Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

01-12-2020 | Acupuncture | Study protocol

Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial

Authors: Zhong-Xue Tian, Cun-Zhi Liu, You-Sheng Qi, Jian-Feng Tu, Ying Lin, Yu Wang, Jing-Wen Yang, Guang-Xia Shi, Jun-Hong Liu, Li-Qiong Wang

Published in: Trials | Issue 1/2020

Login to get access

Abstract

Background

Hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation (TEAS) has been used to treat various diseases, including hypertension, but the scientific evidence for its benefit remains insufficient. Therefore, we will perform a randomized, controlled clinical trial in patients with stage 1 hypertension to evaluate the effect of TEAS.

Methods/design

The study will be a two-arm parallel, randomized controlled trial. Sixty patients with stage 1 hypertension will be randomly assigned to the TEAS group and the control group in a 1:1 ratio. The participants in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 min at four acupoints in the upper and lower extremities at home, 4 times weekly for 12 weeks for a total of 48 sessions. Participants in the control group will not receive any form of acupoint stimulation. All participants in both groups will receive lifestyle education on how to control high blood pressure, including diet, weight control, and exercise. The primary outcome measure will be the change of the mean systolic blood pressure from baseline to 12 weeks. Secondary outcomes include the change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level.

Discussion

This pilot, randomized, controlled trial will explore the feasibility of TEAS. It will also provide potential clinical evidence for the efficacy and safety of TEAS in the treatment of patients with stage 1 hypertension. The results of this study will be published in peer-reviewed journals. Furthermore, this pilot trial as the precursor of a large scale randomized controlled trial will inform the sample size of the subsequent trial.

