This ongoing study is a multicenter, randomized, participant-analyst, single-blind, sham-needle-controlled clinical trial of acupuncture for essential hypertension, conducted in 5 tertiary care hospitals in China. Enrollment will begin in June 2024 and will continue through November 2025. The study will enroll 228 participants with essential hypertension, all of whom will be required to voluntarily sign an informed consent form after rigorous screening. Eligible participants will be randomized in a 1:1 ratio into two groups: the treatment group will be treated with the “HuoXueSanFeng” acupuncture method, and the control group will be treated with sham acupuncture. In this trial, all participants will receive acupuncture 3 times a week for 6 weeks, totaling 18 times. Follow-up visits will be made at weeks 1, 2, and 4 after the treatment.
This study will be conducted at 5 tertiary hospitals in China: Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Beijing Hospital of Traditional Chinese Medicine of Capital Medical University, the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine, and the Dongfang Hospital of Beijing University of Traditional Chinese Medicine. Participants who meet the inclusion criteria will be enrolled in this study, and we will use 3 ways to recruit participants with essential hypertension. First, we will recruit on site by pasting recruitment posters in the outpatient departments of the hospitals. Second, we will disseminate information about this study via WeChat Moments and the hospital's WeChat Official Account; at the same time, we will distribute posters and hold academic lectures at regular intervals at the 5 hospitals and nearby communities. It is important to note that participants will be excluded from the study design, implementation, and outcome assessment throughout the study. The inclusion and exclusion criteria are detailed in
18 years old ≤ age ≤75 years old, both male and female individuals.
Those who meet the diagnostic criteria for primary hypertension in the International Society for Hypertension’s 2020 Practice Guidelines, with a hypertension classification of grade 1 and a risk stratification of low to moderate risk; and those who receive acupuncture treatment while their original treatment is not changed;
Those who had not taken medication in the past, with an office systolic blood pressure of 140-159 mm Hg and/or a diastolic blood pressure of 90-99 mm Hg; and those who had not changed medication for at least 1 month in the past, with an office systolic blood pressure of 120-159 mm Hg and/or a diastolic blood pressure of 80-99 mm Hg. The types of antihypertensive drugs used are calcium channel blocker+angiotensin converting enzyme inhibitor/angiotensin II receptor antagonist, but no more than two types;
Correct understanding of the significance of this clinical study, good compliance with the observations and evaluations of the investigators, and voluntary signing of an informed consent form by the participant himself/herself.
Secondary hypertension such as aldosteronism, pheochromocytoma, Cushing’s syndrome, and pregnancy hypertension;
Patients with other serious cardiovascular, cerebrovascular, renal, retinal, peripheral vascular complications and diabetes mellitus, blood disorders that are not suitable for acupuncture treatment, combined with diagnosed epilepsy, obstructive sleep apnea, hypoventilation syndrome, and so on;
People with mental disorders such as severe anxiety and depression;
Pregnant and lactating women;
Patients who have received acupuncture treatment since the last 1 month or are participating in other clinical trials.
Randomization will be performed using stratified block randomization. Randomization will be performed by a statistician not involved in trial implementation or statistical analysis, and random sequences will be generated using the Proc plan program in SAS 9.3 software (SAS Institute). Eligible participants will be randomized in a 1:1 ratio into a needling group and a sham needling group. Stratification by center factor will be applied, with block sizes of 4 or 6.
The randomization sequence will be kept by a designated person who is not involved in the screening, recruitment, treatment, or evaluation of participants. The randomized grouping scheme is concealed using sequentially numbered, opaque, sealed envelopes, all prepared by staff independent of the study, and after participants sign informed consent and meet inclusion criteria, the envelopes are opened sequentially by the coordinator in the order of enrollment, and the acupuncturist is informed of the grouping in accordance with the allocation scheme inside the envelope.
The grouping results were kept confidential to the participants, outcome assessors, and data statisticians. Participants received acupuncture treatments in separate compartments of the clinic to avoid interactions and ensure confidentiality. The steps of each acupuncture operation and the method of administration were kept as consistently as possible to minimize bias. Due to the specificity of acupuncture therapy, it was not possible to blind the physician who performed the needling operation. Similarly, outcome assessors and data statisticians were not involved in the experiment throughout, thus controlling for bias that might be introduced to the trial due to knowledge of the allocation scheme. In addition, patients were asked relevant questions at the end of the last acupuncture session to assess the success of the blinding.
In the acupuncture group, the original individualized treatment plan will remain unchanged, and the “HuoXueSanFeng” acupuncture method will be used. All therapists have many years of clinical experience in acupuncture.
Disposable sterile acupuncture needles with a diameter of 0.25 mm and a length of 40 mm (Beijing Zhongyan Taihe Medical Equipment Co, Ltd) will be used. Participants will be placed in a supine position, and the local skin will be routinely sterilized. The acupoints chosen here were bilateral Renying (ST9), Baihui (BL7), Hegu (LI4), ZuSanli (ST36), Taichong (LR3), and Quchi (LI11, right side). The specific localization and operation are shown in
Location of acupuncture points.
