Methodological issues in trials of complementary and alternative medicine interventions

Alla Sikorskii*, Gwen Wyatt, David Victorson, Gwen Faulkner, Mohammad Hossein Rahbar

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

16 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)444-451
Number of pages8
JournalNursing Research
Issue number6
StatePublished - Nov 2009


  • Complementary and alternative therapies
  • Methodology

ASJC Scopus subject areas

  • Nursing(all)


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