JAMA 1998 (Nov 11); 280 Editorial: 1618-1619
Phil B. Fontanarosa, MD; George D. Lundberg, MD
There is no alternative medicine. There is only scientifically proven,
evidence-based medicine supported by solid data or unproven medicine, for
which scientific evidence is lacking. Whether a therapeutic practice is "Eastern"
or "Western," is unconventional or mainstream, or involves mind-body techniques
or molecular genetics is largely irrelevant except for historical purposes
and cultural interest. We recognize that there are vastly different types
of practitioners and proponents of the various forms of alternative medicine
and conventional medicine, and that there are vast differences in the skills,
capabilities, and beliefs of individuals within them and the nature of their
actual practices. Moreover, the economic and political forces in these fields
are large and increasingly complex and have the capability for being highly
contentious. Nonetheless, as believers in science and evidence, we must focus
on fundamental issues
namely, the patient, the target disease or condition,
the proposed or practiced treatment, and the need for convincing data on safety
and therapeutic efficacy.
Despite the increasing use of alternative medicine (also termed complementary , integrative, or unconventional medicine) in the United States and throughout
the world, most alternative therapies have not been evaluated using rigorously
conducted scientific tests of efficacy based on accepted rules of evidence.
The lack of properly designed and conducted randomized controlled trials is
a major deficiency. For some published studies, serious concerns have been
raised regarding methodological quality. A National Institutes of Health expert
panel concluded that current evidence is inadequate for development of practice
guidelines for alternative therapies, largely because of lack of relevant
outcomes data from high-quality clinical trials.1
However, some advocates of alternative medicine argue that many alternative
therapies cannot be subjected to the standard scientific method and thus,
instead must rely on anecdotes, beliefs, theories, testimonials, and opinions
to support effectiveness and justify continued use.
Regardless of the origin or type of therapy, the theoretical underpinnings
of its mechanism of action, or the practitioner who delivers it, the critical
questions are the same. What is the therapy? What is the disease or condition
for which it is being used? What is its purported benefit to the patient?
What are the risks? How much does it cost? And, perhaps most important, does
it work? For virtually all medical therapies and interventions, whether conventional
or alternative, determination of effectiveness and recommendations for clinical
application should be based on the strength of the scientific evidence using
explicit criteria for grading the quality of evidence2, 3
(Table 1 ~ NOT AVAILABLE) and ratings for technology
assessment4 (ie, "established," "promising,"
"investigational," "doubtful," or "unacceptable.")
While acknowledging that many therapies used in conventional medical
practice also have not been as rigorously evaluated as they should be, we
agree that most alternative medicine has not been scientifically tested.5 However, for alternative medicine therapies that are
used by millions of patients every day and that generate billions of dollars
in health care expenditures each year, the lack of convincing and compelling
evidence on efficacy, safety, and outcomes is unacceptable and deeply troubling.
We believe that physicians should become more knowledgeable about alternative
medicine and increase their understanding of the possible benefits and limitations
of alternative therapies. By doing so, physicians will be able to serve as
more useful sources of information for their patients and advise them appropriately.
As with conventional therapies, advice should be based on data and scientific
information rather than anecdotal information, misperceptions, or preconceived
or unfounded notions about effectiveness or lack thereof.
This theme issue of JAMA and the annual coordinated theme issues of
the 9 American Medical Association Archives Journals
published this month on alternative medicine represent a planned, concerted
effort by the editors of these scientific journals to address some of these
issues by providing physicians and other health care professionals with clinically
relevant, reliable, fresh scientific information on alternative therapies.
In response to our call for papers on alternative medicine,6
we received more than 200 manuscript submissions to JAMA and many more manuscripts
were received by the Archives Journals. The result,
after our usual rigorous review process, is publication of more than 80 articles
and editorials on alternative medicine in our 10 scientific journals, including
18 randomized trials and systematic reviews, on more than 30 different topics,
and from more than 16 different countries.
This issue of THE JOURNAL includes 6 randomized clinical trials that
evaluate the use of 6 diverse alternative medicine therapies for treatment
of common clinical conditions. The results are intriguing. Bove and Nilsson7 report that chiropractic spinal manipulation is not
effective for episodic tension headache. Cardini and Weixin8
found that moxibustion (stimulation of an acupuncture point by heat generated
from burning a specific herb) is helpful for correction of breech presentation
in late pregnancy. Bensoussan and colleagues9
document that a Chinese herbal medicine formulation improves symptoms of irritable
bowel syndrome. Shlay and coinvestigators10
demonstrate that acupuncture is no more effective than amitriptyline or placebo
for relieving pain due to human immunodeficiency virus–related peripheral
neuropathy. Heymsfield and coworkers11 determined
that Garcinia cambogia, a common component of commercial
weight-loss products, lacks efficacy as an antiobesity agent. In a preliminary
study, Garfinkel and coworkers12 report that
a yoga-based intervention appears to hold promise for relieving some symptoms
of carpal tunnel syndrome. In addition, a systematic review by Wilt and colleagues13 suggests that saw palmetto extracts improve urologic
symptoms in patients with benign prostatic hyperplasia.
