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. 2017 Nov 17;2017(11):CD005067. doi: 10.1002/14651858.CD005067.pub4
Methods Study design: randomised controlled trial
Setting/location: Aleppo, Syria
Study period: June 2009 to December 2010 (19 months)
Sample size calculation: not described
Participants Type of Leishmania: L tropica
Inclusion criteria: not described
Exclusion criteria: not described
N randomised: 79
Withdrawals: 14
N assessed: 65. 46 participants (264 lesions) in the fluconazole group and 19 participants (102 lesions) in the placebo group
Age (years): not described
Sex: not described
Baseline data: not described
Interventions Type of interventions:
  • Group 1: fluconazole orally 200 mg/d for 6 weeks

  • Group 2: placebo orally for 6 weeks


Duration of follow‐up: not reported
Outcomes Healing rates: percentage of lesions 'cured' (follow‐up not reported)
Adverse effects
Time points reported: not described
Notes Study funding sources: none reported
Possible conflicts of interest: none declared
This is an abstract
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly assigned to treatment"
Comment: insufficient detail was reported about the method used to generate the allocation sequence
Allocation concealment (selection bias) Unclear risk Quote: "randomly assigned to treatment"
Comment: no further information provided
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No information about blinding was provided
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information about blinding was provided
Incomplete outcome data (attrition bias) All outcomes High risk Quote: "Side effects were mild and similar in both groups"
Comment: no further information on adverse effects was provided. Withdrawals: 14/79 (17.7%) and no ITT analyses were performed
Selective reporting (reporting bias) Unclear risk No protocol available. Not possible to allocate to high or low risk.
Other bias High risk Sample size calculation and baseline comparability were not correctly reported