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. 2017 Nov 17;2017(11):CD005067. doi: 10.1002/14651858.CD005067.pub4
Methods Study design: randomised controlled trial
Setting/location: Pakistan
Study period: around 4‐5 months
Sample size calculation: not described
Participants Type of Leishmania: Leishmania spp not mentioned
Inclusion criteria: clinical diagnosis of CL and positive Giemsa‐stained smear of parasite
Exclusion criteria: > 5 lesions and pregnant women
N participants randomised (lesions): 104 (215). Group 1: n = 49 (111); group 2: n = 55 (104)
Withdrawals: 8
N assessed: 96. group 1: n = 49; group 2, n = 47
Age:
  • 0‐10 years: group 1, 11; group 2, 12

  • 11‐20 years: group 1, 19; group 2, 17

  • 21‐30 years: group 1, 10; group 2, 11

  • > 30 years: group 1, 9; group 2, 7


Sex (male/female): 58/38
Baseline imbalances: comparability regarding age, sex, number, and site of lesions and duration of the disease
  • Duration of the disease (months)

    • 0–2: group 1, 12; group 2, 11

    • 3‐4: group 1, 13; group 2, 12

    • 5–6: group 1, 11; group 2, 13

    • >6: group 1, 13; group 2, 11

  • No. of lesions in individual participants

    • 1: group 1, 21; group 2, 19

    • 2: group 1, 12 ; group 2, 11

    • 3: group 1, 11; group 2, 10

    • > 3: group 1, 5; group 2, 7

  • Total number of lesions at various anatomic sites in all participants

    • Upper limbs: group 1, 48; group 2, 45

    • Face: group 1, 33; group 2, 31

    • Lower limbs: group 1, 29; group 2, 28

    • Trunk: group 1, 1; group 2, 0

Interventions Type of interventions:
  • Group 1: ILMA injections weekly until complete cure or up to 8 weeks

  • Group 2: ILMA injections fortnightly until complete cure or up to 8 weeks


Duration of intervention: until complete cure or up to 8 weeks
Outcomes Healing: complete cure (100%); partial (> 50%; < 50%); failure (nil)
Speed of healing (time taken to be 'cured')
Duration of remission and percentage of people with treated lesions that recur within 6 months and 1, 2, and3 years:time assessment not specified
Prevention of scarring
Adverse effects
Time points reported: at 2, 4, 6 and 8 weeks 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 Quote: "The patients were randomly divided into two treatment groups"
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 High risk Quote: "Patients in group A were treated with weekly and those in group B with fortnightly intralesional injections"
Comment: we think the outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) All outcomes Low risk Dropouts: 8/104: 7.6% lost to follow‐up
Comment: the results for the defaulters were excluded from the statistical analysis. We think missing outcome data unlikely to be related to true outcome.
Selective reporting (reporting bias) Low risk The study protocol is not available, but it is clear 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