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.