This protocol introduces an effective method to improve the sleep condition of patients with chronic obstructive pulmonary disease and alleviate cough symptoms by using auricular acupuncture techniques to percutaneously stimulate specific acupoints in the patients’ ears.
Chronic obstructive pulmonary disease (COPD) is a clinical syndrome characterized by persistent and irreversible airflow limitation and chronic respiratory symptoms. It has a wide spectrum of complications, and sleep disorders, as part of it, are common in severe cases, especially in elderly patients. Long-term lack of sleep may lead to the aggravation of the original disease, reducing patients’ quality of life. Benzodiazepines are mainly used for symptomatic treatment of COPD combined with sleep disorders. However, such drugs have the side effect of respiratory central inhibition and could probably aggravate hypoxia symptoms. Auricular acupuncture is a special method of treating physical and psychosomatic dysfunctions by stimulating specific points in the ear. This article explains the specific methods of clinical operation of auricular acupuncture in detail, including assessment of patient eligibility, medical devices used, acupuncture points, course of treatment, post-treatment care, responses to emergencies, etc. The Pittsburgh sleep quality index (PSQI) and chronic obstructive pulmonary disease assessment scale (CAT) were used as the observational index of this method. So far, clinical reports have proved that auricular acupuncture has a definite curative effect in the treatment of COPD combined with sleep disorders, and its advantages of simple operation, few adverse reactions are worthy of further study and promotion, which provide a reference for the clinical treatment of such diseases.
Chronic obstructive pulmonary disease (COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction1. Its rate of incidence is closely related to individual factors like age, gender, genetics, and environmental factors such as smoking, air pollution, occupational dust, etc2. In recent years, COPD has represented a significant public health challenge and has gradually become one of the three causes of death worldwide, which threatens human health and affects the quality of life of patients. According to the 2019 global burden of disease survey, 212.3 million COPD epidemics were reported globally, resulting in approximately 3.3 million deaths3. It is worth noting that COPD, as the third leading cause of death globally in 2019, has brought a substantial economic burden to patients and their families, as well as medical and social resources4.
The clinical symptoms of COPD are complex, with a broad spectrum of comorbidities, and sleep disorders (including insomnia, sleep apnea syndrome, etc.), which mainly occur in severe cases, especially in elderly patients, but are often underestimated or ignored. It is estimated that about 40% of COPD patients suffer from sleep disorders5, and often experience nocturnal awakenings due to symptoms such as coughing, dyspnea, mucus production, and nocturnal oxygen desaturation. Chronic sleep deprivation not only reduces a patient's quality of life, but it also significantly increases the risk of COPD exacerbations and respiratory-related emergencies. Studies have shown that sleep disorders are closely related to the progression of COPD and have become an independent risk factor for COPD exacerbation and increased mortality6.
The reasons for this are mainly related to the following mechanisms:
Firstly, sleep brings physiological stress to the respiratory system, which is amplified in respiratory diseases, leading to decompensation7. Secondly, low-quality sleep may lead to cognitive impairment, triggering negative emotions such as anxiety and depression, thereby affecting the self-management behavior of COPD patients8,9. More importantly, poor sleep may impair immune function, resulting in a significantly increased risk of patients exacerbated because of infectious diseases10,11.
Currently, symptomatic treatment measures such as nocturnal oxygen therapy, continuous positive airway pressure (CPAP) and benzodiazepines are mainly adopted for COPD complicated with sleep disorders12,13. Nocturnal oxygen therapy and CPAP can effectively increase blood oxygen levels14. However, critically ill patients usually need to be treated in specialist sleep centers, and the vast overheads can add to the patient's burden. Benzodiazepines have the side effect of central respiratory depression, which may aggravate the exacerbate hypoxia of COPD patients and even increase the risk of respiratory failure15,16. Therefore, improving the therapeutic effect, reducing the side effects and cost of the treatment, and finding an effective measure to improve the sleep quality of patients with COPD combined with sleep disorders remain important issues for current research.
As an essential part of traditional Chinese medicine, the effectiveness of acupuncture has been tested in its long history, but still needs to be thoroughly recognized worldwide17. Existing acupuncture treatments are still dominated by electro-acupuncture or traditional acupuncture. However, since COPD combined with sleep disorder is a chronic disease that requires long-term and stable treatment, the limitations of these two acupuncture stimulation methods, including the risk of unexpected events such as broken needles and bent needles18, immobilization treatment, and fixed treatment time, inconvenience of other medical operations during needle retention and so on, which make it difficult for patients to adhere to long-term acupuncture treatment and lead to unstable curative effect19,20.
