| Objective: Benign prostatic hyperplasia is a common disease among men over the age of 50. Due to the urethral pressure generated by the prostate, it causes urethral obstruction symptoms and signs, such as difficulty of urinating, urine flow thinning, dripping urine, frequent urination and nocturia increased. The incidence of the disease increases with age. According to the theory of Chinese Medicine, “kidney is responsible for reproduction”, “kidney controls urination and defecation”, and “kidney has the exterior and interior relationship with the urinary bladder”. Therefore, it is believed that the main pathological changes of benign prostatic hyperplasia are bladder gasification disorder. The disease mainly happens in the bladder and kidney. The deficiency of kidney qi is the basis of the incidence of benign prostatic hyperplasia. The Zi Gui Yuan Yang capsules are manufacturerd by Hong Kong Han Sheng Tang Herbal Technologies Co. Ltd. The original functions of the Zi Gui Yuan Yang capsules are tonifying kidney qi, replenishing essence and blood, nourishing Tian Gui, promoting blood circulation, strengthening the bones and muscles, invigorating the brain, regulating yin and yang balance. It is used for the symptoms such as weakness in the loins and knees, frequent nocturia, dysuria or clear urine in large amount, short of breath and mental weariness, forgetfulness, irritability and other caused by male menopausal syndrome. Zi Gui Yuan Yang capsule, a Chinese medicine tonifying kidney compound, originally is used for treating male menopause. This article describes the current research progress about treatments of benign prostatic hyperplasia by traditional Chinese medicine. And based on the theory of traditional Chinese medicine of “treating different diseases with the same treatment”, this study also observe the safety and efficacy of for treating the syndrome of deficiency of kidney qi of benign prostate hyperplasia by Zi Gui Yuan Yang capsule.Method:Use random, double-blinded, placebo parallel control and multi-center clinical trial design. The experiment is completed by three clinical trial institutions collaboratively: 1. Dongfang Hospital, Beijing University of Chinese Medicine; 2. Xiyuan Hospital, China Academy of Chinese Medical Sciences; 3. Guang'anmen Hospital, China Academy of Chinese Medical Sciences. The test sample content was 60 cases(30 cases in the treatment group and 30 cases in the control group). The expected withdrawal rate was not more than 20%. The total number of cases identified as 72 cases(36 cases of test group and 36 cases of the control group). Test group: Patients suffering mild to moderate benign prostate hyperplasia, meets the criteria of the syndrome of deficiency of kidney qi, aged between 50-75 years old, and signed informed consent. Test group: Zi Gui Yuan Yang capsules, oral administration, 3 times a day, 2 capsules each time, 0.35g/capsule. Control group: Zi Gui Yuan Yang placebo capsules, oral administration, 3 times a day, 2 capsules each time, 0.35g/capsule. Duration of treatment: 6 weeks. Placebo capsules were also manufacturerd by Hong Kong Han Sheng Tang Herbal Technologies Co. Ltd. The test drug and control drug look identical. Diagnostic criteria: Reference to the Chinese Medical Association in 2006 issued by the Society of Urology, "benign prostatic hyperplasia diagnosis and treatment guidelines", with 1-5 or 6, can be diagnosed as benign prostate hyperplasia: 1.Difficulty urinating, hesitated, urine weak, time-consuming effort, urine interruption; 2.Frequent urination, nocturia frequency, even those who have urinary retention or urinary incontinence; 3.DRE: both sides of the leaf increases, smooth, flexible, shallow or disappearance of the central groove; 4.Ultrasound: prostate enlargement, weight> 20g; 5.Urinary flow rate determination: urine volume> 150 ml, maximum flow rate Qmax <15ml/s. If the urine output <150ml, should consider the urine factor. If repeated efforts, the patient can not meet the above criteria, the available urine output 6.Residual urine: abdominal B-ultrasound or catheterization method to determine whether the residual urine of the bladder. Standard of TCM differentiation of syndrome of deficiency of kidney qi: With the main symptoms and sub- symptoms 3 in 2, with reference to tongue and pulse, can be dialectical for kidney qi deficiency. Main symptoms: Frequent urination, increased nocturia, dysuria. Sub-symptoms: Weakness in the loins and knees, sexual indifference, mental weakness and fatigue. Inclusion criteria: 1.Met the diagnostic criteria of Western medicine mild to moderate BPH, in line with TCM kidney qi deficiency syndrome standard; 2.Men aged 50 to 75 years; 3.Duration of more than 3 months; 4.The maximum flow rate <15ml / s; 5.BPH patients with mild(IPSS score ? 19 points); 6.Need to sign informed consent. Indicators of observation: Primary and secondary efficacy endpoints of TCM syndrome Individual symptoms of Chinese Medicine Other indicators 1.IPSS and Qo L scores before and after treatment; 2.maximum urinary flow rate before and after treatment; 3.weight of prostate; 4.IIEF-5 score; 5.testosterone levels. Evaluation criteria: 1.Effectiveness evaluation TCM syndrome: Clinically controlled: reducing rate ? 90%; significantly effective: 90%> reduced rate ?70% and; effective: 30% ? reduced rate <70%; uneffective: reduced rate <30%. Efficacy of individual symptoms: Changes of the individual symptoms before and after the treatment. According to the reduced level, it is considered as effective by reducing one level, significantly effective by reducing two levels and clinically Qmax results; controlled by reducing more than two levels or turn normal. Other efficacy: IPSS score, maximum urinary flow rate, quality of life, IIEF-5, testosterone values before and after treatment. Analyze the efficacy according to the measurement data. 2. Safety evaluation It mainly investigates any case that is turning into abnormal or the abnormalities aggravated and any adverse effects induced after the treatment. Method of analysis: The numeration data use the method of x2 test or fisher's exact test. The quantitative data use the method of t test or rank sum test. The ranked data use the method of Wilcoxon rank sum test. The analysis about efficacy of the ranked data use CMHx2 test when considering the effect of the center. Baseline comparability analysis: By comparing the demographic characteristics, disease conditions, TCM symptoms, International Prostate Symptom Score(IPSS), quality of life score(Qo L), maximum urine flow(Qmax), prostate weight, IIEF-5 score, testosterone levels and combination therapy etc. of the two groups, the difference was not statistically significant(P> 0.05). It shows that they met the requirement and were comparable.Results: 1. Efficacy of TCM syndrome: The clinically controlled, significantly effective and effective percentage of the test group and control group were 10%, 13%, 57% and 0%, 6.25%, 16% respectively. The total effective rate of the test group and control group were 86% and 22.25% respectively. It indicates that the test group is more effective than the control group(P<0.05). 2. Efficacy of main symptoms: For frequent urination, nocturia and dysuria, the results show that the test group is more effective than the control group. The difference of two groups was statistically significant(P<0.05). The result of PPS population is consistent with the result of FAS population. The efficacy concerning the International Prostate Symptom Score(IPSS), quality of life score(Qo L) and the maximum urinary flow rate(Qmax): By concerning the above indicators, the effect of the test group before and after treatment(P<0.01), the test group is more effective than the control group(P<0.01). No adverse reactions of the two groups were observed in the the blood test, urine test, liver and kidney function, ECG results or other adverse effects.Conclusion: Zi Gui Yuan Yang capsule is significantly effective and safe to treat the benign prostate hyperplasia patients with the syndrome of deficiency of kidney qi. The study lay a theoretical and practical basis for further research and expansion of its clinical application. The study confirmed the theory of Chinese medicine of "treating different diseases with the same treatment". The treatment and the prescription of traditional Chinese medicine on benign prostatic hyperplasia have broad prospects for clinical application. |
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