| ObjectiveThis study was divided into two parts.The first part of the study was to evaluate the efficacy and safety of Chinese herbal medicine in the treatment of primary hypertension in resent 10years and the second part of the study was to observe the efficacy and safety of Songlingxuemaikang(SLXMK)capsule in the treatment of primary hypertension(grade 1)with hyperactivity of liver yang.Method1.CNKI,CBM,VIP,wanfang,ChicTR,Embase,MEDLINE,ClinicalTrials,Web of Science,Cochrane Library were searched.All randomized controlled trial of Chinese herbal medicine in the treatment of essential hypertension were collect.According to Cochrane handbook 5.1,two reviewers independently did the literature selection,data extraction and quality evaluation.Revman5.3 software was used to do data analysis.2.This was a double-blind,double dummy,positive parallel,randomized clinic trail.60 patients,diagnosed as grade 1 of primary hypertension(hyperactivity of liver Yang),were randomly divided into the treatment group and the positive control group according the ratio of 1:1.The treatment group was treated with SLXMK capsule + losartan potassium tablets placebo and the positive control group was treated with losartan potassium tablets + SLXMK capsule placebo for 8 weeks.At the baseline,4th week and 8th week,the blood pressure and hypertension symptom score and TCM syndrome scale were compared in group and groups.At the 4th week and 8th week,blood pressure compliance rate was observed.If P<0.01,the difference between two group was statistically significant.The blood,urine routine,liver function(ALT,AST),renal function(BUN,Cr,UA)were detected before and after the intervention.Adverse reactions and adverse events were recorded at any time during the study.Result1.Meta-analysis of efficacy and safety of randomized controlled trial of traditional Chinese medicine in the treatment of essential hypertensionAccording to the inclusion and exclusion criteria,24 articles were selected from 23311 articles published on the database from January 2007 to March 2017,involving 4502 patients with primary hypertension,2292 patients in the experimental group and 2210 patients in the control group,were included.the overall quality of clinical research was not high.The Chinese medicine combined with western medicine group had advantages over western medicine group in the aspects of anti-hypertensive effect,effect of TCM syndrome,increasing the level of NO,reducing the level of ET-1,improving some indicators of BVP and 24hBP in the comparison.Chinese medicine group had no significant difference compared with the western medicine group in antihypertensive effect,but in reducing clinic blood pressure was better than the western medicine group;the Chinese medicine combined with western medicine group had no significant difference compared with the Chinese medicine placebo with western medicine group in antihypertensive effect,increasing the level of NO,clinic blood pressure and 24Hbp,but had advantages over western medicine group in the effect of TCM syndromes,and reducing the level of ET-1.The manual evaluation bias risk assessment tools in Cochrane Handbook 5.1.0 and improved Jadad scale results showed most trials had low methodological quality,affecting the authenticity of the results of Meta-analysis and conclusion,so the results should be treated with caution,and its results need designed rigorous,high quality,multi-center clinical trials to further verify and support.2.Preliminary clinical observation of SLXMK capsule in the treatment of essential hypertension(grade 1)randomized,controlled trail60 patients,including 30 cases in the treatment group,30 cases in the control group in was selected in the study.1 patients in the control group was unwilling to participate in the test because of his busy work,the other 59 patients actually completed the trail.The age,gender,height,body weight,body mass index,education level,smoking,smoking duration,alcohol consumption,duration of disease,duration of disease,baseline blood pressure,hypertension symptom score,TCM symptom score were balanced and comparable(p>0.05).(1)Compared with the baseline,systolic and diastolic blood pressure of each group decreased significantly at the time points of the 4th week and 8th week(p<0.01);there was no difference between the two groups on anti-hypertensive effect and improvement amplitude the of clinic blood pressure(p>0.05).(2)There was no significant difference in the standard rate of systolic blood pressure between the two groups and the diastolic blood pressure of the two groups was up to standard at the time point of the 4th week.At the time point of the 4th week,the systolic blood pressure of the two groups was up to standard,but in the standard rate of diastolic blood pressure,the control group was 79.31%,the test group was 76.67%,via chi-square test,there was no difference between the two groups,that was no difference between the test group and control group(p>0.05).(3)Compared with the baseline,hypertension symptom score and TCM symptom score of each group at the time point of the 4th week and 8th week decreased significantly(p<0.01);at the time point of the 4th week and 8th week,as for hypertension symptom score and TCM symptom score and their improvement amplitude,there was no difference between the treatment group and control group(p>0.05).(4)Through the examination of the blood and urine routine,liver function,kidney function before and after medication,the test group and control group had lpatients with high Transaminase,but there was no clinical significance in the clinic practice.1 case of high uric acid in the test group was related to diet.In the control group 1 case showed abdominal pain and automatically alleviated with treatment;1 case of the test group appeared a cold and discovered with some medicine.No adverse reaction occurred in both groups.Conclusion1.The current literature research evidence suggests that traditional Chinese medicine in the treatment of primary hypertension had to a certain extent,that can be used as a supplementary treatment of anti-hypertensive drugs.Most research had low methodological quality which affected the authenticity of the results of Meta-analysis and conclusion.There for,high quality,multicenter,large sample randomized double-blind controlled trial is still expected to increase the evidence strength.2.SLXMK capsule for hyperactivity of liver yang hypertension patients,could reduce blood pressure,improve the clinical symptoms(hypertension symptoms,TCM syndrome of hyperactivity of liver Yang symptoms),with less adverse reactions.Due to time and not yet completing the overall unblinded,only part of the outcomes were unblinded,so this study only on the data collection center is currently relatively intact in a preliminary analysis,the final results of the research is still in the large sample,multi-center trial. |
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