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      ‘The Science of CAIM: What's Next for Complementary, Alternative and Integrative Medical Research?’

      meeting-report
      Evidence-based Complementary and Alternative Medicine : eCAM
      Oxford University Press

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          Abstract

          UCLA's Office of the Vice Chancellor for Research and Center for East West Medicine recently hosted a symposium on the future of complementary, alternative and integrative medical research featuring nationally recognized speakers. The symposium took place on the UCLA campus in late January and was targeted to the Geffen School of Medicine's Institutional Review Board (IRB). Its purpose was to address the finding by the National Center for Complementary and Alternative Medicine (NCCAM) that IRB's may be unfamiliar and/or uncomfortable with unconventional medical modalities thus apt to disapprove studies of those modalities (1). The hope was to better this state of affairs by familiarizing the audience with some of the major controversies surrounding CAIM research and its regulation. As it turned out, NCCAM, itself came in for censure. Dr Daniel Cherkin, Associate Director for Research and Senior Investigator at Group Health in Seattle functioned as moderator and began the program with a catalog of ills from which the US health care system suffers, a description of the role CAIM has played in responding to those ills, a review of NCCAM's mission and several questions regarding how that mission has been and should be carried out. A standing-room-only crowd then heard Dr Donald Marcus, Professor of Medicine at Baylor University and well-known CAIM critic and Dr John Longhurst, Director of the Susan Samueli Center for Integrative Medicine and Professor of Medicine at the University of California at Irvine deliver their appraisals of NCCAM. They decried the ‘too-low’ ratio of basic to clinical research, what they view as the inordinate influence on the Advisory Council and review panels of CAIM practitioners, many of whom lack research training and the investigation of ‘scientifically implausible’ therapies for which there is inadequate preliminary data and which, in some cases may be dangerous. NCCAM's EDTA chelation trial was mentioned as being especially ill-advised. While largely critical, both speakers’ remarks included some praise. Dr Marcus made reference to neuroscientific studies, work on the placebo effect and negative trials of herbs as useful NCCAM achievements. Dr Longhurst spoke of NCCAM's unique role in investigating modalities ignored by the rest of NIH. Although he favors continued research on some CAIM treatments, Dr Marcus opined that other NIH Centers are equipped to take on such projects. He repeated his call for an outside review of NCCAM, citing his belief that political rather than scientific considerations drive its agenda. He regards the situation as untenable, particularly in an era of major cutbacks in research funding. While not calling for an independent review, Dr Longhurst spoke strongly in favor of reform, a narrowing of the research agenda as well as an increase in funding. While Professors Longhurst and Marcus gave an overview of the field of CAIM research, Dr Ary Goldberger, Director of the Margret & H. A. Rey Institute for Nonlinear Dynamics in Medicine at Boston's Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School discussed his work on complex systems as one example of where such research may be headed. In Dr Goldberger's view, conventionally designed studies frequently err in focusing on only one molecular mechanism, ignoring communication among pathways and sometimes leading to unforeseen adverse outcomes. Dr Goldberger suggested that conservatism in science extends to the underlying approach to physiological systems, often wrongly privileging homeostasis (‘constancy as the wisdom of the body’) over complex adaptability, multi-scale dynamics and emergent properties. In as much as they are non-linear, non-stationary, non-additive and show time irreversibility, however, complex systems may be inaccessible to conventional analytic techniques, according to the speaker. Dr Goldberger left the impression that he believes both investigators and NIH Centers in general ought to be more open to novel but rigorous research designs and methodology. On the subject of the criticisms leveled at NCCAM, the speaker advocated ‘ruthless neutrality’ in all scientific investigation but suggested that in its imperfection, NCCAM in no way distinguishes itself from other NIH Centers. He criticized the NIH system, generally, for a