Oxford University Press
Pain Medicine
,  volume 24 ,  issue 6

Analgesic effect of topical piroxicam versus phytotherapy gel in the treatment of acute soft tissues injuries: a randomized controlled non-inferiority study

Khaoula Bel Haj Ali 1, 2
, 
Adel Sekma 1, 2
, 
Saoussen Ben Abdallah 3
, 
Hajer Yaakoubi 4
, 
Imen Trabelsi 2
, 
Nourzed Frikha 5
, 
Houda Ben Soltane 6
, 
Mohamed Habib Grissa 1, 2
, 
Hamdi Boubaker 1, 2
, 
Mohamed Amine Msolli 1, 2
, 
Zied Mezgar 6
, 
Kaouthar Beltaief 1, 2
, 
Riadh Boukef 4
, 
Semir Nouira 1, 2
1
 
2
 
3
 
4
 
Emergency Department, Sahloul University Hospital , Sousse, Tunisia | 
5
 
Belpharma Laboratories , Sfax, Tunisia | 
6
 
Publication type: Journal Article
Publication date: 2022-11-10
Oxford University Press
scimago Q1
wos Q1
SJR: 0.982
CiteScore: 6.7
Impact factor: 3.0
ISSN: 15262375, 15264637
DOI:  10.1093/pm/pnac176
PubMed ID:  36355573
Abstract
Objective

The study compared the efficacy and tolerability of piroxicam gel and a new topical combination of medicinal plant products (Soulagel®) to treat pain caused by soft tissue injuries.

Methods

1525 patients were assigned to receive piroxicam gel or Soulagel®. Efficacy assessments included pain-on-movement (POM) VNS (visual numeric scale) change from emergency department (ED) discharge (baseline) by at least 50% at day-7 final assessment, the time required to reach pain resolution criteria, need for rescue analgesia, patients’ satisfaction, and rate of adverse effects.

Results

At day-7, 1216 patients (79.7%) achieved at least 50% reduction of VNS from baseline; 623 patients (82.4%) in Soulagel® group vs. 593 patients (77.1%) in piroxicam group (p = 0.01). Time to decrease POM by 50% was significantly higher with piroxicam gel compared to Soulagel® (34±1 vs 33±1 days respectively; p = 0.54). At day 7, 96.4% of patients in Soulagel® group declared being “very satisfied” to “satisfied” vs. 68% in piroxicam group (p < 0.001). There was no major adverse events in both groups.

Conclusion

Soulagel® is not inferior to piroxicam gel for managing pain related to a soft tissues injuries. Further studies will help ascertain whether this new gel offers an alternative treatment option in this common ED condition.

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GOST Copy
Bel Haj Ali K. et al. Analgesic effect of topical piroxicam versus phytotherapy gel in the treatment of acute soft tissues injuries: a randomized controlled non-inferiority study // Pain Medicine. 2022. Vol. 24. No. 6.
GOST all authors (up to 50) Copy
Bel Haj Ali K., Sekma A., Ben Abdallah S., Yaakoubi H., Trabelsi I., Frikha N., Ben Soltane H., Grissa M. H., Boubaker H., Msolli M. A., Mezgar Z., Beltaief K., Boukef R., Nouira S. Analgesic effect of topical piroxicam versus phytotherapy gel in the treatment of acute soft tissues injuries: a randomized controlled non-inferiority study // Pain Medicine. 2022. Vol. 24. No. 6.
RIS |
Cite this
RIS Copy
TY - JOUR
DO - 10.1093/pm/pnac176
UR - https://doi.org/10.1093/pm/pnac176
TI - Analgesic effect of topical piroxicam versus phytotherapy gel in the treatment of acute soft tissues injuries: a randomized controlled non-inferiority study
T2 - Pain Medicine
AU - Bel Haj Ali, Khaoula
AU - Sekma, Adel
AU - Ben Abdallah, Saoussen
AU - Yaakoubi, Hajer
AU - Trabelsi, Imen
AU - Frikha, Nourzed
AU - Ben Soltane, Houda
AU - Grissa, Mohamed Habib
AU - Boubaker, Hamdi
AU - Msolli, Mohamed Amine
AU - Mezgar, Zied
AU - Beltaief, Kaouthar
AU - Boukef, Riadh
AU - Nouira, Semir
PY - 2022
DA - 2022/11/10
PB - Oxford University Press
IS - 6
VL - 24
PMID - 36355573
SN - 1526-2375
SN - 1526-4637
ER -
BibTex
Cite this
BibTex (up to 50 authors) Copy
@article{2022_Bel Haj Ali,
author = {Khaoula Bel Haj Ali and Adel Sekma and Saoussen Ben Abdallah and Hajer Yaakoubi and Imen Trabelsi and Nourzed Frikha and Houda Ben Soltane and Mohamed Habib Grissa and Hamdi Boubaker and Mohamed Amine Msolli and Zied Mezgar and Kaouthar Beltaief and Riadh Boukef and Semir Nouira},
title = {Analgesic effect of topical piroxicam versus phytotherapy gel in the treatment of acute soft tissues injuries: a randomized controlled non-inferiority study},
journal = {Pain Medicine},
year = {2022},
volume = {24},
publisher = {Oxford University Press},
month = {nov},
url = {https://doi.org/10.1093/pm/pnac176},
number = {6},
doi = {10.1093/pm/pnac176}
}