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注册针灸临床试验中纳入癌症患者的特征。

The characteristics of registered acupuncture clinical trials enrolling cancer patients.

机构信息

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.

School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.

出版信息

Support Care Cancer. 2022 Dec;30(12):10461-10470. doi: 10.1007/s00520-022-07331-9. Epub 2022 Sep 1.

DOI:10.1007/s00520-022-07331-9
PMID:36048280
Abstract

PURPOSE

This study sought to explore and summarize the global state of acupuncture clinical trials enrolling cancer patients included in international registries to date.

METHODS

All relevant trials evaluating acupuncture-related interventions for the treatment of cancer that were registered in 16 trial registries from January 1, 2001, through December 31, 2020, were identified. Subsequent publications related to these trials were additionally retrieved from the PubMed, Cochrane Library, Embase, CNKI (China National Knowledge Infrastructure), VIP (China Science and Technology Journal Database), and Wanfang databases. We compared information included in these registries regarding completed trials with any associated publications, with a focus on study design, sample size, and selective reporting, based on the registered protocol.

RESULTS

In total, 222 eligible trials across 19 countries were identified. These trials included 17 specific cancer types and 32 symptoms. The five most common cancer types were breast cancer, head and neck cancer, colorectal cancer, lung cancer, and gastric cancer, accounting for almost half of all registered trials (48.2%). The top five symptoms included in these trials were chemotherapy-induced peripheral neuropathy (CIPN), cancer-related pain, cancer-related fatigue, chemotherapy-induced nausea and vomiting (CINV), and gastrointestinal dysfunction. The overall rate of article publication was low, with publications being associated with just 33.3% of these registered trials.

CONCLUSIONS

This review is the first snapshot of the landscape of acupuncture clinical trials registered in international trial registries, providing a methodological basis for the management of common treatment- and disease-related side effects among cancer patients undergoing acupuncture and offering useful information that will guide future acupuncture-focused research.

摘要

目的

本研究旨在探索和总结截至目前纳入国际注册中心的癌症患者接受针刺临床试验的全球状况。

方法

确定了 2001 年 1 月 1 日至 2020 年 12 月 31 日期间,在 16 个试验注册中心注册的所有评估针刺相关干预措施治疗癌症的相关临床试验。此外,还从 PubMed、Cochrane 图书馆、Embase、CNKI(中国国家知识基础设施)、VIP(中国科技期刊数据库)和万方数据库中检索到这些试验的相关后续出版物。我们根据注册方案,比较了这些注册中心关于已完成试验的信息与任何相关出版物的信息,重点关注研究设计、样本量和选择性报告。

结果

共确定了来自 19 个国家的 222 项合格试验。这些试验包括 17 种特定癌症类型和 32 种症状。最常见的五种癌症类型是乳腺癌、头颈部癌症、结直肠癌、肺癌和胃癌,占所有注册试验的近一半(48.2%)。这些试验中纳入的前五名症状包括化疗引起的周围神经病(CIPN)、癌症相关疼痛、癌症相关疲劳、化疗引起的恶心和呕吐(CINV)以及胃肠道功能障碍。总体文章发表率较低,仅与这些注册试验的 33.3%相关联。

结论

这是首次对国际试验注册中心注册的针刺临床试验进行的概述,为管理接受针刺治疗的癌症患者的常见治疗和疾病相关副作用提供了方法学基础,并提供了有用的信息,将指导未来以针刺为重点的研究。

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本文引用的文献

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The Effects of Acupuncture on Cancer-Related Fatigue: Updated Systematic Review and Meta-Analysis.针刺对癌症相关性疲劳的影响:更新的系统评价与Meta分析
Integr Cancer Ther. 2020 Jan-Dec;19:1534735420949679. doi: 10.1177/1534735420949679.
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High-quality evidence to inform clinical practice.为临床实践提供依据的高质量证据。
Lancet. 2019 Aug 24;394(10199):633-634. doi: 10.1016/S0140-6736(19)31256-5.
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[Interpretation of acupuncture theory from acupuncture application].从针灸应用解读针灸理论
Zhongguo Zhen Jiu. 2017 Oct 12;37(10):1115-8. doi: 10.13703/j.0255-2930.2017.10.024.
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The Effects of Acupuncture on Chronic Knee Pain Due to Osteoarthritis: A Meta-Analysis.针灸对骨关节炎所致慢性膝关节疼痛的影响:一项荟萃分析
J Bone Joint Surg Am. 2016 Sep 21;98(18):1578-85. doi: 10.2106/JBJS.15.00620.
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Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013.全球临床试验注册趋势:对2004年至2013年世界不同地区注册临床试验数量的分析。
BMJ Open. 2015 Sep 25;5(9):e008932. doi: 10.1136/bmjopen-2015-008932.
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Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine: an empirical methodological study.前瞻性注册、偏倚风险和中医药随机临床试验的结局报告偏倚:一项经验性方法学研究。
BMJ Open. 2013 Jul 16;3(7). doi: 10.1136/bmjopen-2013-002968. Print 2013.
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Do urology journals enforce trial registration? A cross-sectional study of published trials.泌尿学杂志会强制要求试验注册吗?一项已发表试验的横断面研究。
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Legislation for trial registration and data transparency.临床试验注册和数据透明度立法。
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CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials.CONSORT 2010 解释与说明:平行组随机试验报告的更新指南。
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