Individualized Homeopathic Medicines in Chronic Rhinosinusitis: Randomized, Double-Blind, Placebo-Controlled TrialFunding None. The institution had no role to play in the analysis of the study results or the preparation of the paper.
Background Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs. Despite the evidence favoring homeopathy in CRS being inadequate, it is highly popular. This trial attempts to study the efficacy of individualized homeopathy (IH) medicines in comparison with placebo in patients with CRS.
Methods A double-blind, randomized (1:1), placebo-controlled, preliminary trial (n = 62) was conducted at the National Institute of Homoeopathy, West Bengal, India. Primary outcome measure was the sino-nasal outcome test-20 (SNOT-20) questionnaire; secondary outcomes were the EQ-5D-5L questionnaire and EQ-5D-5L visual analog scale scores, and five numeric rating scales (0–10) assessing intensity of sneezing, rhinorrhea, post-nasal drip, facial pain/pressure, and disturbance in sense of smell, all measured at baseline and after the 2nd and 4th months of intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample.
Results Groups were comparable at baseline. Attrition rate was 6.5% (IH: 1, Placebo: 3). Although improvements in both primary and secondary outcome measures were higher in the IH group than placebo, with small to medium effect sizes, the group differences were statistically non-significant (all p > 0.05, unpaired t-tests). Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harmful or unintended effects, homeopathic aggravations or any serious adverse events were reported from either group.
Conclusion There was a small but non-significant direction of effect favoring homeopathy, which ultimately renders the trial as inconclusive. Rigorous trials and independent replications are recommended to arrive at a confirmatory conclusion. [Trial registration: CTRI/2018/03/012557; UTN: U1111–1210–7201].
Keywordsefficacy - homeopathy - chronic rhinosinusitis - sino-nasal outcome test - randomized controlled trial
• A double-blind, randomized, placebo-controlled, clinical trial was conducted at the National Institute of Homoeopathy, West Bengal, India, in 62 patients suffering from chronic rhinosinusitis.
• Though improvements were greater in the homeopathy group than in the placebo group, with small to medium effect sizes, the group differences were statistically non-significant, thus rendering the trial inconclusive.
• Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines.
File 1 Sino-nasal outcome test
File 2 CONSORT 2010 checklist of information to include when reporting a randomized trial
File 3 RedHot checklist of information to include when reporting randomized trials of homeopathy
File 4 Indications of the prescribed medicines
P.M., C.N., A.C. and T.K.P. contributed to the study concept, literature search, conducting the clinical study, data acquisition, data interpretation, and drafting the manuscript. B.G., S.S., K.B., S.R. and M.P. contributed to conducting the clinical study and data acquisition. S.S.A. and A.B. contributed to data management. A.N., M.K. and S.S. contributed to study design, data interpretation, statistical analysis, and drafting the manuscript. All the authors reviewed and approved the final manuscript.
The trial was performed as part of the postgraduate thesis of the corresponding author under the guidance of C.N. A.C. is the Head of the Department of Materia Medica, National Institute of Homoeopathy. Authors B.G., S.S., K.B., S.R. and M.P. are postgraduate trainees at the National Institute of Homoeopathy. A.N. is a former postgraduate trainee at the National Institute of Homoeopathy. S.A. and A.B. are interns at Mahesh Bhattacharyya Homoeopathic Medical College & Hospital. MK and S.S. are independent researchers.
Received: 29 March 2020
Accepted: 26 May 2020
31 August 2020 (online)
© 2020. Thieme. All rights reserved.
The Faculty of Homeopathy
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