A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Pre-diabetes.

Nilanjana Guha, Shubhamoy Ghosh, Sanjukta Mandal, Aakash Deep Das, Chithra Palanisamy, Shukdeb Maiti, Priyanka Ghosh, Navin Kumar Singh, Munmun Koley, Subhranil Saha

Journal: Homeopathy : the journal of the Faculty of Homeopathy 2024;113(2):67-79

PMID: 37364594

Abstract

BACKGROUND

Pre-diabetes (PD) contributes importantly to the disease burden worldwide and is a precursor to stroke, cardiovascular diseases, as well as type-2 diabetes mellitus.

OBJECTIVE

In this project, the efficacy of individualized homeopathic medicines (IHMs) was explored against placebos in the treatment of PD.

METHODS

A 6-month, double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of a homeopathic medical college and hospital in India. Sixty participants with PD were randomized to receive either IHMs ( = 30) or identical-looking placebos ( = 30). Concomitant care measures were advised to both groups of participants in terms of dietary advice, yoga, meditation and exercise. The primary outcome measures were fasting blood sugar (FBS) and the oral glucose tolerance test (OGTT); the secondary outcome was the Diabetes Symptom Checklist-Revised (DSC-R) score. All the outcomes were measured at baseline and after 3 and 6 months of treatment. Inter-group differences and effect sizes (Cohen's ) were calculated using two-way repeated measures analysis of variance models after adjusting baseline differences using analysis of co-variance on the intention-to-treat data.

RESULTS

Between-group differences for FBS were statistically significant, favoring IHMs against placebos (  = 7.798,  = 0.007), but not for OGTT (  = 1.691,  = 0.199). The secondary outcome, DSC-R total score, favoring IHMs significantly compared with placebos (  = 15.752,  < 0.001). , and were the most frequently prescribed medicines. No harm or serious adverse events were recorded from either of the participant groups.

CONCLUSION

IHMs produced significantly better results than placebos in FBS and in DSC-R scores but not in OGTT. Independent replications with larger sample sizes are warranted to substantiate the findings.

TRIAL REGISTRATION

CTRI/2019/10/021711.

Faculty of Homeopathy. This article is published by Thieme.

Address: Department of Cancer Epidemiology, Tata Memorial Center, Varanasi, Uttar Pradesh, India.; Department of Materia Medica, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Government of West Bengal, Howrah, West Bengal, India.; Department of Pathology and Microbiology, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.; Department of Pathology and Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Government of West Bengal, Howrah, West Bengal, India.; Department of Materia Medica, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Government of West Bengal, Howrah, West Bengal, India.; Department of Forensic Medicine and Toxicology, Bengal Homoeopathic Medical College and Hospital, Asansol, West Bengal, India.; Department of Repertory, JIMS Homoeopathic Medical College and Hospital, Shamshabad, Telangana, India.; Department of Repertory, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Government of West Bengal, Drainage Canal Road, Doomurjola, Howrah, West Bengal, India.; Department of Repertory, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Government of West Bengal, Drainage Canal Road, Doomurjola, Howrah, West Bengal, India.; Department of Anatomy, Government Homoeopathic Medical College and Hospital, Thirumangalam, Madurai, Tamilnadu, India.; Department of Pathology and Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Government of West Bengal, Howrah, West Bengal, India.; Laboratory Technologist, Department of Pathology and Microbiology, National Tuberculosis Elimination Program Wing, Imambara Sadar Hospital, Chuchura, Hooghly, Government of West Bengal, India.; Department of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Government of West Bengal, Kolkata, West Bengal, India.; Department of Repertory, The Calcutta Homoeopathic Medical College and Hospital, Government of West Bengal, Kolkata, West Bengal, India.; East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, under Department of Health and Family Welfare, Government of West Bengal, India.; Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.

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