Retrospective cohort study on Shufeng Jiedu granules for SARS-CoV-2 infection: Real-world evidence from multicenter outpatient clinics in a predominantly caucasian population

Due to the lack of clinical evidence on the effectiveness and safety of Shufeng Jiedu (SFJD) Granules in Europe, it is unclear if SFJD can effectively and safely be used as an adjunct treatment for mild SARS-CoV-2 infection in a predominantly Caucasian outpatient population in Germany. Therefore, we conducted a retrospective cohort study to evaluate the real-world effectiveness and safety of SFJD compared to standard symptomatic care . This retrospective cohort study included adult patients (≥ 18 years) with mild SARS-CoV-2 infection symptoms treated between October 2021 and March 2023 across four outpatient clinics in Hamburg, Germany. Patients were allocated to either the SFJD group or a control group receiving standard symptomatic care. Clinical data, including symptom duration, intensity (measured by Visual Analogue Scale (VAS)), and adverse events, were analyzed. The primary endpoint was the time to total symptom alleviation (TTSA), defined as the first 24–hour period with all index symptoms rated VAS ≤ 1 and no temperature ≥ 37.0 °C. Secondary outcomes included symptom-specific duration and intensity. Data were verified by propensity score matching (PSM). Results : A total of 81 patients met inclusion criteria, with 38 patients assigned to the SFJD group and 43 patients assigned to the control group. Baseline characteristics were comparable between groups. The SFJD group showed a statistically significant different Time to Total Symptom Alleviation (TTSA) compared to controls [(5.76 ± 3.74) d and (11.50 ± 7.45) d, difference of 5.74 d, P < 0.001]. Symptom-specific improvement was most pronounced for rhinorrhea, fatigue, fever, and shortness of breath. Intensity scores were also lower in the SFJD group for multiple symptoms. No severe adverse events were observed. Gastrointestinal symptoms were equally distributed and not clearly attributable to treatment. 1:1 Nearest-neighbor PSM confirmed the TTSA results. Conclusion. SFJD Granules demonstrated beneficial effects in reducing the duration and intensity of mild SARS-CoV-2 infection symptoms in a real-world outpatient setting, without significant safety concerns. These findings support the potential of SFJD as an adjunctive therapy for early-stage COVID-19, especially in populations outside of East Asia. Prospective randomized trials are warranted to confirm these results.