Ephedra (Ephedra sinica)
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| Ephedra |
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On February 6, 2004 , the U . S . Food and Drug Administration ( FDA ) issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids ( ephedra ) because such supplements present an unreasonable risk of illness or injury . The rule became effective 60 days from the date of publication .
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In 2005 this rule was struck down in Utah but reversed again four months later, so ephedra is currently banned throughout the United States . It remains unclear whether ephedra will re-appear on the market , despite widespread acknowledgement of significant safety risks , including serious potential cardiovascular events or death .
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Ephedra sinica , a species of ephedra (ma huang), contains the alkaloids ephedrine and pseudoephedrine, which have been found to induce central nervous system stimulation, bronchodilation, and vasoconstriction. In combination with caffeine, ephedrine appears to elicit weight loss (in trials of 1-12 months duration). However, studies of ephedra or ephedrine monotherapy have been equivocal. Numerous trials have documented the efficacy of ephedrine in the management of asthmatic bronchoconstriction and hypotension. However, commercial preparations of non-prescription supplements containing ephedra have not been systematically studied for these indications.
- Major safety concerns have been associated with ephedra or ephedrine use, including hypertension (high blood pressure), tachycardia, CNS excitation, arrhythmia, myocardial infarction (heart attack), and stroke.
- Despite widely publicized safety concerns and the highly publicized 2003 death of a U.S. major league baseball pitcher thought to be related to ephedra, prior to the ban on ephedra, 14% of individuals using non-prescription weight-loss products in the United States continued to take ephedra or ephedrine-containing products.
- Amp II, amsania, brigham tea, budshur, cao Ma huang (Chinese), cathine, chewa, Chinese ephedra, Chinese joint fir, D-pseudoephedrine, desert herb, desert tea, dextro-rotatory, EPH 833, Ephedra altissima , Ephedra americana , Ephedra anti - syphilitica , Ephedra distacha , Ephedra distachya , Ephedra equisetina (Mongolian Ephedra), Ephedra fasciculate , Ephedra geradiana , Ephedra helvetica , Ephedra intermedia (intermediate ephedra), Ephedra likiangensis , Ephedra major , Ephedra minuta , Ephedra monosperma , Ephedra nevadensis , Ephedra przewalskii , Ephedra sinica , Ephedra shennungiana , Ephedra trifurca , Ephedra viridis , Ephedra vulgaris , Ephedraceae (family), ephedra alkaloids, Ephedra distachya, Ephedra intermedia, Ephedra nebrodensis, Ephedra przewalskii, Ephedra regeliana, Ephedra sinica, Ephedra soup medicines, ephedrae herba, ephedrine, ephedrine alkaloids, ephedrine hydrochloride, ephedrine sulphate, ephedroid, epicatechin, epitonin, European ephedra, Gnetales, herba ephedrae, horsetail, hum, huma, Indian joint fir, intermediate ephedra, isoephedrine, joint fir, khama, L-ephedrine, levorotatory ephedrine, mahoàng, máhuáng, "Mao" (Chinese), mao-kon, mahuuanggen, methylephedine, methylephedrine, methylpseudoephedine, Mexican tea, môc tac ma hoàng, Mongolian ephedra, Mormon tea, mu-tsei-ma-huang, muzei mu huang, natural ecstasy, neuropeptide Y, norephedrine, norpseudoephedrine, O-coumaric acid beta-D-glucopyranoside (nebrodenside B), O-coumaric acid glucoside, phok, popotillo, pseudoephedrine, quinoline, san-ma-huang, sea grape, shrubby, soma, song tuê ma hoàng, squaw tea, synephrine, tannins, teamster's tea, trun aa hoàng, tsao-ma-huang, tutgantha, yellow astringent, yellow horse, zhong Ma huang.
- Note: There are approximately 40 species of ephedra.
These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.
| Uses based on scientific evidence | Grade* |
| Weight loss
Ephedra contains the chemical ephedrine, which appears to cause weight loss when used in combination with caffeine, based on the available scientific evidence. The results of research on ephedrine alone without caffeine are unclear. The amounts of ephedrine in commercially available products have varied widely. Other weight loss treatments have been more commonly recommended due to significant safety concerns with combination products containing ephedra and caffeine.
| A |
| Bronchodilator (asthma)
Ephedra contains the chemicals ephedrine and pseudoephedrine, which are bronchodilators (expand the airways to assist in easier breathing). It has been used and studied to treat asthma and chronic obstructive pulmonary disease in both children and adults. Other treatments, such as beta-agonist inhalers (for example, albuterol), are more commonly recommended due to safety concerns with ephedra or ephedrine.
