| Objective This study investigated the clinical efficacy and safety of the treatment of BPH patients by Yiqilishuihuoxue Method through an evidence-based medicine approach,with a view to bringing into play the characteristics and advantages of Chinese medicine,broadening the ideas and pathways of BPH treatment,and providing a reference basis for clinical front-line promotion and application.Methods A total of 60 patients who were diagnosed with benign prostatic hyperplasia and whose TCM evidence belonged to Qi deficiency and water stopping blood were enrolled in this study from October 2018 to December 2019,and were divided into treatment group and control group by random number table method,30 cases in each group.The control group was given oral tamsulosin hydrochloride extended-release capsules,while the treatment group was given a combination of Chinese herbal soup to benefit qi and promote blood circulation on top of the control group.A 12-week observation course was conducted,and the basic information of the cases including age and duration of medical history were assessed for balanced comparability before the start of treatment.The differences in IPSS score,QOL score,Qmax,RU,PV and TCM single symptom score and total TCM evidence score before and after 12 weeks of treatment were recorded and analysed separately.Changes in adverse reactions and safety indicators were observed before and after treatment in both groups to assess the safety of medication.The data collected from the monitoring were processed and analyzed by SPSS23.0 statistical software.The measurement data were described as mean ± standard deviation(`(34)±s)and inferred by t-test or rank sum test,while the count data were expressed as percentage(%)and number of cases and inferred by chi-square test.P<0.05 was considered to be a statistically significant difference.Results(1)A total of 60 patients were included in this study.At the end of the trial,there was one case of shedding in the treatment group and two cases in the control group,for a total of three cases of shedding,with 57 cases actually completed and an overall shedding rate of 5%.(2)Basic information such as age,duration of medical history and efficacy observation indexes such as IPSS score,QOL score,Qmax,PV,RU and TCM single symptom score were not significantly different between the two groups before treatment(P>0.05)and were comparable.(3)After 12 weeks of treatment,the levels of IPSS score,QOL score,Qmax and RU decreased in both groups compared with those before treatment(P<0.05),with the treatment group outperforming the control group in terms of improvement in several indicators such as IPSS score,QOL score and Qmax(P<0.05).The effect on prostate volume was not significant in either group(P>0.05).(4)After treatment,the single TCM symptoms in the treatment group improved compared to those before treatment(P<0.05),with significantly better improvement in the primary symptoms,including frequent nocturia and difficulty in urination;and the secondary symptoms,including discomfort in the small abdomen,weakness and tiredness,and irregular bowel movements,than in the control group(P<0.05).In contrast,the control group only showed some improvement in frequent nocturia,difficult urination,thinning of the urine line and residual draining after urination(P<0.05).The effect of the treatment group was better than that of the control group in terms of reduction of the total TCM evidence points(P < 0.05).(5)The comprehensive efficacy evaluation at the end of observation yielded a total effective rate of 86.20% and 64.28% for the treatment group and the control group respectively,and the comprehensive efficacy of the treatment group was better than that of the control group by chi-square test(P<0.05).(6)After 12 weeks of treatment,the three major routine tests,liver and kidney functions and ECG examination of the two groups did not exceed the normal range,and no adverse events were observed.Conclusion(1)Both the treatment group and and the control group played a facilitating role in improving BPH voiding symptoms,lowering IPSS scores,increasing maximum urinary flow rate and improving quality of life,and the overall efficacy of the treatment group was more significant than that of the control group.(2)The combination of Yiqilishuihuoxue method with Western medicine was effective in improving the symptoms of Chinese medicine in patients with BPH of the Qi deficiency,water stoppage and blood stasis type,and it is worth expanding the clinical application.(3)No adverse reactions were seen in both groups during treatment,and the clinical application was safe and reliable. |
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