Herbal Medicine Used For Chinese Stroke Patients Lacks Strong Evidence
Main Category: Complementary Medicine / Alternative MedicineAlso Included In: Stroke; Neurology / Neuroscience
Article Date: 29 Apr 2007 - 0:00 PDT
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The herbal medicine Dan Shen, a standard treatment for ischemic stroke in China, lacks strong scientific evidence to support such use, according a new review of studies.
Nevertheless, based on the available data, Dan Shen treatment showed a tendency to improve short-term neurological deficits in stroke patients, say researchers at Sichuan University in Chengdu, China.
However, the short-term result "should be interpreted cautiously because of the poor methodological quality of included trials and the small numbers of patients," said review co-author and neurology professor Ming Liu.
The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.
Obstruction of a blood vessel supplying blood to the brain can result in ischemic stroke, which accounts for about 83 percent of all strokes.
In China, post-stroke use of herbal medicine is part of standard care in both Western-style hospitals and in traditional Chinese medicine hospitals. Dan Shen, in various pill, tablet and injection formulations, is the herb most commonly given for ischemic stroke; its use in that context spans more than three decades.
However, few researchers have tested the herb's effectiveness in rigorous clinical trials that approach current international standards.
The reviewers found six studies that met inclusion criteria for the review randomized or quasi-randomized and controlled involving 494 acute ischemic stroke patients.
The Cochrane reviewers found that methods of randomly assigning study subjects to Dan Shen or placebo were unclear, and that this could have led to results exaggerating a positive treatment effect by 30 percent to 41 percent. "It is therefore plausible that Dan Shen is truly ineffective and the apparent benefits are simply due to bias arising from the methodological weaknesses of the studies," they say.
Since treatment and follow-up in these studies ranged from 14 to 28 days, it was not possible to assess the long-term effects of Dan Shen.
"We found no evidence to support the routine use of Dan Shen agents for ischemic stroke," Liu said. "However, if the apparently beneficial effects on neurological impairment were confirmed in methodologically rigorous trials, it would lead to a useful treatment for stroke being identified," she added.
Ted Kaptchuck, O.M.D., associate professor of medicine at Harvard Medical School, said, "in Chinese society, at this time, basic science and laboratory evidence seems to be enough to gain widespread acceptance and adoption for the use herbal and other medications. In the West, we think it is a long shot to go from basic laboratory evidence to demonstrated clinical efficacy in randomized trials. We are not at the point where it is clear that a traditional Chinese herb has a major role in health care."
Liu agreed: "The designs of these trials need to be improved in the future research, not only in the clinical trials on Dan Shen agents, but also in trials on other Chinese herbal medicine."
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.
Wu B, Liu M, Zhang S. Dan Shen agents for acute ischaemic stroke (Review). Cochrane Database of Systematic Reviews 2007, Issue 2.
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Visitor Opinions In Chronological Order (3)
Strong Evidence From Clinical Trials?
posted by Gregory D. Pawelski on 11 May 2007 at 8:55 amIn life or death situations, one must make judgements based upon preponderance of available evidence as opposed to proof beyond reasonable doubt. It seems obvious that "evidence-based medicine" proponents may fail to apply this common sense standard on a consistent basis.
To cite an example in cancer medicine, a fraternal medical society establishes a policy recommending against the use of a diagnostic test as an aid to drug selection in cancer chemotherapy, based on reviews which specifically excluded from consideration studies reporting the predictive accuracy of the test, and including only studies relating to the efficacy of the test in improving treatment outcomes.
This is especially curious, as predictive accuracy is the chief criterion traditionally used to validate all diagnostic laboratory tests currently in use in cancer medicine. Were proof of efficacy (particularly in prospective, randomized trials) to be the standard for evaluating laboratory tests, then clinical oncologists would have to abandon all the laboratory tests currently used in the management of cancer patients, as no tests would pass this standard.
Clinical investigators have too often descended into an exhaustive study of hypotheses which are ultimately of limited importance. Many treatments are of such limited effectiveness that they do not deserve to be protected from the competition of other approaches which are well grounded in peer review science, but which have not yet met the most demanding standards of "evidence based medicine."
Evidence-based medicine is a trial-and-error process of a clinical trials to see what might "appear" to be improving 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.
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.
Pawelski Wrong On Importance Of Accuracy
posted by hchcec on 14 May 2007 at 6:17 amA Hierarchical Model of Efficacy
Level 1: Techical efficacy
Level 2: Diagnostic accuracy efficacy
Level 3: Diagnostic thinking efficacy
Level 4: Therapeutic efficacy
Level 5: Patient outcome efficacy
Level 6: Societal efficacy
Pawelski is happy at level 2 and anything beyond level 2 is meaningless.
The definition of a device is set forth at section 201(h) of the Federal Food,
Drug and Cosmetic Act (the act) (21 U.S.C. 321(h)). It provides in relevant part:
‘‘The term ‘device’ * * * means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or other animals.
Evidence-based science, making use of the scientific method, despite Pawelski's disdain, is required in the scientific community. The anti-science proponents will not win this one.
Michell H (hchcec) Wrong On Evidence-based Medicine
posted by Gregory D. Pawelski on 20 May 2007 at 2:13 pmEvidence-based medicine (population-based evidence) has become a euphemism for managed care, masquerading as science (or profit-maximizing in the guise of science). Control over medical decisions are being shifted from doctors to bureaucrats in big offices. Managed care organizations have used it to solidify their control over medical decisions and the practice of medicine. Instead of explaining their decision by saying the service is not necessary or not cost-effective, they can say it is not scientifically sound.
Individual patients are not the focus of evidence-based medicine and its standardized practice guidelines. The guidelines are created by accessing private medical record data, aggregating the data, and synthesizing it into population-based treatment algorithms for all physicians to use on all patients. In other words, bureaucratized medical practice.
Evidence-based medicine results in overly rigid standards of care by restricting medical practitioners' professional freedom and judgment. It imposes personal agendas by those choosing which research to do, picking between the various studies and calling it evidence, while writing all the guidelines, as well as administrative bias by administrators interpreting the guidelines.
The guidelines often fail to make explicit how recommendations are devised and they rapidly become outdated. Even the "evidence" is suspect. Researcher bias, disagreement in defining best evidence, incomplete reporting of research results, and conflicting findings are some of the problems with research relied on for determining "best practices" or evidence-based medicine.
There are gaps and inconsistencies in the medical literature supporting one practice versus another, as well as biases based on the perspective of the authors, who may be specialists, general practitioners, payers, marketers, or public health officials. Evidence-based medicine changes what it considers to be science in order to suit the goals of its proponents.
Evidence-based medicine is not an objective, purely scientific tool its name suggests. Instead, it is an intrusive encroachment on the patient-doctor relationship and the practice of medicine. An encroachment that policy makers are turning into legal requirements.
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