Presentation (CTI)

OBJECTIVES: Post-infectious cough (PIC) is a major cause of subacute cough, significantly impacts quality of life. This multi-center, randomized, double-blind, parallel-controlled trial evaluated the efficacy and safety of Suhuang Zhike Capsule versus compound methoxyphenamine hydrochloride capsule for PIC.
METHODS: From August 2015 to December 2017, 100 PIC patients (cough duration: 3-8 weeks) were randomized 1:1 to receive Suhuang Zhike Capsule (experimental group) or compound methoxyphenamine hydrochloride capsule (control group) for 7 days. The primary endpoint was the resolution rate of cough symptoms, and the secondary endpoints included time to cough improvement, time to cough control. Safety outcome was also assessed.
RESULTS: After 7 days, cough resolution rates showed no significant difference between groups in both Full Analysis Set (FAS: 84.0% vs. 92.0%, p > 0.05) and Per Protocol Set (PPS: 85.7% vs. 91.8%, p > 0.05). Time to cough improvement (median 3.0 days) and time to cough control (mean 5.8-6.1 days) were comparable (p > 0.05). However, cough control rate (complete resolution) was significantly higher in the control group (FAS: 32.0% vs. 10.0%, p < 0.05; PPS: 32.0% vs. 10.2%, p < 0.05). The experimental group had lower incidences of treatment-emergent adverse events (TEAEs: 8.0% vs. 12.0%) and adverse drug reactions (ADRs: 8.0% vs. 12.0%), though without statistical significance (p> 0.05).
CONCLUSIONS: Suhuang Zhike Capsule demonstrated non-inferior antitussive efficacy and comparable safety to compound methoxyphenamine hydrochloride capsule in PIC treatment, though with significantly lower cough control rate.