| B |
| Allergic nasal symptoms (used as a nose wash)
Early studies suggest that ephedrine nasal spray, a chemical in ephedra, may help treat symptoms of nasal allergies. Additional research is needed before a firm recommendation can be made.
| C |
| Low blood pressure
Chemicals in ephedra can stimulate the heart, increase heart rate, and raise blood pressure. Ephedrine, a component of ephedra, is sometimes used in hospitals to help control blood pressure. However, the effects of over-the-counter ephedra supplements taken by mouth are not well described in this area.
| C |
| Sexual arousal
Early small studies suggest that ephedra may increase sexual arousal in women. Further well-designed research is needed to confirm these results.
| C |
*Key to grades
A: Strong scientific evidence for this use;
B: Good scientific evidence for this use;
C: Unclear scientific evidence for this use;
D: Fair scientific evidence against this use;
F: Strong scientific evidence against this use.
Grading rationale
Uses based on tradition or theory
The below uses are based on tradition or scientific theories. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.
Alertness, anaphylaxis (a severe allergic reaction), anti-inflammatory, antiviral, appetite suppressant, arthritis, athletic performance enhancer, bed-wetting, body building, colds, cough, depression, diuretic, dyspnea (shortness of breath), edema, fatigue, fevers, flu, freckle-removing, gonorrhea, gout, hives, joint pain, kidney disease, lack of perspiration, liver spots, metabolic enhancement, myasthenia gravis, narcolepsy, nephritis, stimulant, syphilis, upper respiratory tract infections, uterine stimulant.
The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.
Adults (18 years or older)
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Note : The U . S . Federal Government has banned the sale of ephedra since 2004. Consumers are urged to stop using the herbal weight control supplement immediately as it has been linked to numerous adverse health effects including death .
- Ephedra may cause serious adverse effects in any dose, particularly when used with other drugs such as caffeine. Because of serious safety concerns, ephedra cannot be recommended in any dose.
Children (younger than 18 years)
- Ephedrine is not recommended in children due to the risk of toxicity and death.
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.
Allergies
- Persons with a known allergy to ephedra, ephedrine, or pseudoephedrine (Sudafed®) should avoid ephedra. Signs of allergy may include rash, itching, or red, flaking skin.
Side Effects and Warnings
- The U.S. Food and Drug Administration (FDA) has collected thousands of reports of serious adverse effects (including over 100 deaths) from the use of various products containing ephedra or ephedrine. The U.S. Federal Government has banned the sale of ephedra since 2004. Consumers are urged to stop using the herbal weight control supplement immediately as it has been linked to numerous adverse health effects including death.
- Some people may experience abdominal discomfort (nausea, vomiting, diarrhea, loss of appetite, constipation), anxiety, dizziness, headache, tremor, insomnia, dry mouth, delirium, or fainting. Ephedra may also cause irritability, euphoria, hallucinations, seizures, or stroke, as well as low potassium levels in the blood, exaggerated reflexes, weakness, muscle aches, muscle damage, depression, mania, agitation, suicidal ideas, or Parkinson's disease-like symptoms. Persons with prior strokes or transient ischemic attacks (TIAs/"mini-strokes"), tremor, or insomnia should avoid ephedra. Individuals with a history of a psychiatric illness, especially if treated with monoamine oxidase inhibitors (MAOIs), must first discuss ephedra with a qualified healthcare provider before taking supplements. Examples of MAOIs include isocarboxazid (Marplan®), phenelzine (Nardil®), and tranylcypromine (Parnate®).
- Ephedra can cause chest tightness, irregular heart rhythms, damage to the heart muscle, high blood pressure, heart attack, inflammation of the heart, fluid retention in the lungs, breathing difficulties, dilated cardiomyopathy, left ventricular systolic dysfunction, coronary dissection, thrombosis, or cardiac arrest. Ephedra should be used with extreme caution in persons with a history of heart disease, heart rate disorders, or high blood pressure. Other side effects may include liver damage, kidney stones, difficulty passing urine or pain when urinating, increased urine production, or contractions of the uterus. These potential effects may limit the use of ephedra by people with kidney disease or enlarged prostate. Individuals with thyroid gland disorders or glaucoma should use ephedra cautiously. In theory, ephedra may lower blood sugar levels. Caution is advised in patients with diabetes or hypoglycemia, and in those taking drugs, herbs, or supplements that affect blood sugar. Serum glucose levels may need to be monitored by a qualified healthcare provider, and medication adjustments may be necessary.
