Palmitoylethanolamide in Fibromyalgia: Results from Prospective and Retrospective Observational Studies

Abstract

IntroductionFibromyalgia syndrome (FM) is characterized by persistent pain which is often refractory to common analgesic therapies and is particularly disabling. The objective of this study was to evaluate the therapeutic efficacy of duloxetine (DLX) + pregabalin (PGB) in patients suffering from FM and the possible added benefit of the lipid signaling molecule, palmitoylethanolamide (PEA). PEA is well-documented to exert anti-inflammatory, analgesic, and pain-relieving effects at both the preclinical and clinical level.MethodsA total of 80 patients were recruited in two steps. The first was a retrospective observational study comprising 45 patients. This patient group received DLX + PGB for 6 months. The second step was a prospective observational study with 35 patients. Patients in this cohort began treatment with DLX + PGB at the same dosage as for the retrospective study plus micronized PEA (PEA-m®; Epitech Group, Italy) and ultramicronized PEA (PEA-um®; Epitech Group, Italy) for 3 months. Positive tender points (TPs), pain evoked, and pain intensity were evaluated at baseline and after 3 and 6 months in both studies. Statistical analyses were employed for comparison of data within the two studies and between them.ResultsThe retrospective observational study (DLX + PGB), after 3 months of treatment showed a decrease of positive TPs, pain evoked, and pain intensity. After 6 months of treatment, these parameters had further improvement. In the prospective observational study (DLX + PGB + PEA), PEA introduction after 3 months of therapeutic regimen with DLX + PGB provided a significant improvement in pain symptoms, with a further reduction in the number of TPs and significant reduction in pain, compared to combined DLX + PGB only (p < 0.0001 for TPs and Visual Analog Scale comparisons). None of the patients experienced adverse side effects.ConclusionOur study confirms the efficacy of DLX + PGB and demonstrates as well the added benefit and safety of PEA in the treatment of pain in patients affected by FM.Electronic supplementary materialThe online version of this article (doi:10.1007/s40122-015-0038-6) contains supplementary material, which is available to authorized users.

Nonsurgical lumbar radiculopathies treated with ultramicronized palmitoylethanolamide (umPEA): A series of 100 cases

“…Furthermore, PEA normalizes mastcell de- granulation and microglial activation thereby maintaining tissue homeostasys and therefore in a progressive decrease in endogenous production of PEA leads to an inability to regulate mastcells and microglial cells, creating pain symptoms [7,8]. Therefore um-PEA (Ultramicronized Palmithoylethanolamide) is used in those diseases in which the mechanisms of neuroinflammation are present such as neuropathies, by nerve entrapment [9] or dismetabolic [10], toxic [11] and others [12][13][14][15] and some primary headaches [16]. In this study, we used um-PEA in degenerative lumbar radiculopathies, a very frequent disorder, related to alterations involving the various structures of the lumbar spine, as vertebral body, intervertebral disc and ligament, which, at the end, cause root compression and consequently onset of pain.…”

An evidence-based review of pregabalin for the treatment of fibromyalgia

“…A total of seven combination studies involving pregabalin were identified (summarized in Table 1; see also Table 3 of the Supplemental Online Material for more details of each individual study) [69][70][71][72][73][74][75]. The placebo-controlled clinical study in which pregabalin was added on top of an antidepressant [51] because has been discussed in detail above as the antidepressant was being administered for the treatment of depression alone and not FM.…”

Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review

“…It is worth mentioning that some new potential agents are being investigated, including IMC-1 (a fixed-dose combination of the anti-herpes virus nucleoside analog famciclovir and the anti-herpes virus active COX-2 inhibitor celecoxib), neurotrophins, mast cell stabilizers, and mirogabalin (which is more specific for calcium channels than pregabalin or gabapentin) [45]. An interesting study from Del Giorno et al [48] evaluated the therapeutic efficacy of duloxetine combined with pregabalin in patients suffering from fibromyalgia, and the possible added benefit of the lipid-signaling molecule PEA. The combination of duloxetine and pregabalin had previously been suggested [49], and was well documented to exert anti-inflammatory, analgesic, and pain-relieving effects in both preclinical and clinical studies.…”

“…The combination of duloxetine and pregabalin had previously been suggested [49], and was well documented to exert anti-inflammatory, analgesic, and pain-relieving effects in both preclinical and clinical studies. The authors concluded that adding PEA to an initial combination therapy of pregabalin plus duloxetine improved the outcome of fibromyalgia, and that when an additional medication is needed, PEA could serve as an optimal option [48]. Nonpharmacological treatments for fibromyalgia may also be appropriate, for example postural counseling [50].…”