Acupoint Application Combined with Ear Plaster Therapy for Treating Sleep Disorders with Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Summary

The present protocol describes the specific process and efficacy of the acupoint application combined with ear plaster therapy for sleep disorders in a patient with acute exacerbation of chronic obstructive pulmonary disease, including medical devices, selection of acupoints, operating methods, and posttreatment care.

Abstract

Chronic Obstructive Pulmonary Disease (COPD) is a lung disease characterized by persistent airflow limitation, which is not fully reversible and progressive. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) refers to acute changes in respiratory distress, cough, and sputum in COPD patients at baseline levels. Sleep disorders are a very common complication in patients with AECOPD. At present, long-term use of sedative-hypnotics alone has many side effects, such as mental and physical dependence and cognitive impairment. While the efficacy of other special intervention methods is not clear, and the cost is high, there is an urgent need for effective and safe treatment in clinics. Acupoint application and ear plaster therapy are considered the characteristic therapies of traditional Chinese medicine. They have the advantages of small side effects, high safety, and simple procedure. This study will elucidate in detail the specific process and efficacy of the two treatment methods for AECOPD complicated with sleep disorders, including medical devices used, selection of acupoints, procedure, and posttreatment care. This study is intended to provide a new reference for the clinical treatment modality of this type of disease.

Introduction

Chronic obstructive pulmonary disease (COPD) is a disease characterized by incomplete reversibility of airflow limitation, with gradual progression, primarily involving the lungs, but also causing damage to various other organs outside the lungs. Its pathogenesis is mainly related to the regulation of apoptosis and promotion of inflammatory response by radical oxygen species (ROS) during oxidative stress (OS)¹, affecting gene transcription and exacerbating protease-antiprotease imbalance finally². It often causes chronic coughing, coughing up sputum, shortness of breath or difficulty breathing, wheezing, and chest tightness. According to a WHO survey, COPD is the third leading cause of death globally, posing a serious threat to human health, and by 2060, the number of deaths from this disease will exceed 5.4 million annually³. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) refers to acute changes in respiratory distress, cough, and sputum in COPD patients at baseline levels. AECOPD patients often experience shortened sleep time and decreased sleep quality due to various factors such as serious respiratory symptoms, nocturnal hypoxia, accompanying psychological problems, medication use, and socio-economic conditions⁴. Therefore, sleep disorders, including obstructive sleep apnea (OSA), restless leg syndrome (RLS), and insomnia, have become common complications for AECOPD patients, especially in elderly severe patients.

The reasons for sleep disorders in AECOPD patients include increased airway resistance and reduced airflow at night and/or in the morning, which aggravate ventilation disorders and ultimately lead to frequent awakenings, shortened sleep time, and difficulty falling asleep^5,6. Moreover, the large financial burden of AECOPD on families makes patients often accompanied by anxiety, depression, and other psychological problems⁴. More notably, sleep disorders can, in turn, increase the risk of pulmonary hypertension in AECOPD patients and are closely related to higher disease severity, more frequent exacerbation, higher utilization of emergency medical services, and higher mortality rates⁷. According to the latest research, the prevalence of OSA, RLS, and insomnia in AECOPD patients, respectively, reached 29.1%, 21.6%, and 29.5%. Patients with OSA may have a higher risk of hypertension and diabetes. Patients with RLS are related to higher Epworth sleepiness scale (ESS) score and a longer COPD duration(year). Furthermore, insomnia is more common in female patients⁸. Therefore, it is essential to carry out timely nursing interventions for AECOPD patients with sleep disorders.

At present, the clinical treatment of AECOPD patients mainly focuses on improving respiratory symptoms while ignoring sleep problems. In addition, benzodiazepines, melatonin, melatonin receptor agonists, and antipsychotics used by patients with severe sleep disorders have adverse reactions such as respiratory inhibition, drug dependence, cognitive impairment, dizziness, and somnolence; therefore, it is mostly used for acute sleep disorders, while it is limited in the application of chronic sleep disorders⁹. Other special intervention methods, including nocturnal oxygen therapy, cognitive behavioral therapy for insomnia, and pulmonary rehabilitation exercise, are not commonly used because of their high cost, unclear effect, and difficulty in clinical practice⁴. Therefore, there is an urgent need to find an effective, safe, and simple treatment for AECOPD patients with sleep disorders.

