How much ephedra is safe

Randomized controlled trials RCT are clinical trials in which participants are assigned randomly to one of two or more treatment groups.

Controlled clinical trials are those in which participants are assigned to a treatment group using a semi-random procedure such as a participant's date of birth, a patient identification number, or the order of enrollment.

In all, we reviewed the results of 52 clinical trials that measured the effects of ephedra or ephedrine on weight loss and athletic performance. Most of these studies included one group of participants who were randomly chosen to receive only a placebo an inactive dummy pill.

This type of study maximizes the likelihood that any differences found between the groups taking the test supplement and those taking the placebo are real, not due to chance or bias. Studies of weight loss usually measure the weight lost over the course of the study, the weight lost per month, or the proportion of an individual's original weight that was lost.

For each group of studies that made the same comparisons for example, all studies that compared the effects of ephedra and herbal caffeine on weight loss with the effects of a placebo , we combined the results of all studies in that group, using a statistical technique called meta-analysis, and calculated the average total weight lost as well as the average lost per month.

Over the short term four to six months , ephedrine, ephedrine plus caffeine, and supplements containing ephedra or ephedra plus caffeine promoted modest increases in weight loss, about two pounds per month more than the weight loss of persons taking the placebo. Products containing caffeine seemed to promote slightly more weight loss than those containing only ephedrine. However, none of the studies lasted longer than six months, far less than the twelve months researchers consider the minimum necessary to establish the value of a weight loss product studies that lasted less than two months were excluded from our analysis because two months is simply too short a time to assess a meaningful change in weight.

We found no studies that assessed the effects of ephedra-containing dietary supplements on athletic performance. Thus we analyzed only studies of products containing ephedrine or ephedrine plus caffeine, seven studies in all.

No two studies were judged similar enough in design to combine their results: Measures of athletic performance varied widely from one study to another. As a result, our conclusions regarding the effects of ephedrine on athletic performance are based on a nonquantitative synthesis of the research rather than on meta-analysis.

In addition, no study looked at long-term changes in performance. Our analysis found that one-time use of ephedrinecontaining products seems to enhance immediate physical performance, but only when taken in combination with caffeine. These results, too, must be interpreted with caution. The studies assessed performance immediately after a single dose; none of the studies examined the type of chronic, long-term use typical of consumers of these products.

What's more, the study participants,all young, fit males,may not be typical of the average consumer. To assess the safety of ephedra- and ephedrine-containing products, we reviewed four sources for reports of adverse events. First, we reviewed the clinical trials included in our analyses of weight loss and athletic performance, most of which reported adverse events for both treatment and placebo groups.

The trials contained no reports of very serious adverse events such as death and cardiovascular events. This is not surprising, considering that the occurrence of such events is likely to be quite rare less than one in a thousand users and the clinical trials included only a few thousand people.

However, we found a two- to threefold increase in the occurrence of nausea, vomiting, anxiety, autonomic hyperactivity, and palpitations, and a trend toward an increase in headaches. Proponents claim that it may help promote weight loss and suppress appetite. Prior to the ban on ephedra supplements, many dietary supplements marketed for weight loss also contained caffeine-containing herbs, such as green tea, yerba mate, and guarana.

Ephedra is similar in structure to amphetamine, so it has been used to increase athletic performance in strength and endurance sports, increase alertness and aggressiveness on the field, and reduce fatigue in sports such as ice hockey, baseball, football, and cycling. There is no strong evidence, however, that it can improve sports performance, and is not recommended for this purpose given the potential side effects.

Ephedra has a long history of use in traditional Chinese medicine and Western herbalism as a remedy for asthma , bronchitis, allergies, fever, chills and cold and flu symptoms, such as nasal congestion. Side effects of ephedra may include:. Use of ephedra has also been associated with stroke , seizures, psychosis, and death when used inappropriately.

A National Institutes of Health review of 16, adverse events linked to ephedra and identified two deaths, nine strokes, four heart attacks, one seizure and five psychiatric cases. The study concluded ephedra is associated with higher risks of heart palpitations, digestive effects, and symptoms of hyperactivity of the autonomic nervous system tremor, insomnia , especially when combined with caffeine or other stimulants such as kola nut, green tea, guarana or yerba mate.