tendency to reward ‘specific-aimsmanship’ in grant writing over originality. He advocated the same non-linearity of thought for the NIH that his work has shown to be associated with good bodily health and adaptability to stress. In noting that taxpayers ‘own’ NIH data, Dr Goldberger suggested that NCCAM take a leadership role in advocacy for open access data and open source software, fostering scientific collaboration by allowing validation of studies already completed. NCCAM and CAIM leaders and investigators have countered several of the arguments made by speakers Longhurst and Marcus in the past (2–10) and UCLA panelists echoed some of those responses, adding queries of their own. Professor-in-Residence Mark Cohen expressed the view that current research tools may be inadequate for measuring the effects of some CAIM treatments. In addition, he noted that taxpayers already support faith-based initiatives and questioned whether conventional science has a ‘special entitlement’ to public funds, given that orientation. On the issue of the research agenda at NCCAM, he made mention of the fact that in creating the R21 grant, NIH acknowledged that existing funding mechanisms didn't sufficiently encourage creativity. With regard to political considerations, he pointed out that these have played a role in the creation of other NIH Centers, including the National Institute of Biomedical Imaging and BioEngineering (NIBIB). Noted UCLA cancer researcher Dr Patricia Ganz seconded Cohen's concern about conservatism at NIH, recounting difficulties convincing colleagues and reviewers of the need to study links between the mind and body. She decried many investigators’ unwillingness to ‘think outside the heart’, a reference to her observation that most rarely emerge from their disciplinary ‘silos’. Dr Marcus agreed on the importance of supporting some mind-body research, but indicated he felt that funders have turned a corner and are now more open to such work. Drs Ganz and Longhurst both spoke in favor of the training of more persons capable of doing rigorous science across disciplines. Distinguished Professor Edwin Cooper (Editor in Chief, Evidence Based Complementary and Alternative Medicine) echoed others’ reluctance to single out NCCAM for castigation. He, too, raised questions about what passes for good research methodology, asking whether studying ancient, whole systems of medicine using Western, reductionistic techniques doesn't strip them of essential features. Associate Professor of Pediatrics, Jennie Tsao agreed on the importance of investigating traditional medicine as practiced remarking that for most users—users in India and China, for example—such therapies are not considered ‘alternative’. Dr Ganz added that some non-western practices are associated with greater longevity and may merit study as potential models for biomedicine as it faces an epidemic of chronic disease. On the subject of NCCAM's achievements, Dr Tsao, suggested taking the long view. She noted that psychological treatments such as cognitive-behavioral therapy (CBT) now have an established evidence base, thanks largely to sponsorship by the National Institute of Mental Health (NIMH). However, it took many years to separate empirically validated approaches from those with little or no value. Thus, to summarily dismiss a whole group of therapies as unsupported would be premature, in her view. Dr Alison Moore, an authority on geriatric alcoholism questioned speakers on funding alternatives outside of NIH and opportunities for training in CAIM research. Participants acknowledged the difficulty of finding research dollars and Dr Longhurst named several non-governmental sources he had used, suggesting that young investigators look to such funding as a bridge to support by NIH. After summarizing points made by the speakers and panelists, Dr Cherkin concluded that there is a need to broaden our view of what constitutes good science and that systems-level investigations and a focus on patients’ concerns as they view them are important means of achieving that end. ‘Science of CAIM’ was unusual in that it brought together experts representing widely divergent opinions on how complementary, alternative and integrative modalities should be studied for a face-to-face discussion. While consensus was not reached on most issues, the symposium did succeed in offering those in the business of evaluating CAIM proposals exposure to some of the most pressing questions regarding its study and regulation, thereby addressing concerns expressed in NCCAM's Strategic Plan. A pod cast of the symposium is available at http://www.cewm.med.ucla.edu/podcasts/index.html

