Palmitoylethanolamide (Normast) in chronic neuropathic pain by compressive type lumbosciatalgia: multicentric clinical study
Randomised controlled trialHumans
- Design
- Randomised controlled trial
- Subjects
- 636 adults (18 to 75) with sciatic pain from nerve root compression or disc disease, VAS 5 or more, at nine Italian hospital and university departments; 17 dropped out (12 placebo, 4 low dose, 1 high dose)
- Dose used in the study
- Micronised PEA (Normast) 300 mg or 600 mg a day, or placebo, on top of usual treatment
- Duration
- 21 days
- What was measured
- Pain on a visual analogue scale and Roland-Morris disability questionnaire at baseline and day 21; blood and urine safety tests.
What the authors reported
Pain and disability changes differed across the three groups (p < 0.001). Both PEA doses beat placebo (p < 0.05) and 600 mg beat 300 mg (p < 0.05). Mean VAS fell from 7.1 to 2.1 on 600 mg and from 6.6 to 4.6 on placebo. No dropouts for adverse events.
Limits of this study
Published in Spanish in a journal not indexed in PubMed; the full results are known mainly through a 2015 review by Keppel Hesselink and Kopsky. Three weeks only. Usual treatments continued in all arms. Product is Epitech's Normast and one author is affiliated with Epitech. The often-quoted number needed to treat of 1.5 is a post hoc calculation from the review, not a protocol endpoint.
Source
No PubMed record or DOI. See the citation above.
Entry checked against the abstract supplied by Devlin, plus the detailed account in Keppel Hesselink and Kopsky 2015 (open access), also supplied by Devlin on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.