| ORIGINAL ARTICLE
|Year : 2018 | Volume
| Issue : 2 | Page : 385--390
Addition of pyridoxine to prednisolone in the treatment of infantile spasms: A pilot, randomized controlled trial
Vedavathi Kunnanayaka1, Puneet Jain2, Suvasini Sharma3, Anju Seth1, Satinder Aneja3
1 Department of Pediatrics, Lady Hardinge Medical College and associated Kalawati Saran Children's Hospital, New Delhi, India
2 Division of Pediatric Neurology, Department of Neonatal, Pediatric and Adolescent Medicine, BL Kapur (BLK) Super Speciality Hospital, New Delhi, India
3 Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and associated Kalawati Saran Children's Hospital, New Delhi, India
Background: West syndrome is a catastrophic epilepsy syndrome characterized by infantile spasms, hypsarrhythmia, and developmental arrest or regression.
Aim: The aim of this study was to explore the role of pyridoxine in the management of infantile spasms.
Setting and Design: This was a pilot, randomized, open-label trial conducted at a tertiary level hospital from November 2012 to March 2014.
Materials and Methods: Children aged 3 months to 3 years presenting with infantile spasms in clusters (at least 1 cluster/day) with hypsarrhythmia or its variants on electroencephalogram (EEG) were enrolled. The study participants were randomized to receive either oral prednisolone (4 mg/kg/day) alone or 30 mg/kg/day of pyridoxine with oral prednisolone. The primary outcome measure was the proportion of children who achieved spasm freedom for 48 h on day-14 after treatment initiation, as per parental reports, in both the groups. The adverse effects were also monitored. The study was registered with clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT01828437).
Results: Sixty-two children were randomized into the two groups with comparable baseline characteristics. The proportion of children with spasm cessation on day-14 was similar in the two groups (39 vs. 37%, P = 0.98). The adverse effects were comparable in both the groups.
Conclusions: The combination of pyridoxine with oral prednisolone was not found to be a beneficial therapy as compared to prednisolone alone in the treatment of infantile spasms in this pilot study. However, high dose pyridoxine may be safe in children with infantile spasms.
Dr. Suvasini Sharma
Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and associated Kalawati Saran Children's Hospital, New Delhi - 110 001
Source of Support: None, Conflict of Interest: None
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