Homeopathy 2018; 107(03): 161-171
DOI: 10.1055/s-0038-1656715
Homeopathy and Public Health
The Faculty of Homeopathy

Effectiveness of Homeopathic Medicines as Add-on to Institutional Management Protocol for Acute Encephalitis Syndrome in Children: An Open-Label Randomized Placebo-Controlled Trial

Praveen Oberai
1  Central Council for Research in Homoeopathy, New Delhi, India
,
Roja Varanasi
1  Central Council for Research in Homoeopathy, New Delhi, India
,
Maya Padmanabhan
2  Former Statistical Assistant, Central Council for Research in Homeopathy, New Delhi, India
,
Alok Upadhyaya
3  Clinical Trial Unit(H), Gorakhpur, Uttar Pradesh, India
,
Supriya Singh
3  Clinical Trial Unit(H), Gorakhpur, Uttar Pradesh, India
,
Samarendra Pratap Singh
3  Clinical Trial Unit(H), Gorakhpur, Uttar Pradesh, India
,
Deepika Vikram
3  Clinical Trial Unit(H), Gorakhpur, Uttar Pradesh, India
,
Tariq Khan
3  Clinical Trial Unit(H), Gorakhpur, Uttar Pradesh, India
,
Ramesh Prasad
3  Clinical Trial Unit(H), Gorakhpur, Uttar Pradesh, India
,
A. K. Gupta
3  Clinical Trial Unit(H), Gorakhpur, Uttar Pradesh, India
,
J. R. Singh
3  Clinical Trial Unit(H), Gorakhpur, Uttar Pradesh, India
,
Raj K. Manchanda
1  Central Council for Research in Homoeopathy, New Delhi, India
› Author Affiliations
Further Information

Publication History

19 December 2017

17 April 2018

Publication Date:
05 June 2018 (eFirst)

Abstract

Background Acute encephalitis syndrome (AES) is endemic to certain parts of India, with limited treatment options. In our initial exploratory comparative observational study of 151 patients with AES, there was significantly reduced mortality with adjunctive homeopathy compared to institutional management protocol (IMP). The present randomized placebo-controlled trial brings more statistical rigor to this research program.

Methods This study was conducted at a pediatric unit from 2013 to 2015. Children aged > 6 months and ≤ 18 years and receiving IMP were randomized to receive adjunctive homeopathy (n = 325) or placebo as control (n = 323). The primary effectiveness analysis was based on Glasgow Outcome Scale (GOS). Morbidity was assessed using the Liverpool Outcome Score for Assessing Children at Follow-up. Analysis was by intention to treat.

Results A total of 612 children were analyzed (Homeopathy [H] = 304; Control [C] = 308). The primary outcome, GOS, differed significantly between H and C groups. There was 14.8% death/neuro-vegetative state in the H group compared to 29.8% in the C group. Relative risk was 0.49 (95% confidence interval [CI]: 0.36 to 0.68), with absolute risk reduction of 15.0% (95% CI: 8.6 to 21.6%). Number needed to treat to prevent one additional death/neuro-vegetative state was 6.6 (95% CI: 4.6 to 11.6). Proportional-odds analysis also revealed a greater effect in the H group: odds ratio, 0.40 (95% CI: 0.27 to 0.60). The most frequently used medicines were Belladonna (n = 116), Stramonium (n = 33), Arsenicum album (n = 25), Sulfur (n = 18), Opium (n = 17), and Nux vomica (n = 10).

Conclusion Adjunctive homeopathic medicines may improve clinical outcomes associated with AES. Further randomized and controlled studies, using double-blinded trial design, are recommended to discover if the current findings may be corroborated.

Highlights

• Children aged 6 months to 18 years were randomized to receive adjunctive homeopathy (n = 325) or adjunctive placebo (n = 323).


• A total of 612 children were analyzed (Homeopathy: 304; Placebo: 308) on ITT basis.


• The primary effectiveness analysis was based on the Glasgow Outcome Scale (GOS).


• GOS differed significantly between the Homoeopathy and Placebo groups: there was 14.8% death/neuro-vegetative state in the former group compared to 29.8% in the latter.