May Be No Help For Fibromyalgia
Last Updated: 2005-08-05 11:11:18 -0400 (Reuters Health)
By Amy Norton
NEW YORK (Reuters Health) - The hormone supplement DHEA may be a
popular choice for people with fibromyalgia , but a new study finds
no evidence it actually works.
The study, which compared 3 months of daily doses of DHEA against a
placebo, found that the supplement did not improve fibromyalgia
patients' pain, fatigue, depression or other symptoms.
read the full article at
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Complementary and alternative medicine: 5 steps in
considering any treatment.The Internet offers an ideal way to keep up with the latest on
complementary and alternative treatments a fast-changing field. But beware
the Internet is also one of the greatest sources of misinformation.
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Arnica 30x is ineffective for muscle soreness after long-distance running;
Clinical Journal of Pain, September 1998, 14:227-231.A.J.Vickers, P.Fisher, C.Smith, et
A randomized, double-blind compared Arnica with placebo in 519 runners "anticipating
delayed onset muscles soreness after long-distance races" and found no markers
significantly more positive than placebo. Nothing in the provings of Arnica suggest it as
applicable for sports injuries from overuse of muscles. It is intended for the results of
blows and injuries where there is swelling and bruising.
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Talk About Herbal Supplements
A new Web site by Memorial Sloan-Kettering Cancer Center discusses their safety,
effectiveness. By Jennifer Thomas HealthScoutNews Reporter
have high blood pressure, did you know you probably shouldn't take ginseng?
St. John's wort can interfere with chemotherapy?
garlic capsules and gingko biloba can hinder blood coagulation, a potentially major
problem if you had to undergo surgery?
Web site created by experts at Memorial Sloan-Kettering Cancer Center in New York City
provides up-to-date information on the safety and efficacy of 135 of the most popular
herbal remedies and dietary supplements, from bee pollen to shark cartilage and skullcap
to milk thistle.
entry includes a summary and a critique of all the known medical studies on the
supplement, as well as a link to the original research on the National Institutes of
past decade, use of alternative treatments has skyrocketed, says Barrie Cassileth, chief
of integrative medicine at Memorial Sloan-Kettering, who started the site. "But until
now there was no easy access to current, comprehensive information about these
agents," she adds.
is under way around the globe to scientifically document the effects of hundreds of herbs
and other dietary supplements.
studies have proven that certain natural substances do have benefits, though in nearly all
cases research is mixed. The element zinc, for example, has shown promise in lessening the
duration of a cold by making it difficult for the rhinovirus to replicate. And some
research shows St. Johns wort can help ease depression.
means the converse is also true -- herbs can be dangerous.
are powerful, biologically active products that do have important biological
effects," Cassileth says. "Those effects can be useful at some times and harmful
under other circumstances."
should not be used in a casual fashion because they are serious medicines," she adds.
instance, ginseng can cause low blood sugar in diabetics. And valerian and kava can lessen
the effectiveness of prescription drugs by interfering with the liver's ability to process
the medicines, Cassileth says.
thing to keep in mind: While much is known about the effects of herbs on the body, much
more is not known.
supplements are not regulated by the U.S. Food and Drug Administration, or any government
agency. That means the potency in one bottle of St. Johns wort, for example, can -- and
often does -- vary dramatically from that in another bottle, Cassileth says.
can't even be sure you're getting St. Johns Wort.
can put anything on a bottle and put it on a health food store shelf," she says.
"Some of the herbal remedies have virtually none of what is assumed to be the active
ingredient, some have much higher levels and some are contaminated with other
new Web site, the 135 supplements are listed in alphabetical order by scientific name. The
common name is below it. (Acanthopanax Senticosus is better known as ginseng. Allium
Sativun is better known as garlic).
entry includes the brand names the herb is sold under, its purported uses, its chemical
properties, and what's known about how the herb works on the body.
entry also includes a summary and a critique of all the known published medical studies,
instances of adverse reactions, and warnings about potentially dangerous drug
critique is fully cited and linked to Medline, so that doctors or patients can retrieve
the original research and read further if they wish.
will be continually updated, Cassileth says. In a few weeks, Cassileth and her colleagues
are planning to launch a second Web site that will be less technical and more easily
understood by patients.
David Rosenthal, past president of the American Cancer Society, endorses the Web site.
resource is an invaluable tool for both doctors and patients looking for comprehensive
information about dietary supplements," Rosenthal says.
information To visit the Sloan-Kettering site, click
here. For more on herbal medicine, visit the National Institutes of
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Designate to Certify Supplements Sid Kirchheimer
2002 Some vitamin and dietary supplements are sporting a new certification seal
from the U.S. Food and Drug Administration (FDA) designated representative in hopes of
assuring consumers that the product lives up to its ingredient labeling claims.
United States Pharmacopeia (USP), an independent agency that serves as the government's
official compendium for dietary supplement standards, has begun to issue the certification
on hundreds of products that it has independently tested as part of its Dietary Supplement
Verification Program (DSVP). This new program is voluntary and open to all manufacturers
of dietary supplements operating in the U.S., a $17-billion-a-year market that includes
vitamins, minerals, herbs, botanicals, and sports supplements sold over the counter and
consumed by two of every three Americans.
is not a rubber stamp co-brand," said USP chief operating officer John T. Fowler.
"There is a great deal of work done. This is not inexpensive, but the value is worth
a lot in the minds of consumers when they take a product off the shelf and know it has the
ingredients that it should and it doesn't have anything it shouldn't have."
receive the certification, manufacturers must submit products they select to a
"vigorous" seven-step testing and evaluation process that the USP says it
ensures meets all labeling claims first in independent laboratories and then on
store shelves. This process includes testing and auditing of declared ingredients, their
amounts or dosages, and meeting requirements of limits on contaminants.
hundreds of supplements by two leading manufacturers have been tested and issued the
certification. Products that will receive the certification label include those by Nature
Made, which just began to hit shelves at some 30,000 stores nationwide, and those under
the Kirkland brand, which will be displayed at Costo stores beginning next week.
Nature Made and Kirkland produce about 30% of all vitamins and minerals consumed
nationally, and about 20% of the total supplement market, said Richard Wailes, USP's head
of sales and marketing. Four other manufacturers have signed up for the certification
program and their products will carry the "Dietary Supplement Verified"
certification in 2003.
the program, manufacturers can submit any products they choose and pay for all testing by
USP, which has been establishing drug and other product standards since 1820 and has
worked hand-in-hand with the FDA since the federal agency was created in 1938.
the FDA regulates dietary supplements as foods and not "conventional" medicines,
manufacturers typically do not have to get FDA approval before producing or selling
dietary supplements. The FDA can take action only if a product is deemed unsafe and is
already on the market. Advertising claims for dietary supplements are regulated by the
Federal Trade Commission, not the FDA.
certification does not ensure that a product is deemed safe or lives up to reported health
claims a move that could mislead consumers, says one consumer advocacy group.
applaud USP for trying to help consumers identify high-quality dietary supplements,"
said David Schardt of the Center for Science in the Public Interest. "But we are
concerned that some consumers will assume that the USP mark means the product is safe and
beneficial. USP risks losing its credibility if it is not clear about what is being
certified and what is not."
Fowler says that monitoring product safety is "not an appropriate role for USP. Our
emphasis is on the quality of ingredients." However, he adds that USP will provide
consumer literature on various supplements on its Web site and in stores where the
certified supplements are sold.
by Gary D. Vogin, MD Medscape Medical News 2002. © 2002 Medscape
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And Drugs: Never Mix, Never Worry Source: Tufts University Health & Nutrition
Letter, July 1999.
Dean. Ive discussed the dangers of taking ginkgo with aspirin. It can increase your
risk of a stroke, but this isnt mentioned on product labels. MY COMMENTS - This
would also apply to Ibuprofen.)
ginkgo shouldnt be used with any anticoagulant drugs or with vitamin E, according to
a nutrition newsletter from Tufts University. The reason is ginkgo acts as a blood thinner
and taking it with other blood-thinning agents can put you at-risk for excessive bleeding
or even stroke.
manufacturers be required to mention the adverse effects of mixing some herbs and drugs?
Ginkgo isnt the only one you have to be careful with. Echinacea is an immune
stimulant commonly used to ward off colds, but it shouldnt be mixed with
corticosteroids, which work to suppress the immune system.
some other examples of herbs and medicines that shouldnt go together:
Might counteract immune-suppressant drugs such as glucocorticoids taken for lupus and
rheumatoid arthritis. Might increase side effects of methotrexate.
Primrose oil Can counteract the effects of anti-convulsant drugs.
--Fish oil: May increase effects of blood-thinning drugs and herbs.
acid: Interferes with methotrexate; ask your doctor how to take it.
Dont mix with coumadin (warfarin) because the herb can reverse the drugs
May increase effects of blood-thinning drugs and herbs.
Can increase effects of blood-thinning drugs and herbs.
Can increase NSAID side effects and effects of blood-thinning drugs and herbs
May increase effects of blood-thinning drugs and herbs.
May increase effects of blood-thinning drugs, estrogens and glucocorticoids;
shouldnt be used by those with diabetes; may interact with MAO inhibitors.
Kava: Dont mix with alcohol, anti-Parkinsons medications, antipsychotics,
sedatives, sleeping pills. The reason is kava can add to the effects of drugs that depress
the central nervous system, causing oversedation as well as tremors, muscle spasms or
licorice: Dont mix with blood pressure medication because of the risk of
counteracting the effects of the drugs treating hypertension.
May interact with blood pressure medications.
Johns Wort: Dont mix with antidepressants. Studies raise concerns of adverse
side effects from the interaction. May enhance effects of narcotics, alcohol, and
antidepressants; increase risk of sunburn; interfere with iron absorption.
Dont use with alcohol, sedatives or sleeping pills because it may result in extreme
interfere with glucocorticoids and other immunosuppressing drugs.
