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

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
Read More Add to Saved list
  • Additional Information
    • Source:
      Publisher: American Academy of Pediatrics Country of Publication: United States NLM ID: 0376422 Publication Model: Print Cited Medium: Print ISSN: 0031-4005 (Print) Linking ISSN: 00314005 NLM ISO Abbreviation: Pediatrics Subsets: MEDLINE
    • Publication Information:
      Publication: Elk Grove Village Il : American Academy of Pediatrics
      Original Publication: Springfield, Ill., Thomas.
    • Subject Terms:
      Adrenocorticotropic Hormone/*therapeutic use ; Anti-Inflammatory Agents/*therapeutic use ; Prednisone/*therapeutic use ; Spasms, Infantile/*drug therapy; Cross-Over Studies ; Drug Administration Schedule ; Electroencephalography ; Female ; Humans ; Infant ; Male ; Prospective Studies ; Single-Blind Method ; Spasms, Infantile/etiology ; Treatment Outcome
    • Abstract:
      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.
    • References:
      Neuropediatrics. 1982 May;13(2):59-62. (PMID: 6290927)
      J Pediatr. 1982 Aug;101(2):294-6. (PMID: 6284904)
      Cleve Clin J Med. 1989;56 Suppl Pt 2:S166-71. (PMID: 2659206)
      Epilepsia. 1991;32 Suppl 6:S11-8. (PMID: 1659981)
      Neurology. 1993 Nov;43(11):2322-7. (PMID: 8232950)
      Neuropediatrics. 1982 May;13(2):55-8. (PMID: 6290926)
      Epilepsia. 1983 Apr;24(2):135-58. (PMID: 6299719)
      Neurology. 1992 Jun;42(6):1171-5. (PMID: 1318521)
      Pediatr Neurol. 1990 May-Jun;6(3):147-50. (PMID: 2163254)
      Exp Neurol. 1994 Jan;125(1):142-61. (PMID: 7905835)
      Epilepsia. 1983 Apr;24(2):159-68. (PMID: 6299720)
      Ann Neurol. 1992 May;31(5):488-94. (PMID: 1596084)
      Ann Neurol. 1991 Apr;29(4):458-60. (PMID: 1929219)
      Neurosci Lett. 1994 Jun 6;174(1):113-6. (PMID: 7970144)
      Am J Physiol. 1990 Apr;258(4 Pt 1):E686-92. (PMID: 2333962)
      J Pediatr. 1994 May;124(5 Pt 1):803-6. (PMID: 8176573)
      J Pediatr. 1966 Dec;69(6):1136-8. (PMID: 4288766)
      Epilepsy Res Suppl. 1991;4:69-85. (PMID: 1815612)
      Ann Neurol. 1993 Mar;33(3):231-6. (PMID: 8388675)
      Brain Res Dev Brain Res. 1991 Jul 16;61(1):97-101. (PMID: 1914160)
      Pediatr Neurol. 1990 Jul-Aug;6(4):240-4. (PMID: 2169750)
      Neurology. 1989 Aug;39(8):1027-31. (PMID: 2548119)
      J Pediatr. 1983 Oct;103(4):641-5. (PMID: 6312008)
      Epilepsia. 1984 Jun;25(3):317-25. (PMID: 6539199)
      Epilepsia. 1991 Mar-Apr;32(2):212-4. (PMID: 1848513)
      J Child Neurol. 1991 Oct;6(4):355-64. (PMID: 1940138)
    • Grant Information:
      R01 NS028912 United States NS NINDS NIH HHS; R01 NS028912-06 United States NS NINDS NIH HHS
    • Accession Number:
      0 (Anti-Inflammatory Agents)
      9002-60-2 (Adrenocorticotropic Hormone)
      VB0R961HZT (Prednisone)
    • Publication Date:
      Date Created: 19960301 Date Completed: 19960513 Latest Revision: 20240321
    • Publication Date:
      20240321
    • Accession Number:
      PMC3100715
    • Accession Number:
      8604274