Ephedra, Ma huang : Dosing and Safety

by MedlinePlus

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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.

Standardization

Standardization involves measuring the amount of certain chemicals in products to try to make different preparations similar to each other. It is not always known if the chemicals being measured are the "active" ingredients. There is wide variability in the alkaloid content of different preparations of ephedra. A 1998 study by Gurley et al. examined the pseudoephedrine and ephedrine content of nine commercially available nutritional supplements containing Ephedra sinica . Significant variations in content were found for pseudoephedrine ranging from 0.52-9.46mg and for ephedrine from 1.08-13.54mg per recommended dose. A 1992 study by Liu et al. was conducted by collecting 22 different ephedra products from herbal shops throughout Taiwan. A four-fold difference was found in the amounts of the various alkaloids, ranging from 0.536-2.308%. Average ephedra supplement content is 1% of the crude plant.

Different ephedra species, yielding markedly different quantities of active alkaloids, are all sold as Ma huang in China, leading to difficulties for consumers trying to find standardized products. Ephedra sinica plants grown in northern China often have a different morphology and alkaloid content from the same species grown in southern China.

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. Controversy Regarding Dosing: There is disagreement regarding the optimal form and dose of ephedra. Traditionally, herbalists have recommended a wide range of doses, which are typically higher than U.S. Food and Drug Administration (FDA) recommendations. In the past, the FDA has recommended a maximum of 8mg up to every six hours (total daily dose of 24mg) for up to seven days. However, doses up to 25mg of total ephedra alkaloids four times daily have been recommended by some experts, and doses in some studies have been as high as 50-100mg of ephedra three times daily. Over-the-counter drugs containing ephedra generally contain warning labels advising adults to take 12.5-25mg every four to six hours, and not to exceed 150mg in 24 hours.

Weight Loss: In the past, the FDA has recommended no greater than 8mg every six hours for up to seven days. Doses used in some clinical trials have been 25-50mg three times daily.

Pediatric Dosing (younger than 18 years):

Ephedrine is not recommended in children due to the risk of toxicity and death. Purified ephedrine has been given to children older than two years of age in doses of 2-3mg/kg/day divided into 4-6 daily doses in hospital settings.

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 and 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.

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