Acupuncture Therapy and Hypertension

Acupuncture Therapy in Non Medicated Hypertensive Patients

Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will not be on hypertensive medications. The course last for 8 weeks and the frequency is once a week.

Study Overview

• Status: Recruiting
• Conditions: Mild to Moderate Hypertension
• Intervention / Treatment: Other: electroacupuncture

Detailed Description

Improvement in BP control rates would lead to one of the largest impacts in improving life expectancy and the quality of life for over 100 million people in the United States and 1 billion people worldwide with immediate and measurable results. In the United States, 80% of patients with HTN are treated, but BP is controlled in only half of these individuals, with control worsening with increasing age1,2. The reasons for inadequate treatment and BP control are complex, but one reason for this therapeutic misalignment may be an incomplete understanding of the mechanisms underlying the development and progression of HTN. The aging process leads to dysfunction of the ANS, resulting in neuroendocrine abnormalities and chronic low-grade inflammation.

The investigators have previously shown that electroacupuncture (EA) at four targeted acupoints, can decrease sympathetic activity [sympathoinhibitory (SI)], approaching levels close to those present prior to onset of HTN and may address this unmet need in HTN management. The investigators are now testing and have preliminary evidence that EA at two additional acupoints (SP6-7) increases parasympathetic activation, thereby decreasing circulating and tissue inflammatory biomarkers [thus anti-inflammatory (AI)] and when combined with SI-EA can improve measures of vascular health including endothelial function and arterial stiffness in preclinical model with overall greater reduction in BP. Together these combined six acupoints, when simultaneously activated by EA may restore optimal autonomic control of the immune system and target an important mechanistic pathway not addressed by BP-lowering pharmacotherapy alone. To date, 12 participants have been enrolled in the study.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashwini Erande; Phone Number: 7144567025; Email: aerande@hs.uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • Recruiting
      • Susan Samueli Integrative Health Institute
      • Principal Investigator: Stephanie Tjen-A-Looi, PhD
      • Sub-Investigator: LiFang Xie, PhD, LAc
      • Principal Investigator: Shaista Malik, MD, PhD, MPH
      • Contact: Mitchell Beasley, MD, PhD, MPH; Phone Number: 949-824-7000; Email: beasleym@uci.edu
      • Contact: Shaista Malik, PhD; Phone Number: 949-824-7000; Email: smalik@hs.uci.edu
    • Orange, California, United States, 92868
      • Recruiting
      • University of California, Irvine, Health Sciences Medical Center
      • Contact: Herlinda Bergman, M.Sc.; Phone Number: 714-456-7090

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects from 50 to 75 years of age
2. Clinically diagnosed with mild to moderate hypertension and NOT on medication (Office SBP > 140 mmHg and < 160 mmHg Or ABPM average SBP > 130 mmHg and < 145 mmHg), and
3. No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.

Exclusion Criteria:

1. Subjects will be excluded if on anti-hypertensive medications.
2. Subjects will be excluded if pregnant or nursing.
3. Subjects will be excluded if they have coronary disease (by history or on ECG screening), conduction abnormalities on ECG consistent with left bundle branch block, cardiac arrhythmias associated with low blood pressure (<90 mmHg), peripheral vascular disease, orthopedic disease, diabetic neuropathy or severe hypertension (BP >170 mmHg systolic or >110 mmHg diastolic), or any other physical or psychological illness.
4. Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.
5. Inability our or unwillingness of individual to give written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-inflammatory EA (AI-EA); Anti-inflammatory electroacupuncture therapy	Other: electroacupuncture; acupuncture needling and stimulation are applied for 30 min; Other Names: acupuncture
Experimental: Sympathoinhibitory EA (SI-EA); sympatho-inhibitory electroacupuncture therapy	Other: electroacupuncture; acupuncture needling and stimulation are applied for 30 min; Other Names: acupuncture
Experimental: Combined EA (cEA); combination of SI-EA and AI-EA	Other: electroacupuncture; acupuncture needling and stimulation are applied for 30 min; Other Names: acupuncture
Experimental: Control EA (Sham-EA); Sham electroacupuncture	Other: electroacupuncture; acupuncture needling and stimulation are applied for 30 min; Other Names: acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in sympathetic and parasympathetic nervous systems	Heart rate variability and its component will be evaluated with EKG.	through study completion, an average of 4.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biomarkers like cytokines	Plasma will be measured for inflammatory markers with ELISA kits.	through study completion, an average of 4.5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Blood pressure (systolic and diastolic) will be measured with an ambulatory blood pressure device every 20 min for 24 hours.	through study completion, an average of 4.5 years

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Shaista Malik, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: August 27, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 19992222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No