[Treatment of type 2 diabetes mellitus patients of qi-yin deficiency phlegm-stasis inter-obstruction syndrome by jiangtang xiaozhi capsule and pioglitazone tablet: a non-inferiority randomized controlled trial].

Unlabelled: OBJECTIVE; To evaluate the efficacy and safety of Jiangtang Xiaozhi Capsule (JTXZC) in treating type 2 diabetes mellitus (T2DM) of qi-yin deficiency phlegm-stasis inter-obstruction syndrome (QYDPSIOS), and to observe its effect on inflammatory factors and fibrinolytic factors.

Methods: By adopting a randomization grouping, parallel control, and prospective study, 73 T2DM patients of QYDPSIOS were assigned to two groups by random digit table, the Pioglitazone Tablet group (36 cases, as the control) and the JTXZC group (37 cases). All patients maintained their basic therapies and lifestyle as previous after recruitment. Patients in the JTXZC group took JTXZC, 4 pills each time, three times per day, while those in control group took Pioglitazone Tablet, 15 mg each time, once daily. The therapeutic course for all was 8 weeks. The body weight (BW), the height, body mass index (BMI), waist circumference (WC), hip circumference, waist-to-hip ratio (WHR), and scoring of Chinese medicine (TCM) symptoms were observed. Levels of fasting blood glucose (FBG), 2 h postprandial blood glucose (2 h PBG), glycated hemoglobin (HbA1c), tumor necrosis factor alpha (TNF-alpha), nuclear factor kappaB (NF-kappaB), and plasminogen activator inhibitor 1 (PAL-1) were detected. The safety indices such as liver and renal functions and adverse reactions were also observed.

Results: Compared with before treatment, BW, BMI, HbA1c, and PBG were obviously lower after 8-week treatment than before treatment in the JTXZC group (P < 0.05). There was no statistical difference in post-treatment BW, BMI, HbA1c, or 2 h PBG between the two groups (P < 0.05). Compared with before treatment, levels of TNF-alpha and PAI-1 were lowered after 8 weeks of treatment in both groups (P < 0.01). The level of NF-kappaB was obviously lowered after 8 weeks of treatment in the control groups (P < 0.05), but it also decreased in the JTXZC group with no statistical difference. The scorings of CM symptoms were somewhat improved after treatment in the two groups (P < 0.01). Besides, better effects were obtained in the JTXZC group (P < 0.05). No severe adverse event occurred in either group during the whole therapeutic course.

Conclusions: JTXZC showed similar therapeutic effect to pioglitazone. Both of them could effectively improve patients' clinical symptoms, the inflammation and fibrinolytic activities in different pathways, with no severe adverse reaction.