Alrajhi 2002

Methods	Study design: randomised controlled trial Setting/location: Al‐Ahsaa and Ryyadh, Saudi Arabia Study period: 15 months Sample size calculation: to detect a difference of 22% in the rate of healing between the placebo group and the treatment group, assuming a healing rate of 45% in the placebo group, with a power of 90% and a two‐sided type I error of 5%, 101 subjects were needed in each group. To compensate for loss to follow‐up, 25% more participants were to be enrolled in each group.
Participants	Type of Leishmania:L major 56 participants (27%) Inclusion criteria: age > 12 years, presence of lesions parasitologically confirmed leishmaniasis, non‐use of antileishmanial therapy during previous 2 months Exclusion criteria: pregnancy, potential for pregnancy, breastfeeding; presence of lesions on the face or ears; presence of more than 10 lesions; history of liver disease; elevated serum, creatinine concentration, abnormal results on liver‐function tests; allergy to fluconazole N randomised: 209. 106 were assigned to the fluconazole group, and 103 were assigned to the placebo group Withdrawals: 63 received the container of capsules at the first visit and never returned for follow‐up: 37 participants assigned to receive placebo and 26 participants of fluconazole group One participant in the placebo group, who was therefore excluded from the analyses. N assessed: 145. Fluconazole group: 80, placebo group: 65 Age and sex: not described Baseline data: Intervention group: MNL: 3.1, MSL: 17 mm, MDLBT: 9.2 weeks Control group: MNL: 3.7, MSL: 19 mm, MDLBT: 7.7 weeks
Interventions	Type of interventions: Group 1: fluconazole orally 200 mg Group 2: placebo 200 mg Duration of intervention: 6 weeks Co‐interventions: SSG was offered during follow‐up if oral therapy was considered to have failed (14 participants in the fluconazole group and 33 in the placebo group) Duration of follow‐up: 1 year post‐treatment
Outcomes	Healing rates: Percentage of participants 'cured' 3 months after treatment Speed of healing (time taken to be 'cured') Adverse effects Time points reported: 6 weeks, 3 months of follow‐up, 1 year post‐treatment
Notes	Baseline imbalances: because of the criteria for inclusion and the limited number of women at risk for Leishmania in the study areas, there was only one female participant. Most of the participants were foreign construction workers or farmers originally from countries where CL is not endemic. One of 5 participants was a local national. Study funding sources: supported in part by a grant (no. 146‐1414) from Pfizer and the Ministry of Health of Saudi Arabia Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "the randomisation sequence was generated from a random‐number table"
Allocation concealment (selection bias)	Unclear risk	Quote: "The randomisation sequence was generated from a random‐number table" Comment: no further information about allocation concealment was provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quotes: "assigned to receive either fluconazole (Diflucan, Pfizer, New York) in the form of a 200‐mg capsule once daily for six weeks or a matching placebo" "An independent observer evaluated the rates of compliance and side effects by interviewing patients and counting their remaining capsules."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No further information about blinding of outcome assessment was provided
Incomplete outcome data (attrition bias) All outcomes	High risk	High rate of drops out: 63/209 (30.14%). Missing outcome data imbalanced in numbers across groups. Fluconazole orally 200 mg: 26. Placebo group: 37. An ITT analysis was performed
Selective reporting (reporting bias)	Low risk	Relevant outcomes were reported
Other bias	Low risk	Other items assessed correctly reported