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


METHODS
A prospective, randomized, single-blinded study.


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.
Baram
T Z
TZ
Division of Neurology, Childrens Hospital Los Angeles, USA.
Mitchell
W G
WG
Tournay
A
A
Snead
O C
OC
Hanson
R A
RA
Horton
E J
EJ
D000324:Adrenocorticotropic Hormone / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004569:Electroencephalography; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011241:Prednisone / Q000627:therapeutic use*; D011446:Prospective Studies; D016037:Single-Blind Method; D013036:Spasms, Infantile / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000324:Adrenocorticotropic Hormone; D011241:Prednisone