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On December 30, 2003, the US Food and Drug Administration (FDA) issued a consumer alertregarding the safety of dietary supplements containing ephedra. The FDA determined that consuming these supplements poses an unnecessary risk of illness or injury, and that consumers should stop buying and using ephedra products immediately. The FDA also notified manufacturers and marketers of these dietary supplements that effective 60 days (March 2004) after the publication of its final ruling, the sale of all products containing ephedra in the United States would be banned. This ruling was temporarily overturned in April of 2005, but was later upheld the following year, making it illegal to sell these products.
The Chinese herb ma huang is a member of a primitive family of plants that look like thin, branching, connected straws. A related species, Ephedra nevadensis, grows wild in the American Southwest and is widely called Mormon tea. However, only the Asian species of ephedra contains the active compounds ephedrine and pseudoephedrine.
Ma huang was traditionally used by Chinese herbalists during the early stages of respiratory infections and also for the short-term treatment of certain kinds of asthma, eczema, hay fever, narcolepsy, and edema.
Japanese chemists isolated ephedrine from ma huang at the turn of the century, and it soon became a primary treatment for asthma in the United States and abroad. Ephedra's other major ingredient, pseudoephedrine, became the decongestant Sudafed.
What Is the Scientific Evidence for Ephedra?
Evidence suggests that ephedrine/caffeine combinations can aid weight loss and help keep the weight off for up to 6 months. However, the benefits are modest.
For example, in a double-blind, placebo-controlled trial, 180 overweight individuals were placed on a weight-loss diet and given either ephedrine/caffeine (20 mg/200 mg), ephedrine alone (20 mg), caffeine alone (200 mg), or placebo, 3 times daily for 24 weeks. 1 The results showed that the ephedrine/caffeine treatment significantly enhanced weight loss, resulting in a loss of more than 36 pounds as compared to only 29 pounds in the placebo group, a 7-pound difference. Neither ephedrine nor caffeine alone produced any benefit. Contrary to some reports, participants did not develop tolerance to the treatment. For the whole 6 months of the trial, the treatment group maintained the same relative weight-loss advantage over the placebo group.
A few side effects were seen in this study, primarily insomnia, dizziness, and tremor, but they tended to fade away after a few weeks. Keep in mind that participants were screened prior to the study and were eliminated if they had high blood pressure or any other serious disease, or if they used medications or illegal drugs that might interact with stimulants.
Another study compared ephedrine/caffeine with the no-longer-available drug dexfenfluramine (Redux), related to fenfluramine of fen-phen fame. 2 A total of 103 overweight individuals were enrolled in this 15-week, double-blind trial. All were placed on a weight-loss diet. Half were given ephedrine/caffeine at the usual dose, while the others were given 15 mg of dexfenfluramine. The results showed comparable weight loss in both groups.
Finally, a double-blind, placebo-controlled trial enrolled 225 heavy smokers who wanted to quit but were afraid of gaining weight. 3 At 12 weeks after quitting smoking, individuals taking ephedrine and caffeine had gained significantly less weight. At that point, the dosage was gradually reduced, and the difference between the groups declined. (Contrary to the hopes of the experimenters, ephedrine/caffeine use did not help individuals quit smoking.)
Benefits have also been seen in smaller studies using herbal sources of ephedrine. 4 We don't know exactly how ephedrine/caffeine works. However, caffeine has actions that cause fat breakdown and enhance metabolism. 5 Ephedrine suppresses appetite and increases energy expenditure. The combination appears to produce synergistic effects, with appetite suppression probably the most important overall factor.
The dosage of ephedra should be adjusted according to the amount of the ephedrine it provides. For adults, no more than 25 mg should be taken at one time, and a total daily intake of 100 mg should not be exceeded. 6 However, a survey of ephedra-containing dietary supplements found that ephedrine content as listed on the label was frequently incorrect. 7 In addition, other chemicals were often present that could increase safety risks (see Safety Issues). For this reason, we do not recommend using herbal ephedra at all.
- Astrup A, Breum L, Toubro S, et al. The effect and safety of an ephedrine/caffeine compound compared to ephedrine, caffeine and placebo in obese subjects on an energy restricted diet. A double-blind trial. Int J Obes Relat Metab Disord. 1992;16:269-277.
- Breum L, Pedersen JK, Ahlstrøm F, Frimodt-Møller J. Comparison of an ephedrine/caffeine combination and dexfenfluramine in the treatment of obesity. A double-blind multi-centre trial in general practice. Int J Obes Relat Metab Disord. 18(2):99-103.
- Nørregaard J, Jørgensen S, Mikkelsen KL, Tønnesen P, Iversen E, Sørensen T, Søeberg B, Jakobsen HB. The effect of ephedrine plus caffeine on smoking cessation and postcessation weight gain. Clin Pharmacol Ther. 60(6):679-86.
- Boozer CN, Nasser JA, Heymsfield SB, Wang V, Chen G, Solomon JL. An herbal supplement containing Ma Huang-Guarana for weight loss: a randomized, double-blind trial. Int J Obes Relat Metab Disord. 25(3):316-24.
- Astrup A, Breum L, Toubro S. Pharmacological and clinical studies of ephedrine and other thermogenic agonists. Obes Res. 3 Suppl 4():537S-540S.
- MedscapeWire. No association between reported adverse events and ephedra when consumed as directed. Available at: http://www.medscape.com/MedscapeWire/2000/0800/medwire.0816.Nol. Accessed August 16, 2000.
- Gurley BJ, Gardner SF, Hubbard MA. Content versus label claims in ephedra-containing dietary supplements. Am J Health Syst Pharm. 57(10):963-9.