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We thank Dr. Polati et al. for their interest in our study. Polati et al. emphasize what we also conclude from our study, namely that ultramicronized palmitoylethanolamide (PEA-um) has no effect as add-on therapy in chronic neuropathic pain after spinal cord injury (SCI), although this does not preclude an effect of PEA in the early stages of SCI or in patients without concomitant treatment.
In some aspects, however, we do not entirely agree with Polati et al. They note, for example, that the negative results of our study contrast with the current literature. However, most studies suggesting an effect of PEA-um in neuropathic pain are preclinical studies, open-label studies, or case reports, and the poor predictive value of preclinical animal models is well known in the field of neuropathic pain.4 In fact, only 2 randomized, controlled, double-blind studies of PEA in neuropathic pain have been published. Both studies, published in Spanish by the same group, showed an effect of PEA in lumbosciatica,1,3 but the effect of PEA or PEA-um in other neuropathic pain conditions has not been examined in randomized controlled trials.
Polati et al. also argue that the large number of patients taking medications for pain and spasticity in our study makes it difficult to expect a beneficial effect of PEA-um. This may not necessarily be the case. Two large studies documenting a pain-relieving effect of pregabalin on SCI-related neuropathic pain included patients with a mean pain duration of 9 to 10 years, similar to our study, and the studies also showed that of these patients 91% to 97% received various concomitant drug treatments while looking at only concomitant pain medications, the percentage was between 69% and 76%.2,5 Polati et al. also point out that the PEA-um and placebo groups were not homogeneous with respect to sex. However, we found no effect of PEA-um when separating the groups into men (n = 49) and women (n = 19).
In conclusion, we agree that although our study showed no effect of PEA-um in chronic neuropathic pain after SCI, it does not provide any data on a possible early preventive effect of PEA-um.
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