The Effect of Auricular Acupuncture On Preoperative Blood Pressure Across Age Groups A Prospective Randomized Controlled Trial

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Clinical and Experimental Hypertension

ISSN: (Print) (Online) Journal homepage: www.tandfonline.com/journals/iceh20

The effect of auricular acupuncture on


preoperative blood pressure across age groups: a
prospective randomized controlled trial

Jingjing Ma, Yiqing Zhang, Qingqing Ge & Keer Wu

To cite this article: Jingjing Ma, Yiqing Zhang, Qingqing Ge & Keer Wu (2023) The effect of
auricular acupuncture on preoperative blood pressure across age groups: a prospective
randomized controlled trial, Clinical and Experimental Hypertension, 45:1, 2169452, DOI:
10.1080/10641963.2023.2169452

To link to this article: https://doi.org/10.1080/10641963.2023.2169452

© 2023 The Author(s). Published with


license by Taylor & Francis Group, LLC.

Published online: 22 Jan 2023.

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CLINICAL AND EXPERIMENTAL HYPERTENSION
2023, VOL. 45, NO. 1, 2169452
https://doi.org/10.1080/10641963.2023.2169452

The effect of auricular acupuncture on preoperative blood pressure across age


groups: a prospective randomized controlled trial
Jingjing Ma, Yiqing Zhang, Qingqing Ge, and Keer Wu
Department of Nursing, Ningbo Medical Center LiHuili Hospital, Ningbo, China

ABSTRACT ARTICLE HISTORY


Purpose: To determine the effect of auricular acupuncture on preoperative blood pressure (BP) elevation Received 12 August 2022
in different age groups. Revised 31 October 2022
Materials and methods: Auricular acupuncture treats elevated BP among patients before surgery. This Accepted 11 January 2023
prospective, randomized clinical trial was performed at Li Huili Hospital of Ningbo Medical Center, China, KEYWORDS
from January to June 2021. We prospectively enrolled 120 patients with elevated BP aged 45 to 75 and Auricular acupuncture; Blood
observed them in the inpatient department. Patients were randomly assigned in a 1:1 ratio to undergo pressure; Randomized
auricular acupuncture or sham control groups. In addition to usual care, the study group underwent controlled trial; Preoperative;
auricular acupuncture bilaterally at HX6 7i–Ear apex, TF4–Shen men, TF1–Superior triangular fossa, and Hypertension
CO15–Heart.
Results: A total of 120 patients completed the study, 60 in the study group and 60 in the control group. Of
these, 76 (63.3%) were men, and the mean (standard deviation) was 64.55 (9.48) years. The differences in
systolic BP comparisons after intervention were significant (7.88 mmHg; 95% confidence interval [CI], 2.94
to 12.81; P = .002). Diastolic BP also showed statistical significance (5.85 mmHg; 95% CI, 3.05 to 8.64; P <
.01. Neither AA-related adverse events nor serious adverse events occurred. Stratified by age, the
differences comparisons of systolic BP (−10.13 mmHg; 95% confidence interval [CI], −16.69 to −3.57;
P < .01) and diastolic BP (−7.65 mmHg; 95% confidence interval [CI], −11.17 to −4.14; P < .01) were
statistically significant for participants aged 60–75 years; The differences comparison of systolic BP
(−2.37 mmHg; 95% confidence interval [CI], −8.04 to 3.31; P = .40) and diastolic BP (−1.46 mmHg; 95%
confidence interval [CI], −5.68 to 2.76; P = .48) were not significant aged 45–59.
Conclusion: Auricular acupuncture can reduce BP before procedures. However, further research is needed
on the antihypertensive effect on people aged 45–59. These findings provide clinicians with evidence of
auricular acupuncture as a standard adjunctive therapy targeting this patient population.

