Ephedra is a dioecious, perennial, evergreen subshrub native to central Asia, widely distributed throughout China, Tibet, India, Pakistan, Japan, and Southern Siberia, also cultivated extensively (Bruneton, 1995; Budavari, 1996; Grieve, 1979; Leung and Foster, 1996).
In Oriental medicines, ephedra is the chief drug for treatment of asthma and bronchitis. It has been used for thousands of years in traditional Chinese medicine (TCM) as a primary component of multi-herb formulas prescribed to treat bronchial asthma, cold and flu, cough and wheezing, fever, chills, lack of perspiration, headache, and nasal congestion. It is listed in the oldest comprehensive materia medica, Shen Nong Ben Cao Jing, among the "middle class" herbs, used to induce perspiration and as an anti-allergy agent (Blumenthal and King, 1995; Bruneton, 1995; Der Marderosian, 1999; Huang, 1999; Leung and Foster, 1996; Weiss, 1988). Today, ephedra is official in the national pharmacopeias of China, Germany,and Japan. In India, ephedra herb is listed in the Ayurvedic pharmacopoeia. Only its isolated derivatives ephedrine and ephedrine hydrochloride are official in the Indian Pharmacopoeia (DAB 1998; IP, 1996; JP XII, 1993; Karnick, 1994; Tu, 1992). The Chinese pharmacopeia indicates its use for common cold with wind-cold syndrome (marked by chilliness and mild fever, headache, stuffy and runny nose, general aching, but no sweating), and for bronchial asthma (Tu, 1992). The Ayurvedic pharmacopeia lists ephedra for asthma, spasms, hayfever, and allergic symptoms (Karnick, 1994). In China, ephedra is a major component of a cold medication used to relieve headache, body ache, coughing, and to lower fever by increasing perspiration. The formula is an aqueous decoction containing ephedra herb, cinnamon twig, licorice root, and almond (Huang, 1999).
In Germany,ephedra is official in the German Pharmacopoeia and is an approved herb in the Commission E monographs. It is used as a primary component of licensed prepared respiratory medicines (BAnz, 1998; DAB 1998). In the United States, the herb ephedra is regulated as a dietary supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA) in aqueous infusion, alcoholic tincture, and dry extract in capsules or tablets. Ephedra is used in TCM herbal teas and prepared professional products prescribed to patients by licensed acupuncturists and naturopathic physicians. The alkaloids (and their salts) from ephedra—i.e., ephedrine and pseudoephedrine—are approved by the Food and Drug Administration (FDA) as over-the-counter (OTC) drug ingredients for common cold, flu, and allergies.
Modern human studies in China have investigated its clinical uses for treatment of bronchial asthma, chronic bronchitis, pneumonia of children, and whooping cough (Chang and But, 1986; Liu, 1989). Human studies in the West have focused on its pharmacokinetics (Gurley et al., 1998; Pickup et al., 1976), cardiovascular effects in healthy adults (White et al., 1997), and potential in weight loss (Nasser et al., 1999).
One clinical study reported that therapeutic effects were achieved in patients suffering from chronic asthmatic bronchitis who were treated with TCM formula "San Ao Decoction" [ephedra stem (Ephedra sinica Stapf.), bitter apricot seed (Prunus armeniaca L. var. ansu Maxim.), licorice root (Glycyrrhiza uralensis Fisch.), perilla fruit (Perilla frutescens (L.) Britt.), and ground dragon body (Pheretima aspergillum (Perier) or Allolobophora caliginosa (Savigny) trapezoides (Ant. Duges)] modified to suit individual manifestations (Chang and But, 1986). Another clinical study reported that satisfactory results were obtained in 288 cases of whooping cough in children, mostly between 3 and 5 years old, treated with the TCM formula "Ephedra-Prunus-Gypsum-Glycyrrhiza Decoction" [ephedra stem (Ephedra sinica Stapf.), bitter apricot seed (Prunus armeniaca L. var. ansu Maxim.), gypsum plaster stone (hydrated calcium sulfate), Chinese licorice root (Glycyrrhiza uralensis Fisch.), stemona root tuber (Stemona sessilifolia (Miq.) Miq., pepperweed seed (Descurainia sophia (L.) Webb ex Prantl.), Chinese date fruit (Ziziphus jujuba Mill.), and maltose (malt sugar)]. The authors reported it to be effective in catarrhal and spastic stages (Chang and But, 1986).
The approved modern therapeutic applications for ephedra are supportable based on its history of clinical use in well established systems of traditional and conventional medicines, extensive phytochemical investigations, pharmacological studies in animals, and human clinical studies.
