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

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.