Meta-analysis of Integrated Traditional Chinese and Western Medicine in Treating

Jia He ,Wen Liu ,Wei Zhang ,Li-Jin Zhang

1Zhujiang Hospitai,Southern Medical University,Guangzhou,510280,China;

2Affiliated hospital of traditional Chinese medicine,Xinjiang Medical University,Urumchi,830000,China.

Abstract Objective:The aim of this study was to compare the clinical emcacy of integration of traditional Chinese medicine (TCM) and we stern medicine,and the western medicine therapy for H type hypertension.Methods:The randomized contmlled trials were collected via searching the internet.The literatures were screened according to inclusion and exclusion criteria.All the assignments were performed by two researchers.If there was disagreement between the two researchers,we would ask evidence based medicine expert for advice,to get an optimal result.The database included the ChianInfo (1978—2015),the Superstar database (1955—2017),the CBM(1985—2017),CNKI(1984—2017),PubMed(1966—2017).Accordingto Meta analysis,the RevMan 5.2 software was used to recover and analyze the literatures,and make the assessment of the integration of TCM and westem medicine in treating H Type Hypertension.Results:In the study,12 trials were included.The total number of cases is 1139.The Meta analysis results showed that:Compared with western medicine the integration of TCM and western medicine would improve the antihypertensive efficacy [OR=0.39,95%CI (0.25,0.59),Z=4.38(P＜ 0.0001)],lower Hcy levels [WMD=-1.93,95%CI (-2.27,0.21),Z=4.38 (P＜ 0.0001)].Conclusion:The combination therapy can effectively reduce Hcy levels,control blood pressure,better than Western medicine.

Keywords:H Type Hypertension;integrated traditional chinese and western medicine;systematic review of clinical efficacy;Meta analysis

Introduction

H Type Hypertension is a special type of essential hypertension characterized by elevated plasma homocysteine levels.At present,the clinical treatment of H Type Hypertension is mainly ACEI,calcium antagonist and folic acid or vitamin B group compound preparations[1-2]However,it is still controversial whether the regulation of blood Hcy level through folic acid supplementation and vitamin B group can effectively reduce the incidence of cardiovascular joint endpoint events and all-cause mortality.Clinical reports that Chinese medicine has a good effect on the treatment of H-type hypertension.It can give full play to the advantages of Chinese medicine in the treatment of hypertension,significantly improve the symptoms of patients and protect target organs,but lacks evidencebased evidence.

In this paper,through collection a randomized controlled trial on the comparison of curative effect between combined treatment of traditional Chinese and Western medicine and that of simple Western medicine,Meta analysis method is used to integrate and analyze the experimental research data and make systematic evaluation.From the perspective of evidence-based medicine,the curative effect of combined Chinese and Western medicine on H Type Hypertension was further verified.

1 Information and Methods

1.1 Inclusion and exclusion criteria

1.1.1 Research Design

Clinical randomized controlled trials or randomized trials of combined traditional Chinese and Western medicine in the treatment of H hypertension,whether blind or not.

1.1.2 Observation object conforms to H Type Hypertension diagnosis,ie,systolic pressure≥140mmHg,and (or) diastolic pressure≥ 90mmHg,diagnosis of essential Hypertension patients with plasma Hcy≥ 10.0 umol/ L.

1.1.3 Intervention study

The treatment group was treated with oral combined Chinese and Western medicine;The control group was treated with oral Western medicine.

1.1.4 Efficacy evaluation indicators

Comparison of Changes of various indexes before and after treatment,the changes of indexes,lower blood pressure effect,Hcy level of blood in treatment group and control group.

1.1.5 Exclusion criteria

(1) Poor quality of documentation Jadad Documents with a score of 0.(2) No control group was established in the literature,The control group did not use Inapril treat instead of other treatment options.(3)The literature of Repeated publication or Unknown data.(4) Literature whose results are inconsistent with the indicators and the data is incomplete and cannot be used.(5) Research type literature such as Experimental research,case reports,experience summaries,theoretical discussions,reviews,abstracts,etc.(6) Literature on other interventions such as drug combination acupuncture and moxibustion.(7) Studies on the Elimination of Combined Diabetes,Metabolic Syndrome and Severe Heart,Brain and Kidney Complications.(8) Animal Experimental Research.

1.2 Documentation retrieval

The research data are derived from the randomized controlled trial of Chinese medicine combined with folic acid tablets for the treatment of H Type Hypertension.Computer Retrieval of the Chinese Academic Journal Full Text Database(CNKI),China Biomedical Documentation Database(CBM),Weipu Chinese Science and Technology Journal Database(VIP),and Universal Data Knowledge Service Platform,PubMed,Web of Science.The time frame for retrieval is from databases to August 2015.Search by combination of subject words and keywords:Chinese search words are“H Type Hypertension”,“hyperhomocysteinemia”,“essential hypertension”,“Chinese medicine”,“combination of Chinese and Western medicine”.Its retrieval type is AND,A total of 141 related documents were retrieved and eventually incorporated into 12 articles,Foreign language search words are“H Hypertension”,“Hypertension”,“High homocysteine”,“Traditional Chinese Medicine”.Its retrieval type is AND.A total of 0 documents were retrieved.Requirement to be able to extract sample content,average,standard deviation,etc.

1.3 Document Screening and Data Extraction

The selection and evaluation process of the literature is independently extracted by two evaluators using the data extraction table.In case of disagreement,resolve through discussion.The main information extracted includes:Basic status of literature,basic characteristics of research subjects,experimental design characteristics,evaluation indicators,etc.Finally,cross-check,and if there is a disagreement on the evaluation of the information,the researcher will discuss or consult experts to help solve the problem.

1.4 Quality Evaluation of Admissions Study by Jadad Method

(1) Random scores:In the literature,it is described as 2 points for random and random,Random improper is 1 point,no random is 0 points.(2) Score according to blind situation:In the literature,the blind method is described as 2 points and the blind method is appropriate,Blind law is not appropriate for 1 point,and no blind law is 0 points.(3) Scores based on follow-up,withdrawal and loss of visits:The reference to followup in the literature was 1 point.2 points describing the specific circumstances of withdrawal and loss of follow-up,0 points not mentioned for follow-up.According to the above-mentioned scoring rules,the comprehensive score of the literature will be included,with less than 3 points for low quality research and 3 and 3 points for high quality research.

1.5 Statistical methods

Comprehensive extraction of various data and information into the literature,Meta-analysis of data using RevMan 5.2 software.According to the type of literature data,choose different statistical methods of efficacy analysis:The relative ratios 0r and 95% ci were selected for data analysis.Selection of weighted mean difference (WMD) and 95% CI for data analysis.Clinical Heterogeneity Test for Inclusive Studies.Inspection level a=0.05.The chisquare test was used.If the heterogeneity result is P＞0.1,there is homogeneity between multiple studies,so the fixed-effect model can be used for analysis.If the heterogeneity result is P less than or equal to 0.1,there is heterogeneity between multiple studies,and random effect model can be used for analysis.I2value was used to determine the heterogeneity.With I2=25%,I2=50%,and I2=75% as boundaries,heterogeneity was divided into low,medium,and high.When I2is more than 50%,random effect model analysis is adopted and literature is grouped for analysis.Taking the sample size as the longitudinal axis and the effect amount as the transverse axis,the funnel graph is drawn.According to the distribution of the funnel graph,the publication bias is judged.

2 Results

2.1 Literature screening process

Input search terms by means of computer retrieval,141 literatures were retrieved,Reading Document Title,abstract,concrete content,According to inclusion criteria,A total of 47 papers were screened for the first time,and the contents of the papers were carefully read,According to exclusion criteria,35 articles were excluded and 12 articles were included,including 1139 patients.The f low chart is shown in Figure 1.

2.2 Basic Situation and Quality Assessment Included in Research Documents

A Authors of literature collection,publishing age,number of observers in each group,specific interventions,Jadad Score Integrates Literature Characteristics.The basic data are shown in table 1,and the literature quality evaluation included in the study is shown in table 2.

2.3 Meta analysis results

Antihypertensive efficacy was reported in 9 literatures,a total of 709 patients were included,Heterogeneity test P=0.009,I²=65%,P ＜ 0.1,the homogeneity between the studies is poor,there is heterogeneity,so the random effect model is adopted,The combined dose [OR=0.39,95%ci (0.25,0.59),Z=4.38 (P ＜ 0.0001)]showed better antihypertensive efficacy in the treatment group than in the control group,As shown in figure 2.Funnel plot analysis showed that there was a certain publication bias,as shown in figure 3.

Eleven literatures reported the degree of reduction of HCY level,a total of 1073 cases were included.Heterogeneity test P ＜ 0.00001,I²=95%,P＜ 0.1.The degree of heterogeneity exists among the studies,so the random effect model is adopted.Volume of consolidation [WMD=-1.93,95%CI,(2.27,0.21),Z=4.38,(P＜0.0001)].In terms of reducing the efficacy of HCY,the treatment group had better antihypertensive effect than the control group,see Figure 4.Funnel diagram is symmetrical,suggesting no publication bias,see Figure 5.

