A Single-center Randomized Clinical Trial Comparing the Treatment Efficacy of High Dose Oral Prednisolone with Intramuscular Adrenocorticotropic Hormone in Patients with Infantile Spasm

Background :

Infantile spasm is a rare condition in infants from 4 to 7 months old. Treatment varies in different cases. Corticosteroids and adrenocorticotropic hormone (ACTH) are the most widely used treatment options; however, there are debates on their efficacy. The aim of our study is to compare corticosteroid treatment with ACTH in patients with infantile spasm.

In a randomized clinical trial, 51 patients with infantile spasm 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: 60 mg) of prednisolone in three divided doses for three weeks, and the dose was later tapered in responders. Non-responders after two weeks received 2-3 U/kg/day of ACTH (max: 100 U) 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.

Twenty-six patients were treated with prednisolone and 25 patients with ACTH. There was no significant difference in 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). As to 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 the treatment outcome (p=0.58).

 Conclusion:

 There was no considerable difference regarding treatment of infantile spasm with high dose prednisolone or ACTH in in this study.