• Khaoula Bel Haj Ali, Adel Sekma, Ben AbdallahSaoussenSCritical Care Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia., Hajer Yaakoubi, Imen Trabelsi, Nourzed Frikha, Houda Ben Soltane, Mohamed Habib Grissa, Hamdi Boubaker, Mohamed Amine Msolli, Zied Mezgar, Kaouthar Beltaief, Riadh Boukef, and Semir Nouira.
• Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.
• Pain Med. 2023 Jun 1; 24 (6): 586592586-592.

ObjectiveThe study compared the efficacy and tolerability of piroxicam gel and a new topical combination of medicinal plant products (Soulagel®; Belpharma Tunisia) to treat pain caused by soft tissue injuries.MethodsPatients (n = 1,525) were assigned to receive piroxicam gel or Soulagel. Efficacy assessments included a change of at least 50% in the pain-on-movement visual numeric scale rating from emergency department discharge (baseline) to day 7 final assessment, as well as the time required to reach pain resolution criteria, the need for rescue analgesia, patients' satisfaction, and the rate of adverse effects.ResultsAt day 7, 1,216 patients (79.7%) achieved at least 50% reduction in visual numeric scale rating from baseline: 623 patients (82.4%) in the Soulagel group vs 593 patients (77.1%) in the piroxicam group (P = 0.01). Time to decrease pain on movement by 50% was significantly higher with piroxicam gel than with Soulagel (34 ± 1 vs 33 ± 1 days, respectively; P = 0.54). At day 7, 96.4% of patients in the Soulagel group declared being "very satisfied" to "satisfied," vs 68% in the piroxicam group (P < 0.001). There were no major adverse events in either group.ConclusionsSoulagel is not inferior to piroxicam gel for managing pain related to a soft tissue injuries. Further studies will help ascertain whether this new gel offers an alternative treatment option for this common emergency department condition.© The Author(s) 2022. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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