Are guidelines for field treatment of leprosy reactions evidence-based? A comprehensive literature review

Purpose: Much of the stigma associated with leprosy is caused by disfiguring disabilities following irreversible nerve damage and much of this damage is the end result of leprosy reactions which are either not recognized in early enough stages, not treated appropriately or both. In an effort to improve access to care, to reduce stigma and to integrate leprosy into general health care services, guidelines for standardized treatment in field conditions of the infection itself and of leprosy reactions have been developed and implemented. This has sparked debate among experts concerning the efficacy of treatment protocols for especially leprosy reactions outlined in the guidelines. The principle points of contention are the duration of treatment, dosage and tapering strategies of the drug mainly used, prednisolone. This study investigates on what evidence these guidelines are based. Methods: Electronic databases were used in search of randomized controlled trials and other non-randomized evidence that could shed light on the validity of the strategies advocated and already implemented in most leprosy control programs worldwide.Results: Randomized controlled trials were found only for reversal reactions (type 1 reaction), and it could be concluded that the current strategies for field treatment of this type of reaction are not efficacious and do not yield better results than placebos. Instead, indications are that longer and higher dosed treatment strategies are needed to yield better results and this is supported by other non-randomized evidence. Conclusions: Further randomized controlled trials are needed to determine optimal dosages, tapering strategies and duration of treatment. Non-randomized evidence suggests that the protocols are not optimal for type 2 reactions either and may need to be reviewed based on further research. An outline for a randomized controlled trial is presented in an effort to further provide evidence for optimal treatment strategies for field treatment of type 1 leprosy reactions.

Publication year:2010

Keywords:Bacterial diseases, Leprosy, Mycobacterium leprae, Reactions, Staging, Guidelines, Treatment, Evidence-based medicine, Randomized controlled trials, Control programs, Efficacy, Placebo, Dosage, Duration, Protocols, Review of the literature