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Steroid prophylaxis for prevention of nerve function impairment in leprosy: randomised placebo controlled trial (TRIPOD1)

Smith, W.C.S., Anderson, A.M., Withington, S.G., Croft, R.P., van Brakel, W.H., Nicholls, P.G. and Richardus, J.H. (2004) Steroid prophylaxis for prevention of nerve function impairment in leprosy: randomised placebo controlled trial (TRIPOD1) BMJ, 328, (1459), pp. 1459-1464. (doi:10.1136/bmj.38107.645926.AE).

Record type: Article


Objective: To determine whether addition of low dose prednisolone to multidrug treatment can prevent reaction and nerve function impairment in leprosy.
Design: Multicentre, double blind, randomised, placebo controlled, parallel group trial.
Setting: Six centres in Bangladesh and Nepal.
Participants: 636 people with newly diagnosed multibacillary leprosy.
Intervention: Prednisolone 20 mg/day for three months, with tapering dose in month 4, plus multidrug treatment, compared with multidrug treatment alone.
Main outcome measures: Signs of reaction, impairment of sensory and motor nerve function, and nerve tenderness needing full dose prednisolone at four months and one year.
Results: Prednisolone had a significant effect in the prevention of reaction and nerve function impairment at four months (relative risk 3.9, 95% confidence interval 2.1 to 7.3), but this was not maintained at one year (relative risk 1.3, 0.9 to 1.8). Fewer events occurred in the prednisolone group at all time points up to 12 months, but the difference at 12 months was small. Subgroup analysis showed a difference in response between people with and without impairment of nerve function at diagnosis.
Conclusions: The use of low dose prophylactic prednisolone during the first four months of multidrug treatment for leprosy reduces the incidence of new reactions and nerve function impairment in the short term, but the effect is not sustained at one year. The presence of nerve function impairment at diagnosis may influence the response to low dose prednisolone.

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Published date: May 2004
Keywords: steroid prophylaxis, prevention of nerve function impairment, leprosy, TRIPOD 1


Local EPrints ID: 19207
ISSN: 0959-8138
PURE UUID: fec1ff68-c2d6-45a4-bf4c-506bbfb53400

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Date deposited: 31 Jan 2006
Last modified: 17 Jul 2017 16:33

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Author: W.C.S. Smith
Author: A.M. Anderson
Author: S.G. Withington
Author: R.P. Croft
Author: W.H. van Brakel
Author: P.G. Nicholls
Author: J.H. Richardus

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