Ephedra (Ma huang) Ma huang is an herb that has been used in China for over three thousand years. Ephedra contains ephedrine alkaloids, which are naturally occurring compounds found in plants. Another alkaloid in ma huang, pseudoephedrine, is less potent than ephedrine and is used in common cold remedies. For the last several years, there has been a great deal of debate involving the use of weight loss products that contain ephedra (also known as ma huang). Some in the medical establishment have claimed that ephedra is unsafe; on the other side of the coin are millions of consumers who rely on these products to aid them in weight loss. The only way to understand what is accurate about ephedra regarding its safety and efficacy as a metabolic enhancer which produces weight reduction is to examine all of the scientific evidence available.

Effectiveness of Ephedra in Weight Loss The most important question that needs to be answered is Does ephedra work in reducing weight? There have been hundreds of studies done on ephedra! s weight loss properties since the early 1990 s, and every one of them shows that ephedra has the capacity to help lower body weight substantially. Let us look at six significant studies which demonstrate why ephedra is the gold standard for weight loss. !" o Recently, a randomized, placebo-controlled clinical study by James Blum, Ph. D.

and Peter Marshall, M. D. , in which the protocol had IRB approval, was completed. The results demonstrated 92% of the participants had significant eight loss using an ephedra / caffeine -based weight reducing agent. After eight weeks, the ephedra / caffeine group lost 12. 75 pounds, while the placebo group lost only 5.

63 pounds. The study group also lost 6. 28 percent body fat, while the placebo group lost 2. 73 percent body fat. There were no major adverse events reported. This study has just been submitted for publication.

(1)!" o One of the most notable studies on ephedra and weight loss was conducted at the New York Obesity Research Center at St. Luke! s-Roosevelt Hospital by Boozer et. al. In this study, 167 obese men and women were given either a combination of ephedra and caffeine or a placebo for six months, in doses of 90 mg. ephedrine alkaloids and 192 mg. of caffeine per day.

The ephedra / caffeine group lost an average of 15. 2 pounds, while the placebo group lost only 6. 8 pounds. The ephedra / caffeine group also lost a significant amount of body fat compared with the placebo group; the ephedra / caffeine group lost 3. 2% body fat, while the placebo group lost only 0. 6% body fat.

In this study, it was concluded that herbal ephedra and caffeine promoted weight loss and fat reduction, as well as improving blood lipids, without adverse events. (2)!" o Boozer et. al. conducted research at St.

Luke! s-Roosevelt Hospital in which sixty-seven overweight subjects were given either placebo or 72 mg. ephedra/ 240 mg. caffeine (guarana) a day for the study period of eight weeks. The ephedra / caffeine group had significantly higher weight loss than the placebo group, 7. 5+/-8. 8 pounds compared to 1.

75+/-5. 3 lbs. The treatment group also had more fat loss than the placebo group, -2. 1+/-3.

0% compared to 0. 2+/-2. 3%. The herbal ephedra / caffeine mixture effectively promoted short-term weight and fat loss.

(3)!" o The effects of ephedra / caffeine on weight loss were studied by Astrup et. al. at the Research Department of Human Nutrition at the Royal Veterinary and Agricultural University in Denmark. One hundred and eighty obese patients were put on a 1000 calorie / day diet and either an ephedrine / caffeine combination (20 mg/200 mg day), ephedrine alone (20 mg), caffeine alone (200 mg), or placebo, three times a day for eight weeks.

Weight loss was significantly higher in the combination group than with placebo from week 8 through 24 (36. 6 +/-15. 0 lbs vs. 29. 1 +/- 14. 55 lbs).

Weight loss in both the ephedrine and caffeine groups was similar to that of placebo. The scientists concluded that the ephedrine / caffeine combination is useful for the treatment of overweight and obesity. (4)!" o Researchers in Denmark, Breum et. al. , found that the combination of ephedrine and caffeine is more effective in weight loss than dexfenfluramine.

One hundred and three obese patients were included in a fifteen week double-blind study. All subjects ate a 1200 calorie / day diet, supplemented by either 15 mg dexfenfluramine twice daily or 20 mg ephedrine/200 mg caffeine three times a day. Those in the herbal ephedrine / caffeine group lost significantly more weight than those in the dexfenfluramine group. After fifteen weeks, the dexfenfluramine group had lost 15.

