A single center randomized clinical trial comparing the treatment efficacy of high dose oral Prednisolone with intramuscular Adrenocorticotropic hormone in patients with infantile spasms


1 Department of Pediatric Neurology, Faculity of Medicine, Mashhad University of Medical Siences, Mashhad, Iran

2 Clinical Research Development Unit, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.

3 Mashad University of Medical Sciences, Mashhad, Iran.


Introduction: Infantile spasm is a rare condition in infants with an age 4 to 7 months. Treatment of this option varies in different cases. Corticosteroids and Adrenocorticotropic hormone (ACTH) are treatment options that are at the top list of usage; however, debates have remained in case of their efficacy. The aim of our study was to compare corticosteroid treatment with ACTH in patients with infantile spasm.
Method: In a randomized clinical trial, 51 infantile spasm patients were enrolled in the study and distributed into two groups, including the corticosteroid (twenty-six patients) and ACTH (twenty-five patients) groups. The patients in the corticosteroid group received a dose of 8 mg/kg/day (max:60mg) of Prednisolone in three divided doses for three weeks, and then it was tapered in responders. Non-responders after two weeks received 2-3 U/kg/day of ACTH (max:100U) for five days. The outcome was assessed using EEG and clinical remission of the disease. The comparison of the two groups was made using SPSS software version 20.0.
Results: Twenty-six patients were treated with Prednisolone, and 25 were treated with ACTH. There was no significant difference regarding gender, age, age of seizure onset, and growth abnormalities. At the end of the study, 13 patients in the Prednisolone group and 17 patients in the ACTH group had normal EEG rhythm with no significant difference (p=0.33). In the case of clinical response, 18 patients in the prednisolone group (69.2%) and 19 in the ACTH group (76%) responded to treatment with no significant difference regarding treatment outcome (p=0.58).
Conclusion: There was no notable difference regarding treatment with high dose Prednisolone or ACTH in infantile spasm in this study.