Evaluation of clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of acute respiratory distress syndrome

INTRODUCTION: Acute respiratory distress syndrome (ARDS) is a common disease in critically ill patients that has a high incidence and mortality rate worldwide. At present, there is no specific treatment for ARDS. Traditional Chinese medicine has been shown to have good potential in preventing and treating ARDS, especially in reducing the dosages of Western medicines and therefore, adverse drug reactions. The purpose of this study is to compare the clinical efficacy of integrated Chinese and Western medicine to that of Western medicine alone in the treatment of ARDS. METHODS: We are proposing a prospective, multicenter, randomized, double-blind, placebo-controlled study in which 110 eligible patients would be enrolled and randomly divided into a Western medicine treatment group and an integrated Chinese and Western medicine treatment group. After 2 weeks of interventions and 1 year of follow-up, the clinical efficacy and safety of Jiawei qianyang dan in ARDS patients would be observed. The outcomes measured would include the Traditional Chinese medicine symptom score, the oxygenation index (PɑO2/FiO2), extravascular pulmonary water index, duration of mechanical ventilation, number of ICU hospitalization days, and the 28-day mortality rate for the 2 groups before and after treatment. The all-cause mortality rate, respiratory failure mortality rate, and readmission rate after 1 year of follow-up will be statistically analyzed and safety will be evaluated. DISCUSSION: In this study, we aim to demonstrate the greater clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of ARDS compared to that of Western medicine alone. In order to do this, we hope to provide evidence for the clinically supportive effect of the Jiawei qianyang dan in the treatment of ARDS and therefore demonstrate a more effective treatment.