Effective Treatment for Heavy Menstrual Bleeding
Author Information
Author(s): Ian S Fraser, Susanne Parke, Uwe Mellinger, Andreas Machlitt, Marco Serrani, Jeffrey Jensen
Primary Institution: University of Sydney
Hypothesis
Does oestradiol valerate/dienogest effectively reduce menstrual blood loss in women with heavy and/or prolonged menstrual bleeding without organic pathology?
Conclusion
E2V/DNG was more effective than placebo in reducing menstrual blood loss in women with heavy and/or prolonged menstrual bleeding without organic pathology.
Supporting Evidence
- Median menstrual blood loss decreased by 88% with E2V/DNG compared to 24% with placebo.
- 83% of investigators rated symptom improvement in the E2V/DNG group compared to 40.6% in the placebo group.
- Significant improvements in iron metabolism parameters were observed in women treated with E2V/DNG.
Takeaway
This study shows that a new pill can help women who bleed a lot during their periods feel better by making their bleeding much less.
Methodology
Women aged ≥ 18 years with heavy and/or prolonged menstrual bleeding were randomised to E2V/DNG or placebo for 196 days, with menstrual blood loss assessed using the alkaline haematin method.
Potential Biases
Potential bias due to the double-blind design and reliance on self-reported data for menstrual bleeding.
Limitations
The study may not be generalizable to all populations due to the specific inclusion criteria and the nature of the trials.
Participant Demographics
The majority of participants were Caucasian, with a higher proportion of Black women in the North American study.
Statistical Information
P-Value
p<0.0001
Confidence Interval
95% CI −30.7, −13.6
Statistical Significance
p<0.0001
Digital Object Identifier (DOI)
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