Background Fibromyalgia (FM) is characterized by debilitating pain that is unresponsive to standard analgesics and the multi-modal approach, including drugs’ combination, represents the standard of care. Combination therapeutic strategies also include the integration of drugs and nutraceuticals. Both palmitoylethanolamide (PEA) and acetyl-L-carnitine (ALC) have demonstrated an effect on chronic widespread pain (CWP).

Objectives The aim of this study was to evaluate the efficacy of pregabalin (PGB) and duloxetine (DLX) supplemented with palmitoylethanolamide (PEA) and acetyl-L-carnitine (ALC) in FM patients over a 24-week period.

Methods After 6 months of stable treatment with DLX+PGB, FM patients were randomized to continue the treatment (Group 1) or to add PEA (600 mg BID)+ALC (500 mg BID) at the ongoing treatment (Group 2). Patients were then followed for 24 weeks. Cumulative disease severity, estimated using the Widespread Pain Index (WPI) (primary outcome), the revised Fibromyalgia Impact Questionnaire (FIQR), and the modified Fibromyalgia Assessment Status (FASmod) (secondary outcomes), was calculated every two weeks during the 24-week follow-up and expressed as time-integrated values (AUC).

Results One hundred and forty-two FM patients started the study (91.5%), 130 completed both steps, respectively 68 patients in Group 1 and 62 in Group 2. After 24 weeks of follow-up after randomization, Group 2 experienced an adjunctive significant improvement in WPI, FIQR (Figure 1), and FASmod, compared to Group 1. Although there was some fluctuation in both Groups throughout the study period, the AUC values of the WPI scores steadily decreased in Group 2 (p=0.048). Group 2 showed better outcomes also in terms of FIQR and FASmod scores’ AUC values (p=0.033 and p=0.017, respectively).

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Figure 1.

Comparison of the trend of the mean values of the FIQR in the two groups.

Conclusion This study supports the supplementary value of PEA+ALC in FM patients care and, to best of our knowledge, it is the first study investigating this association treatment.

References [1]Sarzi-Puttini P et al. Acetyl-L-carnitine in chronic pain: A narrative review. Pharmacol Res 2021; 173: 105874. https://doi.org/10.1016/j.phrs.2021.105874

[2]Del Giorno R et al. Palmitoylethanolamide in Fibromyalgia: Results from Prospective and Retrospective Observational Studies. Pain Ther 2015; 4: 169-178. https://doi.org/10.1007/s40122-015-0038-6

Acknowledgements: NIL.

Disclosure of Interests None Declared.