Mohebali 2007

Methods	Study design: randomised controlled trial Setting/location: Golestan province, in northeastern Iran Study period: 20 November 2005 to 20 July 2006 (8 months) Sample size calculation: not described
Participants	Type of Leishmania: L major Inclusion criteria: observation of Leishman bodies (amastigotes) in dermal lesions, no previous use of anti‐leishmanial drugs, no previously confirmed leishmaniasis (by scar or clinically compatible history), no pregnant or lactating women, no acute or chronic medical condition and no history of allergy, female participants of childbearing age were included after giving consent for effective contraception during therapy and until 3 months thereafter Exclusion criteria: not explicitly reported, but can be inferred from the above inclusion criteria N randomised: 63. Group 1: 32; group 2: 31 Withdrawals: 5. Group 1: 4 (lost after first week because lack of gastrointestinal tolerance); group 2: 1 (lost to follow‐up after 3 months) N assessed: 63 (100%). Group 1: 28; group 2: 30 Mean age: group 1: 20.2 years; group 2: 16.8 years Sex (male/female): 35/28. Group 1: 19/13; group 2: 16/15 Baseline data: Location of the target lesion (%): < 20% of lesions were located on the face in each group: group 1: 12.5%; group 2: 16.1% Mean number of lesions (range): group 1: 2.7 (1‐15); group 2: 2.5 (1‐10) Mean size of lesions (range): group 1: 27.1 mm² (0.9‐80.0); group 2: 19.3 mm² (3‐67.3) Mean duration of lesions: group 1: 45.5 days; group 2: 43.6 days
Interventions	Type of interventions: Group 1: miltefosine orally 2.5 mg/kg daily for 28 days. Miltefosine capsules were administered as follows: 9‐14 kg, 3 capsules of 10 mg; 15‐29 kg, 1 capsule of 50 mg; 30‐45 kg, 2 capsules of 50 mg; 46‐84 kg, 3 capsules of 50 mg Group 2: IMMA at 20 mg SbV⁵/kg body weight daily for 14 days Duration of intervention: miltefosine: 28 days. IMMA: 14 days Duration of follow‐up: 6 months
Outcomes	Healing rates: percentage of participants 'cured' 3 months after treatment Secondary outcomes: duration of remission and percentage of people with treated lesions that recur within 6 months Adverse effects Time points reported: 2 weeks, 3 months, 6 months
Notes	Study funding sources: this study was financially supported by Medical Sciences/University of Tehran, Iran (from grant for full professor) Possible conflicts of interest: not described
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "For randomisation of patients into two groups, we used balanced block method"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "This study was an open‐label, N randomised comparison of miltefosine to meglumine antimonate in 63 patients"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	High risk	Imbalance in numbers and reasons for missing data across intervention groups (4/32 = 12.5% miltefosine group; 1/31=3.22% IMMA group) Comment: the results for the dropouts were not excluded from the statistical analysis. We think missing outcome data likely to be related to true outcome.
Selective reporting (reporting bias)	Low risk	The study protocol is not available but it is probably 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.