Leprosy Mailing List – April 9, 2017
Ref.: (LML) AZALEP trial
From: Joel Almeida, Mumbai and London
Dear Pieter,
A randomised controlled double blind trial (Lockwood et al, 2017) compared prednisolone alone with prednisolone + azathioprine, for nerve damage in leprosy. It was designed and done with reasonable care, and the analysis was on an "Intention To Treat" basis.
This study understandably omitted a comparison between prednisolone and placebo. Probably because that comparison had already been made in a randomised double-blind controlled trial or RCT (van Brakel et al, 2003).
In that earlier RCT, prednisolone had a protective effect on sensory scores, compared to placebo, at the end of 4 months of treatment. The RCT demonstrated a risk ratio of 2.58 for worsened scores in the placebo group between the start and end of treatment (confidence interval 1.19 to 5.60). Therefore prednisolone does have a demonstrable protective effect on sensory scores.
Given those findings, omission or neglect of prednisolone would be unethical in trials or in treatment of nerve damage in leprosy. The AZALEP study understandably did not have a placebo-only group. However, in the absence of a placebo-only group, the report is not well placed to assert a lack of effect for prednisolone, as it appears to do in places. The report appears otherwise reliable.
Prednisolone had already been demonstrated to have a protective effect on sensory scores in nerve function impairment (NFI) in leprosy, when NFI was detected sufficiently early.
Joel Almeida
References
1. Diana N. J. Lockwood , Joydeepa Darlong, Pitchaimani Govindharaj, Royce Kurian, Pamidipani Sundarrao, Annamma S. John. AZALEP a randomized controlled trial of azathioprine to treat leprosy nerve damage and Type 1 reactions in India: Main findings. PLOS NTD. Published: March 30, 2017 http://dx.doi.org/10.1371/journal.pntd.0005348
2. Van Brakel WH, Anderson AM, Withington SG, Croft RP, Nicholls PG, Richardus JH, Smith WC. The prognostic importance of detecting mild sensory impairment in leprosy: a randomized controlled trial (TRIPOD 2). Lepr Rev. 2003 Dec;74(4):300-10.
LML - S Deepak, B Naafs, S Noto and P Schreuder
LML blog link: http://leprosymailinglist.blogspot.it/
Contact: Dr Pieter Schreuder << editorlml@gmail.com
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