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:
Sex (male/female): 58/38 Baseline imbalances: comparability regarding age, sex, number, and site of lesions and duration of the disease
|
|
Interventions |
Type of interventions:
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 |