n-of-1 randomized controlled trials: an opportunity for complementary and alternative medicine evaluation.
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.
Johnston
Bradley C
BC
Complementary 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
Mills
Edward
E
D015982:Bias; D000529:Complementary Therapies / Q000592:standards*; D015987:Effect Modifier, Epidemiologic; D019317:Evidence-Based Medicine; D005240:Feasibility Studies; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards*