Methods |
Study design: randomised controlled trial Setting/location: Dermatology Clinic of Faghihi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran Study period: unclear Sample size calculation: not reported |
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Participants |
Type of Leishmania: not reported Inclusion criteria: participant with CL confirmed Exclusion criteria: not described N randomised: 60 Withdrawals: 0 N assessed: 60 participants distributed into the 3 groups of equal number (n = 20) Age: not reported Sex: not reported Baseline data: lesions were located on the head, neck and lower and upper extremities. Lesion duration was divided in 2 groups: a duration of < 3 months and > 3 months. Regarding lesion size, the authors divided the sizes in 3 groups: < 1 cm, 1‐3 cm and > 3 cm. |
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Interventions |
Type of interventions:
Duration of intervention: weekly for a total of 6‐8 times for each case |
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Outcomes |
Healing rates: percentage of participants 'cured': timing not reported Adverse effects Time points reported: not reported |
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Notes |
Study funding sources: not reported Possible conflicts of interest: none declared |
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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 | Insufficient information to permit judgment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The outcome is likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | High risk | No explanation was provided for missing outcome data. |
Selective reporting (reporting bias) | Low risk | The study protocol is not available, but it is clear that the published reports included all expected outcomes, including those that were pre‐specified. |
Other bias | High risk | Sample size calculation, reporting of Leishmania spp involved and baseline comparability were not correctly reported |