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Ephedra (Má huáng)

Click on the link below for a downloadable [PDF] of this information:
HPRC Dietary Supplement Classification System: Ephedra (Má huáng)

Background

Ephedra (Má huáng)

Má huáng is a traditional Chinese medicine derived from the aerial parts of Ephedra sinica Stapf, E. equisetina Bunge, or E. intermedia Schrenk et C.A. Mey (ephedraceae). In traditional Chinese medicine, ephedra-containing preparations have been used for centuries for treatment of the common cold with wind-cold syndrome marked by chills and mild fever, headache, stuffy and runny nose, and general aching, but without sweating; edema in acute nephritis; and bronchial asthma.1 The protoalkaloid active constituents such as ephedrine and pseudoephedrine are used for the treatment of bronchial asthma, nasal congestion, acute bronchospasm, and idiopathic orthostatic hypertension (rise in blood pressure upon standing).2 Ephedra-containing dietary supplements, however, have been promoted as weight-loss aids or to improve energy levels and athletic performance. The National Collegiate Athletic Association, International Olympic Committee, and National Football League have all banned the use of ephedra.2 In September 2002, the U. S. Air Force adopted a policy to “strongly discourage the use of nutritional supplements containing ephedra by all U. S. Air Force personnel as an operational risk management posture.”3 Effective as of April 2004, ephedra was banned by the FDA for use in dietary supplements due to reports of severe adverse events and death.4 While the effects of ephedra on alertness, physical activity, and calorie intake may be beneficial, the ingestion of products containing ephedra alkaloids is more likely to have negative effects, as noted in Benefits and Risks.

Dose Range and Upper Limit

Ephedra (Má huáng)

Food and Nutrition Board DRI:

RDA/AI: Not relevant for this substance.

Upper Limit: Not relevant for this substance.

Doses Used in Randomized Clinical Trials: Doses of ephedrine and related compounds ranging from 60-150 mg/day have been used for up to six months.1 For weight loss, doses of 12.5 to 25 mg of ephedrine have been taken two to three times daily.

Toxicology Data: Toxicity is common due to the large number of agents with sympathomimetic activity (i.e., mimicking the effects of the sympathetic nervous system). Severe poisoning is uncommon.

Large overdoses and severe toxicity may lead to seizures, hallucinations, agitated delirium, tachydysrhythmias (abnormally rapid, irregular heart rate), vasospasms (spasms of the blood vessels), and severe hypertension. Prolonged agitation can lead to rhabdomyolysis (rapid breakdown of muscle fibers) and hyperthermia (elevated body temperature).5

Benefits and Risks

Ephedra (Má huáng)

Evaluation of Potential Benefits

Data suggest that short-term use of ephedrine, ephedrine plus caffeine, or dietary supplements that contain ephedra (with or without caffeine-containing herbs) produce a statistically but not clinically significant increase in weight loss in the short term (six months) versus a placebo. The short-term weight loss was approximately two pounds per month for as long as four to six months. There are no long-term data on weight loss.5 Adding caffeine to ephedrine modestly increases the amount of weight loss. Evidence that ephedra alkaloids alone can affect performance is uncertain due to the small number of studies and their small sample sizes under a variety of exercise conditions. Two reviews conclude that the majority of studies published show no effect on athletic performance.1,5

Potential Detrimental Effects on…

Military Perfomance: Ephedra has the potential to cause dizziness, restlessness, anxiety, irritability, personality changes, difficulty concentrating, insomnia, headache, increased thirst, dry mouth, anorexia, nausea, vomiting, heartburn, flushing, tingling, difficulty urinating, tachycardia, heart palpitations, hyperthermia, and increased blood pressure.2

Military Survivability: Ephedra has been associated with myocardial infarction (“heart attack”), cardiac arrhythmias (rapid heart rate), cardiac arrest, and sudden death. Ephedra can cause seizures in healthy people. Other reported events include stroke, transient ischemic attack (stroke), cerebral hemorrhage, and loss of consciousness. Case reports of psychosis, vision impairment, and muscle failure also exist.1