- It has been recommended that ephedra (ma huang) use be stopped at least one week prior to major surgical or diagnostic procedures.
Pregnancy & Breastfeeding
- Ephedra should not be used during pregnancy, due to risks to the mother and fetus. Ephedrine crosses the placenta, and has been found to increase fetal heart rate. Ephedra may induce uterine contractions.
- Ephedra should not be used during breastfeeding, due to risks to the mother and child. Ephedrine crosses into breast milk and has been associated with irritability, crying, and insomnia in infants.
Most herbs and supplements have not been thoroughly tested for interactions with other herbs, supplements, drugs, or foods. The interactions listed below are based on reports in scientific publications, laboratory experiments, or traditional use. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy.
Interactions with Drugs
- Many drugs can cause increased stimulation when used with ephedra or ephedrine. Examples include caffeine and theophylline. When combined with ephedra, these drugs may lead to difficulty sleeping, nervousness, or stomach upset. The combination of ephedrine and caffeine may be fatal. Many products contain both ephedrine and caffeine and should be used with caution, if at all.
- Combined ingestion of caffeine and ephedrine has been observed to increase blood glucose and lactate concentrations. Ephedrine and dopamine concentrations are significantly increased. A case report exists of ephedra use associated with the onset of psychosis and autonomic hyperactivity after administration of risperidone.
- Bronchodilators used for asthma or the decongestant pseudoephedrine (Sudafed®) may have increased bronchodilating effects when used with ephedra.
- If ephedra is taken with monoamine oxidase inhibitor (MAOI) antidepressants, such as isocarboxazid (Marplan®), phenelzine (Nardil®), and tranylcypromine (Parnate®), severe side effects may develop, including dangerously high blood pressure, muscle damage, fever, and irregular heart rate. Other antidepressants and medications for psychiatric disorders (phenothiazines, tricyclics, selective serotonin reuptake inhibitors [SSRIs]) may reduce the effects of ephedra and cause low blood pressure and rapid heartbeat.
- Because ephedra affects blood pressure and heart rate, it may alter the effectiveness of medications given to control blood pressure or heart rhythm, including digoxin, alpha-blockers, beta-blockers, diuretics, calcium-channel blockers, or angiotensin converting enzyme (ACE) inhibitors. The side effects of ephedra may be worsened by guanethidine, ergot alkaloids (bromocriptine, dihydroergotamine, ergotamine), oxytocin (Ptosin®), diuretics, morphine, and anesthetic drugs (halothane, cyclopropane, propofol).
- Ephedra may lower blood sugar levels, although ephedra-caffeine combinations may increase blood sugar. Caution is advised when using medications that may also alter blood sugar. Patients taking drugs for diabetes by mouth or insulin should be monitored closely by a qualified healthcare provider. Medication adjustments may be necessary.
- Ephedra may reduce the effects of steroids such as dexamethasone. Ephedra may increase serum levels of thyroid hormones and may alter thyroid hormone treatments. Medications that alter the acidity of urine may reduce the effectiveness of ephedra.
- Effects of cholesterol-lowering medications may be altered by ephedra, although this has not been proven.
- Phenylpropanolamine, previously removed from the U.S. market, may lead to additive effects if taken with ephedra. Caution is advised with other agents takes for weight loss.
- Ephedra may also interact with alcohol, general anesthetics and drugs taken for gout. Ephedra products should be stopped 24 hours prior to surgery.
Interactions with Herbs & Dietary Supplements
- The stimulant effects of ephedra may be increased when combined with herbs and supplements that have stimulant properties or with supplements that contain caffeine, such as guarana, cola nut, bitter orange, and yerba mate. Commercially available products may contain combinations of ephedrine and caffeine or guarana. Ephedra may alter thyroid hormones and should be used cautiously with other herbs or supplements that affect thyroid hormones, such as bladderwrack (seaweed, kelp).
- Ephedra may decrease the effectiveness of cardiac glycosides (supplements taken for heart failure and irregular heart beat).
- Ephedra may raise blood pressure and may increase the blood pressure-raising effects of herbs such as American ginseng.
- Ephedra may lower blood sugar levels. Caution is advised when using herbs or supplements that may also lower blood sugar. Blood glucose levels may require monitoring, and doses may need adjustment.
- Ephedra may increase the diuretic effects of herbs such as artichoke. Ephedra may also interact with urine acidifiers/alkalinizers.
