Mapar 2010

Methods	Study design: randomised controlled trial Setting/location: Ahvaz city, southern Iran Study period: 12 months (2002) Sample size calculation: not described
Participants	Type of Leishmania: not described Inclusion criteria: clinically and parasitologically positive (Leishman bodies in Giemsa‐stained direct smear of the lesion scrapings), duration of lesions < 3 months, aged 15‐40 years, no evidence of secondary bacterial infections, no mucosal involvement, no history of previous treatment of cutaneous leishmaniasis, or of allergic reactions to MA or metronidazole Exclusion criteria: history of underlying disease (such as cardiac, renal, or pulmonary); pregnant or breastfeeding; cutaneous leishmaniasis localised on or near the joints N randomised: 36. Group 1: 18, group 2: 18 Withdrawals: 8. Group 1: 2, group 2: 6 N assessed: 28 (77.78%). Group 1: 16, group 2: 12 Age: mean 28.8 years (range 15‐40) Sex (male/female): 21/15 Baseline data: Total lesions: group 1: 29, group 2: 27 Group 1: lesions were of dry types (without any discharge), the longest diameters of the lesions were 0.5‐2.5 cm Group 2: clinically dry type skin lesions. The longest diameters of the lesions were 0.5‐2.5 cm
Interventions	Type of interventions: Group 1: weekly ILMA injections (150‐600 mg = 0.5‐2 mL of MA ampoule for each skin lesion). Intralesional injections were administered intradermally enough to blanch the lesions surface. Group 2: weekly IL metronidazole (500 mg/100 mL vials were made by Fresenius, Bad Homburg), injected intradermally into each skin lesion enough to blanch the lesions surface (0.5‐2 mL for each lesion) Duration of intervention: 8 weeks
Outcomes	Clinical cure of the lesions: clinical criteria for cure were: complete re‐epithelialisation, disappearance of oedema, induration, and other signs of inflammation, flattening of the lesions and change of colour from erythematous to blue or dark grey Adverse effects: local or systemic adverse effect. Pain of intralesional injection. Local inflammatory reactions with oedema and induration. In both groups the participants complained of severe pain at the site of injections but group 2 had unbearable terrible pain Time points reported: clinical cure: after 8 injections. Adverse effects: after the treatment.
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)	Low risk	The method of randomisation was selecting a card among 36 cards with odd or even numbers
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open trial
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgment
Incomplete outcome data (attrition bias) All outcomes	High risk	28/36 participants completed the study (77.8%)
Selective reporting (reporting bias)	High risk	No protocol available. Adverse effects not reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported