Is Evidence-Based Medicine Sufficient For Complementary And Alternative Medicine Research?
Main Category: Complementary Medicine / Alternative MedicineAlso Included In: Cancer / Oncology
Article Date: 09 Jan 2007 - 20:00 PDT
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Evidence-based medicine (EBM), is widely accepted among researchers as the "gold-standard" for scientific approaches. Over the years, EBM has both supported and denied the value of allopathic medicine practices, while having less association with complementary and alternative medicine (CAM) practices. Since most CAM practices are complex and focus on healing rather than cure the question arises as to whether EBM principles are sufficient for making clinical decisions about CAM. That is the focus of this special issue of Integrative Cancer Therapies by SAGE Publications.
"While evidence-based medicine's emphasis on randomized controlled trials has many benefits, researchers and clinicians have found that this focus may be too limited for complex systems such as complementary and alternative medicine (CAM), and other approaches to healing," said Wayne B. Jonas, MD, president and chief executive officer of the Samueli Institute and this special issue's guest editor.
The December special issue of Integrative Cancer Therapies presents articles that explore EBM and alternative strategies to EBM for evaluating CAM and in particular, options for conducting CAM research on cancer. This issue discusses whether clinical research on CAM using randomized placebo-controlled trial designs is the best strategy for making evidence-based decisions in clinical practice, and describes strategies that use "whole systems" and "integrated evaluation models" as potential new standards for research on CAM for cancer.
The second half of this special issue then explores whether basic science adds value to a debate recently resurrected in "The Lancet" on the value of research on homeopathy. Integrative Cancer Therapies now reports a series of landmark studies on the effects of homeopathy on prostate cancer. These are the first rigorous studies on homeopathy simultaneously using genetic, cellular and whole animal models of cancer. These studies show that rigorous basic science research can be conducted on this controversial CAM practice and that current evidence warrants continued research on this approach for cancer.
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The editorial "Top of the Hierarchy" Evidence for Integrative Medicine: What Are the Best Strategies?" (http://ict.sagepub.com/cgi/reprint/5/4/277) and the article "Evidence Summaries and Synthesis: Necessary but Insufficient Approach for Determining Clinical Practice of Integrated Medicine?"(http://ict.sagepub.com/cgi/reprint/5/4/282) can be accessed at no-charge for a limited time on the SAGE Publications' Integrative Cancer Therapies web site.
About Integrative Cancer Therapies
Written for everyone involved in comprehensive cancer treatment and care--from physicians and other health care professionals to complementary and alternative practitioners to informed patients-- Integrative Cancer Therapies focuses on evidence based and scientifically sound understanding of the mechanisms of cancer therapies and the physiology of disease conditions, as well as the psychosocial and spiritual needs of the patient. The journal is edited by Dr. Keith Block, Medical and Scientific Director of the Institute for Integrative Cancer Care. http://ict.sagepub.com/
About SAGE
SAGE Publications is a leading international publisher of journals, books, and electronic media for academic, educational, and professional markets. Since 1965, SAGE has helped inform and educate a global community of scholars, practitioners, researchers, and students spanning a wide range of subject areas including business, humanities, social sciences, and science, technology and medicine. A privately owned corporation, SAGE has principal offices in Los Angeles, London, New Delhi, and Singapore. http://www.sagepublications.com/
About the Samueli Institute
The Samueli Institute is a non-profit, medical research organization supporting the scientific investigation of healing processes and their application in health and disease. The Institute's mission is to explore the scientific foundations of healing and to apply that understanding in medicine and health care. The Institute is one of an elite group of organizations in the nation with a track record in both complementary and alternative medicine (CAM), healing relationships and military research. Contact: Kendra Calhoun http://www.samueliinstitute.org/
Contact: Valerie Johns
SAGE Publications
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Evidence Based Medicine?
posted by Gregory D. Pawelski on 10 Jan 2007 at 11:55 pmEvidence based medicine, since the 1970's, depended upon the randomized, controlled trial. It rests upon the assumption that evidence should be determined and applied as a basis for medical decision-making. Evidence is based upon quantities, similarities, populations, and averages, rather than qualities, idiosyncracies, individualization, and specifics.
Evidence-based medicine is a "trial and error" process of a clinical trials to see what might "appear" to be improving cancer survival. It is the mindset of rewarding academic achievement and publication over all else. There is this aurora that organizations, government agencies, scientists, researcher and even practitioners work together, sharing information for the benefit of patients.
Each group has its own priorities and its own agenda. Moreover, the image of cooperation between these different groups only gives the illusion that reform isn't needed. The present system exists to serve academic achievement and publication, but not to serve the best interests of people.
The demise of the "discoverer" type with its not so well organized risk-taking, in favor of the "investigator" culture, well organized, exhaustive analysis of trivial hypotheses, is a perfect example of thirty years of the "trial and error" mind-set that has occupied cancer research. A dysfunctional culture that pushes tens of thousands of physicians and scientists toward the goal of finding the tiniest improvements in treatment rather than genuine breakthroughs, that rewards academic achievement and publication even though their proven activity has little to do with "curing" cancer.
While new regimens "appear" to be improving survival, when these same regimens are tested on a wider range of cancer patients, the results have been very disappointing. In other words, oncologists at a single institution may obtain a 40 - 50 percent response rate (not cure rate) in a tightly controlled study, when these same regimens are tested in a real-world setting, the response rates may be 17 - 27 percent.
Also, whatever clinical response that has resulted to the average number of patients in a randomized trial, is no indication of what will happen to an individual at any particular time. They are trying to identify the "best guess" treatment for the average patient. You cannot mate notoriously heterogeneous diseases into "one-size-fits-all" treatments.
Despite scores of prospective randomized clinical trials, involving tens of thousands of patients with aggressive chemotherapy combinations and high dose regimens, the experience with metastatic cancer shows that response rates have gone up, but the overall survival rates have not improved. We relentlessly combine chemotherapy agents in various regimens with ever-increasing dose intensity.
The problem is that ineffective, aggressive chemotherapy can diminish not just the quality of life but also the quantity of life, through organ toxicity, immunosuppression, and inducing mutations in genetically unstable tumor cells to more aggressive phenotypes. The result is that there has not been any improvement in the treatment of the most common forms of metastatic cancer.
There appears to be a number of patients who have had long-term survival after high dose therapy, but there are a number of patients whose tumors are responsive to chemotherapy who have had long-term remissions from standard dose chemotherapy, as well as a number who show no difference in survival when treated with standard-dose or high-dose chemotherapy. Does chemotherapy shorten survival of some patients, while prolonging the survival of others? You do help some patients, but for every patient helped, there's another one you hurt.
You'd want to reserve aggressive therapy for those patients who will derive more benefit than harm, while identifying the most promising treatment regimens for everyone. In patients with tumors very resistant to cytotoxic chemotherapy, the most promising treatments may be angiogenesis inhibitors, growth factor inhibitors, or more integrative medicine approaches.
More emphasis should be put on matching treatment to the patient, through the use of individualized pre-testing, having more respect for minimal partial response or stable disease, when it can be achieved through use of the least toxic and mutagenic drug regimens, and reserve the use of higher dose therapy or aggressive combination chemotherapy to those patients with tumor biologies most amenable to attack and destroy by these aggressive treatments.
Evidently Wrong
posted by Robert McMaster on 22 Mar 2007 at 10:21 amThe evidence is that after decades and countless billions spent our population is in worse health than ever. Evidence based medicine is just marketing spin for 'make us medicos rich'. It is the credo of mere technicians, not scientists. In any other business such miserable results would get you all fired.
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