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 < 0.0001 vs. baseline). NRS pain intensity improved by 28.0% by Week 8 (p < 0.0001). ODI scores reduced by 20.8% (p < 0.0001) and SF-12 scores improved by 4.1% (p < 0.001) compared to baseline. Use of NSAIDs and gabapentinoids decreased by 23.7%, and 22.2%, respectively (p < 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. © 2025 by the authors.
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
Sansone, Pasquale;Gaetano, Dario;Trivelli, Giuseppe;Pace, Maria Caterina;Desiderio, Vincenzo;Maione, Sabatino;Luongo, Livio;
2025
Abstract
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 < 0.0001 vs. baseline). NRS pain intensity improved by 28.0% by Week 8 (p < 0.0001). ODI scores reduced by 20.8% (p < 0.0001) and SF-12 scores improved by 4.1% (p < 0.001) compared to baseline. Use of NSAIDs and gabapentinoids decreased by 23.7%, and 22.2%, respectively (p < 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. © 2025 by the authors.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
