BACKGROUND Early identification and monitoring of preserved ratio impaired spirometry (PRISm) population and active intervention can reduce the incidence rate of chronic obstructive pulmonary disease (COPD) and delay the disease process. However, there is no evidence on the best treatments, and the evidence on the effectiveness and safety of pharmacological interventions is poor. Traditional Chinese medicine (TCM) has been used to treat COPD for many years. OBJECTIVE To clarify the clinical efficacy of Bufei granules and to establish a preventive and treatment programme for reducing the incidence of COPD with Bufei granules, so that to provide high-quality evidence-based evidence for clinical diagnosis and treatment. METHODS This is a multicenter, randomized, double-blind, placebo-controlled trial targeting the PRISm population. Volunteers will be randomly divided into two groups, with the experimental group receiving Bufei granules and the control group receiving placebo granules. The main outcome was the incidence rate of COPD, and the secondary outcome was lung function, COPD screening score, quality of life, clinical symptoms, 6-minute walking distance (6MWD), dyspnea scor, biochemical indicators and economic evaluation. The plan will last for 2 years and will be followed up every 6 months. RESULTS Compared with the placebo granules group, the Bufei granules group is expected to improve lung function and quality of life of the PRISm patients, reduce dyspnea, increase exercise tolerance, delay disease progression, and reduce the incidence of COPD by approximately 40%. Data will be released upon completion of the study. CONCLUSIONS The results of this study will provide valid evidence for the efficacy and safety of Bufei granules in the treatment of PRISm, resulting in a high-level TCM prevention and treatment programme to slow the progression of COPD and reduce morbidity. The programme can be promoted for use in health management departments and medical units at all levels to reduce medical expenditure and the burden of disease. CLINICALTRIAL ClinicalTrials.gov registration number: NCT06375824.
Background: The effectiveness of breathing exercises in the treatment of chronic obstructive pulmonary disease (COPD) has been demonstrated in several systematic reviews (SRs), but a comprehensive review is still lacking. The aim of this study was to synthesize evidence from SRs, to summarise the effects of breathing exercises interventions for COPD patients. Methods: We conducted an overview of the SRs of breathing exercises in the treatment of COPD. We include Systematic Reviews of randomized-controlled clinical trials. In the included COPD, control of breathing exercises alone was the only variable and no restriction was placed on relevant outcome measures. The SRs were screened by computer retrieval from the Chinese National Knowledge Infrastructure (CNKI), WanFang database, Chinese Science and Technology Journal Database (CSTJ), Chinese Biological Medicine (CBM), MEDLINE (PubMed), Embase, Cochrane library, and Web of Science. The Risk of Bias in Systematic reviews (ROBIS) tool, the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement, a Measure Tool to Assess Systematic Reviews (AMSTAR) 2, and the Grades of Recommendations, Assessment, Development and Evaluation (GRADE) were used to evaluate the risk of bias, reporting quality, methodology quality, and evidence quality. Results: Nine SRs met the inclusion criteria and were included in the overview, 4 SRs in Chinese, and 3 SRs in English. All the SRs were published between 2015– 2021. According to the ROBIS tool, 4 SRs (57.14%) were rated as low risk of bias. The PRISMA scale showed that 5 SRs had some defects, and 2 SRs were relatively complete. Reporting deficiencies exist primarily in protocol and registration (28.6%), search (42.9%), risk of bias across studies (0%), additional analyses (42.9%), and funding (28.6%). Based on the AMSTAR-2 scale, 3 SRs were low quality, and the other 4 SRs were very low. The result of evidence quality assessment showed that among the 34 outcomes involved in the 7 studies, 19 were low-level outcomes, 15 were very low-level outcomes, and there were no moderate and high-level quality outcomes. Limitations and publication bias were two major factors that reduced the quality of evidence. Conclusion: Breathing exercises in certain can improve pulmonary function, exercise endurance, dyspnea, quality of life, and respiratory muscle strength of COPD patients. However, there is an urgent need for high-quality studies to guide clinical practice due to certain deficiencies in reporting quality and the low quality of methodology and outcomes. Keywords: breathing exercises, chronic obstructive pulmonary disease, overview, systematic reviews
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