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Efficacy of acupuncture in patients with carotid atherosclerosis: a randomized controlled clinical trial

BMC Complementary Medicine and Therapies volume 24, Article number: 313 (2024) Cite this article

Abstract

Background

The current clinical management of carotid atherosclerosis is based on the control of risk factors and medicine. However, the risk of adverse events associated with the medicine resulting in concerns and low medication compliance makes it necessary to seek a safer alternative therapy. This study assessed the effectiveness and safety of acupuncture as a treatment for carotid atherosclerosis.

Methods

In this randomized controlled trial, patients with carotid atherosclerotic plaques were included and randomly assigned (1:1) to receive real acupuncture or sham acupuncture for 12 weeks. The follow-up period was 12 weeks. The primary outcome included carotid intima-media thickness (cIMT), plaque score (PS), plaque volume (PV) and grey-scale median (GSM). Secondary outcome was pulse wave velocity (PWV). Adverse events results were recorded as safety outcomes.

Results

From January 2021 to February 2022, 60 eligible patients were included. 55 patients (91.7%) completed the intervention and the 12-week follow-up and there was no statistical difference in demographics between the groups. At the end of treatment, the real acupuncture group had significantly reduced PS (P = 0.002), PV (P = 0.000), and improved GSM (P = 0.044). There was no significant difference in the reduction in cIMT (Left cIMT: P = 0.338, Right cIMT: P = 0.204) and PWV between the groups (the left BS: P = 0.429; the left ES: P = 0.701; the right BS: P = 0.211; the right ES: P = 0.083). Three mild adverse reactions occurred during the study.

Conclusion

This study found that acupuncture had a certain effect on reducing the thickness and volume of carotid plaque and improving the stability of plaque with minor side effects. These findings suggest that acupuncture may be a potential alternative therapy for carotid atherosclerosis.

Trial registration

This trial has been registered at ClinicalTrials.gov (ChiCTR2100041762). Submitted 30 December 2020, Registered 4 January 2021 Prospectively registered.

Peer Review reports

Introduction

Stroke is the second leading cause of death and disability worldwide, affecting approximately 15 million people globally each year and burdening public health heavily [1]. Carotid atherosclerosis is the major reason of strokes, particularly ischemic stroke, which accounts for more than 70% of strokes [2]. There are about one-fifth ischemic strokes caused by carotid atherosclerotic plaques [3]. Therefore, early management of carotid atherosclerotic plaques will contribute to reduce the occurrence of stroke events.

Recently the reversibility and stability of carotid atherosclerotic plaques have drawn increasing research attention [4]. There is a clinical preference for non-surgical treatment based on controlling risk factors such as lowering lipid levels with pharmacological treatment and anti-platelet therapy to delay early plaque progression and prevent ischemic stroke events [5]. Statins have been shown to have plaque reversal and stabilization effects [6, 7]. However, they are associated with a range of side effects represented by muscle symptoms [8]. Aspirin, a traditional anti-platelet drug, may bring about a risk of adverse events of severe bleeding during treatment [9]. These side effects make it difficult for patients to adhere to the medication. Consequently, it is necessary to seek an alternative therapy with similar efficacy while being safer.

For the past few years, the therapeutic effect of traditional Chinese medicine, as represented by acupuncture and moxibustion, is obtaining more and more attention [10]. It was found that acupuncture was applied to treat ischemic stroke [11], coronary heart disease [12], peripheral artery disease [13] and other atherosclerotic cardio-cerebrovascular diseases. A meta-study on the treatment of carotid atherosclerosis by acupuncture showed that the improvement of carotid atherosclerosis by acupuncture may be related to lipid regulation and local blood flow velocity [14]. In addition, acupuncture also contributes to reducing inflammation [15,16,17] and protecting vascular endothelial cells [18]. Although acupuncture has been widely used in the treatment of carotid atherosclerosis in China, there is still a lack of high-quality evidence for its efficacy and safety in carotid atherosclerosis [14]. In previous clinical studies, acupuncture is often combined with medicines for treatment [14], which is difficult to prove the unique role of acupuncture in treatment. At the same time, the selection and number of acupuncture points are inconsistent [19], which is difficult to explain the effect of specific acupuncture points. Thus, in order to confirm the specific effects of acupuncture in the treatment of carotid atherosclerosis, we conducted this randomized controlled clinical trial of acupuncture at a single point. Our hypothesis is that acupuncture may prove beneficial in alleviating carotid atherosclerosis.

Methods

Study design

This study was a randomized, single-blind, parallel-controlled, single-center clinical trial. The participants were patients with carotid atherosclerosis disease (CAD) who were randomized 1:1 into the RA group (receiving real acupuncture therapy) and the SA group (receiving sham acupuncture therapy). The protocol was approved by the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no.YF2020-195-01). The study was planned in accordance with the Declaration of Helsinki. All participants gave written informed consent before participating in this study. The design and reporting of this trial adhered to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. It was registered (ChiCTR2100041762, 04/01/2021) before inclusion of the first participant.

Participants

Participants from Ultrasonography and Acupuncture clinic of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine were enrolled in the study after meeting the following criteria.

Inclusion criteria

(1) Age between 45 and 70 (unrestricted sex); (2) Conformation to the diagnostic criteria of CAD; (3) No susceptible plaque and less than five plaques on both sides; (4) Carotid aortic stenosis < 50%; (5) Cholesterol between 2.59 and 8.0 mmol/L and triglycerides between 1.7 and 10.0 mmol/L; (6) No recent two-week usage of any medication related to the improvement of atherosclerosis, such as medicine for hypertension, heart failure, hyperlipidemia, and diabetes; (7) Volunteer to participate in the trail and cooperate with researchers and understand the content of the trail.

Exclusion criteria

(1) More than 4 risk factors such as age over 60 years old, obesity, diabetes, hypertension, low HDL-C, and smoking; (2) A history of cerebrovascular accident, transient ischemic attack, severe trauma or major surgery; (3) Major cardiovascular, hepatic, renal, or hematopoietic deficiency; (4)A history of mental disorders such as cognitive impairment; (5) A history of skin and bleeding disorders: (6) Intolerance to acupuncture or pregnancy or planning to become pregnant; (7) Participation in other trials.

Dropout criteria

(1) If severe cardiovascular condition or cerebrovascular condition occurred, it was recommended that the patient take appropriate treatment after evaluation by a physician; (2) If aggravated complications occurred after receiving acupuncture treatment, it was recommended that the patient take appropriate treatment after evaluation by a physician; (3) The participant was unable to take part in the trail for personal reasons.

Randomization and blinding

The participants were randomly allocated into the RA and SA groups in a ratio of 1:1. Randomization was created by a mathematician, who was not involved in the study, using SPSS Statistics version 22.0 (IBM). Random numbers and grouping results were saved in opaque envelopes by the mathematician who performed the randomization. The envelopes were opened by the research assistant to assign them in the order in which they are registered.

The participants were blinded, while the acupuncturists in this study were not blinded because of the characteristics of acupuncture. Single-blinded acupuncture intervention using a special acupuncture tool for patients in the 2 groups. The acupuncture device is depicted in Fig. 1. In addition, duration of acupuncture and the acupoints used for the 2 groups were the same. All patients’ evaluations of ultrasound were done by an experienced sonographer who was not aware of the study design and who did not know the patients’ classification.

Fig. 1
figure 1

An acupuncture tool applied in the RA and SA groups

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Interventions

Participants in the RA and SA groups received 30-minute acupuncture once per day, twice per week for a period of 12 weeks, with fixed prescriptions according to the traditional Chinese medicine theory. All participants received acupuncture at ST9 (ren ying), PC6 (nei guan), GB34 (yang lingquan), DU20 (bai hui) and EX-HN3 (yin tang) (Table 1; Fig. 2). The names and locations of acupoints are labeled according to the WHO Standard Acupuncture Locations guideline [20]. Before undergoing acupuncture, patients were asked to lie in the supine position in a quiet environment, and his or her skin near the acupoints was sterilized by the acupuncturists with 0.5% iodine. For RA, acupuncture was performed with a stainless steel needle (Huatuo, Suzhou Medical Appliance Factory, Suzhou, China 25 × 25 mm) at ST9. The depth was between 0.5 and 1.0 cm. And then use specific disposable, sanitized, blunt, sham stainless steel needles (Huatuo, Suzhou Medical Appliance Factory, Suzhou, China 25 × 25 mm) at PC6, GB34, DU20 and EX-HN3, which is a noninsertion procedure applied. For SA, acupuncture was performed using the same sham stainless steel needles (Huatuo, Suzhou Medical Appliance Factory, Suzhou, China 25 × 25 mm) at ST9, PC6, GB34, DU20 and EX-HN3. After acupuncture was started, the needle was kept in place for 30 min in both groups.

