Palmitoylethanolamide versus a nonsteroidal anti-inflammatory drug in the treatment of temporomandibular joint inflammatory pain.
Level 2 - randomized trial
Individual randomized controlled trial comparing PEA against an active comparator (ibuprofen)
What was done
A triple-blind randomized clinical trial compared palmitoylethanolamide (PEA) with ibuprofen in 24 patients (16 women, 8 men; aged 24–54 years) diagnosed with temporomandibular joint (TMJ) osteoarthritis or arthralgia at the University of Bologna. Participants were randomized into two groups: Group A (n = 12) received PEA (300 mg morning/600 mg evening for 7 days, then 300 mg twice daily for 7 days); Group B (n = 12) received ibuprofen (600 mg three times daily for 14 days). Spontaneous pain was recorded twice daily on a visual analog scale, and maximum mouth opening was assessed by a blinded operator at baseline and day 14. Data comparisons were performed using t-tests.
What was found
The abstract reports statistical significance without providing absolute point estimates, baseline values, or spread metrics. Pain reduction after 2 weeks was significantly greater in the PEA group compared to the ibuprofen group (P = .0001). Maximum mouth opening also showed significantly greater improvement in the PEA group than in the ibuprofen group (P = .022).
Why it matters
This study provides preliminary evidence that PEA may be more effective than standard ibuprofen dosing for TMJ inflammatory pain and range of motion over a short duration.
Limits
The sample size is very small (12 per group) from a single center, limiting generalizability and power. The abstract omits raw baseline and follow-up numerical values as well as confidence intervals, follow-up was limited to 14 days with no long-term evaluation, and there was no placebo arm to assess natural symptom resolution.
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