Evidence map analysis of clinical studies on 42 commonly used oral Chinese patent medicines for the treatment of stable chronic obstructive pulmonary disease.

ETHNOPHARMACOLOGICAL RELEVANCE: This study rigorously and comprehensively evaluated the clinical evidence of Chinese patent medicines (CPMs) in treating the stable phase of chronic obstructive pulmonary disease (COPD), highlighting problems and solutions. AIM OF THE STUDY: This study aimed to systematically evaluate the clinical evidence of 42 oral CPMs for the treatment of stable COPD using evidence mapping, identifying research trends, methodological quality, and gaps in the current literature. MATERIALS AND METHODS: A comprehensive search was conducted across multiple databases, including CNKI, Wanfang, VIP, SinOMed, PubMed, Web of Science, Embase, and Cochrane Library, up to November 1, 2024. A total of 205 studies (203 in Chinese and 2 in English) were included, comprising 181 randomized controlled trials (RCTs), 8 non-randomized controlled trials (non-RCTs), 2 case-control studies, 9 systematic reviews/Meta-analyses, and 5 guidelines/expert consensuses. Data were extracted and analyzed using evidence mapping techniques, focusing on publication trends, Traditional Chinese Medicine (TCM) syndrome types, interventions, outcome indicators, and methodological quality. RESULTS: The analysis revealed that CPMs are extensively applied in the treatment of stable COPD and have demonstrated remarkable therapeutic efficacy. Among them, Bailing Capsules are the most researched, accounting for 26.70 % of the published studies. However, clinical indications for many CPMs remain ambiguous, and safety information is often incomplete. Methodological quality of the studies was generally low, with issues such as inadequate randomization, lack of blinding, and incomplete outcome reporting. TCM syndrome differentiation was underutilized, with only 32.46 % of studies detailing TCM syndrome classifications. Outcome measures were heterogeneous, with a focus on clinical efficacy and pulmonary function tests, but limited attention to TCM-specific outcomes and long-term follow-up. CONCLUSION: This evidence mapping highlights the need for improved methodological rigor, standardized outcome measures, and better integration of TCM theory in clinical research. While CPMs show promise in managing stable COPD, future studies should address safety gaps, enhance TCM syndrome differentiation, and conduct economic evaluations to optimize their clinical application. These findings provide a roadmap for researchers, clinicians, and policymakers to advance the role of CPMs in global respiratory medicine.