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          Most cited references10

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          Researching complementary and alternative treatments – the gatekeepers are not at home

          Background To explore the strengths and weaknesses of conventional biomedical research strategies and methods as applied to complementary and alternative medicine (CAM), and to suggest a new research framework for assessing these treatment modalities. Discussion There appears to be a gap between published studies showing little or no efficacy of CAM, and reports of substantial clinical benefit from patients and CAM practitioners. This "gap" might be partially due to the current focus on placebo-controlled randomized trials, which are appropriately designed to answer questions about the efficacy and safety of pharmaceutical agents. In an attempt to fit this assessment strategy, complex CAM treatment approaches have been dissected into standardized and often simplified treatment methods, and outcomes have been limited. Unlike conventional medicine, CAM has no regulatory or financial gatekeeper controlling their therapeutic "agents" before they are marketed. Treatments may thus be in widespread use before researchers know of their existence. In addition, the treatments are often provided as an integrated 'whole system' of care, without careful consideration of the safety issue. We propose a five-phase strategy for assessing CAM built on the acknowledgement of the inherent, unique aspects of CAM treatments and their regulatory status in most Western countries. These phases comprise: 1. Context, paradigms, philosophical understanding and utilization 2. Safety status 3. Comparative effectiveness. 4. Component efficacy 5. Biological mechanisms. Summary Using the proposed strategy will generate evidence relevant to clinical practice, while acknowledging the absence of regulatory and financial gatekeepers for CAM. It will also emphasize the important but subtle differences between CAM and conventional medical practice.
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            Evidence-based Research in Complementary and Alternative Medicine I: History

            Contemporary Western medicine has witnessed a fragmentation of our conceptualization of the medical endeavor into ‘traditional medicine’ and ‘non-traditional medicine’. The former is meant to refer to the Western medical tradition, the latter encompasses both ‘complementary’ and ‘alternative’ medical practices. Complementary medicine complements conventional medical treatments, and alternative modes of medical interventions are meant to replace traditional Western medicine. Evidence-based research must be directed at establishing the best available evidence in complementary and alternative medicine. This paper is the first of a set of four ‘lectures’ that reviews the process of evidence-based research, and discusses its implications and applications for the early decades of the 21st century. The purpose of this paper is to introduce the series by examining some of the historical and philosophical foundations of this research endeavor.
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              Evaluating Complex Healthcare Systems: A Critique of Four Approaches

              The purpose of this paper is to bring clarity to the emerging conceptual and methodological literature that focuses on understanding and evaluating complex or ‘whole’ systems of healthcare. An international working group reviewed literature from interdisciplinary or interprofessional groups describing approaches to the evaluation of complex systems of healthcare. The following four key approaches were identified: a framework from the MRC (UK), whole systems research, whole medical systems research described by NCCAM (USA) and a model from NAFKAM (Norway). Main areas of congruence include acknowledgment of the inherent complexity of many healthcare interventions and the need to find new ways to evaluate these; the need to describe and understand the components of complex interventions in context (as they are actually practiced); the necessity of using mixed methods including randomized clinical trials (RCTs) (explanatory and pragmatic) and qualitative approaches; the perceived benefits of a multidisciplinary team approach to research; and the understanding that methodological developments in this field can be applied to both complementary and alternative medicine (CAM) as well as conventional therapies. In contrast, the approaches differ in the following ways: terminology used, the extent to which the approach attempts to be applicable to both CAM and conventional medical interventions; the prioritization of research questions (in order of what should be done first) especially with respect to how the ‘definitive’ RCT fits into the process of assessing complex healthcare systems; and the need for a staged approach. There appears to be a growing international understanding of the need for a new perspective on assessing complex healthcare systems.
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                Author and article information

                Journal
                Evid Based Complement Alternat Med
                ecam
                ecam
                Evidence-based Complementary and Alternative Medicine : eCAM
                Oxford University Press
                1741-427X
                1741-4288
                March 2010
                2 May 2008
                2 May 2008
                : 7
                : 1
                : 145-147
                Author notes
                For reprints and all correspondence: Elizabeth H. Logue, CRNP Fellow, UCLA Center for East West Medicine, 2428 Santa Monica Blvd. Suite 208, Santa Monica, CA 90404. Tel: 310-998-9118; Fax: 310-829-9318; E-mail: elogue@ 123456mednet.ucla.edu
                Article
                nen028
                10.1093/ecam/nen028
                2816385
                18955333
                abf06d1f-52e4-4349-8da7-bf6f096454e3
                © 2008 The Author(s).

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 24 March 2008
                : 4 April 2008
                Categories
                Meeting Report

                Complementary & Alternative medicine
                Complementary & Alternative medicine

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