Trial registration

Chinese clinical trial registry, ChiCTR1900025042, Registered on 8 August 2019 (http://​www.​chictr.​org.​cn/​showproj.​aspx?​proj=​41496).
Appendix
Available only for authorised users
Literature
1.
Lackland DT, Weber MA. Global burden of cardiovascular disease and stroke: hypertension at the core. Can J Cardiol. 2015;31:569–71.CrossRef
2.
Qi SF, Zhang B, Wang HJ, Yan J, Mi YJ, Liu DW, et al. Prevalence of hypertension subtypes in 2011 and the trends from 1991 to 2011 among Chinese adults. J Epidemiol Community Health. 2016;70:444–51.CrossRef
3.
Lewington S, Clarke R, Qizilbash N, Peto R, Collins R. Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360:1903–13.CrossRef
4.
Qin X, Li Y, Sun N, He M, Tang G, Yin D, et al. Impact of achieved blood pressure on first stroke in uncomplicated grade 1 hypertension. J Am Heart Assoc. 2017;6:e005247.PubMedPubMedCentral
5.
Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 Practice Guidelines for the management of arterial hypertension of the European Society of Hypertension and the European Society of Cardiology: ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2018;36:2284–309.CrossRef
6.
Lenzer J. Cochrane review finds no proved benefit in drug treatment for patients with mild hypertension. BMJ. 2012;345:e5511.CrossRef
7.
Dickinson HO, Mason JM, Nicolson DJ, Campbell F, Beyer FR, Cook JV, et al. Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized controlled trials. J Hypertens. 2006;24:215–33.CrossRef
8.
Nicolson DJ, Dickinson HO, Campbell F, Mason JM. Lifestyle interventions or drugs for patients with essential hypertension: a systematic review. J Hypertens. 2004;22:2043–8.CrossRef
9.
Hinderliter AL, Sherwood A, Craighead LW, Lin PH, Watkins L, Babyak MA, et al. The long-term effects of lifestyle change on blood pressure: one-year follow-up of the ENCORE study. Am J Hypertens. 2014;27:734–41.CrossRef
10.
Baena CP, Olandoski M, Younge JO, Buitrago-Lopez A, Darweesh SK, Campos N, et al. Effects of lifestyle-related interventions on blood pressure in low and middle-income countries: systematic review and meta-analysis. J Hypertens. 2014;32:961–73.CrossRef
11.
Espín-Sanchez R. Is there non-pharmacological treatment of hypertension? What is changed on hypertension treatment since Alderman in The Lancet 1994. Hipertens Riesgo Vasc. 2016;33:74–5.CrossRef
12.
Wang J, Xiong X, Liu W. Acupuncture for essential hypertension. Int J Cardiol. 2013;169:317–26.CrossRef
13.
Lee H, Kim SY, Park J, Kim YJ, Lee H, Park HJ. Acupuncture for lowering blood pressure: systematic review and meta-analysis. Am J Hypertens. 2009;22:122–8.CrossRef
14.
Liu F, Guo C, Jin X. Acupuncture for mild-to-moderate essential hypertension: a meta-analysis of randomized clinical trials. Chin J Basic Med Tradit Chin Med. 2012;18:421–3.
15.
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.CrossRef
16.
Wonderling D. The cost-effectiveness of acupuncture. Eur J Integr Med. 2015;7:437–8.CrossRef
17.
Kim SY, Lee H, Chae Y, Park HJ, Lee H. A systematic review of cost-effectiveness analyses alongside randomised controlled trials of acupuncture. Acupunct Med. 2012;30:273–85.CrossRef
18.
Francis RP, Johnson MI. The characteristics of acupuncture-like transcutaneous electrical nerve stimulation (acupuncture-like TENS): a literature review. Acupunct Electrother Res. 2011;36:231–58.CrossRef
19.
Jacobsson F, Himmelmann A, Bergbrant A, Svensson A, Mannheimer C. The effect of transcutaneous electric nerve stimulation in patients with therapy-resistant hypertension. J Hum Hypertens. 2000;14:795–8.CrossRef
20.
Joint Committee for Guideline Revision. 2018 Chinese guidelines for prevention and treatment of hypertension-a report of the revision committee of Chinese guidelines for prevention and treatment of hypertension. J Geriatr Cardiol. 2019;16:182–241.PubMedCentral
21.
Yang DH. Effect of electroacupuncture on Quchi (LI 11) and Taichong (LR 3) on blood pressure variability in young patients with hypertension. Zhongguo Zhen Jiu. 2010;30:547–50.PubMed
22.
Yin C, Du YZ. Observation of anti-hypertensive effect on primary hypertension treated with acupuncture at Renying (ST 9) mainly. Zhongguo Zhen Jiu. 2012;32:776–8.PubMed
23.
Climie RE, Schultz MG, Nikolic SB, Ahuja KD, Fell JW, Sharman JE. Validity and reliability of central blood pressure estimated by upper arm oscillometric cuff pressure. Am J Hypertens. 2012;25:414–20.CrossRef
24.
Shimamoto K, Ando K, Fujita T, Hasebe N, Higaki J, Horiuchi M, et al. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2014). Hypertens Res. 2014;37:253–390.CrossRef
25.
Eckel N, Li Y, Kuxhaus O, Stefan N, Hu FB, Schulze MB. Transition from metabolic healthy to unhealthy phenotypes and association with cardiovascular disease risk across BMI categories in 90 257 women (the Nurses’ Health Study): 30 year follow-up from a prospective cohort study. Lancet Diabetes Endocrinol. 2018;6:714–24.CrossRef
26.
Das RK, Nessa A. Blood pressure in different levels of BMI. Mymensingh Med J. 2013;22:699–705.PubMed
27.
Hallal PC, Victora CG. Reliability and validity of the International Physical Activity Questionnaire (IPAQ). Med Sci Sports Exerc. 2004;36:556.CrossRef
28.
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–33.CrossRef
29.
Wan E, Yu E, Chin WY, Choi E, Wu T, Lam C. Evaluation of the responsiveness of Short Form-12 Health Survey version 2 (SF-12v2) in Chinese patients with hypertension in primary care. Qual Life Res. 2019;28:2851–7.CrossRef
30.
Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1.CrossRef
31.
Soares I, Carneiro AV. Intention-to-treat analysis in clinical trials: principles and practical importance. Rev Port Cardiol. 2002;21:1191–8.PubMed
32.
Redfern A, Peters S, Luo R, Cheng Y, Li C, Wang J, et al. Sex differences in the awareness, treatment, and control of hypertension in China: a systematic review with meta-analyses. Hypertens Res. 2019;42:273–83.CrossRef
33.
Fan M, Yu C, Guo Y, Bian Z, Li X, Yang L, et al. Effect of total, domain-specific, and intensity-specific physical activity on all-cause and cardiovascular mortality among hypertensive adults in China. J Hypertens. 2018;36:793–800.CrossRef
34.
Lodi E, Carollo A, Martinotti V, Modena MG. Hypertension and pharmacological therapy in women. High Blood Press Cardiovasc Prev. 2018;25:147–50.CrossRef
35.
Flachskampf FA, Gallasch J, Gefeller O, Gan J, Mao J, Pfahlberg AB, et al. Randomized trial of acupuncture to lower blood pressure. Circulation. 2007;115:3121–9.CrossRef
36.
Chen H, Shen FE, Tan XD, Jiang WB, Gu YH. Efficacy and safety of acupuncture for essential hypertension: a meta-analysis. Med Sci Monit. 2018;24:2946–69.CrossRef
37.
Cai H, Zhou Q, Bao G, Kong X, Gong LY. Transcutaneous electrical nerve stimulation of acupuncture points enhances therapeutic effects of oral lactulose solution on opioid-induced constipation. J Int Med Res. 2019;47:6337–48.CrossRef
38.
Hsu YC, Liang IT, Huang SY, Wang HS, Soong YK, Chang CL. Transcutaneous electrical acupoint stimulation (TEAS) treatment improves pregnancy rate and implantation rate in patients with implantation failure. Taiwan J Obstet Gynecol. 2017;56:672–6.CrossRef
39.
Hadadian F, Sohrabi N, Farokhpayam M, Farokhpayam H, Towhidi F, Fayazi S, et al. The effects of Transcutaneous Electrical Acupoint Stimulation (TEAS) on fatigue in haemodialysis patients. J Clin Diagn Res. 2016;10:YC01–01YC04.PubMedPubMedCentral
40.
Bolbrinker J, Zaidi Touis L, Gohlke H, Weisser B, Kreutz R. European guidelines on lifestyle changes for management of hypertension: awareness and implementation of recommendations among German and European physicians. Herz. 2018;43:352–8.CrossRef
Metadata
Title
Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
Authors
Zhong-Xue Tian
Cun-Zhi Liu
You-Sheng Qi
Jian-Feng Tu
Ying Lin
Yu Wang
Jing-Wen Yang
Guang-Xia Shi
Jun-Hong Liu
Li-Qiong Wang
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04493-x

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Letter

A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial”

Study protocol

Azithromycin added to hydroxychloroquine for patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)—protocol of randomised controlled trial AZIQUINE-ICU

Study protocol

Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial

Study protocol

Individualized hemodynamic optimization guided by indirect measurement of the respiratory exchange ratio in major surgery: study protocol for a randomized controlled trial (the OPHIQUE study)

Study protocol

Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial

Study protocol

Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial