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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial

Authors: Yu-zheng Du, Xin-xin Gao, Cheng-Ting Wang, Hai-zhen Zheng, Yun Lei, Meng-han Wu, Xue-min Shi, Hai-peng Ban, Wen-long Gu, Xiang-gang Meng, Mao-ti Wei, Chun-xiao Hu

Published in: Trials | Issue 1/2017

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Abstract

Background

Stroke is the prime cause of morbidity and mortality in the general population, and hypertension will increase the recurrence and mortality of stroke. We report a protocol of a pragmatic randomized controlled trial (RCT) using blood pressure (BP)-lowering acupuncture add-on treatment to treat patients with hypertension and stroke.

Methods

This is a large-scale, multicenter, subject-, assessor- and analyst-blinded, pragmatic RCT. A total of 480 patients with hypertension and ischemic stroke will be randomly assigned to two groups: an experimental group and a control group. The experimental group will receive “HuoXueSanFeng” acupuncture combined with one antihypertensive medication in addition to routine ischemic stroke treatment. The control group will only receive one antihypertensive medication and basic treatments for ischemic stroke. HuoXueSanFeng acupuncture will be given for six sessions weekly for the first 6 weeks and three times weekly for the next 6 weeks. A 9-month follow-up will, thereafter, be conducted. Antihypertensive medication will be adjusted based on BP levels. The primary outcome will be the recurrence of stroke. The secondary outcomes including 24-h ambulatory BP, the TCM syndrome score, the Short Form 36-item Health Survey (SF-36), the National Institute of Health Stroke Scale (NIHSS), as well as the Barthel Index (BI) scale will be assessed at baseline, 6 weeks and 12 weeks post initiating treatments; cardiac ultrasound, carotid artery ultrasound, transcranial Doppler, and lower extremity ultrasound will be evaluated at baseline and 12 weeks after treatment. The safety of acupuncture will also be assessed.

Discussion

We aim to determine the clinical effects of controlling BP for secondary prevention of stroke with acupuncture add-on treatment.

