TOC  |    Herbal Medicine    

Be aware that the U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. There is no guarantee of strength, purity or safety of products containing or claiming to contain ephedra. Decisions to use herbs or supplements should be carefully considered. Individuals using prescription drugs should discuss taking herbs or supplements with their pharmacist and other health care providers before starting.

• Unproven Uses
• Potential Dangers
• Interactions
• Dosing
• Summary
• Resources
  

Evidence     

Ephedra is also known as Ma-huang. Ephedra and the chemicals ephedrine and pseudoephedrine in ephedra have been associated with many reports of serious toxicity, including death, and with numerous interactions with drugs, herbs and supplements.

Note: On February 6th, 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. Sales of ephedra have also been banned in several European countries.

On April 14, 2005, a Federal District Court in Utah under Judge Tena Campbell struck down an FDA ban on ephedra. The ruling is specific only to Utah, although it calls into question the FDA ban in general. The suit in question was brought by the dietary supplement manufacturing company Nutraceutical Corporation. The decision specifically questioned the ability of the FDA to ban ephedra completely without conclusively demonstrating danger at low doses.

Although most evidence around the risks associated with ephedra use is based on higher doses or combination use with caffeine, a universal ban was implemented by the FDA, as it would be unethical to conduct human studies of lower doses in order to establish safety. Therefore, Judge Campbell felt there is inadequate safety data at lower doses. This places the FDA in a bind under current dietary supplement regulatory law — it suspects dangers at low doses, but cannot seek to prove these dangers.

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.

Scientists have studied ephedra for the following health problems:

Weight loss

Ephedra contains the chemical ephedrine, which appears to cause weight loss when used in combination with caffeine. However, there are weaknesses with the design of most available studies. There are variable amounts of ephedrine in commercially available products, and thousands of adverse reactions have been reported to the FDA with ephedrine use, including heart attack, stroke, seizure, serious psychiatric symptoms, and death. Before the official ban, the FDA issued a policy that ephedrine products had to be labeled with possible adverse effects, contain no more than 8 milligrams of ephedrine per serving, and be used for no longer than seven days.

Bronchodilator (asthma)

Ephedra contains the chemicals ephedrine and pseudoephedrine. It was used for many years as a treatment for asthma and chronic obstructive pulmonary disease in both children and adults, before the development of more modern treatments. Although ephedrine is an effective bronchodilator, there are drugs that are considered to be safer with less risk of toxicity.

Low blood pressure

Chemicals in ephedra can stimulate the heart, increase heart rate and raise blood pressure. The chemical ephedrine in ephedra has been used in hospitals to control blood pressure during delivery in women receiving spinal anesthesia. However, these effects have not been evaluated for ephedra supplements taken by mouth.

Nasal allergies (used as a nose wash)

Preliminary study suggests possible benefits of ephedrine, a chemical in ephedra, when used as a nasal spray for treating symptoms of nasal allergies. Although results seem promising, further research is needed.

Sexual dysfunction

Preliminary study suggests that ephedra may increase sexual arousal in women. Further research is needed to confirm these results.

Unproven Uses     

Ephedra has been suggested for many other uses, based on tradition or on scientific theories. However, these uses have not been thoroughly studied in humans, and there is limited scientific evidence about safety or effectiveness. Some of these suggested uses are for conditions that are potentially very serious and even life-threatening. You should consult a health care provider before taking ephedra for any use.

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 Obesity Performance enhancer Rash Runny nose Shortness of breath Stimulant Syphilis Upper respiratory tract infection Uterine disorders Water retention

Potential Dangers     

Allergies

• People should avoid ephedra if they have a known allergy. Signs of allergy may include rash, itching or red, flaking skin.

Side Effects

• Ephedra has been associated with thousands of reports of serious toxicity, including over 100 deaths. Ephedra is not considered safe, despite its possible effectiveness for treating certain conditions. Before the official ban of ephedra sales altogether, the FDA issued a policy that ephedrine products be labeled with possible adverse effects, contain no more than 8 milligrams of ephedrine per serving, and be used for no longer than seven days.
• Stomach discomfort, including diarrhea, nausea, vomiting, anorexia, constipation, diuresis (increased urine production), and dry mouth may occur. Liver damage has been reported. Ephedra may also cause seizures, stroke, dizziness, irritability, restlessness, anxiety, nervousness, excitation, euphoria, delirium, confusion, fainting, difficulty sleeping, and headache. There have been cases of psychosis, mania, confusion, and hallucinations after using ephedra. If you have a history of a psychotic illness and are considering using ephedra or other herbs and supplements, discuss this with your health care providers.
• Ephedra may also affect the heart and lungs. Inflammation of the heart; fluid retention in the lungs; breathing difficulties; irregular heart rhythms, including rapid or slowed heartbeats; alterations in blood pressure; heart attack; dilated cardiomyopathy; left ventricular systolic dysfunction; coronary dissection; thrombosis; and cardiac arrest have been reported. Rare side effects include kidney stones, difficulty passing urine or pain when urinating. In theory, ephedra may lower blood sugar levels. Caution is advised if you take prescription drugs to control your blood sugar levels. Ephedra may also lower potassium levels in the blood, cause uterine contractions and lead to tremors, hyperactive reflexes, weakness, muscle aches, degeneration of muscle tissue, depression, mania, agitation, hallucinations, suicidal ideas, and Parkinson's disease-like syndromes.
• If too much ephedra is taken suddenly, symptoms of toxicity may include anxiety, dizziness, difficulty sleeping, chest tightness, decreased appetite, high blood pressure, rapid heartbeats, irregular heart rhythms, stroke, difficulty urinating, vomiting, psychosis or death. When ephedra is used for prolonged periods of time, even at recommended doses, chronic toxicity may lead to weight loss, difficulty sleeping, high blood pressure, dry mouth, irregular heart rhythms, rapid heartbeats, anxiety, obsessive-compulsive disorder, flare, nervousness, and heart damage.
• It has been recommended that ephedra and Ma-huang use be stopped at least one week prior to major surgical or diagnostic procedures.

