The add-on effect of a Chinese herbal formula for patients with resistant hypertension: Study protocol for a pilot cohort study

doi:10.1016/S2095-4964(15)60162-5

Abstract

Background
Despite a recent American Heart Association (AHA) consensus statement emphasizing the importance of resistant hypertension (RH), its control is still a challenge for conventional medicine. The Chinese herbal formula, Qutan Huayu Fang, has been used effectively to assist antihypertensive agents in blood pressure control, but its effect for RH patients is still unclear. This pilot study aims to explore the effects of taking the formula in addition to antihypertensive medication in the management of RH.
Methods/design
A prospective cohort study will be conducted in two first-class hospitals of traditional Chinese medicine (TCM). Eligible RH patients will be classified as the experimental group (n = 100) and the control group (n = 100) based on the interventions they receive. Participants taking antihypertensive agents and the Chinese herbal formula will be in the experimental group and those taking antihypertensive agents alone will be in the control group. The whole study will last 24 weeks, including an 8-week observation and follow-up at 24 weeks. The primary outcomes, assessed against patient baseline conditions, will be the reduction of systolic blood pressure and diastolic blood pressure as well as changes in TCM symptoms and signs. These outcomes will be assessed at weeks 2, 4, 6, and 8. The reductions of blood pressure will also be assessed at week 24. Cardiac events and mortality rate will be secondary outcomes and will be assessed at weeks 8 and 24. Any adverse reactions will be recorded during the study. The causal inference method will be used to assess the effectiveness of the inclusion of TCM herbal medicine in the management of patients with RH.
Discussion
This study will determine whether the Chinese herbal formula is helpful for RH patients treated with antihypertensive agents and the findings will provide a basis for further confirmatory studies.
Trial registration number
ClinicalTrials.gov Identifier NCT01904695.

Key words: Resistant hypertension, Cohort study, Medicine, Chinese traditional, Complementary therapies, Study protocol

Ya Yuwen, Yu-qi Liu, Yan-ping Wang, Jin-gang Dai, Da-sheng Liu, Yue-xi Wang, Xue-jie Han. The add-on effect of a Chinese herbal formula for patients with resistant hypertension: Study protocol for a pilot cohort study. Journal of Integrative Medicine, 2015, 13(2): 122-128.

