ABSTRACT
INTRODUCTION: There are few drugs with proven efficacy in cutaneous leishmaniasis (CL), and pentavalent antimonial derivatives are still the main first-line therapeutic agents worldwide, despite their recognized high toxicities. Randomized controlled clinical trials assessing the efficacy and safety of new therapeutic modalities are of high priority, and the definition of the design of such trials raises debate about the use of placebo as a comparator. To support the use of placebo as a comparator, two main points need to be addressed: 1--the cure rate without any therapeutic intervention and 2--the damage caused by CL and its impact on patients. OBJECTIVE: The aim of this study was to systematically assess the spontaneous cure rate for American CL and to broaden the discussion about placebo use in CL trials. METHODS: The PRISMA guidelines for systematic reviews and the Cochrane manual were followed. The sources used were the PubMed and LILACS databases. Studies were included if they reported cure rates using placebo or no treatment in American CL. RESULTS: Thirteen studies of a total of 352 patients were ultimately included in this review. The summarized global cure rates for all Leishmania species according to the intention-to-treat analyses performed at approximately three ("initial cure") and nine ("definitive cure") months after "no treatment" or placebo use were 26% (CI95%: 16 to 40%) and 26% (CI95%:16 to 38%), respectively. Notably, a significantly lower cure rate was observed for L. braziliensis infection (6.4%, CI95%:0.2 to 20%) than for L. mexicana infection (44%, CI95%:19 to 72%), p = 0.002. Of note, relapse occurred in 20% of patients with initial healing (CI95%:9.2 to 38.9%). CONCLUSION: These results clearly demonstrate a low spontaneous cure rate following no-treatment or placebo use, confirming that this strategy for the control group in CL studies expose patients to greater morbidity, especially for CL caused by L. braziliensis. Therefore, from this point, the crucial question to consider regarding placebo use is the seriousness of the suffering caused by this disease.
Subject(s)
Antiprotozoal Agents/therapeutic use , Leishmaniasis, Cutaneous/drug therapy , Placebos/therapeutic use , Humans , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
Introdução: a hanseníase é uma doença de impacto mundial. No Brasil, o Sistema de Informação de Agravos Notificáveis (SINAN) registra dados referentes ao controle da hanseníase. Poucos trabalhos analisaram a qualidade dos registros desse sistema em relação à hanseníase. Neste estudo, avaliou-se a qualidade do preenchimento das fichas de notificação da hanseníase. Material e método: trata-se de estudo de banco de dados de variáveis de fichas do SINAN para hanseníase e registros de prontuários médicos. Analisaram-se 147 fichas de notificação de pacientes diagnosticados com hanseníase no Centro de Referência de Minas Gerais, de janeiro de 2006 a dezembro de 2010. Construiu-se questionário com dados relativos ao prontuário e à ficha do SINAN com dupla coleta e entrada de dados no banco de dados. Para avaliar a qualidade dos registros, verificaram-se a completitude e consistência dos registros e aplicou-se o coeficiente Kappa para confiabilidade. Resultados: foram avaliados o grau de completitude de 12 variáveis em 147 fichas; 74 (50,3%) apresentaram pelo menos um campo em branco; oito entre 12 variáveis (66,7%) apresentaram percentual superior a 90% de preenchimento. Para a análise da concordância, foram consideradas sete variáveis categóricas, com coeficiente Kappa variando de 0,86 a 1,0. Conclusão: a análise de completitude foi similar à de outros trabalhos, porém a confiabilidade dos registros foi diferente de estudos anteriores, que encontraram graus de concordância inferiores ao estudo atual. Mais estudos são necessários para confirmar a qualidade de registros em outros centros e em etapas diferentes do fluxo de informações do SINAN.
Introduction: Leprosy is a disease of worldwide impact. In Brazil, the Information System of Notifiable Diseases (SINAN) records data relating to leprosy control. Few studies have analyzed data quality of the records of this system in relation to leprosy. In this study, we evaluated the quality of the information reporting forms on leprosy. Methods: This is a study of Database variables evaluating data quality from SINAN forms on leprosy and medical records. We analyzed 147 forms with records of patients diagnosed with leprosy at the Reference Center of Minas Gerais from January 2006 to December 2010. We developed a questionnaire based on selected variables extracted from the SINAN form. Data collection and data entry into the database was performed twice. To assess the quality of the records, we evaluated the completeness and consistency of records and applied kappa statistics for data reliability. Results: We evaluated the completeness of twelve variables in 147 forms; half of the records showed at least one not filled in. Eight out of twelve variables (66.7%) showed more than 90 % coverage. The kappa statistics ranged from 0.86 to 1.0 (almost perfect to perfect agreement). Conclusion: Analysis of completeness was similar to other studies, but the reliability of the records was different from previous studies that found lower degrees of agreement than the current study. More studies are needed to confirm the quality of records in other centers and in different stages of the SINAN information flow.
