Acupuncture treatment of essential hypertension

doi:10.21203/rs.3.rs-2752365/v1

Objective: To study the effect of acupuncture on clinical symptom score, blood pressure (BP), ABI and baPWV index in patients with mild to moderate essential hypertension.

Methods: The single-blind Randomized controlled trial included 90 patients with mild to moderate essential hypertension who were randomly divided into two acupuncture groups and a control group. The control group was treated with Western medicine, while the experimental group was treated with medicine and acupuncture at different acupoints, Acupuncture Group Ⅰ and Acupuncture Group Ⅱ. The treatment lasted for 12 weeks and the indexes were collected before and after treatment. The primary outcome measure was changes in blood pressure. The secondary outcome measures were ABI, baPWV and TCM symptom score. The safety evaluation index was the incidence of adverse events.

Results: Acupuncture Group Ⅰ, Acupuncture Group Ⅱ and Control group all had 30 patients finished the study. The results showed that there were significant differences in blood pressure, ABI, baPWV index and TCM symptom score in the group compared with before intervention (P < 0.05). Acupuncture Group Ⅰ is superior to Acupuncture Group Ⅱ in improving systolic blood pressure, baPWV level, TCM symptom score and total effective rate. There are significant differences between the two groups and control group in various indexes, and the above differences are statistically significant (P<0.05). No significant complications occurred in the acupuncture group, no patient dropped out.

Conclusions: The results show that acupuncture can effectively reduce blood pressure, improve clinical symptoms, and improve the level of arteriosclerosis index with high safety. More effective acupuncture points have been explored.

essential hypertension

the nape seven needles

baPWV

ABI

clinicalobservation.

Essential hypertension is a cardiovascular syndrome with elevated blood pressure as the main clinical manifestation and unknown etiology, accounting for more than 95% of the hypertensive population. As a major global public health problem, the number of patients suffering from hypertension is increasing year by year and tends to be younger.It is estimated that the total number of people with hypertension in the world will increase to 1.5 billion by 2025. [^1] There is a positive correlation between blood pressure level and cardiovascular risk. Patients with long-term hypertension are likely to be accompanied by major target organ damage, which can induce a series of cardiovascular and cerebrovascular events. Therefore, it is necessary and urgent to strengthen the early prevention and treatment of hypertension.

In the treatment of essential hypertension, the clinical treatment is mainly drug intervention. Although the antihypertensive effect is exact, there are adverse factors such as large side effects of long-term medication, poor self-management ability of patients and increased economic burden. Although blood pressure remained within the normal range under the action of drugs, clinical symptoms did not disappear completely.

Acupuncture and moxibustion, as a traditional treatment method of Chinese medicine, In clinical practice and experimental studies for reducing blood pressure[²], Protect vascular endothelium[³], Alleviating cardiac function impairment[⁴], Reduce blood lipid and plaque formation[⁵], Improve sleep quality and other clinical symptoms showed an irreplaceable role[⁶]. Acupuncture is generally accepted as a treatment with few side effects and high safety.

Therefore, our study evaluated the efficacy of acupuncture in treating primary mild to moderate hypertension. By observing the changes of blood pressure level and atherosclerosis index level in patients with hypertension, the relevant mechanism was preliminarily analyzed, providing new ideas and methods for the prevention of clinical acupuncture treatment of hypertension and its complications, and establishing an acupuncture intervention mode for the early prevention and treatment of essential hypertension.

Study Design

This study collected 90 patients with mild to moderate essential hypertension who met the inclusion and exclusion criteria in the Department of Acupuncture and Cardiovascular Medicine, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January 2020 to February 2021.This study has been registered on the Chinese Clinical Trial Registry (Chi-CTR-2000035265) and approved by the Ethics Committee of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine (Lot Number: 2020-034-01).

Inclusion Criteria

Patients aged from 18 to 70 years and both sexes were eligible. Patients meet the diagnostic criteria of traditional Chinese medicine or Western medicine for essential hypertension, combined with arteriosclerosis (baPWV≥1400cm/s), have not taken antihypertensive drugs systematically, or have taken losartan potassium tablets before but their blood pressure has not reached normal levels, the classification belongs Mild to moderate hypertension. Sign the informed consent and voluntarily accept the treatment plan of this study.

