Portland, Ore.--Researchers at Oregon Health Sciences University have discovered that a new hormonal drug combination allows post-menopausal women to get the benefits of estrogen without experiencing the side effects of menses-like bleeding. Their findings appear in the Nov. 6, 1996 issue of the Journal of the American Medical Association.
"Daily treatment with a combination drug containing both progestin and estrogen can significantly increase bone mineral density in post-menopausal women," says Leon Speroff, M.D., lead author and professor of ob/gyn at OHSU. "This protects women from the ravages of osteoporosis without the side effect of monthly bleeding, which is the main reason so many women discontinue estrogen replacement therapy."
Speroff and colleagues conducted a two-year clinical trial in which women aged 40 years or older were randomized into either a placebo group or one of eight treatment groups receiving various doses of the estrogen/progestin combination drug. A total of 695 women completed the trial.
Information cited in the study shows that bone mineral density decreases rapidly in women within five years of menopause. "It is estimated that 15 percent of post-menopausal women will suffer wrist fractures and that 25 percent to 40 percent will incur spinal compression fractures," says Speroff. "Of even greater concern is the morbidity and mortality associated with the 15 percent of older women who have hip fractures: 12 to 20 percent die within six months, and half of the survivors require long-term nursing care."
Speroff's study was conducted at 65 centers around the country and indicated that the estrogen/progestin combination contributed to even greater bone mineral density than occurred when estrogen was administered alone. "We found that the bone mineral density increased from 2.2 to 4.2 percent in the groups taking the estrogen/progestin combinations," says Speroff. "That compares to a 7.4 percent decrease in bone mineral density among those in the placebo group and no significant change among those taking estrogen alone."
Speroff further explains that those women taking the drug combination had a decreased incidence of alterations in the lining of the uterus that could lead to cancer. They also had improved blood levels of good cholesterol, or HDL, and decreased levels of the so-called bad cholesterol, or LDL.
"Well-controlled studies comparing estrogen with combination estrogen/progestin treatments have been few and generally have involved only a small number of subjects and dose ranges," says Speroff. "Therefore, the present study provides important new information regarding the effect of added progestin to estrogen therapy on bone mineral density, the lining of the uterus and blood cholesterol levels."