Clinical Study On Qiyao Xiaoke Oral Liquid In The Treatment Of Type 2 Diabetes Mellitus With Erectile Dysfunction

Objective Diabetes mellitus(DM)is a chronic endocrine and metabolic disease characterized by elevated blood glucose,which has rapidly developed into a global public health problem in recent years.Most of diabetes patients are caused bad effects on important organs with long-term use of hypoglycemic drugs.And it lead to damage of the liver and kidney.Qiyao Xiaoke oral liquid is a kind of medicine can effectively control blood glucose of type 2 diabetes patients.Through the clinic trails,it was found that Qiyao Xiaoke oral liquid was also effective in the treatment of type2 diabetes mellitus complicated with erectile dysfunction(ED).The quality of sexual life of patients and their partners were further improved in this study.Methods and Results Using randomized,double-blind,placebo-controlled,parallel group clinical trial research methods.According to the randomized number table,130 patients with type2 diabetes complicated with ED were random Ly divided into the Qi Yao group(65cases)and the placebo control group(65 cases).All patients in Qi Yao group took Qiyao Xiaoke oral liquid while the patients in control group took placebo.All the patients in both groups took medicine three times a day,for the observation of 12 weeks.The main efficacy study was to evaluate the ability of patients to achieve and maintain successful erections during sexual behaviors.The International Index of Erectile Function(IIEF)questionnaire was used as the evaluated tool for the main efficacy end point,and meanwhile the therapeutic satisfaction of patients and their partners was evaluated.Other assessment included Treatment Satisfaction Scale(TSS)scores,and endocrine hormone levels(testosterone,estradiol,follicle stimulating hormone,luteinizing hormone,progesterone,and prolactin),and blood glucose levels(fasting blood glucose,2-hour postprandial blood glucose,and glycosylated hemoglobin levels)were also studied.During the clinic trails,a total of 9 cases fall off Qi Yao group while 12 cases fall off in the control group for individual reasons.The actual number of cases included in the clinic trails was 109,56 in the Qiyao group and 53 in the control group separately.There was no significant statistical difference in the general data characteristics(body weight,BMI,Hb A1 c,duration of type 2 diabetes,family history of diabetes,and erectile function)of the patients.1.Compared with the placebo group,the IIEF score of Qiyao group increased significantly after 12 weeks of treatment(p<0.001),and the scores of erectile function,libido,orgasm function,sexual intercourse satisfaction and overall satisfaction in the IIEF score increased significantly,the difference was statistically significant.2.After 12 weeks follow-up,in addition to orgasm satisfaction score,TSS scores of patients and their partners in Qiyao treatment group,including erectile capacity,satisfaction,sexual pleasure,satisfaction with drug treatment were significantly higher than those in Control group(p < 0.05).The score of patients’ s self-confidence in sexual behavior was also significantly increased(p < 0.05),and there was a noticeable trend for the score of partner’s self-confidence in sexual behavior(p = 0.056).3.Compared with the control group,the increase of testosterone level(p=0.042)in the Qiyao group was significant.4.The decrease of FBG(p=0.013)and P2BG(p=0.034)indexes in the Qiyao group was statistically significant.The decrease level of Hb A1c(p=0.041)was obviously significant.5.During the test period,the adverse reactions in the Qiyao group included diarrhea(2/65,3.08%)and abdominal distension(1/65,1.54%).Adverse reactions in the control group included constipation(2/65,3.08%)and abdominal distension(2/65,3.08%).All these side effects were tolerated by the patients without special treatment.Conclusions Qiyao Xiaoke oral liquid is a kind of Chinese medicine for the treatment of diabetes.Chinese wolfberry as main effective ingredient has a significant effect of reducing the blood glucose of type 2 diabetes.Patients with type 2 diabetes complicated with ED after taking Qiyao Xiaoke oral liquid for treatment showed significant improvement in various functional indexes of erectile function,patient satisfaction and partner satisfaction,which were statistically significant.The quality of sexual life of patients and their partners were improved.The drug is suitable for patients with type 2 diabetes complicated with ED,and has a safe drug performance and good tolerance.