Nilforoushzadeh 2008

Methods	Study design: randomised, prospective, double‐blind trial Setting/location: Skin Diseases and Leishmaniasis Research Center. Isfahan, Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: L tropica and L major Inclusion criteria: all the participants had positive smear for Leishmania body and had not received any topical or systemic therapy for leishmaniasis, aged 7‐70 years, lesion not more than 3 months Exclusion criteria: pregnant or lactating; history of cardiac, renal, hepatic diseases; any contraindication for the treatment N randomised: 150. Group 1: 50; group 2: 50; group 3: 50 Withdrawals: 26. Group 1: 7; group 2: 14; group 3: 5 N assessed: 124 (82.66%). Group 1: 43 (86%); group 2: 36 (72%); group 3: 45 (90%) Mean (SD) age: group 1: 33.1 years (17.5); group 2: 27.8 years (9.8); group 3: 29.1 years (14.7) Sex (male/female): 88 (70.97%)/36 (29.03%) Group 1: 32 (74.4%)/11 (25.6%) Group 2: 23 (63.9%)/13 (36.1%) Group 3: 33 (73.3%)/12 (26.66%) Baseline data: Type of lesion (no numbers): papule, nodule, plaque, ulcer, sporotrichid Location of lesion (no numbers): face and neck, upper extremity, lower extremity, trunk
Interventions	Type of interventions: Group 1: IMMA 60 mg/kg/d + placebo Group 2: IMMA 30 mg/kg/d + 40 mg oral omeprazole for 3 weeks. Low dose of MA was prepared by adding normal saline to MA Group 3: IMMA 30 mg/kg/d + oral placebo for 3 weeks The oral placebo was identical in appearance to omeprazole capsules and was administered in the similar way Duration of intervention: 3 weeks
Outcomes	Clinical cure: rate of complete response, 3 months (12 weeks) after starting treatment. Scale: complete healing of the lesions was regarded as complete clinical and parasitological healing (negative direct smear). Partial healing of the lesions was regarded as decrease of the size and indurations of the lesions, and no response was regarded as no clinical change or progression of the lesions. Time to healing: proportion of complete improvement in the 3 groups during the course of treatment Adverse effects: at the end of treatment Time points reported: clinical cure: 12 weeks. Time to healing: 2, 4, 6, 8, 12 weeks. Adverse effects: at the end of treatment
Notes	Study funding sources: not reported Possible conflicts of interest: they declared no competing interests.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were selected and randomised by random allocation software into 3 groups.
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The oral placebo was completely similar to omeprazole capsules and was administered in the similar way; low dose of IMMA was prepared by addition of normal saline to IMMA Both the investigating physicians and the participants were blinded to the type of treatment and drug codes were revealed only at the end of the study.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgment
Incomplete outcome data (attrition bias) All outcomes	High risk	Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but it is clear that the published reports include all expected outcomes.
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.