Auricular acupuncture, as a particular type of acupuncture, is a treatment method that stimulates specific points in the ear to diagnose and treat physical and psychosomatic disorders21. This treatment can be subdivided into acupuncture therapy, plaster therapy, needle-embedding therapy, auricular massage therapy, electro-acupuncture therapy, etc., among which auricular needle-embedding therapy and auricular plaster therapy method are most commonly used in clinical practice. Press needles (as shown in Figure 1) are an improved method of intradermal acupuncture. It has a short body and a circular handle buried in a piece of medical adhesive tape. With the advantages of long-lasting effect and high safety, it has been widely used in treating chronic pain, insomnia, paralysis, and other diseases in recent years22,23,24,25. Up to now, with more and more clinical reports proving the efficacy of auricular acupuncture, it is gradually becoming an important non-drug alternative therapy26,27.
This article explains in detail the specific methods of auricular acupuncture for the treatment of COPD combined with sleep disorders, including patient qualification assessment, medical devices used, acupoints, courses of treatment, post-treatment care, adverse reactions, emergency response measures, etc. The Pittsburgh sleep quality index (PSQI) and the chronic obstructive pulmonary disease assessment scale (CAT) were used as primary outcome measures for this method.
The effectiveness of this measure can be concluded by comparing the PSQI and CAT scores of patients before and after treatment. The advantages of auricular acupuncture, such as a simple operation, few adverse reactions, and low price, are worthy of further research and promotion and provide a reference for clinical treatment.
This is a before-and-after self-controlled trial with patients sourced from the Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine. The protocol has been approved by the Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine (Record NO.KY2022007). Patients were informed about the purpose and process of the study and agreed to the use of images and videos during the experiment.
1. Pre-treatment evaluation
2. Study design
NOTE: All the practitioners performing the treatment must have an acupuncturist qualification certificate and have performed clinical treatment independently for more than 1 year. The treatment is carried out under the National Standard of the People's Republic of China Standardized manipulations of acupuncture and moxibustion-Part 3:Ear acupuncture(GB/T 21709.3-2021)30. The acupuncturists will not be changed during the experiment unless necessary.
3. Operating steps
4. Prevention and countermeasures for adverse events
5. Efficacy evaluation
NOTE: Researchers can choose appropriate evaluation indicators after comprehensive consideration and analysis according to the condition of patients. When it comes to subjective indicators such as scale filling, questionnaire content and scoring method should be explained by the same researcher, and patients must complete the scoring independently without any suggestive reminder.
6. Data collection and analysis
The above protocol describes a before-and-after controlled trial to investigate the efficacy of auricular acupuncture in improving life and sleep quality in patients with COPD combined with sleep disorders. In this study, a total of 8 patients who met the criteria participated and completed the trial, and none of them were discharged or excluded during the process. The PSQI and CAT scales were used as the primary evaluation indicators for this trial, with data derived from the scores on the scales completed by patients before and after treatment. For data analysis, paired t-test was used for before-and-after self-controlled comparison, and a p< 0.05 will be considered to indicate statistical significance.
By analyzing the total and individual scores of the 8 patients before and after treatment, including sleep quality, sleep latency, sleep duration, sleep efficiency, hypnotic drugs, daytime dysfunction scores, and total PSQI scores, it was found that the scores were lower than before, and the differences were statistically significant (p < 0.05). This indicates that auricular acupuncture can effectively improve the patients' sleep quality. For more information, please refer to Table 2.
In terms of quality of life, a comparison of the total CAT scores before and after treatment shows that there is a statistical difference between the patients' total CAT scale scores before and after treatment (p<0.05), indicating that the above treatment methods can improve the patients' quality of life. For more information, please refer to Table 3.
Figure 1. Image of press needle. A press needle with dimensions 0.25 mm x 1.3 mm was used here. There are a variety of brands of press needle in the market, shown here is the type of needle chosen for this experiment. Please click here to view a larger version of this figure.
Figure 2. Diagram of acupoint positioning. This diagram is original to the author, which shows the location of the acupoints used in this trail. Specific information on the acupoints can be found in Table 1. Please click here to view a larger version of this figure.
Figure 3. Demonstration of acupoint positioning on the patient's ear. This diagram is intended to give a visual representation of the positioning of acupuncture points. Please click here to view a larger version of this figure.
