Background: Cutaneous leishmaniasis is caused by a parasitic infection and is considered one of the most serious skin diseases in many developing countries. Antimonials are the most commonly prescribed treatment but other drugs have been used with varying success.
Objectives: To assess the effects of treatments for Old World cutaneous leishmaniasis (OWCL).
Search strategy: We searched the Cochrane Skin Group Specialised Register (April 2008), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2008), MEDLINE (2003-April 2008), EMBASE (2005-April 2008), CINAHL (1982-August 2007), LILACS (from inception to April 2008) and ongoing trials databases (August 2007).
Selection criteria: Randomised controlled trials assessing treatments in immuno-competent people with OWCL confirmed by smear, histology, culture or polymerase chain reaction.
Data collection and analysis: Two authors independently assessed trial quality and extracted data.
Main results: We included 49 trials involving 5559 participants. Reporting quality was generally poor and only two studies contained sufficiently similar data to pool.In Leishmania major infections, there was good RCT evidence of benefit of cure around 3 months after treatment when compared to placebo for 200 mg oral fluconazole (1 RCT n = 200, RR 2.78; 95% CI 1.86, 4.16), topical 15% paromomycin + 12% methylbenzethonium chloride (PR-MBCL) (1 RCT n = 60, RR 3.09; 95% CI 1.14, 8.37) and photodynamic therapy (1 RCT n = 60, RR 7.02; 95% CI 3.80, 17.55). Topical PR-MBCL was less efficacious than photodynamic therapy (1 RCT n = 65, RR 0.44; 95% CI 0.29, 0.66). Oral pentoxifylline was a good adjuvant therapy to intramuscular meglumine antimoniate (IMMA) when compared to IMMA plus placebo (1 RCT n = 64, RR 1.63; 95% CI 1.11, 2.39)In Leishmania tropica infections, there was good evidence of benefit for the use of 200 mg oral itraconazole for 6 weeks compared with placebo (1 RCT n = 20, RR 7.00; 95% CI 1.04, 46.95), for intralesional sodium stibogluconate (1 RCT n = 292, RR 2.62; 95% CI 1.78, 3.86), and for thermotherapy compared with intramuscular sodium stibogluconate (1 RCT n = 283, RR 2.99; 95% CI 2.04, 4.37).
Authors' conclusions: Most trials have been designed and reported poorly, resulting in a lack of evidence for potentially beneficial treatments. There is a desperate need for large well conducted studies that evaluate long-term effects of current therapies. We suggest the creation of an international platform to improve quality and standardization of future trials in order to inform clinical practice.