Posted by William on January 13, 2012
Oral contraceptive pills (OCs) are the birth control method of choice for over 12 million American women. Used as directed, OCs are extremely effective at preventing unwanted pregnancies, and have an excellent safety record. When women fail to follow prescribed dosing instructions, for example by not taking a pill daily, the failure rate increases substantially. A new study published in the May 9 issue of the Journal of the American Medical Association promises assistance for women who have problems with the daily dosing requirement of OCs.
A team of researchers from the ORTHO EVRA/EVRA 004 Study Group presented data that compares traditional OCs with a skin patch that delivers similar hormones. The potential advantage of the patch is that it need only be applied once per week, and thus avoids problems with daily dosing requirements.
Forty-five clinics in the United States and Canada provided the study participants—1,417 healthy women between the ages of 18 and 45 years who were sexually active and capable of becoming pregnant. The women were randomly assigned to receive either OCs on a typical daily dosing schedule, or the new skin patch. Each patch was worn for seven days at a time, for a total of 21 consecutive days per month; one week was patch-free.
Effectiveness of the two modes of contraceptive therapy was evaluated by calculating an index of the number of pregnancies per 100 person-years of use, as well as by comparing actual with calculated probability of pregnancy. On both measures, the efficacy of the patch was slightly, (although not significantly) better than that of the OCs. Over all, the probability of pregnancy through 13 monthly cycles was 1.3 percent in the patch users, and 1.8 percent in OC users. This figure includes pregnancies resulting from both failure of the method employed, as well as those due to poor patient compliance with directions for use.
Dr. Audet and colleagues reported that the types and frequencies of adverse events were similar in women using patches or pills for contraception. Women in both groups reported some breast discomfort (more in the group using the patch, but only for the first two monthly cycles). Other adverse effects included: headache; nausea; application site skin reactions for patch users; upper respiratory tract infections (17.9 percent in OC users vs. 13.3 percent in patch users); dysmenorrhea (painful periods) (9.6 percent of OC users vs. 13.3 percent of patch users); and abdominal pain (8.1 percent in patch users vs. 8.4 percent in OC users).
Although initially higher in the patch users, by the third cycle on their respective contraceptives, both groups of women reported similar rates of breakthrough bleeding or spotting.
Gilbert L. Ross, M.D., medical director of the American Council on Science and Health, concurred. He stated, “If the results of this study are confirmed by further research, women will have access to another convenient and reliable means of avoiding unwanted pregnancies.”
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