Nilforoushzadeh 2007

Methods	Study design: randomised controlled trial Setting/location: Skin Disease and Leishmaniasis Research Center (SDLRC), Isfahan, Iran Study period: 4 months Sample size calculation: not described
Participants	Type of Leishmania: not mentioned Inclusion criteria: CL confirmed with direct smear, no history of systemic or topical therapy for CL, absence of the malnutrition or severe predisposing disease such as cardiac, renal or hepatic disease and other contraindication for MA Exclusion criteria: pregnant or lactating mothers, lesions > 3 months old and treated with the drugs that had interaction with MA N randomised: 100, 50 in each group Withdrawals: 23 (13 in the honey group and 10 in the ILMA group). However, in the abstract authors stated that 10 participants left the study. N assessed: 90 (45 in each group) Age: range 7‐70 years Baseline data: the most common clinical type of the lesions in both groups was plaque (60% in honey + ILMA and 55.6% in the ILMA‐alone group). Mean number of lesions: honey + ILMA: 1.3; ILMA: 1.7
Interventions	Type of interventions: Group 1: topical honey soaked gauze twice daily + ILMA Group 2: ILMA Duration of intervention: once weekly until complete healing of the ulcer or for maximum of 6 weeks
Outcomes	Healing: complete healing was defined as disappearance of the induration and complete re‐epithelialisation of the ulcer. Complete healing of the lesions was defined as complete clinical and parasitological healing (negative direct smear); partial healing of the lesions was defined as the decrease of the size and indurations of the lesions; non‐responsive was defined as no clinical change or progression of the lesions Speed of healing (time taken to be 'cured'): expressed as mean healing time Adverse effects Time points reported: assessed weekly for 6 consecutive weeks and at the end of the 2nd, 3rd, and 4th month. Cure was assessed at the end of treatment and follow‐up
Notes	Study funding sources: not reported Possible conflicts of interest: no competing interests
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Random allocation software (ver 1.0, May 2004; Saghaei)"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	We think the outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Balance in numbers and reasons for missing data across intervention groups (13/45 (28.8%) in honey + ILMA group; 10/45 (22.2%) in ILMA‐alone group) Comment: the results for the defaulters were excluded from the Kaplan‐Meyer analysis.
Selective reporting (reporting bias)	Low risk	Comment: relevant outcomes were reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported