Key Takeaways & Executive Findings
- •• GEL significantly reduced HbA1c levels by 0.8% compared to placebo in patients with type 2 diabetes. • Fasting and postprandial plasma glucose levels were significantly improved with GEL treatment. • GEL was well-tolerated with no serious adverse events reported. • These findings support the potential of TCM as an adjunctive therapy for type 2 diabetes.
Abstract
Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder with increasing global prevalence. Traditional Chinese Medicine (TCM) has been used for centuries to manage diabetes, but its efficacy and safety remain controversial. This study aimed to evaluate the efficacy and safety of a TCM formula (GEL) in patients with T2DM. Methods: A randomized, double-blind, placebo-controlled trial was conducted. A total of 240 patients with T2DM were randomly assigned to receive either GEL or placebo for 12 weeks. The primary outcome was the change in HbA1c levels from baseline. Secondary outcomes included fasting plasma glucose (FPG), postprandial plasma glucose (PPG), lipid profiles, and adverse events. Results: After 12 weeks, the GEL group showed a significant reduction in HbA1c compared to placebo (mean difference -0.8%, 95% CI -1.2 to -0.4, p<0.001). FPG and PPG also decreased significantly in the GEL group. No serious adverse events were reported. Conclusion: GEL was effective and safe in improving glycemic control in patients with T2DM. Further studies are warranted to confirm these findings and explore the underlying mechanisms.
1. Introduction
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by hyperglycemia resulting from insulin resistance and relative insulin deficiency. The global prevalence of T2DM has been rising steadily, posing a major public health challenge. Current pharmacological treatments, including metformin, sulfonylureas, and insulin, are effective but often associated with adverse effects and progressive loss of glycemic control over time. Therefore, there is a growing interest in alternative and complementary therapies, particularly Traditional Chinese Medicine (TCM), which has a long history of use in managing diabetes.
TCM approaches diabetes through a holistic framework, focusing on balancing the body's Yin and Yang and improving Qi flow. Various herbal formulas have been used to treat diabetes, with some showing promising results in preclinical and clinical studies. However, the evidence base is limited by methodological flaws, small sample sizes, and lack of standardized outcomes. This randomized controlled trial aimed to rigorously evaluate the efficacy and safety of a specific TCM formula (GEL) in patients with T2DM, using HbA1c as the primary outcome.
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ZHANG Wei, LI Ming, WANG Fang, LIU Yang, CHEN Jing, ZHAO Lei, SUN Hong, ZHOU Qiang, WU Na, XU Lin (2025). A Study on the Efficacy of Traditional Chinese Medicine in Treating Type 2 Diabetes Mellitus: A Randomized Controlled Trial. Chinese Journal of New Drugs. https://doi.org/pub_80__articleID_158
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Frequently Asked Questions
What is the GEL formula used in this study?
GEL is a standardized Traditional Chinese Medicine formula composed of multiple herbal ingredients, including Radix Astragali, Radix Rehmanniae, and Rhizoma Anemarrhenae, among others. It is designed to tonify Qi, nourish Yin, and clear heat, which are key principles in TCM for managing diabetes.
How was the study designed?
This was a randomized, double-blind, placebo-controlled trial. Participants with type 2 diabetes were randomly assigned to receive either GEL or a placebo for 12 weeks. Both participants and investigators were blinded to treatment allocation.
What were the main outcomes measured?
The primary outcome was the change in HbA1c levels from baseline to week 12. Secondary outcomes included fasting plasma glucose, postprandial plasma glucose, lipid profiles, and the incidence of adverse events.
What were the key findings?
The GEL group showed a significant reduction in HbA1c compared to placebo (mean difference -0.8%, 95% CI -1.2 to -0.4, p<0.001). Fasting and postprandial glucose levels also improved significantly. No serious adverse events were reported, indicating good tolerability.
What are the implications of this study?
The findings suggest that GEL may be an effective and safe adjunctive therapy for improving glycemic control in patients with type 2 diabetes. However, larger and longer-term studies are needed to confirm these results and to explore the mechanisms of action.
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