This is a large scale, open-label, multicenter, randomized controlled clinical trial with four parallel arms. This trial aims to evaluate the effectiveness of affected meridian acupuncture for patients with mild hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.
Investigators plan to recruit 428 hypertensive patients. Eligible patients will be randomized to four different groups.ⅰ. the affected meridian acupuncture group (AMA, n=107) will be treated with acupoints on affected meridians.ⅱ.the non-affected meridian acupuncture group (NMA, n=107) will be treated with acupoints on non-affected meridians.ⅲ.invasive sham acupuncture group(ISA, n=107)will be provided with sham acupoints treatment.ⅳ.waiting-list group(WL, n=107)will not be given any intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
In each session, acupuncture are applied bilaterally. Except the acupoints around the neck(ST9.GB20.non-acupoints 4) ,6 auxiliary needles will be punctured at 2mm lateral to each acupoints or non-acupoints.as to auxiliary needle we will not do any manipulation. We use transcutaneous electric acupoints stimulation to stimulate the acupoints and non-acupoints.
In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Average systolic and average diastolic blood pressure by 24-hour ambulatory blood pressure monitoring
The primary outcome is the average systolic and average diastolic blood pressure measured at 6 weeks after randomization by 24-hour ambulatory blood pressure monitoring.
Time frame: 6weeks after randomization.
Visit-to-visit blood pressure variation
Assessed by 24-hour ambulatory blood pressure monitoring
Time frame: 6 weeks after randomization
Average systolic and average diastolic blood pressure during the daytime and nighttime.
The daytime is from 8AM to 10PM,nighttime is 10PM -8AM.
Time frame: 0 day, 6weeks, 9weeks, 12weeks after randomization.
Average systolic and average diastolic blood pressure during the daytime and nighttime.
The daytime is defined as 8AM-10PM.Nighttime is defined as 10PM -8AM.
Time frame: 0 day, 6weeks, 9weeks, 12weeks after randomization.
changes in patients health-related quality of life
SF-36 (Medical Outcomes Study 36-Item Short Form)questionnaire Chinese version. The scale contains eight dimensions (physical function, role physical, bodily pain, general health, vitality, social function, role emotional, mental health) and two summary components (physical and mental ),scale 0-100.lower scores indicate poorer quality of life.
Time frame: 0 day and 6 weeks after randomization.
Adverse events
Adverse events are defined as any unexpected or discomfort signs, symptoms or diseases, regardless of the intervention. If any adverse events happen during the entire observation period, all the details should be documented in the case report form. These adverse events include bleeding, hematoma, fainting, serious pain, and local infection.
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Time frame: 0 day, 6weeks, 9weeks, 12weeks after randomization