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1.  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.
doi:10.1186/1471-2288-7-7
PMCID: PMC1800863  PMID: 17291355
2.  Acupuncture Adverse Events in China: A Glimpse of Historical and Contextual Aspects 
Abstract
The article by He and colleagues, “Adverse Events Following Acupuncture: A Systematic Review of the Chinese Literature for the Years 1956–2010” is an important and timely contribution. In this commentary, the article is reviewed and issues are highlighted about how to interpret and contextualize the results of their study. While their review has been well performed, certain areas have been identified where the results may be inaccurate due to problems in the reporting of original incidents. For example, potential problems were found in the reporting of the minor adverse event (AE) of fainting and the more serious AEs of pneumothorax and hepatitis. The article by He and colleagues highlights the issue that almost all AEs associated with acupuncture in the modern period are due to the administration of the therapy rather than the therapy itself. Future prospective studies can address some of the shortcomings identified in this review.
doi:10.1089/acm.2012.0639
PMCID: PMC3804079  PMID: 23544845
3.  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.
doi:10.1093/ecam/nel079
PMCID: PMC1978227  PMID: 17965757
complex interventions; research methods; whole systems research

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