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Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized
Yu-Zheng Du1, Xin-Xin Gao2, Cheng-Ting Wang3,4
1Acupuncture and Moxibustion Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 88, Changling Road, Xiqing District, Tianjin, 300000, China. hangyezhuanxiang15@163.com.
Insights
This pragmatic randomized controlled trial investigates acupuncture as an add-on therapy for hypertension and stroke patients. The study aims to assess if this treatment reduces stroke recurrence and improves patient outcomes.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Integrative Medicine
Background:
- Stroke is a leading cause of death and disability globally.
- Hypertension significantly increases the risk of stroke recurrence and mortality.
- Effective secondary prevention strategies for stroke patients with hypertension are crucial.
Purpose of the Study:
- To evaluate the clinical efficacy of acupuncture as an add-on treatment for patients with hypertension and ischemic stroke.
- To determine the effect of blood pressure (BP)-lowering acupuncture on secondary stroke prevention.
- To assess the safety and effectiveness of the "HuoXueSanFeng" acupuncture protocol.
Main Methods:
- A large-scale, multicenter, blinded, pragmatic randomized controlled trial (RCT) involving 480 patients.
- Patients randomly assigned to receive "HuoXueSanFeng" acupuncture plus antihypertensive medication or antihypertensive medication alone.
- Outcomes include stroke recurrence, 24-h ambulatory BP, TCM syndrome score, SF-36, NIHSS, BI scale, and various ultrasound assessments over a 9-month follow-up.
Main Results:
- Primary outcome is the recurrence of stroke.
- Secondary outcomes include BP control, neurological deficit, quality of life, and functional status.
- Safety of the acupuncture intervention will be systematically evaluated.
Conclusions:
- The study aims to provide evidence for the use of acupuncture in the secondary prevention of stroke in hypertensive patients.
- Findings will inform clinical practice regarding integrated treatment approaches for stroke and hypertension.
- This research contributes to understanding the role of complementary therapies in managing cardiovascular and cerebrovascular diseases.
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.
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