title: The efficacy of moderate-to-high dose oral prednisolone versus low-to-moderate dose intramuscular corticotropin for improvement of hypsarrhythmia in West syndrome: a randomized, single-blind, parallel clinical trial.
abstract: BACKGROUND
  The role of therapy on improvement of hypsarrhythmia has not been systematically assessed. This study was performed to assess the efficacy of oral prednisolone and intramuscular adrenocorticotrophin hormone in improving hypsarrhythmia in West syndrome.
  
  
  METHODS
  Children (2 months-2 years), with previously untreated West syndrome, were randomized to receive 40-60 IU every other day of intramuscular adrenocorticotrophin hormone or 40-60 mg/day of oral prednisolone for 14 days. Children with tuberous sclerosis were excluded. Improvement of hypsarrhythmia was assessed blindly using a hypsarrhythmia severity scale before and after completion of therapy. Adverse effects were assessed on day 14 using symptom diary. (Clinical trial registry identifier: SLCTR/2010/010.)
  
  
  RESULTS
  From 92 newly diagnosed West syndrome infants, 48 were randomized to receive prednisolone and 44 to receive adrenocorticotrophin hormone. Eighty infants completed the posttreatment evaluation according to specifications. The hypsarrhythmia severity score, significantly improved with hormonal therapy for 2 weeks (10.45 ± 2.65 vs 3.45 ± 2.67); P < 0.01. When individual treatment arms were compared using mean differences in the improvement of scores, improvement in prednisolone arm (7.95 ± 2.76) was significantly greater than that in the adrenocorticotrophin hormone arm (6.00 ± 2.61); P < 0.01. Both forms of therapy were tolerated well. Frequent crying, irritability, weight gain, increased appetite, and abdominal distension were more common (but not statistically significant) with prednisolone.
  
  
  CONCLUSIONS
  Hypsarrhythmia severity score improved significantly with both hormonal therapies, but this improvement was significantly better with oral prednisolone than intramuscular adrenocorticotrophin hormone. This is the first ever documentation of a superior therapeutic role of oral steroids in West syndrome.
authors.affiliation: Department of Pediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. Electronic address: jithangi@gmail.com.
authors.forename: Jithangi
authors.initials: J
authors.lastname: Wanigasinghe
authors.affiliation: Department of Community Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
authors.forename: Carukshi
authors.initials: C
authors.lastname: Arambepola
authors.affiliation: Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
authors.forename: Shalini
authors.initials: S
authors.lastname: Sri Ranganathan
authors.affiliation: Department of Pediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
authors.forename: Samanmali
authors.initials: S
authors.lastname: Sumanasena
authors.affiliation: Department of Pediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
authors.forename: Eindrini C
authors.initials: EC
authors.lastname: Muhandiram
mesh_terms: D000284:Administration, Oral; D000324:Adrenocorticotropic Hormone / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular; D008297:Male; D017063:Outcome Assessment, Health Care; D011239:Prednisolone / Q000008:administration & dosage*; D016037:Single-Blind Method; D013036:Spasms, Infantile / Q000150:complications* / Q000188:drug therapy* / Q000209:etiology*
chemical_list: D000893:Anti-Inflammatory Agents; D000324:Adrenocorticotropic Hormone; D011239:Prednisolone
keywords: ACTH; West syndrome; hypsarrhythmia; prednisolone