There was one case where a 70-year-old man taking aspirin regularly after heart surgery
began using ginkgo biloba twice a day and started bleeding in his eye. After quitting the
herb, the bleeding stopped.
mixing herbs and certain drugs causes adverse effects, shouldnt we be aware of this?
I think herbal supplement labels should include these warnings.
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Herbal Medicines May Contain Modern Drugs By Richard Woodman
(Reuters Health) - Chinese herbal medicines may sometimes work--and may sometimes cause
serious harm--because they are adulterated with synthetic drugs, a British research group
said on Tuesday.
The Bandolier organization, which specializes in reviewing healthcare studies, said
Chinese herbal medicines were becoming more popular and there was even evidence that some
"One of the problems, though, is that these herbal medicines are not standardized,
and usually contain many ingredients. A review tells us that some of those ingredients can
be synthetic drugs, responsible both for good effects, and for serious harm."The
review, published on Bandolier's Web site
(http://www.jr2.ox.ac.uk/bandolier/whatnew.html), found that a wide range of adulterants
were used, including steroids, nonsteroidal anti-inflammatory drugs, anticonvulsants,
benzodiazepines, hypoglycemic agents and even Viagra.
While it was not clear what proportion of remedies contained adulterants, analysis of
2,600 samples in Taiwan showed that 24% contained at least one synthetic medicine. In the
US it was 7%.
Case reports showed that two or more adulterants were present in 14 of 15 Chinese herbal
medicines."There was one death reported in these reports, and at least six
potentially life-threatening events," the organization said.
"Suspicion of adulteration was based not only on adverse effects, but suspiciously
good efficacy. Chinese herbal medicines may work because of the adulterants,"
according to the review.
It warned of the potential for adverse events, especially when other treatments were being
prescribed at the same time. Last Updated: 2002-11-05 10:00:40 -0400 (Reuters
Today's Supplement Guide. A free book containing updated scientific
information on 26 of todays top billed supplements, written by a panel of medical experts.
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Thistle: Effects on Liver Disease and Cirrhosis and Clinical Adverse Effects. The
Agency for Healthcare Research and Quality (AHRQ) is developing scientific information for
other agencies and organizations on which to base clinical guidelines, performance
measures, and other quality improvement tools. Click HERE to read
the entire piece.
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the Prevalence, Content and Readability of Complementary and Alternative Medicine
(CAM) Web Pages on the Internet. Proc AMIA Symp 2002;:672-6 Sagaram S, Walji M, Bernstam
E. Houston, TX, USA.
Complementary and alternative medicine (CAM) use is growing rapidly. As CAM is relatively
unregulated, it is important to evaluate the type and availability of CAM information. The
goal of this study is to deter-mine the prevalence, content and readability of online CAM
information based on searches for ar-thritis, diabetes and fibromyalgia using four common
search engines. Fifty-eight of 599 web pages re-trieved by a "condition search"
(9.6%) were CAM-oriented. Of 216 CAM pages found by the "condi-tion" and
"condition + herbs" searches, 78% were authored by commercial organizations,
whose pur-pose involved commerce 69% of the time and 52.3% had no references. Although 98%
of the CAM infor-mation was intended for consumers, the mean read-ability was at grade
level 11. We conclude that con-sumers searching the web for health information are likely
to encounter consumer-oriented CAM advertis-ing, which is difficult to read and is not
supported by the conventional literature.
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medication: potential for adverse interactions with analgesic drugs. Abebe W.
Department of Oral Biology and Maxillofacial Pathology, School of Dentistry, Medical
College of Georgia, Augusta, GA, USA.
The use of herbal supplements in the US has increased dramatically in recent years. These
products are not regulated by the Food and Drug Administration (FDA) with the same
scrutiny as conventional drugs. Patients who use herbal supplements often do so in
conjunction with conventional drugs. This article is a review of potential adverse
interactions between some of the commonly used herbal supplements and analgesic drugs.
Non-steroidal anti-inflammatory drugs (NSAIDs), particularly aspirin, have the potential
to interact with herbal supplements that are known to possess antiplatelet activity
(ginkgo, garlic, ginger, bilberry, dong quai, feverfew, ginseng, turmeric, meadowsweet and
willow), with those containing coumarin (chamomile, motherworth, horse chestnut, fenugreek
and red clover) and with tamarind, enhancing the risk of bleeding. Acetaminophen may also
interact with ginkgo and possibly with at least some of the above herbs to increase the
risk of bleeding. Further, the incidences of hepatotoxicity and nephrotoxicity may be
augmented by acetaminophen when concomitantly used with the potentially hepatotoxic herbs
Echinacea and kava, and with herbs containing salicylate (willow, meadowsweet),
respectively. The concomitant use of opioid analgesics with the sedative herbal
supplements, valerian, kava and chamomile, may lead to increased central nervous system
(CNS) depression. The analgesic effect of opioids may also be inhibited by ginseng. It is
suggested that health-care professionals should be more aware of the potential adverse
interactions between herbal supplements and analgesic drugs, and take appropriate
precautionary measures to avoid their possible occurrences. However, as most of the
interaction information available is based on individual case reports, animal studies and
in vitro data, further research is needed to confirm and assess the clinical significance
of these potential interactions.
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The Effects of St. John's Wort Extract on Heart Rate Variability, Cognitive
Function and Quantitative EEG: A Comparison With Amitriptyline and Placebo in Healthy Men
Siepmann M, Krause S, Joraschky P, Muck-Weymann M, Kirch W British Journal of
Clinical Pharmacology. 2002;54(3):277-282
The unwanted autonomic, alpha-adrenolytic, and antihistaminic properties of
tricyclic antidepressants often present therapeutic dilemmas for patients and prescribers
seeking an effective treatment for depression. In this trial, 12 healthy adult males were
randomly assigned to treatment with either 25 mg of amitriptyline, 255-285 mg of St John's
wort extract with 900 mcg of hypericin content or placebo. Each treatment was given for 14
days. After a 14-day washout period, study participants were crossed over to another
treatment group until each subject had received each treatment regimen. Heart rate
variability (HRV), electroencephalogram (EEG) signals, and psychometric tests were used to
evaluate the effects of each treatment on the study participants.
Increased heart rate was noted in patients treated with amitriptyline (P <
.001) but not with the other treatments. HRV was affected by amitriptyline but not St.
John's wort extract. Cognitive performance was not affected by either amitriptyline or St.
John's wort extract. Amitriptyline decreased self-rated activity (P < .05) that was not
observed with St. John's wort extract. Both active treatments caused significant
quantitative EEG changes. Editor's Comment This study demonstrates
differences in unwanted physiologic effects of amitriptyline and St. John's wort extract.
Increasing our understanding of both the effectiveness (not evaluated here) and the
adverse event profile of therapeutic doses of St. John's wort extract will enable more
informed decision making about the optimal treatment of depression for individual
patients. In the United States, concerns remain over the inconsistency of ingredients in
available herbal therapies.
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Folate May Ease Depression
07-14-2003 By Garret Condon / Hartford Courant
Depressed? Maybe you need more liver, chickpeas, fortified breakfast cereal or a
All are good sources of folate, a B vitamin that occurs naturally in many foods. The
synthetic version is called folic acid. It has been added to some foods since the late
1990s to help prevent certain birth defects. The current recommendation for pregnant women
is 600 micrograms per day. Women who lack adequate folate around the time of conception
are more likely to have a child with birth defects and are at higher risk for low-weight
and premature babies, according to the National Institutes of Health.
Some studies have shown supplemental folate also helps depressed people. A recently
published study suggests how this might work.
Martha Morris, an epidemiologist with the Jean Mayer USDA Human Nutrition Research Center
on Aging at Tufts University, and four colleagues studied data on nearly 3,000 people,
ages 15 to 39. They found that those who had experienced major depression had lower
concentrations of folate in their bloodstream and red blood cells than those who had never
been depressed. In addition, those with chronic low-level depression -- also known as
dysthymia -- had lower red blood cell levels than the nondepressed.
Morris says folate levels were not particularly low among people who said they were
currently depressed. "Low folate didn't occur until some months after the symptoms
had disappeared," she says. "It does tend to suggest that low folate status is a
consequence of depression." She notes that low levels of folate can cause such
symptoms as fatigue, which is often part and parcel of depression. Improving such
conditions using folate or folic acid, she says, might help lift the spirits.
The study, published in the March-April (2003) issue of Psychotherapy and Psychosomatics,
was accompanied by an editorial written by Dr. Ingvar Bjelland and two colleagues from the
University of Bergen, Norway. They say that while studies on folate and antidepressant
treatment are promising, scientists do not yet know which patients should receive folate
supplements, in what dose or for how long.
Furthermore, the safety of high-dosage supplementation has not been established. The
information analyzed by Morris and her associates was gathered before folic acid was added
to many foods.
Morris says she's not sure what result she'd get from the post-fortification population.
The National Institutes of Health reports adult diets now contain recommended amounts of
either folate or folic acid. In other words, most Americans are probably getting enough.
The Institute of Medicine's Food and Nutrition Board recommends 400 micrograms, or 0.4
milligrams, per day for adult men and women, 600 micrograms for pregnant women and 500 for
Some medicines and medical conditions -- including alcohol abuse -- can cause folate
deficiency. Doctors may put such people on folic acid supplements. For those not
identified as low on folate, a multivitamin with folic acid or an extra helping of
folic-acid-fortified foods might make sense.
However, some individuals may be at risk from folic acid supplements. People with vitamin
B12 deficiency, for example, can develop both anemia and damage to the central nervous
system. Taking folic acid can cure the anemia but not the central nervous system effects.
The folic acid supplement, therefore, could mask the B12 deficiency and delay diagnosis.
The National Institutes of Health's Office of Dietary Supplements recommends people 50 or
older have their doctors check their B12 status before they begin using a folic-acid
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Gadgets and Products.
