DHEA dismissed in Study--or not quite

[Guest guest]

Hi Health Activists,

Back on October 19, 2006 the New England Journal of Medicine(NEJM),

published a study comparing a group of Elderly Men and Women with low levels

of DHEA

and testosterone(in men) who received supplementation over a 2 year

period.The study was randomized and placebo controlled. The Men were divided

into

groups of 29 Men receiving DHEA, 27 received testosterone and 31 received a

placebo.Of the 27 were assigned to receive DHEA and 30 received a placebo.

Although DHEA and testosterone plasma levels were increased in the

supplemented groups as compared to placebo.The abstract and the headlines found

physiological measurement for the DHEA group showed no significant difference

in

body-composition, glucose tolerance or volume of oxygen uptake or muscle

strength but a significant increase in Bone Mineral Density. The testosterone

group

had a slight increase in fat free body mass. The researchers concluded

rather summmarily that neither DHEA or low dose testosterone replacement

therapy

has physiologically relevant beneficial effects.

The actual results reported in the full text of the study found that an

increase in fat-free body mass in the DHEA group was not statistically

significant, but when the men and women were combined the increase was in fat

free

body mass was slightly significant. This was achieved without major adverse

side

effects. The authors bias is apparent.

In the study the men were supplemented 75 mg DHEA daily and the women 50 mg

DHEA. The men receiving low dose testosterone received 5 mg transdermal

testosterone patch. This is a fairly high dose of DHEA. The finding of no

adverse

side effects at this high level is more reassuring for this dietary

supplement. I take only 10 mg daily.

In the February 8,2007 issue of NEJM a number of letters pointed out the

way in which the study over-interpreted it's trumpeted findings. But among the

letters was a revealing letter from Dr. Thomas Perls,MD of Boston University

Medical Center, that was fully laid out the underlying economic motivation of

the rationale for regulating dietary supplements in general and DHEA in

particular.

He is dismayed that after the FDA removed DHEA from the market in 1985 based

on the fact that the manufacturer did not obtain FDA approval for a new drug

based on Safety and efficacy data to support the claims for cardiovascular

health and anti-aging. There was no record of problems with safety. Even to

this day DHEA has a very safe record based on its not being mentioned in the

annual reports of the American Association of Poison Control Centers. In other

words, because the manufacturer did not obtain the expensive new drug

approval recommendation of FDA, as Phen Phen, Horse Estrogens and Vioxx did, it

should not be sold. This arbitrary removal of a safe supplement was precisely

the reason the Dietary Supplement Health Education Act was passed.

arnold