| Methods |
Study design: randomised controlled trial Setting/location: Aleppo, Syria Study period: June 2009 to December 2010 (19 months) Sample size calculation: not described |
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| 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 |
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| Interventions |
Type of interventions:
Duration of follow‐up: not reported |
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| Outcomes |
Healing rates: percentage of lesions 'cured' (follow‐up not reported) Adverse effects Time points reported: not described |
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| Notes |
Study funding sources: none reported Possible conflicts of interest: none declared This is an abstract |
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| 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 |