2+/-9. 5 while the ephedra / caffeine group lost 18. 3+/-11. 5 lbs.

(5)!" o Astrup and Toubro conducted research in Denmark that examined the thermogenic effects of ephedrine and caffeine, given alone and in combination. They concluded that the thermogenic effects of the combination of ephedrine and caffeine (20 mg/200 mg three times a day) was higher than either ephedrine or caffeine alone. The combination had pronounced effects on glucose metabolism and fat loss. The researchers found that the combination! ^0 exerted a supra-additive synergism on thermogenesis! +/-. (6) The knowledge that the combination of ephedra and caffeine is effective and works thermogenic ally to positively influence weight loss is common knowledge at this period in time. Almost all experts agree that ephedra, when combined with the correct amounts of caffeine, works in controlling weight.

This combination herbal treatment works as well as, and in some cases better than, prescription weight loss products. Safety of Ephedra in Weight Loss It is hoped that the information above has proved that ephedra, when combined with caffeine, is the best treatment to improve metabolism. Now it is time to prove that despite the media circus regarding ephedra! s safety, it is possible to use ephedra safely, and minimize any potential risks involved in its use. Conspiracy theories aside, it seems safe to say that an economical, effective, herbal alternative to a big-money pharmaceutical weight-loss pill may threaten the livelihood of companies that rely on obesity to ensure the sales of their drugs.

It is to the benefit of the pharmaceutical industry to demonize ephedra; after all, if the best treatment for being overweight has been around for 3, 000 years and is relatively inexpensive, who will buy all of the chemicals they spent years, plus a great deal of money, creating? But despite any! ^0 conspiracy! +/- to eliminate ephedra, the herb can stand on its own merits, strengths, and safety. Information online is confusing and often contradictory regarding ephedra! s safety. One website may liken eating the herb to consuming nightshade; another may contain some of the truth but not the whole truth. Every substance has its strengths and weaknesses. Every substance has the potential to kill if abused.

For instance, commonly used drugs such as aspirin and other NSAIDS cause the deaths of about 7, 000 people each year. (7) Taking more than the prescribed dose or using aspirin irresponsibly can kill. In the past ten years, the FDA has collected only 88 reports linking ephedra to deaths. (8, 9) That! s about 9 deaths out of 12-14 million people who use ephedra products every year. What does the FDA do about this dangerous drug, aspirin? Nothing.

Because although aspirin has its risks, it benefits many more people than it harms. What are the chances, relatively, of being one of the nine people who may die this year while taking ephedra supplements? Nearly ten times that amount, 85 people, die each year when they are struck by lightning, according to the National Weather Service. (10) According to the Consumer Product Safety Commission, 167 people died while using yard and garden equipment in 2001. (11) Although these comparisons may appear ridiculous, they do show that the risk of dying from ephedra is incredibly small compared to the large number of people who take it each year. Ephedra is one of those substances that definitely have more benefits than risks when used responsibly. The latest statistics show that 300, 000 people die every year as a result of disease related to obesity and being overweight.

(12) The National Institutes of Health warn that being overweight puts one at a higher risk for heart disease, cancer, stroke, and diabetes. (13) As discussed above, the combination of ephedra / caffeine has been proven more effective than the pharmaceutical drug dexfenfluramine in a clinical study on obesity. (5) If ephedra can be a part of causing weight loss and effectively saving the lives of those who cannot lose weight without it, its benefits outweigh its risks. Experts agree that ephedra is a safe and extremely effective weight-loss agent when the directions on the label are adhered to. The industry adopted these precautions as a safeguard for distributors and consumers of dietary supplements that contain ephedra. A group of experts from different scientific and medical backgrounds endorsed these standards.

Nineteen studies of adult obese individuals studied in the Cantox Report found that a No Adverse Effect Level was identified as 90 milligrams a day of ephedrine alkaloids in an herbal ephedra supplement. (14) This level is actually far higher than successful weight loss products currently use. When combined, ephedra and caffeine work synergistically to create thinner, more attractive bodies. Many of the problems which relate to adverse events in ephedra supplements are due to two factors: improper use and poor formulations. (15) If one takes more than the recommended dosage the consequences could be serious, as with all herbal and over-the-counter medications, including aspirin.