Ephedra became controversial in the 1980–1990s due to its popularity as a major ingredient in herbal dietary supplements in the United States. Regulators and health officials were becoming increasingly concerned about its use for various purposes that were not approved for OTC drug use by the FDA, e.g., in products intended as diet aids for weight loss, for stimulation of the central nervous system, for enhancement of athletic performance, and briefly, as substitutes for illegal street drugs (Blumenthal and King, 1995; Blumenthal, 1996b). The FDA and state regulatory officials repeatedly voiced concerns about adverse reaction reports—in some cases, fatalities—that were claimed, but not always confirmed, to be associated with the ingestion of herbal supplement products containing ephedra, as well as products containing the ephedrine alkaloids (e.g., pure ephedrine). Consequently, federal and state regulatory agencies attempted to limit the uses of ephedra in supplements, the level of alkaloids per dose and per day, and, in some states, access to ephedrine-containing products (Anon., 1996; Blumenthal et al., 1995; Blumenthal 1996a, 1997a, 1997b, 1997c; Blumenthal and Dickinson, 1996).
Concerned about the potential risks associated with ephedra, herb industry groups established standards for ephedra products, including daily intake limits of 25 mg total alkaloids per dose and 100 mg total daily consumption. In 1994 the American Herbal Products Association issued a label warning statement for all ephedra products stating, "Seek advice from a healthcare practitioner prior to use if you are pregnant or nursing, or if you have high blood pressure, heart or thyroid disease, diabetes, difficulty in urination due to prostate enlargement, or if taking a MAO inhibitor or any other prescription drug. Reduce or discontinue use if nervousness, tremor, sleeplessness, loss of appetite, or nausea occur. Not intended for use by persons under 18 years of age. Keep out of the reach of children" (McGuffin, 1997). The industry warning and dose limits have been adopted by several states and have become the standard for labeling for ephedra products.
In June 1997 the FDA issued proposed regulations on ephedra-containing dietary supplements that would limit the level of total ephedra alkaloids in herbal preparations to no more than 8 mg per dose, with no more than 24 mg total ingestion per day. The proposed rule would ban the combination with other stimulants like caffeine or caffeine-containing herbs (e.g., cola (Cola nitida), guarana (Paullinia cupana), maté (Ilex paraguariensis), and others) in ephedra-containing herbal products; would prohibit the sale of ephedra products for use in weight loss or for athletic performance; would restrict use of ephedra herbal products to no more than seven days duration; and would require strict warnings on all ephedra product labels. The proposal would ban so-called "street drug knockoffs" containing ephedra or ephedrine alkaloids (FDA, 1997; Blumenthal, 1997c).
In August 1999 the U.S. General Accounting Office (GAO), the government agency that monitors accountability of all federal agencies, issued a 68-page report, Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids (GAO, 1999). The report reveals deficiencies in the FDA's proposed rules on ephedra. GAO acknowledged that the FDA was justified in its concern about the safety of ephedra herbal products, based on the adverse event reports (AERs) it had received. However, GAO questioned the reliability of many of these AERs and also criticized the apparent lack of science employed in formulating the proposed dosage limits of alkaloids. The GAO also commented on the FDA's failure to comply with standard methods for cost-benefit analysis, including the failure to address whether there was any need for an FDA regulation in light of state requirements, and the failure to establish a benefit to the proposed actions.
Recent research suggests that ephedra as a single herb can be used safely in persons with normal blood pressure levels. A small clinical study of 12 healthy men and women between the ages of 23 and 40 employed four capsules twice daily, each containing 375 mg of powdered ephedra herb (Solaray brand, Ogden, Utah) (White et al., 1997). After blood pressure baselines were recorded, during the treatment phase four capsules were taken with breakfast and again nine hours later, with dinner. No additional herbal ingredients were present in the capsules, nor did they contain added ephedra extracts. Alkaloid levels of the capsules were measured by high-performance liquid chromatography (HPLC); the average level for each four-capsule dose was 19.4 mg ephedrine, 4.9 mg pseudoephedrine, and 1.2 mg methylephedrine. (By comparison, an over-the-counter cold capsule or tablet contains 25 mg ephedrine in the hydrochloride or sulfate forms.) Blood pressure was monitored every 15 minutes during the treatment phase. None of the 12 subjects experienced adverse effects during the study. Six experienced statistically significant increases in mean 12-hour heart rate after taking the herb, three had minor increases, and three showed no change. During the first three hours of treatment, four had significant increases in systolic pressure and two had significant decreases in diastolic pressure. The authors did not consider these effects clinically significant. They concluded that "pharmacodynamic aspects of ingestion of ma-huang in a normotensive, young population were fairly benign." They cautioned about the use of ephedra with other stimulants or in high doses. The weakness of this trial is the obvious small sample and lack of data on how the weight of each subject may have affected the results (Leigh, 1998).
