Discussion
retinopathy, myocardial infarction, cardiovascular death, ®, neuropathy, diarrhea, prediabetes [Berberine, diabetic comorbidities, prediabetes, constipation, prediabetic, nephropathy, nausea, vomiting, cardiovascular complications, diabetes
RETINOPATHY, MYOCARDIAL INFARCTION, NEUROPATHY, ADVERSE EVENTS, DISEASE, DIABETES MELLITUS, PREDIABETES, NEPHROPATHY, TYPE 2 DIABETES MELLITUS, CARDIOVASCULAR COMPLICATIONS, DIABETES
Individuals with prediabetes are at higher risk of progressing to type 2 diabetes mellitus and resulting cardiovascular complications such as myocardial infarction and cardiovascular death. They are more prone to nephropathy, neuropathy, and retinopathy as a result of diabetic comorbidities [Dietary supplements are commonly used by a large population around the globe for a variety of health-related goals. In the case of individuals with prediabetes, glycemic control and lifestyle modifications remain the mainstay in preventing and delaying its progression to diabetes. With limited proven pharmacological agents, dietary supplementation is increasingly being considered an early intervention for the prevention of prediabetes [Berberine (BBR, molecular formula: CThe present study was conducted to explore the efficacy of HIMABERB® on glycemic control markers in otherwise healthy individuals with prediabetes. In the present study, HOMA-IR was also significantly reduced in the treatment group. The effects observed in our study were significantly higher than those in a previous study, which may be attributable to a higher dosage in our study of 500 mg three times daily versus 300 mg three times daily [In a meta-analysis and review of 17 randomized controlled trials on berberine for the treatment of diabetes mellitus, Wei XC et al. [In 2019, Friedman et al. conducted a study to assess the effect of polyherbal supplements on prediabetic adults. The supplement was a combination of cinnamon bark, banana leaf, kudzu root, fenugreek seed, gymnema leaf, and berberine hydrochloride. The researchers concluded that herbal supplements, in the combination above, can be used as an adjunct in preventing progression to type 2 diabetes mellitus [The intervention used in the present study contained only HIMABERB® (a high purity and water-extracted berberine hydrochloride) without any excipients. Strict adherence to the protocol was maintained in this double-blinded, randomized, placebo-controlled trial, with regular follow-ups on participants’ supplements and diet diaries. Berberine has been associated with gastrointestinal discomfort and adverse events, including nausea, vomiting, diarrhea, constipation, and abdominal discomfort [Treatment with HIMABERB® over the course of 84 days resulted in decreases in mean FPG and HbA1c to below the clinically defined thresholds for prediabetes. These results are clinically meaningful and have the potential to impact the management of patients that are classified as prediabetic. Control of blood glucose in individuals with prediabetes to below clinical thresholds using natural and non-toxic agents, as demonstrated here, may benefit disease outcomes and safety for patients.Given its potential insulin sensitizing effects as discussed above [While statistically and clinically significant effects of HIMABERB® on glycemic markers in patients with prediabetes were clear, this study was limited by a small sample size, follow up that was limited to 84 days, single-institution design, and lack of analysis of durability and dose-dependency. Additionally, data were not adjusted for age, sex or BMI, which may have confounding effects on analyses. A multicentric long-term study with a larger sample size and adjustments may provide more robust data that is generalizable to the broader population.