Flexofytol®, a Curcuma Extract, for the Treatment of Endometriosis-Associated Pain: a Randomized, Double Blind, Placebo-Controlled Study
Endometriosis is a benign gynecological estrogen-dependent disease that affects 6-10% of women of reproductive age. Although the clinical presentation varies, the main symptom is pain, be it dysmenorrhea, dyspareunia, dyschezia or dysuria. While the exact pathophysiology of endometriosis still remains unclear, many studies have underlined the importance of inflammatory processes that seem to be involved in its development. Since endometriosis is a benign disease, one of the primary goals of any treatment is pain relief to date. Treatment options include hormonal treatments or surgical removal of endometriotic lesions. As with any surgery however, there are risks associated with laparoscopic endometriosis surgery, and for women refusing hormonal treatments, options are limited.
In the past years, Curcuma has gained interest in the scientific field due to its antiinflammatory properties. In-vitro studies have also shown promising results when applied to endometriotic lesions. We therefore decided to plan this randomized double-blind placebocontrolled study, comparing the effect of Curcuma capsules in the treatment of endometriosis-associated pain with placebo. Pain is assessed by use of the numeric rating scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable).
The primary endpoint is the change in the pain score (mean over 5 days with the largest reported pain values out of a period of 28 days) from baseline to four months after treatment start. Secondary endpoints are the change in number of days with pain ≥ NRS 4, the improvement of dyspareunia, dysuria, dyschezia, quality of life and sexual function.
Methods and Skills:
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