/ / Recommend

Add to citation manager EndNote| Reference Manager|ProCite|BibTeX|RefWorks

URL: http://www.jcimjournal.com/EN/10.1016/S2095-4964(15)60162-5

http://www.jcimjournal.com/EN/Y2015/V13/I2/122

[1]	Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM ; American Heart Association Professional Education Committee.Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation, 2008,117(25):e510-e526 doi: 10.1161/CIRCULATIONAHA.108.189141
[2]	Daugherty SL, Powers JD, Magid DJ, Tavel HM, Masoudi FA, Margolis KL, O’Connor PJ, Selby JV, Ho PM . Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation, 2012,125(13):1635-1642 doi: 10.1161/CIRCULATIONAHA.111.068064 pmid: 22379110
[3]	Sang X, Jiang Y, Wang W, Yan L, Zhao J, Peng Y, Gu W, Chen G, Liu W, Ning G . Prevalence of and risk factors for primary aldosteronism among patients with resistant hypertension in China. J Hypertens, 2013,31(7):1465-1471 doi: 10.1097/HJH.0b013e328360ddf6
[4]	Garg JP, Elliott WJ, Folker A, Izhar M, Black HR ; RUSH University Hypertension Service.Resistant hypertension revisited: a comparison of two university-based cohorts. Am J Hypertens, 2005,18(5 Pt 1):619-626 doi: 10.1016/j.amjhyper.2004.11.021 pmid: 15882544
[5]	Assadi F . Strategies to reduce the incidence of chronic kidney disease in children: time for action. J Nephrol, 2013,26(1):41-47 doi: 10.5301/jn.5000157 pmid: 22573528
[6]	Treating essential hypertension. The first choice is usually a thiazide diuretic. Prescrire Int, 2014,23(152):215-220
[7]	Ko DT, Hebert PR, Coffey CS, Sedrakyan A, Curtis JP, Krumholz HM . Beta-blocker therapy and symptoms of depression, fatigue, and sexual dysfunction. JAMA, 2002,288(3):351-357 doi: 10.1001/jama.288.3.351
[8]	Vaur L, Genès N, Chambrelan F, Dutrey-Dupagne C, Pochoy A, Elkik F, Rauss A . Risk factors of adverse effects of angiotensin-converting enzyme inhibitors. Apropos of 30,072 patients treated by trandolapril. Therapie, 1997,52(6):599-605
[9]	Gulati V, White WB . Review of the state of renal nerve ablation for patients with severe and resistant hypertension. J Am Soc Hypertens, 2013,7(6):484-493 doi: 10.1016/j.jash.2013.07.003 pmid: 3855181
[10]	Wang SF, Shen JL, Xu Y, Li QF . Clinical effects of traditional Chinese medicine and Western medicine in treating resistant hypertension: a report of 40 cases. Sichuan Zhong Yi, 2005,23(8):47-48
[11]	Cheng GS . Effects of Jiangya Baolan Tablet combined with Western medicine in treating 60 patients with resistant hypertension due to liver-fire hyperactivity. Zhongguo Zhong Yi Yao Xian Dai Yuan Cheng Jiao Yu, 2012,10(12):21-22
[12]	Cheng ST, Wei YB, Wang JF . Clinical observation on the effects of Jiangya Xiaoling Decoction on resistant hypertension. Jilin Zhong Yi Yao, 2012,32(12):1235-1236
[13]	Song Z . Clinical effect of integration of traditional Chinese medicine and Western medicine in the treatment of 120 refractory hypertension patients. Yunnan Zhong Yi Zhong Yao Za Zhi, 2011,32(8):25-26
[14]	Wang SK . Resistant hypertension treatment with Shexiang Baoxin Pills in 40 cases. Zhongguo Zhong Yi Yao Xian Dai Yuan Cheng Jiao Yu, 2014,12(6):29-31
[15]	Hu XW . Clinical effects of traditional Chinese medicine in treating resistant hypertension. Zhongguo Yi Yao Zhi Nan, 2014,12(8):179-180
[16]	Han XJ, Liu Y, Wang LY, Jia HY, Lian ZH, Ding Y . Theoretical study on the relationship between hypertension and combined phlegm and blood stasis and five zang viscera. Zhonghua Zhong Yi Yao Za Zhi, 2009,24(3):290-293
[17]	Yuwen Y, Han XJ, Xie YM, Liu YQ, Shen SG, Lü AP . Thinking on the effectiveness assessment methods for resistant hypertension treatment with removing both phlegm and blood stasis in real-world. Zhong Yi Za Zhi, 2013,54(24):2095-2097
[18]	Han XJ, Wang LY, Li N, Liu Y, Ding Y . Dynamic clinical study on hypertension treated by synchronic removing phlegm and blood stasis, and detoxification and dredging collaterals. Zhongguo Zhong Yi Ji Zheng, 2011,20(3):377-379
[19]	Han XJ . Chinese medical diagnosis and treatment project of hypertension(First Draft). Zhonghua Zhong Yi Yao Za Zhi, 2008,23(7):611-613
[20]	Sekula P, Caputo A, Dunant A, Roujeau JC, Mockenhaupt M, Sidoroff A, Schumacher M . An application of propensity score methods to estimate the treatment effect of corticosteroids in patients with severe cutaneous adverse reactions. Pharmacoepidemiol Drug Saf, 2010,19(1):10-18 doi: 10.1002/pds.v19:1
[21]	Perkins SM, Tu W, Underhill MG, Zhou XH, Murray MD . The use of propensity scores in pharmacoepidemiologic research. Pharmacoepidemiol Drug Saf, 2000,9(2):93-101 doi: 10.1002/(SICI)1099-1557(200003/04)9:2<93::AID-PDS474>3.0.CO;2-I pmid: 19025807
[22]	Weil A . The state of the integrative medicine in the U.S. and Western World. Chin J Integr Med, 2011,17(1):6-10 doi: 10.1007/s11655-011-0600-y pmid: 21258890
[23]	Shi ZX . Optimal approach in treating and controlling hypertension — Train of thought about treatment of high blood pressure with integrative traditional and Western medicine. Chin J Integr Med, 2004,10(1):2-9 doi: 10.1007/BF02836549
[24]	Robinson N . Integrative medicine-traditional Chinese medicine, a model? Chin J Integr Med. 2011; 17(1):21-25. doi: 10.1007/s11655-011-0602-9 pmid: 21258892
[25]	Schumacher HR . West meets East — observation on integrative medicine in rheumatology from the USA. Chin J Integr Med, 2008,14(3):165-166 doi: 10.1007/s11655-008-0165-6
[26]	Grace S, Higgs J . Integrative medicine: enhancing quality in primary health care. J Altern Complem Med, 2010,16(9):945-950 doi: 10.1089/acm.2009.0437 pmid: 20809810
[27]	Boon HS, Kachan N .Integrative medicine: a tale of two clinics. BMC Complement Altern Med, 2008, 8: 32 doi: 10.1186/1472-6882-8-32 pmid: 2443104
[28]	Borisenko O, Beiqe J, Lovett EG, Hoppe UC, Bjessmo S . Cost-effectiveness of Barostim therapy for the treatment of resistant hypertension in European settings. J Hypertens, 2014,32(3):681-692 doi: 10.1097/HJH.0000000000000071
[29]	Fadl Elmula FE, Hoffmann P, Larstorp AC, Fossum E, Brekke M, Kjeldsen SE, Gjønnæss E, Hjørnholm U, Kjaer VN, Rostrup M, Os I, Stenehjem A, Høieggen A . Adjusted drug treatment is superior to renal sympathetic denervation in patients with true treatment-resistant hypertension. Hypertension, 2014,63(5):991-999 doi: 10.1161/HYPERTENSIONAHA.114.03246
[30]	Pearl J. .Causal inference in statistics: An overview. Statist Surv, 2009, 3: 96-146 doi: 10.1214/09-SS057
[31]	The Methodology Center. Cause inference.[ 2013-09-09]. .