Pregnancy And Breast-Feeding

Interactions     

Interactions with drugs, supplements and other herbs have not been thoroughly studied. The interactions listed below have been reported in scientific publications. If you are taking prescription drugs, speak with your health care provider or pharmacist before using herbs or dietary supplements.

Interactions With Drugs

• 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.
• Many drugs can cause increased stimulant effects when used with ephedra or ephedrine. Some examples include central nervous system stimulants, theophylline and caffeine. In combination with ephedra, these drugs may lead to sleeping difficulties, nervousness, stomach upset or even death. The combination of ephedrine and caffeine may be fatal. Many products contain both ephedrine and caffeine.
• Bronchodilators used for asthma or the decongestant pseudoephedrine may have increased bronchodilating effects when used with ephedra. Increased adverse effects, including dangerously high blood pressure, muscle breakdown, fever and irregular heartbeats, may occur if ephedra is used with monoamine oxidase inhibitor antidepressants, such as phenelzine (Nardil). Some antipsychotics and other types of antidepressants may reduce the effects of ephedra and cause low blood pressure and rapid heartbeat.
• Because ephedra usually increases blood pressure and can affect heart rate, it may decrease the effectiveness of blood pressure-lowering drugs and some antiarrhythmic drugs, including digoxin (Lanoxin). The adverse effects of ephedra may be increased with guanethidine, ergot alkaloids such as ergotamine, oxytocin, diuretics, urinary acidifiers such as ammonium chloride, thyroid hormones, morphine, halothane or other types of anesthesia, and drugs that reduce blood sugar levels. Because ephedra may lower blood sugar levels, caution is advised if you are taking prescription drugs that may also lower blood sugar levels. Patients taking oral drugs for diabetes or using insulin should be monitored closely by their health care provider while using ephedra. Dosing adjustments may be necessary. The effects of corticosteroids such as dexamethasone may be lessened when taking ephedra, and ephedra may be less effective when used with urinary alkalinizers.
• Phenylpropanolamine, also removed from the U.S. market, may lead to additive effects when taken with 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 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).

Interactions With Food:  Ephedra and caffeine may curb appetite.

Dosing      

The doses listed below are based on scientific research, publications or traditional use. Because most herbs and supplements have not been thoroughly studied or monitored, safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients even within the same brand. Combination products often contain small amounts of each ingredient and may not be effective. Appropriate dosing should be discussed with a health care provider before starting therapy; always read the recommendations on a product's label. The dosing for unproven uses should be approached cautiously, because scientific information is limited in these areas.

Wide variations have been found in the amounts of the active chemicals ephedrine and pseudoephedrine in commercial ephedra products. Before the official ban, the FDA issued a policy that ephedrine products be labeled with possible adverse effects, contain no more than 8 milligrams of ephedrine per serving and be used for no longer than seven days. The FDA banned all sales of the product in 2004. Ephedrine or ephedra is often used in combination with caffeine, but this combination has been associated with significant adverse effects, including death.

Adults (Aged 18 Or Older)

• Oral use: 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. Regulatory agencies have recommended a maximum of 8 milligrams taken by mouth up to every six hours (not exceeding 24 milligrams in a 24-hour period) for up to seven days. Higher doses have been used in some studies and are available in over-the-counter products. Doses of 25 to 50 milligrams of total ephedra alkaloids up to three times daily have been used in some studies. Note that ephedra sales have been banned in many countries, including the United States.

Children (Younger Than 18):  There is not enough scientific data to recommend ephedra for use in children, and it is not recommended due to potential serious side effects. Purified ephedrine has been given to children in a controlled setting under direct medical supervision.

Summary    

Ephedra has been suggested as a treatment for many conditions. Although there is evidence that ephedra is effective for weight loss, bronchodilation, and elevating blood pressure, ephedra has been associated with thousands of reports of adverse effects, including death. There is not enough scientific evidence to support the use of ephedra for any other medical condition. Ephedra may cause heart problems, including irregular heart rhythms and even death. It should be avoided in pregnant and breast-feeding women and in children. Ephedra may lower blood sugar. Use caution if you take insulin or drugs by mouth to control your blood sugar levels. Ephedra may interact with many other drugs, herbs, or supplements, and you should check with your health care provider or pharmacist to screen for dangerous interactions. Consult your health care provider immediately if you have any side effects.

The information in this monograph was prepared by the professional staff at Natural Standard, based on thorough systematic review of scientific evidence. The material was reviewed by the Faculty of the Harvard Medical School with final editing approved by Natural Standard.

Resources     

Selected Scientific Studies: Ephedra

Some of the more recent studies are listed below:

Last updated June 17, 2005