title: Designing and reporting clinical trials on treatments for cutaneous leishmaniasis.
abstract: Cutaneous leishmaniasis is considered to be one of the most neglected and serious parasitic infectious skin diseases in many developing countries. We have assessed the design and reporting of randomized, controlled trials evaluating treatments included in 2 Cochrane systematic reviews on cutaneous leishmaniasis. The analysis of the methodological quality identified some potential bias that can make it difficult to determine whether truly effective therapies exist for this disease. We found important weaknesses in the adequacy and transparency of randomization, loss of participants, causative Leishmania species, outcome measures, and follow-up times. Given these distorting effects on the evidence base, we propose guidelines for authors who wish to conduct clinical trials aimed at the development of effective therapies in cutaneous leishmaniasis. The recommendations in this report will hopefully deserve the attention of the World Health Organization and assist in the planning and prioritization of global strategies for improving the interpretation and replication of clinical research on cutaneous leishmaniasis.
authors.affiliation: Department of Dermatology, Research Unit for Evidence-Based Dermatology, Hospital Plató, Barcelona, Spain. urba.gonzalez@hospitalplato.com
authors.forename: Urbà
authors.initials: U
authors.lastname: González
authors.forename: Mariona
authors.initials: M
authors.lastname: Pinart
authors.forename: Ludovic
authors.initials: L
authors.lastname: Reveiz
authors.forename: Monica
authors.initials: M
authors.lastname: Rengifo-Pardo
authors.forename: Jack
authors.initials: J
authors.lastname: Tweed
authors.forename: Antonio
authors.initials: A
authors.lastname: Macaya
authors.forename: Jorge
authors.initials: J
authors.lastname: Alvar
mesh_terms: D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D035843:Biomedical Research / Q000379:methods*; D006801:Humans; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents