PHILADELPHIA -- A low-dose oral contraceptive was effective for relieving dysmenorrhea in adolescent girls in a controlled study with 76 patients.
"This is the first randomized controlled trial to examine the efficacy of a modern, low-dose oral contraceptive for dysmenorrhea in adolescent girls," Dr. Katharine J. O'Connell said while presenting a poster at the annual meeting of the American College of Obstetricians and Gynecologists.
The results were expected, but it's good to get data to back up the anticipated effect, added Dr. O'Connell of Columbia University in New York.
The study used a standard low-dose formulation. Each daily pill contained 20 [micro]g ethinyl estradiol and 100 [micro]g levonorgestrel, the formulation that is marketed as Alesse by Wyeth. Both the active medication and matching placebo pills were supplied for the study by Wyeth.
Dysmenorrhea is a common problem among teenage girls and causes severe pain in 15%. The study enrolled a demographically diverse group of girls who were 19 years old or younger and had moderate to severe dysmenorrhea. The average age of the 76 girls enrolled was 17 years. Their average body mass index was about 24 kg/[m.sup.2].
Dysmenorrhea symptom severity was self-rated by each patient using the Moos Menstrual Distress Questionnaire (MDQ). Baseline assessment showed that 42% had moderate symptoms and 58% had severe dysmenorrhea. The overall average baseline MDQ score was 11.05 among the 38 girls in the active-drug group and 11.82 among the 38 girls in the placebo group.
Patients were asked to take their medication for three cycles, after which they retook the MDQ and were told to answer the questions based on their most recent cycle. The average MDQ scores on the second questionnaire were 2.78 among the girls on active drug and 5.49 among those using placebo, a statistically significant difference.
The difference in dysmenorrhea severity between the two study groups was also clinically significant. The patients on active drug reported having significantly fewer painful days and fewer hours of severe pain on their worst-pain day, compared with the patients in the control group. Despite the large placebo effect in this study, "subjectively, the girls on the oral contraceptive felt a lot better," she said.
Regular use of an oral contraceptive can provide other benefits for adolescents, including improvements in acne, a reduced risk of anemia, fewer ovarian cysts, and a reduced risk of later developing endometrial or ovarian cancer, Dr. O'Connell told this newspaper.
BY MITCHEL L. ZOLER
Philadelphia Bureau
COPYRIGHT 2004 International Medical News Group
COPYRIGHT 2004 Gale Group
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