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Tianma Gouteng decoction for essential hypertension

Tianma Gouteng decoction for essential hypertension Background: Essential hypertension is one of the most common chronic diseases, as well as one of the leading risk factors for cardio-cerebrovascular diseases. Tianma Gouteng decoction has been commonly used in clinical practice for patients with essential hypertension. It is important to update the search and evaluation to provide the best available evidence for essential hypertension. Here, we provide a protocol to evaluate the efficacy and safety of Tianma Gouteng decoction (TGD) for essential hypertension. Methods: Retrieve literature on the TGD treatment for essential hypertension in the databases including PubMed, Cochrane Library, EMBASE, Chinese Biomedical database (CBM), Chinese National Knowledge Infrastructure (CNKI), Wanfang database, and Chinese Science and Technology Periodical database (VIP) on computer. The literature to be collected will be those published from the time when the respective databases were established to January 2018. The therapeutic effects according to the blood pressure (BP) will be accepted as the primary outcomes. We will use RevMan V.5.3 software as well to compute the data synthesis carefully when a meta-analysis is allowed. Results: This study will provide a high-quality synthesis of current evidence of TGD for essential hypertension from several aspects including BP, life quality, heart rate, and adverse events. Conclusion: The conclusion of our systematic review will provide evidence to judge whether TGD is an effective intervention for patient with essential hypertension. PROSPERO registration number: PROSPERO CRD 42018082319. Abbreviations: ACEI = angiotensin-converting enzyme inhibitors, ARBs = angiotensin II receptor blockers, CAM = complementary and alternative medicine, CI = confidence interval, MD = mean difference, RCTs = randomized controlled trials, TCM = traditional Chinese medicine, TGD = Tianma Gouteng decoction. Keywords: essential hypertension, protocol, systematic review, Tianma Gouteng decoction BC and YW contributed equally to this work and are co-first authors. 1. Introduction PX and XY are the guarantor of the article. The manuscript was drafted by BC and YW. ZH and DW developed the search strategy. BC and YW will Essential hypertension is defined as high blood pressure that no independently screen the potential studies and extract data. ZH and DW will secondary cause has been found and the patients diagnosed with assess the risk of bias and finish data synthesis. XY will arbitrate any the disease have systolic pressure >140mmHg, or diastolic disagreement and ensure that no errors occur during the review. All review [1] pressure >90mmHg. Hypertension is one of the most common authors critically reviewed, revised, and approved the subsequent and final version of the protocol. chronic diseases, as well as one of the leading risk factors for [2] This work is supported by Natural Science Foundation of Guangdong Province cardio-cerebrovascular diseases. Their major complications (No. 2015A030313368 to DW), Guangzhou Municipal Science and Technology include stroke, myocardial infarction, heart failure, and chronic Program (No. 201607010337 to XY), and The High-Level Key Disciplines Project of kidney disease, which not only result in high disability and Guangzhou University of Chinese Medicine (No. A1-AFD018171Z11089 to DW). fatality rate but need great healthcare and social resources input, The funders had no role in the design, execution, or writing of the study. a heavy burden for both the families and national healthcare [3,4] The authors have no conflicts of interest to disclose. system. It is estimated that 1 billion people have high blood Supplemental Digital Content is available for this article. pressure worldwide, and about 7.1 million deaths are linked to a [5] The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, the disease every year. High blood pressure is becoming Guangdong Provincial Hospital of Chinese Medicine, The Second Clinical increasingly common due to prolonged life expectancy, wide- College of Guangzhou University of Chinese Medicine, Guangzhou, China. [6] spread obesity, reduced physical activity, and unhealthy diets. Correspondence: Pingchang Xie and Xia Yan, Department of Emergency, Complementary and alternative medicine (CAM) is the term for Guangdong Provincial Hospital of Chinese Medicine, No.111, Dade Road, health therapies and medical products that have typically not been Guangzhou, China (e-mails: xiepingc@163.com; 3207933841@qq.com). [7] part