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

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.

Methods: A prospective, multicenter, randomized, double-blind study conducted over 13 months in three EDs. Patients aged 18 years and older, with minor limb soft tissue injuries, were randomized into Douloff® (n = 765) and paracetamol (n = 750) groups. 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).

Conclusion: Douloff®, a topical herbal paste, is superior to oral paracetamol in the management of acute pain related to soft tissue injuries. It can be considered as an alternative to conventional analgesics.