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BMC Anesthesiol. 2017 Dec 19;17(1):171. doi: 10.1186/s12871-017-0461-9.

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.

Author information

1
Department of Women, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", 80138, Naples, Italy.
2
Department of Women, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", 80138, Naples, Italy. marco.fiore@unicampania.it.
3
Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Piazza L. Miraglia, 2, 80138, Naples, Italy.

Abstract

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.

KEYWORDS:

Add-on therapy; Low back pain; Pain medicine; Tapentadol; Ultramicronized palmitoylethanolamide

PMID:
29258432
PMCID:
PMC5735888
DOI:
10.1186/s12871-017-0461-9
[Indexed for MEDLINE]
Free PMC Article

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