Comparative efficacy of four treatment regimens in Type 2 Leprosy Reactions (Prednisolone alone, Thalidomide alone, Prednisolone plus Thalidomide and Prednisolone plus Clofazimine).

Abstract

This study has been carried out to assess the comparative efficacy of Prednisolone alone or thalidomide alone for the first attack of T2R, and combination of prednisolone plus thalidomide or prednisolone plus clofazimine for chronic and recurrent T2R. Efficacy of all four regimens was assessed on the basis of clinical recovery of T2R measured by reaction severity scores (RSS) ,visual analogue scale (VAS) and other relevant parameters, requirement of extra dose of steroid for clinical recovery, recurrence of T2R and side effects observed in each regimen. The designof study was an open prospective longitudinal single centre investigation. In the first episode T2R group I (prednisolone alone) the efficacy was 58.8% (10/17) compared to 93.75% (15/16) in Group 2 treated with thalidomide alone. This difference was statistically significant p <0.05 when compared using unpaired ttest. When clinical outcome was compared in recurrent/relapse of T2R Groups 3 and 4, it was observed to be statistically significant p<0.05 when compared using unpaired t test. It was 82.35% (14/17) in Group 3 (prednisolone plus clofazimine) and 10/16 (62.5%) in Group 4 (prednislone plus clofazimine). To conclude, for the management of recurrent/chronic ENL, both the combinations-prednisolone with thalidomide or clofazimine appear to be efficacious. While prednisolone with thalidomide appears to be better than prednisolone and clofazimine, however, by 20 weeks difference narrows down. As of now these findings may be considered indicative and larger experience on more number of cases using robust statistical design is required for marchingtowards making recommendations for clinical application.