Data from: Oral Chinese herbal medicine combined with pharmacotherapy for stable COPD: a systematic review of effect on BODE index and six minute walk test

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This systematic review evaluated the effects of Chinese herbal medicine (CHM) plus routine pharmacotherapy (RP) on the objective outcome measures BODE index, 6-minute walk test (6MWT), and 6-minute walk distance (6MWD) in individuals with stable chronic obstructive pulmonary disease (COPD). Searches were conducted of six English and Chinese databases (PubMed, EMBASE, CENTRAL, CINAHL, CNKI and CQVIP) from their inceptions until 18th November 2013 for randomized controlled trials involving oral administration of CHM plus RP compared to the same RP, with BODE Index and/or 6MWT/D as outcomes. Twenty-five studies were identified. BODE Index was used in nine studies and 6MWT/D was used in 22 studies. Methodological quality was assessed using the Cochrane Risk of Bias tool. Weaknesses were identified in most studies. Six studies were judged as ‘low’ risk of bias for randomisation sequence generation. Twenty-two studies involving 1,834 participants were included in the meta-analyses. The main meta-analysis results showed relative benefits for BODE Index in nine studies (mean difference [MD] −0.71, 95% confidence interval [CI] −0.94, −0.47) and 6MWT/D in 17 studies (MD 54.61 meters, 95%CI 33.30, 75.92) in favour of the CHM plus RP groups. The principal plants used were Astragalus membranaceus, Panax ginseng and Cordyceps sinensis. A. membranaceus was used in combination with other herbs in 18 formulae in 16 studies. Detailed sub-group and sensitivity analyses were conducted. Clinically meaningful benefits for BODE Index and 6MWT were found in multiple studies. These therapeutic effects were promising but need to be interpreted with caution due to variations in the CHMs and RPs used and methodological weakness in the studies. These issues should be addressed in future trials.

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本系统评价评估了中草药（Chinese herbal medicine, CHM）联合常规药物治疗（routine pharmacotherapy, RP）对稳定期慢性阻塞性肺疾病（chronic obstructive pulmonary disease, COPD）患者的客观结局指标BODE指数、6分钟步行试验（6-minute walk test, 6MWT）及6分钟步行距离（6-minute walk distance, 6MWD）的影响。
本研究检索了6个中英文数据库（PubMed、EMBASE、CENTRAL、CINAHL、CNKI、CQVIP）自建库至2013年11月18日的相关文献，纳入以口服中草药联合常规药物治疗对比单纯常规药物治疗、以BODE指数和/或6MWT/D为结局指标的随机对照试验。
最终共纳入25项相关研究，其中9项研究采用BODE指数作为结局指标，22项研究采用6MWT/D作为结局指标。
采用Cochrane偏倚风险工具（Cochrane Risk of Bias tool）评估方法学质量，结果显示多数研究存在方法学缺陷：仅6项研究在随机序列生成环节被判定为低偏倚风险。
本研究共纳入22项研究、1834名受试者进行荟萃分析。主要荟萃分析结果显示：在9项涉及BODE指数的研究中，中草药联合常规药物治疗组展现出显著获益（均数差[mean difference, MD] = -0.71，95%置信区间[confidence interval, CI]：-0.94~-0.47）；在17项涉及6MWT/D的研究中，治疗组的步行距离较对照组增加54.61米（95%CI：33.30~75.92），均优于单纯常规药物治疗组。
本研究使用的核心药材为黄芪（Astragalus membranaceus）、人参（Panax ginseng）与冬虫夏草（Cordyceps sinensis），其中16项研究的18个方剂均将黄芪与其他药材联合配伍使用。
本研究开展了详细的亚组分析与敏感性分析，多项研究证实中草药联合常规药物治疗对BODE指数及6MWT具有临床意义上的获益。
上述治疗效果颇具前景，但由于所用中草药与常规药物存在异质性，且纳入研究存在方法学缺陷，临床解读需谨慎。未来相关临床试验应针对上述问题进行优化。