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Open Access Study protocol

Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial

Joo-Hee Kim12, Hyun Jung Jung3, Tae-Hun Kim14, Seunghoon Lee12, Jung-Eun Kim1, Kyung-Won Kang1, So-Young Jung1, Ae-Ran Kim1, Hyo-Ju Park1, Mi-Suk Shin1, Kyung-Min Shin1, Hee-Jung Jung1, Seung-Deok Lee5, Kwon-Eui Hong6 and Sun-Mi Choi1*

Author Affiliations

1 Acupuncture, Moxibustion & Meridian Research Group, Medical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea

2 Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea

3 Department of Diagnostics, College of Oriental Medicine, Deagu Hanny University, Daegu-si, South Korea

4 College of Korean Medicine, Gachon University, Seongnam, South Korea

5 Department of Acupuncture & Moxibustion, College of Oriental Medicine, DongGuk University, Seoul, South Korea

6 Department of Acupuncture & Moxibustion, College of Oriental Medicine, Dae-Jeon University, Daejeon, South Korea

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Trials 2013, 14:303  doi:10.1186/1745-6215-14-303

Published: 22 September 2013

Abstract

Background

Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised controlled clinical trial in patients with prehypertension and stage 1 hypertension to evaluate the effect and safety of auricular acupuncture.

Methods/designs

This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein (hs-CRP). Safety will be assessed at every visit.

Discussion

This pilot multicentre randomised controlled trial will explore the feasibility of further auricular acupuncture research and provide important clinical evidence for the effect and safety of auricular acupuncture on blood pressure in patients with prehypertension and stage 1 hypertension compared with usual care.

Trial registration

Clinical Research Information Service: KCT0000169

Keywords:
Hypertension; Auricular acupuncture; Effect; Safety; Clinical research protocol