RESUMEN
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 164 patients (208 ears) was treated with hypoglycemic anti-deafness capsules based on TCM syndrome differentiation. A control group of 132 patients (184 ears) 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 superoxide dismutase (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.