Introduction Talk and relaxation therapies reduce BP and relieve anxiety;


however, their effects need more research (6).
Preoperative hypertension is a complex problem, encom­
AA is a non-pharmacological treatment that is safe and
passing patients with essential hypertension and those with
effective in clinical practice (7–10). AA can stabilize the auto­
elevated blood pressure (BP) related to surgical stress.
nomic nervous system and reduce BP by activating and sup­
Several studies suggested that preoperative hypertension is
pressing the parasympathetic and sympathetic nervous systems
associated with increased perioperative risk (1,2). The sur­
(11). Several well-designed randomized controlled trials of AA
gery is a severe stressor that can cause vasovagal responses
treating hypertension have been published (12,13). AA has
and unnecessary allostatic loads (3). Preoperative patients
a mild antihypertensive effect and does not cause sharp drops
often produce hypertension via sympathetic nerve excita­
in blood pressure. Nevertheless, there is little evidence of the
tion due to anxiety. Minimizing stressful stimuli accompa­
ability of AA to reduce BP elevated due to the stress surround­
nying procedures is critical but often neglected in hospital
ing surgery. There are few studies on the effect of AA on
routines (4). Preoperative hypertension is a common reason
hypertensive people or in specific age groups. Therefore, we
to cancel or postpone surgery, which will bring quantifiable
designed this study to determine the preoperative pressure
losses of resources and unquantifiable, significant psycho­
effect of AA on patients of different ages.
logical, social, and financial implications for patients and
families (3). Therefore, we focused on preoperative hyper­
tension generated by surgery-related stress that requires Methods/design
immediate resolution.
Design
Medications are used to reduce BP; however, they can cause
unsafe drops in BP, especially in elderly patients. Substantial This study was a randomized trial of AA to treat preoperative
BP variability was significantly associated with coronary ather­ hypertension. The trial was conducted at Li Huili Hospital of
oma progression and major adverse cardiovascular events (5). Ningbo Medical Center from January to June 2021. All patients

CONTACT Jingjing Ma shelleymjj2004@hotmail.com Master, Department of Nursing, Ningbo Medical Center LiHuili Hospital, Ningbo 315000, China

© 2023 The Author(s). Published with license by Taylor & Francis Group, LLC.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits
unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
2 J. MA ET AL.

provided written, informed consent prior to randomization. Recruitment procedures


The Ethics Committee of the Li Huili Hospital of Ningbo
We recruited participants using advertisements for the hospi­
Medical Center approved the trial protocol. Trial registration:
tal. All participants were informed that there were two study
Clinical Trials gov MR-33-20-005594.
groups, i.e., an AA group and a sham control group, with 50%
of the allocation. If patients were taking antihypertensive med­
Participants ications, they were instructed to continue them. All were
informed of their right to withdraw from the trial (Figure 1).
We prospectively enrolled 130 patients from the Li Huili
Hospital of Ningbo Medical Center. Finally, 120 patients
were randomized into two groups (Table 1). Randomization
One appointed investigator was responsible for the randomiza­
tion. Complete randomization was performed using the random
Inclusion criteria
number generator in SPSS 23.0 (IBM Corp, Armonk, NY). After
1. Scheduled for nasopharyngeal surgery under general establishing selection criteria, the recruiters obtained numbers
anesthesia. from the assigning investigator and randomly assigned patients
2. American Society of Anesthesiologists physical status classi­ to the study or control groups. The groups were assigned to
fication of I or II. separate wards to prevent communication.
3. Systolic BP (SBP) ≥ 130 mmHg or diastolic BP (DBP) >
80 mmHg on the day of surgery morning (14).
4. Age 45–75 years. Interventions and comparison
5.Willingness to participate and signed an informed consent Study group
form. In addition to usual care(disease awareness, dietary gui­
dance, exercise, and psychological care), the participants
received AA treatment based on the theory of neuroanatomy
Exclusion criteria
(16), the literature (17,18), and a textbook (19). We chose the
1. Hypertensive crisis (220/140 mm Hg) and DBP 120 to following auricular points(Figure 2): HX6 7i–Ear apex, TF4–
130 mm Hg (15). Shen men, TF1–Superior triangular fossa, and CO15–Heart.
2. History of syncope resulting from applying needles or con­ The licensed acupuncturist had more than 5 years of experi­
traindications to using needles. ence in AA. When the patients were relaxed and prone, the
3. Previous use of opioid or psychotropic medication. acupuncturist held the upper posterior corner of the helix with
4. Canceled surgery. one hand and located sensitive points with an auricular point
5. Complications during treatment (e.g., auricular skin infec­ detector using the other hand. The acupuncturist used 75%
tion or pain). alcohol pads to sterilize the area, then inserted needles

Table 1. Baseline demographic and clinical characteristics.