Table 1 Acupuncture point positioning criteria
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Fig. 2
figure 2

Acupuncture Point Location diagram

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Outcome measures

The primary outcomes and the secondary outcome of all participants in 2 groups were assessed at baseline, posttreatment, and follow-up (12 weeks after posttreatment).

Primary outcome

The primary outcomes mainly reflected the changes of carotid artery structure, which included carotid intima-media thickness (cIMT), plaque score (PS), plaque volume (PV) and grey-scale median (GSM). cIMT and PS were examined by Philips EPIQ color Doppler ultrasonography in a two-dimensional grayscale imaging mode. PV and GSM were three-dimensional ultrasound indexes, which were examined by Philips EPIQ color Doppler ultrasonography. The software automatically identifies and outlines the vessel wall and plaque boundary, collects plaque volume information and plaque echo characteristics, and realizes real-time analysis to obtain PV and GSM values. cIMT, PS, PV are positively correlated with the degree of carotid atherosclerosis, and GSM is positively correlated with carotid plaque stability.

Secondary outcomes

The secondary outcome was pulse wave velocity (PWV), which mainly reflected the changes of carotid artery function. PWV was caused by blood flow along the aorta to the peripheral artery during systolic and dilated phases of cardiac ejection, which was used for assessing the stiffness of the carotid artery as well as degree of carotid atherosclerosis. PWV was measured by French Supersonic Aixplorer ultrasonic diagnostic instrument with the SL10-2 probe, frequency 2–10 Hz, vascular PWV mode. The sonographer selected 1–1.5 cm below the carotid bifurcation of the common carotid artery as measurement site. Indicators included PWV at the beginning of the systole (BS, m/s) and PWV at the ending of the systole (ES, m/s). If the standard deviation is more than 20% of the corresponding speed, the operation is deemed invalid. Both sides carotid arteries were measured at least three times and then the researcher recorded the average PWV value. A higher PWV indicates higher degree of carotid atherosclerosis.

Sample size calculation

The sample size was determined by the variation in the PV in pilot study. The mean (SD) PV of patients who received acupuncture was 9.54 (15.74) mm3, whereas that of patients who received the sham acupuncture was − 1 (8.02) mm3. The sample size estimation was calculated by PASS15.0 software, with a two-sided significance level of α = 0.05, power efficiency 1-β = 0.9, and the ratio of the two groups was 1:1. It was calculated that 31 subjects were needed in each group, and a total of 62 subjects were needed.

Adverse events

Acupuncture may cause some adverse events, such as fainting, bleeding and pain. All adverse events need to be recorded. The record of adverse events should include the symptoms, duration, extent, and relationship with acupuncture.

Statistical analysis

SPSS Statistics version 22.0 (IBM) was used to analyze the study data from January 2021 to February 2022. Continuous variables were conveyed as mean and standard deviation (SD) if meet normal distribution, and categorical variables were conveyed as composition ratio. The Continuous variables of the groups were compared using the t test or Mann-Whitney U test. The categorical variables of the groups were compared using the χ2 test or Fisher’s exact test. The primary outcome and secondary outcome were assessed by repeated measure two factorial analysis of variance with interaction effects of time and group. P < 0.05 was accepted as statistically significant.

Results

Participants

A total of 70 patients with carotid atherosclerosis disease were evaluated between January 2021 to February 2022; 60 eligible patients were enrolled, including 40 women and 20 men; 55 patients (91.7%) completed the intervention and the 12-week follow-up, including 38 women (69.1%) and 17 men (30.9%) (Table 2; Fig. 3). Five participants (8.3%) abandoned the study. The number of patients that dropped out and the reasons for the dropouts are displayed in Fig. 3. Table 2 showed the baseline demographic and clinical characteristics of the included participants.

