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.
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.
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 asleep5,6. 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.
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
2. Research design
3. Preparations before procedure
4. Treatment procedure
5. Post-treatment care
6. Adverse incident handling methods
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 |
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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 |
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Fei | CO14 | The 14th district of concha | Around the Xin (CO15) and Qiguan (CO16) areas |
cough; chest tightness; hoarseness; withdrawal syndrome |
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Qi guan | CO16 | The 16th district of concha | Between the Xin (CO15)area and the external auditory meatus |
Asthma; bronchitis |
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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 |
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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.
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 value23,24,25. 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.
The authors have nothing to disclose.
This research was supported by the National Natural Science Foundation of China (82374291), 2022 "Tianfu Qingcheng Plan" Tianfu Science and Technology Leading Talents Project (Chuan Qingcheng No. 1090), the National TCM Clinical Excellent Talents Training Program (National TCM Renjiao Letter [2022] No. 1), "100 Talent Plan" Project of Hospital of Chengdu University of Traditional Chinese Medicine (Hospital office [2021] 42), Special subject of scientific research of Sichuan Administration of Traditional Chinese Medicine (2021MS539, 2023MS608), Sichuan Science Technology Program (2023ZYD0050, 24NSFJQ0077),"Hundred Talents Program" of the Hospital of Chengdu University of Traditional Chinese Medicine (grant nos. 20-Q06) and Sichuan Philosophy and Social Science Planning Major Programs (SC22ZD010).
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 |