Herbal analgesic patches versus NSAIDs in soft tissue injury management: real-world comparative effectiveness from a 35-center Chinese prospective cohort of 1378 participants.

BACKGROUND

Soft tissue injuries are common sports- and activity-related traumas that are traditionally managed with nonsteroidal anti-inflammatory drugs (NSAIDs). This study compared the efficacy and safety of a traditional Chinese herbal transdermal patch (GTP), NSAIDs, and their combinations in treating soft tissue injuries across 3-day, 1-week, and 2-week intervals.

METHODS

A multicenter prospective cohort of 1378 patients from 35 medical institutions was analyzed. Patients were assigned to one of five groups - GTP: once daily; selective COX-2 inhibitors (SCI): imrecoxib 100 mg twice daily, meloxicam 7.5 mg twice daily, celecoxib 200 mg twice daily, or etoricoxib 60 mg once daily; nonselective COX inhibitors (NSCI): ibuprofen 300 mg twice daily, loxoprofen sodium 60 mg three times daily, or diclofenac sodium 100 mg once daily, GTP + SCI, or GTP + NSCI - and evaluated via visual analog scale (VAS) scores (primary endpoint), time to recovery of joint mobility, time and rate of joint pain relief/resolution, and quality-of-life measures [EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L) and short form health Survey 36 (SF-36)]. GTP was applied topically, and NSAIDs were given orally. The duration of treatment was 14 days or until the patient's pain resolved. Therapeutic dynamics were assessed via linear regression and repeated-measures ANOVA.

RESULTS

Compared with NSCI ( P = 0.014) and GTP + NSCI combination therapy ( P = 0.033), GTP monotherapy exhibited significantly superior analgesic efficacy, although it marginally underperformed against both the SCI ( P < 0.001) and the GTP + SCI regimens ( P = 0.467). No therapeutic synergy was observed for any combination treatment. The results of the joint mobility recovery time and time/rate of joint pain relief/resolution demonstrated a similar trend in analgesic efficacy. EQ-5D-3L analysis revealed that the NSCI and NSCI + GTP cohorts outperformed the GTP monotherapy cohort, which surpassed both the SCI and the GTP + SCI groups in terms of quality-of-life metrics. The SF-36 scores were not significantly different among the groups. The short-term safety profiles remained acceptable across all the GTP-based interventions, whether administered alone or with NSAIDs.

CONCLUSION

GTP is a safe NSAIDs alternative, especially for patients with comorbidities. Monotherapy or a 2-week SCI-to-GTP transition is recommended because of the lack of combination synergy.