Sharquie 1997

Methods	Study design: randomised controlled trial Setting/location: Baghdad, Iraq Study period: October 1994 to November 1995 (8 months) Sample size calculation: not described
Participants	Type of Leishmania: Leishmania spp: L major and L tropica endemic in the area Inclusion criteria: confirmed cases of CL by smear or culture, or both; acute CL with a history of 12 weeks or less Exclusion criteria: cases of reinfection N randomised: 85 Withdrawals: 22 participants (participants who did not show up after the first or second injection were excluded). Losses were not reported by group N assessed: 63. Group 1, 19; group 2, 17; group 3, 18; group 4, 9 Age: range 3 months to 65 years Sex (male/female): 28/37 Baseline data: Group 1: MNL: 2.0. MDLBT: 6.89 weeks Group 2: MNL: 2.35. MDLBT: 7.65 weeks Group 3: MNL: 1.94. MDLBT: 7.00 weeks Group 4: MNL: 4.22. MDLBT: 8.89 weeks
Interventions	Type of interventions: Group 1: IL ZS with a solution of 2% Group 2: IL 7% HSCS Group 3: ILSSG 100 mg/mL Group 4: a few lesions on unimportant and unexposed parts of the body were left as controls Duration of intervention: not described
Outcomes	Healing: responses were graded according to scale (Sharquie 1988): Slight: decreased erythema and oedema of the lesion; mild: reduction in the size of the lesion of up to 30% Moderate: reduction in the size of the lesion of 30%‐60% Marked: reduction in the size of the lesion by ≥ 60% and parasite not detected in the lesion by smear and/or culture Total clearance of the lesion: with parasites not detected in the affected area by smear and/or culture Speed of healing (time taken to be 'cured'); expressed in days Prevention of scarring Adverse effects Time points reported: participants were followed up every 10‐15 days for a period of 45 days. At the end of the 6 weeks follow‐up period, the lesions were reassessed and parasitological proof of cure or otherwise was sought by smear and/or culture
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	Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Insufficient information about the sequence generation process to permit judgment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgment
Incomplete outcome data (attrition bias) All outcomes	High risk	Of the 85 participants initially recruited, 63 participants were followed‐up for the full observation period. Participants who did not show up after the first or second injection were excluded. We do not know numbers of missing data across intervention groups
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but it is clear that the published reports include all expected outcomes, including those that were pre‐specified.
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported.