Evidence map›Paper›PMID 26334329›Full record

ArticlePain and therapy2015

Palmitoylethanolamide in Fibromyalgia: Results from Prospective and Retrospective Observational Studies.

Rosaria Del Giorno, Stephen Skaper, Antonella Paladini, Giustino Varrassi, Stefano Coaccioli

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pain and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 4 pooled it
1.1field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 4 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Pooled it
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  5. Trial
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  8. Palmitoylethanolamide in Human and Animal Obesity.Molecules (Basel, Switzerland) · 2026
    Review
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  13. Article
  14. Article
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  16. Therapeutic approach to fibromyalgia: a consensus statement on pharmacological and non-pharmacological treatment from the neuropathic pain special interest group of the Italian neurological society.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 2 countries.

Rosaria Del GiornoInstitute of Internal Medicine, Rheumatology and Medical Therapy of Pain, Perugia University, District of Terni, Perugia, Italy. delgiornorosaria@yahoo.it.
Stephen SkaperDepartment of Pharmaceutical and Pharmacological Sciences, Padua University, Padua, Italy.
Antonella PaladiniInstitute of Anesthesiology and Pain Therapy, L'Aquila University, L'Aquila, Italy.
Giustino VarrassiPaolo Procacci Foundation, L'Aquila University, L'Aquila, Italy.
Stefano CoaccioliInstitute of Internal Medicine, Rheumatology and Medical Therapy of Pain, Perugia University, District of Terni, Perugia, Italy.
European League Against Rheumatism · CHUniversity of L'Aquila · ITUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Chronic painDuloxetineFibromyalgiaMultimodal therapyPainPalmitoylethanolamidePregabalin

Identifiers

PMID26334329
PMCPMC4676767
OpenAlexW1780505347

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.