背景:传统中药(TCM)代表了丰富的经验开发的传统药物库。这些发现要求对疗效进行更严格的研究,安全,加强中药作用机制的证据基础。
目的:系统回顾涉及中医推荐的失眠临床实践指南的质量,并总结支持推荐的证据的确定性,力量,和建议的一致性,为今后失眠指南的制定提供有价值的研究参考。
方法:我们系统地搜索了PubMed,WebofScience,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,英国国家健康与临床卓越研究所(NICE)和国际指南合作网络(GIN)从开始到2023年3月5日的失眠临床实践指南。4名评估员利用AGREEII工具对准则的质量进行了独立评估。随后,指南建议被合并并作为证据图呈现。
结果:解决失眠的十三个临床实践指南,包括211项建议(包括127项循证建议和84项专家共识建议),被认为有资格纳入我们的分析。评估结果显示总体质量欠佳,“范围和目的”域得分最高(58.1%),而“适用性”域得分最低(13.0%)。具体来说,据观察,74.8%(n=95)的循证建议得到了非常低或低确定性的证据的支持,与专家共识建议相反,占61.9%(n=52)。我们随后将44条建议合成为四张证据图,专注于中成药,中药处方,针灸,按摩,分别。值得注意的是,中草药和针灸显示出强大的支持,由高确定性证据证实,以血府逐瘀汤等干预措施为例,健脾汤,身体针灸,耳针,产生了可靠的建议。相反,中成药需要更多的高确定性证据,主要产生薄弱的建议。至于其他疗法,确定性水平主要分为低或极低.关于磁疗的建议,洗澡,熏蒸主要依靠专家共识,需要更多实质性的临床研究证据,因此形成了薄弱的建议。热熨烫和穴位注射的建议被弱认可,主要基于观察性研究。此外,像气功这样的干预措施,瓜莎,艾灸显示的临床研究数量相对有限,需要进一步探索以确定其功效。
结论:我们的分析显示,所有纳入的与失眠相关的指南的质量都需要大幅改善。值得注意的是,中医(TCM)治疗的建议主要依赖于低确定性证据。这项研究代表了利用推荐映射来呈现和识别中医疗法中证据领域的现有差距的开创性努力。从而为未来的研究举措奠定了基础。必须加强支持中医治疗建议的证据,以实现更实质性的建议和更高的确定性。因此,对致力于中医的高质量临床研究存在关键和紧迫的需求,特别注重确定其长期疗效,安全,以及失眠治疗中的潜在副作用。这些努力有望建立坚实的科学基础,为失眠指南中中医治疗建议的发展提供信息。
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.