Efficacy and safety of traditional Chinese medicine in patients with acute exacerbation of idiopathic pulmonary fibrosis: study protocol for randomized, controlled, exploratory clinical trial

Zhang Hailong,Luo Weixian,Guo Wen,Zhao Limin,Li Jiansheng,Zhang Dong,Wang Lu,Zhou Miao

doi:10.1186/s13063-022-06026-0

Abstract

BackgroundAt present, there is short of effective treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF). The treatment of IPF with traditional Chinese medicine (TCM) has some advantages. However, the evidence is unclear whether TCM can be recommended as an effective therapy to treat AE-IPF. The purpose of the study is to explore the efficacy and safety of TCM for patients with AE-IPF.MethodsA randomized, double-blind, placebo-controlled, exploratory clinical trial will be performed. A total of 80 patients diagnosed with AE-IPF will be randomized into the intervention or control group. In addition to conventional treatment, the intervention group will be treated with Kangxianhuanji granule, and the control group will be given a placebo granule. The administration frequency is 10 g each time and two times daily. After 4 weeks of treatment, the patients were followed up for 12 weeks. The primary outcomes are treatment failure rate and all-cause mortality. Secondary outcome measures will include the length of hospitalization, overall survival, acute exacerbation rate, intubation rate, Modified British Medical Research Council (mMRC) score, the St George’s Respiratory Questionnaire idiopathic pulmonary fibrosis (SGRQ-I) score, and arterial blood gas analysis.DiscussionTCM may be beneficial in IPF. However, it has never been evaluated in patients with AE-IPF, who are incredibly prone to respiratory failure and have a high mortality rate. It is the first clinical trial to explore the efficacy and safety of TCM in the treatment of AE-IPF. This result will provide a basis for further study, which provides a high-quality evidence for the treatment of AE-IPF with TCM.Trial registrationChinese Clinical Trial Registry ChiCTR1900026289. Registered on 29 September 2019.

Highlights

At present, there is short of effective treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-Idiopathic pulmonary fibrosis (IPF))
90% of patients with acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) need to be treated in ICU [14], and those who survive after the first acute exacerbation have a mortality rate of more than 90% after 6 months [15]
According to the clinical manifestations and characteristics of IPF, most scholars believe that IPF belongs to lung wilt disease or lung bi in traditional Chinese medicine (TCM) [26, 27]

Summary

Introduction

There is short of effective treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF). Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrotic lung disease of unknown etiology occurring in adults [1]. It is characterized by worsening lung function and leading to respiratory failure and death [2]. 90% of patients with AE-IPF need to be treated in ICU [14], and those who survive after the first acute exacerbation have a mortality rate of more than 90% after 6 months [15]. It is important to carry out therapeutic research on AE-IPF

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