Evidence-Based Social Science Research Center, School of Public Health, Lanzhou University, Lanzhou, China; Department of Social Medicine and Health Management, School of Public Health, Lanzhou University, Lanzhou, China.
School of Nursing, Gansu University of Chinese Medicine, Lanzhou, China.
J Ethnopharmacol. 2024 Mar 25;322:117601. doi: 10.1016/j.jep.2023.117601. Epub 2023 Dec 18.
Traditional Chinese Medicine (TCM) represents a rich repository of empirically-developed traditional medicines. The findings call for more rigorous study into the efficacy, safety, and mechanisms of action of TCM remedies to strengthen the evidence base.
To systematically review the quality of insomnia clinical practice guidelines that involve TCM recommendations and to summarize the certainty of evidence supporting the recommendations, strength, and consistency of recommendations, providing valuable research references for the development of future insomnia guidelines.
We systematically searched PubMed, Web of Science, Embase, CNKI, Wanfang, Chinese Biomedical Literature Database, Chinese Medical Association, Chinese Sleep Research Society, Medsci, Medlive, British National Institute of Health and Clinical Excellence (NICE), and the International Guidelines Collaboration Network (GIN) for clinical practice guidelines on insomnia from inception to March 5, 2023. Four evaluators conducted independent assessments of the quality of the guidelines by employing the AGREE II tool. Subsequently, the guideline recommendations were consolidated and presented as evidence maps.
Thirteen clinical practice guidelines addressing insomnia, encompassing 211 recommendations (consisting of 127 evidence-based and 84 expert consensus recommendations), were deemed eligible for inclusion in our analysis. The evaluation results revealed an overall suboptimal quality, with the "scope and purpose" domain achieving the highest score (58.1%), while the "applicability" domain garnered the lowest score (13.0%). Specifically, it was observed that 74.8% (n = 95) of the evidence-based recommendations were supported by evidence of either very low or low certainty, in contrast to the expert consensus recommendations, which accounted for 61.9% (n = 52). We subsequently synthesized 44 recommendations into four evidence maps, focusing on proprietary Chinese medicines, Chinese medicine prescriptions, acupuncture, and massage, respectively. Notably, Chinese herbal remedies and acupuncture exhibited robust support, substantiated by high-certainty evidence, exemplified by interventions such as Xuefu Zhuyu decoction, spleen decoction, body acupuncture, and ear acupuncture, resulting in solid recommendations. Conversely, proprietary Chinese medicines needed more high-certainty evidence, predominantly yielding weak recommendations. As for other therapies, the level of certainty was predominantly categorized as low or very low. Recommendations about magnetic therapy, bathing, and fumigation relied primarily on expert consensus, needing more substantive clinical research evidence, consequently forming weak recommendations. Hot ironing and acupoint injection recommendations were weakly endorsed, primarily based on observational studies. Furthermore, interventions like qigong, gua sha, and moxibustion displayed a relatively limited number of clinical studies, necessitating further exploration to ascertain their efficacy.
Our analysis revealed a need for substantial improvement in the quality of all the included guidelines related to insomnia. Notably, recommendations for Traditional Chinese Medicine (TCM) treatments predominantly rely on low-certainty evidence. This study represents a pioneering effort in the utilization of recommendation mapping to both present and identify existing gaps in the evidence landscape within TCM therapies, thus setting the stage for future research initiatives. The evidence supporting TCM therapy recommendations must be fortified to achieve a more substantial level of recommendation and higher certainty. Consequently, there exists a critical and pressing demand for high-quality clinical investigations dedicated to TCM, with a specific focus on ascertaining its long-term efficacy, safety, and potential side effects in the context of insomnia treatment. These endeavors are poised to establish a robust scientific foundation to inform the development of TCM therapy recommendations within the insomnia guidelines.
传统中医（TCM）代表了一个经验丰富的传统药物的丰富资源库。这些发现呼吁对 TCM 疗法的疗效、安全性和作用机制进行更严格的研究，以加强证据基础。
系统评价涉及 TCM 建议的失眠临床实践指南的质量，并总结支持建议的证据的确定性、建议的强度和一致性，为未来失眠指南的制定提供有价值的研究参考。
我们系统地检索了 PubMed、Web of Science、Embase、CNKI、万方、中国生物医学文献数据库、中华医学会、中国睡眠研究会、Medsci、Medlive、英国国家卫生与临床优化研究所（NICE）和国际指南协作网络（GIN），以获取截至 2023 年 3 月 5 日的失眠临床实践指南。四名评估员使用 AGREE II 工具独立评估指南的质量。随后，我们整合了指南建议，并以证据图的形式呈现。
共有 13 项针对失眠的临床实践指南，涵盖 211 项建议（包括 127 项基于证据的建议和 84 项专家共识建议），被认为符合纳入标准。评估结果显示，总体质量较差，“范围和目的”领域得分最高（58.1%），而“适用性”领域得分最低（13.0%）。具体来说，我们发现 74.8%（n=95）的基于证据的建议得到了非常低或低确定性证据的支持，而专家共识建议占 61.9%（n=52）。我们随后将 44 项建议综合成四个证据图，分别关注中药专利药、中药方剂、针灸和按摩。值得注意的是，中药和针灸显示出强大的支持，证据确定性高，如血府逐瘀汤、脾汤、体针和耳针等干预措施，形成了有力的建议。相比之下，中药专利药需要更多的高确定性证据，主要是弱建议。对于其他疗法，确定性水平主要为低或非常低。关于磁疗、沐浴和熏蒸的建议主要基于专家共识，需要更多实质性的临床研究证据，因此形成了弱建议。热熨和穴位注射建议得到了较弱的支持，主要基于观察性研究。此外，气功、刮痧和艾灸等干预措施的临床研究相对较少，需要进一步探索以确定其疗效。
我们的分析表明，所有纳入的失眠相关指南都需要在质量方面有很大的改进。值得注意的是，TCM 治疗建议主要依赖于低确定性证据。本研究代表了利用推荐映射来呈现和确定 TCM 疗法证据领域现有差距的开创性努力，为未来的研究计划奠定了基础。支持 TCM 治疗建议的证据必须得到加强，以实现更高水平的建议和更高的确定性。因此，迫切需要进行高质量的临床研究，专门针对 TCM，以确定其在失眠治疗中的长期疗效、安全性和潜在副作用。这些努力将建立一个强大的科学基础，为 TCM 疗法建议在失眠指南中的制定提供信息。