Traditional Chinese Medicine (TCM) has a long history and rich experience in the treatment of sleep disorders. Acupoint application (AA) and ear plaster therapy (EPT) are both traditional Chinese medicine techniques. A systematic review study also found that AA and EPT have significant curative effects in the treatment of primary insomnia¹⁰. In this study, we will elucidate in detail the process and efficacy of the two treatments for AECOPD, including the medical equipment used, acupoint selection, treatment procedure, nursing, treatment of related accidents, etc. By comparing the changes in the Pittsburgh sleep quality index (PSQI) before and after treatment to evaluate their clinical efficacy, we aimed to provide a new reference for the clinical treatment of this kind of disease.

Protocol

This is a before and after self-controlled trial of seven patients diagnosed with AECOPD complicated with sleep disorders from the Hospital of Chengdu University of Traditional Chinese Medicine between December 2023 and January 2024. The clinical study protocol was reviewed and approved by the Clinical Research Approval Committee of the Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine (KY2022031).

1. Patient selection

1. Inclusion criteria:
   1. Include patients who meet the diagnostic criteria of AECOPD per the Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (2024 report) (GOLD 2024)¹¹.
   2. Include patients who meet the diagnostic criteria of sleep disorders per the third edition of the International Classification of Sleep Disorders (ICSD)¹²or the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)¹³.
   3. Include patients who are hospitalized for treatment.
   4. Include conscious, mentally normal patients informed about the study.
   5. Include patients with no serious diseases of the heart, liver, kidney, immune system, or hematopoietic system and who are not involved in other clinical studies.
2. Exclusion criteria:
   1. Exclude patients having other serious mental illnesses, sleep disorders not caused by AECOPD, and having received sedative-hypnotics treatment and other AA or EPT therapy in the past 1 month.
   2. Exclude patients allergic to medical devices such as adhesive tapes, medical non-woven fabrics, and related herbal medicines.
   3. Exclude patients with auricle injury, sensory disturbances, and skin breakage.
3. Shedding and rejection criteria:
   1. Reject patients who cannot adhere to the treatment and have serious adverse reactions or aggravate the original disease during the test.

2. Research design

1. Adopt the comparative test method of the same patient before and after treatment. Observe patients (n = 7) who suffer from AECOPD complicated with sleep disorders.
2. Ask patients to complete the PSQI questionnaire¹⁴24 h before AA and EPT.
3. Ensure that all the included patients receive the same standardized AECOPD nursing interventions.
   1. Basic interventions: keep the ward clean, comfortable, and tidy, and reduce noise.
   2. Drug intervention: Ensure patients undergo cough expectorant and conventional anti-infective treatment.
      NOTE: Drugs used include Doxofylline, compound ipratropium bromide solution for inhalation, Salmeterol ticarcoson inhalation powder mist, sensitive antibiotics, and glucocorticosteroid.
   3. Dietary intervention: Instruct patients to avoid taking excitatory substances (strong tea, etc.), alcohol, and tobacco, and avoid overeating before going to bed.
   4. Psychological intervention: carry out sleep education, communicate with patients, and eliminate their negative emotions such as anxiety and depression.
   5. Respiratory function exercise: Instruct patients to correctly expectorate and cough and perform abdominal and lip retraction breathing.
4. Have the patients receive AA and EPT therapy (see section 4).
5. Fill in the PSQI questionnaire again after 1 week of treatment.
6. Collate the questionnaire data by two researchers simultaneously and remove the incomplete or incorrect data. Express the PSQI questionnaire scores with mean ± standard deviation using appropriate data analysis software. Consider P < 0.05 as statistically significant in the Paired t-test.
   NOTE: The same researcher who has received relevant professional training explains the contents of the questionnaire to the patient throughout the trial without making any directional prompts.

3. Preparations before procedure

1. Equipment preparation
   1. Prepare items such as the Chinese herbal medicine about Sinapis alba Linnaeus, Asarum sieboldii Miq, Euphorbia kansui T. N. Liou ex S. B. Ho and Corydalis yanhusuo W. T. Wang, acupoint patches, magnetic treatment plaster, sterile cotton swabs, medical tape, tweezers, 75% alcohol cotton balls, medical hand disinfectants, medical disposable sterilization rubber gloves (see Figure 1 and Table of Materials for details).
   2. Take 30 g each of Sinapis alba Linnaeus, Euphorbia kansui T. N. Liou ex S. B. Ho, Corydalis yanhusuo W. T. Wang and 10 g of Asarum sieboldii Miq for a total of 100 g, prepared in the ratio of 3:3:3:1. Use an ultra-micro pulverizer to make them into powder in advance and seal it in a plastic bag for later use.
   3. Before treatment, take 15 g of the mixed powder and use 15 mL of ginger extract to make a paste of medicinal powder. Place the paste on a curved plate.
2. Patient preparation
   1. Create a comfortable, quiet, and clean environment, and tell the patient to avoid taking excitatory substances such as alcohol and tobacco. Let the patient sit upright with the shoulders relaxed and arms bent naturally on the knees.
3. Physician preparation
   1. Pull the bed curtain, pay attention to protect the privacy of the patient, and prevent the patient from catching a cold.
   2. Recheck the patient's name, gender, age, and inpatient number.
   3. Wash hands with soap and water. Disinfect hands with medical hand disinfectant after drying. Finally, wear medical disposable rubber gloves.

