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

1   Department of Pediatrics, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India
,
2   Department of Materia Medica, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India
,
2   Department of Materia Medica, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India
,
2   Department of Materia Medica, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India
,
3   Department of Repertory, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India
,
4   Department of Organon of Medicine and Homeopathic Philosophy, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India
,
4   Department of Organon of Medicine and Homeopathic Philosophy, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India
,
3   Department of Repertory, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India
,
4   Department of Organon of Medicine and Homeopathic Philosophy, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India
,
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
,
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
,
7   Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India
› Institutsangaben
Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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

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



Publikationsverlauf

Eingereicht: 11. April 2022

Angenommen: 29. Juni 2022

Artikel online veröffentlicht:
13. Dezember 2022

© 2022. Faculty of Homeopathy. This article is published by Thieme.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2019; 18: 459-480
  • 2 Fiest KM, Sauro KM, Wiebe S. et al. Prevalence and incidence of epilepsy: a systematic review and meta-analysis of international studies. Neurology 2017; 88: 296-303
  • 3 Camfield P, Camfield C. Incidence, prevalence and aetiology of seizures and epilepsy in children. Epileptic Disord 2015; 17: 117-123
  • 4 Mac TL, Tran DS, Quet F, Odermatt P, Preux PM, Tan CT. Epidemiology, aetiology, and clinical management of epilepsy in Asia: a systematic review. Lancet Neurol 2007; 6: 533-543
  • 5 Sridharan R, Murthy BN. Prevalence and pattern of epilepsy in India. Epilepsia 1999; 40: 631-636
  • 6 Chowdary GV, Murthy JM, Vijay S. Prevalence of Seizure Disorders Associated with Neurocysticercosis: a Community-Based Study Comprehensive Rural Epilepsy Study–South India (CRESS). Singapore: The Asian and Oceanic Congress of Neurology; 2004
  • 7 Radhakrishnan K, Pandian JD, Santhoshkumar T. et al. Prevalence, knowledge, attitude, and practice of epilepsy in Kerala, South India. Epilepsia 2000; 41: 1027-1035
  • 8 Banerjee TK, Ray BK, Das SK. et al. A longitudinal study of epilepsy in Kolkata, India. Epilepsia 2010; 51: 2384-2391
  • 9 Wirrell EC, Grossardt BR, Wong-Kisiel LC, Nickels KC. Incidence and classification of new-onset epilepsy and epilepsy syndromes in children in Olmsted County, Minnesota from 1980 to 2004: a population-based study. Epilepsy Res 2011; 95: 110-118
  • 10 Attumalil TV, Sundaram A, Varghese VO, Vijayakumar K, Kunju PA. Risk factors of childhood epilepsy in Kerala. Ann Indian Acad Neurol 2011; 14: 283-286
  • 11 Berg AT, Nickels K, Wirrell EC. et al. Mortality risks in new-onset childhood epilepsy. Pediatrics 2013; 132: 124-131
  • 12 Beghi E, Giussani G, Sander JW. The natural history and prognosis of epilepsy. Epileptic Disord 2015; 17: 243-253
  • 13 Wirrell E, Wong-Kisiel L, Mandrekar J, Nickels K. Predictors and course of medically intractable epilepsy in young children presenting before 36 months of age: a retrospective, population-based study. Epilepsia 2012; 53: 1563-1569
  • 14 Stafstrom CE, Carmant L. Seizures and epilepsy: an overview for neuroscientists. Cold Spring Harb Perspect Med 2015; 5: a022426
  • 15 LaGrant B, Marquis BO, Berg AT, Grinspan ZM. Depression and anxiety in children with epilepsy and other chronic health conditions: National estimates of prevalence and risk factors. Epilepsy Behav 2020; 103: 106828
  • 16 Scheffer IE, Berkovic S, Capovilla G. et al. ILAE classification of the epilepsies: position paper of the ILAE Commission for Classification and Terminology. Epilepsia 2017; 58: 512-521
  • 17 Steiger BK, Jokeit H. Why epilepsy challenges social life. Seizure 2017; 44: 194-198
  • 18 Guerreiro CA. Epilepsy: is there hope?. Indian J Med Res 2016; 144: 657-660
  • 19 Berg AT, Baca CB, Rychlik K. et al. Determinants of social outcomes in adults with childhood-onset epilepsy. Pediatrics 2016; 137: e20153944
  • 20 Hosseini N, Sharif F, Ahmadi F, Zare M. Determining the disease management process for epileptic patients: a qualitative study. Iran J Nurs Midwifery Res 2016; 21: 54-62
  • 21 Bennett L, Bergin M, Wells JS. The potential of critical social theory as an educational framework for people with epilepsy. Epilepsy Behav 2016; 54: 80-87
  • 22 Perucca P, Scheffer IE, Kiley M. The management of epilepsy in children and adults. Med J Aust 2018; 208: 226-233