Location of acupoints for the acupuncture group.
| Acupoints | Locations | Needling methods |
| Baihui acupoint (GV20) | On the head, the middle of the front hairline is straight up 5 cuna. | Baihui stabbed 10-20 mm along the governor vessel, and then twirled and laxated for 1 min. |
| Renying acupoint (ST9) | In the anterior part of the neck, the upper edge of the thyroid cartilage (approximately at the level of the laryngeal prominence), the anterior border of the sternocleidomastoid muscle, and the pulsation of the common carotid artery are aligned horizontally. | The needle was inserted vertically for 25~40 mm, and the twirling method was applied for 1 min (both sides of the neck). |
| Quchi acupoint (LI11) | On the lateral side of the elbow, at the midpoint of the line between the Chize point (LU5) and the lateral epicondyle of the humerus. Quchi point was only punctured on the left side, while the right side was used to measure the immediate blood pressure. | The needle was vertically inserted for 25~40 mm, and then twirled and laxated for 1 min (one side of the left arm). |
| Hegu acupoint (LI4) | On the back of the hand, between the first and second metacarpals, about the midpoint of the radial side of the second metacarpal. | The needle was vertically inserted for 20 ~25 mm, and the twisting and laxation method was applied for 1 min (both sides of the back of the hand). |
| Zusanli acupoint (ST36) | On the outside of the lower leg, 3 cun below the Du Bi acupoint (ST35), and on the line between Du Bi acupoint (ST35) and JieXi acupoint (ST41). | The needle was inserted vertically for 25~40 mm, and the twirling method was applied for 1 min (both sides of the lower limbs). |
| Taichong acupoint (LR3) | In the dorsum of the foot, between the first and second metatarsals, in the depression in front of the metatarsal base junction, or touching the arterial pulse. | The needle was inserted vertically for 20~25 mm, and the twisting and laxation method was applied for 1 min (both sides of lower limbs). |
a1 cun (≈20 mm) is defined as the width of the interphalangeal joint of the patient’s thumb.
The total observation period was 11 weeks, with a baseline period of 1 week, a clinical treatment period of 6 weeks, and follow-up visits of 15 minutes each at weeks 1, 2, and 4 after the end of treatment.
Participants in the sham needling group will receive the same duration and frequency of treatment as the needling group, while keeping the original treatment unchanged. Participants will be placed in the supine position and nonmeridian and nonacupuncture points will be selected as the needling location. The specific location and operation method can be found in
Location of non-acupoints.
Location of non-acupoints for sham acupuncture group.
| Non-acupoints | Locations |
| Non-acupoint 1 | In the middle of Touwei (ST8) and Yuyao (EX-HN4) |
| Non-acupoint 2 | In the neck, between the anterior and posterior edges of the sternocleidomastoid muscle, 1 cun above the Futu pointa (bilateral neck) |
| Non-acupoint 3 | On the radial side, the midpoint between the medial epicondyle of the humerus and the first process of the ulna (unilateral on the left arm) |
| Non-acupoint 4 | 3 cun above the dorsal stria of the wrist, the midpoint of the line between Pianli (LI6) and Zhigou (SJ6); both sides of the forearm |
| Non-acupoint 5 | Three inches below Yanglingquan (GB34), between the gallbladder and stomach meridians (bilateral lower limbs) |
| Non-acupoint 6 | On the dorsum of the foot, the middle of the connecting line between Qiuxu (GB40) and JieXi (ST41); both sides of the lower limbs |
a1 cun (≈20 mm) is defined as the width of the interphalangeal joint of the patient's thumb. All non-acupoints were directly punctured with a 1 cun blunt head needle through the fixed pad to reach the skin surface, and evenly lifted, inserted and twisted 3 times each, but the skin was not punctured.
In this study, participants are required to maintain their current treatment, including antihypertensive medication, after participating in the trial. This will be documented in detail. Discontinuation of medication, adjustment of medication, and use of over-the-counter or herbal medications will not be permitted during the treatment period.
In this study, the assessor will be blinded to the specific subgroups. The primary outcome will include 24-hour ambulatory blood pressure and in-office immediate blood pressure. We plan to measure 24-hour ambulatory blood pressure once at baseline, once a week 6 of treatment, and once a week 4 after the end of treatment. In-office blood pressure will be measured when the patient first arrives at the office, 5 minutes after lying down, and at 5, 15, and 30 minutes after completing the acupuncture operation and 10 minutes after finishing the needle.
Some of the symptoms associated with essential hypertension, such as vertigo, headache, and insomnia, will be assessed using scales such as the Dizziness Handicap Inventory (DHI), Headache Impact Test-6 (HIT-6), and the Pittsburgh Sleep Quality Index (PSQI). The DHI is a classic tool for assessing vestibular or dizziness-related dysfunction and contains 25 entries covering functional, affective, and somatic dimensions [
The above assessments will be performed at baseline, at week 6 of starting treatment, and at weeks 1, 2, and 4 after the end of treatment. In addition, other safety indicators will be assessed, including general physical examination, liver and renal function and electrocardiogram at baseline. These tests will be performed at baseline and at week 6 of treatment.
