Department of Respiratory, No.3 Affiliated Hospital of Chengdu University of TCM (West District), Chengdu Pidu District Hospital of TCM, Chengdu, Sichuan, China; Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Department of Respiratory, No.3 Affiliated Hospital of Chengdu University of TCM (West District), Chengdu Pidu District Hospital of TCM, Chengdu, Sichuan, China.
Complement Ther Med. 2021 Jun;59:102691. doi: 10.1016/j.ctim.2021.102691. Epub 2021 Feb 20.
Randomized clinical trials and published meta-analyses assessing the clinical effectiveness of Chinese herbal medicine (CHM) on the treatment of stable chronic obstructive pulmonary disease (COPD) yielded inconsistent results in terms of disease outcomes, in which the design of placebo-controlled studies can contribute to the heterogeneity. This study aimed to evaluate the efficacy and safety of CHM compared to placebo on the treatment of stable COPD, to provide robust evidence for the use of CHM in COPD.
Nine electronic databases were searched from inception to October 1, 2019 to identify placebo controlled randomized trials of CHM for the treatment of stable COPD and studies in English or Chinese were included. The primary outcomes were symptom score (CAT score), quality of life (SGRQ) and frequency of acute exacerbations. The secondary outcomes included lung function, clinical total effective rate and adverse events. The selection of studies, data extraction and coding and assessment of risk of bias of the included studies were conducted by two reviewers independently. Mean difference (MD) was used to analyze continuous variable and relative risk ratio (RR) for dichotomous data.
A total of eleven studies involving 1223 patients were included. While maintaining routine western pharmacotherapies (WP), CHM had significant advantage over the treatment of placebo in improving CAT score (MD -3.93; 95 %CI -6.01 to -1.85) and SGRQ score (MD -6.20; 95 %CI -10.13 to -2.28), reducing the frequency of acute exacerbations (MD -0.78; 95 %CI -1.40 to -0.16) and improving clinical effective rate (RR 1.29; 95 %CI 1.14 to 1.45), but had no significant effect on improving FEV%pred (MD 8.18; 95 %CI -4.22 to 20.58). High heterogeneity was found for the changes in exacerbation frequency and FEV%pred. No serious adverse events related to CHM were reported.
This meta-analysis of placebo-controlled RCTs demonstrated that the use of CHM in addition to WP could alleviate clinical symptoms, improve quality of life and clinical efficiency and reduce the frequency of exacerbations, which could be an alternative approach for treatment adjustment of COPD. CHM was a relatively safe treatment. These findings need to be verified in future with high-quality clinical trials.
评估中药（CHM）治疗稳定期慢性阻塞性肺疾病（COPD）的临床疗效的随机临床试验和已发表的荟萃分析结果在疾病结局方面存在不一致，其中安慰剂对照研究的设计可能导致异质性。本研究旨在评估 CHM 与安慰剂相比在治疗稳定期 COPD 方面的疗效和安全性，为 COPD 中 CHM 的应用提供有力证据。
从建库至 2019 年 10 月 1 日，检索 9 个电子数据库，以确定 CHM 治疗稳定 COPD 的安慰剂对照随机试验，并纳入英文或中文的研究。主要结局指标为症状评分（CAT 评分）、生活质量（SGRQ）和急性加重频率。次要结局指标包括肺功能、临床总有效率和不良事件。由两位评审员独立进行研究选择、数据提取和编码以及纳入研究的偏倚风险评估。采用均数差（MD）分析连续变量，二分类数据采用相对危险比（RR）。
共纳入 11 项研究，共 1223 例患者。在维持常规西药（WP）治疗的基础上，CHM 组在改善 CAT 评分（MD-3.93；95%CI-6.01 至-1.85）和 SGRQ 评分（MD-6.20；95%CI-10.13 至-2.28）、降低急性加重频率（MD-0.78；95%CI-1.40 至-0.16）和提高临床有效率（RR 1.29；95%CI 1.14 至 1.45）方面均优于安慰剂组，而对 FEV%pred 的改善无显著影响（MD8.18；95%CI-4.22 至 20.58）。在急性加重频率和 FEV%pred 的变化方面，存在高度异质性。未报告与 CHM 相关的严重不良事件。
本荟萃分析纳入的安慰剂对照 RCT 表明，在 WP 基础上加用 CHM 可缓解临床症状、提高生活质量和临床疗效、降低急性加重频率，可能是 COPD 治疗调整的一种替代方法。CHM 是一种相对安全的治疗方法。这些发现需要未来用高质量的临床试验来验证。
