OBJECTIVETo observe the clinical effects of Qiyao Xiaoke Capsule (QXC) on patients with type 2 pre-diabetes.

METHODSTotally 116 pre-diabetes patients were randomly assigned to the Chinese medicine group (CM, 76 cases) and the blank control group (BC, 40 cases) in the ratio of 2: 1. All patients received proper diet control, health education, and exercises, and so on. Besides, patients in the CM group took QXC (0.4 g/pill), 6 pills each time, three times a day. But patients in the BC group were intervened by life style alone. The fasting blood glucose (FBG), postprandial blood glucose (PBG), insulin (FINS, 2h INS), glycosylated hemoglobin (HbAlc), blood lipids (TG, TC, HDL-C, and LDL-C), and efficacy of CM symptoms were observed in the two groups before and after intervention. The sequelae were observed at the end of the treatment and at follow-ups.

RESULTSAfter treatment FBG, PBG, and HbA1c decreased in all patients of the two groups (P<0.05, P<0.01), with 2 h PBG decreased more significantly. But there was no statistical difference between the two groups (P>0.05). The two methods could improve the secretion of FINS. Especially 2 h INS decreased more significantly in the CM group, showing statistical difference when compared with the BC group (P<0.05). The two methods could improve the metabolism of blood lipids. CM could significantly lower TG and elevate HDL-C, showing statistical difference when compared with before treatment (P<0.05). After treatment the CM symptoms were obviously improved, showing statistical difference when compared with the BC group (P<0.05). The normalization rate was better in the CM group than in the BC group at the end of the treatment and at follow-ups (P<0.05).

CONCLUSIONSQXC combined life style intervention could improve fasting and postprandial insulin secretion of type 2 pre-diabetes patients, regulate glycolipid metabolism, correct the insulin resistance state, and improve the symptoms of qi-yin insufficiency. It could postpone or hinder the occurrence and development of type 2 diabetes. It was more effective and durable than changing the life style alone.