Methodological issues in trials of complementary and alternative medicine interventions.
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.


OBJECTIVE
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.


CONCLUSIONS
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.
Sikorskii
Alla
A
Department of Statistics and Probability, College of Natural Science, Michigan State University, East Lansing, MI, 48824, USA. sikorska@stt.msu.edu
Wyatt
Gwen
G
Victorson
David
D
Faulkner
Gwen
G
Rahbar
Mohammad Hossein
MH
D000529:Complementary Therapies; D009729:Nursing; D016032:Randomized Controlled Trials as Topic; D012107:Research Design