Other Health Risks

Use of ephedra causes a 2.2-fold to 3.6-fold increase in the risk of developing psychiatric, autonomic (nervous system), or gastrointestinal (GI) symptoms.2 Case reports exist of cardiac arrest and permanent neuropsychological deficits in a U.S. Army pilot;6 psychosis;7 severe exercise-induced rhabdomyolysis with permanent sensory and motor neurological deficits;8 transient blindness due to posterior reversible encephalopathy;9 and exertional heatstroke in a highly trained, heat-acclimatized infantry soldier.10

Interactions with Medications or Other Bioactive Substances

Use of ephedra with caffeine or other methylxanthines (vasoactives) such as theophylline might increase the risk of stimulatory adverse effects.2,11 Theophylline is found in antiasthmatic combination drugs. Other potential interactions5 include:

NSAIDS (non-steroidal anti-inflammatory drugs); acetaminophen/caffeine/CNS depressant combinations; caffeine; and CNS depressant/aspirin/caffeine combinations.

OTC products containing one or any combination of the following: aspirin, acetaminophen, chlorpheniramine, brompheniramine, dextromethorphan, NSAID, phenylephrine, pseudoephedrine.

Ephedra is a banned substance and has numerous significant interactions with other drugs and supplements. For details of potential interactions, visit the Natural Medicines Comprehensive Database.5

Withdrawal Effects

No data found.

Concern and Benefit Estimate (see Dietary Supplement Risk Matrix)

Benefit potential: Moderate
Risk (safety concern): High
Classification score: 10

There is no dose of ephedra that can assuredly be safe in all situations, and the potential for adverse effects is significant and possibly lethal. This supplement should not be consumed in any amount, in any situation.

References

Ephedra (Má huáng)

  1. Chinese Pharmacopoeia Commission. Pharmacopoeia of the People’s Republic of China, 2000 English Edition. Vol 1. Beijing: Chemical Industry Press; 2001.
  2. Committee on Dietary Supplement Use by Military Personnel. Use of dietary supplements by military personnel. Washington, DC: Food and Nutrition Board, Institute of Medicine; 2008.
  3. Carlton PK. USAF Policy on the Use of Ephedra (Ma Huang) Containing Nutritional Supplements. In: Force A, ed. Washington, DC 2002.
  4. U.S. Food and Drug Administration (FDA). Guidance for Industry: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Small Entity Compliance Guide. Guidance, Compliance & Regulatory Information: Guidance Documents 2008; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm072997.htm. Accessed October 06, 2011.
  5. Jellin J, Gregory, PJ, eds. Ephedra. Natural Medicines Comprehensive Database 2011; http://www.naturalmedicines.com.
  6. Shekelle PG, Hardy ML, Morton SC, Maglione M, et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance - A meta-analysis. JAMA-J. Am. Med. Assoc. 2003;289(12):1537-45.
  7. Baggett M, Kelly MP, Korenman LM, Ryan LM. Neuropsychological deficits of a US army pilot following an anoxic event as a function of cardiac arrest. Milit. Med. 2003;168(9):769-71.
  8. Walton R, Manos GH. Psychosis related to ephedra-containing herbal supplement use. South.Med.J. 2003;96(7):718-20.
  9. Knee TS, Burke J, Seda G, Allen D. A case of severe exercise-induced rhabdomyolysis associated with a weight-loss dietary supplement. Milit. Med. 2007;172(6):656-8.
  10. Moawad FJ, Hartzell JD, Biega TJ, Lettieri CJ. Transient blindness due to posterior reversible encephalopathy syndrome following ephedra overdose. South.Med.J. 2006;99(5):511-4.
  11. Office of Dietary Supplements. Ephedra and Ephedrine Alkaloids for Weight Loss and Athletic Performance. Dietary Supplement Fact Sheets 2004; http://ods.od.nih.gov/factsheets/EphedraandEphedrine/. Accessed October 03, 2011.