Name | Number | Auricle partition | Location |
Fei | CO14 | The 14th district of concha | Around the Xin and Qiguan areas |
Xin | CO15 | The 15th district of concha | In the central depression of cavum concha |
Shen men | TF4 | The 4th district of triangular fossa | In the upper part of the posterior 1/3 of the triangular fossa |
Pi zhi xia | AT4 | The 4th district of antitragus | On the medial side of the antitragus |
Table 1. Details of the selected acupoints. This table shows the number, zone, and location of the acupoints chosen for this experiment.
PSQI factors | Before | After | P |
Sleep quality | 2.125 ± 0.354 | 1.25 ± 0.463 | <0.05 |
sleep latency | 1.88 ± 0.354 | 1.25 ± 0.463 | 0.011 |
Sleep duration | 2.00 ± 0.535 | 1.13 ± 0.835 | 0.021 |
Sleep efficiency | 2.13 ± 0.835 | 1.25 ± 0.707 | 0.021 |
Sleep disorders | 2.25 ± 0.463 | 1.75 ± 0.886 | 0.104 |
Hypnotic drugs | 1.63 ± 0.744 | 1.00 ± 0.756 | 0.049 |
Daytime dysfunction | 1.88 ± 0.835 | 1.25 ± 0.707 | 0.011 |
total | 13.88 ± 1.727 | 8.88 ± 2.357 | <0.05 |
Table 2. PSQI scores before and after treatment. Comparison of PSQI scores of 8 patients before and after auricular acupuncture treatment shows a reduction in PSQI scores. Paired t-tests were used for the before-and-after self-controlled comparison. The differences were statistically significant (p < 0.05), which indicates that the patients' sleep quality has improved. N=8.
CAT Score | Before | After | P |
CAT total score | 22.13±3.523 | 13.38±2.504 | <0.05 |
Table 3. CAT scoresbefore and after treatment. Comparison of CAT scores before and after treatment in 8 patients shows a reduction in CAT score Paired t-test were used for the before-and-after self-controlled comparison. The differences were statistically significant (p < 0.05), which suggests that the patients' quality of life has improved. N =8.
As an ancient Chinese traditional treatment modality, the efficacy of auricular acupuncture has been tested throughout its long history of development, and the results of various studies in recent years have further demonstrated the independent effectiveness of auricular acupuncture in improving sleep quality in patients with insomnia, relieving symptoms and improving lung function in patients with COPD. The efficacy of the method is mainly dependent on the acupoints chosen. Studies by Runyuan Ren23, Andreia Vieira35, and others have confirmed the positive effects of auricular acupuncture therapy in treating sleep disorders and optimizing sleep structure. As for the therapeutic effects of auricular acupuncture on COPD, several clinical reports have been confirmed in China. However, there is still a need for systematic evaluation, meta-analysis support, and high-quality evidence to support its effectiveness.
According to traditional Chinese medicine theory, the ear is connected to the brain and various viscera through the meridians36. In recent years, some scholars have combined traditional Chinese medicine theories with modern neuroanatomical knowledge to systematically organize the connection between the ear, brain and viscera, and have proposed the theory of ear-brain-viscera axis37, providing new ideas for the principles and mechanisms of auricular acupuncture treatment.
The selection of these four acupuncture points in this protocol, including Fei(CO14), Xin(CO15), Shen men(TF4) and Pi zhi xia(AT4), was established uisng reference to clinical reports38,39,40, combined with data mining results from previous investigators. Studies have shown that Xin, Shen men and Pi zhi xia are the core auricular points for treating multiple sleeping disorders41. Considering the respiratory condition of COPD patients, we have added Fei(CO14) to the above three points. According to acupuncture theory, Shen men(TF4) and Xin(CO15) are closely related to the body's thinking activities and have a calming effect on the mind36. Existing studies have shown their anti-anxiety and anti-depressant effects42, which supports the traditional view. In Chinese, the word Fei means the same as lung and is related to respiratory function. Stimulating Fei point can improve respiratory function and relieve symptoms such as dyspnea, the mechanism of which may be related to the modulatory effect of parasympathetic nerves and the enhancement of immune function43.
