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

<b>Introduction:</b> 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 <i>Acmella oleracea</i> and <i>Boswellia serrata</i> 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. <b>Methods:</b> In this prospective, multicenter, observational, real-world, cohort study, 103 patients with CLBP and neuropathic pain received a standardized <i>A. oleracea</i> and <i>B. serrata</i> 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. <b>Results:</b> 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 <i>p</i> < 0.0001 vs. baseline). NRS pain intensity improved by 28.0% by Week 8 (<i>p</i> < 0.0001). ODI scores reduced by 20.8% (<i>p</i> < 0.0001) and SF-12 scores improved by 4.1% (<i>p</i> < 0.001) compared to baseline. Use of NSAIDs and gabapentinoids decreased by 23.7%, and 22.2%, respectively (<i>p</i> < 0.05). No serious adverse events occurred; mild and transient effects were reported in 8.7% of patients. <b>Conclusions:</b> The <i>A. oleracea</i> and <i>B. serrata</i> 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.

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Journal
Pharmaceuticals
Published
2025-12-17
DOI
https://doi.org/10.3390/ph18121903
Primary Topic
Pharmacological Effects of Medicinal Plants
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article
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article

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

Michele Sofia, Filomena Puntillo, Antonella Paladini, Vincenzo Desiderio et al.
Pharmaceuticals
Pharmacological Effects of Medicinal Plants
article

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

Michele Sofia, Filomena Puntillo, Antonella Paladini, Vincenzo Desiderio, Mariateresa Giglio, Pasquale Sansone, Livio Luongo, Salvatore Sardo, Sabatino Maione, Maria Caterina Pace, Giuseppe Trivelli, Alberto Corriero, Gabriele Finco, Consalvo Mattia, Fara Fornarelli, Fabio Turco, Dario Gaetano
article en

Abstract

<b>Introduction:</b> 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 <i>Acmella oleracea</i> and <i>Boswellia serrata</i> 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. <b>Methods:</b> In this prospective, multicenter, observational, real-world, cohort study, 103 patients with CLBP and neuropathic pain received a standardized <i>A. oleracea</i> and <i>B. serrata</i> 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. <b>Results:</b> 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 <i>p</i> < 0.0001 vs. baseline). NRS pain intensity improved by 28.0% by Week 8 (<i>p</i> < 0.0001). ODI scores reduced by 20.8% (<i>p</i> < 0.0001) and SF-12 scores improved by 4.1% (<i>p</i> < 0.001) compared to baseline. Use of NSAIDs and gabapentinoids decreased by 23.7%, and 22.2%, respectively (<i>p</i> < 0.05). No serious adverse events occurred; mild and transient effects were reported in 8.7% of patients. <b>Conclusions:</b> The <i>A. oleracea</i> and <i>B. serrata</i> 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.

PharmaceuticalsVol. 18(12)
University of Cagliari (IT), University of Campania "Luigi Vanvitelli" (IT), University of L'Aquila (IT), ATS Sardegna (Italy) (IT), Adienne (Switzerland) (CH), University of Bari Aldo Moro (IT), Università della Svizzera italiana (CH), Sapienza University of Rome (IT)
Openalex Percentile: Top 56%
Pharmacological Effects of Medicinal Plants
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