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.

Fig 1

Flow of participants through trial

Fig 2

Time to event for all participants

Fig 3

Time to event for participants without pre-existing nerve function impairment

Fig 4

Time to event for participants with pre-existing nerve function impairment