Mean (SD)
Study group Control group
Characteristic (n = 60) (n = 60) P value
Age, y 63.55(9.82) 65.55(9.10) .25
Body mass indexa 24.59(1.23) 24.74(1.79) .58
Male, No. (%) 37(61.7) 39(65) .70
Medical history, No. (%)
Hypertension 22(36.7) 20(33.3) .70
Diabetes 8(13.3) 4(6.7) .22
Medication, No. (%)
Antihypertensive drugs 22(36.7) 20(33.3) .70
Controlled BP on ≥2drugs 12 (21.7) 11 (18.3) .65
ACE inhibitors/angiotensin receptor antagonists 15 (25.0) 14 (23.3) .83
Calcium channel blockers 7 (11.7) 6 (10.0) .77
Diuretics 12 (20.0) 11 (19.2) .82
Aldosterone antagonist 5 (8.3) 3 (5.0) .71
oral antidiabetics 8(13.3) 4(6.7) .22
Surgical classification 11 (%)
Two-level 25(41.7) 28(46.7) 0.63
three-level 28(46.7) 23(38.3)
four-level 7(11.7) 9(15.0)

1
Surgical classification: In order to ensure the safety of patients, Chinese Ministry of Health issued the “Surgical Classification Catalog” in 2011. According to the risk and
difficulty of the operation, the operation is divided into four grades.
CLINICAL AND EXPERIMENTAL HYPERTENSION 3

Figure 1. Flow diagram depicting the study design.

Figure 2. Auricular acupuncture used in the study group.

Figure 3. Baseline BP was measured the day after admission, BP before AA was
(Figure 3) (length 1.5 mm, diameter 0.22 mm; Seirin Corp, measured at 6:00 on the day of the procedure, and BP after AA was measured
Shizuoka City, Japan) into the four auricular points bilaterally. 30 min before surgery. BPs between 45 and 75 years old include SBP and DBP.
The needles remained in situ. Subsequently, the acupuncturist *P < .05 BP after AA for study group vs control group.
instructed the patient to stimulate the auricular needles for 10s,
with a 3-s pause between the two pressings (20). Optimal the same as the study group. The fake needle is made of round
stimulation was achieved when the subject felt localized tin­ tape with a diameter of 1 cm and no sharp needle. Its appear­
gling pain. Auricular needles were removed before sending the ance, color, and shape were identical to the AA needle. Each
patient to the operating room. The patient would enter the acupuncture point received the same twirling motion as the
operating room accompanied by transport staff and wait about acupuncture group.
15 minutes for anesthesia and surgery.

BP measurement
Control group
The BP measurement device was validated. We had the patient
The control group received sham acupuncture. Acupuncture relax and sit comfortably in a quiet room at a controlled
points and manipulation methods of sham acupuncture were temperature of 18–22°C. Neither the patient nor the observer
4 J. MA ET AL.

