Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Drug Refractory Persistent Atrial Fibrillation (n=80). Intervention: Active acupuncture vs. Sham acupuncture. Primary outcome: AF recurrence rate.

Jimin Park; Hyun Soo Kim; Seung Min Lee; Seung Min Lee; Kanghyun Yoon; Woo‐Shik Kim; Jong Shin Woo; Sanghoon Lee; Sanghoon Lee; Jin‐Bae Kim; Weon Kim

doi:10.1155/2015/613970

January 1, 2015Evidence-based Complementary and Alternative MedicineOpen Access

Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

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Key result

New trial protocol tests acupuncture versus sham for preventing persistent AF recurrence.

n=80

Why the study?

The efficacy of acupuncture for prevention of atrial fibrillation has not been well investigated.

Study Design

Type

RCT (n=80)

Blinding

Participant and assessor blinded

Randomization

1:1 ratio

PICO

P

Population

80 participants with drug refractory persistent atrial fibrillation to be randomized to active or sham acupuncture for 10 weeks.

I

Intervention / Comparator

Active acupuncture vs Sham acupuncture (10 sessions once a week)

O

Primary Outcome

AF recurrence rate

Implication

Protocol for sham-controlled RCT tests acupuncture in persistent AF recurrence prevention; leaves open efficacy and practice change until results reported.

Abstract

Background. Atrial fibrillation (AF) is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF). Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA) and left atrial appendage (LAA) changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs) of Kyung Hee University Hospital (number 1335-04). This trial is registered with clinicaltrials.gov NCT02110537.

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Cite This Study

Park et al. (2015) conducted an RCT in Drug Refractory Persistent Atrial Fibrillation (n=80). Active acupuncture vs. Sham acupuncture was evaluated on AF recurrence rate. This study protocol describes a randomized, sham-controlled trial of 80 patients to investigate the efficacy of 10 weeks of acupuncture for preventing recurrence of persistent atrial fibrillation.

synapsesocial.com/papers/6aaa39d78fc5b3c600e30c67 https://doi.org/10.1155/2015/613970