To quantify the burden of low back pain (LBP) and its risk factors in China from 1990 to 2021 and to assess the efficacy of traditional Chinese medicine (TCM) interventions.

The incidence, prevalence, and years lived with disability (YLDs) of LBP in China were searched. Trends from 1990 to 2021 were assessed using estimated annual percentage changes, stratified by age and sex, and joinpoint regression evaluated temporal patterns in LBP burden attributable to risk factors. Then, we searched ten electronic databases (up to April 2025) for randomized controlled trials (RCTs) of TCM interventions. The primary outcomes were pain intensity and physical function.

In 2021, China had the highest absolute incidence, prevalence, and YLDs of LBP among G20 countries, although its age-standardized YLD rate had decreased significantly since 1990. An estimated 3.31 million YLDs (95% UI: 2.28, 4.53) were attributable to occupational ergonomic factors, 1.85 million (95% UI: 1.08, 2.70) to smoking, and 1.06 million (95% UI: 0.11, 2.23) to high body mass index. The systematic review identified 137 eligible trials involving 11 936 participants. Moderate-confidence evidence showed reduced post-intervention pain intensity with acupuncture plus physiotherapy care (standardized mean difference [SMD] = −1.59, 95% CI [−2.10, −1.09]), acupressure (SMD = −0.87, [−1.17, −0.57]), and acupuncture plus moxibustion (SMD = −2.44, [−2.72, −2.16]) versus physiotherapy care. Improved physical function had moderate-to-very-low confidence with acupuncture (SMD = −1.50, [−2.44, −0.57]) and Tai Chi (SMD = −1.84 [−2.30, −1.37]) compared with physiotherapy care and Western medicine.

Despite the decline in age-standardized YLD rates since 1990, the absolute burden remains substantial. Incorporating TCM into management may help address this burden but requires risk-stratified, large-scale, high-quality RCTs with extended follow-up.

The study protocol was registered with the International Prospective Register of Systematic Reviews (https://www.crd.york.ac.uk/PROSPERO/, CRD420251054137).

With the adoption of international health standards, patient-reported outcomes (PROs) are increasingly used in clinical trials, promoting the effective implementation of patient-centered healthcare. However, the characteristics of PRO use in digestive tract tumor trials in China remain poorly understood. The aim of this study was to evaluate PRO application and characteristics in randomized clinical trials of digestive tract tumors conducted in China.

In this cross-sectional study, we identified data from the ClinicalTrials.gov database and the Chinese Clinical Trial Registry and the dataset was restricted to randomized clinical trials of digestive tract tumors conducted in China between January 1, 2010, and June 30, 2025. Trials were classified into four groups: (1) those listing PROs as primary outcomes; (2) those listing PROs as secondary outcomes; (3) trials listing PROs as co-primary outcomes (both primary and secondary); and (4) trials without any PRO instrument.

Of 2292 trials, 928 (40.5%) incorporated PRO instruments as part of their results. Among these, 29.6% (275/928) listed PRO as primary outcomes, 54.2% (503/928) as secondary outcomes, and 16.2% (150/928) as co-primary outcomes. The most frequent conditions for the explicit use of specific PRO instruments included colorectal (405/928, 43.6%), stomach (229/928, 24.7%), and esophageal (166/928, 17.9%) tumors. Commonly used PRO instruments included the Visual Analog Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, and the Numeric Rating scale. Among relevant trials, only 4.8% (6/125) used the traditional Chinese medicine (TCM) Symptom Score.

Recently, PRO use has shown an increasing trend in randomized clinical trials on digestive tract tumors conducted in China. Nonetheless, the low proportion of clinical trials of digestive tract tumors using PROs remains noteworthy. Future efforts should develop TCM-specific PRO tools and integrate TCM syndrome scales with Western PROs in TCM-oncology trials.