Electroacupuncture as an Adjuvant Therapy for Dyspnea in Patients with Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease

Summary

This protocol describes a therapeutic approach using electroacupuncture to relieve dyspnea in patients with pulmonary hypertension with chronic obstructive pulmonary disease.

Abstract

Pulmonary hypertension (PH) is the most prevalent cardiovascular complication of chronic obstructive pulmonary disease (COPD). Dyspnea is the most prevalent and distressing symptom in Pulmonary Hypertension Associated with COPD (PH-COPD) patients. This study elucidates the operational details of electroacupuncture therapy, encompassing instrument preparation, acupuncture point selection, procedure, precautions, and emergency handling. By assessing with the Modified Medical Research Council Dyspnea Scale (mMRC), the 6-Minute Walk Test (6MWT), the Modified Borg Scale, the UCSD Shortness of Breath Questionnaire (UCSD-SOBQ), and the oxygen partial pressure in arterial blood (PaO₂), the efficacy and safety of electroacupuncture as a supplementary intervention for dyspnea in patient with PH-COPD were explored.

An exploratory randomized controlled study was conducted on 14 patients, with the electroacupuncture group receiving both conventional therapy and electroacupuncture treatment, and the control group receiving only conventional therapy. After 2 weeks, dyspnea improved in both groups, with the electroacupuncture group showing superior results. No serious adverse reactions occurred in either group. The study indicates that electroacupuncture can effectively alleviate dyspnea in PH-COPD patients, enhance their quality of life, and is simple, safe to operate, and worthy of further investigation and promotion, offering an effective adjunct therapy for PH-COPD.

Introduction

Chronic Obstructive Pulmonary Disease (COPD) is defined by persistent respiratory symptoms and airflow limitation. Due to abnormalities in the airways and/or alveoli, patients usually experience symptoms such as dyspnea, excessive sputum, and chronic cough¹. As the disease progresses, pulmonary hypertension (PH) is the most prevalent cardiovascular consequence in patients with COPD². PH arises from pulmonary vascular remodeling triggered by long-term airway inflammation and hypoxia. It will further exacerbate patients' dyspnea and lead to an increase in the load on the right ventricle, which may eventually result in right heart failure³. This greatly affects the prognosis and life quality of patients and is a major factor contributing to the reduced survival rate of patients with COPD^4,5,6.

Dyspnea, as a highly prevalent and distressing symptoms for patients, not only hinders their ability to participate in daily activities but also has a profound impact on their mental health and social participation, thus increasing the socioeconomic burden^6,7. Thus, investigating effective therapeutic approaches to relieve dyspnea in patients with pulmonary hypertension associated with COPD (PH-COPD) is essential for enhancing patient quality of life and reducing socioeconomic pressure.

Currently, the therapeutic approaches for PH-COPD predominantly center around the management of the primary disorder, long-term domiciliary oxygen therapy, and pulmonary rehabilitation training¹. Nevertheless, these interventions frequently prove inadequate in fully alleviating symptoms or effectively curbing disease progression. They may also give rise to a multitude of adverse reactions and entail substantial treatment expenses^8,9. Thus, identifying other safe and effective interventions to relieve dyspnea symptoms and enhance quality of life for PH-COPD patients is clinically imperative.

Traditional Chinese medicine (TCM) treatment is gradually gaining attention as a complementary and alternative therapy. As a traditional medical system, TCM has accumulated a wealth of experience in the treatment of chronic diseases¹⁰. Electroacupuncture is a modern modified adaptation of TCM acupuncture therapy, applying weak electrotherapeutic impulses to acupuncture needles to enhance the stimulating effect and efficacy of acupuncture. It has been widely used in pain management and neurological disorders^11,12.

Studies have shown that electroacupuncture can exert its therapeutic effects through a variety of mechanisms, such as regulating the neuroendocrine system, improving microcirculation, and reducing inflammatory responses^11,13,14. Especially in respiratory diseases, electroacupuncture has been used to assist in the treatment of COPD and asthma, which can improve lung function, reduce inflammatory response, and regulate immune function^15,16,17,18. Despite the progress of electroacupuncture in related diseases, there is still a relative lack of research on electroacupuncture therapy for dyspnea in patients with PH-COPD, and a safe and effective standard protocol is lacking.

