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Effect of Acupuncture on Patients With Mild Hypertension (EAPMH)

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sham acupuncture
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential Hypertension, Acupuncture, Specificity, Acupoints effect, randomized controlled trials

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chengdu University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Acupuncture

Sham acupuncture

Waiting list

Arm Description

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).

we use sham acupoints: The edge of the tibia (1-2cm lateral and horizontal to the zusanli (ST36)) Half way between the tip of the elbow and the axilla On the ulnar side of the arm, half way between the epicondylus medialis of the humerus and the ulnar side of the wrist. 2cm superior to fu tu(LI18)

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.

Outcomes

Primary Outcome Measures

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.
Visit-to-visit blood pressure variation
Assessed by 24-hour ambulatory blood pressure monitoring

Secondary Outcome Measures

Average systolic and average diastolic blood pressure during the daytime and nighttime.
The daytime is from 8AM to 10PM,nighttime is 10PM -8AM.
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.
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.
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.

Full Information

First Posted
September 26, 2012
Last Updated
June 19, 2016
Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Hunan University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01701726
Brief Title
Effect of Acupuncture on Patients With Mild Hypertension
Acronym
EAPMH
Official Title
Acupuncture for Patients With Mild Hypertension: Study Protocol of an Open-label Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Hunan University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential Hypertension, Acupuncture, Specificity, Acupoints effect, randomized controlled trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
we use sham acupoints: The edge of the tibia (1-2cm lateral and horizontal to the zusanli (ST36)) Half way between the tip of the elbow and the axilla On the ulnar side of the arm, half way between the epicondylus medialis of the humerus and the ulnar side of the wrist. 2cm superior to fu tu(LI18)
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
acupuncture
Other Intervention Name(s)
electroacupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.
Primary Outcome Measure Information:
Title
Average systolic and average diastolic blood pressure by 24-hour ambulatory blood pressure monitoring
Description
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.
Title
Visit-to-visit blood pressure variation
Description
Assessed by 24-hour ambulatory blood pressure monitoring
Time Frame
6 weeks after randomization
Secondary Outcome Measure Information:
Title
Average systolic and average diastolic blood pressure during the daytime and nighttime.
Description
The daytime is from 8AM to 10PM,nighttime is 10PM -8AM.
Time Frame
0 day, 6weeks, 9weeks, 12weeks after randomization.
Title
Average systolic and average diastolic blood pressure during the daytime and nighttime.
Description
The daytime is defined as 8AM-10PM.Nighttime is defined as 10PM -8AM.
Time Frame
0 day, 6weeks, 9weeks, 12weeks after randomization.
Title
changes in patients health-related quality of life
Description
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.
Title
Adverse events
Description
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.
Time Frame
0 day, 6weeks, 9weeks, 12weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria： 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fan-rong Liang, MD
Organizational Affiliation
Chengdu University of Tranditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33413552
Citation
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.
Results Reference
derived
PubMed Identifier
24216113
Citation
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.
Results Reference
derived

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Effect of Acupuncture on Patients With Mild Hypertension

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