Health Conditions

What is on the horizon?

Recently, two large, long-term studies and several smaller ones concentrated on defining the risks and benefits associated with ERT and HRT. In 1998, results form the Heart and Estrogen-Progestin Replacement Study (HERS) found no heart disease prevention benefit from HRT. Those findings were confirmed in a follow-up study (HERS II) that concluded in 2002. The good news, however, is this study showed that after an initial treatment period of 2 years with hormones, the risk of blood clots declined to a non-significant difference. Therefore, long-term there seems to be no increased risk of blood clots. The HERS II study also demonstrated that there were no differences between the hormone group and the placebo (inactive pill) group in the incidence of any types of cancer.

An even larger study, the Women's Health Initiative (WHI) sponsored by the National Heart, Lung and Blood Institute of the U.S. National Institutes of Health also examined the use of both ERT and HRT by thousands of women. The part of WHI that concerned HRT began in 1993 and ended in 2002 ? well before the planned end date. It was stopped when higher rates of breast cancer, heart disease, stroke, and blood clots in the lungs were found in women who were taking HRT than in women taking a placebo.

The estrogen-only part of the WHI, scheduled to end in 2005, was also stopped early (in February 2004) after results showed that estrogen apparently increased the risk of both stroke and dementia (decreased mental functioning). Benefits from treatment in this study included a reduction in fractures, conferring protection from osteoporosis. Neither part of WHI found any benefit for ERT or HRT in preventing heart disease.

The Women's International Study of Long Duration Oestrogen After Menopause (WISDOM) was a study performed in the United Kingdom, Australia, and New Zealand that was designed similar to the Women?s Health Initiative study. The trial was stopped early following the publication of results from the Women's Health Initiative study. Reports of results from the portion of the WISDOM study that was completed were consistent with those from the Women?s Health Initiative. Older women beginning HRT many years after the start of menopause were at greater risk for cardiovascular events and blood clots. The investigators suggested that research is needed to assess the long term risks and benefits of starting HRT in younger women, who may have different effects than older women starting HRT.

To investigate this issue, a substudy of the estrogen-only part of the Women?s Health Initiative was recently undertaken. The results of this substudy demonstrated that younger postmenopausal women who had had a hysterectomy and who took ERT had significantly less buildup of calcium plaque in their arteries compared to those who did not take hormone therapy. This is good news for younger women who have had a hysterectomy and want to use short-term estrogen therapy to relieve the symptoms of menopause. However, more studies in this age group are needed, and it should be noted that these findings do not alter the previous recommendation that hormone therapy should not be used to prevent heart disease.

In other research:

The National Center for Complimentary and Alternative Medicine (NCCAM), a division of the U.S. National Institutes of Health, is currently conducting several clinical trials investigating the effectiveness and safety of natural menopause treatments. Black cohosh, soy and other isoflavones, and red clover are the primary agents being studied. However, clinical studies to date have failed to demonstrate positive results with these natural products.

Some evidence suggests that antidepressant drugs may help to control hot flashes. In small studies involving women with hot flashes, drugs known as selective-serotonin reuptake inhibitors (SSRIs), such as fluoxetine, sertraline, and paroxetine, relieved hot flashes up to twice as well as placebo. Another type of antidepressant, venlafaxine, has also shown effectiveness. Possible side effects from antidepressants include constipation or diarrhea, dry mouth, insomnia, nausea, and sexual dysfunction. In addition, antidepressant drugs may interfere with the effectiveness of tamoxifen, a drug used to treat breast cancer.

Gabapentin, a drug used to control epileptic seizures and some types of pain, has also shown some promise for controlling hot flashes. A recent study has demonstrated that gabapentin appears to be as effective as estrogen in treating menopausal hot flashes. The exact mechanism of action in menopause is not completely understood, but it may help to normalize the body?s temperature. In clinical and case studies of its use, women taking gabapentin reported reductions in other menopausal symptoms, such as mood changes and muscle aches, as well. Side effects ? mainly dizziness, tiredness, and swelling in the hands or feet ? were generally mild and appeared to be similar to those experienced by women taking estrogen only. Usually, side effects lessened after a few days of therapy. Gabapentin does not interfere with tamoxifen therapy for women who have breast cancer.

Also under study is the drug clonidine, which is commonly used to treat high blood pressure. Like gabapentin, clonidine can be used at the same time that tamoxifen is being taken. In case reports, clonidine relieved the length, number, and severity of hot flashes, at least mildly, for many women who were taking it. However the effects of clonidine on hot flashes wore off more quickly than anti-depressants or gabapentin. In addition to oral tablets, clonidine is available as a transdermal patch, which may be easier for some women to use. However, women taking clonidine experienced more problems with sleeping than women who were taking a placebo.