Ephedra (Ephedra sinica)

 
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Ephedra
Ephedra

Background

On February 6th 2004 The 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. In April of 2005, a Utah Judge competed with this rule.

 

 It remains unclear whether ephedra will find its way back onto shelves, despite widespread acknowledgement of significant safety risks, including serious potential cardiovascular events or death .

 

 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, tachycardia, CNS excitation, arrhythmia, myocardial infarction, 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 U.S. continued to take ephedra or ephedrine-containing products.

 

Synonyms

4-hydroxy-3-(3-methyl-2-butenyl)phenyl beta-D-glucopyranoside, (nebrodenside A), Amsania, brigham tea, budshur, cao Ma huang (Chinese), chewa, Chinese ephedra, Chinese joint fir, desert herb,  E. altissima, E. americana, E. anti-syphilitica, E. distacha, E. distachya, E. equisetina  (Mongolian Ephedra),  E. geradiana, E. helvetica, E. intermedia  (intermediate ephedra),  E. likiangensis,  E. major, E. minuta, E. monosperma, E. nevadensis,  E. przewalskii, E. sinica,  E. shennungiana, E. trifurca, E. viridis, E. vulgaris, Ephedraceae  (family), ephedra alkaloids, Ephedra distachya, Ephedra intermedia, Ephedra nebrodensis, Ephedra przewalskii, Ephedra regeliana, Ephedra sinica Ephedra soup medicines, Ephedrae herba, ephedrine, ephedrine hydrochloride, ephedrine sulphate, ephedroid, epicatechin, epitonin, European ephedra, herba ephedrae, horsetail, hum, huma, Indian joint fir, intermediate ephedra, joint fir, khama, mahoŕng, máhuáng, "Mao" (Chinese), mao-kon, mahuuanggen, methylephedine, methylephedrine, methylpseudoephedine, Mexican tea, môc tac ma hoŕng, 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, san-ma-huang, sea grape, shrubby, soma, song tuę ma hoŕng, squaw tea, teamster's tea, trun aa hoŕng, tsao-ma-huang, tutgantha, yellow astringent, yellow horse, zhong Ma huang.

 

Note: There are approximately 40 species of ephedra.

 

Evidence

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 has widely varied.

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)

Preliminary study suggests that ephedrine nasal spray, a chemical in ephedra, may help treat symptoms of nasal allergies. Additional research is needed before a 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

One small study suggests 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.

Acute coryza (rhinitis), anaphylaxis (a severe allergic reaction), anti-inflammatory, antiviral, appetite suppressant, athletic performance enhancer, bed-wetting, body building, chills, colds, congenital myasthenic syndrome, cough, decongestant, depression, diuretic, dyspnea (shortness of breath), edema, energy enhancer, euphoria, fevers, flu, gonorrhea, gout, hay fever, hives, increased sweating, joint pain, kidney disease, lack of perspiration, metabolic enhancement, myasthenia gravis, narcolepsy, nasal congestion, nephritis, performance enhancement, runny nose, shortness of breath, stimulation of energy, syphilis, stimulant, upper respiratory tract infections, urticaria (rash), uterine stimulant, water retention.

Dosing

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.

Adult Dosing (18 years or older):
 Note  : The United States Federal Government announced on Tuesday December 30, 2003 that it is banning the sale of ephedra early in 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.  

 

Pediatric Dosing (younger than 18 years):
Ephedrine is not recommended in children due to the risk of toxicity and death.

 

Safety

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.

 

Side Effects and Warnings
The Food and Drug Administration (FDA) has collected thousands of reports of serious toxicity (including over 100 deaths). On December 30, 2003, U.S. federal officials announced plans to ban the sale of dietary supplements containing ephedra, due to continued and growing health concerns. The FDA notified more than 60 companies that market ephedra products, and issued a consumer warning. On February 6th 2004 The 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.

 

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.

 

When used for prolonged periods, even at recommended doses, ephedra may lead to weight loss, difficulty sleeping, anxiety, obsessive compulsive disorder (OCD) flare, high blood pressure, dry mouth, irregular heart rhythms, and heart damage.

 

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.

 

Interactions

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 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) 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 products should be stopped 24 hours prior to surgery.

 

Ephedra may lower blood sugar levels, although ephedra-caffeine combinations may increase blood sugar. Caution is advised when using medications that may also lower 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. One study of Metabolife 356, a product containing ephedra and multiple other ingredients, was associated with heart rhythm abnormalities (arrhythmias, QT prolongation) and may therefore interact with other agents with similar side effects like haloperidol (Haldol®) and metoclopramide (Reglan®).

 

Phenylpropanolamine, previously removed from the US market, may lead to additive effects if taken with ephedra.

 

Ephedra may also interact with alcohol, general anesthetics and urine acidifiers/alkalinizers.

 

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, 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.

 

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 may cause severe side effects, including dangerously high blood pressure, muscle breakdown, fever, and irregular heartbeats.

 

Effects of cholesterol lowering herbs and supplements may be altered by ephedra, although this has not been proven. One study of Metabolife 356, a product containing ephedra, shows that it may cause heart rhythm abnormalities (arrythmias, QT prolongation) and may therefore interact with other agents with similar side effects.