Al Hamdi 2010

Methods	Study design: randomised, prospective clinical trial Setting/location: outpatient clinic of Basra teaching hospital, south Iraq Study period: April 2004 to March 2005 (11 months) Sample size calculation: not described
Participants	Type of Leishmania: Leishmania major and L tropica Inclusion criteria: all patients with cutaneous leishmaniasis who were diagnosed clinically by the same dermatologist Exclusion criteria: ≥ 20 lesions; pregnancy, lactation; hypersensitivity to pentavalent antimonials or local anaesthetic; serious medical illness, lesion in proximity to mucous membranes, face, or cartilage; implanted metallic devices; unwillingness to avoid procreation for at least 2 months N randomised: 38 participants, 70 lesions: group 1 = 35, group 2 = 35 Withdrawals: group 1: 14 lesions; group 2: 8 lesions N assessed: lesions assessed: group 1: 21 (60%); group 2: 27 (77%) Age range: 1.5 to 64 years (1.5–45 years in group 1 and 3–64 years in group 2) with a mean of 21.1 years Sex: 52.5% males, 47.5% females Baseline data: N lesions treated at start of study: group 1, 35; group 2, 35 N lesions per participant: group 1 ‐ 1:7, 2:5, 3:1, > 3:7; group 2 ‐ 1:7, 2:8, 3:2, > 3:5 N lesions by site ‐ face and neck: group 1: 8, group 2: 3; upper limbs: group 1: 19, group : 10; lower limbs: group 1: 7, group 2: 18; trunk group 1: 1, group 2: 4 Mean lesion size before study: group 1, 1.74 cm, group 2, 1.70 cm Range of lesion duration before study: group 1: 1 month–1 year; group 2: 1 month–5 years
Interventions	Type of interventions: Group 1: hypertonic sodium chloride solution (HSCS) (7%) (7 g dissolved in 100 mL distilled water and autoclaved) Group 2: ciprofloxacin solution (2 mg/mL) Both drugs were injected into the lesions in amounts of 0.1–0.5 mL according to the size of the lesion Duration of intervention: 8 weeks
Outcomes	Clinical cure: resolution of active lesion with or without scarring. A scoring system was specially designed as follows. The diameter of lesions was recorded in mm using a ruler and scored as: 0 (total healing); 1 (0 cm to < 0.5 cm); 2 (0.5 cm to < 1 cm); 3 (1 cm to < 1.5 cm); 4 (1.5 cm to < 2 cm); 5 (2 cm to < 2.5 cm); or 6 (≥ 2.5 cm). The degree of induration was assessed by palpation in comparison with the participant's normal skin and given the following scores: 0, 0.5, 1, 1.5, 2, or 3. The degree of erythema was assessed visually and scored as: 0, 0.5, 1, 1.5, 2, or 3. Ulceration was scored as: 1 (present) or 0 (absent). The scores of these 4 parameters were added to give a total score for each lesion. Time points reported: the changes in total score between weeks: lesions were assessed at the start and again at 2‐week intervals after treatment for 8 weeks: 0, 2, 4, 6, and 8 weeks of treatment. Follow‐up continued for 8 weeks until complete healing took place
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)	Unclear risk	Comment: insufficient detail was reported about the method used to generate the allocation sequence
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not reported; probably an open trial
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not reported; probably an open trial. No information on how lesions were assessed
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	After excluding participants who defaulted on treatment, 21/35 lesions were analysed in group 1 (HSCS) and 27/35 in group 2 (ciprofloxacin)
Selective reporting (reporting bias)	Unclear risk	Protocol not available. Not registered in a clinical trial registry. Pre‐specified outcomes of the review were reported. Tables were not available in the links of the journal, and .pdf does not work. No adverse effects reported in the text
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.