Palmitoyethanolamide has been proven to be effective and safe in several double blind trials, for instance in Guida (2010) were 636 patients were randomized and were the NNT of PEA in sciatic pain was below 2. Here a further confirmative double blind trial.
In a double blind placebo controlled clinical dose finding trial in two sites 111 patients were included and treated with placebo (n=35), PEA 300 mg/day (n=38) or PEA 600 MG/day (n=38). Patients included needed to suffer from severe pain due o a compression of the lumbisacratl nerve root(s). Treatment duration was 3 weeks. Endpoints were the severity of pain measured using the visual analogue scale, a secoundary endpoint was the amount of concomittant analgesics (NSAID’s) taken during the three weeks period. Inclusion criteria amongst others were a clear compression syndrome and painscores above a VAS of 5. . The differences in the VAS was examined by ANOVA analysis using, if necessary, an “intention to treat analysis” to compensate for missing data compared with that available at the final control carried out. A multiple comparison between groups was carried out by the ”Scheffé” test. The value of p< 0.05 was chosen as the level of statistical significance.
Results: a significant decrease in pain in both PEA arms, irrespective of concomitant analgesia (P<0.05). The high dose significantly reduced pain more than the low dose of PEA. Initial painscores were between 8 and 9; at endpoint mean painscores in the placebo group was between 5-6, and mead painscores in the active arm at endpoint was between 2-3 for low dose and around 1 for the high dose of PEA.
Canteri L et al. Reduction of analgesics in patients suffering from lumbosciatic pain, treated with palmitoylethanolamide. Dolor 2010; 25:227-234