Modern neuroanatomy has revealed that the auricular region is the only body area where the vagus nerve is distributed44. It has been suggested that stimulation of the vagus nerve in the auricular region for the treatment of sleep disorders may be related to the following mechanisms: it modulates the melatonergic system in the brain45, promotes increased concentrations of transmitters such as γ-aminobutyric acid and decreased concentrations of transmitters such as glutamate in the central nervous system45, and regulates brain areas associated with the limbic lobe – waking brain functional network46.
In order to promote the clinical use of auricular acupuncture and to guarantee efficacy, there is a particular need to regulate the operation. The main aim of this article is to develop a standardized and effective operative protocol for auricular acupuncture in treating COPD associated with sleep disorders. Through auricular acupuncture, we can hopefully find a treatment with high safety and few side effects to relieve the symptoms of breathlessness and improve patients' life and sleep quality.
The method of operation in this article replicates and optimizes the methods used by previous researchers20,47,48,49, the most valuable of which was Jing Gao's study20. Based on Gao's study, we have elaborated on the specific methods of operation, matters requiring strict attention and post-treatment care, developed a more standardized treatment protocol, reduced the risk of adverse reactions, and provided a methodological reference for related studies.
The key points of this operation are the positioning of the acupoints, the operation of needling, and the patient's cooperation. To avoid adverse effects as much as possible and to increase efficiency, the operation should focus on the accuracy of the positioning and ensure the operator's qualification. It is important to note that the patients' cooperation plays a crucial role in the development and effectiveness of the treatment. If the patient is not compliant and does not follow the instructions to stimulate the auricular points on time and with the correct technique, the predicted effect may not be achieved, and the risk of adverse reactions such as hematomas and infections may be increased. If the patient massages the auricular points too vigorously and with too much stimulation, the intense stimulation can cause painful discomfort, further aggravating insomnia. Therefore, detailed communication with the patient to improve compliance and gain the patient's cooperation is one of the crucial aspects of treatment.
As for the limitations of the present method, they exist in the following areas:
To begin with, auricular acupuncture itself has the following shortcomings – firstly, it is unsuitable for patients with allergies or damaged auricles; secondly, the therapeutic effect is slow to take effect; thirdly, the intensity of the stimulation is not easy to maintain at a constant level, and the evaluation of the intensity depends mainly on the subjective feeling of the patient, which needs to be more objective.
Also, patient education in this study could have been improved. Although sleep education was provided to the patients, it did not target the patients' own emotions and was unable to completely shield them from the effects of emotional and psychological factors on their insomnia. Subsequent researchers could add emotional therapy and increase psychological diversion treatment.
In addition, the evaluation indicators in this study were based on scales, which are now widely used in evaluating the quality of life and sleep of patients with COPD. However, there is still room for objectivity. Therefore, selecting objective indicators is particularly important to improve the reliability of the results.
To improve this protocol, the following points can be addressed:
Adding emotional therapy and psychological de-escalation treatment to exclude or reduce the influence of psychological factors on sleep;
To enhance objectivity in evaluating the efficacy, the following objective indicators can be added: polysomnography tests, tests of objective indicators of neurotransmitters such as 5-hydroxytryptamine and norepinephrine, etc.;
Develop an individualized treatment plan for patients with a combination of other non-critical illnesses, the acupuncture points can be adjusted as appropriate.
Apart from the above shortcomings, the advantages of this study, such as simple operation and few adverse reactions, are worthy of further study and promotion. For patients whose physical conditions do not allow the use of benzodiazepines, who cannot afford long-term home oxygen therapy, and who are financially burdened, this study has broad application prospects as an effective alternative therapy that can provide patients with an effective non-pharmacological treatment measure to improve the quality of life and sleep in stable COPD patients, while reducing the financial burden.
The authors have nothing to disclose.
This research was supported by the special subject of scientific research on traditional Chinese Medicine of Sichuan Administration of Traditional Chinese Medicine (2021MS093,2021MS539, 2023MS608) and Sichuan science and technology program of Science & Technology Department of Sichuan Province (2022YF0392).
Cotton swab | Qingdao Hainuo Biological Engineering Co., Ltd. | 20182640215 | |
Iodophor cotton balls | Qingdao Hainuo Biological Engineering Co., Ltd. | 20172140782 | |
Press needle | Suzhou Acupuncture & Moxibustion APPLIANCE Co., Ltd. | 20162200591 | |
Surgical skin marker | Dongguan Tondaus Meditech Co., Ltd. | 20202021011 | |
Tweezers | Yangzhou Guilong Medical Devices Co., Ltd. | 20182010440 |