针刺临床试验中对干预措施报告的国际标准

作者	单位
刘建平	挪威国家补充与替代医学研究中心英国利物浦大学热带医学院北京中医药大学循证中医药临床研究与评价中心北京100029

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中文摘要:

2001年国际针灸研究专家针对针灸临床试验设计和报告中存在的问题,制作了一份《针灸临床试验干预措施报告的标准》,英文简称为STRICTA。旨在促进临床试验报告的规范化,同时也有助于试验设计质量的提高。这一国际标准共有6个条目,包括报告针刺治疗的合理性、针刺的细节、治疗方案、辅助干预措施、实施针刺治疗者的资历以及对照干预的类型。本文对此国际标准进行了介绍,并以国际发表的两篇针刺随机临床试验为例对相关条目进行了解释。

英文摘要:

In clinical trials on acupuncture, the description of experimental intervention and controlled treatment are not usually reported adequately, for example, the acupoints and needles used, manipulation applied, duration of treatment, and other ancillary interventions and so on. This would limit the replication of the trial findings and application of the effective therapy. In 2001, an international group of acupuncture researchers discussed the problems in design and reporting of acupuncture clinical trials, and developed a standard for reporting intervention of the controlled clinical trials, abbreviated as ‘STRICTA’ recommendation,which contains 6 items to describe the rational of treatment, needling details, treatment regimen, co-interventions, practitioner’s background, and control intervention. This essay intends to introduce the standard and take two internationally published randomized trials of acupuncture as examples to illustrate the details.

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