Clinical Study On The Treatment Of Lower Urinary Tract Symptoms Suggestive Of Female Bladder Outlet Obstruction By Regulating Qi

BackgroundLower urinary tract symptoms are common in both men and women,and the incidence rate is increasing.Female bladder outlet obstruction is one of the important factors that may cause the female lower urinary tract symptoms.It can be divided into anatomic obstruction and functional obstruction.The causes of anatomic obstruction include anti-incontinence surgery,pelvic organ prolapse,urethral stricture,cyst beside or around urethra,tumor,infection,etc.The causes of functional obstruction include dysfunctional voiding,primary obstruction bladder neck obstruction and Fowler’s syndrome.The lower urinary tract symptoms of female bladder outlet obstruction are non-specific,and there is no unified diagnostic standard,which makes clinical diagnosis and treatment more difficult.For anatomic obstruction,it is often effective to take corresponding treatment methods after the causes are clear.The key and difficulty of treatment for female bladder outlet obstruction is functional obstruction.At present,the types and effects of treatment methods for female bladder outlet obstruction are unsatisfactory,so it is urgent to explore more treatment methods and exact effects.Lower urinary tract symptoms are a group of symptoms related to urine storage and urination.Urination is one of the contents of traditional Chinese medicine(TCM)consultation and an important factor affecting treatment.TCM has a comprehensive understanding of this.TCM has a long history in the treatment of scrotal disease,with various methods,safety,convenience,flexibility,and unique advantages.Professor Lu Jianxin,the tutor,inherits Professor Gao Ronglin’s academic thought of regulating the viscera and regulating the Qi mechanism,and based on many years of clinical experience,treats female bladder outlet obstruction with TCM.He thinks that the key lies in regulating the ascending and descending of the Qi mechanism,harmonizing the Qi function of the viscera,releasing the water in the Sanjiao channel,and proposes the method of regulating the Qi mechanism to treat the disease.According to the age and physiological characteristics of female bladder outlet obstruction,Professor Lu Jianxin,the tutor,prepared Tiaoqi Fuhua Decoction by himself on the basis of Buzhong Yiqi Decoction and Wuling powder,and based on this prescription,the female bladder outlet obstruction and related lower urinary tract symptoms were treated.At present,the treatment of bladder outlet obstruction caused by benign prostatic hyperplasia with TCM has been widely recognized,but the treatment of female bladder outlet obstruction with TCM is rarely mentioned in the literature.At present,there is no unified diagnostic standard for female bladder outlet obstruction,which is difficult to diagnose clinically.Therefore,this study starts with the lower urinary tract symptoms suggestive of bladder outlet obstruction(the lower urinary tract symptoms suggestive of bladder outlet obstruction refer to the symptoms of any urination period or other symptoms of the lower urinary tract at the same time).In this study,we try to compare the effect of modified Tiaoqi Fuhua Decoction and conventional therapy alone on lower urinary tract symptoms suggestive of bladder outlet obstruction and to provide a preliminary clinical basis for the treatment of lower urinary tract symptoms in female patients with bladder outlet obstruction by TCM.ObjectiveBy comparing the clinical effect of modified Tiaoqi Fuhua Decoction combined with α-1 receptor blocker and simple α-1 receptor blocker in the treatment of female patients with lower urinary tract symptoms suggestive of bladder outlet obstruction,we try to explore the effective treatment of lower urinary tract symptoms suggestive of bladder outlet obstruction in female,and to provide preliminary clinical basis for female bladder outlet obstruction by regulating qi mechanism.Method1 Study designProspective,randomized,two groups of parallel control trials,fully randomized grouping:the subjects were randomly divided into the experimental group and the control group,the sample size ratio of the two groups was 1:1.2 ParticipantsThe subjects were all female patients with lower urinary tract symptoms who were recruited from the outpatient department of Guang’ anmen Hospital,China Academy of Chinese Medical Sciences from January 2019 to January 2020.According to the inclusion and exclusion criteria,the female patients with lower urinary tract symptoms and Qi deficiency syndrome according to TCM syndrome differentiation were randomly divided into experimental group and control group,the ratio was 1:1.3 Interventions and comparisonControl group:the α-1 receptor blocker,terazosin hydrochloride tablets,once a day,2mg each time,was taken