A Comparative randomised controlled trial of Homeopathy -vs- Allopathy in Acute Otitis Media and its recurrence in Children.

Abstract

Objective: This study evaluates the efficacy of homeopathic treatments for Acute Otitis Media (AOM) in children, comparing outcomes to standard allopathic treatments. Building on promising pilot study results that suggested homeopathy's non-inferiority, this multicenter trial aims to validate these findings and assess their broader clinical applicability.

Method: This open-label, randomized controlled trial was conducted on children (aged 02 to 12 years), suffering from acute otitis media. Primary outcome was changes in Acute Otitis Media-Severity of Symptoms (AOM-SOS) scale and Tympanic Membrane Examination scale (TMES) over 21 days and time to improvement in pain through FPS-R (Facial Pain Scale-Revised) over 10 days. The secondary outcomes were the need for antibiotics during acute AOM and the recurrence over 12 months.

Results: Intention to treat analysis was carried out on 222 children; Homeopathy(n=116)(H-group), Allopathy(n=106) (A-group). Statistically significant reduction in AOM-SOS+TMES score in H-group compared to A-group was observed at time point day 3 (mean diff.±sd: 1.67±0.47; 95% CI: 0.75 to 2.59; p=0.001), at day 7 (mean diff.±sd: 1.22±0.56; 95% CI: 0.13 to 2.31, p=0.028) favored homeopathy. However, the median time for FPS-R score to become zero by day 10 (H= 3 days, A= 4 days) was statistically insignificant (p=0.29). None of the children in the H group required antibiotics whereas it was required in 14 children(12.4%) in A group .

Conclusion: Homeopathic treatment helped in managing acute otitis media in children similar to that of Allopathic treatment. Homeopathy can be a safe treatment approach in managing in this condition. Further blinded studies are warranted.