of conventional medicine and treatments. They may lack a Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc. medical explanation and support, however, part of CAM therapies This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and (physical therapy, diet, acupuncture, and traditional Chinese medicine [8] reproduction in any medium, provided the original work is properly cited. [TCM]) are widely accepted. Today, more patients with cardiovas- Medicine (2018) 97:8(e9972) cular disease adopt CAM treatment. TCM is one of the most Received: 30 January 2018 / Accepted: 31 January 2018 important parts of CAM, and many studies have shown that Chinese [9–11] herbal medicine or acupuncture may help controlblood pressure. http://dx.doi.org/10.1097/MD.0000000000009972 1 Chen et al. Medicine (2018) 97:8 Medicine Tianma Gouteng decoction (TGD), a TCM compound, is will be reviewed one by one to avoid omission. TGD and essential composed of 11 commonly used herbs (Uncaria, Gastrodia elata, hypertension will be the search terms. The search strategy of Scutellaria baicalensis Georgi, Eucommia ulmoides Oliv, achyr- PubMed will be shown in Appendix A, http://links.lww.com/ anthes root, Loranthus parasiticus, abalone shell, Gardenia, MD/C146 as an example, and similar strategies will be applied to Leonurus japonicus, caulis polygoni multiflori, and Poria cocos), other databases. all of which are standardly recorded in Chinese Pharmacopoeia 2.2.2. Searching other resources. In the meantime, the 2015 edition. It has been used widely in recent decades in China relevant studies published on journals, along with their to clinically treat symptoms caused by high blood pressure, such [12] references, will be manually reviewed and retrieved as the as dizziness and headache, etc. A new animal study shows that supplementary literature, http://links.lww.com/MD/C146. TGD could alleviate cognitive dysfunction in rats with hypertension, which was possibly by inducing alteration of glucose metabolism in different brain regions with corresponding 2.3. Data collection and analysis [13] 2.3.1. Selection of studies. Two researchers will independently functions. [12] conduct and cross-check the literature screening. In case of Although only 1 systematic review on the TGD treatment disagreement, they shall discuss with each other to come up with for essential hypertension was published 5 years ago, there has a solution or consult another research member. As for the been many high quality randomized controlled clinical studies [14,15] information unavailable, the reviewers shall contact the author of published in recent years. Therefore, it is important to the original paper. They will read the titles of the references first update the search and evaluation to provide the best available to exclude the literature that are obviously irrelevant, and then evidence for essential hypertension. Our systematic review and read the abstract and full text to determine whether the studies meta-analysis will answer 2 clinical questions about the TGD would be finally included. The process of studies selection is treatment for the disease: whether TGD is significantly more presented in a Preferred Reporting Items for Systematic Review effective and safer than the traditional antihypertensive drugs or and Meta-analysis (PRISMA) flow diagram (Fig. 1). placeboes; whether the conventional blood pressure medication assisted by TGD is more effective and safer than using the 2.3.2. Data collection and management. Two researchers will conventional drugs alone. retrieve the following data independently according to the data collection table designed beforehand: information about the 2. Methods included trials, such as research topic, first author, which journal and when it was published etc., research design and key elements 2.1. Inclusion criteria for study selection of quality evaluation, information about the patients in the 2.1.1. Types of studies. All randomized controlled trials treatment and control group, including how many cases are (RCTs) in both Chinese and English will be included in the included and the ages of patients, etc., outcome indicators, research, regardless of whether blinding or allocation conceal- relevant indicators of bias risk assessment. ment was adopted. 