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J Altern Complement Med. 2004 Dec;10(6):979-84.

n-of-1 randomized controlled trials: an opportunity for complementary and alternative medicine evaluation.

Author information

  • 1Complementary and Alternative Research and Education (CARE) Program, Department of Pediatrics, University of Alberta, Mackenzie Health Sciences Centre, Edmonton, Alberta T6G 2R7, Canada. b.johnston@ualberta.ca

Abstract

Complementary and alternative medicine (CAM) practice has traditionally relied on expert opinion and case examples to evaluate the outcome of a particular therapeutic treatment. Such trials are subject to bias, leading to the formation of erroneous conclusions about the effectiveness of most treatments. This paper reviews the feasibility of n-of-1 trials to better evaluate the clinical and statistical significance of CAM therapies. In particular: (1) problems arising from the use of standard therapeutic trials; (2) the n-of-1 trial and data analysis; (3) clinical use and advantages of the n-of-1 trial in conventional medicine; (4) potential clinical uses of the n-of-1 trial in CAM; (5) preliminary guidelines for the use of the n-of-1 trial in CAM; (6) constraints on the use of the n-of-1 trial in CAM; and (7) ethical issues in the conduct of the n-of-1 trial.

PMID:
15673992
[PubMed - indexed for MEDLINE]
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