Chassagne 2000.

Methods	Randomised controlled trial
Participants	206 people (145 women) with at least weekly faecal incontinence associated with chronic rectal emptying (40% of patients had daily faecal incontinence for more than 2 years). 178 were available for analysis after the first week of treatment. Patients were aged 65 years or older and residents of long‐term care units. Mean age: 85.3 years Characteristics of patients were comparable at baseline but not given after losses to follow‐up
Interventions	A: 30 g per day of a single osmotic laxative (lactulose) B: 30 g of an osmotic laxative (lactulose), along with daily glycerine suppository and a tap‐water enema once a week Length of treatment: 8 weeks Dose titration: no
Outcomes	Mean number of FI episodes per week (n, mean, SD): A: 61, 6 (2.9), B: 62, 6 (2.7) (P = 0.9 after 4 weeks) Mean number of bedding and/or clothing changes per week (n, mean, SD): A: 61, 20 (4), B: 62, 19.5 (5.2) (P = 0.55 after 4 weeks) Incidents of FI per day per participant: A: 0.85, B: 0.84 Incidents of soiled laundry per day per participant: A: 2.9, B: 2.8 Adverse effects: not reported.
Notes	Higher dropout rate in Group I than in Group II Results not clearly reported Number of 'responders' and 'non‐responders' were assessed only in Group II No differences in subgroup analyses according to cognitive or mobility impairment, or between centres
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Reported as "prospective randomized study" but the method of sequence generation not specified
Allocation concealment (selection bias)	Unclear risk	Reported as "prospective randomized study" and it is not specified whether or not the allocation was concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	"This study could be randomized but not blinded because outcomes were measured daily and because the treatment was provided by the nursing staff."
Blinding of outcome assessment (detection bias) All outcomes	High risk	"This study could be randomized but not blinded because outcomes were measured daily and because the treatment was provided by the nursing staff."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No missing data, however 32 participants in Group I and 23 participants in Group II withdrew from the trial.
Selective reporting (reporting bias)	Unclear risk	Protocol not available
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.