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Effect of Acupuncture on Patients With Mild Hypertension (EAPMH)

This study has been completed.
Sponsor:
Collaborator:
Hunan University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01701726
First received: September 26, 2012
Last updated: June 19, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Essential Hypertension
Other: acupuncture
Other: Sham acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acupuncture for Patients With Mild Hypertension: Study Protocol of an Open-label Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Average systolic and average diastolic blood pressure by 24-hour ambulatory blood pressure monitoring [ Time Frame: 6weeks after randomization. ] [ Designated as safety issue: No ]
    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.

  • Visit-to-visit blood pressure variation [ Time Frame: 6 weeks after randomization ] [ Designated as safety issue: No ]
    Assessed by 24-hour ambulatory blood pressure monitoring


Secondary Outcome Measures:
  • Average systolic and average diastolic blood pressure during the daytime and nighttime. [ Time Frame: 0 day, 6weeks, 9weeks, 12weeks after randomization. ] [ Designated as safety issue: No ]
    The daytime is from 8AM to 10PM,nighttime is 10PM -8AM.

  • Average systolic and average diastolic blood pressure during the daytime and nighttime. [ Time Frame: 0 day, 6weeks, 9weeks, 12weeks after randomization. ] [ Designated as safety issue: No ]
    The daytime is defined as 8AM-10PM.Nighttime is defined as 10PM -8AM.

  • changes in patients health-related quality of life [ Time Frame: 0 day and 6 weeks after randomization. ] [ Designated as safety issue: No ]
    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.

  • Adverse events [ Time Frame: 0 day, 6weeks, 9weeks, 12weeks after randomization ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 400
Study Start Date: July 2012
Study Completion Date: April 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Two types of acupuncture are given, one is acupuncture at affected meridian points, the other is at non-affected. For the first type, We select the acupoints from the affected meridians.Patients in this group are divided into two subgroups according meridian syndrome differentiation(jue-yin style,yang-ming style).Patients pertaining to Jue-yin-style are treated with taichong (LR3), renying(ST9), taixi(KI3), neiguan(PC6) .Patients pertaining to Yang-ming-style: taichong(LR3), renying(ST9), zusanli(ST36), quchi(LI11). For the second,We select the acupoints from the non-affected meridians.Patients assigned into the non-affected meridian acupuncture group will be treated with Fengchi (GB20), waiguan(SJ5), yinlingquan(SP9), xuehai (SP10).
Other: acupuncture
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.
Other Name: electroacupuncture
Sham Comparator: Sham acupuncture

we use sham acupoints:

  1. The edge of the tibia (1-2cm lateral and horizontal to the zusanli (ST36))
  2. Half way between the tip of the elbow and the axilla
  3. On the ulnar side of the arm, half way between the epicondylus medialis of the humerus and the ulnar side of the wrist.
  4. 2cm superior to fu tu(LI18)
Other: Sham acupuncture
In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.
No Intervention: Waiting list
Participants who will be randomized into the waiting-list group will not receive any acupuncture treatment throughout 13-week observation period. At the end of trial, if the participant would like to be treated with acupuncture, it will be provided three times weekly for 6 weeks.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients whose age between 40 and 75 years old, male and female;
  2. Patients who meet the diagnostic criteria of mild hypertension according to JNC-7 and China's prevention and cure guide of hypertension. mild hypertension (WHO/ISH criteria stage I) Systolic blood pressure 159≥(SBP) ≥140 and/or diastolic blood pressure 99≥(DBP) ≥90 .
  3. Patients who are initially diagnosed as mild hypertension or have been diagnosed as mild hypertension before but have not taken any antihypertensive drugs.
  4. Patients who are diagnosed as yue-yin style (yin-deficiency accompany with hyperactivity of yang) or yang-ming style (obstruction of phlegm and dampness) according to meridian syndrome differentiation
  5. Patients who have a good understanding of our study. and willing to comply with our study protocol.
  6. Informed consent form must be signed by patient or lineal relative.
  7. All the tips are matched will be included.

Exclusion Criteria:

  1. Patients who have been diagnosed as secondary hypertension or malignant hypertension(e.g. Cushing's syndrome, coarctation of the aorta,phaeochromocytoma, renal parenchymal disease,primary aldosteronism, renovascular hypertension, obstructive sleep apnoea,drug induced hypertension et al )
  2. Patients who accompany with other severe medical conditions (e.g. endocrine disorders, cardiovascular disease. Digestive disease. hepatic dysfunction,cerebral vascular disease. renal disease. haematologic disease et al). Who may be not safe to join our study.
  3. Patients with a chronic disease which might not suitable for our study. e.g: epilepsy ,severe depression or anxiety (SAS≥70,SDS≥70) ,psychosis, allergic constitution, accompany with any infection.
  4. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
  5. Patients who currently participate in another clinical trial.
  6. Patients who Had been treated with acupuncture during the previous three months
  7. If one of the tips mentioned above is matched will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701726

Locations
China, Sichuan
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610075
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Hunan University of Traditional Chinese Medicine
Investigators
Study Chair: fan-rong Liang, MD Chengdu University of Tranditional Chinese Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01701726     History of Changes
Other Study ID Numbers: 2012CB518501-1 
Study First Received: September 26, 2012
Last Updated: June 19, 2016
Health Authority: China: Ministry of Science and Technology

Keywords provided by Chengdu University of Traditional Chinese Medicine:
Essential Hypertension
Acupuncture
Specificity
Acupoints effect
randomized controlled trials

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 09, 2016