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.
Authors
- Michele Sofia (ORCID: https://orcid.org/0000-0001-9397-5306)
- Filomena Puntillo (ORCID: https://orcid.org/0000-0001-7274-6467)
- Antonella Paladini (ORCID: https://orcid.org/0000-0002-1219-9315)
- Vincenzo Desiderio (ORCID: https://orcid.org/0000-0003-1819-6083)
- Mariateresa Giglio (ORCID: https://orcid.org/0000-0002-4901-0045)
- Pasquale Sansone (ORCID: https://orcid.org/0000-0003-0873-3586)
- Livio Luongo (ORCID: https://orcid.org/0000-0002-1949-2039)
- Salvatore Sardo
- Sabatino Maione (ORCID: https://orcid.org/0000-0003-3850-6704)
- Maria Caterina Pace (ORCID: https://orcid.org/0000-0002-9352-4780)
- Giuseppe Trivelli
- Alberto Corriero (ORCID: https://orcid.org/0000-0002-9760-9394)
- Gabriele Finco (ORCID: https://orcid.org/0000-0002-3059-9865)
- Consalvo Mattia (ORCID: https://orcid.org/0000-0003-1894-9575)
- Fara Fornarelli (ORCID: https://orcid.org/0000-0002-1984-4313)
- Fabio Turco (ORCID: https://orcid.org/0009-0003-3489-0179)
- Dario Gaetano
Institutions
- 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)
Publication Details
- Journal
- Pharmaceuticals
- Published
- 2025-12-17
- DOI
- https://doi.org/10.3390/ph18121903
- Primary Topic
- Pharmacological Effects of Medicinal Plants
- Type
- article
- Field-Weighted Citation Impact
- 0.00