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 have anti-inflammatory action. Polydatin (PLD) is also a food supplement that has antioxidant and pain inhibiting activities. 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. Women who are booked for surgical treatment of possible 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. The endometriosis will then be confirmed or excluded during the surgery. Lesions of endometriosis, endometrium, pelvic fluid and blood will be collected where possible to assess inflammatory markers. Participants will also complete a survey including pain and quality of life assessments. This survey will be completed at recruitment, after 8 weeks of treatment (pre surgery) and at 6 months (4 months after surgery). We will assess the change in pain scores and quality of life scores between the 2 groups to see if PEA/PLD is beneficial.