A randomized trial of homeopathy in adults with chronic rhinosinusitis
Description
Chronic rhinosinusitis (CRS) substantially affects symptoms and quality of life. Evidence for individualized homeopathic medicines (IHMs) in CRS remains inconclusive. This trial evaluated the efficacy and safety of IHMs against placebo in adults with CRS. This 3-month, randomized (2:1), double-blind, placebo-controlled, parallel-group trial enrolled 105 adults with CRS at a tertiary-care teaching hospital in Kolkata, India. Participants received IHMs (n = 70) or placebo (n = 35), with identical supportive care. The prespecified primary efficacy estimand was the between-group difference in SNOT-22 total at month 3. Primary analyses used baseline-adjusted and multiplicity-corrected Welch’s t-test and Brunner–Munzel testing. SNOT-22 subscales, Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP2), and conventional therapy use were secondary outcomes; longitudinal, causal, Bayesian, sensitivity, and subgroup analyses were exploratory. Safety was monitored. At month 3, IHMs produced a significantly greater reduction in SNOT-22 total score than placebo (mean difference −15.63; 95% CI −17.35 to −13.91; adjusted Welch p < 0.001), with a large effect (Hedges’ g −3.37; 95% CI −4.00 to −2.74). The Brunner–Munzel analysis supported the primary finding. Secondary outcomes also favored IHMs; conventional therapy use was lower in the IHMs group. Longitudinal analyses demonstrated greater improvement over time in the IHMs group than placebo, while all the secondary analyses supported robustness. Three mild adverse events were reported, with no serious treatment-related events. IHMs were associated with a statistically significant and clinically safe and substantial improvement in SNOT-22 total score compared with placebo over 3 months. CTRI/2024/12/078310
Files
Steps to reproduce
SAP has been appended as Supp. file 1. R software has been used in the analysis, and the scripts will be provided on reasonable request.
Institutions
- West Bengal University of Health SciencesWest Bengal, Kolkata