  • 23 Kliegman R. Nelson Textbook of Pediatrics. 21st ed. Philadelphia: Elsevier Saunders; 2019
  • 24 World Health Organization. . Epilepsy. Accessed April 26, 2020 at: http://www.who.int/news-room/fact-sheets/detail/epilepsy
  • 25 Brodie MJ, Besag F, Ettinger AB. et al. Epilepsy, antiepileptic drugs, and aggression: an evidence-based review. Pharmacol Rev 2016; 68: 563-602
  • 26 Tomson T, Marson A, Boon P. et al. Valproate in the treatment of epilepsy in girls and women of childbearing potential. Epilepsia 2015; 56: 1006-1019
  • 27 Englot DJ, Chang EF, Auguste KI. Vagus nerve stimulation for epilepsy: a meta-analysis of efficacy and predictors of response. J Neurosurg 2011; 115: 1248-1255
  • 28 Franco V, Perucca E. The pharmacogenomics of epilepsy. Expert Rev Neurother 2015; 15: 1161-1170
  • 29 Braams O, Maher C, Jennekens-Schinkel A. et al. Social functioning of children after epilepsy surgery: a literature review. Epilepsy Behav 2019; 96: 210-218
  • 30 Doering JH, Reuner G, Kadish NE, Pietz J, Schubert-Bast S. Pattern and predictors of complementary and alternative medicine (CAM) use among pediatric patients with epilepsy. Epilepsy Behav 2013; 29: 41-46
  • 31 Farrukh MJ, Makmor-Bakry M, Hatah E, Tan HJ. Use of complementary and alternative medicine and adherence to antiepileptic drug therapy among epilepsy patients: a systematic review. Patient Prefer Adherence 2018; 12: 2111-2121
  • 32 Hartmann N, Neininger MP, Bernhard MK. et al. Use of complementary and alternative medicine (CAM) by parents in their children and adolescents with epilepsy – Prevelance, predictors and parents' assessment. Eur J Paediatr Neurol 2016; 20: 11-19
  • 33 Power R, Byrne JP, Kiersey R. et al. Are patients ready for integrated person-centered care? A qualitative study of people with epilepsy in Ireland. Epilepsy Behav 2020; 102: 106668
  • 34 Goodwin SW, Ferro MA, Speechley KN. Development and assessment of the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-16). Epilepsia 2018; 59: 668-678
  • 35 Kent JT. Lectures on Homoeopathic Philosophy. 7th ed. New Delhi: B. Jain Publishers (P) Ltd; 2007
  • 36 Cramer JA, French J. Quantitative assessment of seizure severity for clinical trials: a review of approaches to seizure components. Epilepsia 2001; 42: 119-129
  • 37 The PedsQL Measurement Model for the Pediatric Quality of Life Inventory. Accessed August 8, 2021 at: https://www.pedsql.org/about_pedsql.html
  • 38 Schulz KF, Altman DG, Moher D. , for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c332
  • 39 Dean ME, Coulter MK, Fisher P, Jobst K, Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. Homeopathy 2007; 96: 42-45
  • 40 Morrison R. Desktop Companion to Physical Pathology. California: Hahnemann Clinic Publishing; 1993
  • 41 Anderson SF, Kelley K, Maxwell SE. Sample-size planning for more accurate statistical power: a method adjusting sample effect sizes for publication bias and uncertainty. Psychol Sci 2017; 28: 1547-1562
  • 42 Hughes R. The Principles and Practice of Homoeopathy. Leath & Ross; 1902
  • 43 Lilienthal S. Homoeopathic Therapeutics. Boericke & Tafel; 1907
  • 44 Boericke W. New Manual of Homoeopathic Materia Medica with Repertory. 3rd Revised Augmented ed. based on 9th ed, New Delhi: B. Jain Publishers Pvt. Ltd; 2002
  • 45 Dewey WA. Practical Homoeopathic Therapeutics. New Delhi: B. Jain Publishers Pvt. Ltd; 2002
  • 46 Allen HC. Keynotes and Characteristics of Some of the Leading Remedies of the Materia Medica with Bowel Nosodes. New Delhi: B. Jain Publishers Pvt. Ltd.; 2002
  • 47 Paschero TP, Hernandez CA, Soler JA. et al. Translated from Spanish by Peebles WC. Similitude and epilepsy. The Layman Speaks; 1966
  • 48 Kumar VS. A Clinical Study on Epilepsy in Mentally Challenged. Institution of Homoeopaths Kerala News; , October 2008, 21–26
  • 49 Gopinadhan S, Murty GSN, Pramanik MS. et al. Clinical Research Studies: Series 1, Ch. Epilepsy. New Delhi: Central Council for Research in Homoeopathy; 2008: 41-52
  • 50 Tafel LH. ed. The Chronic Diseases, their Peculiar Nature and their Homoeopathic Cure by Samuel Hahnemann. Reprint ed. New Delhi: B. Jain Publishers Pvt. Ltd; 2013
  • 51 Canepa DE, Granata G. Fundamental Archetypes – Remedies in Paediatrics. Liga Medicorum Homoeopathica Internationalis; 1988
  • 52 Raue CS. Diseases of Children. 2nd ed. Philadelphia: Boericke & Tafel; 1906
  • 53 Choudhuri NM. A Study on Materia Medica and Repertory. 2nd Reprint ed. New Delhi: B. Jain Publishers Pvt. Ltd.; 1999
  • 54 Teste A. Translated from French by Côté EH. A Homoeopathic Treatise on the Diseases of Children. 4th ed. New Delhi: B. Jain Publishers Pvt. Ltd.; 2000
  • 55 Fisher CE. A Hand-Book on the Diseases of Children and their Homeopathic Treatment. Chicago: Medical Century Company; 1895
  • 56 Herscu P. Thoughts on the treatment of seizure disorders. New England Journal of Homoeopathy 1998; 7: 23-29 . Available at: https://nesh.com/the-new-england-journal-of-homeopathy/vol-7-no-2-fallwinter-1998/