| High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. | |
MedLine Citation:
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PMID: 8604274 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To compare the efficacy of corticotropin (ACTH) (150 U/m2/day) and prednosone (2 mg/kg/day) given for 2 weeks, in suppressing clinical spasms and hypsarrhythmic electroencephalogram (EEG) in infantile spasms (IS). AACTH and prednisone are standard treatments for IS. ACTH at high doses causes severe dose- and duration-dependent side effects, but may be superior to prednisone, based on retrospective or uncontrolled studies. Blinded prospecive studies have shown equal efficacy of prednisone and low-dose ACTH, and low versus high-dose ACTH. DESIGN: A prospective, randomized, single-blinded study. SUBJECTS AND METHODS: Patient population consisted of consecutive infants fulfilling entry criteria, including the presence of clinical spasms, hypsarrhythmia (or variants) during a full sleep cycle video-EEG, and no prior steroid/ACTH treatment. Response required both cessation of spasms and elimination of hypsarrhythmia by the end of the 2-week treatment period, as determined by an investigator "blinded" to treatment. Treatment of responders was tapered off over 12 days; those failing one hormone were crossed-over to the other. RESULTS: OF 34 eligible infants, 29 were enrolled. Median age of patients was 6 months. Twenty-two infants were "symptomatic" with known or suspected cause, and seven were cryptogenic (two normal). Of 15 infants randomized to ACTH, 13 responded by EEG and clinical criteria (86.6%); Seizures stopped in an additional infant, but EEG remained hypsarrhythmic (considered a failure). Four of the 14 patients given prednisone responded (28.6%,, with complete clinical-EEG correlation), significantly less than with ACTH, (chi2 test). CONCLUSIONS: Using a prospective, randomized approach, a 2-week course of high-dose ACTH is superior to 2 weeks of prednsone for treatment of IS, as assessed by both clinical and EEG criteria. |
Authors:
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T Z Baram; W G Mitchell; A Tournay; O C Snead; R A Hanson; E J Horton |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Pediatrics Volume: 97 ISSN: 0031-4005 ISO Abbreviation: Pediatrics Publication Date: 1996 Mar |
Date Detail:
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Created Date: 1996-05-13 Completed Date: 1996-05-13 Revised Date: 2013-06-11 |
Medline Journal Info:
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Nlm Unique ID: 0376422 Medline TA: Pediatrics Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 375-9 Citation Subset: AIM; IM |
Affiliation:
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Division of Neurology, Childrens Hospital Los Angeles, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adrenocorticotropic Hormone
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therapeutic use* Anti-Inflammatory Agents / therapeutic use* Cross-Over Studies Drug Administration Schedule Electroencephalography Female Humans Infant Male Prednisone / therapeutic use* Prospective Studies Single-Blind Method Spasms, Infantile / drug therapy*, etiology Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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R01 NS028912-06/NS/NINDS NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents; 53-03-2/Prednisone; 9002-60-2/Adrenocorticotropic Hormone |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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