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Steroid prophylaxis for prevention of nerve function impairment in leprosy: randomised placebo controlled trial (TRIPOD 1).

Abstract

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.

More information

Type
Journal Article
Author
Smith CW S
Anderson AM
Withington SG
van Brakel WH
Croft RP
Nicholls PG
Richardus JH
Year of Publication
2004
Journal
BMJ (Clinical research ed.)
Volume
328
Issue
7454
Number of Pages
1459
Date Published
2004 Jun 19
Language
eng
ISSN Number
1756-1833
Call Number
SMITH 2004
DOI
10.1136/bmj.38107.645926.AE
Alternate Journal
BMJ
Publication Language
eng