A New Treatment Time-Table for Controlling Endometriosis-Associated Pelvic Pain

This study uncovers a better treatment tool for endometriosis pain management in Flexible Management of Intracyclic Bleeding regimen consisting of a flexible extended estrogen/progesterone (EP) product with ethinylestradiol 20 μg/drospirenone 3 mg.

Key Points

Highlights:

• This study examines the efficiency and risk associated with using a flexible extended estrogen/progesterone (EP) product that consists of ethinylestradiol 20 μg/drospirenone 3 mg and follows a prescribed course of treatment, namely the Flexible Management of Intracyclic Bleeding (FlexibleMIB) regimen. The authors believe that this method of treatment will be most effective for managing endometriosis pain.

Importance:

• Endometriosis is an extremely painful disease and women suffering from this disease have very few treatment options that are both efficient and safe. This study seeks to eliminate this issue.

What’s done here?

• This study can be classified as a phase 3, randomized, double blind, placebo controlled, parallel group study. This study also has a 24 week double blind treatment phase and a open label extension phase that last 28 weeks and has a unblended reference arm that was primarily used to test the long term safety of FlexibleMIB.
• There were 312 women with endometriosis that participated in this study. These women were older than 20 years and have clinically been diagnosed with endometriosis. One of the major exclusion criteria for this study is if the participant undergoes surgery within 2 months of the beginning of the study.
• The patients were randomly assigned to three groups: a placebo group, a FlexibleMIB group, and a Dienogest group.
• The FlexibleMIB and placebo group received one tablet everyday for 120 consecutive days and then were given no tablets for 4 days. This cycle was only interrupted in the event that the participant had 3 more days of spotting/bleeding, which meant that the participant would stop the cycle, have 4 tablet free days and then start the 120 day cycle once more.
• The placebo group followed the same treatment schedule as the FlexibleMIB for 24 weeks, but after the 24 weeks were through, the placebo group became another FlexibleMIB group.
• The Dienogest group received 2 mg/d for 52 weeks.
• The variable being measured is the change in endometriosis-associated pelvic pain (EAPP) using visual analog scale (VAS) scores from the beginning of the experiment to the first phase, which is the double blind treatment phase.
• Various assessments were conducted every 4 weeks. The assessments include pregnancy tests and adverse event monitoring.
• The quantitative data from this experiment was subject to statistical analysis.

Key results:

• The FlexibleMIB was found to have reduced EAPP, other endometriosis related pain, and endometrioma size when compared to the placebo group. In fact, the mean difference in VAS scores for the two groups were 26.3 mm. This FlexibleMIB group also had less gynecological findings.
• In conclusion, this study shows that FlexibleMIB could be a new avenue for managing endometriosis related pain.

Limitations of the study:

• This study only tests two different treatment regimens in order to determine the most effective method of pain control. There could be more effective treatment courses that were not tested in this experiment.

Lay Summary

It is no secret that Endometriosis is an extremely painful disease. Unfortunately, science has yet to determine a treatment that can effectively treat the disease or the associated pain. In their paper titled “Ethinylestradiol 20 mg/drospirenone 3 mg in a flexible extended regimen for the management of endometriosis-associated pelvic pain: a randomized controlled trial,” Harada et al. strive to find an effective and efficient treatment option. This paper published in Fertility and Sterility proposes the Flexible Management of Intracyclic Bleeding (FlexibleMIB) regimen, which consists of a flexible extended estrogen/progesterone (EP) product that is made up of ethinylestradiol 20 μg/drospirenone 3 mg and is taken in cycles of 120 days with 4 tablet-free days in between the cycles.

In order to test their hypothesis, the researcher designed a study consisting of 312 women with endometriosis. These women were then split up into 3 groups: a placebo group, a Dienogest group, and a FlexibleMIB group. The placebo and FlexibleMIB followed the same tablet regimen of 1 tablet a day for 120 days followed by 4 tablet-free days unless the participant had 3 of more days of spotting/bleeding. After 24 weeks the placebo group was changed to the FlexibleMIB for the open-label extension phase. The Dienogest group, on the other hand, was given 2 mg/d for 52 consecutive weeks. The dependent variable for this experiment was the change in endometriosis-associated pelvic pain (EAPP) for each group, which was evaluated using visual analog scale (VAS) scores. The quantitative data from this study was subject to statistical analysis.

The results show FlexibleMIB reduced EAPP pain, other endometriosis-associated pain, and the size of endometriomas when compared to the control group. The FlexibleMIB also showed other improved gynecological findings. In summary, the FlexibleMIB regimen may be a more effective and well-tolerated form of pain management in women with endometriosis.

Research Source: https://www.ncbi.nlm.nih.gov/pubmed/28911925