Related Articles 15

[1]	Brody Slostad, Tejinder Khalsa, Kathleen Young, Hildalicia Guerra, Anjali Bhagra. A case-based approach to integrative medicine for cardiovascular disease prevention. Journal of Integrative Medicine, 2020, 18(2): 159-162.
[2]	Ameena Yasmeen, Ghulamuddin Sofi, Kaleemullah Khan. Aamar-e-Advia (shelf-lives) of drugs in Unani system of medicine: A conceptual review. Journal of Integrative Medicine, 2020, 18(2): 114-124.
[3]	Louisa Sylvia, Emerson West, Allyson M. Blackburn, Carina Gupta, Eric Bui, Tara Mahoney, Geraldine Duncan, Edward C. Wright, Simon Lejeune, Thomas J. Spencer. Acceptability of an adjunct equine-assisted activities and therapies program for veterans with posttraumatic stress disorder and/or traumatic brain injury. Journal of Integrative Medicine, 2020, 18(2): 169-173.
[4]	Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[5]	Xue-qing Yu, Shu-guang Yang, Yang Xie, Jian-sheng Li. Traditional Chinese medicine in the treatment of idiopathic pulmonary fibrosis based on syndrome differentiation: Study protocol of exploratory trial. Journal of Integrative Medicine, 2020, 18(2): 163-168.
[6]	Chang-quan Ling. Traditional Chinese medicine is a resource for drug discovery against 2019 novel coronavirus (SARS-CoV-2). Journal of Integrative Medicine, 2020, 18(2): 87-88.
[7]	Sajjad Sadeghi, Farzaneh Ghaffari, Ghazaleh Heydarirad, Mehdi Alizadeh. Galen’s place in Avicenna’s The Canon of Medicine : Respect, confirmation and criticism. Journal of Integrative Medicine, 2020, 18(1): 21-25.
[8]	Maryam Naeimia, Narjes Gorjib, Zahra Memarianib, Reihaneh Moeinib, Mohammad Kamalinejadc, Fatemeh Kolangid. Gastroprotective herbs for headache management in Persian medicine: A comprehensive review. Journal of Integrative Medicine, 2020, 18(1): 1-13.
[9]	Mohadeseh Ostovar, Abolfazl Akbari, Mohammad Hossein Anbardar, Aida Iraji, Mohsen Salmanpour, Salar Hafez Ghoran, Mojtaba Heydari, Mesbah Shams. Effects of Citrullus colocynthis L. in a rat model of diabetic neuropathy. Journal of Integrative Medicine, 2020, 18(1): 59-67.
[10]	Preecha Nootim, Nattiya Kapol, Waranee Bunchuailua, Panoopat Poompruek, Parankul Tungsukruthai . Current state of cancer patient care incorporating Thai traditional medicine in Thailand: A qualitative study. Journal of Integrative Medicine, 2020, 18(1): 41-45.
[11]	Md. Anzar Alam, Mohd Aleemuddin Quamri, Ghulamuddin Sofi, Barkati Md.Tarique. Understanding hypothyroidism in Unani medicine. Journal of Integrative Medicine, 2019, 17(6): 387-391.
[12]	Naghmeh Yazdi, Alireza Salehi, Mina Vojoud, Mohammad Hossein Sharifi, Ayda Hoseinkhani. Use of complementary and alternative medicine in pregnant women: a cross-sectional survey in the south of Iran. Journal of Integrative Medicine, 2019, 17(6): 392-395.
[13]	Wen Qiang Lee, Jeremy Teoh, Pei Zheng Kenneth Lee, Zhi Xiong Gerard Low, Xueling Sim, Foong Fong Mary Chong, Norbert Ludwig Wagner. Factors influencing communication of traditional Chinese medicine use between patients and doctors: a multisite cross-sectional study. Journal of Integrative Medicine, 2019, 17(6): 396-403.
[14]	Zienab Mahmoudpour, Javad Shokri, Mohammad Kamalinejad, Neda Meftah, Soraya Khafri, Seyyed Ali Mozaffarpur, Hoda Shirafkan. The efficacy of a Persian herbal formulation on functional bloating: A double-blind randomized controlled trial. Journal of Integrative Medicine, 2019, 17(5): 344-350.
[15]	Giles Gyer, Jimmy Michael, James Inklebarger, Jaya Shanker Tedla. Spinal manipulation therapy: Is it all about the brain? A current review of the neurophysiological effects of manipulation. Journal of Integrative Medicine, 2019, 17(5): 328-337.

