High-dose corticotropin (ACTH) versus prednisone for infantile spasms: A prospective, randomized, blinded study

Author(s): Mitchell, W. G., Tournay, A., Snead, O. C., Hanson, R. A., Horton, E. J.

Journal/Book: Pediatrics. 1996; 97: 141 North-West Point Blvd, Elk Grove Village, IL 60007-1098. Amer Acad Pediatrics. 375-379.

Abstract: Objective. To compare the efficacy of corticotropin (ACTH) (150 U/m(2)/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, (chi(2) 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.

Note: Article TZ Baram, Univ Calif Irvine, Irvine Med Ctr, Dept Pediat, 101 City Dr S, Bldg 27, Orange, CA 92668 USA

Keyword(s): epilepsy; infantile spasms; ACTH; glucocorticoid; West syndrome; therapy; infant; prospective randomized controlled study; BRAIN-ADRENAL AXIS; EFFICACY; CHILDREN

Zurück | Weiter