talked during the measurement. We used the average of two Results


readings obtained twice to estimate an individual’s BP level.
Recruitment and retention
The measurement interval was 10 minutes. All BP measure­
ments were performed by nurses using the same training All of the 120 patients who met the enrollment criteria agreed
techniques. to participate. No patient terminated the study prematurely; all
completed the follow-up assessments and were included in the
analysis (Figure 1). Of the total, 76 (63.3%) were men, the mean
Outcome (SD) age was 64.64 (10.9) years, and 35 (29.1%) were aged 45–
59 years. Baseline demographic, clinical characteristics and
The primary outcome measure was a change in systolic BP, surgery classification are displayed in Table.
measured after AA intervention and immediately before sur­
gery. Secondary outcomes were changes in diastolic BP after
AA intervention and immediately before surgery and adverse Outcomes
events (i.e., pain, hematomas, skin damage, bleeding, and local
infections) (Figure 3). The primary outcome (SBP after intervention) was more sig­
nificant in the study group (mean 9.91 mmHg) than in the
control group (mean 2.03 mmHg), with a mean difference of
7.88 mmHg (95% CI, 2.94 to 12.81; P = .002). The reduction in
Safety and quality control
DBP after the intervention was more significant in the study
Adverse events were appropriately assessed and recorded by group (mean, 6.30 mmHg) than in the control group
the observers. Severe adverse events would have resulted in (0.45 mmHg), with a mean difference of 5.85 mmHg (95%
stopping the trial. Two investigators independently collected CI, 3.05 to 8.64; P < .01). There were no AA-related or severe
and recorded the data in a computer to ensure safety and adverse events (Figure 3).
reliability. Stratified by age, participants aged 60–75 years (SBP after
intervention) in the study group (mean −10.83 mmHg) was
more significant than the control group (mean 0.69 mmHg),
Sample size calculation with a mean difference of −10.13 mmHg (95% CI, −16.69 to
−3.57; P = .003), the reduction in DBP (mean −7.19 mmHg)
The study was powered for a primary outcome measure of the was more significant than the control group (0.46 mmHg),
difference in systolic BP in two groups before and after the with a mean difference of −7.65 mmHg (95% CI, −11.17 to
ðZα þZβ Þ�2σ 2 −4.14; P < .01). (Figure 4) However, participants aged 45–59 in
intervention. We used the formula n ¼ δ2
. the study group had no difference in SBP and DBP after the
N represents the sample size in each group, ϭ represents the intervention compared with the control group. The reduction
standard deviation, and δ represents the between-group differ­ in SBP (mean −2.37 mmHg, 95% CI, −8.04 to 3.31; P =.40) and
ence with clinical significance. At an α value of 0.05, we DBP (mean −1.46 mmHg, 95% CI, −5.68 to 2.76; P =.48) were
obtained Z scores of Za = 1.28 and Zβ = 0.84 from the not different from the control group.
Z score table. The sample size calculation was based on Tu
et al., who showed a decrease of – 8.53 ± 13.50 mmHg in
systolic BP in the control group (13). SBP was expected to Discussion
decrease by 8.5 mmHg. A one-sided 0.05 level of significance
provided 80% statistical power. To accommodate a 10% attri­ Auricular therapy treats physical and psychosomatic diseases
tion rate, we needed to recruit at least 80 patients. by stimulating specific points in the ears; it is a fundamental
method in traditional Chinese medicine for returning the body
to a harmonized, balanced state (21). Western investigators
have also studied auricular points. In 1957, Paul Nogier pro­
Statistical analysis
posed an inverted fetal image to describe the holographic
The data were analyzed using SPSS 23.0. Shapiro-Wilk tests theory. The manipulation of auricular therapy is based on the
were performed to determine the normality of data distri­ holographic theory, a sort of assumption that information
bution. Continuous variables were expressed as means with regarding a part of the entire organism could be retrieved
standard deviations (SDs), and mean differences were from the corresponding point of the ear, so that stimulation
expressed with two-sided 95% CIs. Between-group differ­ to a specific point of ear could ameliorate the function of the
ences at baseline and changes from baseline to the end of corresponding visceral organ or other part of the body (22).
the study were tested using independent t-tests. Paired Preoperative elevated BP is a frequent complication (23). In
t-tests were performed for within-group comparisons from this trial, we aimed to clarify the efficacy and safety of AA for
baseline to the end of the study. Socio-demographic char­ preoperative BP elevation. We found that AA reduced preo­
acteristics, disease-related characteristics, and homogeneity perative SBP and DBP. This phenomenon may involve baror­
of dependent variables were analyzed using the chi-squared eceptor responses and cardiovascular inhibition induced by
(χ2) test. The level of significance was a two-sided P-value auricular acupuncture (24). Hypertension is due to sympa­
less than 0.05. thetic nerve activity increased or vagally-mediated cardiac
CLINICAL AND EXPERIMENTAL HYPERTENSION 5

Figure 4. Stratified by age, the chart shows the change in BP between 60 and 75 years old. BPs include SBP and DBP. *P < .05 BP after AA for study group vs. control
group.

