葛根食疗对2型糖尿病功效和安全性的随机对照试验OA

Objective To evaluate the efficacy and safety of Pueraria Lobata radix as a single medicinal and edible substance in adjunctive dietary therapy for type 2 diabetes mellitus(T2DM).Methods A randomized,double-blind,placebo-controlled trial design was employed.A total of 100 T2DM patients with inadequate glycemic control(HbA1c 6.6％-10.5％)were enrolled and randomly assigned in a 1∶1 ratio to the treatment group(n=50)and the control group(n=50).The treatment group received granules containing 15 g of Pueraria Lobata radix granules daily after meals,while the control group received granules indistinguishable in appearance and taste,for a treatment period of 12 weeks.Both groups maintained their original hypoglycemic drugregimens and received dietary guidance.Follow-up visits were conducted at weeks 0,4,8,and 12.The primary outcome was the change from baseline in HbA1c at week 12.Secondary outcomes included changes in fasting blood glucose(FBG),2-hour postprandial blood glucose(PBG),fasting C-peptide,body mass index,blood pressure,blood lipidparameters,diabetes symptom scores,quality of life scores,and safety indicators such as the incidence of adverse events.Results Compared to the control group,the reduction in HbA1c was significantly greater in the treatment group at week 8 and week 12.Reductions in PBG were also significantly greater in the treatment group at both week 8 and week 12.At week 12,improvement in diabetes symptom scores was significantlygreater in the treatment group,and a trend towards reduction in BMI showed marginal significance(P=0.0503).However,no significant between-group differences were observed in changes of FBG,fasting C-peptide,blood pressure,blood lipids,or quality of life scores.Regarding safety,the incidence of total adverse events did not differ significantly between the treatment group and the control group(14.0％vs.6.0％,P=0.182),and all adverse events were judged to be unrelated to the consumption of Pueraria lobata radix.Conclusions Adding daily dietary therapy with 15 g of Pueraria lobata radix for 12 weeks to hypoglycemic drugeffectively reduces HbA1c and PBG levels and improves diabetes-related symptoms in T2DM patients,with a favorable safety profile.Pueraria lobata radix can be recommended as a safe and effective adjunctive dietary management regimen for T2DM patients.