A Randomized,Double-Blinded,Placebo-Controlled Trial of Homeopathy in Acute Viral Tonsillitis in Children

Abstract

Context:

Acute viral tonsillitis is a common childhood condition, and high-quality randomized evidence on the efficacy of individualized homeopathic medicines (IHMs) remains limited.

Objective:

To evaluate the efficacy and clinical utility of IHMs in children with acute viral tonsillitis.

Design:

Double-blind, randomized (2:1), placebo-controlled clinical trial.

Setting:

Single-center outpatient pediatric clinical setting.

Subjects:

Seventy-eight children with acute viral tonsillitis were enrolled and randomized.

Interventions:

Participants received IHMs prescribed according to a classical individualized approach or a matching placebo, in addition to standard supportive care.

Main Outcome Measures:

The primary outcome was longitudinal change in the Tonsillopharyngitis assessment (TPA) score. Secondary outcomes were the Sore Throat Pain Intensity Scale, Difficulty in Swallowing Score, and Swelling of Tonsils Score. Time to sore throat remission and complete clinical recovery (CCR) were also assessed.

Results:

IHMs produced a significantly greater and faster reduction in objective TPA score than placebo (TPA group × time interaction: F₁,₇₆ = 43.19, p < 0.001; partial η² = 0.362). At day 3, the IHMs group showed a larger improvement in TPA (adjusted mean difference −2.01, 95% confidence interval −2.78 to −1.24; p < 0.001; Cohen’s d = 1.35) and a higher rate of meaningful recovery (88.5% vs. 38.5%; number needed to treat = 2.0). Time to sore throat remission and CCR were significantly shorter with IHMs (median 3.0 vs. 4.8 days; both p < 0.001). A Bayesian hierarchical model confirmed a global benefit across outcomes (standardized mean effect −0.71; 99.97% posterior probability of superiority), and findings remained robust across extensive sensitivity and multiplicity-adjusted analyses. Hepar sulphuris was the most frequently prescribed remedy and also showed the most consistent and clinically meaningful improvement across all outcome measures.