Maleki 2012

Methods	Study design: randomised controlled trial Setting/location: Imam Reza Hospital in Mashhad, Iran Study period: March to September 2004 (7 months) Sample size calculation: not described
Participants	Type of Leishmania: not described Inclusion criteria: confirmation of cutaneous leishmaniasis based on direct smear, ≤ 3 lesions, duration of the disease < 12 weeks, aged 7‐60 years, completion of informed consent form by participant or parents of minor participants, dry cutaneous leishmaniasis Exclusion criteria: pregnant or breastfeeding women; children < 7 years, lesions on ear, nose, joints, and near the eye; > 3 lesions; application of any kind of treatment for cutaneous leishmaniasis, duration of the disease longer than 12 weeks (to omit spontaneous healing cases during the follow‐up period), recurrent infection, wet cutaneous leishmaniasis N randomised: 45 participants Withdrawals: 11 N assessed: 34 participants (24, group 1; 10, group 2) Age: not described Sex: not described Baseline data: mean size of lesions (SD): group 1, 1.27 cm (0.81); group 2, 0.98 cm (0.61)
Interventions	Type of interventions: Group 1: 2 bouts of intralesional 2% zinc sulphate was performed twice within 2 weeks interval Group 2: 6 weekly bouts of ILMA Duration of intervention: group 1, 2 weeks; group 2, 6 weeks
Outcomes	Clinical response Slight: partial reduction of erythema and oedema Mild: reduction of lesion size up to 30% Moderate: reduction of lesion size between 30% and 60% Marked: reduction of lesion size more than 60% or negative smear Total tolerance: complete healing of the lesion with negative smear Time points reported: 8 weeks
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 N randomised controlled trial was performed from March to September 2004 on patients with cutaneous leishmaniasis admitted to Imam Reza Hospital in Mashhad" 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	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	High risk	45 participants were randomised into 2 groups. 11 were lost to follow‐up (24%). No ITT analyses were performed High imbalance between groups
Selective reporting (reporting bias)	High risk	No baseline data. Side effects not clearly reported (no statistical analyses performed either)
Other bias	High risk	Sample size calculation, reporting of Leishmania spp involved and baseline comparability was not correctly reported