Jaffary 2014a

Methods	Study design: double‐blind, randomised controlled study Setting/location: Isfahan, Iran Study period: January 2009 to February 2010 (13 months) Sample size calculation: not described
Participants	Type of Leishmania: not described Inclusion criteria: met the histological criteria for presence of parasite, age > 5 years, acute leishmanial lesions smaller than 5 cm², fewer than 5 lesions, more than 3 months of disease duration Exclusion criteria: pregnancy, women of childbearing age, history of administration of immune suppressive drugs in the last 6 months or anti‐leishmanial drugs in the last month N randomised: 60 participants, 30 in each group Withdrawals: 0 N assessed: 60, 30 in each group Mean (SD) age: 25.29 years (4.01). Achillea millefolium 5%: 25.8 years (3.7); vehicle: 24.6 years (4.2). Sex: 15 (25%) female; 45 (75%) male. A millefolium: 7 (23.3%) female, 23 (76.6%) male; vehicle: 8 (26.6%) female, 22 (73.3%) male) Baseline data: Mean number of lesions (SD): A millefolium: 1.56 (0.8); vehicle: 1.52 (0) Type of lesions (%): A millefolium: papule 8/44 (18.1), ulcer 16/44 (36.3), plaque 10/44 (22.7), nodule 10/44 (22.7). vehicle: papule: 9/38 (23.6), ulcer: 16/38 (42.1), plaque: 11/38 (28.9), nodule: 12/38 (31.5) Mean duration of lesions (SD): A millefolium: 3 months (0.5); vehicle: 2.7 months (0.7)
Interventions	Type of interventions: Group 1: topical gel of 5% A millefolium (yarrow (containing 5% polyphenol) Group 2: vehicle gel. The vehicle gel was prepared using the same material except for the plant extract and chlorophyll was used as colorings agent. Both gels were identical in terms of the colour and consistency Duration of intervention: 4 weeks Co‐interventions: all participants received 4 weekly an injections of MA (Glucantime, Paris, France) at a dose of 20 mg/kg
Outcomes	Definition: complete or partial cure of lesions Time points reported: week 12 (visits months ‐ 3)
Notes	Study funding sources: none reported Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "During this double‐blind randomised study, 60 patients were randomised into two treatment groups by using random allocation computer software."
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "During this double‐blind randomised study ..." Quote: "Both gels were identical in terms of the colour and consistency."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	No losses to follow‐up were reported, therefore ITT analyses performed
Selective reporting (reporting bias)	Unclear risk	Insufficient information to judge
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported