Abstract
Despite the original definition of evidence-based medicine (EBM), which included the best external evidence in conjunction with a practitioner's clinical expertise, 2 the hierarchical ordering of external evidence means that the randomized controlled trial (RCT) is increasingly the only form of evidence considered by health care regulators and policymakers. There is no doubt that well-designed RCTs make valuable contributions to medical science and patient care, particularly in drug or single-agent studies. The issue, which has been raised several times in the pages of this Journal and others, is whether the supremacy of the RCT is warranted, when its conclusions frequently do not address the real-world context of either biomedicical 3,4 or CAM 5 practice. An unfortunate side-effect of the dominance of this rigid definition of EBM is that even public health research, on both domestic and global development fronts, is moving toward using RCTs to evaluate the impact of programs, with some of the same consequences 6,7 regarding external validity that face medical and CAM practitioners. It is as if our need for certainty has eclipsed our actual experience of the world to the extent that some of our most rigorous scientific research has lost touch with reality.
As Wardle and Oberg point out in their article in this issue of the Journal, the primary health concerns for this century (such as type 2 diabetes, obesity, and cardiovascular disease) are chronic, complex conditions, which require lifestyle change as major components of treatment and prevention. Lifestyle change generally entails behavioral change. The sustainable transformation of behavior can be an intricate and unpredictable process. Possibly more than any other CAM system, naturopathic medicine has a whole-person focus that supports both the development of a knowledge base and the embodiment of behavioral patterns that promote and sustain a patient's optimal health and well-being (not just the absence of symptoms) over the course of a lifetime. Education in the sense of providing information is just one component in fostering behavioral change, because it is recognized that a lack of information is not the only reason why a person maintains destructive habits. Naturopathic doctors (NDs) are also trained in the more intangible dimensions of practitioner interpersonal skills such as relational versatility, 8 which is the ability to meet patients at their individual level of readiness and to guide nonjudgmentally from there.
The current paradigm, by which conclusions are considered evidence-based only when they have been found effective by research methods that involve random assignment of participants to experimental and control groups, is too narrow for the assessment of CAM whole systems and living systems in general. Ranking solutions by the evaluation of their methodology instead of finding new ways to assess how well they accomplish important goals is an impoverished stance. The chronic and complex nature of the “epidemics” of the 21st century demand a new approach. Reversing the prevailing research strategy is an obvious way to allow CAM systems to be assessed appropriately. 9,10 This approach would allow for whole-system/whole-practice effectiveness studies to be conducted first, followed by efficacy trials, and finally, trials to determine mechanism of action. As stated by Bodeker and Kronenberg: 11 “New directions must be forged by researchers who are able to transcend limitations in research orthodoxy in the interests of providing sound information to the public on what constitutes good health care.”
It is not just limitations of research orthodoxy that must be transcended. For that to happen pervasively, a paradigm shift in our thinking as a society must take place first. The chronic and complex diseases of modern times require a new metaphor to encompass them and a new body of knowledge to explain them. As Jobst et al. 12 have described, the new metaphor must be about relationship and inter-relationship, taking into account our relationship with ourselves, other living beings, and our broadly defined environments. This needs to be done, not to allocate blame but to do justice to the reality that even as individuals we participate in something greater. The body of knowledge that will foster this kind of understanding has to be built upon meaning: personal meaning and thus the elevation of subjective experience and narrative. Interwoven with this new way of thinking, and perhaps an emergent property of it, is the realization that absence of symptoms does not equal the fullest expression of health and well-being that is possible for any given individual, group, or society. The fullest possible expression of health and well-being is the goal of naturopathic medicine and, essentially, the goal of non-RCT-based, complex models of public- and international-health interventions.
The fields of public health and naturopathic medicine would be powerful partners in fueling the paradigm shift in thinking that is needed to establish health care policy priorities and a public health research agenda that can successfully and sustainably address the behavioral and lifestyle-based health challenges of the modern age.