Assessment of Completeness of Reporting in Randomized Controlled Trials of Acupuncture Therapy for Chronic Obstructive Pulmonary Disease.

Objective: To assess the completeness of reporting in randomized controlled trials (RCTs) of acupuncture therapy (AT) for chronic obstructive pulmonary disease (COPD). Methods: We systematically searched PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), WANFANG Data, and China Biology Medicine (CBM) for studies published from their inception to May 8, 2021. The completeness of reporting was evaluated by CONSORT statement and STRICTA guidelines. Univariate and multivariate regression analyses were performed to preliminarily explore the factors related to completeness of reporting. Results: A total of 44 RCTs were included. The overall quality score (OQS) based on the CONSORT statement and STRICTA guidelines ranged from 3 to 26 and 7 to 14, with a median of 10 and 11, respectively. Among the 35 items of the CONSORT statement, 10 items were fully reported with reporting rate > 70%, and 11 items were poorly reported at a rate < 5%. Among the 17 items of the STRICTA guidelines, 10 items were adequately reported with > 70%, and only 3 items were incompletely reported at a rate < 20%. The agreement of most items was determined as "good", "substantial", or "moderate". By regression analysis, publication language (ß coefficient: 6.432, 95% CI: 3.202 to 9.663, P <0.001) and funding source (ß coefficient: 3.159, 95% CI: 1.045 to 5.273, P =0.004) acted as independent predictors of completeness of reporting according to the CONSORT statement. However, no variables associated with the STRICTA guidelines were identified. Conclusion: The completeness of reporting of AT for COPD was inadequate. The condition relatively improved for trials with publication in the English language and funding source. By recommendation, reports should be strictly standardized in accordance with the CONSORT statement and STRICTA guidelines to improve the clinical research evidence of AT for COPD.

High-coverage lipidomics analysis reveals biomarkers for diagnosis of acute exacerbation of chronic obstructive pulmonary disease.

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of morbidity and mortality in COPD management. However, detecting the progression from the stable stage to acute exacerbation mainly depends on doctors' judgment of clinical symptoms, and there is no biomarker that can be used for auxiliary clinical diagnosis. In this work, serum samples from COPD patients (n = 82) and healthy subjects (n = 29) were collected and analyzed. Patients with COPD were divided into stable COPD (SCOPD) and AECOPD groups, with the latter comprising subtypes 1 and 2. High-coverage lipidomics profiling of 913 lipids belonging to 19 subclasses was carried out by liquid chromatography-Q-Exactive orbitrap mass spectrometry. We performed 4 cross-comparisons to characterize metabolic disturbances associated with the progression of stable COPD to AECOPD-ie, SCOPD vs healthy subjects, AECOPD vs SCOPD, AECOPD subtype 1 vs SCOPD, and AECOPD subtype 2 vs SCOPD. We tentatively identified 86 lipids with differential abundance among groups, lipids that were altered from the stable stage of disease to AECOPD included sphingolipids, ether-containing glycerophospholipids, phosphatidylglycerols, and glycerol lipids. Three panels of lipid biomarkers specific to AECOPD, AECOPD subtypes 1 and 2 vs SCOPD yielded areas under the receiver operating characteristic curve of 0.788, 0.921 and 0.920, respectively, with sensitivity of 77.5%, 80.7% and 91.3%, respectively, and specificity of 75.8%, 97.0% and 87.9%, respectively. The result indicated differences in lipid metabolism may underlie AECOPD and its 2 subtypes and can serve as biomarkers for early diagnosis, and high-coverage lipidomics proved to be an accurate approach to profile the lipid metabolism in biological samples.

Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study.

Purpose: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an essential occurrence in COPD management and is the leading cause of morbidity and mortality. Chinese herbal medicine is widely used in the treatment of AECOPD, but high quality randomized controlled trials are limited. This study aimed to evaluate the efficacy and safety of Chinese herbal medicine as adjuvant therapy for patients with AECOPD. Methods: This was a randomized, double-blind, placebo-controlled study of 378 participants from eight centers in China. Participants were randomly assigned to receive 10 g of Chinese herbal medicine (according to the type of Traditional Chinese medicine syndrome: Sanhanhuayin, Qingrehuatan, or Zaoshihuatan granules) or placebo, two times per day, for 14 days, in addition to conventional medicine. Participants were followed up for 84 days after the treatment. The primary end point was the COPD assessment test (CAT) score. Secondary end points included the Modified British Medical Research Council (mMRC) questionnaire and the COPD patient-reported outcome scale (COPD-PRO). We also assessed treatment failure and treatment success rate, length of hospitalization, number of patients with acute exacerbations, number of patients readmitted due to AECOPD, and number of deaths and intubation. Results: The between-group difference in the change from baseline for CAT on day 14 (end of treatment) was -2.11 (95% confidence interval [CI], -3.198 to -1.050; P<0.001), exceeding the minimal clinically important difference. The mMRC and COPD-PRO scores were lower in the intervention group compared to the control group (between-group difference in the change from baseline, -0.28; 95% CI, -0.48 to -0.08; P=0.007 and -2.51; 95% CI, -4.087 to -0.929; P=0.002, respectively) on day 14. The intervention group had a significantly shorter duration of hospital stay than the control group (mean difference, -1.21days; 95% CI, -2.041 to -0.419; P=0.003), significantly lower of number of exacerbations (risk ratio [RR], 0.60; 95% CI, 0.409 to 0.892; P=0.010), and significantly lower number of readmissions due to AECOPD (RR, 0.41; 95% CI, 0.193 to 0.865; P=0.015). Significant differences in the number of treatment failures or successes, deaths, and intubation were not observed. The difference in safety variables and adverse events between the two groups was not observed. Conclusion: Chinese herbal medicine appears to be safe and beneficial for AECOPD and can be considered a complementary treatment for patients with AECOPD.

Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial.

BACKGROUND: The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. AECOPD have been effectively treated with Chinese medicine for a long time. The aim of this proposed trial is to assess the therapeutic effect of Chinese medicine (CM) on AECOPD. METHODS/DESIGN: This proposed study is a multicenter, double-blind, parallel-group randomized controlled trial (RCT). We will randomly assign 378 participants with AECOPD into two groups in a 1:1 ratio. On the basis of health education and conventional treatment, the intervention group will be treated with CM, and the control group is given CM placebo according to CM syndrome. Patients are randomized to either receive CM or placebo, 10 g/packet, twice daily. The double-blind treatment lasts for 2 weeks and is followed up for 4 weeks. The main outcome is the COPD Assessment Test; secondary outcomes are treatment failure rate, treatment success rate, length of hospital stay, AECOPD readmission rate, intubation rate, mortality, dyspnea, the 36-item Short Form Health Survey, and the COPD patient-reported outcome scale. We will document these outcomes faithfully at the beginning of the study, 2 weeks after treatment, and at the 4 weeks follow-up. DISCUSSION: This high-quality RCT with strict methodology and few design deficits will help to prove the effectiveness of CM for AECOPD. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.