For patients in the acute phase of chronic airway diseases, on the basis of guideline-directed treatment, the experimental group was given acupuncture treatment, while the control group was given sham acupuncture treatment. The treatment lasted for one week, followed by a 13-week follow-up. For asthma and COPD, PEF and CAT were respectively used as the primary outcome measures to evaluate the clinical efficacy and safety of acupuncture. Based on the improvement of the primary outcome measures, the advantageous population was identified. The mechanism by which acupuncture reduces airway mucus hypersecretion was preliminarily explained.
This study was a multicenter, randomized, double-blind, controlled trial. A total of 336 patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and 240 patients with acute attack of asthma were included. On the basis of guideline-directed treatment, the experimental group received acupuncture treatment, while the control group was given sham acupuncture treatment. For patients with AECOPD, the acupoints selected were Zhongfu, Dingchuan, Tiantu, Fenglong, and Feishu. For patients with acute attack of asthma, the acupoints selected were Dingchuan, Zhongfu, Tiantu, Feishu, and Kongzui. The acupoints were connected to electroacupuncture and treated for 30 minutes. The control group received sham acupuncture treatment. The acupoints were located 5 to 10 mm away from the actual acupoints, and the needles were inserted superficially through the skin. The acupoints were connected to electroacupuncture but without electricity. The treatment lasted for 30 minutes, once a day, for one week. Follow-up was conducted for 13 weeks. For COPD, the COPD Assessment Test (CAT) was the primary outcome measure, and the secondary outcome measures included the mMRC scale, assessment of airway mucus hypersecretion, CT assessment of airway mucus, basic vital signs, clinical symptom scores, use of control medications and antibiotics, acute exacerbation status, hospitalization time, tracheal intubation rate, and arterial blood gas. For asthma, the peak expiratory flow (PEF) was the primary outcome measure, and the secondary outcome measures included the Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality of Life Questionnaire (AQLQ), assessment of airway mucus hypersecretion, CT assessment of airway mucus, basic vital signs, clinical symptom scores, use of control medications and antibiotics, acute attack status, hospitalization time, and fractional exhaled nitric oxide (FeNO). The clinical efficacy and safety of acupuncture were evaluated. The population with advantages was identified based on the improvement of the primary outcome measures. The mechanism of acupuncture in reducing airway mucus hypersecretion was preliminarily explained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
576
Dingchuan, Shanzhong, Tiantu, Feishu, Kongji, after obtaining qi, connect the electric needle (continuous wave, The frequency was 2Hz, the current intensity was 1\~5mA, and the current intensity was gradually increased according to patient tolerance), and the treatment was 30min.
Dingchuan, Shanzhong, Tiantu, Feishu, hole the most points open 5\~10mm, shallow piercing through the skin, connected with the electric needle but no electricity, treatment 30min.
Astham part: PEF
Record the peak expiratory flow rate(PEF) for each patient, and evaluate the impact of acupuncture on improving the peak expiratory flow (PEF) of asthma patients.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
COPD part：CTA
Record the COPD Assessment Test (CAT) for each patient, and evaluate the impact of acupuncture on improving the clinical symptoms of patients with AECOPD.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Astham part: the Asthma Control Test (ACT)
ACT includes five questions. Every question will be assessed using a 5-point scale with scores ranging from 5 to 25. The higher the score, the better the symptom control.25 is considered complete control level, 20 \~ 24 is considered good control level, and \<20 is considered non-control level.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Asthma part：Asthma Control Questionnaire(ACQ)
The content of ACQ involves the following aspects: asthma-related, symptoms, the use of first-aid drugs, the impact on daily life and lung function test results.The higher the score, the worse the state.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Asthma part：Asthma Quality of Life Questionnaire(AQLQ)
The asthma quality of life scale (5-point scale-RRB- consists of 35 items, including activity limitation (1-12) , asthma symptoms (13-20) , psychological status (22-26) , response to stimuli (27-31) , concern for one's own health (32-35) . On a 5-point scale, 1 is the worst and 5 is the best.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Asthma part：The cough and expectoration assessment questionnaire (CASA-Q)
Each indicator of the patient is scored from 1 to 5 based on the severity. After reverse scoring, the lower the score, the more severe the airway mucus hypersecretion and the poorer the therapeutic effect.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Asthma part：Evaluation of Airway Mucus Hypersecretion
The assessment includes: the difficulty of expectoration score, the sputum character score, and the sputum viscosity grading. They represent the nature of the sputum and the difficulty of coughing, ranging from 0 to 3 points. The higher the score, the more mucus secretion in the airway and the more severe the symptoms.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Asthma part：Evaluation of Airway Mucus by CT Imaging
Airway mucus CT assessment evaluates the distribution characteristics of airway mucus through the imaging features of thin-layer CT.
Time frame: Before treatment, and day 7
Asthma part：Clinical symptom score
Including wheezing, coughing, expectoration, chest tightness and wheezing sounds.A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Asthma part：Acute attack status
Including the number and severity of acute attacks, the re-admission rate after acute attacks, and the interval between the first acute attack and the subsequent ones.
Time frame: Follow-up at the 4th and 13th weeks
Asthma part：Hospitalization time
The time required from the point of enrollment to the attainment of the discharge criteria
Time frame: At 4 weeks of follow-up
Asthma part：Fractional exhaled nitric oxide (FeNO)
FeNO is measured by a FeNO detector. It is used to determine the concentration of nitric oxide in exhaled breath of the human body. As a biomarker of airway inflammation, its normal range is less than 25ppb (adults) .
Time frame: Before treatment, and day 7
COPD part：clinical symptoms and signs questionnaire
Assessment will be performed by clinical symptoms and signs questionnaire. The clinical symptoms to be evaluated in this study include cough, phlegm, chest tightness, gasp,shortness of breath, feeble and cyanosis. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
COPD part：mMRC
The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "4" means severe dyspnea perception.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
COPD part：The cough and expectoration assessment questionnaire (CASA-Q)
Each indicator of the patient is scored from 1 to 5 based on the severity. After reverse scoring, the lower the score, the more severe the airway mucus hypersecretion and the poorer the therapeutic effect.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
COPD part：Evaluation of Airway Mucus Hypersecretion
The assessment includes: the difficulty of expectoration score, the sputum character score, and the sputum viscosity grading. They represent the nature of the sputum and the difficulty of coughing, ranging from 0 to 3 points. The higher the score, the more mucus secretion in the airway and the more severe the symptoms.
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
COPD part：Evaluation of Airway Mucus by CT Imaging
Airway mucus CT assessment evaluates the distribution characteristics of airway mucus through the imaging features of thin-layer CT.
Time frame: Before treatment, and day 7
COPD part：Acute attack status
The number of acute attacks
Time frame: Follow-up at the 4th and 13th weeks
COPD part：Hospitalization time
The time required from the point of enrollment to the attainment of the discharge criteria
Time frame: At 4 weeks of follow-up
COPD part：Tracheal intubation rate
The proportion of patients with tracheal intubation during the treatment period;
Time frame: At 4 weeks of follow-up
COPD part: Arterial blood gas
The arterial blood PaO2, PaCO2 of the two groups of subjects were measured.
Time frame: Before treatment, and day 7
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