Effect of Pingchuan Guben decoction on patients with chronic obstructive pulmonary disease: Results from a randomized comparative effectiveness research trial

Abstract

Chronic obstructive pulmonary disease (COPD) is known to be a systemic low-grade ongoing inflammation exerting major health and economic burden worldwide. Complementary and alternative medicines, such as Traditional Chinese Medicine, are widely used for the treatment of patients with COPD. The present study was designed to investigate the efficacy of Pingchuan Guben decoction on patients with COPD through a double-blinded, open-labeled, randomized controlled trial. A total of 86 patients were randomly assigned to two groups, with 43 patients in the intervention group and 43 cases in the control group. The patients in the control group were treated with conventional western medicine, and the intervention group received a combination of conventional western medicine and Pingchuan Guben decoction. After 12 weeks of treatment, the mean 6-minute walking distance, forced expiratory volume in 1 sec (FEV1), forced vital capacity (FVC) and FEV1/FVC in the intervention group were significantly higher than those of the control group (P<0.05). The levels of inflammation factors and protease molecules were significantly ameliorated in the intervention group compared with the control group (P<0.05). The levels of Kelch-like ECH-associated protein 1 (Keap1), nuclear factor-E2-related factor-2 (Nrf2), superoxide anions, malondialdehyde, glutathione S-transferase and glutathione peroxidase were significantly more improved in the intervention group compared with those in the control group over the 12-week study period (P<0.05). Therefore, combinations of western medicine with Pingchuan Guben decoction may exert therapeutic effects on patients with COPD via modulations of inflammation factors and protease molecules, as well as the activation of the Keap1/Nrf2 signaling pathway.

Keywords: Kelch-like ECH-associated protein 1; Traditional Chinese Medicine; chronic obstructive pulmonary disease; inflammation factors; nuclear factor-E2-related factor-2.

Figure 1.

Consort flow diagram of participant enrollment.

Figure 2.

Comparisons of inflammation-related factors before and after treatment in the control and intervention group. Data are presented as the mean ± standard deviation. *P<0.05 vs. the control group; ^#P<0.05 vs. 0 week. SP-D, surfactant protein D; PCT, procalcitonin; SAA, serum amylase A; sTREM-1, soluble triggering receptor expressed on myeloid cell-1; IP-10, interferon-G induced protein 10; TRAIL, tumor necrosis factor-related apoptosis-inducing ligand.

Figure 3.

Comparisons of protease molecules before and after treatment in the control and intervention group. Data are presented as the mean ± standard deviation. *P<0.05 vs. the control group; ^#P<0.05 vs. 0 week. NE, neutrophil elastase; α1-AT, α1-antitrypsin; SLPI, secretory leukocyte protease inhibitor; TIMP-1, tissue inhibitor of metalloproteinase 1.

Figure 4.

Comparison of expression of Keap1/Nrf2 pathway molecules in induced sputum before and after treatment in the control and intervention group. Data are presented as the mean ± standard deviation. *P<0.05 vs. the control group; ^†P<0.05 vs. 0 week. Keap1, Kelch-like ECH-associated protein; Nrf2, nuclear factor-E2-related factor-2; ARE, antioxidant response element; MDA, malondialdehyde; GST, glutathione-s-transferase; GPX, glutathione peroxidase; MLU, mean light unit.