A new study on the controversial weight-loss supplement ephedra contradicts previous allegations that the herb can have dangerous effects on cardiac health.
The study, published in the current issued of The International Journal of Obesity, was carried out on a leading, ephedra-based weight-loss product, Xenadrine RFA-1, produced by Cytodyne Technologies, a New Jersey-based supplement supplier.
"Xenadrine RFA-1 had no negative effects on heart functions in healthy obese people involved in the study. And, within the confines of the study, Xenadrine RFA-1 appears to be safe," said chief clinical investigator, Dr Diane Krieger, medical director of Endocrinology, Nutrition and Diabetes, Miami Research Associates at the University of Miami School of Medicine.
The study comes at a time when several health authorities and medical experts are trying to ban the herb, which is a derivative of the Chinese root Ma Huang, a natural stimulant and a primary ingredient in Xenadrine-RFA-1. Many people maintain that ephedra products, especially synthetic ones, can trigger heart palpitations and "adverse events".
In the study 11 men and 19 women aged 21 to 60 received either RFA-1, or a sugar-based placebo over 14 days - a period considered scientifically sufficient to study heart responses. The goal was to seek solid scientific data on the effects of ephedra, focused on the impact, if any, on the heart.
Dr Krieger said: "We measured heart function in these patients by measuring their blood pressures and heart rates. They were given cardiograms and electro-cardiograms. And, over the two-week period, in the patients we examined, we saw no differences between the two groups. So we concluded in our study, that within the confines of what we did, Xenadrine RFA-1 appeared safe over a two week period in our patient population."
However this goes against several strong views that the herb is dangerous. Last month the director of Public Citizen's Health Research Group, said that dietary supplements containing the herb ephedra are associated with more reports of death, heart attack, hypertension, stroke, and seizure than all other dietary supplements combined.
His comment came during a Senate hearing on the supplement, which produced both strong requests to ban the herb, and reaction from the industry requesting merely tighter legislation and better labelling. There are currently proposed anti-ephedra laws in New York, Kansas and Nebraska, and similar proposed bills in most other states. California's governor signed a bill requiring special safety labelling on ephedra products in September.
However, the FDA has not yet taken action, supporting the industry and claiming there is no conclusive evidence that ephedra is unsafe.
Cytodyne claims that millions of Americans consume tens of millions of Xenadrine RFA-1 capsules annually without side effects. And Dr Krieger noted that not all ephedra products are alike. Xenadrine RFA-1 is made with natural, herbal ephedra, while many brands contain questionable synthetic, unstable compounds. She urged people to read ingredients and purchase ephedra products from trusted manufacturers, adding that many "adverse events" might be caused by people failing to follow dosage directions.
Xenadrine RFA-1 is an appetite-suppressing, fat-burning diet product that increases metabolism. It has been the subject of seven other product-specific clinical trials on humans, according to Cytodyne, in which it has consistently been shown to be safe and effective for weight loss.