Effects of Traditional Chinese Patent Medicine on Essential Hypertension: A Systematic Review The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Xiong, Xingjiang, Pengqian Wang, Yuqing Zhang, and Xiaoke Li. 2015. “Effects of Traditional Chinese Patent Medicine on Essential Hypertension: A Systematic Review.” Medicine 94 (5): e442. doi:10.1097/MD.0000000000000442. http://dx.doi.org/10.1097/ MD.0000000000000442. Published Version doi:10.1097/MD.0000000000000442 Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:23473857 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA Effects of Traditional Chinese Patent Medicine on Essential Hypertension A Systematic Review Xingjiang Xiong, MD, Pengqian Wang, MD, Yuqing Zhang, MD, and Xiaoke Li, MD Abstract: Traditional Chinese patent medicine (TCPM) is widely used EH was supported by evidence of class level III. As a result of the for essential hypertension (EH) in China. However, there is no critically methodological drawbacks of the included studies, more rigorously appraised evidence, such as systematic reviews or meta-analyses, designed randomized controlled trials that focus on mortality and car- regarding the potential benefits and disadvantages of TCPM to justify diovascular events during long-term follow-up are warranted before their clinical use and recommendation. The aim of this review was to TCPM can be recommended for hypertensive patients. Two TCPMs, systematically evaluate and meta-analyze the effects of TCPM for EH. Song ling xue mai kang capsules and Yang xue qing nao granules, should Seven databases, the Cochrane Library, PubMed, EMBASE, the be prioritized for further research. China National Knowledge Infrastructure, the Chinese Scientific Jour- (Medicine 94(5):e442) nal Database, the Chinese Biomedical Literature Database, and the Wanfang Database, were searched from their inception to August 2014 Abbreviations: AEs = adverse events, BP = blood pressure, CAM for relevant studies that compared one TCPM plus antihypertensive = complementary and alternative medicine, CCT = controlled drugs versus antihypertensive drugs alone. The methodological quality clinical trials, CFDA = China Food and Drug Administration, CI = of the included trials was assessed using the Cochrane risk-of-bias tool. confidence interval, CNED = Chinese National Essential Drug, The primary outcome measures were mortality or progression to severe CVDs = cardiovascular diseases, DBP = diastolic blood pressure, complications and adverse events. The secondary outcome measures EH = essential hypertension, PPRC = Pharmacopoeia of the were blood pressure (BP) and quality of life (QOL). People’s Republic of China, QOL = quality of life, RCT = Seventy-three trials, which included 8138 patients, on 17 TCPMs randomized controlled trial, RR = risk ratio, SBP = systolic blood were included. In general, the methodological quality was low. Two trials pressure, TCM = traditional Chinese medicine, TCPM = traditional evaluated the effects of TCPMs on mortality and the progression to severe Chinese patent medicine, TPAD = traditional Chinese patent complications after treatment, and no significant difference was identified medicine plus antihypertensive drugs, WMD = weighted mean compared with antihypertensive drugs alone. No severe adverse events difference. were reported. Thirteen TCPMs used in complementary therapy signifi- cantly decreased systolic BP by 3.94 to 13.50 mmHg and diastolic BP by 2.28 to 11.25 mmHg. QOL was significantly improved by TCPM plus INTRODUCTION antihypertensive drugs compared with antihypertensive drugs alone. This systematic review provided the first classification of clinical ypertension is one of the most important worldwide public- evidence for the effectiveness of TCPM for EH. The usage of TCPMs for H health challenges because of its high frequency and con- comitant risks of cardiovascular and kidney disease.1,2 Across all World Health Organization regions, approximately 62% of Editor: Dingchang Zheng. strokes and 49% of myocardial infarctions are caused by high Received: August 29, 2014; revised: November 5, 2014; accepted: 3 December 15, 2014. blood pressure (BP). Hypertension has been identified as the From the Department of Cardiology, Guang’anmen Hospital (XX); Institute fourth leading cause of the global burden of disease.4 The of Basic Research in Clinical Medicine, China Academy of Chinese prevention and effective treatment of essential hypertension Medical Sciences, Beijing, China (PW); Department of Clinical Epide- 5 miology and Biostatistics, McMaster University, Hamilton, Ontario, (EH) is of utmost