Open AccessModified Maimendong decoction in the treatment of patients with idiopathic pulmonary fibrosis
Author(s) -
Wenfan Gan,
Qun Huang,
Guojin Xiao,
Ying Luo,
Jundong Wang,
Chuantao Zhang,
Yuancheng Liang,
Niao Huang,
Tingting Liao
Publication year - 2020
Publication title -
medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.59
H-Index - 148
eISSN - 1536-5964
pISSN - 0025-7974
DOI - 10.1097/md.0000000000023460
Subject(s) - medicine , vital capacity , idiopathic pulmonary fibrosis , pirfenidone , placebo , traditional chinese medicine , decoction , pulmonary function testing , clinical trial , diffusing capacity , lung , pathology , alternative medicine , lung function
With dissatisfaction of western medicine, traditional Chinese medicine becomes alternative treatment for idiopathic pulmonary fibrosis patients. The common syndrome of idiopathic pulmonary fibrosis (IPF) is qi and yin deficiency syndrome. The prescription, Modified Maimendong Decoction (MMD), is usually used for IPF patients with qi and yin deficiency syndrome. However, there is no convinced evidence for the efficacy and safety of MMD to treat IPF. Methods: A double-blind, placebo-controlled, randomized clinical trial was put forward by us. After a 1-day run-in period, 60 eligible patients will be included in the study. These subjects will be allocated to the experiment group or control group in a 1:1 ratio. Patients in the experiment group will take MMD plus Pirfenidone capsule. At the same time, patients in the control group will receive a matched placebo plus Pirfenidone capsule. All subjects will receive 24 weeks of treatment and follow-up period. The primary outcomes are the mean change from the baseline in forced vital capacity and times of acute exacerbations at week 4, 12, 24. Secondary outcomes are the mean change from baseline in the St. George's respiratory questionnaire total score, forced expiratory volume in 1 second percentage/forced vital capacity, diffusing capacity of Carbon monoxide, brain natriuretic peptide, and curative effect of traditional Chinese medicine syndrome at week 4, 12, and 24. Any side effects of the treatment will be recorded. Discussion: The results of this trial will provide the evidence for the effect of MMD in patients with idiopathic pulmonary fibrosis.