Herbal Remedy Noninferior to Piroxicam Gel for Soft Tissue Injury

The herbal product Soulagel® was found to be noninferior to piroxicam gel in managing acute pain associated with soft tissue injury, according to results of a study published in Pain Medicine.

Study authors proposed that “With different and possibly synergic mechanisms of action, medicinal plants with analgesic and anti-inflammatory properties could enhance the therapeutic effect and thus result in an additive effect when used in combination.”

Soulagel is an herbal remedy containing rosemary, mint, and clove essential oils and harpagophytum and meadowsweet natural extracts.

A multicenter, controlled, noninferiority trial (ClinicalTrials.gov Identifier: NCT05054023) was conducted at 4 emergency departments (EDs) in Tunisia between 2021 and 2022. Adults (N=1525) aged 18 to 60 years who presented with nonpenetrating minor soft tissue musculoskeletal limb trauma were randomly assigned in a 1:1 ratio to receive Soulagel (n=756) or piroxicam gel (n=769) applied 3 times daily for 7 days. The patients were contacted by telephone through day 7 to evaluate changes in visual numeric scale (VNS) pain scores.

The mean ages of patients in the Soulagel and piroxicam cohorts were 41.8 (standard deviation [SD], 15) and 41 (SD, 16) years. Most patients had no relevant medical history. Contusion and sprain were the most frequently reported types of injury, and VNS scores at admission to the ED were 55 (SD, 17) and 56 (SD, 17) points, respectively.

The average duration of time that elapsed between injury and presentation to the ED was 45 (SD, 35) minutes.

The adherence rate to treatment was 80% overall, with no difference reported between the 2 groups (P =.43).

At discharge from ED, median pain on movement scores were 50 in the Soulagel and 60 in the piroxicam cohorts (P =.34). At the 7-day follow-up, pain on movement scores decreased significantly in both groups, with 82.4% of Soulagel recipients and 77.1% of piroxicam recipients reporting a greater than 50% reduction in pain on movement score (P =.09). The median time to reach more than 50% reduction in pain on movement VNS score was 3.3 days for Soulagel recipients and 3.4 days for piroxicam recipients (P =.54).

Additional analgesics (nonsteroidal anti-inflammatory drugs or paracetamol) were administered to 28.6% of the Soulagel group and 31.7% of the piroxicam group at day 7 (P =.18).

More of the Soulagel recipients (96.4%) said they were very satisfied or satisfied with their treatment compared with 68% of the piroxicam recipients (P <.001).

A single patient in the Soulagel group and 7 patients in the piroxicam cohort reported a side effect at day 1 (P =.02); by day 7, side effects were reported by 3 patients and 29 patients, respectively (P <.001). All adverse effects were mild or moderate in severity and included rash with red spots and itching, localized rash, pruritus, and dry skin.

This study may have been biased as the 2 gel preparations differed in appearance, which may have affected the quality of blinding. However, patients were unaware of the comparator gel’s appearance.

Study authors concluded that Soulagel was noninferior to piroxicam gel for managing soft tissue injury pain and was better tolerated.