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

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 LMpotencies (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-totreat 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. Acknowledgments and Source of Funding The authors are grateful to the participants who participated in the study. The radiologist for their viewing and assessing the CT scan films. The authors also acknowledge, the contribution of ENT consultants engaged in the assessment of the enrolled patients. Funding: This study was funded by Central Council for Research in Homoeopathy Authors Praveen Oberai, Subhash Kaushik, Sunil Ramteke, M N. Sinha, Sarabjit Sarkar, Kalpana Gautam, Arvind Kumar, Harleen Kaur, Raj Kumar Manchanda, and Roja Varanasi This original article is available in Indian Journal of Research in Homoeopathy: https://ijrh.researchcommons.org/ journal/vol17/iss1/3