Chinese herbal helps keep diabetes at bay for people with prediabetes, metabolic abnormalities

The traditional Chinese medicine compound Jinlida granules, in combination with lifestyle modifications, has shown promise in reducing the risk of progression from impaired glucose tolerance (IGT) to diabetes in individuals with multiple metabolic abnormalities.

In the double-blind randomized controlled FOCUS trial, the risk of progression to diabetes over a median observation period of 2.20 years was 41-percent lower for participants who received Jinlida than for those who received placebo (hazard ratio [HR], 0.59, 95 percent confidence interval [CI], 0.46–0.74; p<0.001). [JAMA Intern Med 2024;doi:10.1001/jamainternmed.2024.1190]

The Jinlida group also achieved greater improvements in secondary health markers, such as waist circumference (between-group difference, 0.95 cm), 2-hour postprandial blood glucose (between-group difference, 9.2 mg/dL), fasting blood glucose (between-group difference, 3.8 mg/dL), HbA1c (between-group difference, 0.20 percent), total cholesterol (between-group difference, 6.6 mg/dL), low-density lipoprotein cholesterol (between-group difference, 4.3 mg/dL), triglyceride (between-group difference, 25.7 mg/dL), and HOMA-IR (between-group difference, 0.47).

A notable finding was that Jinlida exerted a significant beneficial effect on two crucial indicators of arterial stiffness and predictors of cardiovascular and cerebrovascular disease risk compared with placebo, the investigators said.

Specifically, carotid intima-media thickness (CIMT) decreased by a mean of 0.05 mm after 24-month treatment in the Jinlida group but increased by a mean of 0.03 mm in the placebo group. Moreover, ankle-brachial index (ABI) remained relatively unchanged in the Jinlida group but increased by a mean of 0.02 in the placebo group. The between-group differences in both CIMT and ABI were statistically significant, according to the investigators.

In terms of safety, adverse events occurred in 94.81 percent of participants in the Jinlida group and in 91.93 percent of those in the placebo group, with four participants (0.90 percent) in each group dropping out from the study due to these events. One participant in the Jinlida group died by suicide related to depression, an event that was deemed unrelated to the drug.

A boon

Jinlida granules are a traditional Chinese medicine formulation that contains 17 different herbal ingredients. This compound was approved by the Chinese National Medical Products Administration in 2005 for the treatment of type 2 diabetes.

Already, previous research has explored the potential mechanisms by which Jinlida might work. The compound has been shown to influence multiple aspects of diabetes, including blood sugar and cholesterol control, insulin sensitivity, and even fat accumulation. Data on the individual components of Jinlida hint at a potential synergistic efficacy of such herbal components. [J Ethnopharmacol 2015;162:244-252]

“The findings [of the FOCUS trial] suggest a significant role of Jinlida in enhancing insulin sensitivity and managing lipid metabolism disorders while demonstrating favourable drug safety profile,” the investigators said.

This may hold potential clinical importance for individuals with prediabetes and multiple metabolic abnormalities, given that up to 50 percent of individuals with prediabetes, which encompasses impaired fasting glucose and IGT and their combined state, progress to diabetes within 5 years, they pointed out. Importantly, when IGT co-occurs with additional risk factors like obesity, dyslipidaemia, and hypertension, the risk of diabetes increases further. [Cochrane Database Syst Rev 2018;10:CD012661]

The investigators called for further clinical trials to explore Jinlida’s full potential as a therapeutic agent in diabetes management.

FOCUS

FOCUS included 885 adults (mean age 52.57 years, 52.32 percent female) with impaired glucose tolerance and metabolic abnormalities. Following a 1-month lifestyle intervention induction period, these participants were randomly assigned to take Jinlida 9 g or placebo orally, three times daily, as an add-on. The intervention continued until the occurrence of diabetes, study withdrawal, or death.

The incidence rates of diabetes in the Jinlida and placebo groups were 9.95 percent and 15.80 percent (p=0.07) at 12 months, 21.72 percent and 29.12 percent (p=0.006) at 24 months, and 26.92 percent and 40.18 percent (p<0.001) at 36 months, respectively. Among participants completing the study, a higher proportion in the Jinlida group achieved normal glucose tolerance (39.18 percent vs 25.64 percent; p<0.001).