Homeopathic treatment of seizures in children

Phase 3

Completed

• Conditions: Generalized idiopathic epilepsy and epileptic syndromes,

• Registration Number: CTRI/2018/10/016027
• Lead Sponsor: National Institute of Homoeopathy

Brief Summary

Epilepsy, one of the most common neurological diseases, contributes to 0.5% of the total disease burden. The burden was found to be the highest in eastern, western, and southern sub-Saharan Africa, central Asia, central and Andean Latin America, and south-east Asia. Asian countries reported an overall prevalence of 6/1,000 and that in India is 5.59. We examined whether individualized homeopathic medicines (IHMs) can produce significantly different effect from placebos in treatment of pediatric epilepsy in the mutual context of standard care (SC) using anti-epileptic drugs (AEDs). It was a 6-months, 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). Primary outcome measure was Hague seizure severity scale (HASS); secondary outcomes were quality of life in childhood epilepsy (QOLCE-16) and pediatric quality of life inventory (PedsQL) questionnaires; all measured at baseline and after the 3rd and 6th months of intervention. Intention-to-treat sample was analyzed to detect group differences and effect sizes. Recruitment and retention rates were 65.2% and 91.7% respectively. Although improvements were higher in the IHMs group than placebos with small to medium effect sizes, the group differences were statistically non-significant – HASS (*P*=1.000, two-ways repeated measure analysis of variance), QOLCE-16 (*P*=0.237), PedsQL (2-4 years) (*P*=0.432) and PedsQL (5-18 years (*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. Group differences in the outcomes were non-significantly greater in the IHMs group than placebos with small effect sizes. Robust and independent replications are warranted.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-11
• Study Completion: 2020-05-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

a) Cases suffering from epilepsy for at least 3 months b) Both male and female patients c) Age between 4 and 18 years d) Patients with seizure frequency of at least once in three months e) Capability and willingness to give informed consent by the parents and to comply with the study procedures f) Literate parents who can read English and/or Bengali.

Exclusion Criteria

• a) Patients with febrile convulsions b) Patients with intractable epilepsy c) Patients with co-morbidity, like.
• ADHD, mental retardation d) A clinically significant acute or chronic disease that would hinder regular participation in the study e) Patients who are not on anti-epileptic drugs f) Complementary or alternative treatment used simultaneously to the study (for example acupuncture, psychotherapy etc.) g) Homeopathic treatment for at least eight weeks for any chronic diseases h) Cases suffering from uncontrolled systemic illness or life-threatening infections i) Self-reported immune-compromised state j) Patients with substance abuse and/or dependence.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hague Seizure Severity Scale (HASS) measures severity of childhood epilepsy	At baseline, after 3 months, and after 6 months

Secondary Outcome Measures

Name	Time	Method
Quality of life in Childhood Epilepsy (QOLCE-16) measure of health-related quality of life (HRQoL)	At baseline, after 3 months, and after 6 months
Pediatric Quality of Life Inventory (PedsQL) measures health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions	At baseline, after 3 months, and after 6 months

Trial Locations

Locations (1)

National Institute of Homoeopathy; 🇮🇳 Kolkata, WEST BENGAL, India

National Institute of Homoeopathy

🇮🇳Kolkata, WEST BENGAL, India

Bharti Gupta

Principal investigator

9873443820

bhartiguptanhmc@gmail.com