Randomized, Single-Blind, Parallel Clinical Trial on Efficacy of Oral Prednisolone Versus Intramuscular Corticotropin: A 12-Month Assessment of Spasm Control in West Syndrome - 07/11/17
, Carukshi Arambepola, MBBS, MSc, MD (Community Medicine) b, 1, Shalini Sri Ranganathan, MBBS, DCH, MD (Paed), MRCP, PhD c, Samanmali Sumanasena, MBBS, DCH, MD (Paed) dAbstract |
Objective |
We earlier completed a single-blind, parallel-group, randomized clinical trial to test the null hypothesis that adrenocorticotropic hormone (ACTH) is not superior to high-dose prednisolone for short-term control of West syndrome. We now present long-term follow-up data for spasm control for individuals who completed this earlier trial.
Methods |
Infants with untreated West syndrome were randomized to receive 14 days of prednisolone (40 to 60 mg/day) or intramuscular long-acting ACTH (40 to 60 IU every other day). They were evaluated at three, six, and 12 months to evaluate long-term spasm control.
Results |
The total number of infants treated was 97 (48 prednisolone; 49 ACTH). All completed the treatment course. Eighty-five, 82, and 76 children were available for follow-up at three, six, and 12 months. The 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; odds ratio = 2.9; 95% confidence interval = 1.3 to 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 of these time points (58.3% versus 44.9% for ACTH at six months and 56.2% versus 40.8% with ACTH at 12 months). After initial remission by day 14 (n = 46), the likelihood of a relapse within the next 12 months was not statistically different between the two treatment groups (P = 0.1).
Conclusions |
Control of spasms at three months was significantly better if initially treated with prednisolone. Control of spasms at six and 12 months was not significantly different despite a trend favoring prednisolone. Risk of relapse following initial remission was similar in the two groups.
Le texte complet de cet article est disponible en PDF.Keywords : infantile spasms, West syndrome, hypsarrhythmia, ACTH, prednisolone
Plan
| Contributions: Jithangi Wanigasinghe: Principal investigator of the project. Responsible for planning out the trial, obtaining funds, and overall conduct of the trial. She is also responsible for major proportion of the writing of the article. She takes full responsibility for the data and their accuracy and the conduct of the research. Carukshi Arambepola: Bio-statistician of the study. Responsible for the generation of data analysis and writing of results in this article. Shalini Sri Ranganathan: Responsible for the therapeutic observations, follow-up on adverse effects and contribution to development of the paper. Samanmali Sumanasena: Responsible for baseline developmental analysis in the participants. |
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| Conflicts of interest: No part of the trial was industry sponsored. The Sri Lanka Medical Association did part funding. Principal investigator has received a travel grant from Novartis Pharma Services, which does not handle any of the drugs used in this trial. The rest of the authors have no conflicts of interest to disclose. We confirm that we have read the journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines. |
Vol 76
P. 14-19 - novembre 2017 Retour au numéro
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