Table 2 Baseline demographic and clinical characteristics of the included participants
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Fig. 3
figure 3

Procedures and data used for the study

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Primary outcome

Table 3; Fig. 4 show the changes of the primary and secondary outcomes from baseline between the 2 groups. Table 4; Fig. 5 show comparisons of the primary and secondary outcomes based on assessment time in the 2 Groups.

Table 3 Comparison the changes of the primary and secondary outcomes from baseline in the real acupuncture and Sham acupuncture groups
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Fig. 4
figure 4

Comparison of the changes of the primary and secondary outcomes from baseline in the Real Acupuncture and Sham Acupuncture Groups. * represents the RA group compared with the SA group p < 0.05; Abbreviations: cIMT, carotid intima-media thickness; PS, plaque score; PV, plaque volume; GSM, grey-scale median; RA, real acupuncture; SA, sham acupuncture

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Table 4 Comparison of the primary and secondary outcomes based on assessment time in the 2 groups
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Fig. 5
figure 5

Comparison of the primary and secondary outcomes based on assessment time in the 2 Groups. * represents p < 0.05; Abbreviations: cIMT, carotid intima-media thickness; PS, plaque score; PV, plaque volume; GSM, grey-scale median; RA, real acupuncture; SA, sham acupuncture

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Carotid intima-media thickness (cIMT)

At the end of treatment, the left cIMT decreased by 0.05 mm in the RA group and 0.01 mm in the SA group. At the end of treatment, the right cIMT decreased by 0.04 mm in the RA group and 0.01 mm in the SA group. There were no significant differences in the change in the left and right cIMT (Left cIMT: P = 0.338, Right cIMT: P = 0.204) at the end of treatment.

After follow-up, the left cIMT decreased by 0.05 mm in the RA group and 0.01 mm in the SA group. After follow-up, the right cIMT decreased by 0.06 mm in the RA group and 0.01 mm in the SA group. The differences were not statistically significant in the change in the left and right cIMT (Left cIMT: P = 0.170, Right cIMT: P = 0.061) after follow-up.

Plaque scores (PS)

At the end of treatment, the PS decreased by 0.39 mm in the RA group and 0.08 mm in the SA group (P = 0.002). After follow-up, the PS decreased by 0.46 mm in the RA group and 0.01 mm in the SA group (P = 0.002). Further analysis showed that the PS in the RA group had a moderate decrease over time, while the PS in the SA group had a slight decrease. However, there was no significant difference (P = 0.091).

Plaque volume (PV)

At the end of treatment, the PV decreased by 23.39 mm3 in the RA group and 1.37 mm3 in the SA group (P = 0.000). After follow-up, the PV decreased by 24.21 mm3 in the RA group and 2.63 mm3 in the SA group (P = 0.002). Further analysis showed that the PV in the RA group had a decline at the end of treatment and after follow-up compared with the SA group (P = 0.012).

Grey-scale median (GSM)

At the end of treatment, the GSM increased by 13.80 in the RA group and 0.85 in the SA group (P = 0.044). After follow-up, the GSM increased by 16.54 in the RA group and 4.93 in the SA group. There was no statistical difference (P = 0.135). Further analysis showed that the GSM in the RA group increased over time compared with that in the SA group (P = 0.017).

Secondary outcomes

BS is the pulse wave velocity (PWV) at the beginning of systole and ES is PWV at the end of systole. At the end of treatment, the variance in the left and the right carotid PWV between the 2 groups was not statistically significant (the left BS: P = 0.429; the left ES: P = 0.701; the right BS: P = 0.211; the right ES: P = 0.083). After follow-up, the variance in the left and the right carotid PWV between the 2 groups was not statistically significant (the left BS: P = 0.860; the left ES: P = 0.479; the right BS: P = 0.376; the right ES: P = 0.250).

Adverse events

Three mild adverse reactions occurred during the study. No serious adverse events occurred.

Discussion

To our knowledge, this is the first randomized clinical trial of the effectiveness of acupuncture treatment at a single point in asymptomatic patients with carotid atherosclerosis. The results show that in terms of carotid atherosclerotic plaques, acupuncture had certain efficacy and safety. Acupuncture can significantly reduce plaque thickness and volume, and at the same time enhance the internal echo of plaques with mild adverse reactions. And yet, in terms of the carotid artery, acupuncture has no visible results. Acupuncture did not obviously improve the cIMT and the PWV of the carotid artery.

