Addition of pyridoxine to prednisolone in the treatment of infantile spasms: A pilot, randomized controlled trial.

Abstract

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.

• Authors: Vedavathi Kunnanayaka, Puneet Jain, Suvasini Sharma, Anju Seth, Satinder Aneja
• Journal: Neurology India (Neurol India) 2018 Mar-Apr Vol. 66 Issue 2 Pg. 385-390 ISSN: 0028-3886 [Print] India
• PMID: 29547159 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents
• Drug Combinations
• Vitamin B Complex
• Prednisolone
• Pyridoxine

Topics

• Anti-Inflammatory Agents (therapeutic use)
• Child, Preschool
• Drug Combinations
• Electroencephalography
• Female
• Follow-Up Studies
• Humans
• Infant
• Male
• Outcome Assessment, Health Care
• Pilot Projects
• Prednisolone (therapeutic use)
• Pyridoxine (therapeutic use)
• Retrospective Studies
• Spasms, Infantile (drug therapy)
• Vitamin B Complex (therapeutic use)