Effect of Acupuncture on Patients With Mild Hypertension

NCT01701726 | Completed Phase 3 DMC

• 1 other identifier: 2012CB518501-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Essential Hypertension

Keywords

Essential Hypertension; Acupuncture; Specificity; Acupoints effect; randomized controlled trials

Outcome Measures

Primary Outcomes (2)

• 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.

  6weeks after randomization.

• Visit-to-visit blood pressure variation

  Assessed by 24-hour ambulatory blood pressure monitoring

  6 weeks after randomization

Secondary Outcomes (4)

• Average systolic and average diastolic blood pressure during the daytime and nighttime.

  0 day, 6weeks, 9weeks, 12weeks after randomization.

• Average systolic and average diastolic blood pressure during the daytime and nighttime.

  0 day, 6weeks, 9weeks, 12weeks after randomization.

• changes in patients health-related quality of life

  0 day and 6 weeks after randomization.

• Adverse events

  0 day, 6weeks, 9weeks, 12weeks after randomization

Study Arms (3)

Acupuncture

EXPERIMENTAL

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

Sham acupuncture

SHAM COMPARATOR

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

Waiting list

NO INTERVENTION

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.

Interventions

acupuncture OTHER

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.

Also known as: electroacupuncture

Acupuncture

Sham acupuncture OTHER

In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.

Sham acupuncture

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients whose age between 40 and 75 years old, male and female;
• 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 .
• Patients who are initially diagnosed as mild hypertension or have been diagnosed as mild hypertension before but have not taken any antihypertensive drugs.
• 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
• Patients who have a good understanding of our study. and willing to comply with our study protocol.
• Informed consent form must be signed by patient or lineal relative.
• All the tips are matched will be included.

You may not qualify if:

• 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 )
• 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.
• 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.
• Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
• Patients who currently participate in another clinical trial.
• Patients who Had been treated with acupuncture during the previous three months
• If one of the tips mentioned above is matched will be excluded.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead
• Hunan University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

Related Publications (2)

• Wang JM, Yang MX, Wu QF, Chen J, Deng SF, Chen L, Wei DN, Liang FR. Improvement of intestinal flora: accompany with the antihypertensive effect of electroacupuncture on stage 1 hypertension. Chin Med. 2021 Jan 7;16(1):7. doi: 10.1186/s13020-020-00417-8.

  PMID: 33413552 DERIVED

• Li J, Zheng H, Zhao L, Li Y, Zhang Y, Chang XR, Wang RH, Shi J, Cui J, Huang YL, Li X, Chen J, Li DH, Liang FR. Acupuncture for patients with mild hypertension: study protocol of an open-label multicenter randomized controlled trial. Trials. 2013 Nov 11;14:380. doi: 10.1186/1745-6215-14-380.

  PMID: 24216113 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

Acupuncture Therapy; Electroacupuncture

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• fan-rong Liang, MD

  Chengdu University of Tranditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 5, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 21, 2016

Record last verified: 2016-06

Locations

CN (1)