4. Treatment procedure

1. Positioning of acupoints
   1. Select Tian tu (CV22) on the patient's anterior cervical region and bilateral Fei shu (BL13) on the back for AA. Select binaural Fei (CO₁₄), Qi guan (CO₁₆), Shen men (TF₄), and Pi zhi xia (AT₄) for EPT.
      NOTE: In the two treatment methods of AA and EPT, the selection of relevant acupoints and their specific positions are based on the recorded efficacy and positions of National Standard of the People's Republic of China: Nomenclature and location of meridian points published in 2021(GB/T12346-2021)¹⁵and Nomenclature and location of auricular points published in 2008 (GB/T13734-2008)¹⁶. The methods for locating acupuncture points include the anatomical landmark method, proportional bone measurement, and finger-cun measurement¹⁵. See Figure 2 and Table 1 for details .
2. Disinfection of patient treatment areas
   1. Use tweezers to clamp 75% alcohol cotton balls to disinfect the patient's binaural CO₁₄, CO₁₆, TF₄, AT₄, CV22, and bilateral BL13 from the inside to the outside with the acupoint point as the center, with an appropriate range of 5 cm.
      NOTE: Each acupoint should be disinfected three times, and the scope of each disinfection should be narrowed than the previous one. If the patient is allergic to alcohol, iodophor can be used as a substitute.
3. Acupoint application procedure
   1. Take the prepared medicine from the medical curved plate, roughly divide it into 3 equal parts, remove the ointment with a tongue depressor, and apply it in a regular pattern to the center of the acupoint patches(diameter x thickness of about 3 cm x 0.5 cm).
   2. Fix the prepared acupoint patches to the Tian tu (CV22) and Fei shu(BL13) points. See Figure 3 for details.
4. Ear plaster therapy procedure
   1. Let the patients take the sitting position, fix one side of the auricle with one hand, take the magnetic treatment pill with tweezers in the other hand, and then apply it at the CO₁₄, CO₁₆, TF₄, and AT₄. Repeat the procedure on the other side (see Figure 4A-E for details).
   2. Gently press the pill in a clockwise direction with a force that allows the patient to feel acid, numbness, bloating, pain, and heat but can tolerate it as a measure (De qi¹⁷). See Figure 4F for details.

5. Post-treatment care

1. Keep the AA therapy for 4-6 h each time, 1 time/day, and 7 days of continuous treatment. Advise the patient to press the auricular acupoints in the morning, at noon, at night, and before going to bed, 5 min/time, every other day on either ears once for 7 days throughout the treatment course.
2. Tell the patients to keep the treatment site dry and clean as much as possible to avoid the patch falling off.

6. Adverse incident handling methods

1. Tell the patients not to scratch the skin with their hands if there are local allergic reactions such as skin itching, redness, blisters, and exudation. Apply anti-allergy ointment locally to relieve symptoms if necessary.
2. Inform the patients in advance that if nausea, vomiting, dizziness, palpitation, and other discomfort occur during the treatment process, immediately stop the therapy.

Results

Based on the changes before and after treatment, it was found that the total PSQI scores and five components score results of PSQI, including time to fall asleep, sleep quality, sleep time, sleep disorders, and daytime function, were all lower than before, and the differences were statistically significant (P < 0.05). However, there were not many changes before and after treatment regarding sleep efficiency (P = 0.056) and application of medications for sleeping (P = 0.103) (See Table 2 for details). The results showed that AA combined with EPT could significantly improve sleep disorders. However, it has no obvious effect on improving sleep efficiency. The reason may be related to the shorter treatment time. Furthermore, medications for sleeping were used less often before treatment; there was no statistical difference in the application of medications for sleeping before and after treatment. Overall, AA combined with EPT is effective and safe in treating sleep disorders in patients with AECOPD.

Figure 1: The therapeutic tools required for therapy. (A) 75% alcohol cotton balls, (B) sterile cotton swabs, (C) medical hand disinfectants, (D) medical tape, (E) medical disposable sterilization rubber gloves, (F) acupoint patches, (G) auricular pressure pill patches, (H) tweezers. Please click here to view a larger version of this figure.

Figure 2: Schematic diagram of acupoint localization. (A) The acupoints of ear plaster therapy, (B) The acupoints of acupoint application. Please click here to view a larger version of this figure.

Figure 3: Acupoint application. (A,B) Prepared acupoint application patches. (C, D) Acupoint patches applied at Tian tu (CV22) and Fei shu (BL13). Please click here to view a larger version of this figure.

Figure 4: Operating steps of ear plaster therapy. (A,B) Looking for ear acupoints with a sterile cotton swab. (C) Using tweezers to take ear plaster therapy pill patches. (D,E) Aligning the patch with the selected auricular points for pressing. (F) Gently pressing the ear acupoints with the fingers for about 1 min. Please click here to view a larger version of this figure.

Name	Number	Channel tropism /Auricle partition	Location			Diseases
Fei shu	BL13	Bladder meridian	In the spinal region, below the spinous process of the third thoracic vertebra, 1.5 inches paracentral to the posterior median line			cough; asthma; hemoptysis; night sweat; rash
Tian tu	CV22	Conception vessel	In the anterior cervical region, in the center of the superior sternal fossa, on the anterior midline			cough; asthma; chest pain; sore throat
Fei	CO14	The 14th district of concha	Around the Xin (CO15) and Qiguan (CO16) areas			cough; chest tightness; hoarseness; withdrawal syndrome
Qi guan	CO16	The 16th district of concha	Between the Xin (CO15)area and the external auditory meatus			Asthma; bronchitis
Shen men	TF4	The 4th district of triangular fossa	In the upper of the posterior  1/3 of the triangular fossa			insomnia; dreaminess; epilepsy; neurasthenia; withdrawal syndrome
Pi zhi xia	AT4	The 4th district of antitragus	On the inner side of the antitragus			insomnia; neurasthenia; pseudomyopia; pain syndrome

Table 1: Detailed information on acupoints in this study (name, serial number, distribution, localization, treating diseases).

Factors	Before treatment	After treatment	P
Sleep quality	2.857 ± 0.350	1.714 ± 0.452	<0.05
Time to fall asleep	2.857 ± 0.350	1.714 ± 0.452	<0.05
Sleep time	2.857 ± 0.350	1.286 ± 0.452	<0.05
Sleep efficiency	2.571 ± 0.728	1.571 ± 0.904	0.056
Sleep disorders	2.286 ± 0.452	1.286 ± 0.452	0.002
Application of sleeping drugs	0.571 ± 0.728	0	0.103
Daytime function	2.714 ± 0.700	1.571 ± 0.728	0.017
Total	16.714 ± 1.578	9.143 ± 1.726	<0.05

Table 2: Scores of PSQI before and after treatment.

Discussion

This study combined AA with EPT to explore the procedure and efficacy of the treatment of sleep disorders in patients with AECOPD. AA refers to the external treatment method of grinding specific drugs into powder and then mixing them into a paste with water, white wine or rice wine, vinegar, ginger juice, etc., and finally making the paste, pill, powder, paste, mud, cake and other dosage forms, which are applied to specific acupoints. Reviewing the literature on AA in the treatment of sleep disorder in the past ten years, it is found that it is effective and better than the current clinical medication¹⁸. The mechanism of Chinese medicine is through the synergistic effect between drugs and acupoints, thus playing a role in regulating and balancing the functions of the internal organs. In contrast, the mechanism of modern medicine is believed to be related to the transdermal drug delivery system and the specificity of the acupoints. The two stimulate and coordinate each other to adjust the body's neuroimmunity¹⁹. For example, studies found that AA can regulate the secretion and release of hypothalamic 5-HT, 5-HIAA, DA, NA, IL-1β²⁰, the function of the neuroendocrine system under stress, and the reduction of exhaustion state²¹ and the restored normal sleep-wake cycle caused by the increase of serum IL-1β and TNF-α levels²².

The AA therapy used Sinapis alba Linnaeus, Euphorbia kansui T. N. Liou ex S. B. Ho, Corydalis yanhusuo W. T. Wang, and Asarum sieboldii Miq, combined with CV22 and BL13 to treat AECOPD. It can promote blood circulation and dissipate blood stasis, warm the lungs, reduce phlegm, and relieve cough and asthma. The study demonstrated AA for the AECOPD had good clinical efficacy, improved clinical symptoms (cough, sputum, wheezing, shortness of breath, etc.), and shortened hospitalization time. It helped to enhance the lung function and immune function of patients and improved the index of vascular endothelial function, with significant clinical application value^23,24,²⁵. AA combined with EPT treatment can reduce mMRC questionnaire scores and CAT scores in patients with AECOPD combined with insomnia²⁶. The level of respiratory symptoms was all lower than the control group (p < 0.05)^27,28. Moreover, exertion spirometry (FVC), first-second expiratory volume with exertion (FEV1), and FEV1 /FVC were higher in the post-intervention group than in the control group (P < 0.05)²⁹.

