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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.

ABSTRACT: Purpose:The aim of the present study was to evaluate the effectiveness of the ultramicronized-palmitoylethanolamide (um-PEA) and co-micronised palmitoylethanolamide/polydatin m(PEA/PLD) in the management of chronic pelvic pain related to endometriosis in patients desiring pregnancy. Patients and methods:Thirty symptomatic women with laparoscopic diagnosis of endometriosis and pregnancy desire were enrolled. Patients were treated with um-PEA twice daily for 10 days followed by m(PEA/PLD) twice daily for 80 days. Intensity of chronic pelvic pain, dyspareunia, dysmenorrhea, dyschezia, and dysuria were evaluated at baseline, after 10, 30, 60, 90 days and after 30 days from the end of treatment, by VAS. Quality of life and women's psychological well-being were evaluated at baseline and at the end of the treatment after 90 days with 36-Item Short Form Health Survey questionnaire and Symptom Check list-90 questionnaire, respectively. All collected data were analyzed with the non-parametric Wilcoxon test. Results:At the end of the treatment, all patients showed a significant improvement in chronic pelvic pain, deep dyspareunia, dysmenorrhea, dyschezia, as well as in quality of life and psychological well-being. Conclusion:In spite of the study's limited sample size and the open-label design, this research suggests the efficacy of um-PEA and m(PEA/PLD) in reducing painful symptomatology and improving quality of life as well as psychological well-being in patients suffering from endometriosis. Additionally, this treatment did not show any serious side effect, proving particularly suitable for women with pregnancy desire and without other infertility factors.

SUBMITTER: Stochino Loi E

PROVIDER: S-EPMC6697671 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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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.

Stochino Loi Emanuela E Pontis Alessandro A Cofelice Vito V Pirarba Silvia S Fais Maria Francesca MF Daniilidis Angelos A Melis Irene I Paoletti Anna Maria AM Angioni Stefano S

International journal of women's health 20190812

<h4>Purpose</h4>The aim of the present study was to evaluate the effectiveness of the ultramicronized-palmitoylethanolamide (um-PEA) and co-micronised palmitoylethanolamide/polydatin m(PEA/PLD) in the management of chronic pelvic pain related to endometriosis in patients desiring pregnancy.<h4>Patients and methods</h4>Thirty symptomatic women with laparoscopic diagnosis of endometriosis and pregnancy desire were enrolled. Patients were treated with um-PEA twice daily for 10 days followed by m(PE ...[more]

PMID: 31496832

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Project description:Urothelial inflammation plays a key role in the pathogenesis of chronic pelvic pain due to its origin in the bladder. The aim of this study was to evaluate the efficacy of a patent-pending formulation (Pelvipea®) composed of micronized palmitoylethanolamide (PEA), hempseed oil, and maritime pine bark dry extract in reducing urothelial inflammation, as well as the effect of each ingredient individually, in order to define the synergistic effect of the three ingredients. An in vitro bladder urothelium model composed of the T24 cell line was exposed to a conditioned media obtained by treating macrophage-differentiated THP-1 cells with different concentrations of the functional ingredients and a mixture of them in the presence of the pro-inflammatory stimulus of Escherichia coli. Cells exposed only to the inflammatory stimulus in the absence of pre-treatment were considered as a positive control for inflammation. The impact of each functional ingredient and their mixture on inflammation was evaluated by the determination of transcription factor NF-kB and of pro-inflammatory cytokine expression. Statistical analysis was performed using the t-test, comparing the mixture and the single ingredients for every condition tested. All results were reported as fold change (mean ± standard deviation), the ratio between the values obtained from the respective treatments for inflammation control. The three functional ingredients did not induce negative effects on THP-1 cell vitality. The levels of NF-kB were reduced following treatment with hempseed oil, maritime pine bark dry extract, and the mixture at all tested concentrations, and with micronized PEA from 25 to 200 μg/mL. Treatment with the mixture resulted in the lowest expression levels of interleukins (IL)-1β, IL-6, and IL-8 compared to the single functional ingredients at a concentration of 230 μg/mL, with values of 0.08 (±0.00), 0.01 (±0.00), and 0.32 (±0.01), respectively. The mixture of micronized PEA, hempseed oil, and maritime pine bark dry extract (Pelvipea®) at 230 μg/mL showed the best efficacy in urothelial IL-1β, IL-6, and IL-8 reduction compared with the singular components. This formulation may represent a promising therapeutic option to relieve painful symptoms originating in the bladder. However, in vivo studies are needed to confirm these results.

