Individualized homeopathic medicines in the treatment of chronic tonsillitis in adults: Randomized, double-blind, placebo-controlled trial

Abstract

Background

Chronic tonsillitis is said to benefit from homeopathic medicines, however, evidence supporting this claim is inadequate. The objective of this trial was to compare individualized homeopathic medicines (IHMs) against placebos using the sore throat pain model (STPM) in adults with chronic tonsillitis.

Methods

In this 3-month, double-blind, randomized (1:1), placebo-controlled trial at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India, 60 adults with chronic tonsillitis were randomized to receive either IHMs or identical-looking placebos. Included were the patients experiencing three or more episodes of medically confirmed acute tonsillitis per year for the last 2 years, and the patients presenting with 5 clinical signs and symptoms of chronic tonsillitis. Excluded were the cases with peritonsillar abscess or acute or chronic respiratory disease, occlusion of pharynx due to enlarged tonsils, or previous surgery in the past 6 months or need for surgery of the nose, and paranasal sinuses. Conventional management was advised concurrently to all individuals. The primary outcome was composite in nature, three visual analog scales (VAS) of STPM: sore throat pain intensity VAS (STPIS-VAS), difficulty swallowing scale VAS (DSS-VAS), and swollen throat scale VAS (SWOTS-VAS); secondary outcomes were the Tonsil and adenoid health status instrument (TAHSI) and Glasgow benefit inventory (GBI) – all measured monthly, up to 3 months. Blinded were the study participants, trial recruiters, investigators, outcome assessors, and the data-entry operator. Group differences were estimated on the intention-to-treat sample using two-way repeated measure analysis of variance accounting for between groups and time interactions, and additionally by unpaired t-tests to examine whether the group differences were statistically significant at different time points. A Bonferroni-corrected P value < 0.017 two-tailed was considered statistically significant for three primary outcomes.

Results

Sixty individuals were randomized, 30 in each group, and all entered the final analysis. Group differences were non-significant in the primary outcomes – STPIS VAS: F1, 58 = 0.256, P = 0.614; DSS VAS: F1, 58 = 0.315, P = 0.577; SWOTS VAS: F1, 58 = 0.135, P = 0.715; however, the secondary outcomes demonstrated significances favoring IHMs over placebos – TAHSI total: F1, 58 = 10.103, P = 0.002; GBI total: F1, 58 = 13.013, P = 0.001. Additional analyses using unpaired t-tests revealed significances in both primary and secondary outcomes and subscales (all P < 0.05). Rhus toxicodendron, Belladonna, and Bryonia alba were the most frequently indicated medicines. No adverse events or drug reactions were reported during the trial.

Conclusion

While the trial failed to demonstrate a significant benefit of IHMs over placebo in the primary composite outcome, secondary analyses suggest a positive impact on quality of life.