The Effect Of Traditional Chinese Medicine Combined Lifestyle Intervene On IGT Transform

PurposeTo investigate the effect of traditional chinese medicine compound recipe 1 combined lifestyle intervene on the transform to normal glucose, type 2 diabetes and stable IGT from IGT stage; and the effect on CVD risk factors.MethodRandomised controlled double-blind multi-centre prospective clinial trail.Screen 946 subjects of high risk IGT group from 17 hospital all over China between March and December in 2008, then 446 subjects with initail IGT diagnose enter a 1 month wash-out period.No medication but lifestyle interventions were give to these subjects.At the end of the wash-out period,all the 446 subjects were give a secendory OGTT test, finally 410 IGT patients fit into the plan.Randomly give traditional chinese medicine compound recipe 1 (capsule 5#,tid) combined lifestyle intervene(treated group,n=174) or placebo(capsule 5#,tid) combined lifestyle intervene (controlled group,n=167) for 12 month.Evaluate FBG, P2BG, physical examination and TCM symptoms every 3 month. Add blood lipid and safety test at baseline and 12 month later. The trail passed Guang'an Men hospital Ethics Committee of China Academy of TCM medicine.All the patients signed the Informed consent.ResultUntil 2010 march 31st, totally 341 patients completed the trail, enter the per protocol(PPs) after blind review. No stastices differences of Height, weight, BMI, waist circumference(WC), hip circumference(HC),FBG, P2BG, TG, TC, HDL-C,LDL-C and SBP,DBP between the two group at baseline(P>0.05), both groups are compatable. The incidence of diabetes is 16.09% in treated group, and 26.35% in controlled group, statistical difference(P=0.020); 70 patients(40.2%) transformed to normal glucose after 12 month in treated group,and 68 patients(40.7%) in controlled group, no difference between the two group(P=0.927); 76 patients (43.7%)stable at IGT or IFG stage in treated group,which is significantly higher than controlled group(55 patients,32.9%) (P=0.041). Compared to baseline,6m and 9 m FBG level decreased sharply(P <0.01; P<0.001),while no change in the controlled group(P>0.05). P2BG decreased significantly in both group after baseline(treated group P<0.001; controlled groupP<0.01). TG,TC and LDL-C level also decreased after baseline, no defference between the two group(P>0.05);but no change in SBP,DBP and weight.3m,6m BMI decrease better in treated group(P< 0.05),but on change in 9m,12m(P>0.05).3m,6 m WC decrease better in treated group(P<0.05), no change in controlled group(P>0.05).3m HC significantly decreased in treated group(P=0.011); no change in controlled group(P>0.05). TCM symptom score decreased apparently in both group(P< 0.001). Totally,52 patients dropped,22 (11.22%) in treated group and 30 (15.25%)in controlled group, no difference between the two group(P=0.250). 16 patients reported for adverse events,7(3.6%)in treated group and 9(4.5%) in controlled group, no difference between the two group(P=0.624).ConclusionsThe results indicated that traditional chinese medicine compound recipe 1 combined lifestyle intervene do improve FBG and P2BG level of IGT patients. Traditional chinese medicine compound recipe 1 combined lifestyle intervene significantly delay the incidence and progress of type 2 diabese, compaired to lifestyle intervene alone.Long-term oral traditional chinese medicine compound recipe 1 is safe and effecive to IGT patients, no serious adverse events occurred. Offer a new option to IGT people.