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

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.