Clinical efficacy of comprehensive therapy based on traditional Chinese medicine patterns on patients with pneumoconiosis: a pilot double-blind, randomized, and placebo-controlled study

Abstract

Effective therapy options for pneumoconiosis are lacking. Traditional Chinese medicine (TCM) presents a favorable prospect in the treatment of pneumoconiosis. A pilot study on TCM syndrome differentiation can evaluate the clinical efficacy and safety of TCM and lay a foundation for further clinical research. A double-blind, randomized, and placebo-controlled trial was conducted for 24 weeks, in which 96 patients with pneumoconiosis were randomly divided into the control and treatment groups. Symptomatic treatment was conducted for the two groups. The treatment group was treated with TCM syndrome differentiation, and the control group was treated with placebo. The primary outcomes were the six-minute walking distance (6MWD) and the St. George Respiratory Questionnaire (SGRQ) score. The secondary outcomes were the modified British Medical Research Council Dyspnea Scale (mMRC), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), and pulmonary function. Only 83 patients from the 96 patients with pneumoconiosis finished the study. For the primary outcome, compared with the control groups, the treatment group showed a significantly increased 6MWD (407.90 m vs. 499.51 m; 95% confidence interval (CI) 47.25 to 135.97; P <0.001) and improved SGRQ total score (44.48 vs. 25.67; 95% CI −27.87 to −9.74; P <0.001). The treatment group also significantly improved compared with the control group on mMRC score (1.4 vs. 0.74; 95% CI −1.08 to −0.23; P =0.003), CAT score (18.40 vs. 14.65; 95% CI −7.07 to −0.43; P =0.027), and the total symptom score (7.90 vs. 5.14; 95% CI −4.40 to −1.12; P <0.001). No serious adverse events occurred. This study showed that TCM syndrome differentiation and treatment had a favorable impact on the exercise endurance and quality of life of patients with pneumoconiosis.

Keywords

pneumoconiosis / randomized controlled trials / traditional Chinese medicine

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Acknowledgements

This work was supported by the Henan Province Priority and Advantage Discipline Construction Engineering Projects—Traditional Chinese Medicine (No. STS-ZYX-2017025) and the Special Project of Traditional Chinese Medicine Research in Henan Province (Nos. 20-21ZYZD01 and 2018ZY1003).

Compliance with ethics guidelines

Jiansheng Li, Hulei Zhao, Yang Xie, Jieya Li, Qingwei Li, Xuexin Chen, and Weiyu Zhang declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All procedures were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent was obtained from all patients for being included in the study.

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