With regard to the safety of Ma huang:
- Use of the Ephedra herb in Middle Paleolithic times (over 20,000 years ago) has been demonstrated.
- There is a 5,000 year history of the use of Ma huang in the Far East, and a 3,500 year history of the use of a related herb in India.
- The herb is traditionally used in China in dosages that are 3 to 10 times greater than those for Dietary Supplements containing this herb in North America.
- There are no reports of adverse effects in the historical literature.
- An exhaustive search of 20th Century scientific literature up to the present day has failed to reveal any reports of adverse effects with Ma huang, or even concern that such effects might occur. A similar search of the ephedrine literature revealed remarkably few reports of adverse effects, and these were almost invariably related to abuse or significant overdosing.
- The literature from the last 20 years indicates that the combination of ephedrine with caffeine is not only safe, but it is also possibly the most effective adjunctive treatment for obesity and weight problems ever discovered! The literature also confirms that these findings apply equally to combinations of Ma huang with caffeinaceous herbs.
- The recent scientific literature also reveals that treatment with ephedrine and caffeine combinations, whether as pharmaceutical agents or as herbs, in appropriate dosages does not increase blood pressure and heart rate, but may actually cause these to fall. In addition, such treatment has beneficial effects on blood lipid parameters!
- On April 28, 1995, a release entitled "MA HUANG (EPHEDRA) PRODUCTS CLEARLY SAFE SAYS BROAD BASED INDUSTRY COMMITTEE" stated, "The Ad Hoc Committee on the Safety of Ma huang includes and represents numerous individuals and companies who import, process, manufacture, and/or distribute safe Ma huang (ephedra dietary supplements)". These products are regulated by the Food and Drug Administration (FDA), pursuant to the requirements of the Dietary Supplement Health and Labeling Act of 1994, which permits such products to be sold unless FDA can prove they constitute a significant or unreasonable risk of illness or injury. The FDA has taken no regulatory action against Ma huang products. To the contrary, it recently lifted its existing import restrictions against this Chinese herb."
- Dr. Joseph Borzelleca, one of the country’s leading toxicologists, former president of the Society of Toxicology, and a long-time consultant on food ingredient safety to the FDA and the Federation of American Societies of Biology, and his colleague Dr. Graham Patrick of the Medical College of Virginia reported that, "with a reasonable degree of scientific certainty, neither the individual nor the combination product would cause adverse effects requiring medical intervention in individuals not excluded by the warnings on the label."
- Dr. Wayne Snodgrass, head of the Texas Poison Prevention Bureau, states, "the animal and human studies, point out that a study of 50 mg ephedrine and 200 mg caffeine amounted to ingesting two Sudafed and a cup and a half of coffee." He further explained that "Medically, there was not enough ephedrine in a labeled dose to bring on heart palpation." He cited the basic pharmacy textbook as saying that 25/50-mg is an acceptable ephedrine dose. He explained the concept of relative risk, "Taking a prescription drug risks an adverse event 1/3000 times; Driving to work, a 1/8000 risk of death; and 1/100,000 for a plane flight. Consuming Ma huang products is far less risky than these basic human actions."
- The action pending with the Texas Board of Health (TBH) mentioned earlier in this report to take steps to restrict the sale and distribution of foods and drugs containing Ma huang, after careful review of the thousands of scientific related documents and testimonials pertaining to the safety of Ma huang, was suspended. The same action was taken in the State of Ohio’s decision to ban Ma huang related products and that decision has since been reversed.
- Market surveillance has also provided useful information. In particular, a survey has been made of users of one formulation containing Ma huang as a 1:4 dry extract. Each capsule of the product provided about 20 mg of total alkaloids, of which 65% - 88% were ephedrine itself. The results of the survey covered approximately 230,000 subjects who had used the product for periods of 6 weeks or more, generally about 11 weeks, in some cases much longer, at an average dose of 3 to 4 capsules per day. It was estimated that this represents about 1% of the total market for products containing Ma huang in the United States. Thus since, the study covered about 3 years of use. During the last three years, approximately 23,000,000 Americans have used Ma huang.
There were a number of reports of significant improvements in blood lipids and falls in blood pressure and heart rate, as well as many reports of greatly improved rates of weight loss. However, no adverse effects were seen!
It can be concluded that dietary supplements containing genuine Ma huang, correctly formulated, are safe, and have beneficial effects on the function of the human body when used appropriately. However, as with any food, drug or dietary supplement, they must be used in accordance with the directions for use, and with attention for any cautionary statements on the label! In this respect, for products containing Ma huang…
An article in the Research Section, page 170 of the December 1997 issue of "All Natural Muscular Development" stated that "To summarize, the estimated lethal dose of ephedrine alone is approximately 100 times the therapeutic dose; however, combining ephedrine and caffeine may reduce the lethal dose to 30 times the dose used for weight loss. To put this in perspective, this means that the combination of ephedrine and caffeine is roughly as safe as aspirin and Tylenol(acetaminophen)."
"It is also worth quoting a 1977 study performed on asthmatic children seven to 13 years-old who were given 25 mg of ephedrine plus 125 mg of theophylline (which potentiates ephedrine like caffeine) every eight hours for eight weeks:"
"Ephedrine is a potent bronchodilator that, in appropriate doses, can be administered safely along with therapeutic doses of theophylline without fear of progressive tolerance or toxicity."(Tinkelman DG, and Avener SE. Ephedrine therapy in asthmatic children. Clinical tolerance and absence of side effects. Jama, 1977 Feb 7, 237 (6):553-7.)
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