This study intends to evaluate the safety and efficacy of electroacupuncture integrated with conventional treatment on dyspnea associated with PH-COPD. Efficacy and safety will be evaluated by comparing the improvement of dyspnea symptoms and the changes in cardiopulmonary function index in two groups of patients. This study is expected to provide an innovative treatment modality and standardized protocol for PH-COPD patients and enrich the application of TCM acupuncture therapy in cardiopulmonary diseases.

Protocol

The clinical study protocol underwent review and approval by the Clinical Research Approval Committee of Chengdu Xinjin District Hospital of Traditional Chinese Medicine (NO. 202411). All participants were informed of the objectives and procedures of this research and consented to photographic and video recording.

1. Clinical information

1. Source of cases
   1. Identify observed cases as hospitalized patients in the respiratory and cardiovascular departments of Chengdu Xinjin District Hospital of Traditional Chinese Medicine and the Hospital of Chengdu University of Traditional Chinese Medicine.
2. Inclusion criteria
   1. Refer to the 2025 reported and 2022 ESC/ERS Guidelines to identify patients with a previous clinical diagnosis of PH-COPD^1,3.
   2. Use the modified Medical Research Council (mMRC) scale to assess dyspnea symptoms, and diagnose dyspnea when the mMRC is grade 2 or above.
   3. Enroll participants who voluntarily join the study and obtain their written informed consent.
   4. Select participants aged 18-85 years old, without gender limitation.
3. Exclusion criteria
   1. Exclude participants- with other serious heart or lung diseases.
   2. Rule out participants with bleeding tendency or coagulation disorders.
   3. Exclude participants with mental illnesses or inability to cooperate with treatment.
   4. Exclude pregnant or nursing women.
   5. Reject those with allergic reactions or fear of acupuncture/electroacupuncture treatment.
4. Abscission criteria
   1. Withdraw participants who voluntarily exit the study for any reason.
   2. Remove participants experiencing adverse reactions/complications or showing deteriorating conditions during the study.
   3. Discontinue participants with poor compliance (failure to follow the treatment protocol) or incomplete evaluation results.
5. Exclusion criteria
   1. Exclude participants violating inclusion criteria.
   2. Remove those unilaterally altering the treatment protocol during the study.
   3. Terminate patients who withdraw from the study for various reasons, miss visits, take prohibited drugs privately or use other treatments prohibited by the study, or do not co-operate for complete data collection.

2. Research methodology

1. Study type
   1. Conduct a prospective, exploratory, small-sample randomized controlled study.
   2. Enroll patients and randomly assign them to the experimental or control group.
      NOTE: In this protocol, we enrolled 14 patients, seven each in the experimental and control groups.
2. Randomization method
   1. Use statistical software to generate random numbers.
   2. Fill the randomly generated numbers and group assignments into allocation cards.
   3. Distribute the cards to participants in the order of their clinic visits, assigning them to the experimental group or control group accordingly.
3. Intervention methods
   1. Control group: Administer conventional medical treatment following -the 2025 reported and 2022 ESC/ERS Guidelines (Supplemental Table S1)^1,3. Complete one treatment course over 2 weeks.
   2. Experimental group: Administer electroacupuncture in addition to conventional medical treatment. Conduct 1 treatment course over 2 weeks, with each session lasting 30 minutes and administered once daily (total of 14 sessions over 14 consecutive days).
      NOTE: All practitioners must be certified as acupuncturists and have conducted clinical treatment independently for over one year. The treatment is performed according to the National Standard^19,20. Acupuncturists will not be changed during the study unless necessary.
4. Equipment preparation
   1. Make sure that the following materials are within the expiration date: sterile cotton swabs, 75% alcohol, disposable sterile acupuncture needles (size 0.25 mm x 25 mm), pulsed acupuncture therapeutic device, lead wires, and alligator clips (Figure 1).
5. Doctor preparation
   1. Check the power switch, keep batteries on hand for the main unit that uses dry batteries, and make sure the power is sufficient.
   2. Check the output electrode wires and ensure that the conductivity is good, should ensure that the pulse acupuncture therapy instrument works properly.
   3. Wear medical masks and hats.
   4. Before operating with needles, wash hands with soap and water, maintain dryness, and use alcohol hand sanitizer.
6. Patient preparation
   1. Have the patient empty their bladder.
   2. Assess the patient's blood pressure, heart rate, respiratory rate, and oxygen saturation.
   3. Ensure that the skin is not damaged or ulcerated.
   4. Direct the patient to adopt a supine or prone position for acupoint exposure.
   5. Instruct the patient to inform the practitioner immediately if discomfort arises during treatment.
7. Acupuncture point selection
   1. Cleanse the acupuncture site with a 75% alcohol swab.
   2. According to the standardized acupoints in Therapeutics of Acupuncture and Moxibustion²¹, select Fei Shu (BL13), Zhong Fu (LU1), Tai Yuan (LU9), Ding Chuan (EX-B1), Dan Zhong (CV17), Gao Huang (BL43), and Shen Shu (BL23) (Figure 2 and Table 1).
8. Acupuncture and needling techniques
   1. Separate the index and middle fingers of the left hand at the point of puncture.
   2. Hold the needle handle with the right thumb and index finger, brace the middle finger's pad against the needle body, slightly flex the middle finger to create lever support, then press vertically to insert the needle to the standard depth.
   3. Perform lifting-thrusting motions (3 mm depth, 60 cycles/min) combined with bidirectional rotation (≤180° angle) until achieving de qi (soreness, numbness, distension, or heaviness).
9. Electroacupuncture connection and stimulation
   NOTE: Based on the requirement of the current circuit, acupoint selection should be in pairs. When choosing a single acupuncture point for treatment, an indifferent electrode should be used.
   1. Check the output knobs or buttons of the electroacupuncture instrument and adjust them to the "zero" position.
   2. Insert the plug end of the electrode cable into the corresponding output jack of the host, and use the crocodile clip to connect the two output terminals of the electrode cable to the handle or body of the needle, respectively. Make sure the connection is secure and conductive.
   3. Patients receive treatment in both supine and prone positions sequentially. Position patients in the supine position, connect bilateral LU1 and EX-LU9 and bilateral CV17. Switch to the prone position, connect bilateral BL13, EX-B1, BL43, and BL23 (Figure 3).
   4. Turn on the Electroacupuncture Meter power switch after securing power. Adjust the waveform and frequency knobs or buttons to select the waveform and frequency required for treatment.
   5. Set the parameters of the electroacupuncture device: expanding waveform at 2/100 Hz, current amplitude from 0.1 to 5 mA according to participant tolerance.
      ​NOTE: Incrementally adjust the corresponding output controls to raise the output amplitude in gradual increments, slowly, to the extent that it is tolerated by the patient. It is preferable that the skin around the acupuncture point trembles slightly without pain. In order to prevent the patient from feeling electric shock when adjusting, the amplitude of adjustment should be small.
   6. Start electroacupuncture stimulation for 30 minutes per session.
10. Post treatment management
    1. After the completion of electroacupuncture treatment, first slowly adjust the intensity knob or button so that the output intensity is at the zero position.
    2. Turn off the power switch of the electroacupuncture instrument, and then remove the crocodile clips and electrode wires from the needle handle (needle body).
    3. Remove the needle when the sensation under the needle is light and smooth. If the needle sinks, then slightly push upward to lift the needle.
    4. Use one hand to hold a sterile dry cotton ball and lightly press the puncture site, while using the other hand to pinch the needle handle with the thumb and index finger and pull out the needle. Immediately press the needle entry point with the cotton ball after removing the needle to prevent bleeding.
    5. After removing the needle, closely examine the needle insertion sites for bleeding, inquire about any discomfort, and verify needle count. Advise the patient to rest in bed and avoid strenuous exercise.
11. Precautions
    1. Before performing acupuncture, assess the patient's physical condition to prevent adverse events like needle fainting.
    2. Strictly implement sterilization protocols during acupuncture and instruct patients to keep the insertion site dry for 2 h to prevent infection.
    3. Closely observe the patient's reactions throughout the process to ensure safety.
    4. After the treatment, record the patient's feedback and any adverse reactions.
    5. Before and after each treatment, record the patient's sign changes and treatment parameters in detail.
12. Treatment of abnormalities and adverse reactions
    1. Subcutaneous hematoma: Small ones may need no treatment. For large ones, advise cold then hot compresses until it fades.
    2. Fainting from needles: Turn off electroacupuncture, stop needling, remove all needles, let the patient lie down, and offer warm or sugar water if needed.
    3. Stagnant needles: Gently press the area or shake the needle handle in reverse. Remove the needle when the muscles relax.
    4. Bending needle: For slight bends, remove the needle slowly. For severe bends, adjust the angle and remove along the bent direction. If the patient changed their position, instruct them to return to the original position and relax their muscles before removing the needle.
    5. Fractured needle: Should a needle break with some part remaining in the body, calm the patient and prevent position changes. If the stump is exposed, remove it by hand or forceps. Should the stump be flush with the skin, squeeze the needle hole to expose and extract with forceps. For needles embedded in the body, perform surgical removal with X-ray localization.

