Renin-angiotensin system mechanism underlying the effect of auricular acupuncture on blood pressure in hypertensive patients with phlegm-dampness constitution: Study protocol for a randomized controlled trial

PLoS One. 2024 Feb 1;19(2):e0294306. doi: 10.1371/journal.pone.0294306. eCollection 2024.

Abstract

Background: Phlegm-dampness constitution is a traditional Chinese medicine constitution typically associated with essential hypertension. Previous studies have demonstrated that auricular acupuncture effectively decreases blood pressure and adjusts the constitution. However, the mechanism underlying auricular acupuncture's effect is poorly understood.

Methods: A non-blinded, randomized controlled trial will be undertaken between September 2022 and May 2023. Eighty essential hypertensive patients with a phlegm-dampness constitution will be randomly allocated to one of two groups. The intervention group will receive eight weeks of auricular acupuncture and regular use of antihypertensive drugs, while the control group will only receive antihypertensive drugs. The primary outcome will be any mean differences in office systolic blood pressure. The secondary outcomes investigations will include proteins of the renin-angiotensin system, office blood pressure of different genotypes, and phlegm-dampness constitution scores.

Discussion: By demonstrating how auricular acupuncture affects the renin-angiotensin system, this research will offer significant new information on the mechanism underlying the action of auricular acupuncture in hypertension. Moreover, the results will provide crucial clinical information on the associations between renin-angiotensin system gene polymorphisms and the antihypertensive effects of auricular acupuncture.

Trial registration: Registered at the chictr.org.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Acupuncture Therapy*
  • Acupuncture, Ear*
  • Antihypertensive Agents
  • Blood Pressure
  • Humans
  • Hypertension*
  • Randomized Controlled Trials as Topic
  • Renin-Angiotensin System
  • Treatment Outcome

Substances

  • Antihypertensive Agents

Grants and funding

This trail was supported by the Zhejiang province scientific research fund project of traditional Chinese medicine (2022ZA053). The funder was not involved in the study design and will not contribute to data collection, analysis, interpretation of data or manuscript writing and the decision to submit the report for publication and will not have ultimate authority over any of these activities.