ked questions such as: 'During the past month, how distressed were you by: heavy bleeding during your menstrual period, feeling tightness or pressure in your pelvic area, or feeling fatigued'
Researchers assessed bleeding with a daily log and hemoglobin tests, and administered ultrasound and other tests to assess uterine volume and tumor size. Safety monitoring was conducted throughout the trial. The National Institute of Child Health and Human Development funded the study.
Results were dramatic. By the end of the study, for example, virtually every woman in the mifepristone group was certain she had been receiving the drug because of so many improvements - despite the study's intentional design to keep everyone 'blind' to the data and outcomes.
Here are some statistics cited by the study authors: Although quality of life measurements were the same for both groups at the start of the study, the women on mifepristone reported a 135-percent improvement in quality of life after six months, compared to a 41-percent improvement in the placebo group. Symptoms decreased in both groups, but severity was significantly less in the mifepristone group.
Blood loss also improved among women taking mifepristone. For example, hemoglobin levels went up in the treatment group from 12.0 to 13.5 g/DL, compared to a decrease in hemoglobin levels in the placebo group. At the start of the study, 11 of 22 women (50 percent) in the mifepristone group were anemic, but after six months of treatment only 2 or 22 women (9 percent) were anemic. In the placebo group anemia rose, with 9 of 22 women (45 percent) anemic at the start of the study, and 12 of 22 women (60 percent) anemic after six months.
'These very promising findings warrant replication through a large multicenter study,' the authors wrote. Further studies should evaluate whether the drug can be safely taken for longer periods, and how long after stopping the drug would regrowth of fPage: 1 2 3 Related medicine news :1
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