[Masci] Applying Science to Alternative Medicine

[Hristo Sendov]

http://www.nytimes.com/2008/09/30/health/research/30tria.html?_r=1&oref=slogin&pagewanted=print

September 30, 2008


Applying Science to Alternative Medicine


By WILLIAM J. BROAD

  


 
More than 80 million adults in the United States are estimated to use some
form of alternative medicine, from herbs and megavitamins to yoga and
acupuncture.
But while sweeping claims are made for these treatments, the scientific
evidence for them often lags far behind: studies and clinical trials,
when they exist at all, can be shoddy in design and too small to yield
reliable insights. 
Now the federal government is working hard to raise the standards of
evidence, seeking to distinguish between what is effective, useless and
harmful or even dangerous.
“The research has been making steady progress,” said Dr. Josephine
P. Briggs, director of the National Center for Complementary and
Alternative Medicine, a division of the National Institutes of
Health. “It’s reasonably new that rigorous methods are being used to study
these health practices.”
The need for rigor can be striking. For instance, a 2004 Harvard
study identified 181 research papers on yoga therapy reporting that it
could be used to treat an impressive array of ailments — including asthma,
heart disease, hypertension, depression, back pain, bronchitis, diabetes,
cancer, arthritis, insomnia, lung disease and high blood pressure.
It turned out that only 40 percent of the studies used randomized
controlled trials — the usual way of establishing reliable knowledge
about whether a drug, diet
or other intervention is really safe and effective. In such trials,
scientists randomly assign patients to treatment or control groups with
the aim of eliminating bias from clinician and patient decisions. 
Sat Bir S. Khalsa, the study’s author and a sleep researcher at the
Harvard Medical School, said an added complication was that “the vast
majority of these studies have been small,” averaging 30 or fewer
subjects per arm of the randomized trial. The smaller the sample size,
he warned, the greater the risk of error, including false positives and
false negatives.
Critics of alternative medicine have seized on that weakness. R. Barker
Bausell, a senior research methodologist at the University of Maryland
and the author of “Snake Oil Science” (Oxford, 2007), says small
studies often have a built-in conflict of interest: they need to show
positive results to win grants for larger investigations. 
“All these things conspire to produce false positives,” Dr. Bausell
said in an interview. “They make the results extremely questionable.”
That kind of fog is what Dr. Briggs and the National Center for
Complementary and Alternative Medicine, with a budget of $122 million
this year, are trying to eliminate. Their trials tend to be longer and
larger. And if a treatment shows promise, the center extends the trials
to many centers, further lowering the odds of false positives and
investigator bias.
For instance, the center is conducting a large study to see if extracts
from the ginkgo biloba tree can slow the progression of Alzheimer’s
disease.
The clinical trials involve centers in California, Maryland, North
Carolina and Pennsylvania and recruited more than 3,000 patients, all
of them over 75. The study is to end next year.
Another large study enrolled 570 participants to see if acupuncture
provided pain relief and improved function for people with osteoarthritis
of the knee. In 2004, it reported positive results. Dr. Brian M.
Berman, the study’s director and a professor of medicine at the
University of Maryland, said the inquiry “establishes that acupuncture
is an effective complement to conventional arthritis treatment.”
In an interview, Dr. Briggs said another good way to improve
clinical trials was to ensure product uniformity, especially on herbal
treatments. “We feel we have really influenced the standards,” she said.
Over the years, laboratories have found that up to 75 percent of the
samples of ginkgo biloba failed to show the claimed levels of the
active ingredient. Scientists doing a clinical trial have a large
incentive to fix that kind of inconsistency.
Dr. Briggs said such investments would be likely to pay off in the
future by documenting real benefits from at least some of the
unorthodox treatments. “I believe that as the sensitivities of our
measures improve, we’ll do a better job at detecting these modest but
important effects” for disease prevention and healing, she said.
An open question is how far the new wave will go. The high costs of
good clinical trials, which can run to millions of dollars, means
relatively few are done in the field of alternative therapies and
relatively few of the extravagant claims are closely examined.
“In tight funding times, that’s going to get worse,” said Dr. Khalsa
of Harvard, who is doing a clinical trial on whether yoga can fight
insomnia. “It’s a big problem. These grants are still very hard to get
and the emphasis is still on conventional medicine, on the magic pill
or procedure that’s going to take away all these diseases.”

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