Efficacy, Safety, and Pharmacoeconomic Evaluation of Shiwei Longdanhua Capsules in Acute Exacerbation of Chronic Bronchitis with Phlegm-Heat Obstructing Fei (Lung): A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Control Trial.

OBJECTIVE: To evaluate the efficacy, safety, and pharmacoeconomic profile of Shiwei Longdanhua Capsules (SWLDH) for treating acute exacerbation of chronic bronchitis (AECB) patients with Chinese medicine (CM) syndrome of phlegm-heat obstructing Fei (Lung, PHOF). METHODS: This multicenter, randomized, double-blind, double-dummy, active-controlled trial enrolled AECB patients with PHOF syndrome across 14 centers in China from February 2023 to January 2024. Participants were randomized in a 3:1 ratio to the SWLDH and Feilike Capsules (FLK) groups. The SWLDH group received SWLDH (1.35 g) plus FLK placebo, while the FLK group received FLK (1.20 g) plus SWLDH placebo, administered orally 3 times daily for 14 d. The primary endpoint was the improvement rate of CM syndrome after 14-d treatment; the secondary endpoints included cough-related outcomes, CM symptom scores, quality of life, safety, and pharmacoeconomic outcomes. RESULTS: A total of 193 patients were enrolled in the study, with 144 in the SWLDH group and 49 in the FLK group. The improvement rate of CM syndrome after 14-d treatment was significantly higher in the SWLDH group than that in the FLK group (95.1% vs. 81.3%, P=0.006). SWLDH also significantly improved the cough disappearance or near-disappearance rate on day 14 (81.1% vs. 63.3%, P=0.011). For individual CM symptom efficacy, the improvement rate of cough was significantly higher in the SWLDH group than in the FLK group after 14-d treatment (89.3% vs. 77.6%, P=0.040). Both groups showed improvements in quality of life assessed by Leicester Cough Questionnaire scores, with no significant between-group differences. SWLDH showed a comparable safety profile with FLK and no discontinuations due to adverse events. Compared with FLK, SWLDH incurred an additional cost of 1,344.09 RMB per additional case of effective CM symptom improvement and an incremental cost of 202,733.75 RMB per quality-adjusted life year gained, which was below the willingness-to-pay threshold. CONCLUSIONS: SWLDH significantly improved CM symptoms, accelerated cough resolution, and enhanced quality of life in AECB patients with PHOF syndrome, with a favorable safety profile and cost-effectiveness. (Trial registration No. ChiCTR2200066665).