title: Effect of hypoglycemic anti-deafness capsules in diabetic patients with deafness and toxicological assessment in rats.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.forename: Ruiyu
authors.initials: R
authors.lastname: Li
authors.forename: Meng
authors.initials: M
authors.lastname: Li
authors.forename: Kaoshan
authors.initials: K
authors.lastname: Guo
authors.forename: Bin
authors.initials: B
authors.lastname: Li
authors.forename: Jinjie
authors.initials: J
authors.lastname: Hou
authors.forename: Liping
authors.initials: L
authors.lastname: Wu
authors.forename: Xianyun
authors.initials: X
authors.lastname: Liu
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D001786:Blood Glucose / Q000378:metabolism; D002214:Capsules / Q000008:administration & dosage; D003638:Deafness / Q000188:drug therapy / Q000209:etiology / Q000378:metabolism / Q000503:physiopathology / Q000517:prevention & control*; D048909:Diabetes Complications / Q000188:drug therapy / Q000209:etiology / Q000378:metabolism / Q000503:physiopathology / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000378:metabolism; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006309:Hearing / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D051379:Mice; D008875:Middle Aged; D051381:Rats; D017208:Rats, Wistar
chemical_list: D001786:Blood Glucose; D002214:Capsules; D004365:Drugs, Chinese Herbal; D007004:Hypoglycemic Agents