N-of-1 Randomized Trials of Ultra-Micronized Palmitoylethanolamide in Older Patients with Chronic Pain
Randomised controlled trialHumans
- Design
- Randomised controlled trial
- Subjects
- 11 older patients enrolled, all women with a mean age of 83. 7 completed.
- Dose used in the study
- 600 mg of ultramicronised palmitoylethanolamide twice a day, against placebo
- Duration
- Two 3-week treatment phases for each patient, separated by 2-week washouts
- What was measured
- Pain intensity on an 11-point scale and a back pain function scale, analysed patient by patient. The trial also measured the impact of each N-of-1 result on the clinician's intention to treat and confidence.
What the authors reported
A small, statistically significant effect on pain favoured palmitoylethanolamide in 2 of the 7 patients, about 8% of baseline pain, with an effect on function in 1 patient, the authors reported. The only adverse event, diarrhoea, occurred on placebo. After the trial, palmitoylethanolamide was prescribed to 4 of the 7 patients; the clinician changed their pre-trial treatment intention in 2 patients, and confidence in the treatment plan increased in 5 patients and stayed the same in 2.
Limits of this study
Seven patients completed. Each patient served as her own control, so the results describe individuals and do not give a group estimate. Effects were small and absent in most patients. The study had no funding, and the authors declared no conflicts.
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.