|
|
|
|
July 6,
2001 |
|
In its June issue, Consumer Reports published a report, "Sports-supplement
dangers," which points out the health risks of using products that contain
the potentially harmful ingredients ephedra, androstendione, and creatine.
These products are widely used to lose weight or gain energy. In response
to some questions subsequently raised by the ephedra industry, Consumer Reports
has issued the following statement:
Products containing ephedra, often used to control weight, may be the most potentially hazardous of the major sports supplements. Many of these supplements combine ephedra with caffeine. The FDA found the combination so dangerous that it banned it from over-the-counter drugs in 1983. While we acknowledge that obesity is a major public health concern, and that many people need to control their weight, we advise against taking ephedra to lose weight or for any other purpose.
In preparing our report, we reviewed a wide range of medical research. Our conclusions are based on studies and analyses published in peer-reviewed journals.
The medical research we reviewed for our article included a study by researchers at the Columbia University College of Physicians and Surgeons, which showed that a small number of people in a small trial lost weight while taking an ephedra-caffeine supplement. The people who received the active ingredients in this placebo-controlled trial had statistically significant increases in heart rate and blood pressure. Seven of the original 35 active treatment subjects dropped out of the trial because of palpitations, chest pain, and/or elevated blood pressure. None of the 32 placebo recipients experienced those side effects nor did any of the placebo dropouts leave because of treatment effects. It is worth noting that anyone with pre-existing heart disease, diabetes, or high blood pressure was ineligible for the study, so those side effects were not exaggerations of baseline problems. The authors of the report raised the question of "whether the risk-benefit ratio should be greater for an over-the-counter treatment that can be purchased by medically unsupervised individuals vs. a medication that is provided for use only under physician supervision." This study was partially funded by Metabolife, a manufacturer of nutritional supplements.
While preparing our report, we
reviewed a study in the New England Journal of Medicine by Christine Haller
and Neal Benowitz, researchers at the University of California in San Francisco.
We also reviewed a letter to the editor that was later sent by Drs. Haller
and Benowitz to the New England Journal of Medicine. The letter makes the
point that "the effects of ephedrine and caffeine - constricting blood
vessels, increasing blood pressure, and releasing catecholamines -- would
be most likely to cause injury in persons with underlying cardiovascular disease…Most
important, these cases illustrate that people with unrecognized cardiovascular
disease are using products that are potentially dangerous to them." This
letter points out that even if the supplement labels warn people with cardiovascular
disease not to take the products, the warnings are useless for those who are
unaware they have this condition. "Until there is a way to identify persons
who are at risk for adverse effects, supplements containing ephedra alkaloids
should be considered unreasonably dangerous," the researchers wrote.
It seems to us that obese people are certainly at risk for both hypertension
and heart disease.
The researchers further note that their original article on the adverse effects
of ephedra was based on case reports and that for total proof of causality
one would need a large-scale case control study similar to the one that led
to the removal of phenylpropanolamine, a stimulant similar to ephedrine, from
over-the-counter products.
We also reviewed a report commissioned
by the Council for Responsible Nutrition, an industry trade group, and prepared
by Cantox Health Sciences International, a private consulting firm that specializes
in supporting industry positions in regulatory proceedings. This report was
not published in a peer-reviewed journal. We disagree with several of its
basic assumptions and do not accept its conclusion.
We are not aware of any studies that look at the addictive potential of ephedra,
although we believe this is certainly an issue worth investigation.
We stand firmly behind our recommendation against taking sports supplements,
especially products containing ephedra. Evidence for sports supplements' effectiveness
is sketchy at best, and concerns about their safety are too numerous. Consumers
who want to increase muscle or energy or to slim down should focus instead
on the basics of fitness and nutrition to reach these goals.
"Sports-supplement dangers" and other related materials, including audio of Consumer Reports experts discussing this issue, can be accessed free at http://www.consumersunion.org/products/products.htm#sports
