02958nas a2200325   4500000000100000008004100001100001500042700001100057700001500068700001300083700001100096700001400107700001000121700001300131700002900144700001300173700001200186700001100198700001500209700001400224700002400238700001600262700001700278245014600295856007800441300001300519490000700532520207900539022001402618       2017                            d1 aWagenaar I1 aPost E1 aBrandsma W1 aBowers B1 aAlam K1 aShetty VP1 aPai V1 aHusain S1 aRosita Sigit Prakoeswa C1 aAstari L1 aHagge D1 aShah M1 aNeupane KD1 aTamang KB1 aTENLEP study group 1 aNicholls PG1 aRichardus JH00aEffectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial.  uhttp://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0005952  ae00059520 v113 a<p><strong>BACKGROUND: </strong>While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function.</p>

<p><strong>METHODS: </strong>In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (&lt;6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient's body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported.</p>

<p><strong>RESULTS: </strong>We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm.</p>

<p><strong>CONCLUSION: </strong>In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.</p>
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