Steroid prophylaxis for prevention of nerve function impairment in leprosy: randomised placebo controlled trial (TRIPOD 1).
OBJECTIVE
To determine whether addition of low dose prednisolone to multidrug treatment can prevent reaction and nerve function impairment in leprosy.


METHODS
Multicentre, double blind, randomised, placebo controlled, parallel group trial.


METHODS
Six centres in Bangladesh and Nepal.


METHODS
636 people with newly diagnosed multibacillary leprosy.


METHODS
Prednisolone 20 mg/day for three months, with tapering dose in month 4, plus multidrug treatment, compared with multidrug treatment alone.


METHODS
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.
Smith
W Cairns S
WC
Department of Public Health, University of Aberdeen, Aberdeen AB25 2ZD. w.c.s.smith@abdn.ac.uk
Anderson
Alison M
AM
Withington
Stephen G
SG
van Brakel
Wim H
WH
Croft
Richard P
RP
Nicholls
Peter G
PG
Richardus
Jan Hendrik
JH
D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007918:Leprosy / Q000150:complications*; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000517:prevention & control*; D011239:Prednisolone / Q000008:administration & dosage*; D011596:Psychomotor Disorders / Q000382:microbiology / Q000517:prevention & control*; D012678:Sensation Disorders / Q000382:microbiology / Q000517:prevention & control*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005938:Glucocorticoids; D011239:Prednisolone