Questions and Answers About Using Magnets To Treat Pain (This
link will open a new window)
Pain-relieving magnets attract scientific scrutiny
and pain are an old married couple. As early as 200 AD, Greek healers prescribed magnetic
rings to people wracked by arthritic pains. In 19th century America, magnetic salves,
corsets, belts, suspenders, insoles, liniments and even underwear were sold as balms for
Today, the market for magnetic cures remains hugean estimated US$500 million in the
US and US$5 billion around the world. It includes wrist and knee bands, neck and back
braces, magnetic dog collars and resting pads, as well as blankets, toothbrushes, water,
soap, dental floss, razors, car seats, exercise balls, face masks, horse massagers,
panties, head caps, pillows and mattresses. In short, if you want a magnetic anything, you
can probably find it.
And yet despite nearly 2,000 years of medical use, separating magnetic flim-flam from real
pain relief is hugely contentious.
When it comes to magnets, most do not work; almost none have been clinically tested, and
just because something says it is magnetic doesnt mean it is biologically effective.
Most arent, says Michael Weintraub, a professor of neurology and internal
medicine at New York Medical College.
What makes Weintraubs views especially worth noting is that he actually is, in a
massively skeptical medical community, a proponent of magnetic pain relief for some
conditions. In 2003, he published a landmark study showing that magnetic shoe insoles were
able to significantly reduce pain in 375 people with diabetes-induced foot aches. The pain
reduction was equal or superior to what people reported after taking painkilling drugs.
What made the study even more significant is that, unlike most studies about magnets, it
came with the highest research pedigree. Namely, there were a large enough number of
patients to make the results statistically significant, the magnetic insoles were compared
to nonmagnetic insoles, people were assigned to both soles at random, and nobody knew who
had what insole.
The latter issue highlights a huge issue in magnetic pain reduction research.
Its impossible not to detect a magnetic field, therefore, somebody who wants
to see if their device is actively magnetic can easily do so, says Weintraub.
All you have to do is pass it near something iron and see if it attracts.
And if study participants know the device they have been given is magnetic, then any
improvement may be a result of the placebo effectthe minds presumption that
any new treatment must produce a positive result. As an example, a 2002 study of magnetism
and carpal tunnel syndrome found that after 45 minutes of treatment there were significant
improvements from braces with and without magnets. The phantom improvements continued to
be seen after two weeks.
More consistent improvement, but not absolutely consistent, has been found in patients
using magnetic fields generated by electricity to treat pains ranging from low back pain,
to arthritic knee pain, to facial pain.
Mysterious but not magical
One explanation of the failure to conclusively prove or disprove magnetisms claims
might be lack of standardization amongst manufacturers. We did a study on back pain
with a magnet a manufacturer said penetrated into the body, but when we tested it we found
it didnt, says Weintraub.
Another problem is that there is no generally agreed upon explanation for how magnets
might work in dulling pain. In 2004, the National Center for Complementary and Alternative
Medicine (NCCAM) of the US National Institutes of Health listed eight possible reasons for
how magnets might affect the body.
These ranged from changing how nerve cells respond to pain, to increasing blood flow, to
changing the brains perception of pain, to allowing the body to flush toxins more
easily. None of the theories or claims
have been conclusively proven,
So what is a cautious consumer to do in a world replete with claims for miraculous pain
alleviation with magnets? Investigate before you buy, says Weintraub. This means you have
to check to see if a magnet is as powerful as it claims, if its force can actually
penetrate the skin, and if any benefit has been reported in the scientific literature in
Magnets are not magical; people have to be aware of this. Just because they put
magnets on doesnt mean it will work, says Weintraub. Let the buyer
beware. © 2007 Bell Inc., Microsoft Corporation and/or their
contributors. All rights reserved
fail to ease back pain
FAUBER of the Journal Sentinel staff
test that pitted one of America's most common health complaints against one of the hottest
forms of alternative medicine, therapeutic magnets failed to help low back pain, according
to a study published today in JAMA, the Journal of the American Medical Association.
estimated that 85% of Americans will experience back pain during their lives. At the same
time, a media campaign promoting magnets for pain has resulted in worldwide sales of $5
billion, according to the authors of the study.
study found that magnet therapy applied for six hours a day, three times during one week
of treatment had no effect on chronic low back pain.
study, which looked at 20 patients from a Veterans Affairs hospital in Arizona, is not
likely to end the debate over whether magnets are humbug or healing. The patients all had
chronic low back pain that had lasted an average of 19 years. Each patient received a week
of treatment with both sham magnets and real magnets.
end of each treatment regimen, the patients were given standard tests designed to assess
pain levels. The magnet group fared no better the placebo group.
the study is one of the few randomized, double-blind, placebo-controlled tests of magnet
therapy, the study's authors said it was not intended to definitively prove or disprove
the effectiveness of magnets in general.
magnets might have yielded different results, the authors said. For the study, researchers
used 300 gauss, bipolar permanent magnets. Gauss is the unit of measurement used in rating
a magnet's strength.
the popularity of magnets has grown, testimonials are easier to find than scientific
evidence showing they have benefit.
have been only two previous, small double-blind, placebo- controlled studies, one
involving patients with post-polio pain and the other involving peripheral neuropathy,
foot pain caused by a circulation problem.
Arthritis Foundation, the Food and Drug Administration and the Federal Trade Commission
warn that science does not support the use of magnets.
of Magnetic vs Sham-Magnetic Insoles on Plantar Heel Pain
Randomized Controlled Trial Mark H. Winemiller, MD; Robert G. Billow, DO; Edward R.
Laskowski, MD; W. Scott Harmsen, MS JAMA. 2003;290:1474-1478.
Despite anecdotal reports, rigorous scientific evidence of the effectiveness of magnetic
insoles for the pain of plantar fasciitis is lacking.
To determine whether magnetic insoles provide greater subjective improvement for treatment
of plantar heel pain compared with identical nonmagnetized insoles.
Setting, and Participants Randomized, double-blind, placebo-controlled trial
conducted from February 12, 2001, to November 9, 2001, of a volunteer sample of 101 adults
with diagnoses of plantar heel pain for at least 30 days from a multispecialty group
practice clinic in Rochester, Minn. Daily pain diaries were kept for 8 weeks.
Cushioned insoles, with either active bipolar magnets or sham magnets, which were worn
daily by the participants for 8 weeks.
Outcome Measures Reported average daily foot pain (by metered visual analog scale
[VAS] and by categorical response of change from baseline) at 4 and 8 weeks, and impact of
insoles on employment performance and enjoyment.
No significant between-group differences were found on any outcome variables studied when
comparing active vs sham magnets. Both the nonmagnetic and magnetic groups reported
significant improvements in morning foot pain intensity, with mean (SD) VAS scores
improving from 6.9 (2.3) and 6.7 (2.0), respectively, at baseline to 3.9 (2.6) for each
group at 8 weeks (P = .94). At 8 weeks, 33% of the nonmagnetic group and 35% of the
magnetic group reported being all or mostly better (P = .78). At baseline, foot pain
interfered moderately with participants' employment enjoyment (mean VAS, 4.2) and improved
in both groups by 8 weeks (1.3 and 1.5, respectively; P = .68).
Static bipolar magnets embedded in cushioned shoe insoles do not provide additional
benefit for subjective plantar heel pain reduction when compared with nonmagnetic insoles.
Author Affiliations: Department of Physical Medicine and Rehabilitation (Drs Winemiller
and Laskowski) and Section of Biostatistics (Mr Harmsen), Mayo Clinic, Rochester, Minn;
and Northwest Orthopaedic Surgeons, Mount Vernon, Wash (Dr Billow).
Bipolar permanent magnets for the treatment of chronic low back pain: a
Veterans Affairs Medical Center, Prescott, Ariz 86313, USA. firstname.lastname@example.org
CONTEXT: Chronic low back pain is one of the most prevalent and costly
medical conditions in the United States. Permanent magnets have become a popular treatment
for various musculoskeletal conditions, including low back pain, despite little scientific
support for therapeutic benefit. OBJECTIVE: To compare the effectiveness of 1 type of
therapeutic magnet, a bipolar permanent magnet, with a matching placebo device for
patients with chronic low back pain. DESIGN: Randomized, double-blind, placebo-controlled,
crossover pilot study conducted from February 1998 to May 1999. SETTING: An ambulatory
care physical medicine and rehabilitation clinic at a Veterans Affairs hospital. PATIENTS:
Nineteen men and 1 woman with stable low back pain of a mean of 19 years' duration, with
no past use of magnet therapy for low back pain. Twenty patients were determined to
provide 80% power in the study at P<.05 to detect a difference of 2 points (the
difference believed to be clinically significant) on a visual analog scale (VAS).
INTERVENTIONS: For each patient, real and sham bipolar permanent magnets were applied, on
alternate weeks, for 6 hours per day, 3 days per week for 1 week, with a 1-week washout
period between the 2 treatment weeks. MAIN OUTCOME MEASURES: Pretreatment and
posttreatment pain intensity on a VAS; sensory and affective components of pain on the
Pain Rating Index (PRI) of the McGill Pain Questionnaire; and range of motion (ROM)
measurements of the lumbosacral spine, compared by real vs sham treatment. RESULTS: Mean
VAS scores declined by 0.49 (SD, 0.96) points for real magnet treatment and by 0.44 (SD,
1.4) points for sham treatment (P = .90). No statistically significant differences were
noted in the effect between real and sham magnets with any of the other outcome measures
(ROM, P = .66; PRI, P = .55). CONCLUSIONS: Application of 1 variety of permanent magnet
had no effect on our small group of subjects with chronic low back pain.
Therapy: A Skeptical View Stephen Barrett, M.D.
on Using Magnets to Treat Pain Surprises Skeptics By LAWRENCE K. ALTMAN, M.D.
was more skeptical about using magnets for pain relief than Dr. Carlos Vallbona, former
chairman of the department of community medicine at Baylor College of Medicine in Houston.
So Dr. Vallbona was amazed when a study he did found that small, low intensity magnets
worked, at least for patients experiencing symptoms that can develop years after polio.
Vallbona had long been fascinated by testimonials about magnets from his patients, and
even from medical leaders. But his interest in magnet therapy became more serious in 1994
when he and a colleague, Carlton F. Hazlewood, tried them for their own knee pain. The
pain was gone in minutes. ''That was too good to be true,'' Dr. Vallbona said.
Vallbona knew that the power of suggestion can fool both patient and doctor. But he also
wondered: could strapping small, low intensity magnets to the most sensitive areas of the
body for several minutes relieve chronic muscular and joint pains among patients in his
post-polio clinic at Baylor's Institute for Rehabilitation Research.
studies could allow consumers to make informed choices. And if magnet therapy were found
to be safe and effective, it could relieve pain with fewer drugs -- and their unwanted
from professional athletes are one reason Americans spend large sums on magnets to seek
pain relief. But most doctors take a ''buyer beware'' attitude because many claims lack
scientific proof or explanation of how they might work. The Food and Drug Administration
has warned doctors and manufacturers about health claims for magnets.
the medical profession's skepticism about magnet therapy, Dr. Vallbona sought to conduct
science's most rigorous type of study. Participants would agree to allow the investigators
to randomly assign them to groups getting treatment with active magnets or sham devices.
But neither the patients nor the doctors treating them would know what therapy was used on
Dr. Vallbona informally tested magnets on a few patients. One was a priest with post-polio
syndrome who celebrated mass with difficulty due to marked back pain that prevented him
from raising his left hand. After applying a magnet for a few minutes the pain was gone,
Dr. Vallbona recalled, and, ''the priest said this was a miracle.''
human experimentation committee allowed Dr. Vallbona to test 50 volunteers with magnets
that at 300 to 500 gauss, were slightly stronger than refrigerator magnets. They were made
in different sizes so they could fit over the anatomic area identified as setting off
difficult to design a system to prevent participants from learning whether they were being
treated with a magnet or a sham.
Vallbona asked Magnaflex Inc., a magnet manufacturer in Corpus Christi, Tex., to prepare
active magnets and inactive devices that could not be told apart. The devices were labeled
further precaution, a staff member observed the patients throughout the 45-minute period
of therapy to make sure they would not try to find out -- by testing with a paper clip,
say -- what treatment they were receiving.
the investigators identified the source of the pain and then pressed on it, the 39 women
and 11 men in the study graded the pain on a scale of 0 (none) to 10 (worst). Then after
the experimental treatment, the participants rated their pain in a standard questionnaire.
The volunteers were tested only one time.
who received an active magnet reported a reduction in pain to 4.4 from 9.6, compared with
a smaller decline to 8.4 from 9.5 among the 21 treated with a sham magnet.
Baylor scientists emphasized that their study applied only to pain from the post-polio
condition. Nevertheless, their report in last month's issue of Archives of Physical and
Rehabilitation Medicine, a leading specialty journal, has shocked many doctors who have
scoffed at claims for magnets' medical benefits.
Ionized Bracelets for Musculoskeletal Pain Mayo Clin
Proc, November 2002, Vol 77 1164 Mayo Clin Proc. 2002;77:1164-1168 1164 © 2002 Mayo
Foundation for Medical Education and Research Effect of "Ionized" Wrist
Bracelets on Musculoskeletal Pain: A Randomized, Double-Blind, Placebo-Controlled Trial
ROBERT L. BRATTON, MD; DANIEL P. MONTERO, MD; KEVIN S. ADAMS, MD; CAPT MARK A. NOVAS,
USAF, MC; TRACY C. MCKAY, DO; LINDA J. HALL, CCRC; JOSEPH G. FOUST, MD;MICHAEL B. MUELLER,
DO; PETER C. OBRIEN, PHD; ELIZABETH J. ATKINSON, MS; AND MEGAN S. MAURER, BS From
the Department of Family Medicine (R.L.B., D.P.M., K.S.A., M.A.N., T.C.M., J.G.F., M.B.M.)
and Division of Research Services, Clinical Studies Unit (L.J.H.), Mayo Clinic,
Jacksonville, Fla; and Division of Biostatistics, Mayo Clinic, Rochester, Minn (P.C.O.,
E.J.A., M.S.M.). Dr Montero is in private practice in Chesapeake, Va. Dr Adams is in
private practice in Athens, Ga. Dr Novas is in the Medical Corps, United States Air Force,
San Antonio, Tex. Dr McKay is in private practice in Dade City, Fla. Dr Mueller is in
private practice in Crystal River, Fla. Address reprint requests and correspondence to
Robert L. Bratton, MD, Department of Family Medicine, Mayo Clinic, 4500 San Pablo Rd,
Jacksonville, FL 32224.
Objective: To assess objectively the perceived benefits of wearing an
"ionized" wrist bracelet to treat muscle or joint pain.
Subjects and Methods: This study was performed at the Mayo Clinic in
Jacksonville, Fla, in 2000 and 2001. In a randomized, double-blind design, 305
participants wore an ionized bracelet and 305 wore a placebo bracelet for 4 weeks. For
each location where pain was present at baseline, participants rated the intensity of
pain. Followup ratings were made after 1, 3, 7, 14, 21, and 28 days of wearing the
bracelet. Two primary end points were defined for evaluating efficacy. The first was the
change at 4- week follow-up (day 28) in the pain score at the location with the highest
baseline value (maximum pain score). The second was the change at 4-week follow-up in the
sum of the pain scores for all locations.
Results: Analysis of the data showed significant improvement in pain
scores in both groups, but no differences were observed between the group wearing the
placebo bracelet and the group wearing the ionized bracelet.
Conclusion: The finding that subjective improvement in pain scores was
equivalent with ionized and placebo bracelet use questions the benefit of using an ionized
bracelet. New treatments in alternative medical therapy must be shown to be effective
through vigorous, unbiased, objective testing before physicians acknowledge potential
benefits or recommend these treatments to patients. Mayo Clin Proc. 2002;77:1164-1168
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Magnesium, Malic Acid, Super Malic
Role of Magnesium in Fibromyalgia. An investigatory paper by Mark London
of fibromyalgia syndrome with Super Malic: a randomized, double blind, placebo controlled,
crossover pilot study. J Rheumatol 1995 May;22(5):953-8 Russell IJ, Michalek JE, Flechas
JD, Abraham GE.
Department of Medicine, University of Texas Health Science Center, San Antonio 78284-7874,
OBJECTIVE. To study the efficacy and safety of Super Malic, a proprietary tablet
containing malic acid (200 mg) and magnesium (50 mg), in treatment of primary fibromyalgia
syndrome (FM). METHODS. Twenty-four sequential patients with primary FM were randomized to
a fixed dose (3 tablets bid), placebo controlled, 4-week/course, pilot trial followed by a
6-month, open label, dose escalation (up to 6 tablets bid) trial. A 2-week, medication
free, washout period was required before receiving treatment, between blinded courses, and
again before starting open label treatment. The 3 primary outcome variables were measures
of pain and tenderness but functional and psychological measures were also assessed.
RESULTS. No clear treatment effect attributable to Super Malic was seen in the blinded,
fixed low dose trial. With dose escalation and a longer duration of treatment in the open
label trial, significant reductions in the severity of all 3 primary pain/tenderness
measures were obtained without limiting risks. CONCLUSIONS. These data suggest that Super
Malic is safe and may be beneficial in the treatment of patients with FM. Future
placebo-controlled studies should utilize up to 6 tablets of Super Malic bid and continue
therapy for at least 2 months. Publication Types: Clinical Trial Randomized Controlled
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Magnesium and MK-801 have a similar effect in two experimental models of
Brain Res 2000 Dec 29;887(2):436-9 Begon S, Pickering G, Eschalier A, Dubray C INSERM EPI
9904, Pharmacologie Fondamentale et Clinique de la Douleur, Laboratoire de Pharmacologie
Medicale, Faculte de Medecine, B.P. 38, 63001 Clermont-Ferrand, Cedex 1, France. email@example.com
Considering that magnesium and non-competitive NMDA receptor
antagonists inhibit the opening of the channel linked to the NMDA receptor, we assessed
their effects on mechanical hyperalgesia in two animal models of neuropathic pain (rats
with a sciatic nerve ligature and diabetic rats). Our data show that magnesium reverses
the hyperalgesia, as does MK-801. These results suggest that magnesium could be an
alternative for the treatment of neuropathic pain in patients. PMID: 11134637
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and affective disorders.
Murck H. Laxdale Ltd, Stirling, UK. firstname.lastname@example.org
There are several findings on the action of magnesium ions supporting their possible
therapeutic potential in affective disorders. Examinations of the
sleep-electroencephalogram (EEG) and of endocrine systems point to the involvement of the
limbic-hypothalamus-pituitary-adrenocortical axis as magnesium affects all elements of
this system. Magnesium has the property to suppress hippocampal kindling, to reduce the
release of adrenocorticotrophic hormone (ACTH) and to affect adrenocortical sensitivity to
ACTH. The role of magnesium in the central nervous system could be mediated via the
N-methyl-D-aspartate-antagonistic, gamma-aminobutyric acidA-agonistic or a angiotensin
II-antagonistic property of this ion. A direct impact of magnesium on the function of the
transport protein p-glycoprotein at the level of the blood-brain barrier has also been
demonstrated, possibly influencing the access of corticosteroids to the brain.
