Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on stable chronic obstructive pulmonary disease: a randomized, double-blind, placebo-controlled trial

Tianyi Lyu; Demin Li; Xiang Lei; Yuteng Zhang; Shilei Cheng; Xinyang Shu; Hongchun Zhang

doi:10.3389/fphar.2023.1164818

Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on stable chronic obstructive pulmonary disease: a randomized, double-blind, placebo-controlled trial

Front Pharmacol. 2023 Jun 27:14:1164818. doi: 10.3389/fphar.2023.1164818. eCollection 2023.

Authors

Tianyi Lyu¹, Demin Li², Xiang Lei³, Yuteng Zhang⁴, Shilei Cheng⁴, Xinyang Shu², Hongchun Zhang²

Affiliations

¹ School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
² Department of Traditional Chinese Medicine for Pulmonary Diseases, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Chinese Academy of Medical Sciences, Beijing, China.
³ Beijing Qi-Huang Technology Co., Ltd., Beijing, China.
⁴ Beijing University of Chinese Medicine, Beijing, China.

Abstract

Objective: The aim of this study was to evaluate the efficacy and safety of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke (SHGBZK) as a treatment for patients with stable chronic obstructive pulmonary disease (COPD) diagnosed with lung-spleen Qi deficiency. Method: A randomized, double-blind, placebo-controlled trial was designed. 98 adults aged between 40 and 80 years with stable COPD diagnosed with lung-spleen Qi deficiency were included. All participants received basic treatment for COPD. Patients in the experimental group took SHGBZK, while the control group took placebo. The primary outcome was the frequency of acute exacerbation. The secondary outcomes were lung function, symptom score, exercise capacity and quality of life. Results: Of 98 patients who underwent randomization, 50 patients in the SHGBZK group and 48 in the placebo group were included in the full analysis set. After 24-week therapy and 28-week follow-up, patients in treatment group had significant improvements in symptom, exercise capacity and quality of life. After Subgroup analysis, the frequency of acute exacerbation in patients with a COPD Assessment Test (CAT) score of at least 10 or a modified Medical Research Council (mMRC) score of at least 2 was significantly lower in the SHGBZK group than in the placebo group. Lung function in patients with frequent exacerbation was significantly higher in the SHGBZK group than in the placebo group. The incidence of adverse events was generally similar in the two groups. Conclusion: SHGBZK had beneficial effects on symptom, exercise capacity and quality of life in stable COPD patients. SHGBZK also had the potential to reduce the frequency of exacerbation and improve lung function in specific groups of COPD patients. Clinical Trial Registration: https://www.chictr.org.cn/showproj.html?proj=26933, identifier ChiCTR1800016349.

Keywords: San-Huang Gu-Ben Zhi-Ke; chronic obstructive pulmonary disease; clinical trials; subgroup analysis; traditional Chinese medicine.

Grants and funding

This work was supported by Capital’s Funds for Health Impovement and Research (No. 2018-2-4067) and Elite Medical Professionals Project of China-Japan Friendship Hospital (no. ZRJY2021-GG06).