Ephedra (medicine)
Ephedra is a medicinal preparation from the plant
Biochemistry and effects
A wide variety of
Ephedra is widely used by athletes as a
Ephedra has been used as a weight-loss aid, sometimes in combination with aspirin and caffeine. Some studies in regulated and supervised environments have shown that ephedra is effective for marginal short-term weight loss (0.9 kg/month more than the placebo), although it was untested whether such weight loss is maintained.[17] However, several reports have documented a number of adverse events attributable to unregulated ephedra supplements.[18]
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.[20][21][22] 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.[23][24]
Regulation in the United States
Escalating concerns regarding the safety of ephedra supplements led the FDA to ban the sale of supplements containing ephedrine alkaloids (specifically ephedrine, pseudoephedrine, norephedrine, and methylephedrine) in the United States in 2004. This ban was challenged by supplement manufacturers and initially overturned, but ultimately upheld.
Initial concerns and 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, and death.[25]
In response, the
Metabolife, makers of the best-selling brand of ephedra supplement, had received over 14,000 complaints of adverse events associated with its product. These reports were not initially provided to the FDA.[26][27] Co-founder of Metabolife, Michael Ellis, was sentenced in 2008 to six months in federal prison for his failure to report adverse effects from his company's products to the FDA.[28] Senators Orrin Hatch (R. Utah) and Tom Harkin (D. Iowa), 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, Senator Hatch's son was working for a firm hired to lobby Congress and the FDA on behalf of ephedra manufacturers.[29]
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.
In 2000, the FDA withdrew the proposed labeling changes and restrictions.[32]
Additional evidence and deaths
A review of ephedra-related adverse reactions, published in the
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.[35] 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 [after Bechler's death] Congress dropped objections to an ephedra ban and started demanding that the FDA act."[26]
Senator Orrin Hatch (R. Utah), who in 1999 had helped block the FDA's attempts to regulate ephedra, said in March 2003 that "...it has been obvious to even the most casual observer that problems exist", and called FDA action to regulate ephedra "long overdue."[29]
Ephedrine supplement ban
In response to renewed calls for the regulation of ephedra, the
On December 30, 2003, the FDA issued a
Legal challenges
Nutraceutical Corporation, a supplement manufacturer based in
The ruling was appealed to the
Use in sports
Ephedrine is listed as a
Prominent cases
In the 1994
Connections to Soma rituals
History of Soma
Throughout the many hymns, prayers, and philosophy found in the Vedas (written around 1500 BC), a mysterious plant is mentioned often and with great reverence. This plant alternates from a holy substance to an actual personified god and is considered a teacher, doctor, medicine, a bringer of insight and a vector of inspiration.[43] The deity version of Soma was associated with medicinal herbs and the moon and was considered a bringer of health and prosperity.[44] The plant was an essential aspect of Vedic religion to alter one’s mind, enabling communion with the divine. The ritual drinking of Soma was also found in the ancient Zoroastrian text, the Avesta.[43] The rituals and importance of the plant were very similar to those in Vedic culture but were instead called by the name haoma.[43] It is unknown why, but eventually in both the Vedic and Zoroastrian cultures a substitute substance was used in these religious ceremonies and over time the definitive identity of Soma-Haoma has been lost.[citation needed] There is much debate over which species of plant are the sacred plant of the Vedic and Zoroastrian faiths.
Ritual use of Ephedra
The Rigveda is one of the four oldest and most sacred collections of stories in Hinduism. In the Rigveda soma is a drink consumed by two of the main gods; Agni and Indra. In the texts the drink helped the gods in battle by strengthening them physically.[45] Because of this, soma was given and consumed by warriors before wartime or a battle. The drink was supposed to give the warriors strength and luck in the upcoming conflict.[46] Immortality is also a quality associated with soma due to it being a drink of the divine. At religious ceremonies the drink was consumed to give consumers longevity in life. At birth the drink was also given to the babies for these same reasons.[46]
In Zoroastrianism the drink is called haoma and has similar uses. Just like in Hinduism, the drink was related to immortality and long life. Haoma was the first thing newborns drank. This assured the child would be healthy and live a long life.[46] The drink was also administered to people close to death to resurrect them back into good health.[46]
The physical appearance of Ephedra is also a reason it is believed to be the soma plant. According to the Vedic text Rigveda, the plant composing soma is shaped like an arrow. Ephedra sinica is a gymnosperm that forms stalks with buds on the end. It is easy to see how this shape could be described like an arrow.[46] Another text refers to soma as a twig, which is much like Ephedra sinica when it is dried out.[43]
See also
- Chinese medicine
- Sida cordifolia
- Pinellia
- Synephrine
References
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- ^ "National Center for Complementary and Alternative Medicine Consumer Advisory on ephedra". 2004-10-01. Retrieved 2007-02-13.[permanent dead link]
- ^ a b "Food and Drug Administration summary of actions regarding sale of ephedra supplements". Food and Drug Administration. Archived from the original on 2007-02-10. Retrieved 2007-02-13.
- ^ U.S. Food and Drug Administration. Retrieved 7 February 2007.
- ^ U.S. Food and Drug Administration.
- ^ a b c "Is Ephedra legal? Consumer Reports Investigates". www.consumerreports.org. Retrieved 2015-11-23.
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- ^ a b "Swallowing Ephedra" Archived 2007-10-12 at the Wayback Machine, by Sharon Brownlee. Published online at Salon.com on June 7, 2000. Accessed 8 February 2007.
- ^ Dietary Supplements: Background Information Archived 2008-09-16 at the Wayback Machine. From the Office of Dietary Supplements at the National Institutes of Health. Accessed 7 February 2007.
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- ^ "Dietary Supplements Containing Ephedrine Alkaloids; Proposed Rule" Archived 2007-02-14 at the Wayback Machine, from the Federal Register, June 4, 1997. Accessed 7 February 2007.
- ^ a b c d "Dangerous supplements: Still at large", from Consumer Reports magazine. Published May 2004, accessed 7 February 2007.
- ^ Criminal investigation sought for diet supplement seller, published in USA Today on August 15, 2002. Accessed April 10, 2007.
- ^ Metabolife Founder Sentenced For Lying To FDA
- ^ a b "Senator, His Son Get Boosts From Makers of Ephedra" Archived 2013-03-01 at the Wayback Machine, published in the Los Angeles Times on March 5, 2003. Purchase required to view full text. Accessed 7 February 2007.
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- ^ "Dietary Supplements Containing Ephedrine Alkaloids; Withdrawal in Part" Archived 2007-02-03 at the Wayback Machine, from the Federal Register, April 3, 2000. Accessed 7 February 2007.
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- ^ a b Vikings: Stringer's use of ephedra contributed to death, published online by Sports Illustrated on February 25, 2003. Accessed March 15, 2007.
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- ^ "FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra": Press release from the FDA website, issued December 30, 2003, accessed 7 February 2007.
- ^ a b "Judge's Decision Lifts Ban On Sale of Ephedra in Utah", from The New York Times, published April 15, 2005. Accessed 7 February 2007.
- MiB) Accessed March 15, 2007.
- ^ Denver Poston July 6, 2006. Accessed March 15, 2007.
- ^ "Maradona's fall from grace", by John May. From the BBC, published April 19, 2004. Accessed March 15, 2007.
- ^ "Haga Saga" Archived 2007-09-26 at the Wayback Machine, by Dirck Edge. From motorcycledaily.com, May 24, 2000. Accessed March 15, 2007.
- ^ a b c d Houben, Jan. “The Soma-Haoma problem : Introductory overview and observations on the discussion.” Electronic Journal of Vedic Studies, 2003.
- ^ Cartwright, Mark. "Soma." Ancient History Encyclopedia. Ancient History Encyclopedia, 30 Jan 2016. Web. 17 Apr 2020.
- ^ Shah, N.C. “Soma, an Enigmatic, Mysterious Plant of the Vedic Aryas: An Appraisal” Indian Journal of History of Science, vol. 50.1, (2015): 26-4
- ^ a b c d e Mahdihassan, S. “Ephedra, the oldest medicinal plant with the history of an uninterrupted use.” Ancient science of life vol. 7,2 (1987): 105-9.
External links
- United States FDA links to actions
- United States NIH Factsheet regarding weight loss and athletic performance
- Dietary Supplements: Balancing Consumer Choice and Safety. A report of the New York State Task Force on Life & the Law.
- The history of Ephedra (ma-huang).