Telephone follow-ups will be conducted at weeks 1, 2, and 4 after the completion of acupuncture treatment. Patients will record their home self-measured blood pressure values, medication intake, and related scale contents accurately and completely in the case report form (CRF). The researcher will provide professional guidance to the patients according to their blood pressure level and related accompanying symptoms.
The sample size of this study was estimated using the 2-sample
Statistical analyses we will leave to a statistician who is unaware of the groups. Data will be analyzed using the SAS 9.3 and SPSS 29.0 (IBM Corp) packages, and a 2-sided
Baseline data on participants’ demographic information and general state characteristics such as age, gender, and disease duration will be represented by descriptive statistics for both groups. We will measure in-office immediate blood pressure values at different time points of the needle prick and 24-hour ambulatory blood pressure values at baseline, week 6 of treatment and week 4 after the end of treatment, and comparisons between groups will be assessed using repeated measures ANOVA.
For continuous variables, expressed as mean (SD), grouped
During acupuncture treatment, participants may experience adverse events such as bleeding, subcutaneous hematomas, persistent feeling of getting gas, increased pain, infection, needle fainting, stress elevation of blood pressure, and allergic reactions to alcohol. As investigators, we will carefully observe changes in the participant’s vital signs and record them in the CRF at all times.
A thorough assessment will be performed during the screening and preparation phase of the trial and periodically throughout the trial. The screening phase will last for 1 week and will include assessment of basic information such as gender, age, temperature, heart rate, respiration, BMI, etc, as well as detailed information about the participant's chief complaint, current medical history, past history, family history, routine checkups, blood pressure, and medication use. The timing and process of data collection are detailed in
Before the formal commencement of the study, all researchers will undergo a uniform and rigorous training to ensure that they are familiar with and equipped with the diagnostic and therapeutic measures and basic assessment skills to improve the consistency of internal observations. According to the study protocol, we will collect complete and authentic raw data from the participants and keep detailed records. Any data that deviate significantly from the clinically acceptable range must be examined and interpreted. The completed and validated CRF will be given to the relevant personnel for data entry, management and statistics, and the data on the CRF will not be modified. Professionals will be assigned to provide regular supervision and quality control throughout the study.
Clinical research flowchart.
| Phase project | Baseline period | On-treatment | Follow-up period | ||||
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Week 0 | Week 1 | Week 6 | Week 7 | Week 8 | Week 10 | |
| Signed informed consent | ✓a |
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| Filling in demographic information | ✓ |
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| Previous diseases and medication | ✓ |
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| Prestudy medication and other treatments | ✓ |
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| General physical examination items | ✓ |
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| Physical examination | ✓ |
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| Acceptance and discharge standard | ✓ |
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| 24-hour ambulatory blood pressure monitoring | ✓ |
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✓ |
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✓ | |
| Immediate blood pressure in the consulting roomb |
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✓ | ✓ |
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| Biochemical function testc | ✓ |
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✓ |
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| Electrocardiogram | ✓ |
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✓ |
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| Scale evaluationd | ✓ |
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✓ | ✓ | ✓ | ✓ | |
| Blinded evaluation |
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✓ |
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| Adverse reactions/adverse events (ADR/AE) | ✓e | ✓e | ✓e | ✓e | ✓e | ✓e | |
| New drug combinations | ✓e | ✓e | ✓e | ✓e | ✓e | ✓e | |
a“✓” in this table represents the items that must be completed; The participants made corresponding records after treatment.
bImmediate blood pressure in the consulting room: it needs to be measured in the first to sixth weeks.
cBiochemical function test: liver function, kidney function, blood lipid, etc.
dScale evaluation: Traditional Chinese medicine symptom scale, Dizziness Handicap Inventory (DHI), Headache Impact Test-6 (HIT-6), Pittsburgh Sleep Quality Index (PSQI), 36-Item Short Form Health Survey.
eRecorded at any time.
At the end of the trial, we will endeavor to share the results with other experts from the Chinese medical field, with the aim of benefiting them by exploring the immediate antihypertensive effects of the “HuoXueSanFeng” acupuncture method and its effects on the central nervous system.
Routine blood tests will be performed and analyzed to collect the necessary data.
This trial was conducted in strict accordance with the Declaration of Helsinki and relevant Chinese clinical trial research norms and regulations. The study protocol has been approved by the Ethics Committee of the Clinical Research Unit (number: 2024DZMEC-153-03) and was successfully registered on May 23, 2024, at ChiCTR2400084696 (Chinese Clinical Trial Registry). Before each participant is enrolled in this study, the investigator will provide a complete and comprehensive written introduction to the purpose, procedures, and potential risks of the study. Participants will be informed of their right to withdraw from the study at any time. If a participant withdraws during the course of the trial, we reserve the right to retain the data obtained for statistical analysis. All data will be anonymized. All participants are entitled to 18 free acupuncture treatments, as this study does not include compensation for transportation and lost wages.