To systematically review the current status of randomized controlled trials (RCTs) on acupuncture combined with traditional Chinese tedicine (TCM) for low back pain (LBP) and evaluate their reporting quality.

Computer-based retrieval was conducted in the China National Knowledge Infrastructure (CNKI), VIP Chinese Journal Service Platform (VIP), and Wanfang Data Knowledge Service Platform (Wanfang) for RCT literatures on acupuncture combined with TCM in the treatment of LBP, published from the establishment of each database to December 31, 2024. Literatures were screened according to inclusion and exclusion criteria. Basic literature information, research elements, and methodological contents were extracted for bibliometric analysis. The reporting quality of literatures was evaluated with reference to the Consolidated Standards of Reporting Trials (CONSORT) Statement, Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA), and Consolidated Standards of Reporting Trials for TCM Compound Formulas (CONSORT-CHM Formulas).

A total of 482 RCTs were included. Among them, 443 (91.9%) were published in the past 10 years, 19 (3.9%) were published in core journals, and 371 (77.0%) had no funding support. Regarding research focus and intervention methods: 43.8% of the literatures focused on intervertebral disc herniation; 50.2% used filiform needle acupuncture; the top 6 acupoints in terms of frequency of use were Weizhong (BL 40), Shenshu (BL 23), Huantiao (GB 30), Jiaji (EX-B2), Dachangshu (BL 25), and Ashi Point (EX-UE1).Regarding TCM application: 462 (95.9%) literatures used TCM compound formulas; the top 4 classic compound formulas in frequency of use were Duhuo Jisheng Decoction, Shentong Zhuyu Decoction, Ganjiang Lingzhu Decoction, and Yangyuan Huoxue Decoction; the top 4 TCM syndrome types of LBP were cold-damp syndrome, qi stagnation and blood stasis syndrome, blood stasis syndrome, and liver-kidney deficiency syndrome.Regarding control and outcome measures: The most frequently used western medicine in the control group was celecoxib capsules; the most frequent efficacy evaluation index was total effective rate, followed by the visual analogue scale (VAS) score for LBP; the top 2 functional assessment scales in frequency of use were the Japanese orthopaedic association (JOA) score and oswestry disability index (ODI). Less than 10% of the studies evaluated physical and chemical indicators, among which the top 2 inflammatory factors in frequency of detection were tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). The results of literature reporting quality analysis showed that: the reporting rate of random allocation methods was 57.3%; only 4 literatures included "random" in their titles; 2 literatures distinguished primary and secondary outcome indicators; 1 literature mentioned implementation division of labor; 3 literatures mentioned "blinding" but did not report specific details of blinding implementation; none of the included literatures reported the basis for sample size calculation, allocation concealment, or clinical trial protocol registration information.

The number of RCTs on acupuncture combined with TCM for LBP is growing rapidly, but there are significant limitations: Research focuses on intervertebral disc herniation, with insufficient studies on other types of LBP; Trial design is mainly two-arm, lacking multi-arm comparisons (e.g., acupuncture alone / TCM alone / combination of acupuncture and TCM) and placebo controls; Outcome indicators rely excessively on subjective scales, with a lack of objective indicators; Methodological quality and reporting standardization are generally poor, which seriously affects the credibility and reproducibility of results.