Palmitoylethanolamide and polydatin effect on pain and dysmenorrhea in women scheduled for laparoscopic treatment of possible endometriosis: a double blind randomised controlled trial
Effective medical therapies for the treatment of endometriosis-related pelvic pain are limited and are often associated with side-effects. Palmitoylethanolamide (PEA) is a food supplement that has been shown to reduce inflammation. Polydatin (PLD) is also a food supplement that has antioxidant and pain reduction properties. There have been some small studies performed to assess if the combination of PEA/PLD is helpful for persistent pain associated with endometriosis. The results suggest it might have benefit, but further studies are required. Multiple studies that assessed PEA/PLD for pain relief in various other pain conditions have not reported any significant side effects.
The aim of this study is to determine if treatment with PEA/PLD improves endometriosis associated pain. Patients who are booked for surgical treatment of endometriosis will be offered participation in this study. Participation will not change their surgeon’s care plan. The participants will be randomised to either receive 8 weeks of PEA/PLD treatment or placebo prior to their surgery. Endometriosis will then be confirmed or excluded during the surgery. Endometriosis lesions, endometrium (the uterus lining), pelvic fluid and blood will be collected where possible to assess inflammatory markers. We will assess the change in pain scores and quality of life scores between the 2 groups to see if PEA/PLD is beneficial.
Are you eligible to participate in this project?
If you are planning to have a laparoscopy (key- hole surgery) for pelvic pain and are booked for it in more than 2 months’ time, and you will use reliable contraception in the 2 months before surgery, you may be eligible.
What happens if I participate in this project?
You will be asked to answer an online questionnaire before starting treatment with either PEA/PLD or placebo (you will not know which one). You will take the treatment for 8 weeks and there will be another questionnaire after the treatment but before surgery. The third and last questionnaire will occur 4 months after surgery. Findings at your surgery will be recorded. A single additional blood sample will be taken for the study.
Your surgical wait time will not be altered. Your surgical treatment will be the same as planned and based on the findings during the surgery. Tissue samples removed as part of your treatment will be taken for the study. There will be no extra visits required.