Ranawaka 2010

Methods	Study design: randomised, prospective, double‐blind trial Setting/location: Anuradhapura Teaching Hospital, Anuradhapura, Sri Lanka Study period: 32 months. Participant selection: April 2006 to June 2007 (15 months) Sample size calculation: not described
Participants	Type of Leishmania: L donovani Inclusion criteria: participants with CL who attended to Anuradhapura Teaching Hospital, Anuradhapura, Sri Lanka from April 2006 to June 2007 Exclusion criteria: not described N randomised: a total of 154 participants with 229 lesions were included in the study. IL 7% HSCS: 67; ILSSG: 87 Withdrawals: (4.5%: 7/154). HSCS: 3, ILSSG: 4 N assessed: 147 (95.45%) CL participants with 222 lesions completed treatments. HSCS: 64 (95.52%); ILSSG: 83 (95.40%). Age: mean 32 years (range 16 months to 74 years) Sex (male/female): 99/55, M:F ratio of 1.8:1 Baseline data: N lesions: HSCS: 93, ILSSG: 136 Location of the target lesion: head and neck 41, upper limb 123, lower limb 43, trunk 14, buttock 1. 93.2% of lesions being on exposed parts of the body Clinical presentation (n(%)): papules ≤ 1 cm diameter: 52 (23.6%); nodules > 1 cm diameter: 28 (12.7%); plaques: 14 (6.34%); central ulcer with erythematous induration around the lesion: 121 (55%); chronic non‐healing ulcers with undermined edges without surrounding induration; 5 (2.2%) 19 lesions were wet lesions and all others (91.4%) were dry lesions
Interventions	Type of interventions: Group 1: HSCS was prepared by dissolving 12.2 g of sodium chloride in 200 mL of 0.9% sodium chloride (normal saline) solutions. The solution was injected intralesionally and not subcutaneously Group 2: ILSSG (Pentostam) Duration of intervention: HSCS: 1‐29 weeks, depending on the size and the duration of the lesions (mean 8.78 weeks). SSG: 1‐13 weeks, depending on the size and the duration of the lesions (mean 5.11 weeks) Participants were seen weekly for the first 3 injections; fortnightly for the fourth and fifth injections; then monthly until cure.
Outcomes	Clinical cure: the percentage of lesions that were cured with SSG and HSCS Number of injections required per each lesion in total for cure (scales: 1‐10 injections) Adverse effects: systemic side effects with SSG or HSCS. Local side effects: pain during injection. Scarring after healing, postinflammatory hyperpigmentation Time points reported: at the end of treatment. Participants were followed‐up every 3 months after cure for 18 months to assess recurrences and evidence of visceralisation
Notes	Study funding sources: none 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	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "double blind" Insufficient information to permit judgment
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "double blind", "At each visit the patients were examined by the primary investigator who was blind to the therapy" Insufficient information to permit judgment
Incomplete outcome data (attrition bias) All outcomes	Low risk	4.5% (7/154) did not complete the study
Selective reporting (reporting bias)	Unclear risk	No protocol was available; not registered. Insufficient information to permit judgment SD not provided for duration of treatment and number of injections
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.