One year of combination hormone replacement therapy significantly improves some menopausal symptoms and health-related quality of life for women, compared with placebo, according to the large, randomized, Women's International Study of Long Duration Oestrogen after the Menopause.
“In light of the WISDOM findings on quality of life, consideration should be given to revisiting HRT guidelines,” according to Dr. Alastair H. MacLennan of the University of Adelaide (Australia) and his colleagues on the WISDOM team.
In the study, a total of 1,043 women aged 50–69 years with follow-up data were randomised to daily oral combination hormone therapy (HT).
They took conjugated equine estrogen 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg (Prempro, Wyeth Ayerst).
Their symptoms, quality of life, and other outcomes were compared with 1,087 women who took a once-daily oral placebo. Participants were enrolled in the United Kingdom, Australia, and New Zealand.
Fewer hot flushes (9% vs. 25% of the placebo group) and a lower rate of night sweats (14% vs. 23%) were among the significant benefits of combination HT at 1 year. In addition, fewer participants in the combination HT group reported aching joints and muscles (57% vs. 63%), insomnia (35% vs. 41%), or vaginal dryness (14% vs. 19%).
At the same time, women in the treatment group reported significantly more breast tenderness (16% vs. 7%) and vaginal discharge (14% vs. 5%) than did women in the placebo group (BMJ 2008; 337:a1190 [doi:10.1136/bmj.a1190
“This study shows just how effective hormone therapy can be in alleviating hot flushes and sleep disturbances and in generally improving other components of quality of life and well-being,” Dr. Amos Pines of the department of medicine at Ichilov Medical Center, Tel Aviv, said in a written statement.
Dr. Pines is not affiliated with the study and commented on behalf of the International Menopause Society.
“This is a significant study, which supports our views on HT,” Dr. David W. Sturdee, IMS president, said in the same statement. “It shows that HRT can offer real benefits to most women experiencing menopausal symptoms. This study reinforces the benefits of appropriate use [of HT].” Dr. Sturdee is in the department of obstetrics and gynaecology, Solihull (U.K.) Hospital.
“Taking everything into account, latest data [show] that hormone therapy in healthy women during the early postmenopausal period is really pretty safe,” Dr. Pines said.
Consider these benefits in individualised decisions about use of combined HT, the study authors wrote. And weigh them against short- and long-term risks of therapy, including potential increased cardiac events, venous thromboembolism, and breast cancer,
Other menopausal symptoms, depression, and overall quality of life were not significantly different between groups. The WISDOM outcome measures included a modified version of the Women's Health Questionnaire, a 28-item meno-pause symptom questionnaire, the European quality of life instrument, a generic overall quality of life visual analog scale, and a 20-item Center for Epidemiologic Studies Depression Scale.
The positive outcomes of the WISDOM study are consistent with vasomotor symptoms, sleep, and bodily pain improvements reported in the Women's Health Initiative (WHI) study (JAMA 2002;288:321–33). Similar health-related quality of life improvements were demonstrated in another study (N. Engl. J. Med. 2003;348:1839–54), but WISDOM is the first to use instruments specific to menopause.
WISDOM was initially launched in 1999 as a 10-year study to assess many possible effects of combined HRT. However, it was halted early after safety concerns of the WHI study were announced. Nevertheless, the WISDOM authors collected enough quality of life and symptom data from the women to perform the current analysis. A loss to follow-up and considerable discontinuation of study medication may have introduced selection bias and are potential limitations of the study, the authors noted.
The authors had no relevant financial disclosures.