When one identifies an improperly formulated product we are speaking about products which contain more than 20 mg of ephedra per dose and are consumed by individuals who ingest unsafe multiples of the recommended dose. These will accelerate blood pressure and can cause nervousness and agitation. Another major complaint is gastric upset. This is due to the use of salicin, a natural form of salicylic acid. Salicylic acid is incorporated into these formulas to counter the effects of elevated body temperature due to excessive amounts of ephedra per dose. Salicylic acid is normally found in acne preparations as a keratolytic (that is to say it removes the top layer of skin).

You can imagine what that will do to the lining of your stomach. Critics of ephedra often site Adverse Event Reports (AERs) as proof that ephedra is harmful to the body. AERs, anecdotal reports that are collected by the Food and Drug Administration, are not reliable. In 1994, the FDA proposed new dose limits for ephedra products. In their review of the validity of this proposal, the United States General Accounting Office (GAO) investigators came to the conclusion that the FDA! s recommendations were not based on the scientific evidence that was currently available regarding the safety of ephedra, and reported this information to Congress. (16) The number of AERs filed is miniscule in comparison with the number of people who take ephedra products each year.

The FDA claimed to have over eight hundred reports that showed that ephedra was dangerous. But when the GAO studied these reports more closely it was determined that the FDA was basing its case on only thirteen AERs. Many of these thirteen reports were suspicious, and some proved to have nothing to do with the use of ephedra at all. In a report issued in 1999, the GAO criticized the FDA for! ^0 bad science! +/-. U. S.

Senator Tom Harkin said, ! ^0 To base a recommended dosage level on 13 adverse events is highly questionable. More troubling, however, is GAO! s finding that FDA did not even determine that these adverse events were caused by the ingestion of dietary supplements containing Ephedra. In fact, GAO found that many of the adverse events were clearly not related to the taking of Ephedra supplements. For example, of the 13 reports, three contain physician reports that stated that the cause of the person! s adverse event was not related to their taking a dietary supplement. Also three individuals reporting adverse events had experienced similar problems prior to or well after taking the supplement.

! +/- (17) Because of these thirteen AERs, the FDA was proposing that ephedra use be limited to 8 mg per serving, three times a day, for not more than seven days. The level of ephedra most commonly used in weight-loss products is 20 mg, three times a day. Another important criticism was that the FDA did not establish a causal link between the use of ephedra products and the occurrence of AERs, for either its proposed dosing level or the duration of use. There are numerous scientific studies that not only show ephedra! s effectiveness, but its safety when taken according to the instructions. A study by Astrup et.

al. found that although ephedra and caffeine offset the hypo tensive effect of energy restriction, the effect was temporary. After eight weeks, blood pressures between the EC group and the control group were indistinguishable. (18) A different study by Astrup et. al.

found that the side effects most often associated with ephedra! a tremor, insomnia, and dizziness! are transient. After eight weeks of treatment, the level of these reported side effects in the EC group and the placebo group was the same. (19) The industry! s main objection to the FDA! s debate is that it is based only on AERs and not scientific evidence. Nevertheless, the Ephedra Education Council has remained a strong supporter of the U. S. Department of Health and Human Services, as well as the National Institutes of Health and its Department of Dietary Supplements to study all the evidence on ephedra to determine whether these AERs are cause for any concern.

(20) In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (D SHEA) which amended the Federal Food, Drug, and Cosmetic Act (FDC Act). This new document gave the FDA more authority to stop the distribution of dangerous dietary supplements. Although many people believe that dietary supplements are unregulated, this simply is not true. The industry maintains extensive requirements regulating product safety and quality, and supports diligent enforcement of these requirements. (17) It should be mentioned that any ephedra product that claims to be a! ^0 legal alternative to a street drug, ! +/- such as ecstasy (MDMA), is not legitimate and should not be used under any circumstances. These products sometimes contain dangerous amounts of ephedra, as well as other substances that may cause serious health consequences.

Why is a thermogenic blend of ephedra and caffeine necessary for weight loss in America, as well as other countries? Americans are losing the war on obesity. More than half of Americans are overweight or obese. Between 1960 and 1994, the rate of Americans who were obese jumped from 13. 4 to 22. 3 percent. America! s weight control problem is spinning out of control; it is quickly becoming an epidemic.