Exclusion Criteria

(1) Patients with acute cerebrovascular accidents, acute coronary syndromes and other acute diseases or serious diseases such as heart, brain, liver, kidney, endocrine, hematopoietic system, or mental diseases; (2) Extremities trauma or skin diseases cannot Cooperate with patients who have completed relevant examinations; (3) During the trial period, those who need to take other drugs that affect blood pressure in addition to the drugs specified in the study, or those who are allergic to the drug components of the study, or have drug contraindications such as renal artery stenosis, high potassium (4) Pregnant or lactating women; (5) Those who are participating in other clinical trials.

Randomization and Allocation Concealment

The patients were screened strictly according to the selection criteria, and 90 patients were randomly divided into acupuncture group Ⅰ, acupuncture group Ⅱ and control group, with 30 cases in each group. According to SPSS 26.0 software, the random numbers corresponding to the grouping results were generated, and 90 random distribution cards were made and put into 90 opaque envelopes. Envelopes were randomly selected according to the selection order, and envelopes were grouped and processed according to the card contents. Groups cannot be changed at will. Due to the particularity of this test scheme, double-blind method cannot be adopted. In order to minimize the influence of subjective factors on the experiment, the principle of separation of researchers, data collection personnel and statistical analysts must be observed, and the research plan and grouping should not be disclosed to data collection personnel and statistical analysts.

Interventions

The measurement data of 90 patients were included in the analysis sample. The control group (n=30) was given oral losartan potassium tablets (Cozaar)(Hangzhou Merck Pharmaceutical Co., LTD., 50mg/ tablet, 50mg/ time, once a day), and the whole hypertension health education, such as low-fat diet, reduce sodium intake, moderate exercise, weight control, smoking cessation and alcohol restriction, reduce mental stress, etc. All patients received the same intervention as the control group, 4 weeks as a course of treatment, a total of 3 courses of intervention.

Acupuncture group Ⅰ (n=30) was treated with the nape seven needles. The patient was placed in a prone position with the neck exposed. The doctor at the point of each acupoint massage, so that it relax. The hands and acupoints were routinely disinfected with 75% alcohol cotton balls, and 7 acupoints were pricked successively: bilateral anguu (GB12), bilateral Fengchi (GB20), bilateral Tianzhu (BL10) and Fengfu (GV16). Then the needling apparatus is rotated from side to side with small amplitude and low frequency.After the qi was obtained by acupuncture, all points were treated with the leveling,

Acupuncture group Ⅱ (n=30) was treated with conventional acupuncture. Main acupoints: Baihui (GV20), bilateral Quchi (LI11), bilateral Taichong (LR3), bilateral Hegu (LI4), bilateral Sanyinjiao (SP6). After the qi was obtained by acupuncture, all points were treated with the leveling, reinforcing and purging technique, and the corresponding matching points were selected according to different syndrome types for routine acupuncture and the reinforcing and purging technique.

Acupuncture treatment was performed 3 times a week, leaving the needle for 20 minutes each time. 4 weeks was a course of treatment, a total of 3 courses of intervention.

Evaluations

Main outcome indicators

Blood pressure changes before and after intervention were recorded and the total effective rate of blood pressure was calculated. We selected a proven medical electronic upper arm sphygmomanometer (Model: HBP-1100, manufactured by Omron (Dalian) Co., LTD.) to measure the upper arm blood pressure of the patient while seated. To reduce measurement error, blood pressure values were repeated twice, at least 1-2 minutes apart, taking the average of the two readings; If the difference between the two measurements is more than 5mmHg, measure again and take the average of the three readings. Measurements were taken and recorded by the same person from 8:30am to 10:00am on the first day before intervention and 4, 8 and 12 weeks after intervention.