Many adverse effects are attributed to overdose, abuse, and combining it with other stimulants that heighten its effect, such as caffeine. Side effects of ephedra, however, can vary and are not dose dependent. Serious side effects may also occur in susceptible people at low doses. Ephedra is believed to increase the risk of heat stroke because it increases metabolism and impairs the body's ability to lose heat. The risk of adverse effects may be greater in people with preexisting conditions, including:.

People with these health conditions should avoid ephedra. People with allergies to ephedra, ephedrine, or pseudoephedrine should also avoid ephedra. Ephedra shouldn't be taken two weeks before or after surgery. It shouldn't be used by pregnant or nursing women or children. People with anorexia nervosa or bulimia should avoid ephedra because it affects appetite. Between ephedra and ephedrine, 50 additional cases were identified as possible sentinel events.

Another study, funded by the National Center for Complementary and Alternative Medicine NCCAM , released preliminary results on the relative safety of ephedra compared with other herbal products. The study found that the relative risk for an adverse reaction from ephedra was more than times greater compared with other herbs.

Based upon the recent case reports and studies, the HHS issued a press release on February 28, announcing a series of actions designed to protect consumers from products containing ephedra. Warning letters have been sent to dozens of manufacturers challenging them to remove unproven claims or substantiate those claims, particularly with regard to performance enhancement.

A black box warning label about the risk of adverse effects and death will also be mandated. Additionally, the FDA is seeking comments from health professionals, the supplement industry and the general public.

Comments may include any additional data on ephedra's safety, as well as whether the evidence of significant safety concerns is sufficient for new restrictions on products regulated under the DSHEA. Once the day comment period has ended, the FDA will analyze the comments and publish its conclusions.

The NCCAM met on March 17, , to assess the evidence on ephedra's safety and effectiveness in order to develop a research agenda on ephedra. The recent concern towards the safety of ephedra-containing supplements is warranted due to an abundance of case reports and studies.

As health care professionals, it is important to be aware of the adverse effects, including death, which may potentially occur with the use of ephedra. It is also important to advise patients of these adverse effects until the FDA gives further direction.

Wyman Pharm. Leonard Pharm. Lehmann Pharm. Martin Pharm. Drug Information Pharmacist Katie L. Stabi Pharm. All Rights Reserved. CV: stimulant Resp: bronchospasm, asthma, bronchitis, allergic disorders, nasal congestion CNS: stimulant, appetite suppressant Other: weight loss, performance enhancement, energy.

Resp: Possibly effective when taken orally for short-term treatment of diseases of respiratory tract. NOTE: doses for this use often exceed safe limit. Additionally, many ephedrine studies examine the combination of ephedrine and caffeine rather than ephedrine alone Ephedrine, a major component of ephedra, can increase the number of calories your body burns. Research has shown this results in greater weight and fat loss over weeks to months, though long-term studies are limited.

Many studies examining the weight loss effects of ephedrine have combined this ingredient with caffeine. The combination of ephedrine and caffeine appears to exert greater effects on your body than either ingredient alone 12 , For example, ephedrine plus caffeine increases metabolic rate more than ephedrine alone Some research has even reported that caffeine and ephedrine individually had no effects on weight loss, while the combination of the two did produce weight loss Over 12 weeks, ingesting a combination of ephedra and caffeine 3 times per day led to a reduction of 7.

Another 6-month study in overweight and obese people compared a supplement containing ephedrine and caffeine to a placebo during a weight loss program The group taking ephedrine lost 9. The ephedrine group also decreased body weight and LDL bad cholesterol more than the placebo group.

Overall, the available evidence indicates that ephedrine-containing products — particularly when paired with caffeine — may increase weight and fat loss.

Ephedrine plus caffeine may increase metabolic rate and fat loss more than either ingredient alone. Studies show the combination of ephedrine and caffeine produces greater weight and fat loss than a placebo.

Doses of ephedrine used in research vary, with intakes of less than 20 mg per day considered low, 40—90 mg daily considered moderate, and doses of — mg per day considered high. Although some positive effects on metabolism and body weight have been seen across a variety of doses, many have questioned the safety of ephedrine. Individual studies have shown mixed results regarding the safety and side effects of this substance across a variety of doses.

Some have reported no significant side effects, while others indicate a variety of side effects that even caused participants to withdraw from the studies 10 , 17 , In-depth reports have combined the results of multiple studies to better understand concerns associated with ephedrine consumption. One analysis of 52 different clinical trials found no serious adverse events such as death or heart attack in studies on ephedrine — with or without caffeine