We searched the Cochrane Skin Group Specialised Register (January 2009), the Register of Controlled Clinical Trials in The Cochrane Library (Issue 1,2009), MEDLINE (2003 to January 2009), EMBASE (2005 to January 2009), LILACS (from inception to January 2009), CINAHL (1982-May 2007) and other databases.
SELECTION CRITERIA: Two authors independently assessed trial quality and extracted data.
MAIN RESULTS: We included 38 trials involving 2728 participants. Results are based on individual studies or limited pooled analyses. There was good evidence in:Leishmania braziliensis and L. panamensis
infections:Intramuscular (IM)
meglumine antimoniate (MA) was better than oral
allopurinol for 28 days (1RCT n=127, RR 0.39; 95% CI 0.26, 0.58). Intravenous (IV)MA for 20-days was better than 3-day and 7-day
IVMA plus 15%
paromomycin plus 12%
methylbenzethonium chloride (PR-MBCL) or 7-day
IVMA (1RCT n= 150, RR 0.24; 95% CI 0.11, 0.50; RR 0.69; 95% CI 0.53, 0.90; RR 0.64; 95% CI 0.44, 0.92 respectively). Oral
allopurinol plus antimonials was better than IV antimonials (2RCT n= 168, RR 1.90; 95% CI 1.40, 2.59; I(2)=0%).L. braziliensis
infections:Oral
pentoxifylline plus IV
sodium stibogluconate (SSG) was better than IVSSG (1RCT n= 23, RR 1.66; 95% CI 1.03, 2.69);
IVMA was better than IM
aminosidine sulphate (1RCT n= 38, RR 0.05; 95% CI 0.00, 0.78) and better than IV
pentamidine isethionate (1RCT n= 80, RR 0.45; 95% CI 0.29, 0.71). Intramuscular MA was better than Bacillus Calmette-Guérin (1RCT n= 93, RR 0.46; 95% CI 0.32, 0.65).L .panamensis
infections:Oral
allopurinol was better than
IVMA (1RCT n= 58, RR 2.20; 95% CI 1.34, 3.60).
Aminosidine sulphate at doses of 12 mg/kg/day and 18 mg/kg/day for 14 days were better than
aminosidine sulphate 12 mg/kg/day for 7 days (1RCT n= 60, RR 0.23; 95% CI 0.07, 0.73; RR 0.23; 95% CI 0.07, 0.73 respectively). Oral
ketoconazole for 28 days, oral
miltefosine and topical PR-MBCL were better than placebo.
AUTHORS' CONCLUSIONS: Most trials have been designed and reported so poorly that they are inconclusive. There is a need for large well conducted studies that evaluate long-term effects of current
therapies to improve quality and standardization of methods.