系统梳理针刺联合中药治疗腰痛的随机对照试验（RCT）研究现状并评价报告质量。

运用计算机检索中国期刊全文数据库（CNKI）、维普资讯中文期刊服务平台（VIP）、万方数据知识服务平台（Wanfang）数据库中从建库至2024年12月31日发表的针刺联合中药治疗腰痛的RCT文献，根据纳入排除标准筛选文献，提取文献基本信息、研究要素及方法学内容进行计量学分析，参照临床试验报告统一标准（CONSORT）声明、针刺临床试验干预措施报告规范（STRICTA）、中药复方临床试验报告的统一标准（CONSORT-CHM Formulas）对文献报告质量进行评价。

研究共纳入482篇RCT文献，其中443篇（91.9%）文献发表于近10年，19篇（3.9%）文献发表在核心期刊，371篇（77.0%）文献无资金资助。43.8%的文献为椎间盘突出症的研究，50.2%的文献使用毫针针刺，穴位出现频次前6位的依次为委中、肾俞、环跳、夹脊穴、大肠俞、阿是穴；462篇（95.9%）文献使用中药复方，经典复方出现频次前4位的依次为独活寄生汤、身痛逐瘀汤、甘姜苓术汤、养元活血汤，腰痛证型出现频次前4位的依次为寒湿证、气滞血瘀证、血瘀证、肝肾不足证；对照西药出现频次最高的是塞来昔布胶囊。疗效评价指标出现频次最多的是总有效率，其次为腰痛视觉模拟量表评分，功能评定量表使用频次前2位的依次为日本骨科协会评估治疗分数和Oswestry功能障碍指数。不到10%的研究评价了理化指标，其中出现频次前2位的炎症因子是肿瘤坏死因子-α、白细胞介素-6。文献报告质量分析结果表明，随机分配方法的报告率为57.3%，仅有4篇文献的题目包含“随机”，2篇文献区分了主要和次要结局指标，1篇提到了实施分工，3篇文献提到了“盲法”但未报告盲法实施的具体细节，所有纳入的文献均未报告样本量估算依据、分配隐藏及临床试验方案注册信息。

针刺联合中药治疗腰痛的RCT研究数量增长迅速，但存在显著局限：研究聚焦于椎间盘突出症，其他腰痛类型研究不足；试验设计以双臂为主，缺乏多臂比较（如单纯针刺/单纯中药/针药结合）及安慰对照；结局指标过度依赖主观量表，客观指标匮乏；方法学质量和报告规范性普遍欠佳，严重影响结果可信度和可重复性。未来研究亟需严格遵循报告指南并优化设计以提升证据质量。

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.