A multicenter randomized controlled trial and metabolomics exploration of Traditional Chinese Medicine pattern-based...

To evaluate the efficacy of Traditional Chinese Medicine (TCM) pattern-based comprehensive therapy on stable chronic obstructive pulmonary disease (COPD) patients and its influence on metabolic profiles.

In this multicenter trial, 270 participants from nine hospitals were randomly divided into a trial group and a control group at a 1∶2 ratio. The trial group received Tiotropium Bromide Powder for Inhalation (TBPI) plus one of three TCM granules [Shenqi Wenfei formula, Shenqi Buzhong formula, or Shenqi Tiaoshen formula], while the control group got only TBPI. The study had a 24-week treatment and 52-week follow-up. The main outcome was the frequency of acute COPD exacerbations. Secondary outcomes included related rates, scores on COPD assessment test (CAT) and modified medical research council (mMRC) dyspnea scale, 6-min walk test (6MWT) distance, and lung function, measured at weeks 0, 24, and 52. Serum samples for metabolomics were taken from the trial group before/after treatment and from healthy people.

A total of 256 out of 270 patients completed the study. The trial group had fewer acute exacerbations than the control group during 52-week follow-up (P <0.05). At 24 weeks, the trial group improved in CAT, mMRC, and 6MWT compared to the control (P <0.05), with mMRC and 6MWT improvements lasting at week 52. Lung function showed no significant group differences. Metabolomics found 32 different metabolites between healthy and pre-treatment patients, 17 reversing post-treatment. Bioinformatics showed pathway changes in pre-treatment patients reversed after treatment.

TCM pattern-based comprehensive therapy reduces acute exacerbation risk and improves quality of life, respiratory symptoms, and exercise tolerance in stable COPD patients, likely by modulating energy, protein, and amino acid metabolism pathways.