- Combining ephedra with herbs that have possible monoamine oxidase inhibitor (MAOI) antidepressant activity such as St. John's wort may cause severe side effects, including dangerously high blood pressure, muscle breakdown, fever, and irregular heartbeats. Ephedra may also interact with other antidepressant herbs such as those that have selective serotonin reuptake inhibitor (SSRI) activity.
- Effects of cholesterol-lowering herbs and supplements may be altered by ephedra, although this has not been proven.
- Ephedra may also interact with herbs taken for gout or with hormonal activity.
- This patient information is based on a professional level monograph edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com): Ethan Basch, MD (Memorial Sloan-Kettering Cancer Center); Samuel Basch, MD (Mt. Sinai School of Medicine, NY); Steve Bent, MD (University of California); Dawn Costa, BA, BS (Natural Standard Research Collaboration); Cynthia Dacey, PharmD (Natural Standard Research Collaboration); Edzard Ernst, MD (University of Exeter); Dana A. Hackman, BS (Northeastern University); Paul Hammerness, MD (Harvard Medical School); Jenna Hollenstein, MS, RD (Natural Standard Research Collaboration); Van Nguyen, PharmD (Massachusetts College of Pharmacy); Kimberly Pacitto, PharmD (Massachusetts College of Pharmacy); Daniel Robinson, PharmD (University of Florida); Shaina Tanguay-Colucci, BS (Natural Standard Research Collaboration); Catherine Ulbricht, PharmD (Massachusetts General Hospital); Mamta Vora, PharmD (Northeastern University); Wendy Weissner, BA (Natural Standard Research Collaboration).
Methodology details
- Abourashed EA, El Alfy AT, Khan IA, et al. Ephedra in perspective--a current review. Phytother Res 2003;17(7):703-712.
- Ashar BH, Miller RG, Getz KJ, et al. A critical evaluation of Internet marketing of products that contain ephedra. Mayo Clin Proc 2003;78(8):944-946.
- Baker SK, Silva JE, Lam KK. Pseudoephedrine-induced hemorrhage associated with a cerebral vascular malformation. Can J Neurol Sci 2005;32(2):248-52.
- Bent S, Tiedt TN, Odden MC, et al. The relative safety of ephedra compared with other herbal products. Ann Intern Med 3-18-2003;138(6):468-471.
- Boozer CN, Daly PA, Homel P, et al. Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial. Int J Obes Relat Metab Disord 2002;26(5):593-604.
- Coffey CS, Steiner D, Baker BA, et al. A randomized double-blind placebo-controlled clinical trial of a product containing ephedrine, caffeine, and other ingredients from herbal sources for treatment of overweight and obesity in the absence of lifestyle treatment. Int J Obes Relat Metab Disord 2004;28(11):1411-1419.
- Hackman RM, Havel PJ, Schwartz HJ, et al. Multinutrient supplement containing ephedra and caffeine causes weight loss and improves metabolic risk factors in obese women: a randomized controlled trial. Int J Obes (Lond) 2006;30(10):1545-56.
- Meadows M. Public health officials caution against ephedra use. Health officials caution consumers against using dietary supplements containing ephedra. The stimulant can have dangerous effects on the nervous system and heart. FDA Consum 2003;37(3):8-9.
- Milic M, Bao X, Rizos D, et al. Literature review and pilot studies of the effect of QT correction formulas on reported beta2-agonist-induced QTc prolongation. Clin Ther 2006 Apr;28(4):582-90.
- Molnar D, Torok K, Erhardt E, et al. Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents. Int J Obes Relat Metab Disord 2000;24(12):1573-1578.
- Morgenstern LB, Viscoli CM, Kernan WN, et al. Use of Ephedra-containing products and risk for hemorrhagic stroke. Neurology 1-14-2003;60(1):132-135.
- Natural Standard Research Collaboration, Chief Editors: Ulbricht C, Basch E, Natural Standard Herb and Supplement Reference - Evidence-Based Clinical Reviews, USA: Elsevier/Mosby, 2005.
- No authors listed. Working to get ephedra banned. Consum.Rep 2003;68(2):6.
- Samenuk D, Link MS, Homoud MK, et al. Adverse cardiovascular events temporally associated with ma huang, an herbal source of ephedrine. Mayo Clin Proc 2002;77(1):12-16.
- Shekelle PG, Hardy ML, Morton SC, et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. JAMA 3-26-2003;289(12):1537-1545.
February 01, 2008.
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This evidence-based monograph was prepared by the Natural Standard Research Collaboration. The information provided should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. Talk to your health care provider before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Copyright© 2008 Natural Standard (www.naturalstandard.com). All Rights Reserved.
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