Patient profile and treatment satisfaction of Brazilian leprosy patients in a clinical trial of uniform six-month multidrug therapy (U-MDT/CT-BR).

OBJECTIVE: To describe the profile of patients who participated in the Randomised Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR) and determine the level of satisfaction with a uniform therapy regimen, especially among paucibacillary patients.
DESIGN: This is a descriptive cross-sectional epidemiologic study nested in the wider U-MDT/CT-BR. The study was conducted using a convenience sample composed of patients from the Dona Libânia Dermatology Centre in Fortaleza, Ceará and from the Alfredo da Matta Foundation in Manaus, Amazonas in Brazil. The absolute and relative frequencies of categorical variables and the median age were calculated. Hypothesis testing was done using the Chi-squared and Mann-Whitney tests with a 0.05 level of significance.
RESULTS: Of the 859 patients included in the clinical trial, 342 were interviewed. The majority of patients were male (58.2%) and multibacillary (78.3%) with a median age of 42 (7-65) years. Most of the interviewees had not completed primary education (48.0%), earned an income below three times the minimum wage (53.8%), were non-smokers (85.1%), did not regularly consume alcohol (88.3%), had not experienced any leprosy-related discrimination (69.2%) and showed a basic knowledge of the disease. With regards to paucibacillary patients, 87.8% and 90.9% of the PB U-MDT and PB R-MDT groups, respectively, indicated that they had not thought of defaulting treatment at any time. On a satisfaction scale of 1-5 (with five as the highest score), 92.7% of PB U-MDT and 100.0% of PB R-MDT patients gave a mark between three and five.
CONCLUSIONS: The data suggest that the introduction of clofazimine into the therapeutic regimen did not diminish the level of treatment satisfaction among PB patients.

RCT Entities:   Population Interventions Outcomes