Individualized homeopathic medicines in preventing the progression from pre-diabetes to diabetes: A double-blind, randomized, placebo-controlled, parallel-arm trial.

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. OBJECTIVE: To study the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes. DESIGN: Six-month, double-blind, randomized (11), two parallel arms, placebo-controlled trial. SETTING: Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India. PATIENTS Sixty participants with pre-diabetes. INTERVENTIONS: Verum HMPs plus yoga therapy (YT; n = 30); control identical-looking placebos plus YT (n = 30). 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. 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. TRIAL REGISTRATION Clinical Trials Registry - India CTRI/2022/04/042,026; UTN U1111-1277-0021.