Interventions for American cutaneous and mucocutaneous leishmaniasis.
BACKGROUND
Pentavalent antimonial drugs are the most prescribed treatment for American cutaneous and mucocutaneous leishmaniasis. Other drugs have been used with varying success.


OBJECTIVE
To assess the effects of therapeutic interventions for American cutaneous and mucocutaneous leishmaniasis.


METHODS
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.


METHODS
Randomised controlled trials (RCTs) assessing treatments for American cutaneous and mucocutaneous leishmaniasis.


METHODS
Two authors independently assessed trial quality and extracted data.


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.


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.
Department of Dermatology, Research Unit for Evidence-based Dermatology, Hospital Plató, c/ Plato 21, Barcelona, Catalunya, Spain, 08006. urba.gonzalez@hospitalplato.com
Urbà
U
González
Mariona
M
Pinart
Mónica
M
Rengifo-Pardo
Antonio
A
Macaya
Jorge
J
Alvar
John A
JA
Tweed
D000284:Administration, Oral; D000981:Antiprotozoal Agents / Q000008:administration & dosage; D001500:BCG Vaccine / Q000627:therapeutic use; D006801:Humans; D006979:Hyperthermia, Induced; D007273:Injections, Intramuscular; D007275:Injections, Intravenous; D007371:Interferon-gamma / Q000627:therapeutic use; D054332:Leishmaniasis Vaccines / Q000627:therapeutic use; D016773:Leishmaniasis, Cutaneous / Q000628:therapy*; D007897:Leishmaniasis, Mucocutaneous / Q000628:therapy; D016032:Randomized Controlled Trials as Topic
D000981:Antiprotozoal Agents; D001500:BCG Vaccine; D054332:Leishmaniasis Vaccines; D007371:Interferon-gamma