Comparative evaluation in treating qi-yin deficiency and phlegm stasis syndrome of type 2 diabetes mellitus in a rat model

Objective:To compare the efficacy of traditional Chinese medicine (TCM),western medicine and integrative medicine in treating type 2 diabetes mellitus (T2DM) in a rat model.Methods:The T2DM rat model was established with a high-fat diet (HFD) for 35 days and a single injection of streptozotocin (STZ,30 mg/kg).The T2DM-induced rats were divided into three groups,and treated with Yiqi Yangyin Huatan (YQYYHT) granules (3.84 g/kg per day),pioglitazone (1.35 mg/kg per day) or YQYYHT granules + pioglitazone (3.84 g/kg per day+1.35 mg/kg per day) respectively for 14 days.Clinical features and behavioral changes,as well as T2DM indicators,were recorded to evaluate therapeutics effects in each treatment group.Results:The T2DM rat model expressed insulin resistance (IR),with features similar to qi-yin deficiency and phlegm stasis syndrome,including decreased cyclic adenosine monophosphate/cyclic guanosine monophosphate (cAMP/cGMP) ratio,decreased levels of Na+-K+-ATPase,superoxide dismutase (SOD) and high density lipoprotein-cholesterol (HDL-C),and increased levels of serum triglyceride (TG),total cholesterol (TC) and low density lipoprotein (LDL-C).All three treatment groups showed significant decreases in fasting blood glucose (FBG) and fasting insulin (Fins),and improvement of TCM syndrome to different degrees.Importantly,YQYYHT improved the most of the indicators of T2DM,followed by integrative medicine and pioglitazone alone.Conclusion:Compared with western medicine or integrative medicine,prescription of TCM based on syndrome differentiation may offer more advantages in the prevention and treatment of T2DM.

Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial

Objective To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule(养阴益气活血颗粒,YYHG)in the treatment of ischemic stroke(IS)patients with qi-yin deficiency and blood stasis syndrome(QYDBSS),and to explore its effective dosage.Methods The total of 288 patients were randomly assigned to the YYHG high-dose,YYHG low-dose,positive control(administered Xiaoshuantong Granule,XSTG,消栓通颗粒),or placebo control(administered inert granule)groups(72 cases per group)by software-drived competitive block randomization.The trial was conducted for a 28-day period,with a 180-day follow-up period.The primary outcome was the comprehensive curative evaluation,and secondary outcomes were the National Institute of Health Stroke Scale(NIHSS)score,Barthel activities of daily living(ADL)index score,the quality of life index(QLI)score,and the Chinese medicine syndrome(CMS)score.All analyses were done on an intention-to-treat basis.The clinical safety was also assessed.Results The total of 288 participants were recruited between June 1,2008 and September 30,2009,and 287 patients received intervention;the treatment groups were well balanced at baseline.The comprehensive cure rates of YYHG high-dose,low-dose,positive and placebo control groups were 63.38%,31.94%,36.11%and 6.14%,respectively;there was a statistical difference between the two groups(P<0.01),while the high-dose YYHG treatment group was significantly higher than the other 3 groups(P<0.01).The improvement of NIHSS,ADL,QLI and CMS scores of the YYHG high-dose and low-dose groups was significantly better than that of the positive control group and the placebo control group(P<0.05).In terms of improving the classification of the NIHSS scale and the assessment of the ADL scale,the YYHG high-dose group was significantly better than the other three groups(P<0.05),and the YYHG low-dose group was better than the placebo control group(P<0.01).At the same time,except for the QLI score,the high-dose group was better than the low-dose group(P<0.05).In terms of safety,adverse reactions after YYHG treatment were generally mild(3.78%),and no serious adverse reactions have been reported.Conclusion YYHG is safe and effective in the treatment of IS patients with QYDBSS.