Complementary and Alternative Medicine in the United States (2005) / Chapter Skim
Currently Skimming:
4 Need for Innovative Designs in Research on CAM and Conventional Medicine
4 Need for Innovative Designs in Research on CAM and Conventional Medicine
Pages 108-128
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From page 108... ...
therapies on disease prevention and wellness. Several characteristics of CAM treatments and modalities are also difficult to incorporate into treatment effectiveness studies with shorter time lines as well as studies with more clearly defined symptom relief or disease state endpoints.
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From page 109... ...
One reason that research questions may be posed about whole CAM modalities at a time is that in some CAM modalities (e.g., traditional Chinese medicine) there is no such thing as a "standard" treatment or dose.
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From page 110... ...
In evaluations of CAM therapies, end points may be difficult to measure in a standardized way. The techniques used to measure subjective experiences like pain, fatigue, the ability to perform daily activities, and mood state have experienced significant advances in the past 20 years (IOM, 1999)
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From page 111... ...
, but it may be possible to evaluate the effectiveness of the approach taken as a whole in comparison with that of some alternative approach to the same problem. INNOVATIVE STUDY DESIGNS TO ASSESS TREATMENT EFFECTIVENESS OF CAM1 Addressing the special challenges mentioned above for research in CAM will require a broadening of thinking about the types of study designs that can produce valid evidence of treatment effectiveness.
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From page 112... ...
Each N-of-1 trial, if successful, would provide evidence of the effectiveness of a specific treatment in that one patient; multiple successful trials would provide evidence of the effectiveness of the general concept or manual methods. Preference RCTs In most RCTs, patients who agree to participate in the trial also agree to accept randomization to study arms, that is, to active treatment or a placebo treatment.
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From page 113... ...
This type of study design may be useful for the study of many CAM modalities for which therapies are widely presumed by practitioners and the lay public to be safe and effective and patients may have existing preferences either for or against a specific therapy. Observational and Cohort Studies Observational and cohort studies involve the identification of patients who are eligible for study and who may receive a specified treatment but who may not choose the therapy received as part of the study.
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From page 114... ...
Case-Control Studies Other study designs discussed in this chapter are prospective, that is, they identify a pool of eligible patients before treatment is given, and the patients are then monitored through the period of treatment with a series of structured and scheduled measurement instruments. For some questions about CAM treatment effectiveness, however, it may not be possible to mount a reasonable prospective study (for example, if there is no practical way of identifying patients with a defined health problem or identifying and recruiting patients before treatment begins)
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From page 115... ...
This will not be fully satisfying to most scientists trained in Western reductionist traditions, but such studies may be adequate to help patients make informed decisions about treatment approaches or for health policymakers or insurance companies to make decisions about coverage and payment. Some study designs and analytic methods, however, are better suited than others to unraveling the effects of specific parts of a complex treatment package.
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From page 116... ...
(2003) call "practical clinical trials." With some CAM modalities, it may be possible to study the effectiveness of an approach, the school or the intensity of treatment, and the use of a no-treatment or a placebo control as the comparison group.
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From page 117... ...
would be examples of this kind of study design. The only CAM therapies or modalities for which this design would not be appropriate would be those that do not claim any mechanism of action other than the patients' own expectations or self-healing processes.
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From page 118... ...
Even for CAM modalities whose mechanisms of action are largely or exclusively patient expectations or self-healing processes, it may be possible to design studies that compare the relative abilities of two or more modalities to activate those processes and produce measurable health benefits. For example, an ongoing study of patients with irritable bowel syndrome funded by the National Center for Complementary and Alternative Medicine is exploring whether placebo effects (via a sham acupuncture treatment)
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From page 119... ...
; and · understand patients' and providers' models of health and illness and how those models influence CAM use and assessment of treatment effectiveness. USE OF BOTH TRADITIONAL AND INNOVATIVE STUDY DESIGNS TO CREATE A RICH BODY OF KNOWLEDGE The committee does not wish to recommend a single study design that is inevitably superior to others or to recommend that studies of treatment effectiveness in CAM always be conducted in a specific way.
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From page 120... ...
. The use of a variety of study designs to produce a rich, complementary body of evidence for specific treatments or modalities is a desirable approach, but in practice, only limited amounts of money and time are available for effectiveness studies.
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From page 121... ...
about underlying mechanisms of treatment action? · Should special requests for proposals be issued for studies of the basic biological mechanisms of specific CAM therapies?
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From page 122... ...
Basic Science Excellence In the basic science excellence model, the highest priority is given to projects that may provide significant breakthroughs in or enhancements of understanding of fundamental biological mechanisms. The concept can be extended to funding decisions about clinical research, in which a conscious choice would be made to fund studies that shed light on underlying mechanisms in preference to those that address only more limited efficacy or effectiveness questions.
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From page 123... ...
One could preferentially study CAM modalities with known or expected relatively good cost-effectiveness. Or, one could design studies to assess the cost-effectiveness of a modality or a specific therapy and require that clinical studies include a cost-effectiveness component to be funded.
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From page 124... ...
Regardless of the specific choices made about study design, whether it be traditional or innovative, a question that the committee addressed was whether CAM therapies should be held to the same standards of evidence as medications, surgical procedures, or other therapies used in conventional medicine. By the "same standards of evidence," the committee means that an insurance company would require "A-level evidence" (that is, evidence derived from consistent findings from multiple RCTs)
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From page 125... ...
Although CAM and conventional medicine may differ in terms of the nature of the treatments provided and the presumed mechanisms by which treatments produce beneficial effects, there is no fundamental diference in the basic nature of either the cause-effect relationships being tested or the major domains of patient outcomes being studied. Therefore, The committee recommends that the same principles and standards of evidence of treatment effectiveness apply to all treatments, whether currently labeled as conventional medicine or CAM.
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From page 126... ...
It will be even more challenging to apply these concepts to any CAM modalities that emphasize the uniqueness of each individual patient and that patient's complex of symptoms and to avoid diagnostic classifications entirely. · Endpoints like feelings of emotional or spiritual well-being that are difficult to measure.
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From page 127... ...
A CAM research portfolio with a variety of types of studies will provide a great deal of knowledge about the use of CAM therapies by the American public. The next chapter discusses what is known about efficacies of some CAM therapies, identifies existing gaps, and proposes a framework that can be used to conduct research on CAM.
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From page 128... ...
2002. Insurance coverage, medical conditions, and visits to alternative medicine providers: Results of a national survey.
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