2.3.3. Assessment of risk of bias in included studies. Two 2.1.2. Types of patients. The objects of the study will be evaluators will assess the risks of the included literature using the patients clinically diagnosed with essential hypertension, who tool provided by Cochrane Handbook for Systematic Reviews of have systolic pressure >140mmHg and/or diastolic pressure Interventions V.5.1.0. The tool includes 7 parts, that is, random >90mmHg or take antihypertensive drugs. sequence generation, allocation concealment, blinding method 2.1.3. Types of interventions. The experimental group used for patients, researchers and outcomes assessors, incomplete TGD or combined with other conventional antihypertensive result data, and selective reports. The evaluation results will be drugs, the control group of drugs for conventional antihyperten- divided into 3 levels, namely, low-risk, unclear, and high-risk. sive drugs or placebo. They will cross-check the evaluation and data retrieval. Where there are inconsistencies, the problem will be resolved through 2.1.4. Types of outcome measures group discussion, or decided by another researcher. 2.1.4.1. Primary outcomes. The primary outcome measure was blood pressure. 2.3.4. Measures of treatment effect. The study will employ RevMan 5.3 (Version 5.3, Copenhagen: The Nordic Cochrane 2.1.4.2. Secondary outcomes. Center, The Cochrane Collaboration, 2014) to conduct meta- analysis. The rate ratio will be used to indicate the enumeration Life quality data while the mean difference (MD) the measurement data. A Heart rate 95% confidence interval (CI) will be adopted to present the effect Adverse events sizes. 2.3.5. Dealing with missing data. If the required data are not 2.2. Search methods for the identification of studies clear or not reported in clinical papers, the reviewers will collect 2.2.1. Electronic searches. Retrieve literature on the TGD the missing data with the data collection table by contacting the first treatment for essential hypertension in the databases including or corresponding author of the studies via phone, e-mail, or mail. PubMed, Cochrane Library, EMBASE, Chinese Biomedical database (CBM), Chinese National Knowledge Infrastructure 2.3.6. Assessment of heterogeneity. The heterogeneity of the (CNKI), Wanfang database, and Chinese Science and Technolo- results of the included studies will be analyzed through chi- gy Periodical database (VIP) on computer. The literature to be squared test (a=0.1), with its value determined by I . The collected will be those published from the time when the heterogeneity among the trials will be considered significant if I respective databases were established to January 2018. All is >50%, and further subgroup analysis will be carried out to references that can meet the inclusion requirements of the study investigate the potential causes. 2 Chen et al. Medicine (2018) 97:8 www.md-journal.com Figure 1. Flow diagram of study selection process. require an ethical board review and approval. The findings will be 2.3.7. Assessment of reporting bias. The visual asymmetry on published in a peer-reviewed journal and disseminated in conference a funnel plot will be used to judge whether a publication bias presentations. It will provide the latest analysis of the currently exists if at least 10 trials are included in the study. available evidence for TGD treating essential hypertension. 2.3.8. Data synthesis. The meta-analysis will be performed using the fixed effects model if no statistic heterogeneity among 3. Discussion the results of the study is found. On the other hand, the random Currently, the first-line drugs used in the treatment of essential effect model will be employed to carry out the analysis with the hypertension include thiazide diuretics, long-acting calcium effect of the obvious clinical heterogeneity excluded if there is a channel blockers, angiotensin-converting enzyme inhibitors statistical heterogeneity. When obvious clinical heterogeneity is [16] (ACEI), and angiotensin II receptor blockers (ARBs). observed, the researchers can turn to the subgroup or sensitivity However, long-term use of these drugs can bring certain side analysis, or only descriptive analysis. a=0.05 is used to evaluate effects to patients, such as headache, facial flush, and other the meta-analysis. symptoms. TGD may be an alternative to effectively treat 2.3.9. Subgroup analysis. Subgroup analysis will be performed essential hypertension with less side effects. Whereas the efficacy based on different interventions, controls, and outcome mea- and safety of TGD in treating essential hypertension are sures. Adverse effects will be assessed and tabulated with uncertain. Therefore, it is necessary to conduct a high quality descriptive techniques. systematic review and meta-analysis, in which our rigorous approach will provide objective evidence for TGD treatment for 2.3.10. Sensitivity analysis. If P value of the heterogeneity is essential hypertension. The process of performing this systematic <.1 when the data extraction is examined, and subgroup analysis review, shown in Fig. 2, will be separated into 4 parts: performed, the meta-analysis will be reconducted with the low- identification of studies, selection of studies, data extraction quality studies ruled out. and management, and data analysis. Nevertheless, the study may 2.3.11. Ethics and dissemination. The outcomes of this have some limitations. First, only the literature in Chinese and systematic review will offer implications of the use of TGD English will be searched, which may lead to language bias. treatment for essential hypertension patients. It uses aggregated Second, the different doses of TGD adopted in the interventions published data instead of individual patient data and does not of the included studies may lead to significant heterogeneity. 3 Chen et al. Medicine (2018) 97:8 Medicine Figure 2. Flow diagram of the systematic review and meta-analysis. [8] Barnes PM, Bloom B, Nahin RL. National Center for Health Statistics (U. Preferred Reporting Items for Systematic review and Meta- S.)Complementary and Alternative Medicine Use Among Adults and Analysis Protocols (PRISMA-P) checklist of this protocol is Children: United States, 2007. Dept. of Health and Human Services, presentedin onlinesupplementary, http://links.lww.com/MD/C146. Centers for Disease Control and Prevention, National Center for Health Statistics, Hyattsville, MD:2008. [9] Kalish LA, Buczynski B, Connell P, et al. Stop hypertension with the References acupuncture research program (SHARP): clinical trial design and screening results. Control Clin Trials 2004;25:76–103. [1] Mancia G, Fagard R, Narkiewicz K, et al. 2013 ESH/ESC guidelines for [10] Macklin EA, Wayne PM, Kalish LA, et al. Stop hypertension with the the management of arterial hypertension: the Task Force for the acupuncture research program (SHARP): results of a randomized, Management of Arterial Hypertension of the European Society of controlled clinical trial. Hypertension 2006;48:838–45. Hypertension (ESH) and of the European Society of Cardiology (ESC). [11] Wang J, Xiong X. Control strategy on hypertension in chinese medicine. Eur Heart J 2013;34:2159–219. Evid Based Complement Alternat Med 2012;2012:284847. [2] Haspula D, Clark MA. Neuroinflammation and sympathetic overactivi- [12] Wang J, Feng B, Yang X, et al. Tianma gouteng yin as adjunctive treatment ty: mechanisms and implications in hypertension. Auton Neurosci 2018; pii: S1566-0702(17)30250-3. doi: 10.1016/j.autneu. 2018.01.002. for essential hypertension: a systematic review of randomized controlled [3] Hajjar I, Kotchen TA. Trends in prevalence, awareness, treatment, and trials. Evid Based Complement Alternat Med 2013;2013:706125. control of hypertension in the United States, 1988–2000. JAMA [13] Zhang XJ, Sun TC, Liu ZW, et al. Effects of Tianmagouteng particles on 2003;290:199–206. brain cognitive function in spontaneously hypertensive rats with [4] Zhang Y, Moran AE. Trends in the prevalence, awareness, treatment, hyperactivity of liver-yang: A [F-18] FDG micro-PET imaging study. and control of hypertension among young adults in the United States, Biomed Pharmacother 2017;95:1838–43. 1999 to 2014. Hypertension 2017;70:736–42. [14] Wei H. Effect of tianma gouteng decoction on blood pressure and [5] Geleijnse JM, Kok FJ, Grobbee DE. Blood pressure response to changes vascular endothelial function of liver yang syndrone hypertension. in sodium and potassium intake: a metaregression analysis of J Hubei Univ Tradit Chin Med 2017;19:37–9. randomised trials. J Hum Hypertens 2003;17:471–80. [15] Yang PR, Shih WT, Chu YH, et al. Frequency and co-prescription [6] Singh RB, Suh IL, Singh VP, et al. Hypertension and stroke in Asia: pattern of Chinese herbal products for hypertension in Taiwan: a Cohort prevalence, control and strategies in developing countries for prevention. study. BMC Complement Altern Med 2015;15:163. J Hum Hypertens 2000;14:749–63. [16] Carey RM, Whelton PK. Committee AAHGWPrevention, detection, [7] Bishop FL, Yardley L, Lewith GT. Why consumers maintain evaluation, and management of high blood pressure in adults: synopsis of complementary and alternative medicine use: a qualitative study. the 2017 American College of Cardiology/American Heart Association J Altern Complem Med 2010;16:175–82. Hypertension Guideline. Ann Intern Med 2018. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Medicine Wolters Kluwer Health

Tianma Gouteng decoction for essential hypertension

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Wolters Kluwer Health
Copyright
Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc.