The problems of obesity and overweight cost Americans a total of 99. 2 billion dollars a year. About 300, 000 people in America die each year from diseases related to obesity, making obesity the second leading cause of preventable death behind smoking. From 1991 to 1998, the incidence of obesity increased in every state, every race / ethnicity , and in persons from all educational levels. (12) As research shows, weight loss helps to drastically cut the risk of other health problems. With the obesity epidemic looming over America, weight-loss products containing ephedra are valuable and needed to put Americans back on the road to optimum health and well-being.

Ephedra weight-loss aids have given thousands of people hope that they will be able to solve their weight-loss problem. The reason for this hope is that ephedra, in combination with caffeine, works. Ephedra 1) Blum Ph. D. J, Marshall M. D.

P. Randomized Clinical Trial for Healthy Weight-Management. 2001 August: Bangor, Maine, USA. 2) Boozer CN, Daly PA, Home P, Solomon JL, Blanchard D, Nasser JA, et. al. Herbal ephedra /caffeine for weight loss: a 6-month randomized safety and efficacy trial.

Int J Obes Relat Metab Disord. 2002 May; 26 (5): 593-604. 3) 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.

Obesity Research Center, St. Luke! s-Roosevelt Hospital Center and Department of Medicine, Columbia University College of Physicians and Surgeons, New York, 10025, USA. 4) Astrup A, Breum L, Toubro S, Hein P, Quaade F. 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 Apr; 16 (4): 269-277. 5) Breum L, Pedersen JK, Ahl strom F, Frimodt-Moller J. Comparison of an ephedrine / caffeine combination and dexfluramine in the treatment of obesity. A double-blind multi-centre trial in general practice. Int J Obes Relat Metab Disord. 1994 Feb; 18 (2): 99-103.

6) Astrup A, Toubro S. Thermogenic, metabolic, and cardiovascular responses to ephedrine and caffeine in man. Int J Obes Relat Metab Disord. 1993 Feb; 17 Suppl 1: S 41-43. 7) Family Council on Drug Awareness: Death Rates. Available at: web Accessed February 27, 2003.

8) The Food and Drug Administration. Available at: web Accessed February 27, 2003. 9) ESPN Baseball: No! (R) death knell! for ephedra. Available at: web > Accessed February 26, 2003. 10) National Weather Service: Lightning! aThe Underrated Killer.

Available at: web > Accessed February 27, 2003. 11) Consumer Product Safety Commission: April is National Lawn and Garden Month. Available at: web > Accessed February 27, 2003. 12) U. S. National Institute of Diabetes & Digestive & Kidney Diseases of the National Institute of Health.

Statistics Related to Overweight and Obesity. Available at: web Accessed February 19, 2003. 13) National Institutes of Health: NIH News Release. Available at: web > Accessed February 27, 2003.

14) The Cantox Report on Ephedra: Safety Assessment and Determination of a Tolerable Upper Limit for Ephedra. Prepared by Cantox Health Sciences International: Ontario, Canada, December 19, 2000. Prepared for Council for Responsible Nutrition: Washington, D. C. USA. 15) Interview, February 2003.

16) U. S. General Accounting Office (GAO) Report to the Chairman and Ranking Minority Member, Committee on Science, House of Representatives, B-281581. Dietary Supplements: Uncertainties in Analysis Underlying FDA! s Proposed Rule on Ephedrine Alkaloids. United States General Accounting Office, Washington D. C.

July 2, 1999. 17) Nutrition & Health Online. The Ephedra Debate: Do You Know the Truth? Available at: web Accessed February 19, 2003. 18) Astrup A, Breum L, Toubro S. Pharmacological and clinical studies of ephedrine and other thermogenic agonists. Obes Res.

1995 Nov; 3 Suppl 4: 537 S-540 S. 19) Astrup A, Toubro S, Christensen NJ, Quaade F. Pharmacology of thermogenic drugs. Am. J. Clinical Nutrition.

1992; 55: S 246-S 248. 20) Ephedra Education Council. Public Policy Center. Available at: web February 19, 2003.