Currently, the world is facing an enormous burden of carotid atherosclerosis. According to a recent meta-analysis, there are about 2 billion patients aged 30–79 with carotid atherosclerosis in the world, including 1 billion with abnormal carotid intima-media thickness while 1 billion with carotid plaques or carotid stenosis [21]. Asymptomatic extracranial arterial stenosis that develops from plaque enlargement and intimal thickening is a well-known risk factor for stroke and is associated with new episodes of cardiovascular disease, especially stroke [22]. Early detection and management of plaque is important for the prevention and reduction of vascular disease. Results of this study suggest that acupuncture helps to reduce plaque thickness and volume at large scale. The previous reported the effectiveness of acupuncture as an adjunctive therapy involved in the treatment of carotid atherosclerosis [23]. In order to avoid the interference of medication on the efficacy of acupuncture, we only included patients who had not taken medication for carotid atherosclerosis in the last two weeks. Patients were allowed to take medication for other conditions which were recorded in detail. Therefore, this study further confirmed the effectiveness of acupuncture as a single therapy in treating the thickness and volume of carotid plaques.

At the same time, this study focused on the effect of single point (ST 9) in order to identify the specific effects of acupuncture point. In the theory of traditional Chinese medicine, the cause of carotid atherosclerosis is stagnant phlegm and stasis [24]. Atherosclerotic plaques will form when phlegm and stasis build up in the blood. The buildup of phlegm and blood stasis is related to the abnormal function of the spleen and stomach [24]. The abnormal function of the spleen and stomach can affect the transport and absorption of fine matter of water and grain, resulting in the formation of phlegm and stasis. Therefore, we chose ST9 as the acupuncture point in this study. ST9 is one of the points on the stomach meridian of foot yang brightness. Acupuncture at ST9 will facilitate the clearing up phlegm and dispelling stasis. At the same time, the stomach meridian of foot yang brightness goes up to the head and down to the chest and abdomen, even the foot. ST9 as an important hub of stomach channel, can promote the flow of the whole body’s qi and make the blood run smoothly [25]. Furthermore, ST9 is located near the carotid artery. The local effect is one of the important effects of acupuncture point [26]. Acupuncture at ST9 can affect the local carotid artery, so as to play the role of anti-atherosclerosis. Therefore, this trial observed the effect of acupuncture at ST9 on carotid atherosclerosis. However, if only one acupoint is set, it is difficult for patients to accept and understand. The reason is that acupuncture therapy rarely involves only one point clinically. As a consequence, we also set up other points in addition to ST9, which contributes to increase patient compliance. In order to avoid the interference of other points, sham needles were used at the other points. In group receiving real acupuncture therapy, real needles were used at ST9, and sham needles were used at other points. In group receiving sham acupuncture therapy, sham needles were used at all points. Patients at low risk, such as those without a history of stroke, coronary heart disease, or diabetes, are not recommended for secondary prevention with statins [27]. Since this study has excluded high-risk patients, using sham acupuncture as a control group is in line with ethical requirements. In this study, the PS decreased by 0.39 mm in the RA group and 0.08 mm in the SA group at the end of treatment (P = 0.002), and the PS decreased by 0.46 mm in the RA group and 0.01 mm in the SA group after follow-up (P = 0.002). Unfortunately, this apparent decrease in the RA group was not statistically significant over time compared to the SA group (P = 0.091). A study has shown that 3 months of intensive lipid-lowering therapy can promote the reduction of carotid plaque score from 3.64 to 2.34 [28]. It can be seen that acupuncture ST9 may have a certain effect on reducing the carotid plaque score. Surprisingly, the changes of PV in the RA group also decreased obviously. The results showed that the PV decreased by 23.39 mm3 in the RA group and 1.37 mm3 in the SA group (P = 0.000) after the treatment. After follow-up, the PV decreased by 24.21 mm3 in the RA group and 2.63 mm3 in the SA group (P = 0.002). Further analysis showed that the PV in the RA group had a decline at the end of treatment and after follow-up compared with the SA group (P = 0.012). A study reported that high-dose statins can reduce the PV in patients with ischemic stroke [29]. After 6 months of statin administration, the PV decreased from 32.07 mm3 to 17.06 mm3. It can be seen that acupuncture with ST9 has similar advantages to statins in reducing plaque volume. However, in terms of cIMT, the results showed that although the TA group had a decrease compared to the SA group at the end of treatment, there was no statistical difference. This is inconsistent with previous studies reporting that acupuncture has the effect of reducing cIMT [23, 30]. We consider that it may be related to the insufficient effect of ST9. IMT is only a weak predictor of atherosclerosis and changes so little over time [31]. Acupuncture at a single point may not be sufficient to cause significant changes in cIMT.

