{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T16:30:38Z","timestamp":1792600238897,"version":"4.5.0"},"reference-count":47,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T00:00:00Z","timestamp":1765929600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Introduction: Chronic low back pain (CLBP) with neuropathic components poses a therapeutic challenge due to the limited efficacy and tolerability of conventional pharmacologic options. Botanical extracts such as Acmella oleracea and Boswellia serrata have demonstrated anti-inflammatory and analgesic properties. This study aimed to explore the role of a food supplement containing a standard formulation of these extracts as an adjunct to standard care in patients with CLBP. Methods: In this prospective, multicenter, observational, real-world, cohort study, 103 patients with CLBP and neuropathic pain received a standardized A. oleracea and B. serrata extract for 8 weeks as an add-on to ongoing therapy. Neuropathic pain was assessed using the painDETECT (PD-Q) and Neuropathic Pain Symptom Inventory (NPSI). General pain intensity (NRS), disability (ODI), quality of life (SF-12), concomitant analgesic use, and safety were also monitored at baseline, and at Weeks 2, 4, and 8. Results: PD-Q scores significantly decreased by 13.4% at Week 2, 25.5% at Week 4, and 37.1% at Week 8 and NPSI scores decreased by 15.8%, 24.4%, and 36.9%, respectively (all p &lt; 0.0001 vs. baseline). NRS pain intensity improved by 28.0% by Week 8 (p &lt; 0.0001). ODI scores reduced by 20.8% (p &lt; 0.0001) and SF-12 scores improved by 4.1% (p &lt; 0.001) compared to baseline. Use of NSAIDs and gabapentinoids decreased by 23.7%, and 22.2%, respectively (p &lt; 0.05). No serious adverse events occurred; mild and transient effects were reported in 8.7% of patients. Conclusions: The A. oleracea and B. serrata extract as adjunctive therapy resulted in significant improvements in neuropathic pain, functional disability, and reduced medication use, with good tolerability. While these findings suggest a potential role for this botanical combination in managing CLBP with neuropathic components, the absence of a control group limits causal inference. Randomized controlled trials are needed to establish efficacy and confirm these preliminary observations.<\/jats:p>","DOI":"10.3390\/ph18121903","type":"journal-article","created":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T15:53:46Z","timestamp":1765986826000},"page":"1903","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and Safety of Acmella oleracea and Boswellia serrata Extract as Add-On Therapy for Chronic Low Back Pain: An Observational, Real-World Cohort Study"],"prefix":"10.3390","volume":"18","author":[{"given":"Mariateresa","family":"Giglio","sequence":"first","affiliation":[{"name":"Department of Interdisciplinary Medicine, ICU and Pain Therapy Section, University of Bari \u201cAldo Moro\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Consalvo","family":"Mattia","sequence":"additional","affiliation":[{"name":"Department of Anesthesia, Intensive Care Medicine and Pain Therapy, La Sapienza University, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0873-3586","authenticated-orcid":false,"given":"Pasquale","family":"Sansone","sequence":"additional","affiliation":[{"name":"Department of Women, Child and General and Specialized Surgery, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3059-9865","authenticated-orcid":false,"given":"Gabriele","family":"Finco","sequence":"additional","affiliation":[{"name":"Department of Medical Science and Public Health, University of Cagliari, 09124 Cagliari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7664-8928","authenticated-orcid":false,"given":"Salvatore","family":"Sardo","sequence":"additional","affiliation":[{"name":"Department of Medical Science and Public Health, University of Cagliari, 09124 Cagliari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Sofia","sequence":"additional","affiliation":[{"name":"ASST Rhodense, The Hospital of Garbagnate Milanese, 20024 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dario","family":"Gaetano","sequence":"additional","affiliation":[{"name":"Department of Women, Child and General and Specialized Surgery, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Trivelli","sequence":"additional","affiliation":[{"name":"Department of Women, Child and General and Specialized Surgery, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Caterina","family":"Pace","sequence":"additional","affiliation":[{"name":"Department of Women, Child and General and Specialized Surgery, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-3489-0179","authenticated-orcid":false,"given":"Fabio","family":"Turco","sequence":"additional","affiliation":[{"name":"Cannabiscientia SA, 6900 Lugano, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1819-6083","authenticated-orcid":false,"given":"Vincenzo","family":"Desiderio","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9760-9394","authenticated-orcid":false,"given":"Alberto","family":"Corriero","sequence":"additional","affiliation":[{"name":"Department of Interdisciplinary Medicine, ICU and Pain Therapy Section, University of Bari \u201cAldo Moro\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fara","family":"Fornarelli","sequence":"additional","affiliation":[{"name":"Department of Interdisciplinary Medicine, ICU and Pain Therapy Section, University of Bari \u201cAldo Moro\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Paladini","sequence":"additional","affiliation":[{"name":"Department of MESVA, University of L\u2019Aquila, 67100 L\u2019Aquila, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabatino","family":"Maione","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, Division of Pharmacology, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Livio","family":"Luongo","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, Division of Pharmacology, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7274-6467","authenticated-orcid":false,"given":"Filomena","family":"Puntillo","sequence":"additional","affiliation":[{"name":"Department of Interdisciplinary Medicine, ICU and Pain Therapy Section, University of Bari \u201cAldo Moro\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,12,17]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e316","DOI":"10.1016\/S2665-9913(23)00098-X","article-title":"Global, Regional, and National Burden of Low Back Pain, 1990\u20132020, Its Attributable Risk Factors, and Projections to 2050: A Systematic Analysis of the Global Burden of Disease Study 2021","volume":"5","author":"Ferreira","year":"2023","journal-title":"Lancet 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