{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,17]],"date-time":"2026-01-17T04:26:22Z","timestamp":1768623982593,"version":"3.49.0"},"reference-count":48,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2025,3,5]],"date-time":"2025-03-05T00:00:00Z","timestamp":1741132800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Importance<\/jats:title>\n                  <jats:p>Post traumatic pain remains poorly managed in emergency departments.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>This study aims to evaluate the effectiveness and tolerability of a phytotherapeutic topical gel (Douloff) compared to oral paracetamol for acute pain resulting from minor limb soft tissue injuries.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Design and setting<\/jats:title>\n                  <jats:p>A prospective, multicenter, randomized, double-blind study conducted over 13\u2009months in three EDs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Participants and intervention<\/jats:title>\n                  <jats:p>Patients aged 18\u2009years and older, with minor limb soft tissue injuries, were randomized into Douloff (n\u2009=\u2009765) and paracetamol (n\u2009=\u2009750) groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Main outcome and measures<\/jats:title>\n                  <jats:p>The primary outcome was the pain resolution rate [reduction of at least 50% of pain intensity, measured by the numeric rating scale (NRS) on active motion at day-7compared to NRS at discharge]. Secondary outcomes included time to pain resolution, rescue analgesia, patient satisfaction, and adverse events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The groups were comparable in terms of baseline characteristics. On day-7, resolution of pain was observed in 641 patients (83.7%) in Douloff group versus 535 patients (71.3%) in paracetamol group (OR 1.27; 95% CI 1.015-1.6; P\u2009=\u20090.02). Median time to reach pain resolution was 4.5\u2009\u00b1\u20092.9\u2009days in Douloff group compared with 5.6\u2009\u00b1\u20093.3\u2009days in paracetamol group (P\u2009&amp;lt;\u20090.001). Patients in Douloff group required less rescue analgesics (48.2%) compared to paracetamol group (59.1%) (\u221210.9%, 95% CI \u221215.89 to \u22125.9; P\u2009&amp;lt;\u20090.001). No major adverse events were observed in either group, and 89.4% of patients in Douloff group were satisfied, compared to 92.5% in the paracetamol group (P\u2009&amp;lt;\u20090.001).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Douloff, a topical herbal paste, is superior to oral paracetamol in the management of acute pain related to soft tissue injuries.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Relevance<\/jats:title>\n                  <jats:p>Douloff can be considered as an alternative to conventional analgesics.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical trial registration<\/jats:title>\n                  <jats:p>The enrollment began from December 2022. The study has been registered in clinicaltrials.gov under the study number NCT05647681.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/pm\/pnaf006","type":"journal-article","created":{"date-parts":[[2025,3,6]],"date-time":"2025-03-06T04:26:47Z","timestamp":1741235207000},"page":"329-336","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy of a natural herbal topical analgesic versus oral paracetamol in patients with soft tissue injury: a randomized, double-blind, placebo-controlled study"],"prefix":"10.1093","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0309-8376","authenticated-orcid":false,"given":"Marwa","family":"Toumia","sequence":"first","affiliation":[{"name":"Research Laboratory LR12SP18, Monastir University , Monastir 5019,","place":["Tunisia"]},{"name":"Emergency Department, Haj Ali Soua Regional Hospital , Ksar Hellal 5070,","place":["Tunisia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Randa","family":"Dhaoui","sequence":"additional","affiliation":[{"name":"Research Laboratory LR12SP18, Monastir University , Monastir 5019,","place":["Tunisia"]},{"name":"Emergency Department, Fattouma Bourguiba University Hospital , Monastir 5000,","place":["Tunisia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarra","family":"Sassi","sequence":"additional","affiliation":[{"name":"Research Laboratory LR12SP18, Monastir University , Monastir 5019,","place":["Tunisia"]},{"name":"Emergency Department, Fattouma Bourguiba University Hospital , Monastir 5000,","place":["Tunisia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cyrine","family":"Kouraichi","sequence":"additional","affiliation":[{"name":"Research Laboratory LR12SP18, Monastir University , Monastir 5019,","place":["Tunisia"]},{"name":"Emergency Department, Fattouma Bourguiba University Hospital , 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Habib","family":"Grissa","sequence":"additional","affiliation":[{"name":"Research Laboratory LR12SP18, Monastir University , Monastir 5019,","place":["Tunisia"]},{"name":"Emergency Department, Fattouma Bourguiba University Hospital , Monastir 5000,","place":["Tunisia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jamel","family":"Saad","sequence":"additional","affiliation":[{"name":"Department of Imaging and Interventional Radiology, Fattouma Bourguiba University Hospital , Monastir 5000,","place":["Tunisia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hamdi","family":"Boubaker","sequence":"additional","affiliation":[{"name":"Research Laboratory LR12SP18, Monastir University , Monastir 5019,","place":["Tunisia"]},{"name":"Emergency Department, Fattouma Bourguiba University Hospital , Monastir 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