Jaffar 2006

Methods	Study design: randomised controlled trial Setting/location: Saudi Arabia (Bahrain) Study period: 12 months Sample size calculation: not described
Participants	Type of Leishmania: not described Inclusion criteria: proved positive for Leishmania parasites (amastigotes) on microscopic examination or biopsy Exclusion criteria: not described N randomised: 62. Rifampicin: 46; placebo: 16. Rifampicin: 2 groups were analysed; group 1a (children aged 3‐11 years ‐ mean age, 7.5 years), and group 1b (adults aged 12‐65 years ‐ mean age, 33 years). 32 participants enrolled in group 1a and 30 in group 1b. Out of these, 8 participants in each group (16 in total) served as control to receive the placebo. Withdrawals: 21 participants lost to follow‐up. Rifampicin: 12; placebo: 9 N assessed: 41. Rifampicin: 34; placebo: 7. Number participants imbalanced between groups Age: range 3‐65 years; mean 20 years Sex (male/female): 43/19 Baseline data: the duration of the lesions varied between 1 and 12 months (mean 2.6 months). The lesions of CL were single or multiple and were mostly over the extremities (upper limbs 51% and lower limbs 38%) and to a lesser extent on the face 30%. Most of the lesions were active being nodular, nodule‐ulcerative, or ulcerative. 2 of the participants were members of the same family. However, the rest of the participants had a negative family history.
Interventions	Type of interventions: Group 1: rifampicin orally in a dose of 10 mg/kg/d Group 2: placebo Duration of intervention: 2 equally divided doses during meals for 4‐6 weeks Duration of follow‐up: 3 months
Outcomes	Primary outcome: percentage of participants 'cured' 3 months after treatment Secondary outcomes: duration of remission and percentage of people with treated lesions that recur up to 3 months of follow‐up Adverse effects
Notes	Study funding sources: not reported Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Randomized" Comment: insufficient detail was reported about the method used to generate the allocation sequence
Allocation concealment (selection bias)	Unclear risk	Comment: "Randomized" but no further information was provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Each subject in the control group was given placebo, which was supplied, in capsules/suspension identical in shape and colour to that given in the rifampicin group." Participants look blinded but no information about personnel were provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: "Double‐blinded" but no further information
Incomplete outcome data (attrition bias) All outcomes	High risk	There is a 38.87% of follow‐up, the percentage is very different between the groups, and it isn't explained.
Selective reporting (reporting bias)	High risk	No adverse effects data available
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported