BACKGROUND: 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. OBJECTIVES: The aim of this study was to review important issues that affect the design of randomized clinical trials for CAM interventions. METHODS: 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. DISCUSSION: 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.
BACKGROUND: Complementary and alternative medicine (CAM) use is widespread among cancerpatients. 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. OBJECTIVES: The aim of this study was to review important issues that affect the design of randomized clinical trials for CAM interventions. METHODS: 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. DISCUSSION: 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.
Authors: Cornelis J A Punt; Marc Buyse; Claus-Henning Köhne; Peter Hohenberger; Roberto Labianca; Hans J Schmoll; Lars Påhlman; Alberto Sobrero; Jean-Yves Douillard Journal: J Natl Cancer Inst Date: 2007-06-27 Impact factor: 13.506
Authors: Suzanna M Zick; Mack T Ruffin; Julia Lee; Daniel P Normolle; Rivka Siden; Sara Alrawi; Dean E Brenner Journal: Support Care Cancer Date: 2008-11-13 Impact factor: 3.603
Authors: Stacie A Salsbury; James W DeVocht; Maria A Hondras; Michael B Seidman; Clark M Stanford; Christine M Goertz Journal: Chiropr Man Therap Date: 2014-12-03