ISSN
0025-7974
eISSN
1536-5964
DOI
10.1097/MD.0000000000009972
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29465596
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Abstract

Background: Essential hypertension is one of the most common chronic diseases, as well as one of the leading risk factors for cardio-cerebrovascular diseases. Tianma Gouteng decoction has been commonly used in clinical practice for patients with essential hypertension. It is important to update the search and evaluation to provide the best available evidence for essential hypertension. Here, we provide a protocol to evaluate the efficacy and safety of Tianma Gouteng decoction (TGD) for essential hypertension. Methods: Retrieve literature on the TGD treatment for essential hypertension in the databases including PubMed, Cochrane Library, EMBASE, Chinese Biomedical database (CBM), Chinese National Knowledge Infrastructure (CNKI), Wanfang database, and Chinese Science and Technology Periodical database (VIP) on computer. The literature to be collected will be those published from the time when the respective databases were established to January 2018. The therapeutic effects according to the blood pressure (BP) will be accepted as the primary outcomes. We will use RevMan V.5.3 software as well to compute the data synthesis carefully when a meta-analysis is allowed. Results: This study will provide a high-quality synthesis of current evidence of TGD for essential hypertension from several aspects including BP, life quality, heart rate, and adverse events. Conclusion: The conclusion of our systematic review will provide evidence to judge whether TGD is an effective intervention for patient with essential hypertension. PROSPERO registration number: PROSPERO CRD 42018082319. Abbreviations: ACEI = angiotensin-converting enzyme inhibitors, ARBs = angiotensin II receptor blockers, CAM = complementary and alternative medicine, CI = confidence interval, MD = mean difference, RCTs = randomized controlled trials, TCM = traditional Chinese medicine, TGD = Tianma Gouteng decoction. Keywords: essential hypertension, protocol, systematic review, Tianma Gouteng decoction BC and YW contributed equally to this work and are co-first authors. 1. Introduction PX and XY are the guarantor of the article. The manuscript was drafted by BC and YW. ZH and DW developed the search strategy. BC and YW will Essential hypertension is defined as high blood pressure that no independently screen the potential studies and extract data. ZH and DW will secondary cause has been found and the patients diagnosed with assess the risk of bias and finish data synthesis. XY will arbitrate any the disease have systolic pressure >140mmHg, or diastolic disagreement and ensure that no errors occur during the review. All review [1] pressure >90mmHg. Hypertension is one of the most common authors critically reviewed, revised, and approved the subsequent and final version of the protocol. chronic diseases, as well as one of the leading risk factors for [2] This work is supported by Natural Science Foundation of Guangdong Province cardio-cerebrovascular diseases. Their major complications (No. 2015A030313368 to DW), Guangzhou Municipal Science and Technology include stroke, myocardial infarction, heart failure, and chronic Program (No. 201607010337 to XY), and The High-Level Key Disciplines Project of kidney disease, which not only result in high disability and Guangzhou University of Chinese Medicine (No. A1-AFD018171Z11089 to DW). fatality rate but need great healthcare and social resources input, The funders had no role in the design, execution, or writing of the study. a heavy burden for both the families and national healthcare [3,4] The authors have no conflicts of interest to disclose. system. It is estimated that 1 billion people have high blood Supplemental Digital Content is available for this article. pressure worldwide, and about 7.1 million deaths are linked to a [5] The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, the disease every year. High blood pressure is becoming Guangdong Provincial Hospital of Chinese Medicine, The Second Clinical increasingly common due to prolonged life expectancy, wide- College of Guangzhou University of Chinese Medicine, Guangzhou, China. [6] spread obesity, reduced physical activity, and unhealthy diets. Correspondence: Pingchang Xie and Xia Yan, Department of Emergency, Complementary and alternative medicine (CAM) is the term for Guangdong Provincial Hospital of Chinese Medicine, No.111, Dade Road, health therapies and medical products that have typically not been Guangzhou, China (e-mails: xiepingc@163.com; 3207933841@qq.com). [7] part of conventional medicine and treatments. They may lack a Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc. medical explanation and support, however, part of CAM therapies This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and (physical therapy, diet, acupuncture, and traditional Chinese medicine [8] reproduction in any medium, provided the original work is properly cited. [TCM]) are widely accepted. Today, more patients with cardiovas- Medicine (2018) 97:8(e9972) cular disease adopt CAM treatment. TCM is one of the most Received: 30 January 2018 / Accepted: 31 January 2018 important parts of CAM, and many studies have shown that Chinese [9–11] herbal medicine or acupuncture may help controlblood pressure. http://dx.doi.org/10.1097/MD.0000000000009972 1 Chen et al. Medicine (2018) 97:8 Medicine Tianma Gouteng decoction (TGD), a TCM compound, is will be reviewed one by one to avoid omission. TGD and essential composed of 11 commonly used herbs (Uncaria, Gastrodia elata, hypertension will be the search terms. The search strategy of Scutellaria baicalensis Georgi, Eucommia ulmoides Oliv, achyr- PubMed will be shown in Appendix A, http://links.lww.com/ anthes root, Loranthus parasiticus, abalone shell, Gardenia, MD/C146 as an example, and similar strategies will be applied to Leonurus japonicus, caulis polygoni multiflori, and Poria cocos), other databases. all of which are standardly recorded in Chinese Pharmacopoeia 2.2.2. Searching other resources. In the meantime, the 2015 edition. It has been used widely in recent decades in China relevant studies published on journals, along with their to clinically treat symptoms caused by high blood pressure, such [12] references, will be manually reviewed and retrieved as the as dizziness and headache, etc. A new animal study shows that supplementary literature, http://links.lww.com/MD/C146. TGD could alleviate cognitive dysfunction in rats with hypertension, which was possibly by inducing alteration of glucose metabolism in different brain regions with corresponding 2.3. Data collection and analysis [13] 2.3.1. Selection of studies. Two researchers will independently functions. [12] conduct and cross-check the literature screening. In case of Although only 1 systematic review on the TGD treatment disagreement, they shall discuss with each other to come up with for essential hypertension was published 5 years ago, there has a solution or consult another research member. As for the been many high quality randomized controlled clinical studies [14,15] information unavailable, the reviewers shall contact the author of published in recent years. Therefore, it is important to the original paper. They will read the titles of the references first update the search and evaluation to provide the best available to exclude the literature that are obviously irrelevant, and then evidence for essential hypertension. Our systematic review and read the abstract and full text to determine whether the studies meta-analysis will answer 2 clinical questions about the TGD would be finally included. The process of studies selection is treatment for the disease: whether TGD is significantly more presented in a Preferred Reporting Items for Systematic Review effective and safer than the traditional antihypertensive drugs or and Meta-analysis (PRISMA) flow diagram (Fig. 1). placeboes; whether the conventional blood pressure medication assisted by TGD is more effective and safer than using the 2.3.2. Data collection and management. Two researchers will conventional drugs alone. retrieve the following data independently according to the data collection table designed beforehand: information about the 2. Methods included trials, such as research topic, first author, which journal and when it was published etc., research design and key elements 2.1. Inclusion criteria for study selection of quality evaluation, information about the patients in the 2.1.1. Types of studies. All randomized controlled trials treatment and control group, including how many cases are (RCTs) in both Chinese and English will be included in the included and the ages of patients, etc., outcome indicators, research, regardless of whether blinding or allocation conceal- relevant indicators of bias risk assessment. ment was adopted. 