Figure 1.Flow chart in screening RCTs

Table 2.Jadad score of literature included in the study

Figure 2.buck Meta-analysis of the total effciency of forest plot

4 Discuss

This paper adopts Jadad quality score method to evaluate the quality of adopted literature.The results showed that the quality of RCT report of combined treatment of traditional Chinese and western medicine for H Type Hypertension was not satisfactory.RCT should be standardized randomization,random allocation scheme hiding,blind method,Randomization is the selection of appropriate random methods,such as random number table method,Hiding randomly assigned sequences helps avoid selective bias.Subjects,researchers,and implementers of interventions will be blinded to avoid bias and measurement.However,there were 12 studies included in this study,and the quality of the literature was not high,only 4 of them had a Jadad score of 3 points,and the strength of argument was limited.Only 4 studies [6,7,9,10]mentioned the use of random number table method,and did not specify the specific random allocation method and the hiding of allocation scheme.Only 1 experiment implemented the single-blind method,and the rest did not mention.

Figure 3. Publish biased funnel charts

Figure 4.lower Hcy levels Meta forest plot

Figure 5.Publish biased funnel charts

Funnel plot analysis was conducted on the anti hypertensive efficacy of the included studies,and the results showed that the distribution was relatively dispersed,indicating that there was a certain publication bias in the included studies.Meta analysis results of clinical efficacy showed that OR is 0.39,and 95%CI is 0.25,0.59),which can be considered that traditional Chinese medicine combined with western medicine is more effective than western medicine alone in the treatment of H Type Hypertension.Funnel plot analysis of the included studies showed that the distribution was basically symmetrical,indicating that there was no publication bias in the included studies.Meta analysis results of clinical efficacy in reducing HCY level showed that After treatment,the combined effect volume WMD of HCY was -1.93umol/L,and 95% CI of the combined effect volume was (-2.27,0.21) umol/L,with statistically significant difference.Amlodipine besylate combined with folic acid tablets can effectively lower blood pressure while lowering Hcy levels,but there is still room for improvement in clinical symptoms[17];Modified Wendan Decoction combined with amlodipine besylate tablets and folic acid tablets for the treatment of H-type hypertension with high safety and safety[18].Modified Wendan Decoction Combined with Amlodipine Besylate and Folic Acid for Hypertension

Clinical observation of the effect of phlegm and dampness[19];The results indicated that compared with the treatment with western medicine alone,the HCY of patients with H Type Hypertension was decreased more by the combination of traditional Chinese medicine and western medicine,indicating that the effect of the combination of traditional Chinese medicine and western medicine on the treatment of H Type Hypertension was better than that of conventional anti hypertensive drugs.

This study is insufficient:1.The risk of methodological bias included in the study was high:The only sign that most studies can identify as randomized controlled trials is the mention of "randomized grouping".2.The included literatures are characterized by TCM syndrome differentiation for treatment and the addition and subtraction of prescriptions with syndrome,The specific prescription,dose and course of treatment are also different in each study,which leads to greater clinical heterogeneity.3.Most nano-human studies will be the effective rate of hypotension as a clinical efficacy index,However,different studies use different criteria for the evaluation of efficacy,the criteria are not consistent,will produce a certain degree of bias.4.From the current literature review,it is found that the treatment of H Type Hypertension by traditional Chinese medicine should follow the treatment based on syndrome differentiation of traditional Chinese medicine,which is dialectical and accurate,with obvious effect of syndrome application and no need to stick to a single prescription.However,at present,the literature reports on the etiology and pathogenesis of H Type Hypertension by traditional Chinese medicine are limited,and the syndrome type is not unified,which needs to be further standardized.

To sum up,Compared with western medicine alone,traditional Chinese medicine combined with western medicine in the treatment of patients with H Type Hypertension has a better clinical antihypertensive effect and can lower HCY level more effectively,which is suitable for clinical promotion.The Meta analysis into the research of effect indexes except this article analysis the index and blood lipid,blood pressure variability,carotid artery plaque,adverse reactions and so on,and reported less,is not conducive to analysis,therefore also need more than one center,large sample and double blind randomized controlled trials,and focus on the long-term curative effect,at the same time to the study of combining traditional Chinese and western medicine treatment of H Type Hypertension observation of curative effect more indicators,again for the future analysis of Chinese and western medicine combined treatment H provides the basis for high blood pressure.