Source:Pediatric Neurology
Author(s): Jithangi Wanigasinghe, Carukshi Arambepola, Shalini Sri Ranganathan, Samanmali Sumanasena
ObjectiveWe earlier completed a single blind, parallel-group, randomized clinical trial to test null hypothesis that ACTH is not superior to high dose prednisolone for short-term control of West Syndrome(WS). We now present long-term follow-up data for spasm control for individuals who completed this earlier trial.MethodsInfants with untreated WS were randomized to receive 14 days of prednisolone(40-60mg/day) or intramuscular long-acting ACTH(40-60 IU every other day). They were evaluated at three, six and twelve months to evaluate long-term spasm control.ResultsTotal number treated was 97 (48 prednisolone;49 ACTH). All completed the treatment course. 85, 82 and 76 children were available for follow-up at 3, 6 and 12 months. Number lost to follow up at each interval was not statistically different. Likelihood of spasm freedom at three months was significantly higher for prednisolone(64.6%) than for ACTH (38.8%)(p=0.01; OR=2.9; 95% CI=1.3-6.6). At six months (p=0.19) and twelve months (p=0.13), the control of spasms was not statistically different, although a trend in favor of prednisolone was documented at both these time points(58.3% versus 44.9% for ACTH at six months and 56.2% versus 40.8% with ACTH at twelve months). After initial remission by day 14 (n=46), getting a relapse within next 12 months was not statistically different between the two treatment groups(p=0.1).ConclusionControl of spasms at three months was significantly better if initially treated with prednisolone. Control of spasms at six and twelve months was not significantly different despite a trend favouring prednisolone. Risk of relapse following initial remission was similar in the two groups.
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