Background: Complementary and alternative therapy is widely used to treat chronic obstructive pulmonary disease (COPD). A Chinese herbal medicine, Jian Pi Yi Fei Wan, have been shown to improve COPD patients’ quality of life, however long-term effectiveness has not been examined.
Purpose: To investigate whether long-term treatment with Jian Pi Yi Fei Wan is effective and safe for patients with stable, moderate to very severe COPD.
Study design and methods: A multicentre, randomised, double-blinded, placebo-controlled trial was conducted. Eligible participants from six hospitals were randomly assigned 1:1 to receive either Jian Pi Yi Fei Wan or placebo for 52 weeks. The primary outcome was the change in St. George’s Respiratory Questionnaire (SGRQ) score during treatment.
Secondary outcomes included the frequency of acute exacerbations during treatment, COPD Assessment Test (CAT), 6-minute walking test (6MWT), lung function, body mass index, airflow obstruction, dyspnoea, exercise capacity (BODE) index, and peripheral capillary oxygen saturation (SpO2) at the end of treatment.
Results: A total of 276 patients (138 in each group) were included in the analysis. Jian Pi Yi Fei Wan led to a significantly greater reduction in SGRQ score (-7.33 points, 95% CI -10.59 to -4.07; p < 0.0001) which reflects improved quality of life. Jian Pi Yi Fei Wan improved CAT (-3.49 points, 95% CI -5.12 to -1.86; p < 0.0001) and 6MWT (45.61 metres, 95% CI 20.26 to 70.95; p = 0.0005), compared with placebo. Acute exacerbations were less frequent with Jian Pi Yi Fei Wan than with placebo (0.87 vs. 1.34 events per patient; p = 0.0043). There were no significant differences between the groups in lung function, BODE index and SpO2. Jian Pi Yi Fei Wan were well tolerated and no significant adverse effects were noted.
Conclusions: Long-term treatment with Jian Pi Yi Fei Wan is effective in moderate to very severe COPD, improving quality of life and exercise capacity, decreasing the risk of acute exacerbation, and relieving symptoms.