Many Women With Lupus Can Safely Use the Pill: Study
Findings run counter to conventional wisdom
WEDNESDAY, Dec. 14, 2005 (HealthDay News) -- Contrary to conventional wisdom, two new studies show that women with mild-to-moderate forms of lupus can take oral contraceptives without exacerbating the disease.
The findings mean that thousands of women with the autoimmune disease will have more choice when it comes to birth control, the researchers said.
"This is a huge shock to the entire rheumatology community because we've been telling everyone for 30 to 40 years, 'No oral contraceptives for lupus'," said Dr. Michelle Petri, lead author of one of the studies and a professor of medicine at Johns Hopkins University School of Medicine in Baltimore.
"We would have sworn on a stack of bibles that oral contraceptives were bad, but they don't cause flares. This is very important news for women with lupus," Petri said.
The findings appear in the Dec. 15 issue of the New England Journal of Medicine.
Dr. Bonnie Bermas, author of an accompanying editorial in the journal and director of the Lupus Clinic at Brigham and Women's Hospital in Boston, added, "In patients with mild, well-controlled disease, the use of oral contraceptives do not appear to increase the risk of flare rates. This is very encouraging news."
And in a statement, Sandra C. Raymond, president and CEO of the Lupus Foundation of America, hailed the results as "welcome news."
There are some cautionary notes involving the research, however. The findings do not apply to women with more severe forms of the disease. And neither study involved particularly large numbers of women, said Dr. Mark Horowitz, an assistant professor of medicine at Mount Sinai School of Medicine, in New York City. In addition, many women dropped out of the studies, he said.
"It's a select group of patients and a small number," Horowitz said. "This article should be a catalyst for a very large, multi-center study."
Doctors have been uncomfortable prescribing the pill to women with lupus on the basis of animal studies and other studies that indicated the risk of unwanted side effects. The fact that 90 percent of the estimated 1.5 million cases of lupus in the United States occur in women also suggested that hormones such as estrogen might play a role.
"There was a good reason to be very conservative in offering this as an option," Bermas said.
On the other hand, women with lupus are in need of an effective birth control method.
"Pregnancy is a high-risk time for women with lupus," Petri said. "They're more likely to have preeclampsia or premature birth and many studies have suggested that lupus is more likely to flare [during pregnancy]. Unfortunately, women with lupus are often taking medicines that are forbidden because they might cause birth defects."
According to the Lupus Foundation of America, lupus is a disease that causes inflammation in different parts of the body, often the skin, joints, blood and kidneys. Although the precise causes of the disease aren't known, the immune systems of those with lupus attack their own cells and tissues.
Petri's study involved 183 women at 15 sites in the United States with inactive or "stable active" lupus. The women were randomly assigned to take either the pill or a placebo. Flare rates were almost equivalent -- 7.7 percent of women taking the pill experienced a severe flare-up, compared to 7.6 percent of women in the placebo group.
In a second, single-center study that took place in Mexico, 162 women were randomly assigned to take the pill, a progestin-only birth-control pill or an IUD. Again, there were no significant differences among the groups in disease activity.
Both findings corroborate a recent study that found that menopausal women with lupus who took a short course of hormone-replacement therapy were not risking severe flare-ups of their disease. The women did, however, have a slight increase in mild-to-moderate flare-ups.
The authors of the new findings stressed that oral contraceptives should probably not be used by women with severe forms of the disease, or by women with a proclivity to clotting.
For women who can consider using them, oral contraceptives may have additional benefits, such as controlling lupus activity and preventing bone loss, the researchers said.
"The nice thing is these are two studies done very differently and both studies came to the same conclusions," Bermas said. "You have each study supporting the finding of the other."
The Lupus Foundation of America has more on this disease.