Ludovic Reveiz

Designing and Reporting Clinical Trials on Treatments for Cutaneous Leishmaniasis

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.

The Latin American Ongoing Clinical Trial Register (LATINREC)

Debido a los sesgos que afectan a la publicacion de ensayos clinicos y sus resultados, los estudios cuyos resultados son positivos son mas faciles de encontrar que los que tienen resultados sin significacion estadistica y a ello se debe que los primeros esten sobrerrepresentados. Para contrarrestar este tipo de sesgo se ha propuesto ingresar en un registro toda investigacion, desde sus comienzos. No obstante, estos registros se encuentran en distintas fases de evolucion, especialmente en paises en desarrollo, de tal manera que la Red Cochrane Iberoamericana, parte de la Colaboracion Cochrane, ha establecido el Registro Latinoamericano de Ensayos Clinicos en Curso (LATINREC, por Latin American Clinical Trial Registry) con la idea de facilitar el registro de los datos contenidos en el protocolo de todo ensayo clinico que se este llevando a cabo en un momento dado y poner esa informacion a la disposicion del publico. El LATINREC, que viene a respaldar los objetivos de la Organizacion Mundial de la Salud (OMS), representa un intento por reducir la duplicacion de trabajo y el financiamiento poco equitativo de la investigacion sobre enfermedades rezagadas al olvido; por evitar que se efectuen investigaciones sobre asuntos de poca cuantia o que se midan resultados poco utiles; y por fomentar las practicas eticas y la transparencia. Se han detectado algunos obstaculos mayores que hasta ahora han impedido crear un registro unico y comun de ensayos clinicos. Con el fin de franquearlos, LATINREC sera un registro gratuito que permitira hacer busquedas y que se cenira a la Plataforma Internacional de Registro de Ensayos Clinicos (ICTRP) de la OMS. Ademas, LATINREC permitira que los investigadores ingresen en el registro cualquier modificacion del protocolo, asi como los resultados preliminares. LATINREC ofrecera grandes ventajas para los consumidores, el gobierno, los profesionales de la salud publica y la industria farmaceutica al incrementar la accesibilidad de la informacion y la participacion en los ensayos clinicos. La disponibilidad de informacion objetiva acerca de todo ensayo clinico que se inicie ayudara a garantizar que todos tengan libre acceso a los conocimientos generados.

Distribution and trends of hematology and oncology research in Latin America: A decade of uncertainty

Although hematology and oncology research is a highly relevant and evolving field, research contributions by Latin American countries, apart from Brazil, remain unclear.

Colchicine mouth washings to improve oral mucositis in patients with hematological malignancies: a clinical trial.

OBJECTIVE Oral mucositis (OM) is a frequently encountered problem as a complication of cancer treatment. We investigated whether daily washings with colchicine solution improved mucositis in patients with hematological malignancies undergoing chemotherapy. METHODS This study was a one-arm, nonrandomized clinical trial that used a historical control group. Patients were included in the study from the first day of mucositis and followed up until discharge. Patients received 2 mg colchicine mouthwashes daily for 5 days or saline solution. OM was assessed once daily until symptom resolution, using the WHO grading scale of 0-4 and a visual analogue scale. We determined that at least 40 patients in the colchicine group would be needed to detect a 20% difference in the duration of OM between Groups A and B, with a 95% confidence level and a power of 80%. RESULTS 82 patients were included in the final analysis, 40 in the colchicine group and 42 in the control group. Median duration of OM was significantly different among groups; 9 days (range 1-17 days) for the control group versus 6 days (range 3-13 days) for those exposed to colchicine mouthwash (p = .028). The median days of regression of mucosal lesions were significantly different (p = .047) among the control group (7 days [range 3-20]) compared to the colchicine group (4 days [range 2-14]). SIGNIFICANCE OF RESULTS Although our findings suggest that colchicine mouthwash is helpful in reducing the severity and duration of chemotherapy-induced OM, randomized trials are needed to confirm these results.