Secondary outcome indicators

(1)baPWV and ABI index detection. The detection process is operated by a dedicated person, and it is performed once before the intervention and after 4 weeks of the intervention.BP-203RPE III arteriosclerosis detection device (manufactured by Omron Medical Equipment (Beijing) Co., Ltd.) is used for detection, the baPWV is the left and right average value, and the ABI is the lower value for comparison; (2)To evaluate the TCM symptom score and the total effective rate of clinical symptoms, the relevant standards refer to the "Guiding Principles for Clinical Research of New Chinese Medicines" promulgated by the Ministry of Health.^[7]

Safety evaluation

We monitor the safety of patients when receiving acupuncture treatment, observe whether the patient has any unfavorable conditions such as dizziness, stuck needles, or broken needles during the acupuncture treatment. Once found, the treatment will be terminated immediately.

Statistical analysis

All data were statistically processed by SPSS 26.0 software. Measurement datawere described by mean±standard deviation. When the data were normally distributed among homogeneity of variance, paired T-test was used for intra-group comparison and LSD test was used for inter-group comparison. If the normal distribution is not followed, the non-parametric test is used. Chi-square tests was used for counting data, and rank sum test was used for rank data. All test results were evaluated with p<0.05 as the standard of statistical significance.

Patients’ demographic and clinical characteristics

A total of 90 patients participated in this study, including 30 cases in each of the Control group, Acupuncture group Ⅰ and Acupuncture group Ⅱ. There were no significant differences in age, course of disease, systolic blood pressure, diastolic blood pressure, baPWV, Abi and TCM symptom score among the three groups (Table 1) .

Table 1 Baseline Characteristics of Participants

Characteristics		A(N = 30)	B(N = 30)	C(N = 30)
Age		61.37±6.46	60.63±7.08	60.73±6.22
Course of disease		8.23±6.36	7.87±5.99	8.43±5.16
Blood pressure level	Level 1	16	18	18
	Level 2	14	12	12
Systolic blood pressure(mmHg)（mmHg）		158.63±9.40	157.17±9.48	159.40±6.73
Diastolic blood pressure(mmHg)		97.17±4.52	97.47±5.10	96.83±4.13
baPWV(cm/s)		1723.33±236.97	1699.72±183.47	1719.52±243.71
ABI		1.08±0.14	1.11±0.10	1.09±0.09
TCM symptom score		29.87±5.04	28.80±4.31	28.67±4.92

Data are reported as Numbers or Mean±SD.

A Acupuncture group Ⅰ , B Acupuncture group Ⅱ, C Control group.

Blood pressure value and total effective rate

Comparison of blood pressure values before and after intervention: The systolic blood pressure and diastolic blood pressure of the three groups were compared with those before the intervention after 4, 8, and 12 weeks, and the results were significantly lower than those before the intervention (P<0.05); Weeks, 8 weeks, and 12 weeks later, the systolic and diastolic blood pressure reduction effects of the nape seven needles group and the conventional acupuncture group were better than those of the control group (P<0.05), and the antihypertensive effect of the nape seven needles group was better than that of the conventional acupuncture group. Significantly (P<0.05), there was no statistically significant difference in diastolic blood pressure between the nape seven needles acupuncture group and the conventional acupuncture group (P>0.05) (Table 2).

After 12 weeks of intervention, the total effective rate of antihypertensive in the nape seven needles group was 93.33%, 86.67% in the conventional acupuncture group, and 70.00% in the control group; the antihypertensive effect of the nape seven needles group and the conventional acupuncture group was better than that of the control group ( P<0.05), there was no statistically significant difference in antihypertensive effect between the nape seven needles group and the conventional acupuncture group (P>0.05). In terms of the total curative effect of clinical symptoms, the total effective rate of the seven needles group was 90.00%, the conventional acupuncture group was 80.00%, and the control group was 63.33%; the clinical symptoms of the seven needles group and the conventional acupuncture group were better than those of the control group ( P＜0.05), and the nape seven needles group was better than the conventional acupuncture group (P＜0.05) (Figure 1).

