Treatment with a combination of a fatty acid called palmitoylethanolamide (PEA) and an antioxidant compound known as polydatin (PLD) reduced pain, and improved the quality of life and psychological well-being of women with endometriosis, according to a small pilot study.
Researchers said the PEA-PLD combo’s lack of any serious side effects made it “particularly suitable” for women who desire to become pregnant.
The study, “Effect of Ultramicronized-palmitoylethanolamide and Co-Micronized Palmitoylethanolamide/Polydatin on Chronic Pelvic Pain and Quality of Life in Endometriosis Patients: An Open-Label Pilot Study,” was published in the International Journal of Women’s Health.
PEA, first isolated from soybean lecithin, has analgesic and anti-inflammatory properties. It is a nutraceutical — a product isolated from foods that is generally sold in medicinal forms — marketed by Epitech Group as Normast in some European countries. Specifically, Normast is an ultramicronized form of PEA (um-PEA). That means it’s been designed for better distribution and effectiveness in the body.
In endometriosis, PEA is believed to work by reducing the activity of mast cells. These immune cells are filled with granules containing inflammatory and pain mediators, which can be released abruptly. Increased numbers of activated mast cells have been found in endometriotic lesions.
PLD is a derivative of resveratrol, a compound produced by plants in response to injury. Its antioxidant properties may be beneficial against the formation of endometriotic lesions. An exploratory trial suggested that resveratrol may lower the levels of two enzymes — MMP-2 and MMP-9 — implicated in the development of endometriosis and its associated infertility.
These two therapies — PLD and PEA — are often combined in a co-micronized form for the treatment of endometrial pain. Epitech Group markets one such formulation — 400 mg of PEA and 40 mg of PLD — as Pelvilen Forte. One prior study in Italy showed significant beneficial effects of such a formulation in treating chronic pelvic pain related to endometriosis.
Now, researchers from Italy and Greece tested whether oral treatment with Normast and Pelvilen Forte would be beneficial for the management of chronic pelvic pain related to endometriosis in women desiring pregnancy. The study enrolled 30 women with endometriosis, ages 18 to 48.
All had chronic pain, as revealed by a score within 4 and 8 in the Visual Analogue Scale (VAS), and were experiencing symptoms for at least one month. None of the women had taken any medicines for endometriosis for one month before enrollment, although the pain therapy ketoprofen lysine (up to 80 mg, twice daily) was allowed throughout the study.
The participants took Normast (600 mg) twice a day for 10 days, followed by Pelvilen Forte twice daily for another 80 days. The intensity of chronic pelvic pain, and of pain during intercourse, menstruation, defecation, and urination were evaluated by the VAS at the start of the study (baseline) and after 10, 30, 60, and 90 days (end of study). Pain levels also were assessed 30 days after finishing treatment.
Before and after treatment, quality of life was assessed with the 36-Item Short Form Survey (SF-36). Psychological well-being also was assessed before and after treatment with the Symptom Checklist-90, which covers symptoms such as obsessive-compulsive syndrome, interpersonal sensitivity, depression, anxiety, hostility, and sleep disorders.
At the end of treatment, all patients showed significantly less chronic pelvic pain (mean VAS score decreased from 7.2 to 2.6), and pain during intercourse (4.9 to 1.9), menstruation (7.7 to 5.5), defecation (3.6 to 1.8), and urination (2.5 to 1.6).
The women also showed better psychological well-being and quality of life, as revealed by better scores of all tested domains. These included physical functioning, body pain, role limitations due to physical health or personal or emotional problems, emotional well-being, social functioning, energy and fatigue, and general health perceptions.
When the participants were assessed 30 days later, the reductions in chronic pelvic pain and pain during menstruation were still significant compared with baseline.
“Our research indicates the efficacy and safety of um-PEA [Normast] and m(PEA/PLD) [Pelvilen Forte] in the treatment of endometriosis,” the researchers said.
“Additionally, this treatment did not show any serious side effect, proving particularly suitable for women with pregnancy desire and without other infertility factors,” they added.
However, the team cautioned that double-blind studies with more patients and with a placebo group are still needed.