Sadeghian 2007

Methods	Study design: randomised controlled trial Setting/location: Skin Diseases and Leishmaniasis Research Center, Iran Study period: 7 months Sample size calculation: not reported
Participants	Type of Leishmania: not reported Inclusion criteria: smear from a suspected CL lesion was confirmed positive for Leishmania Exclusion criteria: pregnant women, children < 5 years of age, patients with facial lesions, those who had already received or were under other specific antileishmanial therapy, significant underlying diseases N randomised: 117 Withdrawals: 0 N participants assessed (lesions): 117: 57 (83) lesions in group 1 and 60 (94) in group 2 Mean age: group 1, 25.12 years; group 2, 22.6 years Sex (male/female): group 1, 37/20; group 2, 29/31 Baseline data: the shape of lesions was papule, nodule and plaque‐like. Lesions were located in the trunk and upper and lower limbs. Group 1: mean number of lesions: 1.4. Mean duration of lesions: 4.42 weeks. Mean largest diameter: 15.6 mm Group 2: mean number of lesions: 1.5. Mean duration of lesions: 3.85 weeks. Mean largest diameter: 14.7 mm
Interventions	Type of interventions: Group 1: controlled localised heating using an RF heat generator (4 MHz, maximum output 90 W). The affected area was heated to 50ºC surface temperature for 30 s Group 2: ILMA. The volume of the drug was 0.1‐4 mL (each mL contains 85 mg MA), depending on lesion size Duration of intervention: once weekly for 4 consecutive weeks Duration of follow‐up: 6 months
Outcomes	Percentage of participants 'cured': Complete (lesions flattened, no induration, and epidermal creases appeared) Partial (size of the lesion decreased but without the appearance of epidermal creases) Poor (size of induration was unchanged or had increased) Duration of remission and percentage of people with treated lesions that recur within 6 months Prevention of scarring Adverse effects Time points reported: at the end of treatment, and 6 months after
Notes	Study funding sources: technical and financial support from the joint WHO Eastern Mediterranean Region (EMRO), Division of Communicable Diseases (DCD) and the WHO Special Program for Research and Training in Tropical Diseases (TDR): the EMRO/TDR Small Grant Scheme for Operational Research in Tropical and other Communicable Disease. Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomly allocated to one of two treatment groups using a random number list generated by Epi Info (a software package designed to provide easy form and database construction, data entry, and analysis with epidemiologist statistics, map sand graphs)"
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Group 1 was treated with controlled localised heating using an RF heat generator. Group 2 was treated with ILMA
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Follow‐up evaluation was made by clinical assessment of treated lesions by a second dermatologist who was blinded to the method of treatment."
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data
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	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported