Ephedra Medical Consequences

What are ephedra alkaloid dietary supplements (EADS)?

EADS are dietary supplements that contain varying amounts and types of ephedra alkaloids. Alkaloids, in general, are chemical substances that contain nitrogen. Alkaloids often possess strong pharmacological activity and their names usually end in "-ine." Caffeine, cocaine, morphine, nicotine, and quinine are familiar alkaloids. Metabolife 356 and many other EADS also contain caffeine, which intensifies the supplements' effects.

There are at least 40 species of evergreen plants that are members of the genus Ephedra. The ephedra plant has a pine-like odor and is also known as the joint fir or joint pine. The dried branchlets of the ephedra plant constitute the Chinese herb ma huang. The ephedra plant contains from 0.5% to 2.5% alkaloids, of which two are clinically important: ephedrine and pseudoephedrine.

How do I know what ingredients are in EADS?

It is difficult to be certain, even when the ingredients are identified on the product's label. Bill J. Gurley and others studied the content of 20 ephedra-containing dietary supplements and found that the alkaloid content often differed markedly from label claims and was inconsistent even between two lots of the same product. "Half of the products exhibited discrepancies between the label claim for ephedra alkaloid content and actual alkaloid content in excess of 20%."

Total alkaloid content ranged from 0.0 to 18.5 mg. per dosage unit, with ephedrine ranging from 1.1 to 15.3 mg. and pseudoephedrine ranging from 0.2 to 9.5 mg. The authors of the study warn: "Until GMPs [Good Manufacturing Practices] are in place, consumers intent on purchasing an ephedra supplement are best advised to heed the adage of caveat emptor -- let the buyer beware."

What does Metabolife 356 contain?

According to the label, Metabolife contains herbs, vitamins, minerals, and formulation ingredients. Its most active ingredients are two stimulants: 40 mg. of caffeine alkaloids in the form of guarana (seed) and 12 mg. of ephedrine alkaloid groups in the form of ma huang extract (aerial part).

What is ephedra used for?

Ephedra was traditionally used for diseases of the respiratory tract, such as asthma since ephedrine acts as a bronchodilator, and as a nasal decongestant though prolonged use can cause reboud congention and chronic rhinitis. Other uses have included hives, urinary incontinence, narcolepsy, myasthenia gravis, painful menstruation, and chronic postural hypotension.

However, "ephedrine is rarely prescribed today for medical purposes, because newer drugs have more specific actions and fewer side effects."

Today, ephedra alkaloids are found in dietary supplements that are promoted and used by approximately 12 million people in the United States to lose weight, boost energy, and enhance athletic performance and endurance.

Is ephedra effective for weight loss?

Most scientists agree that EADS have not been proven effective for long-term weight loss. The summary report for information presented at the August 8-9, 2000 FDA Public Meeting: "Safety of Dietary Supplements containing Ephedrine Alkaloids," indicates that the "efficacy of ephedra or EADS for weight loss or body building specifically is not supported by a large number of high quality, randomized controlled clinical trials.

The few trials and studies reported at the meeting consisted primarily of small groups (fewer han 150) and short durations of use (6-8 weeks); data on long-term weight loss and maintenance are scarce and may be confounded by calorie-restricted diets."

Metabolife has pointed to several animal studies and two human studies to support its claims of safety and effectiveness: one at Vanderbilt University and the other at Columbia University. When contacted by Newsweek in August of 1999, "researchers from both studies said that neither was comprehensive enough to support any conclusions about long-term usage of the product . . . Vanderbilt insisted that its name be removed from Metabolife's promotional materials."

Most importantly, researchers assert that the risks do not outweigh any benefits. After evaluating 140 reports of ephedra-related adverse events, UCSF senior researcher Christine Haller, MD, concluded that "the potential risks of ephedra are not accompanied by any clear benefits."

FDA requested Haller and other scientists from the Division of Clinical Pharmacology and Experimental Therapeutics, Departments of Medicine and Biopharmaceutical Sciences, University of California, San Francisco, and the California Poison Control System, San Franciso Division, to analyze ephedra-related adverse events reported between June 1, 1997 and March 31, 1999. Authored by Haller and Neal Benowitz, MD, the team's analysis was published in the December 21, 2000 issue of the New England Journal of Medicine (NEJM).