High-dose Corticotropin (ACTH) Versus Prednisone for Infantile Spasms: A Prospective, Randomized, Blinded Study
1 The Division of Neurology, Childrens Hospital Los Angeles and the Departments of Neurology and Pediatrics, University of Southern California, Los Angeles
2 The Department of Neurology, Southern California Permanente, Los Angeles.
Objective. To compare the efficacy of corticotropin (ACTH) (150 U/m2/day) and prednisone (2 mg/kg/day), given for 2 weeks, in suppressing clinical spasms and hypsarrhythmic electroencephalogram (EEG) in infantile spasms (IS). ACTH 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 prospective 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 both EEG and clinical criteria (86.6%); seizures stopped in an additional infant, but EEG remained hypsarrhythmic (considered a failure). Four of 14 patients given prednisone responded (28.6%, with complete clinical-EEG correlation), significantly less than with ACTH, (x2 test).
Conclusions. Using a prospective, randomized approach, a 2-week course of high-dose ACTH is superior to 2 weeks of prednisone for treatment of IS, as assessed by both clinical and EEG criteria.
Key Words: epilepsy • infantile spasms • ACTH • glucocorticoid • West syndrome • therapy • infant • prospective randomized controlled study
Submitted on March 13, 1995
Accepted on May 2, 1995
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