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Individualized homeopathic medicines in preventing the progression from pre-diabetes to diabetes: A double-blind, randomized, placebo-controlled, parallel-arm trial.
- Source :
-
Explore (New York, N.Y.) [Explore (NY)] 2024 Sep-Oct; Vol. 20 (5), pp. 102995. Date of Electronic Publication: 2024 Apr 04. - Publication Year :
- 2024
-
Abstract
- Context: Pre-diabetes is a significant public health problem worldwide. India has a very high rate of progression from pre-diabetes to diabetes, 75-78 per thousand persons per year.<br />Objective: To study the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes.<br />Design: Six-month, double-blind, randomized (1:1), two parallel arms, placebo-controlled trial.<br />Setting: Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.<br />Patients: Sixty participants with pre-diabetes.<br />Interventions: Verum: HMPs plus yoga therapy (YT; n = 30); control: identical-looking placebos plus YT (n = 30).<br />Main Outcome Measures: The primary efficacy endpoint was the proportion of participants progressing from pre-diabetes to diabetes, measured after three and six months. Secondary outcomes comprised of fasting blood glucose (FBS), oral glucose tolerance test (OGTT), glycated hemoglobin percentage (HbA1c%), lipid profile, liver enzymes (alanine transaminase, aspartate transaminase), urea and creatinine, and Measure Yourself Medical Outcome Profile version 2 (MYMOP-2); all measured after 3 and 6 months.<br />Results: The proportion of participants converted from pre-diabetics to diabetics (n/N; n = diabetics, N = prediabetics) was significantly less in the verum group than control: HbA1C% (month 3: verum - 2/30 versus control - 11/30, p = 0.003; month 6: 3/30 vs. 2/30, p = 0.008), OGTT (month 3: 0/30 vs. 8/30, p = 0.015; month 6: 0/30 vs. 1/30, p = 0.008), but not according to FBS (month 3: 1/30 vs. 1/30, p = 0.779; month 6: 1/30 vs. 3/30, p = 0.469). Several secondary outcomes also revealed significant improvements in the verum group than in placebo: HbA1C% (p < 0.001), OGTT (p = 0.001), serum ALT (p = 0.031), creatinine (p = 0.012), and MYMOP-2 profile scores (p < 0.001). Sulphur, Bryonia alba, and Thuja occidentalis were the most frequently indicated medicines. Thus, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes.<br />Trial Registration: Clinical Trials Registry - India CTRI/2022/04/042,026; UTN: U1111-1277-0021.<br /> (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Subjects :
- Humans
Double-Blind Method
Male
Female
Middle Aged
Adult
India
Homeopathy methods
Yoga
Glucose Tolerance Test
Diabetes Mellitus, Type 2 drug therapy
Treatment Outcome
Prediabetic State drug therapy
Blood Glucose drug effects
Blood Glucose metabolism
Glycated Hemoglobin metabolism
Disease Progression
Materia Medica therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1878-7541
- Volume :
- 20
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Explore (New York, N.Y.)
- Publication Type :
- Academic Journal
- Accession number :
- 38631987
- Full Text :
- https://doi.org/10.1016/j.explore.2024.03.003