before sleep,and the treatment lasted for 4 weeks.Experimental group:on the basis of intervention in the control group,combining with modified Tiaoqi Fuhua Decoction.Tiaoqi Fuhua Decoction:its components include baked Astragalus 30g,Cimicifuga 6g,bupleurum 6g,tangerine peel 10g,Epimedium 9g,Guizhi 10g,Alisma 10g,stir fried Atractylodes 10g,Poria 10g,Polyporus 10g,almond 9g,Platycodon 6g.According to the patients’ tongue,pulse and syndrome,the drugs are added and subtracted along with the syndrome.In principle,the added and subtracted drugs are no more than 4.The granules are taken orally twice a day.Two weeks are a course of treatment,sharing two courses of treatment.4 OutcomesMain outcome measures:International Prostate Symptom Score(IPSS).Secondary outcome measures:peak flow rate,mean urinary flow rate,quality of life score(QOL),residual urine volume,number of nocturia,TCM symptom score.The safety indexes include alanine aminotransferase(ALT)、aspartate aminotransferase(AST)、serum creatinine(Scr)、blood urea nitrogen(BUN).The main efficacy index and the secondary efficacy index were recorded once before the treatment,and once at 2 weeks and 4 weeks respectively.ResultsIn this study,40 subjects were enrolled,20 in the experimental group and 20 in the control group.At the end of 4 weeks,36 subjects completed the study(19 in the experimental group and 17 in the control group)Main outcome indicators:after 2 weeks of treatment,IPSS of the two groups decreased,and there were statistically significant differences in the two groups(P<0.01 in the experimental group,P<0.01 in the control group).There was no statistically significant difference between the experimental group and the control group(P>0.05).After 4 weeks of treatment,IPSS of the two groups decreased,the difference between the two groups was statistically significant(P<0.05),and the effect of the experimental group was better than that of the control group.Secondary outcome indicators:① After 4 weeks of treatment the peak flow rate in the two groups increased compared with the baseline,and the differences in the two groups before and after treatment were statistically significant(P<0.01 in the experimental group and P<0.05 in the control group).The difference between the groups was statistically significant(P<0.05),and the effect of the experimental group was better than that of the control group.The differences of mean uroflow rate in the two groups before and after treatment were statistically significant(P<0.01 in the experimental group and P<0.01 in the control group),and there was no significant difference between the two groups(P>0.05).② After 4 weeks of treatment,the QOL score of the two groups decreased,the differences in both groups were statistically significant(P<0.01 in the experimental group,P<0.05 in the control group),and there was no statistical difference between the two groups(P>0.05).The TCM syndrome score of the two groups decreased,the differences in the two groups were statistically significant(P<0.01 in the experimental group,P<0.01 in the control group),and the difference between the two groups was statistically significant(P<0.05).③ After 4 weeks of treatment,there was no significant difference in residual urine volume in both groups compared with the baseline,and there was no significant difference between the two groups(P>0.05).There was significant difference in the number of nocturia in both groups compared with the baseline(P<0.05 in the test group,P<0.05 in the control group),and there was no significant difference between the two groups(P>0.05).Safety evaluation:after 4 weeks of treatment,the indicators,ALT、AST、Scr、BUN,of all patients were all in normal range.A total of 3 subjects reported adverse events,1 case in the experimental group had dizziness,1 case in the control group had dizziness and 1 case had nausea,abdominal distention and gastrointestinal discomfort.The adverse events in both groups were mild.Conclusions1.After 4 weeks of treatment,IPSS of the two groups were all decreased.The effect of modified Tiaoqi Fuhua Decoction combined with α-1 receptor blocker was better in the experimental group.2.In the aspect of improving the peak flow rate,the combination of modified Tiaoqi Fuhua Decoction and α-1 receptor blocker is better than that of α-1 receptor blocker alone.3.The modified Tiaoqi Fuhua Decoction combined with α-1 receptor blocker can significantly reduce the TCM syndrome score,relieve the symptoms of dysuria,frequency of urination,urgency of urination,fatigue,shortness of breath,abdominal feeling of falling down,mental fatigue and sloth,spontaneous sweating,etc.4.There was no significant difference between modified Tiaoqi Fuhua Decoction combined with α-1 receptor blocker and simple α-1 receptor blocker in improving the mean uroflow rate,QOL score,residual urine volume and times of nocturia.