Study dismisses HRT as clinically useless

Hormone replacement therapies such as Wyeth's Prempro - at the centre of a health controversy last year - have no "clinically meaningful effect" in treating post-menopausal symptoms, reports the New England Journal of Medicine.

(The Financial Times) -- The report, released yesterday, said treatments combining estrogen and progestin made no difference in mental health, depression or sexual satisfaction between women on the drug and the placebo group.

"Estrogen plus progestin did not have a clinically meaningful effect on any aspect of health-related quality of life," the NEJM said.

A benefit in sleep disturbance and pain was observed, but researchers said it was too small to be clinically significant and was restricted to the first year of use.

The news is another serious blow to Wyeth, by far the leading producer of such treatments in the US. Following reports last year that Wyeth's Prempro can increase the risks of breast cancer, heart attack and stroke, combined fourth-quarter sales of the treatment and the related drug Premarin fell 21 per cent to $338m. They remain, however, one of Wyeth's biggest revenue sources.

The company had hoped to revive the business following last week's US Food and Drug Administration approval of a lower-dose version of Prempro, which is expected to be shipped to drug stores in June.

The lower dose version of Prempro was meant to address health risk concerns, but "a lower dose would have even less of an impact, presumably, on symptoms", said Shaojing Tong, an analyst with the pharmaceutical research group Mehta in New York.

It is unclear how the research will impact Premarin, a mono-therapy that contains estrogen but not progestin. Because the NEJM study looked at women of 50 and older, Prempro may still benefit women in the middle of or immediately following menopause. "It may be the drug should only be prescribed to younger women," Mr Tong said.

Wyeth added progestin to Prempro to guard against uterine cancer.

A large, federally-funded clinical trial, the Women's Health Initiative, last year took the unusual step of releasing information before it completed the scheduled eight years of observation. Physicians said they had observed a big enough hike in breast cancer and heart disease five years into the trial to warrant early release of results to the public.

The news created confusion among women using HRTs to relieve the symptoms of menopause.