Abstract
BackgroundAcute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common cause of morbidity and mortality. Traditional Chinese medicine (TCM) is used to treat AECOPD as adjunctive therapy. This study aimed to evaluate the efficacy and safety of the TCM formula Xuan Bai Cheng Qi as an adjuvant therapy for AECOPD patients with the syndrome type of phlegm-heat obstructing the lungs.MethodsA multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 244 patients were divided into the intervention group (n = 122, treated with conventional medicine and Xuan Bai Cheng Qi) and the control group (n = 122, treated with conventional medicine and placebo). Total symptom scores (cough, phlegm, wheezing, chest congestion) before treatment and at 3, 5, 7, 10 days post-treatment were recorded. Lung function, arterial blood gas, serum inflammatory cytokines, oxidation/anti-oxidation index were observed before treatment and at the end of the 10-day treatment.ResultsA total of 242 patients completed the study. The full analysis set (FAS) population was 244 and the per-protocol analysis set (PPS) population was 229. After the 10-day treatment, symptom scores of the Xuan Bai Cheng Qi group were significantly lower over time compared with the control group (FAS: mean difference -1.84, 95% CI -2.66 to -1.03, P < .001; PPS: mean difference -1.87, 95% CI -2.71 to -1.03, P < .001). FEV1, FVC, and FEV1%pred were significantly higher over time in the Xuan Bai Cheng Qi group compared with those in the control group (day 10, FAS and PPS: P < .05). PaO2 and PaCO2 were significantly improved in the Xuan Bai Cheng Qi group (day 10, FAS and PPS: P < .05). Xuan Bai Cheng Qi was also found to ameliorate cytokine levels and oxidation/antioxidant index compared with placebo. There were no differences in safety variables and adverse events between the two groups.ConclusionsXuan Bai Cheng Qi formula appears to be a safe and beneficial treatment for AECOPD of phlegm-heat obstructing the lungs syndrome type.
Highlights
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common cause of morbidity and mortality
A total of 242 evaluable participants were in the study, with 121 in the Xuan Bai Cheng Qi group and 121 in the control group
Arterial blood gas analysis At day 10, PaO2 and PaCO2 were significantly improved in the Xuan Bai Cheng Qi group compared with PaO2 and PaCO2 in the control group (PaO2, full analysis set (FAS): mean difference 4.75, 95% confidence interval (CI) 1.21 to 8.28, P = .009, per-protocol analysis set (PPS): mean difference 4.08, 95% IC 0.04 to 7.76, P = .030; PaCO2, FAS: mean difference −2.48, 95% CI −4.53 to −0.44, P = .018, PPS: mean difference −2.69, 95% CI −4.56 to −0.81, P = .005)
Summary
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common cause of morbidity and mortality. This study aimed to evaluate the efficacy and safety of the TCM formula Xuan Bai Cheng Qi as an adjuvant therapy for AECOPD patients with the syndrome type of phlegm-heat obstructing the lungs. Hastening of normal reduction in lung function that occurs with age and repeated exacerbations are key features of COPD. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common cause of morbidity and mortality in COPD patients [2]. These exacerbations are associated with worsening respiratory symptoms and lung function [3]. Median time postexacerbation to recovery of peak flow is 6 days and time to recovery from symptoms is 7 days [4]
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