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

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 (1:1), 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 prediabetes 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 prediabetes to diabetes.