Everything about Ephedra totally explained
Ephedra refers to the plant
Ephedra sinica.
E. sinica, known in Chinese as
ma huang (; pinyin: má huáng), has been used in
traditional Chinese medicine for 5,000 years for the treatment of
asthma and
hay fever, as well as for the
common cold. Several additional species belonging to the
genus Ephedra have traditionally been used for a variety of medicinal purposes, and are a possible candidate for the
Soma plant of
Indo-Iranian religion.
Native Americans and
Mormon pioneers drank a tea brewed from an
Ephedra, called
Mormon Tea.
In recent years, the safety of ephedra-containing
dietary supplements has been questioned by the
United States Food and Drug Administration (FDA), the
National Center for Complementary and Alternative Medicine, and the medical community as a result of a high rate of serious side effects and ephedra-related deaths. In response to accumulating evidence of adverse effects and deaths related to ephedra, the FDA banned the sale of ephedra-containing supplements on
April 12 2004. A suit by an ephedra manufacturer was upheld by a
Federal District Court judge in
Utah on
April 14 2005. The FDA appealed this ruling, and on
August 17 2006 the
U.S. Court of Appeals for the Tenth Circuit upheld the FDA's ban of ephedra. As of June 2007, the sale of ephedra-containing dietary supplements remains illegal in the United States due to their health risks.
Ephedra biochemistry
The
alkaloids
ephedrine and
pseudoephedrine are the active constituents of the plant. Pseudoephedrine is used in
over-the-counter decongestants. Derivatives of ephedrine are used to treat
low blood pressure, but alternatives with reduced cardiovascular risk have replaced it for treating
asthma. Ephedrine is also considered a
performance-enhancing drug and is prohibited in most competitive sports. Some species in the
Ephedra genus have no alkaloid content and are therefore essentially inert; however, the most commonly used species,
E. sinica, has a total alkaloid content of 1–3% by dry weight. Ephedrine constitutes 40–90% of the alkaloid content, with the remainder consisting of pseudoephedrine and the demethylated forms of each compound.
Effects and uses
Ephedra is both a
stimulant and a
thermogenic; its biological effects are due to its ephedrine and pseudoephedrine content. These compounds stimulate the brain, increase
heart rate, constrict blood vessels (increasing
blood pressure), and expand bronchial tubes (making breathing easier). Their thermogenic properties cause an increase in metabolism, evidenced by an increase in body heat.
In traditional
Chinese herbology,
E. sinica is included in many herbal formulas that treat cold and flu such as 麻黃湯
ma huang tang (ephedra decoction) or 麻杏石甘湯
ma xing shi gan tang (ephedra, apricot kernel, gypsum, and licorice decoction). Ephedra is used therapeutically as a
diaphoretic to help expel exterior pathogens and regulate the proper functioning of the lungs.
Ephedra is widely used by athletes, despite a lack of evidence that it enhances athletic performance. Ephedra may also be used as a precursor in the illicit manufacture of
methamphetamine.
Ephedra has also been used for weight loss, sometimes in combination with
aspirin and
caffeine. Some studies have shown that ephedra, when taken in a regulated and supervised environment, is effective for marginal short-term weight loss (0.9kg/month more than the placebo), although it's unclear whether such weight loss is maintained. However, several reports have documented the large number of
adverse events attributable to unregulated ephedra supplements.
Side effects of ephedra may include severe skin reactions, irritability, nervousness, dizziness, trembling,
headache,
insomnia, profuse perspiration,
dehydration, itchy scalp and skin, vomiting,
hyperthermia,
irregular heartbeat,
seizures,
heart attack,
stroke, or
death.
Purity and dosage
There are no formal requirements for
standardization or
quality control of dietary supplements in the United States, and the dosage of effective ingredients in supplements may vary widely from brand to brand or batch to batch. Studies of ephedra supplements have found significant discrepancies between the labeled dose and the actual amount of ephedra in the product. Significant variation in ephedrine alkaloid levels, by as much as 10-fold, was seen even from lot to lot within the same brand.
Safety and regulatory actions in the United States
Escalating concerns regarding the safety of ephedra supplements led the FDA to ban the sale of ephedra-containing supplements in the United States in 2004. This ban was challenged by supplement manufacturers and initially overturned, but ultimately upheld.