Furthermore, magnesium dampens the calciumion-proteinkinase C related neurotransmission
and stimulates the Na-K-ATPase. All these systems have been reported to be involved in the
pathophysiology of depression. Despite the antagonism of lithium to magnesium in some
cell-based experimental systems, similarities exist on the functional level, i.e. with
respect to kindling, sleep-EEG and endocrine effects. Controlled clinical trials examining
the effect of Mg in affective disorder are warranted. PMID: 12509067
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magnesium sulfate relieves cluster headaches in patients with low serum ionized magnesium
levels.Headache Prevention Institute http://www.h-p-i.com
Author Mauskop A; Altura BT; Cracco RQ; Altura BM Address
Department of Neurology, State University of New York, Health Science Center at Brooklyn,
USA. Source Headache, 35(10):597-600 1995 Nov-Dec
Patients with cluster headaches have been reported to have low serum ionized magnesium
levels. We examined the possibility that patients with cluster headaches and low ionized
magnesium levels may respond to an intravenous infusion of magnesium sulfate. Thirty-eight
infusions of magnesium sulfate were given to 22 patients with cluster headaches. The mean
ionized magnesium level prior to 23 infusions which provided relief for at least 2 days
and enabled the patient to skip two or more attacks, was 0.521 +/- 0.016 mmol/L; this
value was 0.561 +/- 0.016 prior to 15 infusions which were ineffective. These latter 15
preceded by higher total magnesium levels. The ionized magnesium level prior to the 23
effective infusions was below 0.54 mmol/L in 19 patients. Five of the 15 ineffective
infusions were accompanied by basal ionized magnesium levels below 0.54 mmol/L. In 76% of
the infusions, there was a correlation between a response and an ionized magnesium level
below 0.54 mmol/L. Nine patients (41%) obtained clinically meaningful improvement.
Spontaneous remissions and a placebo effect might have accounted for some of the
improvement. However, this should have applied equally to all patients, regardless of the
ionized magnesium level. Measurements of ionized magnesium may prove useful in elucidating
the pathogenesis of cluster headache and in identifying patients who may benefit from
treatment with magnesium.
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American College of Physicians on Malic Acid for Treating Fibromyalgia and CFS
report titled Management of Fibromyalgia, the American College of Physicians
& American Society of Internal Medicine listed malic acid among treatments recommended
for Fibromyalgia pain. The report was published in the December 1999 issue of the Annals
of Internal Medicine and was authored by Lawrence J. Levanthal, M.D.
1999 book, Making Sense of Fibromyalgia, by Daniel J. Wallace, M.D. and Janice Brock
Wallace, the authors noted the success of malic acid and magnesium in FM patients with the
interesting preparation, containing magnesium and malic acid is now available
Controlled studies from England and Texas in peer-reviewed journals have documented modest
effects of this preparation in muscle spasm, fatigue and pain in Fibromyalgia. If patients
take a dose larger than recommended on the bottle
its effects become apparent within
a week; side effects are uncommon. This combination may work as a result of interactions
between magnesium and calcium channels within muscles and the generation of adenosine
triphosphate (ATP), our cellular fuel.
Confirms Malic Acids Use to Alleviate Pain and Fatigue
healthcare professionals familiar with CFS are continuing to recommend malic acid for the
chronic muscle soreness and fatigue that most patients experience.
have found that patients using a combination of malic acid and magnesium hydroxide report
improvements with reduction of muscle pain and tiredness.
those physicians recommending the malic acid/magnesium hydroxide combination are Daniel
Peterson, M.D., of Incline Village, CA, Paul Cheney, M.D. and Jay Goldstein, M.D.,
director of the CFS Institute.
Peterson comments, the patients who improved reported diminishing symptoms
an increase in exercise tolerance.
Dr. Goldstein has found malic acid to be a safe, inexpensive nutritional supplement for
CFS symptoms and suggests it should be added to the list of therapeutic approaches. He
currently prescribes it for his patients with symptoms associated with CFS, and those
diagnosed with FM. He explains,
it may have a modest effect on fatigue and/or
pain may respond within 48 hours, while fatigue may take about two weeks.
effectiveness of the supplement has a sound scientific base. Malic acid, a fruit acid
extracted from apples and widely used in the food industry, is essential in the formation
of ATP, which is our bodys energy source. Malic acid has the ability to allow the
body to make ATP more efficiently, even under low oxygen, or hypoxic, conditions.
Magnesium is a mineral that is required for over 100 enymatic reactions in the body.
Interestingly, many researchers such as Dr. Cheney, have noted that a large percentage of
patients are magnesium depleted on an intra-cellular basis (inside the cell). Standard
blood tests are not sensitive to intra-cellular magnesium.
study published in the May, 1995 edition of the Journal of Rheumatology, the results of FM
treatment with malic acid were assessed in terms of pain, tenderness, ability to function,
and psychological well-being.
results showed no therapeutic effects on Fibromyalgia symptoms when malic acid was taken
at the dosage of 600mg for twice a day for four weeks.
when the dosage of malic acid was increased to 1200mg twice a day there were significant
reductions in the pain and tenderness of the Fibromyalgia symptoms. [Treatment of
Fibromyalgia syndrome with Super Malic: a randomized, double-blind, placebo-controlled,
crossover pilot study. Russell IJ; Michalek JE; Flechas JD; Abraham GE; J Rheumatol,
22(5):953-8 1995 May]
Flechas, M.D., M.PH., a holistic practitioner in Hendersonville, N.D., has participated in
two medical studies that have tested the combination of malic acid and magnesium for
Fibromyalgia patients. In these studies, patients reported a significant reduction in pain
and tenderness within 48 hours and without any side effects. In his practice, Flechas has
used this supplement combination for six years on about 500 Fibromyalgia patients. I
have found the results are positive 90 percent of the time, he says.
Jay Sahley, Ph.D., a San Antonio nutritional specialist and author of the indepth book,
Malic Acid and Magnesium for Fibromyalgia and Chronic Pain Syndrome reports impressive
results in Fibromyalgia patients. The sooner malic acid and magnesium are started,
the faster patients begin to return to their normal lifestyles, remarks Sahley. HW
DEFICIENCY IN FIBROMYALGIA SYNDROME Magazine: Journal of Nutritional Medicine,
Spring, 1994 Section: ORIGINAL RESEARCH
Since patients with either fibromyalgia syndrome (FS) or low magnesium (Mg) levels can
have fatigue, sleep disturbance and anxiety, it was necessary to determine if some
patients with FS also have low Mg levels.
- A VITAL MINERAL
Magnesium is a mineral that is abundant both in nature and in the human body, where it is
involved in the activation of more than 300 enzymes and body chemicals. The
Department of Health has set the Reference Nutrient Intake (RNI) for magnesium at 300mg
per day. However, many nutritionists now feel that the average world RNI should be
set at 450mg per day. A survey in 1994 showed that 72% of women and 42% of men aged
between 19 and 50, and 89% of females aged 16-18 years do not achieve the RNI for
magnesium. Low levels of magnesium in the diet and in our bodies increase
susceptibility to a variety of diseases, including heart disease, high blood pressure,
kidney stones, cancer, insomnia, PMS, and menstrual cramps. Signs and symptoms of
magnesium deficiency are fatigue, mental confusion, irritability, weakness, heart
disturbance, problems in nervous conduction and muscle contraction, muscle cramps, loss of
appetite, insomnia and predisposition to stress. Magnesium is essential for the
proper functioning of the entire cardiovascular system. Because magnesium
contributes greatly to the strength of contraction by heart muscle, magnesium
supplementation has been found to be helpful in the management of angina, atherosclerosis,
intermittent claudication and high blood pressure.
the most important components of any osteoporosis programme is magnesium. As much as
60% of all magnesium in the body is found in the bones. A defect of bone crystal
formation in magnesium-deficiency women is thought to be one of the factors that increase
works in many ways to preserve the health of the nervous system. During times of
stress, magnesium stores are depleted and large amounts of this mineral are lost in the
urine. With its ability to exert a calming effect on the nervous system together
with its muscle relaxing role, magnesium, taken 30-40 minutes before retiring, may help
those suffering stress or insomnia.
have shown a low intracellular magnesium content in patients with bronchial asthma.
Magnesium deficiency can also increase the release of histamine into the bloodstream.
Thereby increasing allergic reactivity in general.
also plays a central role in the secretion and action of insulin. Without adequate
magnesium levels within the body's cells, control over blood sugar levels is
has also been found to play a role in the aetiology of migraines, fibromyalgia, PMS,
kidney stones and attention deficit hyperactivity disorder (ADHD). Williams, E.
NUTRIT. PRACT. 1999,1 (3) 27-9
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supplement called SAM-e could be a new ally in the battle against the pain of
osteoarthritis and fibromyalgia and the depression that so often accompanies chronic
last spring, hardly anybody in this country had heard of a European supplement called
S-adenosylmethionine. But when it hit the market as a natural remedy named SAM-e
(pronounced "sammy") it zoomed in a matter of months from an unknown import to
one of the top-selling dietary supplements in the country.
that user-friendly nickname, you almost expect "sammy" pills to be wearing a
little smiley face. And no wonder: Its being touted as a treatment for depression
and osteoarthritis (OA) pain (because of regulations, vaguely referenced on labels as
"emotional well-being" and "joint health"). Studies suggest it can
also help fibromyalgia symptoms and alcoholdamaged livers, and there are claims that it
may help with migraine headaches and maybe even Alzheimers disease. And it seems to
have no serious side effects and no known drug interactions.
kinds of sweeping claims have a tendency to make doctors wary, says James McKoy, MD, chief
of rheumatology at Kaiser Permanente in Honolulu, Hawaii. "Whenever something is
promised to be a cure-all for so many diseases, physicians are very skeptical because so
many miracle cures usually only benefit the producer and the seller," he says.
I think this substance has promise," he adds, and several other doctors agree.
McKoy says he has some arthritis patients using SAM-e supplements, "and they like it.
SAM-e might be one of the most effective alternative supplements for osteoarthritis and
fibromyalgia, and I think it is going to prove to be a great alternative for
depression," he says.
particularly like SAM-e supplements because they dont have the side effects of
nonsteroidal anti-inflammatory drugs (NSAIDs), which can cause gastrointestinal damage; or
of antidepressants, which can include sexual dysfunction, dry mouth or nausea. It takes a
week or so for SAM-e to take effect, which is slower than NSAIDs but about twice as fast
as most antidepressant drugs.
