Use of micronized palmitoylethanolamide and trans-polydatin in chronic pelvic pain associated with endometriosis. An open-label study

Aim. The purpose of this pilot study was to evaluate the efficacy of treatment with micronized palmitoylethanolamide (PEAm (R))+ trans-polydatin (food for special medical purpose) on chronic pelvic pain related to endometriosis, in comparison to usual hormonal therapies. The chance to get pregnant during PEA-m (R) + trans-polydatin treatment was also evaluated. Methods. Thirty outpatients of reproductive age with a history of chronic pelvic pain associated to endometriosis were randomly assigned to three groups of 10, who underwent a 6-month treatment with: PEA-m (R)+ trans-polydatin, leuprorelin acetate or ethinylestradiol + drospirenone. Chronic pelvic pain, dysmenorrhea, dyspareunia and Quality of Life were assessed monthly using the Numeric Rating Scale (NRS) and the SF12 questionnaire. Results. Painful symptom intensity significantly decreased over time in all three groups, irrespective of the treatment applied. In the PEA-m (R) + trans-polydatin group one patient withdrew due to pregnancy. Conclusions. In spite of the study's limited sample size, the data demonstrate that PEA-m (R) + trans-polydatin is as effective as hormonal therapy in reducing painful symptomatology related to endometriosis in patients of reproductive age, without anti-ovulatory effects. While further investigation is warranted, these results suggest the therapeutic use of PEA-m (R) + trans-polydatin in chronic pelvic pain due to endometriosis, especially in patients who wish to conceive. The treatment of chronic pelvic pain due to endometriosis in reproductive-age women with PEA-m (R) + trans-polydatin reduces pain intensity as the hormonal agents without suppressing ovulation, allowing to conceive where possible and showing excellent tolerability.