Vulnerable plaque in the carotid arteries is associated with a higher risk of stroke [32]. Management targeting atherosclerotic plaque burden and composition is beneficial in reducing ischemic vascular events [33]. GSM has the ability to identify vulnerable plaques. Stable plaques exhibit extensive fibrotic tissue and calcification, accompanied by stronger echo and higher GSM [34]. The results showed that the GSM increased by 13.80 in the RA group and 0.85 in the SA group (P = 0.044). Further analysis showed that the GSM in the RA group increased over time compared with that in the SA group (P = 0.017). A meta-analysis indicated that statin therapy was related with carotid plaque echo. Plaque GSM is elevated after statin therapy [35]. Changes in the composition of vulnerable plaques after statin therapy, such as a reduction in the lipid core, may be in connection with anti-inflammatory effects [36]. The present study is the first to report on the validity of acupuncture in increasing the plaque GSM value, which is similar to the results of studies with statins [35]. Previous studies have reported that acupuncture can improve atherosclerosis by regulating lipid metabolism [14] and reducing inflammation [15,16,17]. Combined with the results of this study, anti-inflammatory or lipid-lowering mechanisms may be the potential mechanisms of acupuncture at ST 9 to improve plaque stability. As it is a prospective study, it is not designed in terms of molecular biological mechanism. The potential mechanism of action can be further explored from the perspective of lipids or inflammation in the future.

Most have found that increased carotid stiffness is associated with carotid plaque, degree of atherosclerosis, and new stroke [37]. PWV is the most widely used index of arterial stiffness to predict the development of carotid atherosclerosis [38]. In this study, a new technique allows the acquisition of PWV in local vessels to assess changes in vascular stiffness [39]. Unfortunately, the results showed that the TA group had no significant improvement in arterial stiffness compared with the SA group. Changes in carotid stiffness are mainly influenced by the age, blood pressure and BMI of the individual [40]. Short-term changes in PWV, such as blood pressure, require continuous PWV detection during the intervention [41]. This study evaluated the effect of acupuncture on carotid artery stiffness at a three-month interval. However, after acupuncturing local acupoints for three months in this study, the carotid artery stiffness did not change significantly. This may be related to the insufficient duration, frequency or intensity of acupuncture selected in this study. PWV changes steadily with age, so it is often used as an evaluation indicator of vascular aging [42]. If it is to achieve long-term stable change, it may require a strong intensity of intervention. In contrast, the results of this study show that measures such as PS and PV can be reduced within three months. A meta-study on the treatment of carotid atherosclerosis by acupuncture showed that the improvement of carotid plaque by acupuncture mainly occurred within 1–3 months [43]. Changes in carotid plaque appear to occur more easily than changes in the carotid artery itself. In the future, the intensity of acupuncture intervention can be increased to further explore the changes of acupuncture on carotid artery stiffness.

At present, the treatment of atherosclerosis is usually based on pharmacological therapy. The use of and compliance with statin are not very satisfactory [44], especially the adverse events caused by statins have been closely observed in recent years. Although studies have shown that its benefits far outweigh the risk of adverse events, concerns about side effects remain [45]. Only three cases of mild adverse reactions occurred in this study, specifically localized subcutaneous bleeding. Acupuncture has the potential to be an alternative therapy for plaque regression as a feasible and non-severe side effect approach.

This research has its advantages. First, this study performed real acupuncture interventions on an only single acupuncture point. Previous acupuncture studies have commonly applied acupuncture treatment protocols with multiple acupoints. Its single point protocol ensures the credibility of the acupuncture effect. Second, this is a single-blind trial conducted by blinding patients. The acupuncture devices we used are consistent in size, shape, and color. Except for the different needles selected, the entire acupuncture operations consistency of two groups avoids the bias in both patients.

