Efficacy of a natural herbal topical analgesic versus oral paracetamol in patients with soft tissue injury: a randomized, double-blind, placebo-controlled study

Abstract Importance Post traumatic pain remains poorly managed in emergency departments. Objective 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. Design and setting A prospective, multicenter, randomized, double-blind study conducted over 13 months in three EDs. Participants and intervention Patients aged 18 years and older, with minor limb soft tissue injuries, were randomized into Douloff (n = 765) and paracetamol (n = 750) groups. Main outcome and measures 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. Results 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 = 0.02). Median time to reach pain resolution was 4.5 ± 2.9 days in Douloff group compared with 5.6 ± 3.3 days in paracetamol group (P < 0.001). Patients in Douloff group required less rescue analgesics (48.2%) compared to paracetamol group (59.1%) (−10.9%, 95% CI −15.89 to −5.9; P < 0.001). 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 < 0.001). Conclusions Douloff, a topical herbal paste, is superior to oral paracetamol in the management of acute pain related to soft tissue injuries. Relevance Douloff can be considered as an alternative to conventional analgesics. Clinical trial registration The enrollment began from December 2022. The study has been registered in clinicaltrials.gov under the study number NCT05647681.