Sadeghian 2006a

Methods	Study design: randomised controlled trial Setting/location: Iran Study period: 3 months Sample size calculation: not described
Participants	Type of Leishmania: L major Inclusion criteria: CL in whom the diagnosis was confirmed by laboratory demonstration of the parasite in the lesions by direct smear Exclusion criteria: allergic to antimonial drugs or pentoxifylline, lactating or pregnant, history of systemic illness N randomised: 64, 32 in each group Withdrawals: 1 participant withdrew from the MA + placebo group N participants assessed (lesions): 63. Group 1: 32 (143), group 2: 31 (164) Mean age: group 1: 27 years, group 2: 31 years Sex (male/female): 29/34 Baseline data: duration of the disease approximately 1.3 months. Group 1: 59.5% had plaque, 24.5% nodule and 16% papule type of lesions, and they were primarily located in the face (35%), upper limbs (24.5%), lower limbs (21%) and trunk (19.5%). MNL: 4, MDLBT: 1.2 months Group 2: 42.7% had plaque, 33.6% nodule and 23.7% papule type of lesions, and they were primarily located in the face (33.5%), upper limbs (24.3%), lower limbs (22%) and trunk (20.2%). MNL: 5, MDLBT: 1.3 months
Interventions	Type of interventions: Group 1: IMMA (20 mg pentavalent antimony/kg/d) + pentoxifylline (400 mg 3 times daily) Group 2: IMMA (20 mg pentavalent antimony/kg/d) + placebo (3 tablets daily) Duration of intervention: 20 days Duration of follow‐up: 3 months
Outcomes	Healing rates: Complete improvement defined as flattened lesions, no induration and appearance of epidermal creases Partial improvement defined as reduction in the size of the lesions but without the appearance of epidermal creases Poor response defined as no reduction in the size of the lesions Adverse effects Time points reported: after end of treatment and 3 months' follow‐up
Notes	Study funding sources: not described Possible conflicts of interest: not described
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The patients were randomly divided into two groups" Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Study was described as "double blind" but has no description about allocation method.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Study was described as "double blind" but has no description about the blinding method.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	One patient withdrew in the placebo group. Reasons for withdrawal were reported. However, no ITT analyses were performed.
Selective reporting (reporting bias)	Low risk	Comment: relevant outcomes were reported
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.