Project description:Complex regional pain syndrome type 1 (CRPS-I) is a disabling and frequently chronic condition. It involves the extremities and is a frequent consequence of distal tibia and radius fractures. The inflamed appearance of the affected CRPS-I limb suggests that local production of inflammatory mediators may be implicated in the ensuing etiology. A rodent tibia fracture model, characterized by inflammation, chronic unilateral hindlimb warmth, edema, protein extravasation, allodynia and hyperalgesia resembles the clinical features of patients with acute CRPS-I. N-palmitoylethanolamine (PEA), a member of the family of naturally-occurring N-acylethanolamines, is well-known for its ability to modulate inflammatory processes and regulate pain sensitivity. However, the large particle size and lipidic nature of PEA may limit its bioavailability and solubility when given orally. Micronized formulations are frequently used to enhance the dissolution rate of drug and reduce its variability of absorption when orally administered. The aim of this study was to assess the effects of a formulation of micronized and ultramicronized PEA (PEA-MPS), given orally in a mouse model of CRPS-I. CD-1 male mice were subjected to distal tibia fracture and divided into two groups: control and treated with PEA-MPS (PEA micronized 300 mg/kg and ultramicronized 600 mg/kg). Sensibility to pain was monitored in all mice throughout the course of the experiment. Twenty-eight days after tibia fracture induction animals were sacrificed and biochemical parameters evaluated. The PEA-MPS-treated group showed an improved healing process, fracture recovery and fibrosis score. PEA-MPS administration decreased mast cell density, nerve growth factor, matrix metalloproteinase 9 and cytokine expression. This treatment also reduced (poly-ADP)ribose polymerase activation, peroxynitrite formation and apoptosis. Our results suggest that PEA-MPS may be a new therapeutic strategy in the treatment of CRPS-I.

Project description:OBJECTIVE:To evaluate sensitization, myofascial trigger points, and quality of life in women with chronic pelvic pain with and without endometriosis. METHODS:A cross-sectional prospective study of women aged 18-50 years with pain suggestive of endometriosis and healthy, pain-free volunteers without a history of endometriosis. Patients underwent a physiatric neuromusculoskeletal assessment of clinical signs of sensitization and myofascial trigger points in the abdominopelvic region. Pain symptoms, psychosocial, and quality-of-life measures were also assessed. All participants with pain underwent laparoscopic excision of suspicious lesions to confirm endometriosis diagnosis by histologic evaluation. RESULTS:Patients included 18 with current, biopsy-proven endometriosis, 11 with pain only, and 20 healthy volunteers. The prevalence of sensitization as measured by regional allodynia and hyperalgesia was similar in both pain groups (83 and 82%) but much lower among healthy volunteers (15%, P<.001). Nearly all women with pain had myofascial trigger points (94 and 91%). Adjusting for study group, those with high anxiety (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.004-1.099, P=.031) and depression (OR 1.06, 95% CI 1.005-1.113, P=.032) scores were more likely to have sensitization. Pain patients with any history of endometriosis had the highest proportion of sensitization compared with the others (87% compared with 67% compared with 15%; P<.001). Adjusting for any history of endometriosis, those with myofascial trigger points were most likely sensitized (OR 9.41, 95% CI 1.77-50.08, P=.009). CONCLUSION:Sensitization and myofascial trigger points were common in women with pain regardless of whether they had endometriosis at surgery. Those with any history of endometriosis were most likely to have sensitization. Traditional methods of classifying endometriosis-associated pain based on disease, duration, and anatomy are inadequate and should be replaced by a mechanism-based evaluation, as our study illustrates. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, www.clinicaltrials.gov, NCT00073801. LEVEL OF EVIDENCE:II.

Dataset Information

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.

Publications

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.

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