Phospholipid-Based Delivery System Optimizes the Solubility and Systemic Exposure of Palmitoylethanolamide and Supports Clinical Benefits in Chronic Neuropathic Low Back Pain
Randomised controlled trialHumans
- Design
- Randomised controlled trial
- Subjects
- 120 adults with chronic neuropathic low back pain (40 per group: PEA-PL 600 to 300 mg, PEA-PL 450 mg, placebo), plus a separate healthy-volunteer pharmacokinetic group
- Dose used in the study
- Phospholipid-formulated PEA (Cronilief, Phytosome delivery) 600 mg tapering to 300 mg/day, or 450 mg/day, versus placebo, added to standard of care
- Duration
- 8 weeks (clinical trial); 2 weeks in the pharmacokinetic sub-study
- What was measured
- PEA solubility in simulated intestinal fluid; plasma PEA levels after supplementation; neuropathic pain (DN4, NPRS), functional disability (ODI), sleep quality (PSQI), quality of life (SF-12), and analgesic use.
What the authors reported
The trial found:
- The phospholipid formulation increased PEA solubility about eight-fold and produced higher plasma PEA levels than unformulated PEA.
- Both dose regimens significantly improved pain, disability, sleep and quality-of-life scores versus placebo (all p<0.0001), with larger effects for the 600 to 300 mg regimen.
- Analgesic use was discontinued more often in the PEA-PL groups (65 to 70%).
Limits of this study
Four authors are employees of Indena S.p.A., which supplied the phospholipid PEA formulation, unformulated PEA and placebo; the remaining authors declare no conflicts.
Source
PubMed 41751279 · doi:10.3390/biomedicines14020380
Entry checked against the abstract on PubMed on 2026-09-22. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.