Lumi 2009.

Methods	Randomised controlled trial
Participants	Adults patients > 21 years old who, having undergone coloproctectomy with ileoanal anastomosis and J‐shaped ileal reservoir, presented with nocturnal faecal incontinence Exclusion criteria: associated anal pathology, active pouchitis, stenotic ileoanal anastomosis, concomitant treatment with loperamide, monoaminoxidase inhibitors and/or tricyclic antidepressants, pregnancy, narrow angle glaucoma, uncontrolled arterial hypertension/coronary disease/cardiac arrhythmias/aortic aneurysm, epilepsy 37 patients initially identified from 98 interviews Reasons for non ‐ inclusion/withdrawal: 9 with associated anal pathology or intercurrent illness, 9 did not complete previous evaluations, 4 refused to participate, 3 did not complete treatment 12 participants included in final analysis Group A: 5 (2 men, 3 women. Mean age: 49.0 [Range 27‐62]) Group B: 7 (6 men,1 woman. Mean age: 38.7 [Range: 24‐63])
Interventions	A: Cream with active ingredient (10% phenylephrine) B: Placebo cream 0.5 mg cream to be applied digitally around anal margin by patients before going to bed Length of treatment: 1 month (number of days unclear). A faecal incontinence diary was kept for 21 days before treatment and during the treatment month. All patients received 3.5g Plantago ovata thereby guaranteeing minimal fibre intake. Liquid intake restricted to 1.5 L/day
Outcomes	Occurence of faecal incontinence during treatment; median (range) Group A: 5.4 (0‐14) Group B: 9 (0‐19)
Notes	9 patients with ulcerative colitis (Group A; 5 Group B; 4,). 3 patients previously operated for Familial Adenomatous Polyposis (all Group B). Inconsistent with exclusion criteria of the trial (associated anal pathology). Discrepancy between text and table: texts states 3 men in group A whereas table states 2 men
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	'Fueron randomizados en dos grupos (A) y (B), utilizando la técnica de muestreo en bloque' 'They were randomised into two groups (A) and (B), using the technique of block sampling'
Allocation concealment (selection bias)	Unclear risk	None mentioned
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Technique not mentioned
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Technique not mentioned
Incomplete outcome data (attrition bias) All outcomes	High risk	Two participants in Group B and 1 in Group A did not complete treatment, these results were not included in final analysis
Selective reporting (reporting bias)	High risk	Results of two participants not completing trial not reported
Was use of a cross over design appropriate?	Low risk	This is a randomised controlled trial and not a cross‐over trial and this domain of 'Risk of bias' assessment is not applicable and would be judged as low risk.
Is it clear that the order of receiving treatment was randomised?	Low risk	This is a randomised controlled trial and not a cross‐over trial and this domain of 'Risk of bias' assessment is not applicable and would be judged as low risk.
Can it be assumed that the trial was not biased from carry over effects?	Low risk	This is a randomised controlled trial and not a cross‐over trial and this domain of 'Risk of bias' assessment is not applicable and would be judged as low risk.