Homoeopathic potencies within versus beyond Avogadro limit: Efficacy on glycaemic control among pre-diabetic adults — A comparative, randomised, exploratory study

Objectives: Pre-diabetes (PD) is a global health concern, with up to 50% of cases progressing to type-II diabetes mellitus within 5 years if untreated, leading to complications such as kidney failure, blindness, neuropathy and foot issues. Material and Methods: An exploratory, randomised, comparative study was conducted over 6 months at the outpatient department of Metropolitan Homoeopathic Medical College and Hospital, Kolkata. Pre-diabetic adults with glycated haemoglobin (HbA1c) between 5.7% and 6.4%, impaired fasting glucose (IFG) between 100 and 125 mg/dL, and/or impaired oral glucose tolerance (IGT) between 140 and 199 mg/dL were randomised to receive individualised homoeopathic medicines (IHMs) within Avogadro Limit or potencies within 12CH/24X (IHMs-WA, n = 35), otherwise beyond Avogadro limit or beyond 12CH/24X (IHMs-BA, n = 35) for 3 months. The primary outcome was HbA1c, with IFG and IGT as secondary outcomes, measured at baseline and after 3 months. Results: Of 154 screened participants, 70 were included in the intention-to-treat analysis. After 3 months, intergroup differences were not statistically significant in HbA1c ( p = 0.37), IFG (F1,68 = 1.8, p = 0.18), IGT (F1,68 = 0.56, p = 0.456) and intra-group differences were shown notable significance in both groups in HbA1c (IHMs-WA: p < 0.01; IHMs-BA: p < 0.001), IFG (IHMs-WA: p < 0.05; IHMs-BA: p < 0.001) and IGT (IHMs-WA: p < 0.01; IHMsBA: p < 0.001). After 3 months, a lower progression rate from PD to diabetes in IHMs-BA group (8.6%, 11.4% in IHMs-WA), and higher rate of conversion to non-diabetic status in IHMs-BA (43.0%, 31.4% in IHMs-WA) were observed with inter-group non-statistical significance differences ( p < 0.05). No adverse events were reported. Conclusion: This exploratory, randomised, comparative trial demonstrated no statistically significant inter-group differences; while demonstrating significant intra-group improvements, and higher percentage of participants progressing to non-diabetic status in both groups. This may suggest that IHMs administered beyond the Avogadro limit (comparative higher dilution) are equivalent to those the within limit (comparative lower dilution), in their efficacy on glycaemic control. Although, observed slightly more promising trend in magnitude of improvement on IHMs-BA, require validation through further robust, long-term, multi-centric, blinded superiority trials with larger sample sizes.