@Article{info:doi/10.2196/14705,
author="Schlaeger, Judith
and Cai, Hui Yan
and Steffen, Alana D
and Angulo, Veronica
and Shroff, Adhir R
and Briller, Joan E
and Hoppensteadt, Debra
and Uwizeye, Glorieuse
and Pauls, Heather A
and Takayama, Miho
and Yajima, Hiroyoshi
and Takakura, Nobuari
and DeVon, Holli A",
title="Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2019",
month="Jul",
day="29",
volume="8",
number="7",
pages="e14705",
keywords="acupuncture; stable angina; ischemic heart disease; complementary medicine",
abstract="Background: Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha. Objective: This study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables. Methods: We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non--pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life. Results: This study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020. Conclusions: We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication. International Registered Report Identifier (IRRID): DERR1-10.2196/14705 ",
issn="1929-0748",
doi="10.2196/14705",
url="http://www.researchprotocols.org/2019/7/e14705/",
url="https://doi.org/10.2196/14705",
url="http://www.ncbi.nlm.nih.gov/pubmed/31359872"
}