Developing a Core Outcome Set for Clinical Trials of Traditional Chinese Medicine for Lumbar Disc Herniation

Traditional Chinese medicine (TCM) is widely used in managing lumbar disc herniation (LDH), but heterogeneous outcome reporting in its trials hinders evidence synthesis. This study intends to develop a core outcome set (COS) for TCM-LDH to standardize reporting and improve research quality.

Candidate outcomes were identified via a systematic review of TCM-related randomized controlled trials (RCTs) for LDH, with studies retrieved from multiple databases between January 1 2019 and December 31 2023 and supplemented by clinical trial registry searches. Semistructured interviews with LDH patients and clinician questionnaires were conducted to refine candidate outcomes. Two Delphi rounds were carried out among clinicians, pharmaceutical researchers, journal editors, methodologists, and patients, followed by an online-offline consensus meeting to finalize the COS.

A candidate outcome pool was established via a systematic review (413 RCTs, 51 registered studies), 30 LDH patient interviews, and 73 clinician surveys. After integration, deduplication, and steering committee refinement, two rounds of Delphi surveys were conducted. Following a consensus meeting attended by 24 multidisciplinary experts, 7 core outcomes were finalized for LDH: lumbar dysfunction, pain/discomfort, recurrence rate, straight leg raise angle, adverse reactions/adverse events, TCM syndromes, and sciatica frequency.

The developed COS for TCM-related LDH clinical trials provides standardized recommendations for outcome selection and reporting, which can enhance the consistency of research evidence, facilitate meta-analysis, and ultimately advance the quality of TCM-based interventions for LDH.