Aims: To carry out a randomized clinical trial to compare the effect of palmitoylethanolamide (PEA) versus ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), for pain relief in temporomandib- ular joint (TMJ) osteoarthritis or arthralgia. PEA acts as an endog- enous agent with an autacoid local inflammation antagonism and modulates mast cell behavior controlling both acute and chronic inflammation.
Methods: A triple-blind randomized clinical trial was conducted on 24 patients (16 women and 8 men) aged 24 to 54 years and suffering from TMJ osteoarthritis or arthralgia. The patients were enrolled from a group of 120 consecutive patients referred to the University of Bologna’s Department of Orthodontics. Patients were randomly divided into two groups: group A (12 subjects) received PEA 300 mg in the morning and 600 mg in the evening for 7 days and then 300 mg twice a day for 7 more days. Group B (12 subjects) received ibuprofen 600 mg three times a day for 2 weeks. Every patient recorded the intensity of spontaneous pain on a visual analog scale twice a day. Maximum mouth opening was recorded by a blind operator during the first visit and again after the 14th day of drug treatment. A t test was used for data comparisons. Results: Pain decrease after 2 weeks of treatment was significantly higher in group A than in group B (P = .0001); maximum mouth opening improved more in group A than in group B (P = .022).
Conclusion: These data suggest that PEA is effective in treating TMJ inflammatory pain.
J OROFAC PAIN 2012;26:99–104