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

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

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Clinical Protocols
  • Diuretics / therapeutic use
  • Electroacupuncture*
  • Female
  • Follow-Up Studies
  • Heart Failure / therapy*
  • Humans
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care
  • Research Design

Substances

  • Diuretics