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Currently accepted at: JMIR Research Protocols

Date Submitted: May 13, 2019
Open Peer Review Period: May 16, 2019 - May 30, 2019
Date Accepted: Jun 27, 2019
(closed for review but you can still tweet)

This paper has been accepted and is currently in production.

It will appear shortly on 10.2196/14705

The final accepted version (not copyedited yet) is in this tab.

The final, peer-reviewed published version of this preprint can be found here:

Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial

Schlaeger J, Cai HY, Steffen AD, Angulo V, Shroff AR, Briller JE, Hoppensteadt D, Uwizeye G, Pauls HA, Takayama M, Yajima H, Takakura N, DeVon HA

Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial

DOI:

PMID: 31359872

Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial

  • Judith Schlaeger; 
  • Hui Yan Cai; 
  • Alana D Steffen; 
  • Veronica Angulo; 
  • Adhir R Shroff; 
  • Joan E Briller; 
  • Debra Hoppensteadt; 
  • Glorieuse Uwizeye; 
  • Heather A Pauls; 
  • Miho Takayama; 
  • Hiroyoshi Yajima; 
  • Nobuari Takakura; 
  • Holli A DeVon

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:

DERR1-10.2196/14705


 Citation

Please cite as:

Schlaeger J, Cai HY, Steffen AD, Angulo V, Shroff AR, Briller JE, Hoppensteadt D, Uwizeye G, Pauls HA, Takayama M, Yajima H, Takakura N, DeVon HA

Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial

JMIR Research Protocols. (forthcoming/in press)

DOI: 10.2196/preprints.14705

URL: https://preprints.jmir.org/preprint/14705

PMID: 31359872


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