Jinlida granules may reduce diabetes risk in patients with impaired glucose tolerance

Jinlida (JLD) granules may be effective at preventing diabetes in patients at higher risk, a recent study found.

Researchers in China performed a randomized, double-blind, placebo-controlled trial to assess the effect of long-term JLD use on diabetes incidence versus placebo in patients with impaired glucose tolerance (IGT) and metabolic abnormalities. JLD is a traditional Chinese medicine compound with 17 herbal ingredients that was approved in China in 2005 for treating type 2 diabetes. In the trial, patients at 35 centers in 21 cities were randomly assigned to receive oral JLD or placebo (9 g three times per day) until they developed diabetes, withdrew from the study, were lost to follow-up, or died. All patients received an ongoing lifestyle intervention that included monthly sessions with at least 20 minutes of professional guidance, as well as a standardized lifestyle intervention booklet with specific recommendations on diet and exercise. Diabetes, the study's primary outcome, was determined by two consecutive oral glucose tolerance tests. The corresponding author disclosed that their spouse is a shareholder and company director of JLD's manufacturer, which provided the study medication and placebo. The results of the trial were published June 3 by JAMA Internal Medicine.

A total of 885 people were included in the complete analysis, 442 in the JLD group and 443 in the placebo group. The mean age was 52.57 years, and 52.32% were female. After a median of 2.20 years, 27.83% of the JLD group developed diabetes compared to 42.66% of the placebo group (hazard ratio, 0.59 [95% CI, 0.46 to 0.74]; P<0.001). Between-group differences on secondary outcomes were 0.95 cm for waist circumference, 9.2 mg/dL (0.5 mmol/L) for two-hour postprandial blood glucose level, 3.8 mg/dL (0.2 mmol/L) for fasting blood glucose level, 0.20% for HbA1c level, 6.6 mg/dL for total cholesterol level, 4.3 mg/dL for low-density lipoprotein cholesterol level, 25.7 mg/dL for triglyceride level, and 0.47 for homeostatic model assessment for insulin resistance.

The authors noted several limitations, including potential lack of generalizability and limited knowledge about the specific active ingredients in JLD. They concluded that to their knowledge, their study was the first to show that JLD in conjunction with lifestyle modifications could reduce risk for diabetes and improve other health markers in patients with IGT and metabolic disorders. "This [randomized controlled trial] demonstrated that JLD can lower the risk of IGT progressing to diabetes by ameliorating multiple metabolic abnormalities," the authors wrote. "Jinlida granules were found to be safe and effective, offering a promising intervention for participants with IGT with multiple metabolic disorders to prevent diabetes onset."

An Editor's Note accompanying the study pointed out that it would be difficult to gain FDA approval for JLD in the United States since it is an herbal product. "Besides proving effectiveness and safety, a company producing any medication has to demonstrate that the product tested in a clinical trial can be consistently manufactured and marketed with equivalent composition and dosage of all active ingredients," the note said. "This is very difficult for heterogeneous botanical products, which may vary with growing conditions and contain many chemical signatures." The Editor's Note also said that JLD may be able to be marketed as a dietary supplement, since in that case the manufacturer would need only to notify the FDA why it believed the supplement would be safe for consumer use.