Khatami 2012

Methods	Study design: randomised controlled trial Setting/location: Bam and Mashhad in Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: not described Inclusion criteria: parasitologically proven cases of CL; otherwise healthy subjects on the basis of medical history, physical examination and results of blood tests; age 12–50 years; body weight >40 kg; willingness to participate in the trial and signing the informed consent Exclusion criteria: not described N randomised: 138 participants (75 in IMMA and 63 in miltefosine) Withdrawals: 33 in IMMA and 32 in miltefosine N assessed: 42 in IMMA arm and 31 in miltefosine Age (years): not described Sex: not described Baseline data: not described
Interventions	Type of interventions: Group 1: oral miltefosine 2.5/kg/d for 28 days Group 2: IMMA 60 mg/kg/d for 14 days Duration of intervention: not described Co‐interventions: not described
Outcomes	Healing of their lesions and occurrence Adverse effects Time points reported: participants were evaluated weekly for 28 days and then 1 month later
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:"This open N randomised controlled trial was carried out in Bam and Mashhad in Iran …" Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote:"This open N randomised controlled trial was carried out in Bam and Mashhad in Iran …"
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote:"This open N randomised controlled trial was carried out in Bam and Mashhad in Iran…"
Incomplete outcome data (attrition bias) All outcomes	High risk	Losses to follow‐up quite high (around 50%) Intervention group: 32/63= 50.8% Control group: 33/75= 44%
Selective reporting (reporting bias)	Unclear risk	It is an abstract. At least they reported complete cure of cases and adverse effects.
Other bias	High risk	Sample size calculation, reporting of Leishmania spp involved and baseline comparability was not correctly reported