tone reduction (25). The auricular conchae are innervated by induced BP increases within a very short period in young
the auricular branch of the vagus nerve, and acupuncture at individuals (29).
a concha can induce afferent projection through the vagus The acupuncture points we chose are unique; they stimulate
nerve to the nucleus of the solitary tract (11). Acupuncture cranial nerves that modulate stress-related brain areas (30). In
has been used to treat high BP in China (26–28). Auricular a previous trial, five or more acupoints were used to lower BP.
acupuncture evokes cardiovascular inhibition similar to the In our trial, we used only four points to simplify the treatment
baroreceptor in regulating cardiovascular function. in the perioperative setting.
Hypertension maintains optimal levels and achieves less Surgery is a stressful event for most patients (31). BP can be
BP variability (19). BP changes even if patients are not reduced once sympathetic nerve excitation is relieved. When
diagnosed with hypertension (27). Medications may reduce general anesthesia begins, the sympathetic nerve excitement is
BP too quickly and increase the risk of hypotension perio­ relieved. Therefore, we removed the needles at the beginning of
peratively. In our trial, AA safely altered BP, particularly the procedure and only studied patients with elevated BP
systolic BP. preoperatively.
However, age is an influencing factor of BP in the guide­ It is worth mentioning that the safety of AA should draw
lines, especially after age 60; the range of BP has changed. The our attention, as it is a kind of traumatic intervention. We
population in our study was 45–75 years old, and the BP recorded no AA-related adverse events or severe adverse
analysis was carried out according to the age factor, with events. Our subcuticular needle (Figure 5) method circumvents
60 years old as the cutoff line. It is concluded that AA sig­ the limitations of conventional acupuncture (fixed treatment
nificantly affects preoperative BP control in 60–75-year-olds and time, inconvenience of other medical operations during
but not in 45–59- year-olds. This may be related to the small needle retention, and patient aversion to needles). In addition,
sample size of 45–59-year-olds; only 35 (29.1%) were aged we designed sham acupuncture. The fake needle is made of
45–59 in this trial. This could be attributed to the individuals’ round tape with a diameter of 1 cm and has no sharp needle. Its
perceptions of the controllability of the stressor. Stress- appearance, color, and shape are identical to the AA needle.
induced increases or decreases in dopamine secretion in the Most of the participants could hardly distinguish this device
nucleus accumbens depend on many factors (28). Stress- from real acupuncture.

Figure 5. Auricular acupuncture.


6 J. MA ET AL.

Limitation postoperative nausea and vomiting in patients undergoing craniot­


omy: study protocol for a randomised controlled trial. BMJ Open.
Our findings suggest the safety and efficacy of AA as adjunctive 2019;9(11):e032417.doi:10.1136/bmjopen-2019-032417.
therapy in patients with perioperative hypertension. 11. Thi Mai Nguyen H, Lee DY, Wu HM, Hsieh CL, Zhu G. Auricular
Nevertheless, this study has several limitations. First, the study acupuncture to lower blood pressure involves the adrenal gland in
was the unblended single center. Second, the study lacked more spontaneously hypertensive rats. Evid Based Complement Alternat
Med. 2020;2020:3720184.
extensive age stratification, there were no individuals under the 12. Liu Y, Park JE, Shin KM, Lee M, Jung HJ, Kim AR, Jung SY,
age of 45, and there was an insufficient sample size for 45–59- Yoo HR, Sang KO, Choi SM. Acupuncture lowers blood pressure
year-olds. Further research is needed to address this issue. in mild hypertension patients: a randomized, controlled,
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Disclosure statement 13. Tu JF, Wang LQ, Liu JH, Qi YS, Tian ZX, Wang Y, Yang JW,
Shi GX, Kang SB, Liu CZ. Home-based transcutaneous electrical
No potential conflict of interest was reported by the author(s). acupoint stimulation for hypertension: a randomized controlled
pilot trial. Hypertens Res. 2021;44(10):1300–06.doi:10.1038/
s41440-021-00702-5.
Funding 14. 2017ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/
NMA/PCNA guideline for the prevention, detection, evaluation,
This work was supported by the Zhejiang Provincial Medical and Health and management of high blood pressure in adults.
Technology Project [2021KY1042]. 15. Cherney D, Straus S. Management of patients with hypertensive
urgencies and emergencies: a systematic review of the literature.
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