Abstract
Background There is no effective therapy for silicosis, and Dahuang Zhechong pill (DHZCP), an ancient Chinese medicine prescription, may have a therapeutic effect on silicosis. This study aims to verify the efficacy and safety of DHZCP in silicosis. Methods This is a randomized controlled clinical trial done at Panzhihua Second People's Hospital (Panzhihua City, Sichuan Province, China). Participants diagnosed with silicosis were recruited and randomized to the conventional treatment group (CG) or DHZCP combined with the conventional treatment group (DG). Forced vital capacity % predicted (FVC%), diffusing capacity of the lung for carbon monoxide % predicted (DLCO%), six-minute walk distance (6MWD), peripheral oxygen (SpO2), King's Brief Interstitial Lung Disease Questionnaire (K-BILD), and safety outcomes were measured at baseline and 9 weeks. Results Fifty-six participants (28 in each group) completed the study, and 53 of them (26 in DG and 27 in CG) completed pulmonary function. At 9 weeks, compared with no DHZCP, DHZCP treatment was associated with significant improvements in FVC% (mean ± SD, 95%CI) (8.2 ± 3.9, 0.3 to 16.0), DLCO% (8.6 ± 3.5, 1.5 to 15.7), SpO2 (3.8 ± 0.7, 2.3 to 5.2), and K-BILD total score (6.0 ± 2.3, 1.4 to 10.7). And, there were no statistical differences of safety outcomes between the two groups. Eight patients accepting DHZCP developed mild diarrhea during the first week, which subsequently resolved on its own. Conclusion DHZCP could improve the pulmonary function, the quality of life, and the exercise capacity of silicosis patients.
Highlights
Silicosis is a fatal and irreversible fibrotic pulmonary disease, which is one of the most common occupational respiratory diseases worldwide [1, 2]
Some studies have reported that diffusing capacity of the lung for carbon monoxide % predicted (DLCO%) of patients with silicosis was 59.9% ± 5.9% after conventional treatment, and it was 65.9% ± 6.1% after Traditional Chinese Medicine (TCM) combined with conventional treatment [19]. erefore, we assumed that mean DLCO% was 65.9% after Dahuang Zhechong pill (DHZCP) combined with conventional treatment, and standard deviations (SD) was 6.0%
In order to make sure that the sample sizes were equal, block randomization was adopted in the study. e size of each block was set as 4. e group of DHZCP combined with conventional treatment (DG) was set as group A, and the group of no DHZCP but conventional treatment (CG) was set as group B. en, there were 6 arrangement methods in each block: AABB, ABAB, ABBA, BAAB, BABA, and BBAA. e 6 arrangement methods were numbered from 1 to 6
Summary
Silicosis is a fatal and irreversible fibrotic pulmonary disease, which is one of the most common occupational respiratory diseases worldwide [1, 2]. It is caused by the inhalation and deposition of respirable crystalline silica (SiO2) (particles
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