SAM-e has shown no signs of drug interaction and so can be taken along with most, if not
all, prescription drugs, according to Richard Brown, MD, a New York psychiatrist who has
been using SAM-e for years in his practice.
Science Behind Sam-E
SAM-e, unlike many dietary supplements, arrived in the marketplace with a thorough
background of scientific studies and a history of use.
in Europe have been studying and using SAM-e for more than two decades as a treatment for
osteoarthritis and depression. There are dozens of European studies, including controlled
clinical trials that show it relieves osteoarthritis pain as well as NSAIDs; and that it
works as well as tricyclic antidepressants in improving mood.
several countries, its a prescription drug, says Teodoro Bottiglieri, PhD, a
neuropharmacologist at the Baylor University Institute for Metabolic Diseases in Dallas.
Bottiglieri, who has been studying SAM-e for some 15 years, also recently co-wrote a book
on SAM-e, Stop Depression Now (Putnam Publishing Group, 1999), along with Dr. Brown.
a compound that occurs naturally in all living cells, and is a key player in a process
called methylation that affects more than 100 complex biochemical reactions in the human
helps our bodies make and regulate hormones, cell membranes and the neurotransmitters that
affect mood. SAM-e also contributes to the building blocks for cartilage, and is involved
in making glutathione, which the liver uses to remove poisons such as alcohol.
bodies usually make all the SAM-e we need. But the level of SAM-e decreases as we age, and
levels are low in those who are depressed, or who have deficiencies of B vitamins or
methionine, says Bottiglieri. Good diet and vitamin B supplements can help our bodies
better use SAM-e, but unfortunately they are not going to do much to help people who have
low levels of SAM-e, he says.
supplements, however, can raise levels of this compound. And while scientists dont
know for certain how taking SAM-e supplements works, science has shown it relieves OA pain
and some fibromyalgia symptoms, as well as depression.
Some doctors are suggesting SAM-e to their patients with fibromyalgia, because
antidepressant drugs in small doses are often used to ease fibromyalgia symptoms. In
standard-size doses they can also help relieve the depression that frequently accompanies
antidepressant effects of SAM-e are documented in several studies. Its being
prescribed by some psychiatrists to treat depression, particularly for people who
havent responded to other drugs, or who are reluctant to take prescription
antidepressants because of side effects.
a promising drug," says Maurizio Fava, MD, lead author of a study that shows SAM-e is
an effective antidepressant. Dr. Fava is director of the Clinical Depression Research
Program at Massachusetts General Hospital, where he uses SAM-e to treat some of his
there are mixed results in studies of SAM-e for fibromyalgia. In one small European study
of fibromyalgia and SAM-e, 200-mg daily injections reduced the number of tender points and
improved mood in patients with fibromyalgia. In another, those taking 800 mg of SAM-e in
pill form had less pain, fatigue and morning stiffness than patients taking placebo, but
no effect on tender points. A third study showed no benefit.
are also mixed opinions from physicians.
think SAM-e is even better for fibromyalgia than for osteoarthritis," says Dr. McKoy,
who has several patients using it.
Brown agrees, saying he finds the supplement more effective than antidepressants for
fibromyalgia, and that some of his patients get significant pain relief from taking it.
Don Goldenberg, MD, a fibromyalgia specialist and chief of rheumatology at
Newton-Wellesley Hospital in the Boston area, says hes not convinced SAM-e has much
to offer people with fibromyalgia. His laboratory began and abandoned a study on SAM-e
about eight years ago when it didnt appear to have any benefit for fibromyalgia
Dr. Goldenberg notes that the SAM-e product that was used in the discontinued trial could
have been too old and thus not effective. He says he would like to see more studies.
Downsides and the Bottom Line
However, there are some potential downsides to taking SAM-e. Although it has been used for
20 years, there are no controlled, long-term studies to show what effects might occur in
people who take SAM-e daily for years, as they would for either osteoarthritis or
rheumatologists know enough about SAM-e or its research to be able to advise you. And the
appropriate dosage isnt known: Between 200 and 1,600 mg per day of SAM-e was used in
studies, with the highest dosage used for depression.
not a cure: You have to keep taking it to get the effects, and its pricey for some:
SAM-e costs approximately $60 to $230 per month, depending on the amount taken, and
its not covered by insurance.
with all supplements, loose regulations mean that there is no guarantee that consumers are
getting active ingredients in the products they buy.
all agreed SAM-e appears to be safe when it is used short term. Both Bottiglieri and Dr.
Brown say it can be taken with most prescription drugs, including antidepressants, under a
doctors supervision. None of the experts interviewed thought SAM-e had any serious
side effects "except poverty," one scientist said, half-joking about the
cost of the supplement.
really dont have enough information to say if its effective or not," says
Dr. Moskowitz. "But we need to keep an open mind."
If you decide you would like to try SAM-e for OA, fibromyalgia or depression, keep this
advice in mind:
try SAM-e without a doctors supervision if you are severely depressed. You must be
under medical care. If you have bipolar disease (also known as manic-depression), SAM-e
could cause a manic episode.
to tell your doctor you are planning to try SAM-e, especially if you are taking
prescription drugs. And dont stop any prescribed drugs without checking with your
doctor: It can be harmful to stop some medications abruptly.
choose a SAM-e product that is stabilized. Look for SAM-e butanedisulfonate on the label.
SAM-e loses potency easily, so it has to be carefully packaged in airtight, light-proof
containers. Also, tablets should be coated to dissolve in your intestines, not your
stomach, or youll be wasting some of that expensive substance.
take more than 1,600 mg per day of SAM-e. For OA pain, some doctors suggest starting with
800 mg per day, taken in two doses. If you see an improvement in pain or mood symptoms in
two weeks, reduce the dosage to 400 mg. But if you dont see any change, you may want
to increase the dosage and try for another two weeks.
taking B vitamins 800 mg of folic acid and 1,000 mg of B12 a day along with
SAM-e, because these vitamins are known to help your body utilize SAM-e.
doctor about any side effects you experience. He may advise you to stop taking SAM-e or
lower your dosage. Side effects are rare, but some people may get a temporary skin
irritation or nausea. Nausea may be eased by taking SAM-e with meals.
up your regular routine of exercise, and maintain a healthy weight to ease pressure on
Return to Top
on SAM-e by Stacey Booth 11-16-1999
When news of a supplement comes along that promises to lift depression, ease joint pain,
reverse toxicity in the kidneys and, last but not least, bring relief from Fibromyalgia, a
likely response may be made up of equal parts hope and skepticism. Yet, is this "too
good to be true" attitude of today's consumer necessary? The product with all this
promise is SAM-e (pronounce it "sammy"), and it's causing even the skeptics to
give it serious attention.
prescription drug or an herb, SAM-e (S-adenosylmethionine) is a synthetic replication of a
compound that the body makes naturally from methionine, an amino acid found in
protein-rich foods. Used in Europe for over twenty years, SAM-e is just beginning to make
national headlines in publications like Newsweek magazine and the Los Angeles Times and in
books and on major television networks.
to understanding the way SAM-e works is by recognizing its role in a process called
methylation. Methylation happens a billion times a second throughout the body and is
responsible for, among other things, the regulation of brain function, preserving bone
health and protecting against heart disease. It helps regulate various hormones and
neurotransmitters including serotonin, melatonin, dopamine and adrenaline. During the
methylation process a molecule in the body "gives up" a methyl group comprised
of four atoms to another molecule, changing both the original molecule and the recipient
of the methyl group in the process. "It [SAM-e] is involved in almost
everything," says Teodoro Bottiglieri, Ph.D. and co-author of the book, "Stop
Depression Now," which discusses his extensive use of SAM-e to treat a number of
it ease depression?
are a few theories. One may be SAM-e's regulation of serotonin and dopamine, which are
mood-lifting neurotransmitters. This hypothesis was confirmed in one study where SAM-e was
shown to cross the blood-brain barrier. This research further found that the cerebrospinal
fluid levels of SAM-e were significantly lower in patients with severe depression, as
compared to the control group. Researchers concluded that SAM-e has antidepressant
there is little, if any, debate over SAM-e's depression-easing abilities. In fact, SAM-e's
ability to lift mood is comparable to that of standard antidepressants, yet without the
possible side-effects of headache, stomach upset and sexual dysfunction that prescription
drugs often bring.3 Richard Brown, who authored "Stop Depression Now" with
Teodoto Bottiglieri and has treated several hundred patients with SAM-e, calls it,
"...the best antidepressant I've ever prescribed. I've seen only benefits." 4
SAM-e Stop Pain?
was first given to patients for use in treating depression, but when some of those same
patients began to report relief from osteoarthritis joint pain, researchers began to study
this second benefit of the product. Over 22,000 arthritis sufferers reported, after only
four weeks of treatment, that SAM-e gave comparable results to NSAID pain relievers like
ibuprofen.3 The vital distinction is that instead of causing stomach upset like NSAIDs
often do, SAM-e may actually protect the stomach lining. Furthermore, animal studies show
that SAM-e could help restore damaged cartilage in addition to relieving pain.1 This
happens when B-vitamins convert homocysteine into the antioxidant glutathione. This
glutathione conversion yields molecules called sulfate groups that actually help to
restore cartilage. Proof positive: the Arthritis Foundation recently stated that they were
satisfied that SAM-e provides pain relief.
Brown and Bottiglieri dedicate an entire chapter on SAM-e's positive effects on
Fibromyalgia in their book, "Stop Depression Now." They state that depression
and soreness, of all of FM's symptoms, are the most stubborn. They are careful to point
out that the depression that is common among FM's sufferers is not a symptom of the
disease, but often a by-product of living with chronic illness. They support the benefit
of SAM-e's non-prescription effects: "...fibromyalgia patients get the best of all
worlds--relief from depression and muscle soreness without the side-effects or possible
adverse interactions with other medications." 1
not alone in their findings. In a study of 47 FM patients treated daily with 200mg of
SAM-e intramuscularly and 400mg orally, patients reported significant reduction in tender
points, significant improvement in well-being, and significant reduction in the mean
scores of the Hamilton Rating Scale for Depression, the Zung SelRating Scale, the Hamilton
Rating Scale for Anxiety, and the Lorish and Maisiak's Face Scale. All reported that SAM-e
was well-tolerated, with no adverse side effects.5
another study of 30 patients with FM, Sjogren's Syndrome, or both, the patients were
treated with 200mg of SAM-e daily through intramuscular injection. At the end of the four
week study, the patients with Sjogren's Syndrome and FM reported a significant reduction
in painful areas and tender points. The patients with only Sjogren's Syndrome reported a
significant reduction on the Hamilton Rating Scale for Depression. Finally, the patients
with FM finished the trial with significant reductions in symptoms of FM, numbers of
tender point areas and painful areas, pain severity scores and depression scales.6
SAM-e Should I Take and How Much?
SAM-e is created equal and those who wish to make SAM-e a part of their supplementation
program should look for two distinctive qualities before purchasing: type and coating.
First, full-strength SAM-e is in a form called butanedisulfonate, which should not be
confused with tosylate or SAM-e sulfate. Second, look for SAM-e tablets that are enteric
coated, meaning that the tablets pass through the acidic environment of the stomach
intact, and can be absorbed most efficiently by the body. Lastly, the amounts used in
various SAM-e studies vary widely, leaving the consumer confused about effective dosage.
The starting dose is 400mg of SAM-e daily on an empty stomach.1
There Are Precautions or Warnings About Taking SAM-e?
those who have jumped on the SAM-e bandwagon are clear to point out that it is not a
"cure" for severe depression and advise consumers to consult with their
physician before taking SAM-e (good advice for anyone beginning a new supplementation
at least one group of people who should avoid SAM-e: those with bi-polar disorder.
Commonly called manic depression, these individuals should be aware that SAM-e may induce
mania in those with the disorder.
the mass availability of SAM-e earlier this year, the buzz has been strong and the
research to support it very promising, if not yet iron-clad. As stated above, it's a good
idea to consult your physician when beginning any new supplementation program. However, it
does appear that for those wishing to lift their mood, soothe painful joints and muscles,
and lighten the load of FM's many symptoms, SAM-e is a safe complimentary treatment,
nearly without side-effect.
1. Brown, Richard, M.D., Bottigileri, Teodoro, Ph.D., Colman, Carol. Stop Depression Now.
New York, 1999. 2. J Neurol Neurosurg Psychiatry (England) Dec. 1990, 53 (12) p1096-8.
"Cerebrospinal Fluid S-andenosylmethionine in Depression and Dementia: Effects of
Treatment with Parenteral and Oral S-andenosylmethionine." 3. Cowley, Geoffrey and
Underwood, Anne. "What is SAM-e?" Newsweek, July 5, 1999. 4. Curr. Ther. Res.
Clin. Exp. (USA), 1994, 55/7 (797-806). "Primary Fibromyalgia is Responsive to
S-adenosylmethionine." 5. Curr. Ther. Res. Clin. Exp. (USA), 1994, 55/6 (699-706).
"S-adenosylmethionine in Sjogren's Syndrome and Fibromyalgia."
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short for S-adenosylmethionine, an essential molecule naturally occurring in the cells of
plants and animals. SAM-e is not an herb. As we age, our bodies produce less SAM-e, so
some think that SAM-e may be a helpful supplement when used to treat depressive symptoms.
It has been available in European countries through prescription.
SAM-e used for?
has been getting attention in recent years in the United States for the treatment of
depression or to preserve emotional well-being, as well as for other conditions.
studies indicate that SAM-e may be effective in helping with depressive symptoms; however,
studies are ongoing, and no clinical trials have proven SAM-e safe or effective in the
treatment of depression.
present, the safety of SAM-e has not been proven. The U.S. Food and Drug Administration
(FDA) does not approve or regulate the distribution of supplements in the United States.
Not all formulations of SAM-e are the same. Some brands are more potent than others,
depending upon the quality of the ingredients used.
can have numerous adverse side effects, including:
issue in deciding whether to use SAM-e is cost. The recommended oral dose is 200 to 800 mg
twice per day. Most studies used 1,600 mg per day to get any positive effects in relieving
depressive symptoms. A 1-month supply of SAM-e at 1,600 mg per day would cost about $228.
Other herbal treatments are more cost-effective.
doctor about any evidence on the safety and effectiveness of SAM-e. Clinical trials are
ongoing. Since there is no current evidence that SAM-e is helpful in the treatment of
depression, you may want to delay trying it.
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SAM-e by Leslie Knowlton and GT Staff
than eight years, Richard P. Brown, M.D., associate professor of clinical psychiatry at
Columbia University College of Physicians and Surgeons, has used the natural dietary
supplement S-adenosylmethionine (SAM-e) to treat an estimated 400 patients suffering from
depression, many of whom were previously treatment-resistant.
also has co-authored the book Stop Depression Now: SAM-e, the Breakthrough Supplement that
Works as Well as Prescription Drugs in Half the Time... With No Side Effects. His primary
collaborator was Teodoro Bottiglieri, Ph.D., director of neuropharmacology and senior
research scientist at Baylor University's Institute for Metabolic Disease. Bottiglieri,
also associate professor of biomedical studies at Baylor, has been conducting research on
SAM-e for 15 years.
interview with Geriatric Times, Brown reviewed research on, and his clinical experience
with, SAM-e. Although SAM-e has only been on the U.S. market since 1999, it has been
studied for decades internationally and is approved as a prescription drug in Spain,
Italy, Russia and Germany. More than 1 million Europeans have used it, primarily for
depression and arthritis.
first heard about SAM-e 20 years ago when I was doing my residency in psychiatry at New
York Hospital, Cornell Medical Center," Brown recalled. "At a meeting of the
American College of Neuropsychopharmacology, a colleague had learned about an exciting new
antidepressant being studied in Europe that was nontoxic, without side effects, and worked
better and faster than traditional medications."
years later, after Brown had developed a subspecialty practice treating patients resistant
to conventional drug therapy by integrating alternative approaches such as nutrients and
herbs with prescription medications, a patient brought him information about SAM-e from
to Brown, SAM-e was discovered in Italy about four decades ago (Cantoni, 1952). Since
then, SAM-e "has been evaluated for various disorders in more than 75 clinical trials
involving over 23,000 people," Brown added. However, the first clinical study of its
use for depression was not completed until the 1970s (Agnoli et al., 1976).
explained that SAM-e is produced in the body from methionine, a sulfur-containing amino
acid, and the energy-producing compound adenosine triphosphate. SAM-e is a physiologically
essential compound, he said, adding that some chemists believe it ranks with adenosine
triphosphase (ATP) as a pivotal molecule in living cells. Distributed throughout the body,
SAM-e is most concentrated in the brain and liver and is crucial to three central pathways
of metabolism that stimulate more than 35 different reactions.
three major pathways are transmethylation, transulfuration and
transaminopropylation," he said. "Animal studies show that the transmethylation
pathway boosts levels of the neurotransmitters serotonin, dopamine and norepinephrine.
This process probably contributes to the antidepressant action" (Andreoli et al.,
1978; Curcio et al., 1978; Czyrak et al., 1992; Fava et al., 1990; Losada and Rubio, 1989;
Otero-Losada and Rubio, 1989).
said that donation of carbon groups by SAM-e protects catecholamine neurons and that SAM-e
improves nerve cell membrane uptake of phospholipids, enabling the coupling of protein
receptors to second messengers within a more fluid lipid bi-layer and enhancing
transmission of impulses by neurons.
is vital to the production of our most important antioxidant glutathione, as well as the
secondary antioxidants cysteine and taurine," he noted. "The American diet
yields insufficient quantities of SAM-e either for wellness or treatment of illness.
Moreover, the form of SAM-e found in food is not stable. It oxidizes too rapidly to absorb
well. Our bodies can only generate a small amount of SAM-e...Therefore, SAM-e levels are
most easily increased through dietary supplementation."
to Brown, lower than normal levels of SAM-e are found in cerebrospinal fluid in some
patients with depression, Alzheimer's disease, dementia, Parkinson's disease treated with
levodopa (Atamet, Sinemet), disorders of folate metabolism and other illnesses
(Bottiglieri et al., 1994, 1990).
a study indicating that folate, B12 and B6 are necessary for efficient use of SAM-e
(Crellin et al., 1993) and reported that SAM-e has been effective for treating major
depressive disorder in 13 trials comparing it to placebo and 19 trials comparing it to
tricyclic antidepressants (TCAs), with more than 1,400 patients studied.
1973 to 1988, 14 double-blind, European studies [Janicak et al., 1988] showed that
intravenous and intramuscular preparations of SAM-e were more effective than placebo and
comparable to imipramine [Tofranil], amitriptyline [Elavil, Endep] and clomipramine
[Anafranil] for treatment of major depression," Brown said.
American psychopharmacologists Bell and colleagues conducted a double-blind, randomized,
two-week trial comparing intravenous SAM-e to oral imipramine. By the end of week 2, 66%
of the patients treated with SAM-e "had a clinically significant improvement in
depressive symptoms, compared to 22% of the imipramine patients," the study authors
1988, double- and single-blind studies using higher doses of SAM-e have shown it to be
effective in treating major depression (Bressa, 1994; Delle Chiaie and Boissard, 1997;
Delle Chiaie et al., 2000), depression secondary to medical illness (Criconia et al.,
1994), postmenopausal depression (Salmaggi et al., 1993) and treatment-resistant
depression (Rosenbaum et al., 1990), Brown reported.
response to SAM-e was shown in a double-blind trial of 30 depressed inpatients who
received either 1600 mg/day of oral SAM-e or imipramine (averaging 140 mg/day) for six
weeks," Brown added. "The SAM-e group was significantly better by day 10. Both
groups were comparably improved by week 6" (De Vanna and Rigamonti, 1992).
