| Objective:To study the clinical efficacy and safety of modified Danggui Beimu Kushen Pills in combination with tamsulosin hydrochloride sustained-release capsules in the treatment of chronic prostatitis with dampness-heat and stasis syndrome,to enrich the methods of integrated traditional Chinese and Western medicine for the treatment of chronic prostatitis.Methods:A randomised controlled trial was conducted to collect 76 chronic prostatitis patients with dampness-heat and stasis syndrome who were treated at the Andrology/Reproductive Medicine Outpatient Clinic of the First Affiliated Hospital of Yunnan University of Chinese Medicine from December 2021 to December 2022.Patients were randomised into two groups: experimental group(n=38)and control group(n=38),and then the experimental group was treated with Danggui Beimu Kushen Pills combined with tamsulosin hydrochloride sustained-release capsules,and the control group was treated with tamsulosin hydrochloride sustained-release capsules.The treatment lasted 4 weeks.Curative effect was assessed using the NIH-CPSI score,the UPOINT phenotypic classification system score,and the Traditional Chinese Medicine(TCM)syndrome classification and quantification standard score.Routine haematuria as well as liver and kidney function were used as an index of safety.To observe and compare the curative effect between the two groups after treatment and before and after treatment in the two groups,and at the same time to evaluate its safety.To evaluate the prospects of the clinical application of the modified Danggui Beimu Kushen Pills in combination with tamsulosin hydrochloride sustained-release capsules for the treatment of chronic prostatitis.In this study,the data from the cases were statistically analysed using the SPSS 27.0 software,and the results were analysed and discussed.Results:In the end,a total of 5 cases in the experimental group and in the control group were shed,and 2 cases were excluded from the control group.Finally,69 cases were clinically observed.After 4 weeks of treatment,the total comprehensive curative effect of the experimental group was 91.7%,while that of the control group was 78.8%,and the effect of the experimental group was better(P<0.05)(see Table 19).NIH-CPSI score: The total score of the experimental group before and after treatment was 24.08±5.85,7.61±3.57,and that of the control group before and after treatment was 25.88±4.33,13.55±5.56.The post-treatment scores of both groups were significantly lower than the pre-treatment scores(P<0.01),and the score of the experimental group was more significantly lower than that of the control group(P<0.01)(see Table 23).Compared to the control group,the experimental group significantly improved the symptoms of pain and abnormal urination(P<0.01)and the patients’ quality of life(P<0.01)(see Tables 24 to 26).The total UPOINT classification system scores before and after treatment in the experimental and control groups were 32.61±8.26,10.00±4.75,34.52±6.81 and 14.64±4.55,respectively.The post-treatment scores of both groups were significantly lower than the pre-treatment scores(P<0.01),and the scores of the experimental group were more significantly lower than those of the control group(P<0.01)(see Table 27).Among these,lower urinary tract symptoms,neurological and systemic symptoms,pelvic floor pain and bloating symptoms were significantly improved in the experimental group(P<0.01)(see Tables 28,32,33).At the same time,there was an improvement in the symptoms of psychosocial abnormalities,and the effect of the experimental group was better(P<0.05)(see Table 29).However,there was no difference in the improvement of symptoms between the two groups(P>0.05)according to the patients’ infection symptoms and prostate specific symptoms(see Tables30 to 31).The total TCM syndrome scores before and after treatment in the experimental and control groups were 30.22 ± 4.08,9.17 ± 4.51,31.03 ± 1.90 and 14.27 ± 5.94,respectively.Post-treatment scores for both groups were significantly lower than pre-treatment(P<0.01)(see Tables 34 to 35),and the experimental group’s scores were significantly lower than the control group’s(P<0.01)(see Table 36).Curative effect on TCM syndrome: the cured and significantly effective rate of the experimental group was66.7%,while that of the control group was 27.3%.In comparison with the two groups,the clinical cure rate and the clear response rate were better in the experimental group(P<0.05)(see Table 22).Among these,the degree of improvement in syndrome factors such as frequent urination,urgency,lower abdominal,lumbosacral and perineal pain,secondary symptoms,and tongue and pulse was significantly better in the test group than in the control group(P<0.01)(see Table 36).(see Table 36)There was no significant difference(P>0.05)in the improvement of urinary pain and dribbling.Throughout the entire clinical trial,there were no apparent adverse reactions in either of the two groups of patients.Conclusions:(1)Danggui Beimu Kushen Pills combined with tamsulosin hydrochloride sustained-release capsules can effectively relieve the pain,discomfort and abnormal urination symptoms caused by damp heat and blood stasis in chronic prostatitis,improve patients’ quality of life and significantly reduce patients’ NIH-CPSI score,which is significantly better than that of tamsulosin hydrochloride sustained-release capsules alone.(2)Danggui Beimu Kushen Pills combined with tamsulosin hydrochloride sustained-release capsules can significantly improve the symptoms of the UPOINT classification system in chronic prostatitis patients with damp-heat and stasis syndrome.Among them,the improvement in infection and prostate specific symptoms was similar to that of tamsulosin hydrochloride sustained-release capsules alone,but the improvement in psychosocial symptoms was better than that of tamsulosin hydrochloride sustained-release capsules.Improvements in urinary tract symptoms,neurological and systemic symptoms and pelvic floor pain and urgency were significantly better than with tamsulosin hydrochloride sustained-release capsules alone.(3)Danggui Beimu Kushen Pills combined with tamsulosin hydrochloride sustained-release capsules can significantly reduce the TCM syndrome grading score of chronic prostatitis patients with dampness-heat and stasis syndrome,and can significantly improve the TCM syndrome performance,and the improvement degree and overall effective rate of TCM syndrome grading score are better than those of tamsulosin hydrochloride sustained-release capsules.In addition,the curative effect of modified Danggui Beimu Kushen Pills combined with tamsulosin hydrochloride sustained-release capsules on frequent urination,urgency,lower abdominal,lumbosacral and perineal pain,secondary symptoms and tongue and pulse syndrome was significantly better than that of tamsulosin hydrochloride sustained-release capsules alone.In conclusion,compared with taking tamsulosin hydrochloride sustained-release capsules alone,taking Danggui Beimu Kushen Pills in combination with tamsulosin hydrochloride sustained-release capsules can not only improve the symptoms of abnormal urination in chronic prostatitis patients,but also improve TCM symptoms such as anxiety and depression,and improve the quality of life.This study suggests that Danggui Beimu Kushen Pills combined with tamsulosin hydrochloride sustained-release capsules has a good application prospect in the treatment of chronic prostatitis with dampness-heat and stasis syndrome,enriching the method of integrated traditional Chinese and Western medicine in the treatment of chronic prostatitis. |
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