Practice-Based Research in Complementary Medicine: Could N-of-1 Trials Become the New Gold Standard?

Abstract

Complementary medicines and therapies are popular forms of healthcare with a long history of traditional use. Yet, despite increasing consumer demand, there is an ongoing exclusion of complementary medicines from mainstream healthcare systems. A lack of evidence is often cited as justification. Until recently, high-quality evidence of treatment efficacy was defined as findings from well-conducted systematic reviews and meta-analyses of randomized controlled trials. In a recent and welcome move by the Oxford Centre for Evidence-Based Practice, however, the N-of-1 trial design has also been elevated to the highest level of evidence for treatment efficacy of an individual, placing this research design on par with the meta-analysis. N-of-1 trial designs are experimental research methods that can be implemented in clinical practice. They incorporate much of the rigor of group clinical trials, but are designed for individual patients. Individualizing treatment interventions and outcomes in research designs is consistent with the movement towards patient-centered care and aligns well with the principles of holism as practiced by naturopaths and many other complementary medicine practitioners. This paper explores whether rigorously designed and conducted N-of-1 trials could become a new ‘gold standard’ for demonstrating treatment efficacy for complementary medicine interventions in individual patients in clinical practice.