Trial registration

ClinicalTrials.gov, ID: NCT02967484. Registered on 13 February 2017; last updated on 27 June 2017.
Appendix
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Literature
1.
Party ISW. National Clinical Guidelines for Stroke. 2nd ed. London: Royal College of Physicians; 2004.
2.
Chen Z. The third national survey on the cause of death. Beijing: Peking Union Medical University Press; 2008.
3.
Liu M, Wu B, Wang WZ, Lee LM, Zhang SH, Kong LZ. Stroke in China: epidemiology, prevention, and management strategies. Lancet Neurol. 2007;6:456–64.CrossRefPubMed
4.
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, et al. Heart disease and stroke statistics—2012 update: a report from the American Heart Association. Circulation. 2012;125:e2–e220.CrossRefPubMed
5.
Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, et al. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011;42:227–76.CrossRefPubMed
6.
Wang Y, Xu J, Zhao X, Wang D, Wang C, Liu L, et al. Association of hypertension with stroke recurrence depends on ischemic stroke subtype. Stroke. 2013;44:1232–7.CrossRefPubMed
7.
Hardie K, Hankey GJ, Jamrozik K, Broadhurst RJ, Anderson C, Hardie K. Ten-year risk of first recurrent stroke and disability after first ever stroke in the Perth Community stroke study. Stroke. 2004;35:731–5.CrossRefPubMed
8.
Mohan KM, Crichton SL, Grieve AP, Rudd AG, Wolfe CD, Heuschmann PU. Frequency and predictors for the risk of stroke recurrence up to 10 years after stroke: the South London Stroke Register. J Neurol Neurosurg Psychiatry. 2009;80:1012–8.CrossRefPubMed
9.
Wu L, Wang A, Wang X, Zhao X, Wang C, Liu L, et al. China National Stroke Registry investigators. Factors for short-term outcomes in patients with a minor stroke: results from China National Stroke Registry. BMC Neurol. 2015;15:253.CrossRefPubMedPubMedCentral
10.
Lulebo AM, Mutombo PB, Mapatano MA, Mafuta EM, Kayembe PK, Ntumba LT, et al. Predictors of non-adherence to antihypertensive medication in Kinshasa, Democratic Republic of Congo: across-sectional study. BMC Res Notes. 2015;8:526.CrossRefPubMedPubMedCentral
11.
Matsumura K, Arima H, Tominaga M, Ohtsubo T, Sasaguri T, Fujii K, et al. Impact of antihypertensive medication adherence on BP control in hypertension: the COMFORT study. QJM. 2013;106:909–14.CrossRefPubMed
12.
Brescacin L. Is it possible to apply secondary stroke prevention guidelines to very old populations? Cardiovasc Hematol Disord Drug Targets. 2011;11:9–16.CrossRefPubMed
13.
Sanossian N, Ovbiagele B. Prevention and management of stroke in very elderly patients. Lancet Neurol. 2009;8:1031–41.CrossRefPubMed
14.
Wang WT, You LK, Chiang CE, Sung SH, Chuang SY, Cheng HM, et al. Comparative effectiveness of BP-lowering drugs in patients who have already suffered from stroke: traditional and Bayesian network meta-analysis of randomized trials. Medicine (Baltimore). 2016;95:e3302.CrossRef
15.
Strauss MH, Hall AS. The divergent cardiovascular effects of angiotensin converting enzyme inhibitors and angiotensin receptor blockers on myocardial infarction and death. Prog Cardiovasc Dis. 2016;58:473–82.CrossRefPubMed
16.
Roush GC, Sica DA. Diuretics for hypertension: a review and update. Am J Hypertens. 2016;29:1130–7.CrossRefPubMed
17.
Odden MC, McClure LA, Sawaya BP, White CL, Peralta CA, Field TS, et al. Achieved BP and outcomes in the secondary prevention of small subcortical strokes Trial. Hypertension. 2016;67:63–9.CrossRefPubMed
18.
Li J, Zheng H, Zhao L, Li Y, Zhang Y, Chang XR, et al. Acupuncture for patients with mild hypertension: study protocol of an open-label multicenter randomized controlled trial. Trials. 2013;14:380.CrossRefPubMedPubMedCentral
19.
Kim JH, Jung HJ, Kim TH, Lee S, Kim JE, Kang KW, et al. Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomized controlled trial. Trials. 2013;14:303.CrossRefPubMedPubMedCentral
20.
Longhurst JC, Tjen-A-Looi S. Acupuncture regulation of BP: two decades of research. Int Rev Neurobiol. 2013;111:257–71.CrossRefPubMed
21.
Yu Z, Wu QF, Liang FR. Considerations about mechanisms of acupuncture therapy for improving hypertension by regulating immune system. Zhen Ci Yan Jiu. 2014;39:333–6.PubMed
22.
Zhao XF, Hu HT, Li JS, Shang HC, Zheng HZ, Niu JF, et al. Is acupuncture effective for hypertension? A systematic review and meta-analysis. PLoS One. 2015;10:e0127019.CrossRefPubMedPubMedCentral
23.
Liu Y, Park JE, Shin KM, Lee M, Jung HJ, Kim AR, et al. Acupuncture lowers BP in mild hypertension patients: a randomized, controlled, assessor-blinded pilot trial. Complement Ther Med. 2015;23:658–65.CrossRefPubMed
24.
Li P, Tjen-A-Looi SC, Cheng L, Liu D, Painovich J, Vinjamury S, et al. Long-Lasting Reduction of BP by electroacupuncture in patients with hypertension: randomized controlled trial. Med Acupunct. 2015;27:253–66.CrossRefPubMedPubMedCentral
25.
Yang X, Liu W. Primary hypertension treated with acupuncture combined with auricular point sticking: a randomized controlled trial. Zhongguo Zhen Jiu. 2015;35:227–331.PubMed
26.
27.
Gao XX, Ma F, Zhao Q, Zhang Y, Du YZ. The efficacy of “HuoXueSanFeng” acupuncture to reduce BP of stroke patients with hypertension. Zhongguo Zhenjiu. 2016;05:459–62.
28.
Wang ZR, Rong WZ, Jin SS, Gu WL, Ma F, Li XZ, et al. Regulation of activating blood and dispersing wind, harmonizing liver and spleen acupuncture method on morning blood pressure and blood pressure variability in patients with hypertension complicated with cerebral infarction. Liaoning Journal of Traditional Chinese Medicine. 2016;04:815–8.
29.
Gu WL, Liu CX, Wang ZR, Gong FM, Wang T, Du YZ. Effects of blood activating wind dissipating acupuncture on blood pressure of prehypertension patients. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2015;35:1318–21.PubMed
30.
Yin C, Du YZ. Observation of anti-hypertensive effect on primary hypertension treated with acupuncture at Ren-ying (ST9) mainly. Zhongguo Zhen Jiu. 2012;32:776–8.PubMed
31.
Shen PF, Shi XM. Evaluation of antihypertensive effect on essential hypertension from acupuncture by ambulatory blood pressure monitoring. Mode Tradit Chin Med Mater Med. 2010;12:44–6.
32.
Zhang L, Shen P, Wang S. Acupuncture treatment for hypertension: a case study. Acupunct Med. 2014;32:73–6.CrossRefPubMed
33.
Zheng H, Zhao X, Du Y, Shi X. Acupuncture for blood pressure control in stroke patients: case reports. Forsch Komplementmed. 2016;23:351–5.PubMed
34.
Shi XM. “Xing Nao Kai Qiao” needling method formula. In: Shi XM, editor. Stroke and “Xing Nao Kai Qiao” needling method. 1st ed. Tianjin: Tianjin Science and Technology Publishing Company; 1998. p. 112–7.
35.
Lawes CM, Vander Hoorn S, Rodgers A. Global burden of blood-pressure-related disease, 2001. Lancet. 2008;371:1513–8.CrossRefPubMed
36.
Katsanos AH, Filippatou A, Manios E, Deftereos S, Parissis J, Frogoudaki A, et al. Blood pressure reduction and secondary stroke prevention: a systematic review and metaregression analysis of randomized clinical trials. Hypertension. 2017;69:171–9.CrossRefPubMed
37.
Park SU, Ko CN, Bae HS, Jung WS, Moon SK, Cho KH, et al. Short-term reactions to acupuncture treatment and adverse events following acupuncture: a cross-sectional survey of patient reports in Korea. J Altern Complement Med. 2009;15:1275–83.CrossRefPubMed
38.
Zhang S, Wu B, Liu M, Li N, Zeng X, Liu H, et al. Acupuncture efficacy on ischemic stroke recovery: multicenter randomized controlled trial in China. Stroke. 2015;46:1301–6.CrossRefPubMed
39.
He Y, Li Y, Chen Y, Feng L, Nie Z. Homocysteine level and risk of different stroke types: a meta-analysis of prospective observational studies. Nutr Metab Cardiovasc Dis. 2014;24:1158–65.CrossRefPubMed
40.
Li J, Wang Y, Lin J, Wang D, Wang A, Zhao X, et al. Soluble CD40L is a useful marker to predict future strokes in patients with minor stroke and transient ischemic attack. Stroke. 2015;46:1990–2.CrossRefPubMed
41.
Metadata
Title
Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial
Authors
Yu-zheng Du
Xin-xin Gao
Cheng-Ting Wang
Hai-zhen Zheng
Yun Lei
Meng-han Wu
Xue-min Shi
Hai-peng Ban
Wen-long Gu
Xiang-gang Meng
Mao-ti Wei
Chun-xiao Hu
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2171-5

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