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 authors reported that 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 from 3.7 to 1.9 and tender points fell further (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
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.