2.3.3. Assessment of risk of bias in included studies. Two 2.1.2. Types of patients. The objects of the study will be evaluators will assess the risks of the included literature using the patients clinically diagnosed with essential hypertension, who tool provided by Cochrane Handbook for Systematic Reviews of have systolic pressure >140mmHg and/or diastolic pressure Interventions V.5.1.0. The tool includes 7 parts, that is, random >90mmHg or take antihypertensive drugs. sequence generation, allocation concealment, blinding method 2.1.3. Types of interventions. The experimental group used for patients, researchers and outcomes assessors, incomplete TGD or combined with other conventional antihypertensive result data, and selective reports. The evaluation results will be drugs, the control group of drugs for conventional antihyperten- divided into 3 levels, namely, low-risk, unclear, and high-risk. sive drugs or placebo. They will cross-check the evaluation and data retrieval. Where there are inconsistencies, the problem will be resolved through 2.1.4. Types of outcome measures group discussion, or decided by another researcher. 2.1.4.1. Primary outcomes. The primary outcome measure was blood pressure. 2.3.4. Measures of treatment effect. The study will employ RevMan 5.3 (Version 5.3, Copenhagen: The Nordic Cochrane 2.1.4.2. Secondary outcomes. Center, The Cochrane Collaboration, 2014) to conduct meta- analysis. The rate ratio will be used to indicate the enumeration Life quality data while the mean difference (MD) the measurement data. A Heart rate 95% confidence interval (CI) will be adopted to present the effect Adverse events sizes. 2.3.5. Dealing with missing data. If the required data are not 2.2. Search methods for the identification of studies clear or not reported in clinical papers, the reviewers will collect 2.2.1. Electronic searches. Retrieve literature on the TGD the missing data with the data collection table by contacting the first treatment for essential hypertension in the databases including or corresponding author of the studies via phone, e-mail, or mail. PubMed, Cochrane Library, EMBASE, Chinese Biomedical database (CBM), Chinese National Knowledge Infrastructure 2.3.6. Assessment of heterogeneity. The heterogeneity of the (CNKI), Wanfang database, and Chinese Science and Technolo- results of the included studies will be analyzed through chi- gy Periodical database (VIP) on computer. The literature to be squared test (a=0.1), with its value determined by I . The collected will be those published from the time when the heterogeneity among the trials will be considered significant if I respective databases were established to January 2018. All is >50%, and further subgroup analysis will be carried out to references that can meet the inclusion requirements of the study investigate the potential causes. 2 Chen et al. Medicine (2018) 97:8 www.md-journal.com Figure 1. Flow diagram of study selection process. require an ethical board review and approval. The findings will be 2.3.7. Assessment of reporting bias. The visual asymmetry on published in a peer-reviewed journal and disseminated in conference a funnel plot will be used to judge whether a publication bias presentations. It will provide the latest analysis of the currently exists if at least 10 trials are included in the study. available evidence for TGD treating essential hypertension. 2.3.8. Data synthesis. The meta-analysis will be performed using the fixed effects model if no statistic heterogeneity among 3. Discussion the results of the study is found. On the other hand, the random Currently, the first-line drugs used in the treatment of essential effect model will be employed to carry out the analysis with the hypertension include thiazide diuretics, long-acting calcium effect of the obvious clinical heterogeneity excluded if there is a channel blockers, angiotensin-converting enzyme inhibitors statistical heterogeneity. When obvious clinical heterogeneity is [16] (ACEI), and angiotensin II receptor blockers (ARBs). observed, the researchers can turn to