3. Observation Indicators

1. Safety indicators: Observe the occurrence of adverse reactions during the test, and record the triggers, duration, clinical manifestations, and whether there is any relief.
2. Demographics and clinical characteristics: Record sex, age, height, weight, tricuspid regurgitation velocity, pulmonary artery systolic pressure, FEV₁/FVC.
3. Efficacy indicators: Assess mMRC, and the 6-Minute Walk Test (6MWT), the UCSD Shortness of Breath Questionnaire (UCSD-SOBQ), the Modified Borg Scale, oxygen partial pressure in arterial blood (PaO₂)^22,23,24.
4. Safety evaluation
   1. Record and describe adverse reactions occurring during the study, including clinical manifestations, onset time, frequency, severity, relationship to the treatment regimen, and treatment measures.
      NOTE: Mild adverse reactions should be treated symptomatically. Moderate adverse reactions should be terminated and treated. Serious adverse reactions should be immediately withdrawn from the study and given emergency treatment.

4. Data analysis

1. Describe continuous data by mean (standard deviation) or median (quartile), describe categorical data by frequency (percentage).
2. Use paired t-tests or Wilcoxon signed-rank tests for within-group pre-post changes. Employ independent sample t-tests or Mann-Whitney U tests for between-group treatment effect comparisons.
3. Consider P < 0.05 to be statistically significant.

Results

Fourteen patients were included in this research, with seven assigned to the experimental group and seven to the control group. No participants withdrew during the study, and all 14 completed the protocol. Two males and five females were enrolled in the experimental group. In the control group, there were three males and four females. Table 2 shows the results of the comparison between the control and the experimental groups for variables, including age, sex, body mass in...

Discussion

This study found that electroacupuncture therapy significantly alleviated dyspnea and improved life quality in PH-COPD patients. Results revealed that the- experimental group exhibited significantly greater improvement than the control group in 6MWT, UCSD-SOBQ, Modified Borg Scale scores, and PaO₂ following intervention. This suggests that the treatment regimen received by the experimental group had a positive effect on improving the patient's ability to walk, reducing symptoms of shortness of breath, and ...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
75% alcohol	Shenzhen Baoke Medical Devices Co., Ltd.	20182140792
alligator clips	Bozhou Rongjian Medical Supplies Co., Ltd.	2300442G5
disposable sterile acupuncture needles	Suzhou Medical Supplies Factory Co., Ltd.	100014261834
IBM SPSS Statistics 25.0	IBM Corp.	/
lead wires	Bozhou Rongjian Medical Supplies Co., Ltd.	2300442G5
pulsed acupuncture therapeutic device	Bozhou Rongjian Medical Supplies Co., Ltd.	2300442G5
Sterile cotton swabs	Chengdu Zhongxin Hygiene Materials Co., Ltd.	20240420
The R Programming Language 4.3.2	The R Foundation.	/