Randomized Clinical Trial of Topical Piroxicam Versus a New Herbal Medicine Based Gel in the Treatment of Acute Extremity Pain After Emergency Department Discharge

Acute soft tissues injuries are a common complaint for emergency department (ED) visit. RICE and Topical non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used to reduce pain and inflammation. Herbal therapy is commonly used to treat pain but few studies assessed its efficacy and tolerability.

Start Date21 Oct 2021

Sponsor / Collaborator

Université de Monastir

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01 Jun 2023·Pain Medicine

Analgesic Effect of Topical Piroxicam vs Phytotherapy Gel in the Treatment of Acute Soft Tissue Injuries: A Randomized Controlled Noninferiority Study

Article

Author: Ben Soltane, Houda ; Bel haj ali, Khaoula ; Frikha, Nourzed ; Yaakoubi, Hajer ; Grissa, Mohamed Habib ; Msolli, Mohamed Amine ; Beltaief, Kaouthar ; Nouira, Semir ; Boukef, Riadh ; Trabelsi, Imen ; Mezgar, Zied ; Boubaker, Hamdi ; Ben Abdallah, Saoussen ; Sekma, Adel

AbstractObjectiveThe 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.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Pain	Phase 3	TN	Université de Monastir	21 Oct 2021

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