Effect of hypoglycemic anti-deafness capsules in diabetic patients with deafness and toxicological assessment in rats

OBJECTIVE:Through experiment on animals and clinical trials to explore the safety and efficacy of hypoglycemic anti-deafness capsules on diabetic patients with deafness.METHODS:Total 296 patients with non-insulin dependent diabetes mellitus(NIDDM)were randomly divided into two groups.A treatment group of 164patients(208 ears)was treated with hypoglycemic anti-deafness capsules based onTCM syndrome differentiation.A control group of 132 patients(184ears)was treated with glibenclamide and conventional drug treatment for deafness.The following were observed:hearing,fasting plasma glucose(FPG),2 h postprandial plasma glucose(2hPG),24 h urine glucose(24hUG),improvement of main symptoms,platelet function,and changes in superoxidedismutase(SOD)and lipid peroxide(LPO)levels.In animal studies,Kunming mice,weighing 18-22 g were used.Half of the mice were males and half were females.Wistar rats,weighing 80-120 g were used.Half of the rats were males and half were females.Male Wistar rats,weighing 200-220 g,were also used.Their acute and chronic toxicity was studied.RESULTS:The hearing improvement was 56.7%in the treatment group and 26.6%in the control group.FPG,2hPG,and 24hUG were improved significantly(P<0.05,P<0.01,P<0.01,respectively)in the treatment group and 2hPG and 24hUG improved significantly in the control group(P<0.05,P<0.05).The improvement in 2hPG and 24hUG in the treatment group was significantly greater than that in the control group P<0.01).There was no significant difference in FPG between the two groups(P<0.05).Main symptoms in the treatment group were significantly more improved than those in the control group(P<0.05,P<0.01).In the treatment group,platelet adhesion and aggregation,SOD,and LPO were all significantly improved from before treatment(P<0.05,P<0.01).However,in the control group,except LOP(P<0.05),there were no significant differences from before treatment to after(P<0.05).In animal studies,no obvious acute or long-term toxicity was observed from capsule administration.CONCLUSION:Through experiment on animals and clinical trials,we can found that hypoglycemic anti-deafness capsules could decrease blood glucose and serum triglycerides of alloxan-induced diabetic rats.This herbal capsule is effective for safely treating diabetic patients with deafness.