This study also has certain limitations. First, it was conducted in a single center with a relatively small sample size. Second, this study only included Chinese participants, and it is unclear whether the findings can be extrapolated to other ethnic groups. Third, in future research, economic benefits and patient acceptance should also be considered to evaluate the acupuncture applications. Finally, carotid ultrasonography is prone to error, and it is possible for existing the interobserver variability in ultrasound assessment.

In conclusion, this trial found that acupuncture had a certain effect on reducing the thickness and volume of carotid plaque and improving the stability of plaque with minor side effects. This may provide a new strategy for the treatment of carotid atherosclerotic plaques, especially in patients who are intolerant to drugs. This trial is a preliminary exploratory study. Further research is required to verify our findings and explore the molecular biological mechanisms of acupuncture on plaque regression and increased stability by conducting multi-center, large-scale, randomized controlled trials.

Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Abbreviations

BS:

the beginning of the systole

BMI:

body mass index

cIMT:

carotid intima-media thickness

CAD:

carotid atherosclerosis disease

CONSORT:

Consolidated Standards of Reporting Trials

DBP:

diastolic blood pressure

ES:

the ending of the systole

GSM:

grey-scale median

HDL-C:

high-density lipoprotein cholesterol

PS:

plaque score

PV:

plaque volume

PWV:

pulse wave velocity

RA:

real acupuncture

SA:

sham acupuncture

STRICTA:

Standards for Reporting Interventions in Clinical Trials of Acupuncture

SD:

standard deviation

SBP:

systolic blood pressure

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Acknowledgements

None.

Funding

This research was supported by Shenzhen Bao’an Research Center for Acupuncture and Moxibustion (BAZJ2018239); and Sanming Project of Medicine in Shenzhen (SZSM201806077); and Double First Class and High-level University Discipline Collaborative Innovation Team Project of Guangzhou University of Chinese Medicine (2021xk22); and Scientific Research Project of Guangdong Provincial Bureau of Traditional Chinese Medicine (20201137); and Key-Area Research and Development Program of Guangdong Province (2020B1111100007); and Fu Wenbin, Guangdong Provincial Bureau of Traditional Chinese Medicine Guangdong Famous Traditional Chinese Medicine Inheritance Studio (Guangdong Traditional Chinese Medicine Office Letter [2020] No. 1); and Situ Ling studio of Lingnan acupuncture school (Second Hospital of Traditional Chinese Medicine [2013] No. 233).

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Author notes

  1. Wenbin Fu and Peng Zhou are co-corresponding authors.

Authors and Affiliations

  1. Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China

    Xichang Huang, Lin Zhao, Xiaoxi Wu & Yanhui Jiang

  2. Department of Ultrasound Imaging, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China

    Lingcui Meng, Shuang Yang, Danhui Lai & Jianxing Zhang

  3. Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China

    Junhe Zhou & Wenbin Fu

  4. Shenzhen Ban’an Traditional Chinese Medicine Hospital Group, Shenzhen, 518133, China

    Peng Zhou & Wenbin Fu

  5. Fu Wenbin Guangdong Province Famous Traditional Chinese Medicine Inheritance Studio, Guangzhou, China

    Wenbin Fu

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  1. Xichang Huang
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Contributions

Conceptualization: WBF; Methodology: JHZ; Validation: JHZ; Formal analysis: LZ; Investigation: XCH, LCM; Resources: XCH, LCM; Writing – Original Draft: XCH, XXW; Writing – Review & Editing: XCH; Visualization: SY, DHL, YHJ; Supervision: PZ, JXZ; Project administration: WBF. All authors have read and approved the manuscript.

Corresponding authors

Correspondence to Peng Zhou or Wenbin Fu.

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The research was approved by the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no.YF2020-195-01). Informed consent was obtained from all participants.

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The authors declare no competing interests.

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Huang, X., Meng, L., Zhao, L. et al. Efficacy of acupuncture in patients with carotid atherosclerosis: a randomized controlled clinical trial. BMC Complement Med Ther 24, 313 (2024). https://doi.org/10.1186/s12906-024-04601-3

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Keywords

BMC Complementary Medicine and Therapies

ISSN: 2662-7671

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