Non-hormonal chemicals for endometriosis related pain reduction

Clinical trial finds two non-hormonal chemical combination beneficial in endometriosis-related pain

Key Points

Highlight:

• Ectopic endometrial foci lead to the formation of adhesions, interfere with the normal reproductive processes. 
• Severe chronic pain in endometriosis causes functional disability and requires medical or surgical treatment. 
• Activated mast cells in endometriosis foci especially in deep infiltrating lesions proximal to nerves suggest that these cells may contribute to pain by a direct effect on nerve structures. 
• The current search for the treatment modalities primarily aims to resolve symptoms in a palliative, non-invasive fashion. 

Importance:

• Medical management of symptoms related to endometriosis, especially in patients unable to receive hormonal therapy or who desire pregnancy is not ideal yet. 
• Chemicals acting on immune-inflammatory cells, like palmitoylethanolamide which is an endogenous fatty acid amide may help the resolution of inflammatory processes. 

What's done here:

• Thirty symptomatic women with endometriosis and pregnancy desire were enrolled in this clinical trial.
• Patients were treated with ultra micronized- palmitoylethanolamide twice daily for 10 days followed by co-micronized palmitoylethanolamide/polydatin twice daily for 80 days.
• The intensity of chronic pelvic pain, dyspareunia, dysmenorrhea, dyschezia, and dysuria were evaluated at baseline, and at time intervals up to 90 days. 

Data:

• Statistical analysis revealed that pain symptoms decreased between baseline and 90 days.
• Especially, the visual analog score, the mean score of chronic pelvic pain significantly decreased. 
• Average values from self-administered questionnaires indicated a positive change in the quality of life and psychological status. 

Limitation:

• The small number of enrolled volunteers and a relatively short time span in this study needs to be validated with further placebo-controlled, double-blind clinical trials

Lay Summary

Loi and colleagues conducted a clinical prospective study at the Department of Obstetrics and Gynecology, University of Cagliari, Italy, and published in the journal "International Journal of Women’s Health". 

Formation of adhesions and/or interference with the reproductive process endometriosis, severe chronic pain results and may cause functional disability requiring treatment. Activated mast cells in these lesions especially in deep infiltrating lesions being proximal to nerves, may contribute to pain by a direct effect on nerve structures. Cytokines and growth factors secreted by mast cells appear to promote invasion and growth of ectopic endometrium by inducing proliferation and angiogenesis. 

Current treatment modalities, aim to resolve symptoms in a palliative, non-invasive way. Palmitoylethanolamide is an endogenous fatty acid amide belonging to the family of fatty acid ethanolamides acting on immune-inflammatory cells, which may help the resolution of inflammation. Polydatin (PLD), a glycoside of resveratrol, has well-known antioxidant and anti-chemotactic effects. The combination of these compounds in a co-micronized form is used in this study for the treatment of pain associated with endometriosis. The purpose was to investigate whether this treatment in symptomatic patients with a laparoscopic diagnosis of endometriosis improves symptoms and also the quality of life.

Thirty women with endometriotic symptoms and pregnancy desire were included in this clinical trial. Patients were treated with ultra micronized above drugs.

Chronic pelvic pain intensity, dyspareunia, dysmenorrhea, dyschezia, and dysuria were recorded as a baseline, and at time intervals up to 90 days. Statistical analysis showed that all pain symptoms declined until the termination of clinical trial. The visual analog score (VAS), the mean score of chronic pelvic pain also significantly decreased. Average values from self-administered questionnaires revealed a positive trend towards a better quality of life and psychological status. The general improvement of these variables was accompanied by a significant reduction in using analgesic ketoprofen at the end of the treatment.

This study showed that treatment with um-PEA followed by m(PEA/PLD) in patients affected by symptomatic endometriosis leads to a significant reduction in the intensity of pain symptoms and improved the quality of life and psychological well-being. Previous clinical studies also showed that both um-PEA and m-PEA reduced chronic pain in patients suffering from various conditions including pelvic pain in the bladder pain syndrome, menstrual pain in adolescents, and in particular in endometriosis.

The combination of these compounds in a co-micronized form for the treatment of pain associated with endometriosis is beneficial, however, the small number of enrolled volunteers makes this study open to validation by further placebo-controlled, double-blind clinical trials.

Research Source: https://www.ncbi.nlm.nih.gov/pubmed/31496832/