Scientific Studies and Reports
Ephedra products have been the subject of numerous
scientific studies and reports. All studies and reports have demonstrated
that Ephedra products are safe and effective in contributing to
weight loss when used as directed.
EEC Expert Panel Report
The EEC Expert Panel was convened in response to a request for information on Ephedra from the U.S. Department of Health and Human Services. The panel's report reflects the conclusions of the most comprehensive consensus panel review to date of the Ephedra safety issue. The EEC Expert Panel, composed of seven medical and scientific experts from a variety of relevant disciplines, reviewed all of the available scientific data as well as the AERs collected by FDA. Their conclusion was that Ephedra was safe as a weight loss product when taken according to Industry recommended standards.
Click here for more details about
the report.
Back to top
The Cantox Report: Safety
Assessment and Determination of a Tolerable Upper Limit for Ephedra
Cantox Health Science International, an internationally
recognized scientific research organization, prepared this report
for the Council for Responsible Nutrition. Referred to as the "Cantox
Report," this report is the only formal risk assessment that has
been done to date for dietary supplements containing Ephedra. The
method of analysis used was developed by the Food and Nutrition
Board, Institute of Medicine, National Academies, for application
to nutrients. This risk assessment establishes that Ephedra is safe
when consumed according to the industry
recommendation, which has been adopted as state law in several
states.
Click below to view the Cantox Report:
Abstract
Executive
Overview
Council for Responsible Nutrition Comments to FDA
Download Complete Cantox Report (Read-only MS Word document)
Back to top
Harvard/Columbia Study:
Herbal Ephedra/Caffeine for Weight Loss: A 6-Month Safety and Efficacy
Trial
The data from this double-blind, placebo-controlled
clinical study was published in the May 2002 issue of the International
Journal of Obesity (IJO). The study, which used Holter monitors
to provide extensive data on heart function and blood pressure,
was designed to assess both the safety and efficacy of a "generic"
Ephedra/caffeine combination product at a dose of 30 mg of ephedrine
alkaloids per serving three times per day. Dr. Carol Boozer and
Dr. Patricia Daly, study authors, concluded that "...herbal
ephedrine/caffeine herbal supplements, when used as directed by
healthy overweight men and women in combination with healthy diet
and exercise habits, may be beneficial for weight reduction without
significantly increased risk of adverse events."
Back to top
St.Luke's Hospital/Columbia
University Study: An Herbal Supplement Containing Ma Huang-Guarana
for Weight Loss: A Randomized, Double-Blind Trial
This clinical study, published in a peer-reviewed journal in March 2001, shows that a commercial product, Metabolife 356, produced significant weight loss over an eight-week period. The authors concluded that safety for long-term use required further study. The 6-month Harvard/Columbia study described above, conducted by some of the same researchers after this study on Metabolife's product was completed, was specifically designed to address questions concerning longer-term use mentioned in this study.
Back to top
Greenway Article: The Safety
and Efficacy of Pharmaceutical and Herbal Caffeine and Ephedrine
Use as a Weight Loss Agent
This is a peer-reviewed article published in March 2001 reviewing more than 100 published papers evaluating the benefits and risks of synthetic ephedrine and ephedrine alkaloids from Ephedra from the standpoint of their usefulness in weight control. The author, Dr. Frank Greenway, is an internationally recognized expert and researcher in bariatric medicine from the Pennington Biomedical Research Center. Dr. Greenway concludes that the combination of Ephedra and caffeine is effective as a weight loss agent, the weight loss benefits of these products "appear to outweigh the small associated risks," and Ephedra products should remain on the market while further clinical studies are conducted to confirm his conclusions.
Back to top
Pennington Study: Safety
and Efficacy of an Herbal Dietary Supplement Containing Caffeine
and Ephedra for Obesity Treatment
This double-blind placebo controlled clinical study and the study described below, both conducted on commercial Ephedra products, were published in abstract form in October 2001. The authors of this study, which was conducted at the Pennington Biomedical Research Center by Dr. Frank Greenway and others, concluded that caffeine and Ephedra "increased metabolic rate and gave weight loss safely in this 3-month trial."
Back to top
Dr. Stephen Kimmel, chair of the EEC Expert Panel, compared the incidence of seizures, strokes, and MIs in users of dietary supplements containing ephedrine alkaloids to the incidence of events in the general population. Dr. Kimmel estimated the number of events in the general population by using incidence data obtained from recent studies (i.e., articles published from 1985 to present).
Back to top
New England Journal of
Medicine: Adverse Cardiovascular and Central Nervous System Events
Associated with Dietary Supplements Containing Ephedrine Alkaloids
This article, published in the New
England Journal of Medicine (NEJM) in December 2000, is a review
of 140 AERs on Ephedra. The authors of the article concluded that
31% of the AERs were definitely or probably related to Ephedra consumption;
however, the authors conceded in a
letter to the editor of NEJM, published on April 5, 2001, that
"[o]ur report does not prove causation, nor does it provide quantitative
information with regard to risk."
In a letter to the editor regarding
the NEJM article, also published on April 5, 2001, Dr. Grover Hutchins,
an EEC Expert Panel member, noted that he had previously reviewed
eight of the AERs that the authors believed to be related to the
use of Ephedra products, and he came to a different conclusion -
that there was an adequate explanation for those AERs and that the
implication of ephedrine-type alkaloids in deaths from a wide variety
of conditions that occur in the general population is no more than
idle speculation."
Back to top
Other Studies and Reports
include:
Eastern Michigan University Study
Miami Research Associates Study
Peak Wellness Study
|