importance both in China and the West. Canada (YZ); and Bio-organic and Natural Products Laboratory, McLean However, the effective control of hypertension is far from Hospital, Harvard Medical School, Belmont, Massachusetts, USA (XL). satisfactory and is limited by the availability, cost, and adverse Correspondence: Xingjiang Xiong, MD, Department of Cardiology, effects of antihypertensive medications.1 Therefore, a certain Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beixiange 5#, Xicheng District, Beijing 100053, China (e-mail: proportion of patients have turned to complementary and [email protected] or [email protected]). alternative medicine (CAM), including traditional Chinese The study was financially supported by the National Natural Science medicine (TCM), in the search for a treatment modality with Foundation Project of China (No. 81403375). potential efficacy and few adverse effects. In Western countries, Author contribution: XJX conceived the idea, set the objectives, and con- tributed to design and interpretation. PQW, XKL, and YQZ ran the interest in TCM stems from the hope that it might complement searches, and assessed the methodological quality. XJX made the Western medicine. This situation is also partially supported by analysis, having full access to all of the data in the study and taking recent studies.6 responsibility for the integrity of the data and the accuracy of the data The most significant distinction between China and the analysis. XJX and PQW wrote the manuscript. All authors approved the final version of the manuscript. West in EH treatment is the application of acupuncture and The authors have no conflicts of interest to disclose. traditional Chinese patent medicines (TCPMs), which have Copyright # 2015 Wolters Kluwer Health, Inc. All rights reserved. been considered complementary or adjunctive therapies for This is an open access article distributed under the Creative Commons symptom management and quality of life (QOL) enhancement Attribution License 4.0, which permits unrestricted use, distribution, and 7–9 reproduction in any medium, provided the original work is properly cited. along with mainstream care. Although no TCPMs have been ISSN: 0025-7974 listed as an investigational new drug by the US Food and Drug DOI: 10.1097/MD.0000000000000442 Administration, all TCPMs have resulted in great economic and Medicine Volume 94, Number 5, February 2015 www.md-journal.com | 1 Xiong et al Medicine Volume 94, Number 5, February 2015 clinical benefits in China. For example, yang xue qing nao control groups, and in which treatment allocation was not granules are composed of Rehmannia (Dihuang, Radix necessarily randomized, were defined as controlled clinical Rehmanniae Glutinosae), Chinese Angelica Root (Danggui, trials (CCTs). Radix Angelicae Sinensis), Gambir Vine Stems and Thorns (Gouteng, Ramulus Uncariae Cum Uncis), Mother of Pearl Types of Participants (Zhenzhumu, Concha Margaratiferae), Foetid Cassia Seeds Participants enrolled in the studies of this review had to (Juemingzi, Semen Cassiae Torae), Prunella (Xiakucao, Spica meet at least one of the current or past guidelines or definitions Prunellae Vulgaris), White Peony Root (Baishao, Radix Albus of EH, which are described as follows: systolic BP (SBP) Paeoniae Lactiflorae), Szechuan Lovage Root (Chuanxiong, 140 mmHg and/or diastolic BP (DBP) 90 mmHg on at least Rhizoma Ligustici Chuanxiong), Spatholobus (Jixueteng, Cau- 2 occasions with off-antihypertensive treatment (after a 4-week lis Milletiae Seu Spatholobi), Corydalis Rhizome (Yanhusuo, washout period) and/or treatment with antihypertensive medi- Corydalis Rhizome), and Chinese Wild Ginger (Xixin, Herba cation, while excluding secondary hypertension.1 Trials without Asari Cum Radice). Yang xue qing nao granules have been a description of the detailed diagnostic criteria but that included extensively tested in various types of clinical trials. In 2012, the patients with definite EH were also included. Because there are global market of yang xue qing nao granules was approximately many TCM syndromes (also known as zheng or patterns) of 0.5 billion RMB (equivalent to 81.7 million USD). Several EH,7,8,9,13,14 no restriction regarding the diagnostic criteria of randomized controlled trials (RCTs) and systematic reviews TCM was utilized. Trials that included patients of any age, sex, regarding the efficacy of acupuncture for EH have been pub- 10–12 or ethnic origin with EH were eligible. There were no restric- lished in English. However, there is insufficient clinical tions on population characteristics. evidence to support