Chronic bronchitis (CB) is a long-standing inflammatory airway disorder with a high global burden and limited treatment success. In recent years, the combined use of traditional Chinese medicine (TCM) with standard medical care has been increasingly adopted for CB and has shown encouraging therapeutic potential. A multicenter randomized controlled trial directed by the China–Japan Friendship Hospital (Beijing, China) recruited 300 individuals with CB aged 18–75 years. Participants were allocated in a 2:2:1 ratio to one of three groups: Guben Kechuan Granules (test group, n=120), Guilong Kechuanning Capsules (active comparator, n=120), or a subject-education arm (blank control, n=60). The intervention lasted 24 weeks, followed by a 24-week observation phase. Efficacy assessments included clinical symptoms, acute exacerbation of CB (AECB), pulmonary function metrics, immune-related indicators, and quality-of-life measurements. Adverse events were recorded for safety analysis. All statistical evaluations were performed with SAS 9.4.
Among the study population, 299 patients (99.7%) were part of the full analysis set, 298 were eligible for safety monitoring, and 278 met criteria for the per-protocol dataset. Relative to the blank control, Guben Kechuan Granules markedly extended the time to first AECB and lowered AECB duration, intensity, and frequency (all p<0.05). After 24 weeks, notable reductions were observed in cough scores (−21.85±19.73), sputum scores (−22.74±18.66), and wheezing scores (−21.33±18.76) (p<0.05), and these improvements persisted throughout the 24-week follow-up (p<0.05). Significant gains in mobility, self-care, daily function, and overall health were also recorded (all p<0.05). No meaningful changes in FEV1/FVC%, FEV1%pred, PEF, MMEF, FVC, or FEV1 were detected in any group after 24 weeks. No severe adverse events occurred in the experimental arm during long-term follow-up. Guben Kechuan Granules provided clear therapeutic benefit and exhibited good tolerability in patients with CB, improving symptoms, reducing AECB occurrence and severity, and enhancing quality of life. Registered on 4 September 2022, ChiCTR2200063321. Traditional Chinese Medicine Inheritance and Innovation “Ten-Hundred-Thousand” Talents Program (Qihuang Program, 2019-QTL-003). Chinese Clinical Trials Registry: https://www.chictr.org.cn/showproj.html?proj=177683.
