Old World cutaneous leishmaniasis (OWCL) is a disfiguring and stigmatising disease occuring in areas of the Mediterranean, Middle East and Asia, caused by a parasitic infection transmitted by sandflies. Pentavalent antimonial drugs such as sodium stibogluconate (Pentostam, Stibanate) and meglumine antimoniate (Glucantime), have been used since the 1940s as the main first-line therapeutic agents for cutaneous leishmaniasis worldwide. However, many different treatments for OWCL have been described.
We assessed 49 trials involving different interventions. In Leishmania major infections there was good evidence of benefit for the use of 200 mg oral fluconazole for 6 weeks, topical paromomycin + 12% methylbenzethonium chloride (MBCL), photodynamic therapy and oral pentoxifylline as an adjuvant therapy to intramuscular meglumine antimoniate. However, compared with other interventions there was not enough good evidence for the use of intralesional zinc sulphate weekly compared with antimonials, and topical 15% paromomycin +12% MBCL for 28 days compared with photodynamic therapy. There was good trial evidence of benefit for the use of 200 mg oral itraconazole for 6 weeks in Leishmania tropica infections, and to support the use of intralesional sodium stibogluconate and thermotherapy rather than intramuscular stibogluconate. There was good RCT evidence for not supporting the use of topical 5% imiquimod cream combined with antimonials.
The major drawback associated with intralesional treatments is local pain which causes significant patient discomfort. Intramuscular or intravenous drugs are associated with more severe adverse effects. While there is no general consensus on optimal treatment, alternatives to intramuscular or intravenous treatments are under active investigation. Efficacious, well tolerated and inexpensive oral agents are clearly needed in OWCL because we still do not have an ideal treatment that can treat all target species with few serious adverse effects.
The current evidence for the treatment of OWCL has many limitations and there is much scope for improving the design and reporting of clinical trials. None of the studies reported the degree of functional and aesthetic impairment and only two assessed the quality of life. Since resources are limited for clinical research into neglected diseases there is a need to prioritise and carry out properly designed clinical trials.
We suggest the creation of an international platform to improve the quality and standardization of future trials in order to develop a better evidence-based approach.