Evaluation of the Clinical Efficacy of a Novel Palmitoylethanolamide–<i>Equisetum arvense</i> Supplement for the Management of Chronic Pain: Findings from a Prospective Clinical Trial

<b>Background</b>: Chronic pain represents a major therapeutic challenge due to the limited efficacy and tolerability of conventional pharmacological treatments. <i>Equisetum arvense</i> L., a medicinal plant with potent antioxidant properties, and palmitoylethanolamide (PEA)...

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Published in:Medical Sciences
Main Authors: Marco Invernizzi, Simone Mulè, Lorenzo Lippi, Rebecca Galla, Arianna Folli, Sara Ferrari, Domenico Tiso, Francesca Uberti
Format: Article
Language:English
Published: MDPI AG 2025-09-01
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Online Access:https://www.mdpi.com/2076-3271/13/3/169
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author Marco Invernizzi
Simone Mulè
Lorenzo Lippi
Rebecca Galla
Arianna Folli
Sara Ferrari
Domenico Tiso
Francesca Uberti
author_facet Marco Invernizzi
Simone Mulè
Lorenzo Lippi
Rebecca Galla
Arianna Folli
Sara Ferrari
Domenico Tiso
Francesca Uberti
author_sort Marco Invernizzi
collection DOAJ
container_title Medical Sciences
description <b>Background</b>: Chronic pain represents a major therapeutic challenge due to the limited efficacy and tolerability of conventional pharmacological treatments. <i>Equisetum arvense</i> L., a medicinal plant with potent antioxidant properties, and palmitoylethanolamide (PEA), an endogenous fatty acid amide with well-established anti-inflammatory and analgesic effects, are increasingly recognised as promising nutraceutical agents. <b>Methods</b>: This prospective, single-centre clinical trial aimed to evaluate the efficacy and safety of a novel oral supplement (Assonal<sup>®</sup>PEA) combining 600 mg of PEA and 300 mg of <i>Equisetum arvense</i> L. in improving the reduction of pain and quality of life in patients with chronic pain, also obtaining information on the patient’s state of satisfaction after the treatment. Fifty patients suffering from chronic pain (low back pain and radiculopathy) for two months were enrolled and received the supplement over eight weeks in a tapered regimen (two tablets daily for two weeks, followed by one tablet daily). <b>Results</b>: Clinical outcomes were evaluated using validated instruments, including the Numeric Pain Rating Scale (NPRS), Verbal Rating Scale (VRS), Short-Form McGill Pain Questionnaire (SF-MPQ), Global Perceived Effect (GPE), and EuroQol-5D-5L. Results showed a significant decrease in pain intensity (NPRS: −3.8 points; VRS: −2.1 points; <i>p</i> < 0.0001), along with meaningful improvements in patient-perceived benefit, pain descriptors, and quality of life (EQ-5D-5L: +35%; <i>p</i> < 0.0001). <b>Conclusions</b>: These findings endorse the use of this novel PEA–<i>Equisetum arvense</i> formulation as a safe, well-tolerated, and potentially effective supplementary intervention for managing chronic pain. No adverse events were reported, and the overall response rate reached 94%.
