To assess the efficacy of a micronized-palmitoylethanolamide-polydatin (m-PEA-Pol) based product on chronic pelvic pain and severity of other symptoms in interstitial cystitis/bladder pain syndrome (IC/BPS) patients refractory to conventional therapies.
A pilot, open-label bicentric study was carried out involving 32 IC/BPS patients. Chronic, oral m-PEA-Pol treatment lasted 6 months. Bladder pain was evaluated using the visual analog scale, while changes from baseline in other urinary symptoms were evaluated by means of the O'Leary-Sant Interstitial Cystitis Symptom and Problem Index and the Pelvic Pain and Urgency/Frequency (PUF) symptom scale questionnaires. The generalized linear mixed model was used to evaluate significant mean changes across time.
A significant and progressive reduction of pain intensity was observed during m-PEA-Pol treatment (p < 0.0001 for reduction over time). The effect was associated with a reduction in severity of patients' symptoms evaluated with the O'Leary-Sant questionnaire (p=0.0110 and p=0.0014 for cystitis symptoms and problem mean scores, respectively) and the PUF scale (p=0.0163 and p=0.0005 for symptom and bother mean scores, respectively). m-PEA-Pol therapy elicited a significant reduction over time in the urinary frequency evaluated with voiding diary (p=0.0005) and a small but not significant improvement of bladder capacity.
These data highlight the potential benefit of m-PEA-Pol in patients with rare pathology such as IC/BPS and confirm the good safety profile of micronized PEA-based products.
BioMed research international. 2019 Nov 11*** epublish ***
M Cervigni, L Nasta, C Schievano, N Lampropoulou, E Ostardo
Interstitial Cystitis Referral Center, San Carlo di Nancy Hospital, Rome, Italy., Italian Interstitial Cystitis Association, Rome, Italy., Innovative Statistical Research, Padua, Italy., Division of Neurourology and Urodynamic, S. Maria Degli Angeli Hospital, Pordenone, Italy.