Observational studyBMC anesthesiology2017
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.
Observational study in BMC anesthesiology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
19 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Extended Treatment with Micron-Size Oral Palmitoylethanolamide (PEA) in Chronic Pain: A Systematic Review and Meta-Analysis.Nutrients · 2024Pooled it
- Long-term and serious harms of medical cannabis and cannabinoids for chronic pain: a systematic review of non-randomised studies.BMJ open · 2022Pooled it
- A systematic review of treatment for patients with burning mouth syndrome.Cephalalgia : an international journal of headache · 2022Pooled it
- Palmitoylethanolamide: A Nutritional Approach to Keep Neuroinflammation within Physiological Boundaries-A Systematic Review.International journal of molecular sciences · 2020Pooled it
- New Adjuvant Therapies for Obesity-Related Disorders Associated with Meta-Neuroinflammation.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Studies on Burning Mouth Syndrome in the Past 20 Years: A Bibliometric and Visualised Analysis.International dental journal · 2025Review
- Palmitoylethanolamide in the Treatment of Pain and Its Clinical Application Prospects.Drug design, development and therapy · 2025Review
- Article
- Effects of Palmitoylethanolamide (PEA) on Nociceptive, Musculoskeletal and Neuropathic Pain: Systematic Review and Meta-Analysis of Clinical Evidence.Pharmaceutics · 2022Review
- Fibromyalgia: Pathogenesis, Mechanisms, Diagnosis and Treatment Options Update.International journal of molecular sciences · 2021Review
- Chronic Pain in Dogs and Cats: Is There Place for Dietary Intervention with Micro-Palmitoylethanolamide?Animals : an open access journal from MDPI · 2021Review
- Synthesis, Molecular Modeling and Biological Evaluation of Metabolically Stable Analogues of the Endogenous Fatty Acid Amide Palmitoylethanolamide.International journal of molecular sciences · 2020Article
- ALIAmides Update: Palmitoylethanolamide and Its Formulations on Management of Peripheral Neuropathic Pain.International journal of molecular sciences · 2020Review
- Management of Traumatic Brain Injury: From Present to Future.Antioxidants (Basel, Switzerland) · 2020Review
- Clinical applications of palmitoylethanolamide in pain management: protocol for a scoping review.Systematic reviews · 2019Article
- Efficacy of a Combination of N-Palmitoylethanolamide, Beta-Caryophyllene, Carnosic Acid, and Myrrh Extract on Chronic Neuropathic Pain: A Preclinical Study.Frontiers in pharmacology · 2019Article
- Tapentadol for neuropathic pain: a review of clinical studies.Journal of pain research · 2019Review
- Tapentadol: an effective option for the treatment of back pain.Journal of pain research · 2019Review
- Oral Ultramicronized Palmitoylethanolamide: Plasma and Tissue Levels and Spinal Anti-hyperalgesic Effect.Frontiers in pharmacology · 2018Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis 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).
methodsThis 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.
resultsStatistical 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.
conclusionOverall, 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.
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