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spelling doaj-art-ef1b22f8d2f048e5aef6f63a0ce5ecec2025-09-26T14:58:22ZengMDPI AGMedical Sciences2076-32712025-09-0113316910.3390/medsci13030169Evaluation of the Clinical Efficacy of a Novel Palmitoylethanolamide–<i>Equisetum arvense</i> Supplement for the Management of Chronic Pain: Findings from a Prospective Clinical TrialMarco Invernizzi0Simone Mulè1Lorenzo Lippi2Rebecca Galla3Arianna Folli4Sara Ferrari5Domenico Tiso6Francesca Uberti7Department of Health Sciences, University of Piemonte Orientale (UPO), 28100 Novara, ItalyDepartment for Sustainable Development and Ecological Transition, University of Piemonte Orientale (UPO), 13100 Vercelli, ItalyTranslational Medicine, Dipartimento Attività Integrate Ricerca e Innovazione (DAIRI), Azienda Ospedaliero-Universitaria (AOU) SS, Antonio e Biagio e Cesare Arrigo, 15121 Alessandria, ItalyNoivita Srls, Spin Off, University of Piemonte Orientale (UPO), Strada Privata Curti 7, 28100 Novara, ItalyDepartment of Health Sciences, University of Piemonte Orientale (UPO), 28100 Novara, ItalyDepartment for Sustainable Development and Ecological Transition, University of Piemonte Orientale (UPO), 13100 Vercelli, ItalyDepartment of Clinical Nutrition, “Villa Maria” Hospital, 47921 Rimini, ItalyDepartment for Sustainable Development and Ecological Transition, University of Piemonte Orientale (UPO), 13100 Vercelli, Italy<b>Background</b>: Chronic pain represents a major therapeutic challenge due to the limited efficacy and tolerability of conventional pharmacological treatments. <i>Equisetum arvense</i> L., a medicinal plant with potent antioxidant properties, and palmitoylethanolamide (PEA), an endogenous fatty acid amide with well-established anti-inflammatory and analgesic effects, are increasingly recognised as promising nutraceutical agents. <b>Methods</b>: This prospective, single-centre clinical trial aimed to evaluate the efficacy and safety of a novel oral supplement (Assonal<sup>®</sup>PEA) combining 600 mg of PEA and 300 mg of <i>Equisetum arvense</i> L. in improving the reduction of pain and quality of life in patients with chronic pain, also obtaining information on the patient’s state of satisfaction after the treatment. Fifty patients suffering from chronic pain (low back pain and radiculopathy) for two months were enrolled and received the supplement over eight weeks in a tapered regimen (two tablets daily for two weeks, followed by one tablet daily). <b>Results</b>: Clinical outcomes were evaluated using validated instruments, including the Numeric Pain Rating Scale (NPRS), Verbal Rating Scale (VRS), Short-Form McGill Pain Questionnaire (SF-MPQ), Global Perceived Effect (GPE), and EuroQol-5D-5L. Results showed a significant decrease in pain intensity (NPRS: −3.8 points; VRS: −2.1 points; <i>p</i> < 0.0001), along with meaningful improvements in patient-perceived benefit, pain descriptors, and quality of life (EQ-5D-5L: +35%; <i>p</i> < 0.0001). <b>Conclusions</b>: These findings endorse the use of this novel PEA–<i>Equisetum arvense</i> formulation as a safe, well-tolerated, and potentially effective supplementary intervention for managing chronic pain. No adverse events were reported, and the overall response rate reached 94%.https://www.mdpi.com/2076-3271/13/3/169oral supplementneuroinflammation modulationneuroprotective supplementationpain-related disabilityanalgesic effectchronic pain
spellingShingle Marco Invernizzi
Simone Mulè
Lorenzo Lippi
Rebecca Galla
Arianna Folli
Sara Ferrari
Domenico Tiso
Francesca Uberti
Evaluation of the Clinical Efficacy of a Novel Palmitoylethanolamide–<i>Equisetum arvense</i> Supplement for the Management of Chronic Pain: Findings from a Prospective Clinical Trial
oral supplement
neuroinflammation modulation
neuroprotective supplementation
pain-related disability
analgesic effect
chronic pain
title Evaluation of the Clinical Efficacy of a Novel Palmitoylethanolamide–<i>Equisetum arvense</i> Supplement for the Management of Chronic Pain: Findings from a Prospective Clinical Trial
title_full Evaluation of the Clinical Efficacy of a Novel Palmitoylethanolamide–<i>Equisetum arvense</i> Supplement for the Management of Chronic Pain: Findings from a Prospective Clinical Trial
title_fullStr Evaluation of the Clinical Efficacy of a Novel Palmitoylethanolamide–<i>Equisetum arvense</i> Supplement for the Management of Chronic Pain: Findings from a Prospective Clinical Trial
title_full_unstemmed Evaluation of the Clinical Efficacy of a Novel Palmitoylethanolamide–<i>Equisetum arvense</i> Supplement for the Management of Chronic Pain: Findings from a Prospective Clinical Trial
title_short Evaluation of the Clinical Efficacy of a Novel Palmitoylethanolamide–<i>Equisetum arvense</i> Supplement for the Management of Chronic Pain: Findings from a Prospective Clinical Trial
title_sort evaluation of the clinical efficacy of a novel palmitoylethanolamide i equisetum arvense i supplement for the management of chronic pain findings from a prospective clinical trial
topic oral supplement
neuroinflammation modulation
neuroprotective supplementation
pain-related disability
analgesic effect
chronic pain
url https://www.mdpi.com/2076-3271/13/3/169
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