Auricular Acupuncture as a Traditional Chinese Medicine Therapy for Chronic Obstructive Pulmonary Disease Combined with Sleep Disorders

Summary

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.

Abstract

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.

Introduction

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 patients^8,9. More importantly, poor sleep may impair immune function, resulting in a significantly increased risk of patients exacerbated because of infectious diseases^10,11.

Currently, symptomatic treatment measures such as nocturnal oxygen therapy, continuous positive airway pressure (CPAP) and benzodiazepines are mainly adopted for COPD complicated with sleep disorders^12,13. 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 failure^15,16. 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 effect^19,20.

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 years^22,23,24,25. Up to now, with more and more clinical reports proving the efficacy of auricular acupuncture, it is gradually becoming an important non-drug alternative therapy^26,27.

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.

Protocol

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

1. Inclusion criteria: Include patients who fulfill the following conditions: Between the age of 50 and 75 years; conscious, mentally normal, and informed about the study; not involved in other clinical studies; meet the diagnostic criteria for stable COPD based on the GOLD COPD report, 2023 update( global strategy for prevention, diagnosis, and management of COPD)¹, and have a comprehensive analysis of the patients' past medical history, clinical manifestations, pulmonary function, and imaging findings, etc.; meet the diagnostic criteria for sleep disorders as per the Chinese classification of mental disorders (CCMD-3)²⁸ or the diagnostic criteria for the international classification of sleep disorders²⁹.
2. Exclusion criteria: Exclude participants who meet any of the following criteria: Coexisting with other serious physical or mental illnesses; under acute exacerbation of COPD; have sleep disorders known to be caused by specific causes other than COPD (such as endocrine diseases, drug use, etc.); refusal to accept acupuncture treatment; allergic to medical devices (such as tape, metal needles, etc.); auricle injury; sensory disturbances; patients who have received acupuncture, sleeping pills, or treatment other than basic COPD treatment within the past 2 weeks.
   NOTE: Coagulation should be checked in patients with potential coagulation disorders because there is a certain chance that auricular acupuncture in such patients will lead to subcutaneous purple spots and excessive bleeding.
3. Dropout criteria: Withdraw participants who meet any of the following criteria from the study: Serious adverse reactions; subjects voluntarily withdraw from the study; subjects who have serious complications or disease progression during the study.

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.

1. Perform auricular acupuncture based on conventional COPD treatment according to the 2023 global strategy for prevention, diagnosis, and management of COPD¹. Other treatments for sleep disorders are not supported to guarantee the independence of the auricular acupuncture treatment.
2. If an acute exacerbation occurs during the treatment, take prompt emergency measures, and record the acute attack and treatment process in detail. After the condition improves, consult the patients and re-evaluate to decide whether to continue the experiment.
3. If there is no improvement after 1 week of active treatment, withdraw the patient from the experiment as a dropout participant.

3. Operating steps

1. Pre-operation preparation
   1. Provide sleep hygiene education to patients 1 week before the start of treatment, including maintaining regular sleep and wake times to establish a biological clock, developing a reasonable exercise schedule, and avoiding strenuous exercise before bed, creating a quiet sleeping environment, eating regularly to avoid hunger or satiety at night, avoiding drinking too much liquid at night to avoid going to the toilet at night, no tea, coffee, or energy drinks after 4 pm, and avoid smoking before going to bed.
   2. Verify the patient's information: Name, bed number, and ID. Explain detailed treatment procedures and methods to patients and their families to reduce or eliminate patients' tension or fear.
   3. Check the medical devices used in the treatment: Sterile cotton swab, 0.5% iodophor, tweezers, and 0.25 mm x 1.3 mm press needle (see Figure 1). Ensure that all materials are within the validity period.
2. Selection and positioning of acupuncture points
   1. For selection of acupuncture points, refer to Experimental Acupuncture and Moxibustion³¹. Select four acupuncture points, Fei (CO₁₄), Xin(CO₁₅), Shen men(TF₄) , and Pi zhi xia(AT₄), according to the criteria. The specific information of the selected acupoints is shown in Table 1.
      NOTE: The location of the acupoints refers to the National Standard of the People's Republic of China: Nomenclature and location of auricular points³² published in 2008 (GB/T13734-2008). See Figure 2 and Figure 3 to accurately identify the correct location of the acupuncture point.
   2. Hold the auricle with one hand and use a cotton swab with the other hand to probe the auricular acupoints one by one with an appropriate strength. Take sensitive points as specific acupuncture points and mark the points with a sterile marker.
3. Operation procedure
   1. Disinfection of the operator's hands: Wipe fingers with 75% alcohol cotton ball.
   2. Hold an iodophor cotton ball with tweezers to thoroughly disinfect the acupuncture site, hold the edge of the tape of the press needle with tweezers, aim the needle tip at the acupoint, and pierce vertically and slowly.
      ​NOTE: When holding press needles, use tweezers rather than directly by hand to avoid contamination of needles.
   3. Make sure that the round handle on the top of the needle fits flat against the skin surface and is firmly fixed with tape. Then press gently with fingertips for about 1-2 min.
   4. At the same time, ask the patient if there is a comprehensive feeling of soreness, numbness, bloating, and heaviness. If so, it indicates that a state of De Qi is achieved, which is considered as an essential part of the efficacy of acupuncture, indicating that the operation is successful, and the predicted effect is achieved.
   5. Instruct the patient to use the correct manipulation, immediately after needle insertion, as described below, to press the acupuncture site: use thumb and index finger to press from the back and front of the auricle, strength from light to heavy.
   6. Carefully observe the patient's feelings, whether there is a state of De Qi or dizziness, pain, and other discomforts. Report to the doctor if any discomfort occurs and take countermeasures in time (read step 4 for details)
   7. Ask the patients to rest on their backs for at least 30 min after the needle is inserted to avoid accidents and adverse reactions.
   8. Perform the treatment for 2 weeks, 3x a week, scheduled on Monday, Wednesday, and Friday. The time of each indwelling needle is 36 h. After this time, ask the patient to return to the clinic for needle removal and post-treatment care as described in step 3.4.
   9. In the follow-up treatment, ask the patients to massage the auricular points 3x a day for 1-2 min each time on their own. To avoid over-stimulating the skin of the ear, instruct to massage only one side of the ear each day and then switch to the other side the next day.
4. Post-treatment care
   1. Keep the puncture sites dry and clean to prevent infection.
   2. When removing the needle, use tweezers to hold the tape and pull it out. Carefully check whether there is any broken needle. If so, report to the doctor in time and take countermeasures.
   3. After removing the needle, disinfect the acupoints again on the puncture site to prevent infection.

4. Prevention and countermeasures for adverse events

1. Precautions
   1. Before the start of the study, communicate with the patients and their families in detail, explain the purpose of treatment, specific operations, and precautions to obtain the active cooperation of the patients.
   2. Strictly follow the operating procedures during the trial.
   3. Stop the trial if the patient's condition changes or worsens and take corresponding treatment measures in time. Adjust the treatment plan according to the global strategy for prevention, diagnosis, and management of COPD ¹ and re-evaluate after improvement.
   4. Adverse reaction event report: Record adverse reactions (including bleeding, hematoma, infection, severe pain, etc.) occurring during the treatment process in detail.
2. Countermeasures
   1. If the press needle falls off: Check the integrity and notify the acupuncturist to replace the needles.
   2. If the needle breaks: Press around with appropriate force to make the broken end protrude out and remove it with tweezers.
   3. If there is infection, bleeding, or hematoma at the acupuncture site: Take disinfection, anti-infection, and anti-inflammatory treatment and closely observe the patient's condition.
   4. Needle syncope: When needle syncope occurs, remove the press needle immediately and check the integrity of the removed needle. Ask the patient to lie down to increase blood flow to the brain and reduce dizziness. Appropriately loosen the patient's collar and waistband, keep warm, and ensure air circulation, administer intravenous glucose to the patient if necessary. Administer first aid immediately if the patient is in critical condition.
      NOTE: Needle syncope (also called fainting during acupuncture), is a kind of acupuncture accident which often occurs in the process of acupuncture. Patients may have conscious symptoms such as dizziness, nausea, palpitations, etc., often accompanied by signs such as pallor face, cold sweat, decreased blood pressure, and weak pulse. In severe cases, there can even be a sudden loss of consciousness³³. According to modern medicine, needle syncope is a kind of vasogenic syncope. Its primary mechanism is the stimulation of solid needling through the vagus nerve reflex, causing the dilation of the vascular bed (especially the surrounding muscles). Reduced peripheral vascular resistance and return blood flow result in reduced cardiac output and decreased blood pressure, which together lead to a temporary, widespread reduction in cerebral blood flow and subsequent syncope. Its diagnosis is mainly based on the patients' subjective feelings (dizziness, nausea, etc.) and objective signs (pallor, low blood pressure, etc.).³⁴
   5. After the condition stabilizes, consult the patient and re-evaluate to decide whether to continue the treatment according to the actual situation.

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.

1. Outcome measures
   1. Use the COPD assessment test (CAT) to evaluate patients' quality of life: Patients with a score of 0-10 rated COPD as minor impact; scores between 11-20 indicate moderate impact; scores between 21-30 indicate severely affected; scores between 31-40 indicate very serious impact.
   2. Determine a difference or change in patient CAT >2 as clinically meaningful. Changes of more than 2 points in patients' CAT scores before and after treatment may indicate that the treatment has clinical significance.
   3. Use the Pittsburgh sleep quality index (PSQI) to evaluate the sleep quality of the patients. Evaluate the effect of auricular acupuncture by comparing the total points before and after treatment. A higher score indicates poorer sleep quality, while a reduction in PSQI scores indicates an improvement in sleep quality.

6. Data collection and analysis

1. For analysis, use data from the scales filled out by the patients before and after treatment, which were collected 24 h before the first treatment and 24-36 h after the last treatment.
2. For data analysis, use a commercial data analysis software, and consider a p< 0.05 to indicate statistical significance. Use the paired t-test for before-and-after self-controlled comparison.

Results

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 b...

Discussion

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

Materials

Name	Company	Catalog Number	Comments
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