Complementary and Alternative Medicine in the United States (2005) / Chapter Skim
Currently Skimming:
5 State of Emerging Evidence on CAM
5 State of Emerging Evidence on CAM
Pages 129-167
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From page 129... ...
This chapter discusses the evidence that forms the basis for such decision making and the methods of evaluation, as well as the available resources providing access to the results of existing research on CAM interventions. In CAM as well as in conventional medicine, randomized controlled trials (RCTs)
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From page 130... ...
The introduction of these terms allows interested individuals to make simple queries of MEDLINE to estimate changes in the evidence base for CAM from the results of RCTs and systematic reviews over time. Figure 5-1 charts the tremendous growth in the number of RCTs over the past 20 years, and Figure 5-2 shows that the rate of increase of reviews and meta-analyses is even greater.
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From page 131... ...
. 600 Systematic reviews Meta-analyses 500 Meta-analyses 400 and 300 Reviews 200 of 100 Number 0 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 Year FIGURE 5-2 Number of reviews and meta-analyses related to CAM indexed on MEDLINE, 1982 to 2002.
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From page 132... ...
If no review is available on the Cochrane Database of Systematic Reviews, one can check The Cochrane Library's Database of Abstracts of Reviews of Effectiveness (a database of reviews collected by the Cochrane Collaboration but not prepared according to the strict standards of Cochrane reviews) or the applicable trials registered with the Cochrane Central Register of Controlled Trials.
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From page 133... ...
The ultimate aim of developing the Cochrane CAM register is to provide a comprehensive source of trials of CAM therapies and modalities, thus reducing the need for systematic reviewers and others to search multiple sources. At present The Cochrane Library contains 145 CAM-related systematic and an additional 340 non-Cochrane CAM-related systematic reviews (see Table 5-1 for a sampling of therapies covered by Cochrane and nonCochrane reviews)
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From page 134... ...
Cochrane Review Evidence for CAM1 All Cochrane reviews, be they of CAM or conventional medicine therapies, apply the same standards, that is, therapies within both categories are 1The committee did not include information about the general direction of effect for the AHRQ reports because the individual reports covered too wide a range of conditions (e.g., SAdenosyl-L-Methionine (SAMe) for Depression, Osteoarthritis, and Liver Disease)
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From page 135... ...
When the two raters differed on their classification of the treatment described in a review, a third rater trained in RCT and systematic review methodologies assigned the final classification. This rating system was used in a previous study to assess the evidence base for conventional medicine according to the information found in Cochrane reviews (Ezzo et al., 2001)
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From page 136... ...
, and classification of the therapies as having positive or a possibly positive effect was approximately equal for CAM and conventional medicine therapies (41.3 percent for conventional medicine versus 38.4 percent for CAM)
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STATE OF EMERGING EVIDENCE ON CAM 137 TABLE 5-3 Cochrane CAM Reviewsa with Positive Effects Limitation/ Study Therapy Indicationb Commentc Atallah AN et al., Calcium Preventing 1, 4 2004 hypertensive disorders and related problems in pregnancy Beckles WN Omega-3 fatty Cystic fibrosis 1, 2 et al., 2004 acids (from fish oil) Brosseau L et al., Transcutaneous Rheumatoid 1 2004 electrical nerve arthritis stimulation in the hand (TENS)
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From page 138... ...
Lumley J et al., 2004 Periconceptual Preventing 4 supplementation neural tube defects with folate and/or multivitamins Mahomed K, 2004 Folate Biochemical 3, 4 supplementation parameters and in pregnancy pregnancy outcome Mahomed K, 2004 Iron and folate Biochemical 3, 4 supplementation parameters and in pregnancy pregnancy outcome Mahomed K, 2004 Iron Biochemical 3, 4 supplementation parameters and in pregnancy pregnancy outcome Melchart D et al., 2004 Acupuncture Headache - Melchart D et al., 2004 Echinacea Preventing and 1 treating the common cold Ortiz Z et al., 2004 Folic acid and Reducing side 1 folinic acid effects in patients receiving methotrexate
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From page 139... ...
; the setting in which the therapy is used (e.g., hospital, self-care) ; the current state of the evidence for the therapy (e.g., a therapy such as folic acid for neural tube defects has strong supportive evidence which has resulted in its integrated into the health care system)
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From page 140... ...
, an international resource providing metadata about registers of controlled trials in a searchable database. Government agencies also compile registers: the NCCAM website contains a list of NCCAM-funded clinical trials, whereas ClinicalTrials.
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From page 141... ...
. AHRQ Evidence Reports AHRQ, the leading federal agency concerned with research on health care quality, efficiency, effectiveness, and safety, prepares evidence reports and technology assessments that provide information on the clinical efficacies of medical interventions on the basis of systematic reviews and, when appropriate, meta-analyses.
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From page 142... ...
The NIH consensus statement recommended further research, as future studies will probably discover additional therapeutic uses for acupuncture. Although systematic reviews are not themselves meant to function as recommendations or guidelines, they should ideally form the basis for guideline creation.
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From page 143... ...
It is also important that RCTs have a sample size large enough to determine the effectiveness of the intervention. Systematic reviews are evaluated on the basis of whether they undertake a comprehensive literature search with unambiguous inclusion and exclusion criteria for studies, as well as on the basis of whether they use explicit and transparent methods to evaluate and summarize study data.
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From page 144... ...
. Efforts to Improve Quality Many efforts are under way to improve the quality of trials and systematic reviews, including the establishment of CONSORT, QUOROM, and STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupunture)
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(2001) , systematic reviews demonstrate that only 22.5 percent of conventional medicine interventions have a clearly positive effect.