Metrics

Viewed

Full text

Abstract

Cited

Shared

Discussed

Comments

Recommended 10

[1]	SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[2]	Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022
[3]	Yan-bo Zhu , Qi Wang, Cheng-yu Wu, Guo-ming Pang, Jian-xiong Zhao, Shi-lin Shen, Zhong-yuan Xia , Xue Yan . Logistic regression analysis on relationships between traditional Chinese medicine constitutional types and overweight or obesity. Journal of Chinese Integrative Medicine, 2010, 8(11): 1023-1035
[4]	Hong Liu , Guo-liang Zhang, Li Shen , Zhen Zeng, Bao-luo Zhou, Cheng-hai Liu, Guang Nie . Application and evaluation of a pseudotyped virus assay for screening herbs for anti-H5Nl avian influenza virus. Journal of Chinese Integrative Medicine, 2010, 8(11): 1036-1040
[5]	Ya-hui Liang , Ping Li, Jing-xia Zhao, Xin Liu, Qi-fu Huang. Acetyl-11-keto-beta-boswellic acid and arsenic trioxide regulate the productions and activities of matrix metalloproteinases in human skin fibroblasts and human leukemia cell line THP-1. Journal of Chinese Integrative Medicine, 2010, 8(11): 1060-1069
[6]	Chan Chen, Yong-mei Meng , Peng Zhang, Juan Wang, Hui-hui Zhao, Shu-zhen Guo , Wei Wang. Diagnosis and treatment rule of traditional Chinese medicine for syndrome factors of chronic congestive heart failure: a study based on Shannon entropy method. Journal of Chinese Integrative Medicine, 2010, 8(11): 1080-1084
[7]	Zhao-guo Li . A discussion of English translation of 1995 and 1997 Chinese National Standards of Traditional Chinese Medical Terminologies for Clinical Diagnosis and Treatment. Journal of Chinese Integrative Medicine, 2010, 8(11): 1090-1096
[8]	Rui Jin, Bing Zhang. A complexity analysis of Chinese herbal property theory: the multiple formations of herbal property (Part 1). Journal of Chinese Integrative Medicine, 2012, 10(11): 1198-1205
[9]	Nian-hong Wang , Jun-tao Yan , Wu-quan Sun , Yong-shan Hu , Jun Xia , Li-cheng Wei , Jie Jia , Gui-lin Ouyang , Yong He , Yan-ming Guo , Jie Xu . Effects of early application of Tuina treatment on quadriceps surface myoelectricity in patients after total knee arthroplasty: a randomized controlled trial. Journal of Chinese Integrative Medicine, 2012, 10(11): 1247-1253
[10]	Zhao-guo Li , Rui-qiang Liu. Comparative study on WHO Western Pacific Region and World Federation of Chinese Medicine Societies international standard terminologies on traditional medicine: Diseases in Internal Medicine (Part 7). Journal of Chinese Integrative Medicine, 2012, 10(11): 1310-1315