The primary use for ephedra in dietary supplements—other than for athletic performance—is for weight loss and thermogenesis (burning of fatty tissue). Much of the industry-generated promotion for this purpose is based on research on a formula containing the alkaloid ephedrine, combined with caffeine and aspirin (Astrup et al., 1997; Astrup et al., 1992; Daley et al., 1993; Pardoe et al., 1993; Toubro et al., 1993). However, one unpublished study conducted at the Obesity Research Center, St. Luke's-Roosevelt Hospital Center, and Columbia University in New York tested a combination of ephedra herb with guarana, a natural source of caffeine (Nasser et al., 1999). The herbal combination (Metabolife 356®) was used in a double-blind, placebo-controlled eight-week trial on healthy subjects ages 25 to 55 years. The total daily intake of ephedrine alkaloids was 72 mg; caffeine, 240 mg (equivalent to 2 to 3 average cups of coffee). Of the 48 subjects completing the study (67 had initially been randomized), 24 taking the herbal product had greater weight reduction (-8.7±7.5 lbs.) versus the placebo group (1.8±5.4 lbs.), lower percentage of body fat, and lower serum triglyceride levels. The authors concluded that the herbal formula promotes weight loss but may also produce undesirable side effects in some subjects (dry mouth, heart palpitations, changes in blood pressure, and insomnia). The researchers suggest further study to determine long-term safety of the product.
Chinese pharmacopeial grade ephedra must be composed of the dried herbaceous stem collected in autumn, containing not less than 0.8% total alkaloids, calculated as ephedrine. Botanical identity must be confirmed by thin-layer chromatography (TLC) as well as by macroscopic and microscopic examinations (Tu, 1992). The Japanese Pharmacopoeia requires a minimum of only 0.6% total alkaloids but has additional purity requirements, including not more than 5% woody stems and the absence of stems of Equisetaceae or Gramineae plants (JP XII, 1993). The German Pharmacopoeia requires not less than 1% total alkaloids as well as identity, purity, and quality requirements comparable to those of the Chinese and Japanese monographs (DAB, 1997; DAB, 1998).
Description
Ephedra consists of the dried, young branchlets, harvested in the fall, of Ephedra sinica Stapf, E. shennungiana Tang [Fam. Ephedraceae], or other equivalent Ephedra species, and their equivalent preparations in effective dosage. The herb contains alkaloids; main alkaloids are ephedrine and pseudoephedrine. Ed. Note: The species listed by the Commission E are quite rare in U.S. commerce. Many species of ephedra are used in commerce, including E. equisetina Bge (Leung, 1999).
Chemistry and Pharmacology
Ephedra herb contains alkaloids (approx. 1.3%) mostly composed of l-ephedrine (50–90%), d-pseudoephedrine, l-norephedrine, d-norpseudoephedrine, l-N-methylephedrine and d-N-methylpseudoephedrine; flavonoid glycosides; glycans (ephedrans); citric, malic, and oxalic acids; proanthocyanidins (condensed tannins); and tannins and volatile oils (l-α-terpineol, limonene, and linalool) (Bruneton, 1995; Budavari, 1996; Leung and Foster, 1996).
The Commission E reported antitussive actions in animal experiments. Ephedrine acts by indirectly stimulating the sympathomimetic and central nervous systems. Bacteriostatic activity is also reported.
A diaphoretic action in humans has been reported for the aqueous decoction and volatile oil forms, and antiallergic effects in vitro have been demonstrated for the decoction and alcoholic extract forms of ephedra herb (Leung and Foster, 1996).
The pure alkaloid ephedrine acts as an indirect sympathomimetic. It is structurally similar to adrenaline. It stimulates cardiac automaticity with a positive inotropic action. It accelerates and increases the intensity of respiration and functions as a bronchodilator (Bruneton, 1995; Robbers and Tyler, 1999). The Merck Index lists the therapeutic category of l-ephedrine as bronchodilator and d-pseudoephedrine as decongestant (Budavari, 1996).
Uses
The Commission E approved the internal use of ephedra herb for diseases of the respiratory tract with mild bronchospasms in adults and children over the age of 6.
The World Health Organization has found the following uses of ephedra preparations to be supported by clinical data: treatment of nasal congestion due to hay fever, allergic rhinitis, acute coryza (rhinitis), common cold, sinusitis, and as a bronchodilator in treatment of bronchial asthma (WHO, 1999).