EPT method is a kind of auricular acupuncture method, which refers to using auricular points as the stimulation site and pressing pills on auricular points to achieve the purpose of disease prevention and treatment. The pressed pill materials are mainly pills with smooth surfaces, appropriate size and hardness, and easy to obtain, such as Wang Bu Liu Xing seeds, magnetic beads, rapeseed, and Raphani seeds. According to the traditional theory of TCM, the distribution of ear acupoints in the ear is like an inverted fetus in the uterus. A study showed that EPT significantly improved the hypoventilation index, respiratory disturbance index, and other respiratory parameters as well as the sleeping parameters such as the time and the waking time and rate³⁰. The pill material may stimulate the acupoint to produce afferent impulses, block the original pathological activity, and carry out the corresponding physiological regulation to regulate qi and blood to improve the sleep disorder finally³¹. It may also act on the hypothalamus pituitary adrenal axis to increase melatonin secretion and reduce leptin levels, improving sleep quality³².

The CV22 is located in the center of the superior sternal fossa. The AA therapy operated at CV22 can quickly dredge the stagnant qi and blood³³, significantly reducing airway resistance, especially when exhaling³⁴. The BL13 belongs to the Bladder meridian of foot Taiyang and is a reaction point of the lung on the back. It is well used in the treatment of various respiratory diseases such as pulmonary fibrosis, cough, asthma, and so on³⁵. Moreover, the mechanism of treating AECOPD may be related to regulating TNF-α levels³⁶. The ear acupoint CO₁₄ corresponds to the lung, and stimulating it can harmonize qi and blood. CO₁₆ has the effects of relieving cough, resolving phlegm, and tonifying lung qi. TF₄ is the most commonly used auricular acupoint in the treatment of insomnia, which can calm nerves and help with sleep³⁷. It may regulate autonomic nervous function and promote the brain to secrete sleep-related neurotransmitters³⁸. As for the AT₄, it can inhibit the excitability of the cerebral cortex and enhance the effect of tranquilizing the mind¹⁴.

The key steps to the whole procedure are the preparation of ointment, positioning of acupoints, aligning the part with ointment to the acupoint, pressing of auricular points at regular intervals, and informing of precautions to patients during treatment. First, the preparation of ointment and the positioning of acupoints accurately directly affect the efficacy. Secondly, the appropriate intensity of stimulation used to massage the corresponding acupoints improves the curative effect after EPT. Furthermore, informing the patient of the precautions during treatment in advance can ensure the patient's health and the smooth progress of the test.

There are also some limitations in this research method. For example, the number of cases included in this study is small. A large number of high-quality clinical studies still need to be continued. Clinical data on improving AECOPD symptoms by AA combined with EPT have not been collected yet. Considering the completeness and accuracy of the study, we plan to collect further relevant data in future studies and publish new findings in due course. In general, AA and EPT have the advantages of small side effects, low cost, and simple procedure. It can not only avoid a variety of side effects of hypnotics and sedatives but also make up for the disadvantages of difficult procedures and the high cost of nocturnal oxygen therapy and cognitive behavioral therapy for insomnia. Moreover, it can also be used for the treatment of other kinds of diseases, such as vomiting during pregnancy and secondary constipation, by changing the acupoints and Chinese herbs. Therefore, they are worth popularizing in clinics.

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
75% alcohol cotton balls	Shanghai Honglong Industrial Co., Ltd	20231116
Acupoint patches	Jiangsu Guangyi Medical Dressing Co., Ltd	20230718
Chinese herbal medicine	Guangdong Kanghe Pharmaceutical Co.,Ltd	230802
Magnetic treatment plaster	Suzhou Medical Supplies Factory Co., Ltd	233010
Medical disposable sterilization rubber gloves	Shandong Yuyuan Latex Gloves Co., Ltd	230806R22
Medical hand disinfectants	Shanghai Likang Disinfection High tech Co., Ltd	20230113J
Medical tape	Minnesota Mining Manufacturing Medical Equipment (Shanghai) Co., Ltd	23063GO
Sterile cotton swabs	Shanghai Honglong Medical Equipment Co., Ltd	20231108
Tweezers	Yangzhou Huayue Technology Development Co., Ltd	20231106