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Homeopathy 2023; 112(03): 170-183
DOI: 10.1055/s-0042-1755361
Original Research Article

Individualized Homeopathic Medicines as Adjunctive Treatment of Pediatric Epilepsy: A Double-Blind, Randomized, Placebo-Controlled Trial

Authors

  • Bharti Gupta 

    1   Department of Pediatrics, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India

  • Pankhuri Misra 

    2   Department of Materia Medica, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India

  • Avaranjika Karuppusamy 

    2   Department of Materia Medica, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India

  • Dharshna Balamurugan 

    2   Department of Materia Medica, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India

  • Maneet Parewa 

    3   Department of Repertory, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India

  • Maneela Tomar 

    4   Department of Organon of Medicine and Homeopathic Philosophy, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India

  • Shruti Rai 

    4   Department of Organon of Medicine and Homeopathic Philosophy, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India

  • Himani Vashishth 

    3   Department of Repertory, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India

  • Satarupa Sadhukhan 

    4   Department of Organon of Medicine and Homeopathic Philosophy, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India

  • Navin Kumar Singh 

    5   Department of Repertory, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, West Bengal; affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, West Bengal, India

  • Munmun Koley 

    6   Department of Homeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, West Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, West Bengal, India

  • Subhranil Saha 

    7   Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India

Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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Abstract

Introduction Epilepsy, one of the most common neurological diseases, contributes to 0.5% of the total disease burden. The burden is highest in sub-Saharan Africa, central Asia, central and Andean Latin America, and south-east Asia. Asian countries report an overall prevalence of 6/1,000 and that in India of 5.59/1,000. We examined whether individualized homeopathic medicines (IHMs) can produce a significantly different effect from placebos in treatment of pediatric epilepsy in the context of ongoing standard care (SC) using anti-epileptic drugs (AEDs).

Methods The study was a 6-month, double-blind, randomized, placebo-controlled trial (n = 60) conducted at the pediatric outpatient department of a homeopathic hospital in West Bengal, India. Patients were randomized to receive either IHMs plus SC (n = 30) or identical-looking placebos plus SC (n = 30). The primary outcome measure was the Hague Seizure Severity Scale (HASS); secondary outcomes were the Quality of Life in Childhood Epilepsy (QOLCE-16) and the Pediatric Quality of Life inventory (PedsQL) questionnaires; all were measured at baseline and after the 3rd and 6th month of intervention. The intention-to-treat sample was analyzed to detect group differences and effect sizes.

Results Recruitment and retention rates were 65.2% and 91.7% respectively. Although improvements were greater in the IHMs group than with placebos, with small to medium effect sizes, the inter-group differences were statistically non-significant – for HASS (F 1, 58 = 0.000, p = 1.000, two-way repeated measures analysis of variance), QOLCE-16 (F 1, 58 = 1.428, p = 0.237), PedsQL (2–4 years) (F 1, 8 = 0.685, p = 0.432) and PedsQL (5–18 years) (F 1, 47 = 0.000, p = 0.995). Calcarea carbonica, Ignatia amara, Natrum muriaticum and Phosphorus were the most frequently prescribed medicines. No serious adverse events were reported from either of the two groups.

Conclusion Improvements in the outcome measures were statistically non-significantly greater in the IHMs group than in the placebos group, with small effect sizes. A different trial design and prescribing approach might work better in future trials.

Trial registration CTRI/2018/10/016027

Keywords

homeopathy - pediatric epilepsy - placebo - quality of life - randomized controlled trial - seizure

Authors' Contribution

B.G. contributed toward concept and the literature search; B.G., P.M., A.K., D.B., M.P., M.T., S.R. and H.V. undertook the clinical study and data acquisition; S.S., N.K.S., M.K. and S.S. contributed toward design, data interpretation, statistical analysis, and preparation of the article. All the authors reviewed and approved the final manuscript.


Supplementary Material



Publication History

Received: 11 April 2022

Accepted: 29 June 2022

Article published online:
13 December 2022

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