The integrated traditional Chinese and Western medicine has proved to be significantly effective in low back pain. But the response rate, a key composite outcome index for assessing the efficacy, has not been unified and standardized in clinical research.

To perform a scoping review of the definition and contents of rate of chronic low back pain response to integrated traditional Chinese and Western medicine in clinical studies with response rate as a composite outcome indicator, offering a reference for appropriately selecting composite outcome indicators of this disease.

Databases including Web of Science, PubMed, EMBase, Cochrane Library, CNKI, CQVIP, Wanfang Data and SinoMed were searched for clinical studies of chronic low back pain treated by integrated traditional Chinese and Western medicine published from January 2015 to December 2019. Two researchers independently enrolled studies according to inclusion and exclusion criteria, extracted data according to the BPICOS principles, and reviewed and summarized the criteria for defining the response rate as a composite outcome indicator.

Among 830 included studies, lumbar muscle degeneration had been studied the most 〔178 (21.4%) 〕, followed by the third lumbar transverse process syndrome〔103 (12.4%) 〕, lumbar disc herniation〔91 (11 .0%) 〕, low back pain〔89 (10.7%) 〕, lumbodorsal myofasciitis〔72 (8.7%) 〕, lumbar spinal stenosis〔69 (8.3%) 〕, and lumbar spondylolisthesis〔61 (7.3%) 〕. 808 studies (97.3%) described the reference for the definition of response rate or explained the definition of response rate developed by the author. Specifically, different versions of Criteria for the Diagnosis, Syndrome Differentiation, and Response Assessment of Diseases by Chinese Medicine was referred the most〔271 (32.7%) 〕. Clinical symptoms, level of daily life activities, pain, signs and work & living ability, these five indictors were used most frequently as composite outcome indicators, and 2-5 of them were often randomly used in combination as the third or fourth level of response criteria. In addition, common low back pain measurement tools were also used.

Due to the lack of unified standard, composite outcome indicators used for response assessment in clinical studies about chronic low back pain treated by traditional Chinese and Western medicine might have many problems, such as various definitions, division criteria, and assessment items. In view of this, it is suggested to standardize the composite outcome indicators for response assessment in accordance with the CORE Outcome Measurement and Evaluation Tool, and to improve their validity to be used in clinical studies regarding integrated traditional Chinese and Western medicine as unified indicators, thereby improving the quality and value of such studies.

中西医结合治疗腰痛的疗效显著，复合结局指标——有效率作为重要的疗效观察指标，在临床研究中尚未得到统一规范。

系统回顾以有效率为复合结局指标的中西医治疗慢性腰痛的临床研究，分析其中有效率的定义和具体内容，为后期研究合理地选择慢性腰痛的复合结局指标提供参考。

计算机检索Web of Science、PubMed、EMBase、Cochrane Library、中国期刊全文数据库、维普网、万方数据知识服务平台和中国生物医学文献服务系统关于中西医治疗慢性腰痛的临床研究，检索时限为2015—2019年。由2名研究者根据纳入、排除标准独立排除不符合纳入标准的文献，根据BPICOS原则提取文献中的内容，并对复合结局指标（有效率）的判定标准进行回顾与总结。

共纳入研究830篇，以腰肌劳损患者作为研究对象的最多，共178篇（21.4%），其他研究对象包括第三腰椎横突综合征患者103篇（12.4%）、腰椎间盘突出患者91篇（11.0%）、腰背痛患者89篇（10.7%）、腰背肌筋膜炎患者72篇（8.7%）、腰椎管狭窄患者69篇（8.3%）、腰椎滑脱患者61篇（7.3%）。830篇研究中808篇（97.3%）具体表述了有效率的参照标准或自定义评判标准，其中参考最多的是不同版本的《中医病证诊断疗效标准》，共271篇（32.7%）。在复合结局指标中使用最多的是临床症状、活动功能、疼痛、体征、工作生活能力这5项评判指标，常见以2~5项指标随意结合成三级或四级疗效评判标准，此外，常见的腰痛测量工具也被应用其中。

由于缺乏统一的规范化标准，中西医治疗腰痛的临床研究在使用复合结局指标——有效率时存在诸多问题，例如定义、划分标准、评价项目等不统一，笔者认为有效率这一复合结局指标可通过核心结局体系（COMET）进一步规范，并提高其效度形成统一标准以供临床研究使用，以提高中西医临床研究的质量与价值。