Effects of YuPingFeng granules on acute exacerbations of COPD: a randomized, placebo-controlled study

Abstract

PurposeRecurrence of acute exacerbations has a major impact on patients with COPD. Therefore, effective prevention and treatment of exacerbation is crucial in the management of COPD, especially for patients with moderate to severe disease. This study evaluated the effectiveness of YuPingFeng granule administration in preventing exacerbation and improving symptom score, as well as its long-term (1 year) safety profile, in patients with COPD.Patients and methodsThis was a randomized, double-blind, parallel, placebo-controlled study of 240 patients from eight centers in China. Participants were eligible if they had mild to severe COPD as defined by Global Initiative for Chronic Obstructive Lung Disease, had a history of at least two COPD exacerbations or one hospitalization within the previous year, and had remained clinically stable for over 4 weeks before the study. They were randomly assigned to receive 5 g of YuPingFeng or placebo, three times per day, for 1 year. The primary end point was the exacerbation rate over 1 year, and the analysis was by intention to treat. Secondary end points included symptom score, which was assessed by COPD assessment test (CAT) score and safety profiles. This trial was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn; registration number: ChiCTR-IPR-15007023).ResultsThe YuPingFeng group had a significantly lower exacerbation rate than the placebo group (1.15 vs 1.55; risk ratio=0.677 [95% CI 0.531–0.863]; P=0.002) and a significantly reduced risk of second exacerbation (95% CI 0.326–0.772; P=0.002). After treatment, the mean change in the CAT score in the YuPingFeng group (−4.41±7.01) differed significantly from that in the placebo group (−2.49±5.31; P=0.001). YuPingFeng was well tolerated.ConclusionYuPingFeng granules can be considered as a treatment option for COPD; this treatment prevents acute exacerbations of COPD and has a good safety profile.

Kampo Medicine for Various Aging-Related Symptoms: A Review of Geriatric Syndrome

“…Iwasaki et al (34)(35)(36). In the majority of the studies, crude drugs added to the conventional therapy prevented recurrence of acute exacerbation.…”

Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial

“…There are four groups with two variables in this trial—TCM treatment and systemic glucocorticoid treatment. Therefore, according to primary endpoints collected from previous trial [ 34 , 41 ], we choose the maximum sample size needed, as calculated by two way on http://www.powerandsamplesize.com (Table 2 ). At the 5% significance level, a total of 67 patients per group will be required for a 2-group, 1-sided calculation to achieve 80% power and the differences of 10.30 ± 6.31 and 12.95 ± 5.99 in CAT mean score between the TCM treatment group and placebo group (Table 5 ).…”

“…Hopefully, traditional Chinese medicines (TCM) can expand COPD treatment in terms of syndromic difference, also called Zheng [ 29 ]. Not only has TCM alleviated symptoms such as coughing, shortness of breath, and sputum for thousands of years, but also has demonstrated its efficacy and safety [ 30 – 34 ]. However, there are rarely studies focused on COPD patients during the acute exacerbation period, most of them focused on the relatively stable period.…”

Preliminary Study to Evaluate Three Different Treatments on Stable Chronic Obstructive Pulmonary Disease Patients Based on Markov Model

“…A large number of clinical trials, such as TORCH [6], UPLIFT [7], INSPIRE [8], and small-dose-theophylline [9], have all confirmed that Western medicine could decrease the mortality rate and the risks of AE for stable COPD patients and slow down the annual decline of lung function. Recent study has also shown that treating patients with stable COPD is positive for managing the disease and preventing its exacerbation [10] and progression [11]. The medication can alleviate the clinical symptoms of COPD, but it cannot stop or reverse the decline of lung function, and some important problems caused by Western medicine need to be solved, such as side effects of medicine and pneumonia [6, 8].…”

“…In view of the above deficiency, more relevant researches have been conducted, which have obtained some certain achievements. Evidences indicate that TCM has some positive effects in the treatment of stable COPD, which could be showed in clinical trials [10, 12] and animal experiments [13–15]. It could bring a reduction of clinical symptoms and disease progression.…”