Palmitoylethanolamide in Fibromyalgia: Results from Prospective and Retrospective Observational Studies
Observational studyHumans
- Design
- Observational study
- Subjects
- 80 patients with fibromyalgia: 45 in a retrospective group and 35 in a prospective group
- Dose used in the study
- All patients took duloxetine and pregabalin. The prospective group then added palmitoylethanolamide for 3 months: ultramicronised 600 mg twice a day at first, then micronised 300 mg twice a day.
- Duration
- 6 months
- What was measured
- Number of positive tender points and pain on a visual analogue scale
What the authors reported
The study found:
- On duloxetine and pregabalin alone, pain scores fell from 6.9 to 3.0 over 6 months.
- In the prospective group, after palmitoylethanolamide was added, pain scores fell further, from 3.7 to 1.9, and tender points fell further still (p < 0.0001 against the drug combination alone).
- No patient had adverse effects.
Limits of this study
Open-label, with no randomisation or blinding. The comparison is with a separate retrospective group. The authors state that they cannot tell how much of the improvement came from patient or investigator expectations. They reported no funding.
Source
PubMed 26334329 · doi:10.1007/s40122-015-0038-6
Entry checked against the article page at the publisher (Springer) on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.