TropIKA.net reader Urbà González has written to alert us to a new study [1] she has conducted with her colleagues at the Research Unit for Evidence-Based Dermatology, Hospital Plató, Barcelona, Spain. Their topic was treatments for cutaneous leishmaniasis (CL), which is considered to be one of the most neglected and serious parasitic infectious skin diseases in many developing countries.
A number of treatment trials have been conducted, both for Old World CL and for New World cutaneous and mucocutaneous leishmaniasis. These trials have been included in two Cochrane reviews [2,3]. However, the Hospital Plató team examined the trials further and found many methodological weaknesses. For example, many of the trials claiming to be randomised are inadequately reported, in that the methods used to generate the randomisation sequence and for concealing allocation are not given. Some of the trials were not blinded. Many studies did not carry out original assigned group analyses.
Such failings lead to bias and cast doubt on the reliability of trial findings. Urbà González and her colleagues have, therefore, proposed guidelines for authors who intend to conduct clinical trials aimed at the development of effective therapies in cutaneous leishmaniasis.
Hopefully, these guidelines will be adhered to in future research on CL treatments. Existing treatments for this dreadful condition are of limited effectiveness, with a risk of serious adverse effects. It is important that new treatments should be developed and evaluated in rigorously conducted trials in which bias is minimised.
The research has been published in Clinical Infectious Diseases, which is not an open access journal. A subscription to the journal is therefore required to read the full paper.
Reference
1. González U, Pinart M, Reveiz L, Rengifo-Pardo M, Tweed J, Macaya A, Alvar J (2010). Designing and reporting clinical trials on treatments for cutaneous leishmaniasis. Clin Infect Dis; 51(4):409-419. Abstract available here.
2. González U, Pinart M, Reveiz L, Alvar J 2008. Interventions for Old World cutaneous leishmaniasis. Cochrane Database Syst Rev; 4:CD005067.
3. González U, Pinart M, Rengifo‐Pardo M, Macaya A, Alvar J, Tweed J (2009). Interventions for New World cutaneous and mucocutaneous leishmaniasis. Cochrane Database Syst Rev; 2:CD004834.