{"title":"Individualized Homeopathic Medicines as Adjunctive Treatment of Pediatric Epilepsy: A Double-Blind, Randomized, Placebo-Controlled Trial.","authors":"Bharti Gupta, Pankhuri Misra, Avaranjika Karuppusamy, Dharshna Balamurugan, Maneet Parewa, Maneela Tomar, Shruti Rai, Himani Vashishth, Satarupa Sadhukhan, Navin Kumar Singh, Munmun Koley, Subhranil Saha","doi":"10.1055/s-0042-1755361","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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).</p><p><strong>Methods: </strong>The study was a 6-month, double-blind, randomized, placebo-controlled trial (<i>n</i> = 60) conducted at the pediatric outpatient department of a homeopathic hospital in West Bengal, India. Patients were randomized to receive either IHMs plus SC (<i>n</i> = 30) or identical-looking placebos plus SC (<i>n</i> = 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 3<sup>rd</sup> and 6<sup>th</sup> month of intervention. The intention-to-treat sample was analyzed to detect group differences and effect sizes.</p><p><strong>Results: </strong>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 (<i>F</i> <sub>1, 58</sub> = 0.000, <i>p</i> = 1.000, two-way repeated measures analysis of variance), QOLCE-16 (<i>F</i> <sub>1, 58</sub> = 1.428, <i>p</i> = 0.237), PedsQL (2-4 years) (<i>F</i> <sub>1, 8</sub> = 0.685, <i>p</i> = 0.432) and PedsQL (5-18 years) (<i>F</i> <sub>1, 47</sub> = 0.000, <i>p</i> = 0.995). <i>Calcarea carbonica</i>, <i>Ignatia amara</i>, <i>Natrum muriaticum</i> and <i>Phosphorus</i> were the most frequently prescribed medicines. No serious adverse events were reported from either of the two groups.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>CTRI/2018/10/016027.</p>","PeriodicalId":13227,"journal":{"name":"Homeopathy","volume":"112 3","pages":"170-183"},"PeriodicalIF":1.2000,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Homeopathy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1055/s-0042-1755361","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
引用次数: 1
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 (F1, 58 = 0.000, p = 1.000, two-way repeated measures analysis of variance), QOLCE-16 (F1, 58 = 1.428, p = 0.237), PedsQL (2-4 years) (F1, 8 = 0.685, p = 0.432) and PedsQL (5-18 years) (F1, 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.
期刊介绍：
Homeopathy is an international peer-reviewed journal aimed at improving the fundamental understanding and clinical practice of homeopathy by publishing relevant high-quality original research articles, reviews, and case reports. It also promotes commentary and debate on matters of topical interest in homeopathy.
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