placebo
Dose: four times a day
Length of treatment: two one‐week treatment periods with a three day washout period
Dose titration: no |
| Outcomes |
Number with FI (soiling): A: 3/17, B: 10/17
Stool frequency (n, mean SD): A: 17, 5.98 (2.97), B: 17, 9.65 (4.1)
Adverse effects: A: 6 people experienced nausea and 2 abdominal pain (8/17), B: 0/17
Perianal skin irritation due to contact with faeces: A:3/17, B: 9/17
Anal canal resting pressure, mm Hg (n, mean, SD) (at 7 days): A: 17, 63.6 (12.4), B: 17, 42.5 (8.9)
Anal canal motility (amplitude, frequency and voluntary contractions) |
| Notes |
Sodium valproate has contractile effects on the internal anal sphincter
Patients ate a controlled hospital diet and took no other drugs |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not specified. Reported as "The valproate sodium and placebo series were carried out in random order" |
| Allocation concealment (selection bias) |
Unclear risk |
Not specified |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not specified |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not specified |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No incomplete data |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not assessed |
| Was use of a cross over design appropriate? |
Unclear 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? |
Low risk |
There was a 3‐day washout period |