Initial concerns and supplement industry response
In 1997, in response to mounting concern over serious side effects of ephedra, the FDA proposed a ban on products containing 8 mg or more of ephedrine alkaloids and stricter labeling of low-dose ephedra supplements. The FDA also proposed that ephedra labels be required to disclose the health risks of ephedra, such as
heart attack,
stroke, or death.
In response, the supplement industry created a
public relations group, the Ephedra Education Council, to oppose the changes, and commissioned a scientific review by a private consulting firm, which reported that ephedra was safe. The Ephedra Education Council also attempted to block publication of a study confirming wide discrepancies between the labeled potency of supplements and the actual amount of ephedra in the product. Senators
Orrin Hatch and
Tom Harkin, authors of the Dietary Supplements Health and Education Act, questioned the scientific basis for the FDA's proposed labeling changes and suggested that the number of problems reported were insufficient to warrant regulatory action. At the time, Hatch's son was working for a firm hired to
lobby Congress and the FDA on behalf of ephedra manufacturers.
In addition to the activities of the Ephedra Education Council, Metabolife spent more than $4 million between 1998 and 2000 lobbying against state regulation of ephedra in Texas.
Business Week reported that efforts to regulate ephedra and other potentially harmful supplements had been "beaten down by deep-pocketed industry lobbying."
Ultimately, in 2000, the FDA withdrew the proposed labeling changes and restrictions.
Additional evidence
A review of ephedra-related adverse reactions, published in the
New England Journal of Medicine in 2000, found a number of cases of
sudden cardiac death or severe disability resulting from ephedra use, many of which occurred in young adults using ephedra in the labeled dosages.
Death of Steve Bechler
Steve Bechler, a
pitcher for the
Baltimore Orioles, died of complications from heatstroke following a
spring training workout on
February 17 2003. The
medical examiner found that ephedra toxicity played a "significant role" in Bechler's sudden death. Following Bechler's death, the FDA re-opened its efforts to regulate ephedra use. According to Bruce Silverglade, legal director for the
Center for Science in the Public Interest, "All of a sudden [afterBechler's death] Congress dropped objections to an ephedra ban and started demanding the FDA act."
Ephedra banned
In response to renewed calls for the regulation of ephedra, the FDA commissioned a large
meta-analysis of ephedra's safety and efficacy by the
RAND Corporation. This study found that while ephedra promoted modest short-term weight loss, there was no evidence that it was effective for long-term weight loss or performance enhancement. The use of ephedra in this study was associated with significant gastrointestinal, psychiatric, and
autonomic side effects. Almost simultaneously, a study in
Annals of Internal Medicine found that ephedra was 100 to 700 times more likely to cause a significant adverse reaction than other commonly used supplements such as
kava or
Ginkgo biloba. Subsequently, on
April 12 2004, the FDA issued a final rule banning the sale of ephedra-containing dietary supplements.
Tommy Thompson, the
Secretary of Health and Human Services, stated that "...These products pose unacceptable health risks, and any consumers who are still using them should stop immediately."
The ruling was appealed to the
U.S. Court of Appeals for the Tenth Circuit in
Denver, Colorado. On
August 17 2006, the Appeals Court upheld the FDA's ban of ephedra, finding that the 133,000-page administrative record compiled by the FDA supported the agency's finding that ephedra posed an unreasonable risk to consumers. The U.S.
National Football League banned players from using ephedra as a dietary supplement in 2001 after the death of
Minnesota Vikings offensive tackle Korey Stringer; ephedra was found in Stringer's locker and lawyers for the team contend that it contributed to his death. The substance is also banned by the
National Basketball Association.
Prominent cases of ephedra use
In the 1994
FIFA World Cup, the
Argentine footballer
Diego Armando Maradona tested positive for ephedrine. The
Japanese
motorcycle racer
Noriyuki Haga tested positive for it in 2000, being disqualified from two races and banned from two more as a result. NFL
punter Todd Sauerbrun of the
Denver Broncos was suspended for the first month of the 2006 season after testing positive for ephedra.
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