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. 2017 Nov 17;2017(11):CD005067. doi: 10.1002/14651858.CD005067.pub4
Methods Study design: randomised controlled trial
Setting/location: skin department of PNS Shifa, a naval hospital in Karachi. Endemic areas of Balochistan province, Pakistan
Study period: not described
Sample size calculation: not described
Participants Type of Leishmania: Leishmania spp not mentioned
Inclusion criteria: never received any treatment for their skin disease
Exclusion criteria: very young and very old people, those who had received some treatment for the disease, people suffering from diffuse CL or leishmaniasis recidivans, people with some known cardiac, renal or hepatic disease
N randomised: 40. 20 in each group
Withdrawals: 0
Participants assessed: 40 (100%). 20 in each group
Age: range 20‐40
Sex: 100% male
Baseline data. Nodular, ulcerative and crusted forms were the most common morphological patterns seen. Most lesions were on hands and feet.
  • Group 1: MSL: 570.7 mm². MDLBT (range): 8.6 weeks (4‐20)

  • Group 2: MSL: 960.3 mm². MDLBT: 12.6 weeks (8‐24)

Interventions Type of interventions:
  • Group 1: oral AL 20 mg/kg/d in 3‐4 divided doses tablet

  • Group 2: IVSSG 20 mg/kg/d


Duration of intervention: 15 days
Duration of follow‐up: 3 months
Outcomes Healing rates: percentage of participants 'cured' at the end of treatment
Adverse effects
Time points reported: at the end of treatment
Notes Study funding sources: not reported
Possible conflicts of interest: none declared
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 Not described
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Not described
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) All outcomes Unclear risk Not described
Selective reporting (reporting bias) Low risk The study protocol is not available but it is probably that the published reports include all expected outcomes
Other bias High risk Sample size calculation and reporting of Leishmania spp involved was not correctly reported