Sikorskii Alla, Wyatt Gwen, Victorson David, Faulkner Gwen, Rahbar Mohammad Hossein
Department of Statistics and Probability, College of Natural Science, Michigan State University, East Lansing, MI, 48824, USA.
Nurs Res. 2009 Nov-Dec;58(6):444-51. doi: 10.1097/NNR.0b013e3181bf15fe.
Complementary and alternative medicine (CAM) use is widespread among cancer patients. Information on safety and efficacy of CAM therapies is needed for both patients and healthcare providers. Well-designed randomized clinical trials of CAM therapy interventions can inform both clinical research and practice.
The aim of this study was to review important issues that affect the design of randomized clinical trials for CAM interventions.
Using the methods component of the Consolidated Standards for Reporting Trials as a guiding framework and a National Cancer Institute-funded reflexology study as an exemplar, methodological issues related to participants, intervention, objectives, outcomes, sample size, randomization, blinding, and statistical methods were reviewed.
Trials of CAM interventions designed and implemented according to appropriate methodological standards will facilitate the needed scientific rigor in CAM research. Interventions in CAM can be tested using proposed methodology, and the results of testing will inform nursing practice in providing safe and effective supportive care and in improving the well-being of patients.
补充和替代医学（CAM）在癌症患者中广泛使用。患者和医疗服务提供者都需要有关CAM疗法安全性和有效性的信息。精心设计的CAM疗法干预随机临床试验可为临床研究和实践提供参考。
本研究的目的是回顾影响CAM干预随机临床试验设计的重要问题。
以《报告试验的统一标准》的方法部分为指导框架，并以一项由美国国立癌症研究所资助的反射疗法研究为例，对与参与者、干预措施、目标、结局、样本量、随机化、盲法和统计方法相关的方法学问题进行了回顾。
根据适当的方法学标准设计和实施的CAM干预试验将有助于在CAM研究中实现所需的科学严谨性。CAM中的干预措施可以使用所提出的方法进行测试，测试结果将为护理实践提供信息，以提供安全有效的支持性护理并改善患者的健康状况。