Perhaps just as important as the results of their studies, these investigators
demonstrate that alternative medicine therapies and interventions can and
should be evaluated using explicit, focused research questions14
along with established and accepted rigorous research methods15
(eg, appropriate controls, effective blinding procedures, adequate power,
state-of-the-art techniques for systematic reviews); incorporating measurable,
objectively assessed end points (eg, blinded assessment); and reporting meaningful
patient-centered outcomes.
Two other studies in this issue provide additional new information on
alternative medicine. In a replication of their previous nationally representative
survey,16 Eisenberg et al17
report that the prevalence of use of at least 1 of 16 specific alternative
therapies during the previous 12 months has increased significantly (from
33.8% in 1990 to 42.1% in 1997), that the estimated number of visits to alternative
medicine practitioners increased dramatically (from 427 million in 1990 to
629 million in 1997), and that only 38.5% of those who used alternative therapies
discussed them with their physician. Total out-of-pocket expenditures associated
with use of alternative medicine in 1997 were estimated at $27 billion. In
an analysis of data from malpractice insurers from 1990 through 1996, Studdert
and colleagues18 found that claims against
chiropractors, massage therapists, and acupuncturists generally occurred less
frequently and usually involved less severe injury than claims against medical
doctors. The authors also summarize the legal issues and principles for physicians
to consider when advising or contemplating referral of patients to alternative
medicine practitioners.
Taken together, the articles published in this issue of THE JOURNAL
and in the Archives Journals' theme issues on alternative
medicine add a substantial amount of new information and scientific data on
alternative therapies to the peer-reviewed mainstream medical literature.
However, given the burgeoning use of alternative medicine therapies, the increasing
numbers of patients who consult both medical doctors and alternative medicine
practitioners, and the increasing number of insurance companies and managed
care organizations offering programs and benefits for alternative medicine,19 the need for additional, carefully conducted, high-quality
research is essential.
Priority for research funding for alternative medicine should be given
to investigations of relevant clinical problems for which well-designed studies
have shown encouraging results for alternative therapies, especially for conditions
that are common and those for which conventional medicine has not been effective.
Attention should be given to evaluation of safety and efficacy, but also to
examining the effectiveness of a treatment strategy, with consideration of
community practice settings, patient expectations and compliance, and cost-effectiveness.20 Collaborative research, especially among the federally
funded centers for alternative medicine research in the US and with international
alternative medicine research centers, may improve efficiency in answering
important research questions. We encourage high-quality, rigorous research
on alternative medicine and invite authors to submit their best papers for
our objective evaluation and consideration for publication.
However, until solid evidence is available that demonstrates the safety,
efficacy, and effectiveness of specific alternative medicine interventions,
uncritical acceptance of untested and unproven alternative medicine therapies
must stop. Alternative therapies that have been shown to be of no benefit
(aside from possible placebo effect) or that cause harm should be abandoned
immediately. Physicians, insurance plans, medical centers and hospitals, managed
care organizations, and government policymakers should base decisions regarding
incorporation of and payment for alternative medicine therapies on evidence-based
research and objective cost-effectiveness analyses19
rather than on consumer interest, market demand or competition, well-publicized
anecdotal reports, or political pressures from well-organized and influential
interest groups.
Ultimately, answering fundamental questions about efficacy, safety,
appropriate clinical applications, and meaningful outcomes for all medical
therapies, including those considered alternative medicine, requires critical
and objective assessment using accepted principles of scientific investigation
and rigorous standards for evaluation of scientific evidence. For patients,
for physicians and other health care professionals, and for alternative medicine
practitionersindeed, for all who share the goal of improving the health
of individuals and of the publicthere can be no alternative.
Author/Article Information
Dr Fontanarosa is Senior Editor, JAMA, and Dr Lundberg is Editor, JAMA.
Reprints: Phil B. Fontanarosa, MD,
American Medical Association,
515 N State St,
Chicago, IL 60610
phil_fontanarosa@ama-assn.org
Editorials represent the opinions of the authors and The Journal and
not those of the American Medical Association
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