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. 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. Context, paradigms, philosophical understanding and utilization Safety status Comparative effectiveness. Component efficacy Biological mechanisms. 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.

The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery). The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability). Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform.

Objective To describe the prevalence of use of complementary and alternative medicine (CAM) in Norway, Denmark and Stockholm County. Design, setting, and subjects In Norway, a national representative sample of 1000 participants completed telephone interviews regarding their CAM use in 1997 (response rate 51). In Denmark, a national representative sample of 16 690 participants completed questionnaires and interviews regarding their health and morbidity in 2000 (response rate 74). In Stockholm County, a randomly selected sample of 1001 participants completed telephone interviews about their CAM use in 2000 (response rate 63). Results Prevalence of ever-use of CAM was 34% in Norway, 45% in Denmark, and 49% in Stockholm. Use of CAM is associated with poor self-reported health in all three studies, and with visits to a medical doctor in Denmark and Norway. More women than men, and more with higher education, reported use of CAM. Most frequently used CAM therapy was homeopathy in Norway, reflexology in Denmark, and massage in Stockholm County. Conclusions Use of CAM is common in the Scandinavian countries, and there are national differences regarding therapy preferences. Many individuals use both CAM and conventional health services.

The use of complementary and alternative Medicine (CAM) has increased over the past two decades in Europe. Nonetheless, research investigating the evidence to support its use remains limited. The CAMbrella project funded by the European Commission aimed to develop a strategic research agenda starting by systematically evaluating the state of CAM in the EU. CAMbrella involved 9 work packages covering issues such as the definition of CAM; its legal status, provision and use in the EU; and a synthesis of international research perspectives. Based on the work package reports, we developed a strategic and methodologically robust research roadmap based on expert workshops, a systematic Delphi-based process and a final consensus conference. The CAMbrella project suggests six core areas for research to examine the potential contribution of CAM to the health care challenges faced by the EU. These areas include evaluating the prevalence of CAM use in Europe; the EU cititzens’ needs and attitudes regarding CAM; the safety of CAM; the comparative effectiveness of CAM; the effects of meaning and context on CAM outcomes; and different models for integrating CAM into existing health care systems. CAM research should use methods generally accepted in the evaluation of health services, including comparative effectiveness studies and mixed-methods designs. A research strategy is urgently needed, ideally led by a European CAM coordinating research office dedicated to fostering systematic communication between EU governments, the public, charitable and industry funders, researchers and other stakeholders. A European Centre for CAM should also be established to monitor and further a coordinated research strategy with sufficient funds to commission and promote high quality, independent research focusing on the public’s health needs and pan-European collaboration. There is a disparity between highly prevalent use of CAM in Europe and solid knowledge about it. A strategic approach on CAM research should be established to investigate the identified gaps of knowledge and to address upcoming health care challenges.

Background: Collaboration between providers of conventional care and complementary therapies (CTs) has gained in popularity but there is a lack of conceptualised models for delivering such care, i.e. integrative medicine (IM). The aim of this paper is to describe some key findings relevant to the development and implementation of a proposed model for IM adapted to Swedish primary care. Methods: Investigative procedures involved research group and key informant meetings with multiple stakeholders including general practitioners, CT providers, medical specialists, primary care administrators and county council representatives. Data collection included meeting notes which were fed back within the research group and used as ongoing working documents. Data analysis was made by immersion/crystallisation and research group consensus. Results were categorised within a public health systems framework of structures, processes and outcomes. Results: The outcome was an IM model that aimed for a patient-centered, interdisciplinary, non-hierarchical mix of conventional and complementary medical solutions to individual case management of patients with pain in the lower back and/or neck. The IM model case management adhered to standard clinical practice including active partnership between a gate-keeping general practitioner, collaborating with a team of CT providers in a consensus case conference model of care. CTs with an emerging evidence base included Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong. Conclusion: Despite identified barriers such as no formal recognition of CT professions in Sweden, it was possible to develop a model for IM adapted to Swedish primary care. The IM model calls for testing and refinement in a pragmatic randomised controlled trial to explore its clinical effectiveness.