Table 2 Comparison of blood pressure before and after intervention(`x±s, mmHg)

Group	Blood pressure type	Before intervention	4 weeks later	8 weeks later	12 weeks later
A	Systolic blood pressure	158.63±9.40	144.07±7.88^▲●★	135.20±7.36^▲●★	130.13±7.44^▲●★
	Diastolic blood pressure	97.17±4.52	90.57±3.91^▲●	85.50±3.14^▲●	82.30±2.85^▲●
B	Systolic blood pressure	157.17±9.48	148.30±8.66^▲●	140.70±7.95^▲●	135.17±7.92^▲●
	Diastolic blood pressure	97.47±5.10	90.80±4.18^▲●	86.00±3.44^▲●	83.53±3.26^▲●
C	Systolic blood pressure	159.40±6.73	152.43±7.20^▲	145.93±7.25^▲	141.30±8.09^▲
	Diastolic blood pressure	96.83±4.13	92.83±3.70^▲	88.47±3.18^▲	86.40±3.81^▲

A Acupuncture group Ⅰ , B Acupuncture group Ⅱ, C Control group. Comparison within the group, compared with this group before the intervention, ^▲P＜0.05. Compared with the group, compared with the control group, ^●P＜0.05; compared with the conventional acupuncture group,^★P＜0.05.

TCM symptom score and clinical symptom total effective rate result

Comparison of TCM symptom scores before and after intervention: The TCM symptom scores of the three groups were significantly reduced after different periods of intervention compared with before intervention (P<0.05). Comparing the three groups after 4 weeks of intervention, the score improvement of the nape seven needles item group and the conventional acupuncture group was better than that of the control group (P<0.05), but the difference between the nape seven needles item group and the conventional acupuncture group was not statistically significant ( P>0.05); Comparing the three groups after 8 weeks of intervention and 12 weeks of intervention, the scores of the nape seven needles group and the conventional acupuncture group are better than those of the control group (P<0.05), and the improvement of the nape seven needles group is better than that of the conventional In the acupuncture group (P<0.05), the nape seven needles group and the conventional acupuncture group had the same efficacy at 4 weeks of intervention, but after 8 weeks and 12 weeks of intervention, the nape seven needles group improved clinical symptoms more significantly (Table 3).

After 12 weeks of intervention, the total effective rate of TCM clinical symptoms in the nape seven needles group was 90.00%, that of the conventional acupuncture group was 80.00%, and that of the control group was 63.33%. After testing among the three groups, it was found that the therapeutic effect difference between the nape seven needles item group and the conventional acupuncture group was statistically significant (P＜0.05), and there were statistical differences between the nape seven needles item group and the conventional acupuncture group Significance (P<0.05) (Figure 2).

Table 3 Comparison of TCM symptom scores before and after intervention(x±s, mmHg)

Group	Before intervention	4 weeks later	8 weeks later	12 weeks later
A	29.87±5.04	20.97±3.53^▲●	14.63±3.26^▲●★	11.57±3.50^▲●★
B	28.80±4.31	21.50±4.05^▲●	16.87±4.93^▲●	14.03±5.34^▲●
C	28.67±4.92	23.70±4.19^▲	19.83±4.22^▲	17.40±4.85^▲

A Acupuncture group Ⅰ , B Acupuncture group Ⅱ, C Control group ;Comparison within the group, compared with this group before the intervention, ^▲P＜0.05. Compared with the group, compared with the control group, ^●P＜0.05; compared with the conventional acupuncture group,^★P＜0.05.

Table 4 Changes in levels of baPWV (`x±s, cm/s) and ABI (`x±s) before and after the intervention

Group	Before intervention		12 weeks later
Group	baPWV	ABI	baPWV	ABI
A	1723.33±236.97	1.08±0.14	1376.20±238.86^▲●★	1.17±0.08^▲●
B	1699.72±183.47	1.11±0.10	1496.32±181.63^▲●	1.16±0.07^▲●
C	1719.52±243.71	1.09±0.09	1618.55±266.80^▲	1.11±0.08^▲

A Acupuncture group Ⅰ , B Acupuncture group Ⅱ, C Control group ;Comparison within the group, compared with this group before the intervention, ^▲P＜0.05. Compared with the group, compared with the control group, ^●P＜0.05; compared with the conventional acupuncture group,^★P＜0.05.

