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Original research
Efficacy of pulse intravenous methylprednisolone in epileptic encephalopathy: a randomised controlled trial
  1. Anush Rangarajan1,
  2. Ravindranadh Chowdary Mundlamuri1,
  3. Raghavendra Kenchaiah1,
  4. Parthipulli Vasuki Prathyusha2,
  5. Lakshminarayanapuram Gopal Viswanathan1,
  6. Ajay Asranna1,
  7. Aparajita Chatterjee1,
  8. Madhu Nagappa1,
  9. Doniparthi Venkata Seshagiri1,
  10. Karthik Kulanthaivelu3,
  11. Rose Dawn Bharath3,
  12. Saini Jitender3,
  13. Kandavel Thennarasu2,
  14. Sanjib Sinha1
  1. 1Department of Neurology, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India
  2. 2Department of Biostatistics, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India
  3. 3Neuroimaging and Interventional Radiology, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India
  1. Correspondence to Dr Sanjib Sinha, Department of Neurology, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India; sanjib_sinha2004{at}yahoo.co.in

Abstract

Background High-level evidence for using steroids in epileptic encephalopathy (EE), other than West syndrome (WS), is lacking. This study investigated the efficacy and safety of pulse intravenous methylprednisolone (IVMP) in EE other than WS.

Methods This is an open-label evaluator-blinded randomised controlled study. Children aged 6 months or more with EE other than WS were included. Eighty children were randomised into intervention and non-intervention groups with 40 in each group. At the first visit (T1) seizure frequency, electroencephalographic (EEG) and Vineland Social Maturity Scale (VSMS) were obtained, and antiseizure medication (ASM) were optimised. After 1 month (T2), subjects were randomised to intervention (ASM+3 months IVMP pulse) or non-intervention group (only ASM) with 40 subjects in each group. They were followed up for 4 months (T3) and assessed.

Results After 4 months of follow-up, 75% of patients receiving IVMP had >50% seizure reduction versus 15.4% in control group (χ2=28.29, p<0.001) (RR 4.88, 95% CI 2.29 to 10.40), median percentage change in seizure frequency (91.41% vs 10%, p<0.001), improvement in EEG (45.5% vs 9.4%, χ2=10.866, p=0.001) and social age domain of VSMS scores (Z=−3.62, p<0.001) compared with baseline. None of the patients in the intervention group had any serious side-effects.

Discussion Three-month pulse IVMP therapy showed significant improvement in seizure frequency, EEG parameters and VSMS scores, with no steroid-related serious adverse effects. It can be considered as a safe and effective add on treatment in children with EE other than WS.

Trial registration number CTRI/2019/02/017807.

  • EPILEPSY
  • EEG
  • PAEDIATRIC NEUROLOGY
  • RANDOMISED TRIALS

Data availability statement

Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. Data are available upon reasonable request.

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Footnotes

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  • Contributors The trial was initiated by SS and AR, and all the authors contributed to its design. Allocation and monitoring of treatment related adverse effects was done by AR. LGV, AC, MN and DVS assessed the primary outcomes, SS and RCM analysed the EEGs of the trial participants; RK and AA assessed developmental outcomes. Randomisation and the statistical analysis were done by PVP and KT. The first and second authors (AR and RCM) wrote the first draft of the manuscript and all the authors reviewed the manuscript and vouch for adherence of the trial to the protocol and for the completeness and accuracy of the data. Corresponding author (SS) is responsible for the overall content as the guarantor. The corresponding author (SS) accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.