Brown reported that in a small, double-blind, four-week inpatient study of oral SAM-e
(1600 mg/day) versus 250 mg/day of desipramine (Norpramin), improvement in depression in
those who responded to either SAM-e or desipramine correlated with their SAM-e blood
levels (Bell et al., 1994).
findings highlight the need for larger and longer-term studies to elucidate the role of
SAM-e in recovery from depression and the use of SAM-e in combination with prescription
antidepressants," he said. He added that the longest controlled-trial studies of
SAM-e efficacy for depression were 42 days (Delle Chiaie et al., 2000; De Vanna and
Rigamonti, 1992; Fava et al., 1992).
said he has also found SAM-e effective for fibromyalgia (Jacobsen et al., 1991; Tavoni et
al, 1998, 1987, as cited in Brown et al., 2000), depression in Parkinson's disease, the
aging brain, liver diseases (Friedel et al., 1989) and arthritis (Bradley et al., 1994, as
cited in Brown et al., 2000; Konig, 1987). It also seems to reverse some effects of
alcoholic hepatitis and cirrhosis (Mato et al., 1999) and is used to dissolve gallstones.
noted that American companies only sell SAM-e in 50 mg, 100 mg and 200 mg tablets. He
recommended a daily dose of 400 mg for mild depression.
in mind that absorption is better on an empty stomach," he said. "Starting
patients with 200 mg 30 minutes before breakfast and 30 minutes before lunch minimizes the
overstimulation and insomnia which some patients report in the first few weeks [Berger and
Nowak, 1987]. This can be switched to 400 mg before breakfast after a few weeks."
Patients typically notice improvement in energy within two weeks.
continued, "As with most medications, clinical sense indicates starting with lower
doses in geriatric, medically ill and anxious patients. SAM-e, like all antidepressants,
should be used with some caution in patients with a history of cardiac arrhythmia."
for severe depression, Brown said, generally requires higher doses. "Some studies
have started unipolar patients on 800 mg or 1600 mg per day," he said. Side effects
occurring at the higher doses include mild jitteriness, loose bowels and headaches.
date, SAM-e has not been systematically studied in well-defined samples of psychotic
noted that SAM-e is generally available in two forms: a butanedisulfonate form and a
my practice, the butanedisulfonate seems superior, particularly the enteric-coated
form," he said, adding that good brands currently available in this country include
Nature Made and GNC. "If a patient hasn't responded to an appropriate dose of SAM-e,
the physician must be sure that the patient is using a potent brand.
about 3% to 5% of patients discontinue SAM-e because of side effects, primarily
gastrointestinal," Brown said. "That is a relatively low rate compared to
placebo discontinuation rates. In study after study, the investigators said there was no
difference from placebo in the side effect rate."
biggest study of SAM-e, Brown said, was a two-year postmarketing study of 20,641 patients
conducted in Germany after SAM-e was approved for treatment of osteoarthritis (Berger and
investigators found that 80% of patients said they basically felt great on it and had no
side effects, [while the other] 20% complained of mild side effects in the first month on
high doses like 1200 mg/day to 1600 mg/day," Brown said.
starting doses of 400 mg/day to 600 mg/day for mild depression, Brown said, there are no
significant side effects. At higher doses, there are some "mild, temporary side
of drug interactions have been nearly nonexistent, according to Brown. He mentioned a case
report of an elderly woman who was given clomipramine together with SAM-e. The patient
exhibited symptoms of what the clinicians diagnosed as serotonin syndrome (Iruela et al.,
1993). The investigators attributed the side effects to a "toxic interaction produced
by S-adenosylmethionine and clomipramine association."
had some misgivings about the case report, however, explaining, "If you look at the
world's literature of serotonin syndrome, the preponderance of cases are from
have been no reports of SAM-e effects on cytochrome P450 metabolism or on the binding of
prescription drugs to serum proteins (Brown et al., 2000).
studies (Bell et al., 1994; Criconia et al., 1994; De Vanna and Rigamonti, 1992; Kagan et
al., 1990) and his own clinical experience, Brown said, demonstrate that some patients
have a dramatic response to SAM-e even after failing on prescription antidepressants.
said he has treated more than 30 patients with treatment-resistant depression who
responded well to SAM-e augmentation of all categories of antidepressants without adverse
reactions, and noted a review of four studies suggesting that SAM-e boosted and hastened
response to TCAs, mianserin and fenoterol, a ß-agonist (Friedel et al., 1989). He also
cited a randomized, double-blind study (Berlanga et al., 1992) of 40 outpatients with
moderate to severe major depression that confirmed his own clinical experience of using
SAM-e to augment imipramine.
said accumulated evidence indicates that SAM-e in higher doses is perhaps as effective for
major depression as TCAs.
starts to work in approximately half the time needed for tricyclics. Studies show very few
side effects, and SAM-e does not cause the sexual dysfunction or weight gain associated
with other medications," he said.
expressed concern about the need for most depressed patients to take antidepressants for
long periods of time.
medicine hasn't yet tackled the issue of long-term effects of prescription drugs," he
said. "We hope they are insignificant, but there are no studies to assure us that
these drugs are safe in the long-term. Part of our confidence derives from the clinical
experience of prescribing tricyclics for over 35 years. Our experience with fluoxetine
[Prozac] is only 12 years and with other SSRIs is even less."
said that considering SAM-e's efficacy in treating depression, its mild side-effect
profile, and its ability to boost antioxidants and protect DNA through methylation, this
nutrient has advantages over prescription antidepressants.
research is needed to clarify SAM-e's role as a possible first-line treatment for
affective disorders," Brown said.
have been about eight controlled studies comparing SAM-e in the oral version in decent
doses from 1989 through 1997, Brown said, adding that a published review article describes
the details of those studies (Brown et al., 2000).
everybody wants right now is a study comparing SAM-e to an SSRI," he said.
"There are five studies showing that SAM-e boosts regular antidepressants [e.g.,
TCAs] in both their efficacy and speed of onset of therapeutic efficacy (Berlanga et al.,
1992; Friedel et al., 1989; Torta et al., 1988). And we need more controlled studies
showing that SAM-e can be a booster for other antidepressants
Those studies will
probably get going in the United States within the next year or two."
that there is a planned study comparing the combination of SAM-e and an SSRI to an SSRI
alone, but it has not yet been funded.
the future, perhaps SAM-e will become available...as a prescription drug approved by the
[U.S. Food and Drug Administration]," Brown said. "In the meantime, physicians
should be knowledgeable about SAM-e in order to advise patients on its appropriate use as
a complementary treatment or as an alternative to traditional pharmacotherapy."
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Benefits Depression, Osteoarthritis, Liver Disease Laurie Barclay, MD
2002 The U.S. Agency for Healthcare Research and Quality (AHRQ), a division of the
Department of Health and Human Services, has assembled the evidence available on
s-Adenosyl-L-Methionine (SAMe) and has shown actual benefit for the treatment of
depression, osteoarthritis, and liver disease.
[AHRQ] report indicates that that this is a compound worthy of further
investigation," Maurizio Fava, MD, director of the depression clinic and research
program at Massachusetts General Hospital in Boston, tells Medscape. "True, these are
very small studies, but they consistently suggest the efficacy of this compound in
treating depression, SAMe is more effective than placebo and as effective as standard
antidepressants, with fewer adverse effects. Compared with nonsteroidal anti-inflammatory
drugs (NSAIDs), SAMe also relieves the pain of osteoarthritis, but with fewer
gastrointestinal adverse effects. It also reduces cholestasis secondary to use of oral
contraceptives or estrogen, pregnancy, or birth defects, for which there is currently no
other effective treatment.
report reviewed the literature on the use of SAMe in these conditions and identified 294
meta-analyses, clinical trials, and reports, of which 99 articles referencing 102 studies
met the screening criteria. Of these 102 studies, most of which enrolled small numbers of
patients, 47 focused on depression, 14 focused on osteoarthritis, and 41 focused on liver
meta-analysis of 28 studies, treatment with SAMe was associated with an improvement,
compared with placebo, of approximately 6 points on the Hamilton Rating Scale for
Depression score measured at three weeks (95% confidence interval [CI], 2.2 to 9.0).
Compared with conventional antidepressants, treatment with SAMe was not associated with a
statistically significant difference in outcomes.
never had a large double-blind study [of SAMe in depression] in the U.S.," Fava says.
It's time for researchers to look at this more closely."
unique studies considered, 10 studies were included in a meta-analysis of the efficacy of
SAMe to decrease the pain of osteoarthritis. In one large randomized clinical trial, SAMe
reduced the pain of osteoarthritis by 20% (95% CI, -0.39 to - 0.02) compared with placebo,
which was not significantly different from results with NSAIDs.
meta-analysis of eight studies of the efficacy of SAMe to relieve pruritus and decrease
elevated serum bilirubin levels associated with cholestasis of pregnancy, treatment with
SAMe was associated with an effect size compared with placebo of nearly a full standard
deviation (-0.95; 95% CI, -1.45 to -0.45) for decrease in pruritus and of over one and
one-third standard deviations (-1.32; 95% CI, -1.76 to -0.88) for decrease in serum
clinical trials which were not pooled favored ursodeoxycholic acid over SAMe for the
treatment of pruritus. In a meta-analysis of six studies of the efficacy of SAMe to
relieve pruritus and decrease elevated bilirubin levels associated with intrahepatic
cholestasis, treatment with SAMe for pruritus was more than twice as likely to reduce
pruritus as was placebo (risk ratio 0.45; 95% CI, 0.37 to 0.58).
need exists for additional review studies, studies elucidating the pharmacology of SAMe,
and clinical trials," the authors write. "A better understanding of the risk
benefit ratio of SAMe compared to conventional therapy, especially for depression and
osteoarthritis, is very important. To that end, additional analysis of existing data could
be done, but it would likely be more productive to support new definitive clinical studies
to address this issue." Sept. 30, 2002
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