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BMC Complement Altern Med. 2017 Jul 11;17(1):361. doi: 10.1186/s12906-017-1864-3.

Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial.

Leem J1,2,3, Lee SMK3,4, Park JH3,4, Lee S3,4, Chung H5,6, Lee JM6, Kim W5,6, Lee S7,8, Woo JS9,10.

Author information

1
DongShin Korean Medicine Hospital, 351, Omok-ro, Yangcheon-gu, Seoul, 07999, Republic of Korea.
2
ChungYeon Medical Institute, 64, Sangmujungang-ro, Seo-gu, Gwangju, 61949, Republic of Korea.
3
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
4
Department of Acupuncture and Moxibustion, Kyung Hee University Korean Medicine Hospital, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
5
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
6
Department of Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
7
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. shlee777@khu.ac.kr.
8
Department of Acupuncture and Moxibustion, Kyung Hee University Korean Medicine Hospital, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. shlee777@khu.ac.kr.
9
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. snowball77@hanmail.net.
10
Department of Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. snowball77@hanmail.net.

Abstract

BACKGROUND:

The purpose of this trial is to evaluate the effectiveness and safety of electroacupuncture in the treatment of acute decompensated heart failure compared with sham electroacupuncture.

METHODS:

This protocol is for a randomized, sham controlled, patient- and assessor-blinded, parallel group, single center clinical trial that can overcome the limitations of previous trials examining acupuncture and heart failure. Forty-four acute decompensated heart failure patients admitted to the cardiology ward will be randomly assigned into the electroacupuncture treatment group (n = 22) or the sham electroacupuncture control group (n = 22). Participants will receive electroacupuncture treatment for 5 days of their hospital stay. The primary outcome of this study is the difference in total diuretic dose between the two groups during hospitalization. On the day of discharge, follow-up heart rate variability, routine blood tests, cardiac biomarkers, high-sensitivity C-reactive protein (hs-CRP) level, and N-terminal pro b-type natriuretic peptide (NT-pro BNP) level will be assessed. Four weeks after discharge, hs-CRP, NT-pro BNP, heart failure symptoms, quality of life, and a pattern identification questionnaire will be used for follow-up analysis. Six months after discharge, major cardiac adverse events and cardiac function measured by echocardiography will be assessed. Adverse events will be recorded during every visit.

DISCUSSION:

The result of this clinical trial will offer evidence of the effectiveness and safety of electroacupuncture for acute decompensated heart failure.

TRIAL REGISTRATION:

Clinical Research Information Service: KCT0002249 .

KEYWORDS:

Acupuncture; Electroacupuncture; Heart failure; Randomized controlled trial

PMID:
28697773
PMCID:
PMC5504710
DOI:
10.1186/s12906-017-1864-3
[Indexed for MEDLINE]
Free PMC Article

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