In Oriental medicine, ephedra herb, known as mahuang, is the primary drug used in treatment of asthma and bronchitis (Bruneton, 1995). Mahuang has been used for more than two thousand years to treat bronchial asthma, cold and flu, fever, chills, lack of perspiration, headache, nasal congestion, aching joints and bones, and cough and wheezing (Leung and Foster, 1996; Morton, 1977).
Contraindications
Anxiety and restlessness, high blood pressure, glaucoma, impaired circulation of the cerebrum, adenoma of prostate with residual urine accumulation, pheochromo–cytoma, thyrotoxicosis.
Side Effects
Insomnia, motor restlessness, irritability, headaches, nausea, vomiting, disturbances of urination, tachycardia.
In higher dosage: Drastic increase in blood pressure, cardiac arrhythmia, development of dependency.
Use During Pregnancy and Lactation
Not recommended (McGuffin et al., 1997).
Interactions with Other Drugs
In combination with:
Cardiac glycosides or halothane: Disturbance of heart rhythm.
Guanethidine: Enhancement of the sympathomimetic effect.
MAO-inhibitors: Greatly raising the sympathomimetic action of ephedrine.
Secale alkaloid derivatives or oxytocin: Development of hypertension.
Dosage and Administration
Unless otherwise prescribed:
Adults: 1.2-2.3 g of cut herb containing approximately 1.3% (13 mg/g) total alkaloids.
Children: 0.04 g (40 mg) of cut herb per kg of body weight (Single dose for a 30 kg child, 1.2 g of cut herb).
Single dosage:
Adults: Herb preparations corresponding to 15-30 mg total alkaloid (=1.2-2.3 g of cut herb), calculated as ephedrine.
Children: Herb preparations corresponding to 0.5 mg total alkaloid (=0.04 g of cut herb) per kg of body weight.
Infusion or decoction: 1.2-2.3 g in 150 ml water.
Fluidextract 1:1 (g/ml): 1.2-2.3 ml.
Tincture 1:5 (g/ml): 5.75-11.5 ml.
Native extract 3.5-4.5:1 (w/w): 0.25-0.65 g.
Maximum daily dosage:
Adults: Herb preparations corresponding to 300 mg total alkaloid (=23 g of cut herb), calculated as ephedrine.
Children: 2 mg total alkaloid (=0.15 g of cut herb) per kg of body weight.
Duration of administration: Commission E recommended that ephedra preparations should only be used short-term because of tachyphylaxis and danger of addiction.
Note: When the monograph was published in January, 1991, the Commission E stated that ephedrine-containing preparations are listed as addictive by the International Olympic Committee and the German Sports Association. However, a more recent analysis of the available U.S. health and safety data compiled by Edgar H. Adams, M.S., Sc.D., former Director of the Division of Epidemiology and Statistical Analysis at the U.S. National Institute on Drug Abuse, indicates that there is no evidence of significant abuse of, or addiction to, ephedra, despite decades of widespread use, establishing that any potential for addiction is low and does not rise to the level of regulatory concern to the extent that it warrants scheduling (as is done with addictive narcotic drugs) (Adams, 1999).
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This material was adapted from The Complete German Commission E Monographs—Therapeutic Guide to Herbal Medicines. M. Blumenthal, W.R. Busse, A. Goldberg, J. Gruenwald, T. Hall, C.W. Riggins, R.S. Rister (eds.) S. Klein and R.S. Rister (trans.). 1998. Austin: American Botanical Council; Boston: Integrative Medicine Communications.
1) The Overview section is new information.
2) Description, Chemistry and Pharmacology, Uses, Contraindications, Side Effects, Interactions with Other Drugs, and Dosage sections have been drawn from the original work. Additional information has been added in some or all of these sections, as noted with references.
3) The dosage for equivalent preparations (tea infusion, fluidextract, and tincture) have been provided based on the following example:
Unless otherwise prescribed: 2 g per day of [powdered, crushed, cut or whole] [plant part]
Infusion: 2 g in 150 ml of water
Fluidextract 1:1 (g/ml): 2 ml
Tincture 1:5 (g/ml): 10 ml
4) The References and Additional Resources sections are new sections. Additional Resources are not cited in the monograph but are included for research purposes.
This monograph, published by the Commission E in 1994, was modified based on new scientific research. It contains more extensive pharmacological and therapeutic information taken directly from the Commission E.
Excerpt from Herbal Medicine: Expanded Commission E Monographs Copyright 2000 American Botanical Council Published by Integrative Medicine Communications Available from the American Botanical Council.