the subgroup or sensitivity However, long-term use of these drugs can bring certain side analysis, or only descriptive analysis. a=0.05 is used to evaluate effects to patients, such as headache, facial flush, and other the meta-analysis. symptoms. TGD may be an alternative to effectively treat 2.3.9. Subgroup analysis. Subgroup analysis will be performed essential hypertension with less side effects. Whereas the efficacy based on different interventions, controls, and outcome mea- and safety of TGD in treating essential hypertension are sures. Adverse effects will be assessed and tabulated with uncertain. Therefore, it is necessary to conduct a high quality descriptive techniques. systematic review and meta-analysis, in which our rigorous approach will provide objective evidence for TGD treatment for 2.3.10. Sensitivity analysis. If P value of the heterogeneity is essential hypertension. The process of performing this systematic <.1 when the data extraction is examined, and subgroup analysis review, shown in Fig. 2, will be separated into 4 parts: performed, the meta-analysis will be reconducted with the low- identification of studies, selection of studies, data extraction quality studies ruled out. and management, and data analysis. Nevertheless, the study may 2.3.11. Ethics and dissemination. The outcomes of this have some limitations. First, only the literature in Chinese and systematic review will offer implications of the use of TGD English will be searched, which may lead to language bias. treatment for essential hypertension patients. It uses aggregated Second, the different doses of TGD adopted in the interventions published data instead of individual patient data and does not of the included studies may lead to significant heterogeneity. 3 Chen et al. Medicine (2018) 97:8 Medicine Figure 2. Flow diagram of the systematic review and meta-analysis. [8] Barnes PM, Bloom B, Nahin RL. National Center for Health Statistics (U. Preferred Reporting Items for Systematic review and Meta- S.)Complementary and Alternative Medicine Use Among Adults and Analysis Protocols (PRISMA-P) checklist of this protocol is Children: United States, 2007. Dept. of Health and Human Services, presentedin onlinesupplementary, http://links.lww.com/MD/C146. Centers for Disease Control and Prevention, National Center for Health Statistics, Hyattsville, MD:2008. [9] Kalish LA, Buczynski B, Connell P, et al. Stop hypertension with the References acupuncture research program (SHARP): clinical trial design and screening results. Control Clin Trials 2004;25:76–103. [1] Mancia G, Fagard R, Narkiewicz K, et al. 2013 ESH/ESC guidelines for [10] Macklin EA, Wayne PM, Kalish LA, et al. Stop hypertension with the the management of arterial hypertension: the Task Force for the acupuncture research program (SHARP): results of a randomized, Management of Arterial Hypertension of the European Society of controlled clinical trial. Hypertension 2006;48:838–45. Hypertension (ESH) and of the European Society of Cardiology (ESC). [11] Wang J, Xiong X. Control strategy on hypertension in chinese medicine. Eur Heart J 2013;34:2159–219. Evid Based Complement Alternat Med 2012;2012:284847. [2] Haspula D, Clark MA. Neuroinflammation and sympathetic overactivi- [12] Wang J, Feng B, Yang X, et al. Tianma gouteng yin as adjunctive treatment ty: mechanisms and implications in hypertension. Auton Neurosci 2018; pii: S1566-0702(17)30250-3. doi: 10.1016/j.autneu. 2018.01.002. for essential hypertension: a systematic review of randomized controlled [3] Hajjar I, Kotchen TA. Trends in prevalence, awareness, treatment, and trials. Evid Based Complement Alternat Med 2013;2013:706125. control of hypertension in the United States, 1988–2000. JAMA [13] Zhang XJ, Sun TC, Liu ZW, et al. Effects of Tianmagouteng particles on 2003;290:199–206. brain cognitive function in spontaneously hypertensive rats with [4] Zhang Y, Moran AE. Trends in the prevalence, awareness, treatment, hyperactivity of liver-yang: A [F-18] FDG micro-PET imaging study. and control of hypertension among young adults in the United States, Biomed Pharmacother 2017;95:1838–43. 1999 to 2014. Hypertension 2017;70:736–42. [14] Wei H. 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MedicineWolters Kluwer Health

Published: Feb 1, 2018

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