A randomised, double-blind, placebo-controlled and parallelarm trial to assess the effect of homoeopathic medicines on chronic rhinosinusitis

Abstract

Background: Chronic rhinosinusitis (CRS) is a significant health problem impacting health related quality of life. Objectives: This study assesses the efficacy of individualised homoeopathy (IH) in LM potency in CRS. Methods: A randomised, double-blind and placebo-controlled trial on patients with CRS was undertaken at four institutes, from July 2012 to December 2013. Eligible participants were randomised to IH in LM-potencies (n = 60) or a similar placebo (n = 60). Primary outcome was change in the total symptoms score (TSS) (area under the curve [AUC]) and in sinus nasal outcome test 22 over 3 months. Intention-to-treat approach was used for analyses. Results: TSS AUC over 3 months was less in the homoeopathy group compared to the placebo group but was statistically insignificant (IH: 1303.1 ± 612.2; P = 1380.1 ± 811.8; 95% CI: −336.9, 182.9; P = 0.56). The absolute difference in TSS from baseline had a statistically significant difference at day 60 (mean difference = 4; 95% CI: 0.3–7.7, P = 0.03) and day 75 (mean difference =3.8; 95%: 0.1–7.5, P = 0.04) favouring homoeopathy. The global assessment by the investigator and patient showed satisfactory improvement at day 60 mean difference = 0.6, 95% CI: 0.27–0.86, P = 0.0001 and day 75 mean difference = 0.5, 95% CI: 0.27–0.84, P = 0.0001, respectively. A positive trend was observed in rhinoscopy score in homoeopathy group (mean difference: 0.9, 95% CI: −0.00–1.8, p=0.05). There was no difference in computed tomography scan scores of paranasal sinuses between the groups. Conclusion: This study provides a positive trend to support the effect of individually selected homoeopathic remedies in patients with CRS and warrants further evaluation.