Article Publish Status: FREE
Abstract Title:

The beneficial use of ultramicronized palmitoylethanolamide as add-on therapy to Tapentadol in the treatment of low back pain: a pilot study comparing prospective and retrospective observational arms.

Abstract Source:

BMC Anesthesiol. 2017 Dec 19 ;17(1):171. Epub 2017 Dec 19. PMID: 29258432

Abstract Author(s):

Maria Beatrice Passavanti, Marco Fiore, Pasquale Sansone, Caterina Aurilio, Vincenzo Pota, Manlio Barbarisi, Daniela Fierro, Maria Caterina Pace

Article Affiliation:

Maria Beatrice Passavanti


BACKGROUND: This pilot study was designed to compare the efficacy of ultramicronized palmitoylethanolamide (um-PEA) as add-on therapy to tapentadol (TP) with TP therapy only in patients suffering from chronic low back pain (LBP).

METHODS: This pilot observational study consists in two arms: the prospective arm and the retrospective one. In the prospective arm patients consecutively selected received um-PEA as add-on therapy to TP for 6 months; in the retrospective arm patients were treated with TP only for 6 months. Pain intensity and neuropathic component were evaluated at baseline, during and after 6 months. The degree of disability and TP dosage assumption were evaluated at baseline and after 6 months.

RESULTS: Statistical analysis performed with generalized linear mixed model on 55 patients (30 in the prospective group and 25 in the retrospective group) demonstrated that um-PEA as add-on treatment to TP in patients with chronic LBP, in comparison to TP alone, led to a significantly higher reduction in pain intensity, in the neuropathic component, the degree of disability and TP dosage assumption. No serious side effects were observed.

CONCLUSION: Overall, the present findings suggest that um-PEA may be an innovative therapeutic intervention as add-on therapy to TP for the management of chronic LBP with a neuropathic component, as well as to improve patient quality of life. Additionally, this combination treatment allowed a reduction in TP dose over time and did not show any serious side effects.

Study Type : Human Study
Additional Links
Pharmacological Actions : Analgesics : CK(3498) : AC(646)

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