Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives

To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

Study Overview

• Status: Completed
• Conditions: Hypertension,Essential
• Intervention / Treatment: Device: Acupuncture; Device: Sham Acupuncture

Detailed Description

Acupuncture has been widely used for blood pressure management. Its effect on the cardiovascular-related targeted metabolome is still unknown. This pilot study aimed to assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged between 45 and 75 years;
• were diagnosed as stage I hypertension in the first visit, or used to be diagnosed with stage I hypertension in recent 1 year, but without any medication history;
• without neurological, other cardiovascular, hepatic and renal disease, and other visceral diseases;
• the basal metabolism rate of a patient, which was measured by the retrospective dietary questionnaire at baseline, should be approximately 1:1.4;
• didn't administer any drugs or herbs in at 15 days before the start of the study;
• didn't participate in any study other than this;
• agreed to cooperate with researchers in all research procedures after they were introduced this study; and
• provided with written informed consent.

Exclusion Criteria:

• age≤45 or age≥75;
• with hypertension which was secondary to other diseases, such as renal vascular disease, Cushing's syndrome, hyperadrenocorticism and drug-induced hypertension;
• had complicated cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system and other severe primary diseases and failed to effectively control in clinic;
• accompanied by epilepsy, sleep apnea, hypopnea syndrome, etc.;
• with psychiatric symptoms such as severe depression or anxiety (SAS≥70, or SDS≥72);
• pregnant or lactating woman, or woman of reproductive age who was intended to conceive in recent 1 year;
• with abnormality in laboratory test of blood biochemistry, or with contagious risks, such as HIV virus carrier, or patient with positive Hepatitis B Virus (HBV) superficial antigen;
• with malignant tumor or other severe consuming diseases, or patients with infections or bleeding disorders;
• alcoholics or drug abusers, or vegetarians;
• used to suffer from acute diseases in recent 2 weeks, such as high fever, or gastritis;
• used to administer any drug that may potentially impaired renal or hepatic function;
• with cardiovascular disease that had been treated with acupuncture within recent three months; or
• undergoing other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; Use real acupuncture treatment for blood pressure management in patients with hypertension	Device: Acupuncture; Stimulate acupoint with filiform needles to restore the healthy condition of patients
Sham Comparator: Sham Acupuncture; Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension	Device: Sham Acupuncture; Stimulate non-acupoint with filiform needles to treat the condition of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24 hour ambulatory blood pressure	up to week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
targeted plasma metabolome	up to week 6

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Chengdu University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Fan-rong Liang, Prof., Chengdu University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): August 19, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: hypertension; acupuncture; pilot clinical trial; targeted metabolome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: 2012KL-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Patient Data will be shared upon request.

Drug and device information, study documents

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