Safety evaluation

During the treatment period, all patients did not suffer from acupuncture problems such as dizziness, stuck needles, or broken needles.

There is no clear corresponding name for essential hypertension in Chinese medicine. At present, the common clinical symptoms of hypertension during the onset of hypertension are mainly classified into the categories of "vertigo" and "headache".In 1997, the national standard "Chinese Medicine Clinical Diagnosis and Treatment Terminology·Part of Diseases" began to uniformly name elevated blood pressure as "wind dizziness".[^8]The basic etiology involves both congenital and acquired aspects. Innate endowment is the potential root cause, and the acquired pathogenic factors are closely related to emotional disorder, improper diet, loss of work and rest, external feelings of evil, internal injury, and physique bias.Acupuncture for the treatment of essential hypertension has been widely recognized in clinical practice. Acupuncture can improve the circadian rhythm of blood pressure, reduce blood pressure load, reverse non-dipper blood pressure, and reduce target organ damage. Combined with modern western medicine, acupuncture Acupuncture to lower blood pressure mainly involves the three major systems of nerve, endocrine, and immunity, which are balanced and integrated to achieve the effect of lowering blood pressure.[⁹,¹⁰,¹¹,¹²,¹³,¹⁴,^15]

The nape seven needles intervention for essential hypertension, on the one hand, is the effect of local acupoint selection, "where the acupoints are, where the main treatment is"; on the other hand, by regulating the Qi Street and the marrow sea of the head, the whole body function can be adjusted to promote qi and blood. Smooth operation can improve the clearing of yang and nourish the brain, that is, it has the effect of reconciling the viscera, removing blood stasis and phlegm, clearing the brain, relieving dizziness, filling the essence and nourishing the marrow, and dizziness, headaches and other symptoms can also be relieved. In addition, the viscera is regulated, the qi machine is unobstructed, the turbidity is eliminated, and the blood vessel is nourished, so the patient's vein disease can also be improved. During clinical application, different methods of acupuncture tonic and reducing should be given according to the patient's condition.

The results of this study show that the seven needles, conventional acupuncture and basic western medicine treatment can effectively reduce the systolic and diastolic blood pressure, but the seven needles have a more obvious effect on reducing blood pressure. From the perspective of long-term treatment, the nape seven needles treatment program is more effective in improving clinical symptoms such as dizziness, headache, and tinnitus. The levels of baPWV and ABI after the intervention of seven needles were significantly improved. The intervention of seven needles can enhance arterial compliance, reduce vascular stiffness and occlusion, speed up peripheral blood flow, increase lumen, and improve arteriosclerosis.

In summary, the use of seven needles to intervene in patients with mild to moderate essential hypertension can effectively reduce blood pressure levels, improve clinical symptoms, and at the same time have a certain improvement effect on arteriosclerosis index levels, and has high safety. It is worthy of clinical application.

Acknowledgments

We would like to thank all doctors and patients who participated in this study for their cooperation.

Author contributions

The authors confirm contribution to the paper as follows: study conception and design: ZH, CF and HJ; data collection: YJ and XZ; analysis and interpretation of results: QW, YD, and YZ; draft manuscript preparation: HZ CZ and YZ. All the authors reviewed the results. All authors read and approved the final manuscript.

Funding

This work was funded by the Natural Science Foundation of Shandong Province, based on the NPY-Y1R/Y2R signaling pathway to explore the mechanism of the nape seven needles in the treatment of cervicogenic headache (ZR2019MH079) and the Shandong Traditional Chinese Medicine Science and Technology Development Program the nape seven needles Intervention of Essential Hypertension Supported by the clinical research project of patients' ABI and baPWV index levels (2019-0248) .

Availability of data and materials

The data used to support the findings of this study are included within the article.

Ethics approval and consent to participate

This study was approved by the Ethics Committee of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine (approval number: 2020-034-01). All patients voluntarily accepted the treatment regimen of our research group and signed the informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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No competing interests reported.

Acupuncture treatment of essential hypertension

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Abstract

Figures

Background

Materials And Methods

Results

Discussion

Declarations

References

Additional Declarations

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