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From page 146... ...
For example, measures of mood, quality of life, and preferences for outcome states that are used in clinical studies of conventional medicine therapies could be included in studies of CAM therapies. Measures of the outcomes that are often of interest to CAM patients and providers need to be developed that can then be used in conventional medicine research as well as CAM research.
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From page 147... ...
(1998) conducted a systematic review of six studies on the mechanism of placebo analgesia in humans and concluded that the studies provide evidence that a placebo analgesia effect exists.
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From page 148... ...
. Transdiciplinary research on CAM therapies could involve teams composed of a rheumatologist, immunologist, neuroscientist, epidemiologist, biostatistician, traditional Chinese medicine practitioner, and physician who is trained in conventional medicine and CAM and is investigating chronic pain disorders such as osteoarthritis.
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From page 149... ...
Such interest can be fanned in a variety of ways, including conferences focused on particular CAM modalities that invite science-oriented CAM practitioners and scientists from other areas to participate. Invitations to scientists to apply their knowledge and skill to CAM research questions will be more attractive if they include certain kinds of collaborations.
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From page 150... ...
For example, the first core, the database and evaluation core, locates the existing literature in the field, synthesizes the data, and conducts systematic reviews to aid in formulating appropriate research hypotheses and designing appropriate studies. Until recently this task was greatly hindered by the fact that CAM journals were not listed in MEDLINE, and literature search strategies such as those that use keywords were inadequate.
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From page 151... ...
Furthermore, the gathering and analysis of accurate information about CAM (and conventional medicine) practices and their use are crucial to measuring and understanding outcomes of care.
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, a sentinel surveillance system, practice-based research networks (PBRNs) , and CAM research centers.
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to practice Practitioner and prevalence surveys Practitioner Private particular Special establish of CAM research CAM CAM of hospital - medicine for Conventional CAM: emerging of Members and Medicine Teaching Clinic model Identifies patterns conventional use Sentinel Surveillance Network A HMO Specialty 5-3 FIGURE
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From page 154... ...
Another key component of that model, the sentinel surveillance system, plays an important role in answering these types of questions by providing timely information about treatment trends that demand research and is described below. Sentinel Surveillance System Surveillance is defined as "ongoing systematic collection, analysis and interpretation of data and the distribution to those who need to know" (Thacker and Berkelman, 1988)
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. For CAM, a sentinel surveillance system is important to monitoring changes in the American public's use of CAM alone or in combination with conventional medicine, thereby highlighting high-priority areas for practicebased research.
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. That report recommend that "the Department of Health and Human Services provide adequate and stable financial support to practice-based primary care research networks." According to Thomas et al.
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, provide the opportunity to ask and answer practicerelevant questions, and study CAM treatments in the manner in which they
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From page 158... ...
. For example, the center at the Oregon Health Sciences University focuses on CAM research in neurological disorders; the center at Columbia University investigates CAM use in aging; the center at the University of California at Los Angeles fosters research evaluating safety and efficacy of botanical dietary supplements; and the center at the University of Illinois at Chicago is studying botanical dietary supplements for women's health.
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From page 159... ...
A Model for CAM Research and Surveillance In the model for CAM research and surveillance shown in Figure 5-3 the left-hand hub represents the sentinel surveillance function. Sentinel surveillance sites would be responsible for the systematic collection and reporting of data on common and emerging patterns of CAM use as well as the use of both CAM and conventional medicine.
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From page 160... ...
Together, the center and the network would · Select target conditions to be evaluated · Develop a protocol designed to capture -- Health care practices engaged in by patients as self-care -- Health care administered or prescribed by practitioners -- Interactions between self-care and practitioner care and between conventional medical care and CAM care -- Notable lifestyle changes that may effect health status, e.g., inter actions between medication use and special diets the population has adopted -- Exposure of the population to marketing and public health messages · Identify sites attending to patients (by both CAM and conventional medicine) with the targeted conditions · Organize the data collection on the basis of an agreed-upon sampling procedure · Develop an effectiveness study or intervention activity linked to the surveillance data It is the committee's belief that the model for research and translation illustrated and described above would provide a coordinated mechanism directed at answering the myriad questions about CAM use, such as Who is using CAM and why are they doing so?
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The gaps discussed include the paucity of clinical research in which CAM interventions are compared with each other and with conventional medicine therapies, the need for expanded basic research to include areas other than botanicals, the lack of cost-effectiveness research, the need for crossdisciplinary and transdisciplinary research, and the importance of drawing established scientists to the field of CAM research. The committee has proposed a research framework to address these gaps as well as conduct the kinds of research recommended in Chapter 2.
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population. The committee recommends that the National Institutes of Health and other public agencies provide the support necessary to · develop and implement a sentinel surveillance system, practicebased research networks, and CAM research centers to facilitate the work of the networks; · include CAM-relevant questions in federally funded health care surveys (e.g., the National Health Interview Survey)
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1998. The Cochrane Collaboration: Evaluation of health care and services using systematic reviews of the results of randomized controlled trials.
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1998. Methodol ogy and reports of systematic reviews and meta-analyses: A comparison of Cochrane reviews with articles published in paper-based journals.
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2001. Systematic reviews in health care: Assessing the quality of controlled clinical trials.
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2002. Assessing the quality of reports of systematic reviews in pediatric complementary and alternative medicine.
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Pygeum africanum for benign prostatic hyperplasia. Cochrane Database Syst Rev 2004; (1)
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