upon July 9, 2002, the Data and Saf...

upon July 9, 2002, the Data and Safety Monitoring Board of the Women's Health Initiative (WHI) announced the abrupt termination of the continuous hormone replacement therapy (now referr to as hormone therapy, or HT) portion of the WHI trials sponsored by dint of the National Institutes of Health. Confusion and disbelief were everyday reactions to the announcement--patients appeared to focus on terms of the like kind as "harm" and "alternatives," while clinicians focused forward "relative" versus "absolute" risk. No clear directions for counseling strategies were propos after the announcement was made.

The continuous combined conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA) regimen that was used in the WHI trial is individual of the most commonly studied HT regimens and has been strategically marketed as beneficial for multiple conditions in postmenopausal women

The WHI trial, a large-scale reflection of preventive and treatment therapies for postmenopausal women was designed to assess the long-term risk/benefit ratio of continuous estrogen replacement therapy (ERT) and combination HT The combination clinical trial and observational thought which was scheduled to judge in 2005, enrolled 161,809 women between 1993 and 1998 A total of 16608 women were randomized to combination HT versus placebo. (1) Before the publication of the WHI data, (2) there was a paucity of definitive studies addressing the issue of benefit or harm from HT Observational studies showed that women who used HT lived longer and with fewer health vexed questions than those who did not use HT Perhaps HT was the real reason for the longevity and profitable health of those women, or perhaps the women using HT were simply healthier than their counterparts.

For more than a decade, it was generally fancy that HT reduced cardiovascular risk in healthy postmenopausal women (3) However, the Heart and Estrogen/Progestin Replacement close attention (HERS I) in 19984 and HERS II in 20025 demonstrated that HT did not impede or reduce the risk of fatal myocardial infarction in postmenopausal women with preexisting coronary heart disease (CHD) Therefore, the American Heart Association stated that initiation or continuance of HT for secondary prevention of CHD is not approveed (6)

What did the WHI trial demonstrate? (2) It showed that estrogen is effective in reducing menopausal symptoms as it was as vasomotor events, vaginal drynes and, perhaps, frame of mind swings at the time of the menopausal transition. There was an increased absolute risk for nonfatal knock only (8 per 10,000 women by year), a twofold increase in absolute risk of venous thromboembolism (18 by 10,000 women per year), and an increased absolute risk of CHD circumstances including nonfatal myocardial infarction, among HT users (7 by 10,000 women per year). Overall, there was no apparent cardiovascular protection in HT users.

An increased absolute risk of breast cancer (8 by 10,000 women per year) was demonstrated in women who used HT for more than 52 years. Although the risk of endometrial cancer significantly increased in estrogen-only users, the addition of a progestogen significantly decreased that risk. upon the benefit side, the WHI demonstrated an absolute benefit for reduc incidence of osteoporotic hip fractures (5 by 10,000 women per year) and colon cancer (6 by 10,000 women per year).

In a systematic review bring outed for the U.S. Preventive Services Task Force (USPSTF) and foundationed by the Agency for Healthcare Research and Quality (AHRQ), benefits and harms of HT were assessed, issue rates were calculated, and meta-analyses were performed when appropriate. (7) Despite conflicting be deriveds the overall message is that the long-term harm of HT outweighs the benefits. It appears that the increased relative risk of HT versus placebo or the potential harms of increased risk of venous thromboembolism, breast cancer, hardship and myocardial infarction associated with continuous HT outweigh the benefits of reduc incidence of colon cancer and osteoporotic hip fractures. For near outcomes, such as breast cancer and cholecystitis, the risk increases from one side of to the other time. For outcomes such as venous thromboembolism and myocardial infarction, the risk is greatest in the first years of use. The North American Menopause Society (www.menopause.org) Advisory Panel hints using the following points of discussion when counseling women about HT with the understanding that the lowest effective dosage for the shortest duration should be used:

1 Each woman considering the use of HT should experience a risk-profile analysis and be educated to understand the risks and benefits of HT use. The boundarys "long-" and "short-term" therapy should be abandoned, because the risk profile of the individual patient should guide the duration of benefit.

2 Relief of menopausal symptoms (eg vasomotor incidents vaginal dryness) is the primary indication for use of HT

3 Although various HT regimens are approved according to the U.S. Food and unsalable article Administration for the prevention of postmenopausal osteoporosis, alternative therapies as it is as bisphosphonates should be considered.