Document Detail


High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study.
MedLine Citation:
PMID:  8604274     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
T Z Baram; W G Mitchell; A Tournay; O C Snead; R A Hanson; E J Horton
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Pediatrics     Volume:  97     ISSN:  0031-4005     ISO Abbreviation:  Pediatrics     Publication Date:  1996 Mar 
Date Detail:
Created Date:  1996-05-13     Completed Date:  1996-05-13     Revised Date:  2013-06-11    
Medline Journal Info:
Nlm Unique ID:  0376422     Medline TA:  Pediatrics     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  375-9     Citation Subset:  AIM; IM    
Affiliation:
Division of Neurology, Childrens Hospital Los Angeles, USA.
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MeSH Terms
Descriptor/Qualifier:
Adrenocorticotropic Hormone / 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:
R01 NS028912-06/NS/NINDS NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Inflammatory Agents; 53-03-2/Prednisone; 9002-60-2/Adrenocorticotropic Hormone
Comments/Corrections

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