Kochar 2006

Methods	Study design: randomised controlled trial Setting/location: hospital, Bikaner, India Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: L tropica Inclusion criteria: participants with a confirmed diagnosis of anthroponotic CL. Exclusion criteria: — N randomised: 50. Intervention group: 25, placebo group: 25 Withdrawals: 6 lost to follow‐up. Intervention group: 2, placebo group: 4 N assessed: 44. Intervention group: 23, placebo group: 21 Age: intervention group: n = 12, 16‐20 years; n = 5, 21‐30 years; n = 3, 31‐40 years; n = 2, 41‐50 years; n = 2, 51‐60 years; n = 0, 61‐70 years. Placebo group: n = 10, 16‐20 years; n = 4, 21‐30 years; n = 5, 31‐40 years; n = 3, 41‐50 years; n = 2, 51‐60 years; n = 1, 61‐70 years Sex (male/female): 34/16. Intervention group: 17/8; placebo group: 17/8 Male predominance was probably due to the habit of sleeping in open spaces outside the house without mosquito nets and improper clothing during night when the sandflies are active. Baseline data: Type of lesion: Intervention group: erythematous nodular: 11; erythematous plaque: 3; ulcerative: 3; erythematous ulcerative: 2; nodular: 4; nodular ulcerative: 2 Placebo group: erythematous nodular: 9; erythematous plaque: 5; ulcerative: 2; erythematous ulcerative: 5; nodular: 2; nodular ulcerative: 2 Ratio lesions:participant Intervention group: 1:14; 2:5; 3:5; > 3:1 Placebo group: 1:14; 2:7; 3:4; > 3:0 Distribution of lesions: Intervention group: face: 4; neck: 3; arms: 6; hand: 9; back: 2; abdomen: 1; buttock: 1; legs: 4; foot: 3 Placebo group: face: 11; neck: 2; arms: 6; hand: 9; back: 2; abdomen: 3; buttock: 1; legs: 3; foot: 4 Most cases were presented with 1 to 3 months of duration of the disease.
Interventions	Type of interventions: Group 1: rifampicin (1200 mg/d) in 2 divided doses + omeprazole 20 mg Group 2: placebo Duration of intervention: 6 weeks Duration of follow‐up: 6 weeks
Outcomes	Healing rates: percentage of participants 'cured' at the end of treatment: complete healing; partial response; no response Time points reported: at the end of treatment
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	"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 provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: "Double‐blinded" but no further information provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: "Double‐blinded" but no further information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across group
Selective reporting (reporting bias)	High risk	Comment: no adverse effects information reported
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.