Table 7.
Pain relieving effect of PEA-Pol (i.e., PEA co-micronized with the antioxidant polydatin in 10:1 ratio) on chronic pelvic pain: overview of clinical trials in chronological order.
| Diagnosis [Trial Design] |
No. of Pts |
Dose | Main Result | Ref. |
|---|---|---|---|---|
| Chronic pelvic pain associated with endometriosis/dysmenorrhea/ interstitial cystitis (Open-label study) |
25 | (200 + 20) mg/tid for 40 days | Significant reduction of pain on VAS (from 6.8 to 1.7); significant decrease in the use of NSAIDs. | [250] |
| Adolescent primary dysmenorrhea (Open-label study) |
20 | (400 + 40) mg/bid for six months |
70% decrease in pelvic pain | [251] |
| Chronic pelvic pain and dyspareunia associated with endometriosis (Open (case series)) |
4 | (200 + 20) mg/bid for three months |
Significant decrease of pelvic pain and dyspareunia; significant reduction in the use of analgesics. | [252] |
| Pudendal neuralgia (Case report) |
1 | PEA-um 300 mg/tid gradually decreased to 300 mg/die for one year |
Resolution of chronic pelvic pain | [253] |
| Chronic pelvic pain associated with endometriosis (Double-blind, randomized parallel-group (celecoxib), placebo-controlled) |
61 | (400 + 40) mg/tid for three months | Significant decrease of chronic pelvic pain, dysmenorrhea and dyspareunia | [254] |
| Endometriosis associated with severe pelvic pain (Open-label study) |
24 | (400 + 40) mg/bid for three months | Statistically significant decrease of pain, dysmenorrhea and dyspareunia and improved QoL, as well as decreased assumption of NSAIDs | [255] |
| Pain related to endometriosis (Prospective study) |
47 | (400 + 40) mg/bid for three months | Significant decrease of chronic pelvic pain, dyspareunia and dysmenorrhea on VAS since the first visit (day 30) | [256] |
| Vestibulodynia (Randomized, placebo-controlled, combined with TENS) |
20 | (400 + 40) mg/bid for two months | Significant decrease of pain on VAS in both groups. Superior decrease of current perception threshold for C fibers in treated (40%) compared to placebo group (4.6%) | [257] |
| Primary dysmenorrhea (Randomized placebo-controlled with follow-up) |
220 | (400 + 40) mg/die for 10 days (from the 24th day of cycle) |
Improvement of pelvic pain in 98% of cases in the treated group vs. 56% in the placebo group. Statistically superior effect compared to placebo | [258] |
| Irritable bowel syndrome (Randomized double-blind placebo-controlled) |
54 | (200 + 20) mg/bid for 12 weeks | Reduction of abdominal pain and discomfort | [259] |
| Symptomatic women with laparoscopic diagnosis of endometriosis (Single-arm, open-label) |
30 | (400 + 40) mg/bid for 80 days, after 10 days PEA-um 600 mg/bid | Significant decrease of symptoms (pain on VAS, dysmenorrhea, dyspareunia, and dyschezia, dysuria); increased QoL and psychological well-being; significant reduction in the use of the analgesics | [260] |
| Interstitial cystitis/bladder pain syndrome (IC/BPS) (Pilot, open-label bicentric study) |
32 | (400 + 40) mg/tid for three months followed by (400 + 40) mg/die for three months |
Significant decrease of pelvic pain intensity on VAS from 6.9 ± 0.4 to 4.6 ± 0.4 (the effect persisting up to two months after treatment withdrawal); PUF significantly and progressively decreased; significant reduction in urinary frequency |
[261] |
Abbreviations. bid, bis in die = twice daily; die, daily; NSAIDs, non-steroidal anti-inflammatory drugs; PUF, Pelvic Pain and Urgency/Frequency Symptom Scale; Pts, patients; QoL, quality of life; tid, ter in die = three times daily; TENS, transcutaneous electrical nerve stimulation therapy; VAS, visual analogue pain scale.