Efficacy and safety of Maekmoondong-tang for chronic dry cough: a study protocol for a randomized controlled trial.

Kwan-Il Kim,Junhee Lee,Kyuseok Kim,Seungwon Shin

doi:10.1186/s12906-016-1028-x

Abstract

BackgroundChronic cough, defined it lasts more than 8 weeks. The symptom is common, but highly troublesome, and it reduces quality of life. Despite much effort to develop a protocol for diagnosis and treatment of chronic cough, it remains problematic to determine its cause. As a result, treatment is often unsuccessful. Thus, there is much interest regarding the use of symptomatic drugs to control chronic cough. Maekmoondong-tang is widely used in East Asian countries to treat chronic dry cough. Several experimental studies have reported that the herbal medicine has immunomodulatory and antitussive effects. Clinical studies involving Maekmoondong-tang have also been carried out; however, these studies have involved treating various diseases as a whole rather than chronic cough itself. Thus, we aim to evaluate the efficacy and safety of Maekmoondong-tang in chronic dry cough patients with a randomized controlled trial.Methods/DesignThis study is designed as an exploratory, single-center, placebo-controlled, double-blind, randomized, parallel group clinical trial. Patients with dry cough that has lasted more than 8 weeks will be recruited, after a 1-week run-in period, and randomly allocated to either the Maekmoondong-tang treatment group or the placebo group. The patients will receive Maekmoondong-tang or placebo granules 3 times daily for 4 weeks, with a 2-week follow-up. The primary outcome is a 10-point cough diary that will be recorded on a daily basis. The secondary outcomes comprise a cough visual analog scale, the Leicester Cough Questionnaire (Korean version), the Pattern Identification for Chronic Cough Questionnaire, biomarkers, safety testing, etc. Adverse events will also be reported.DiscussionThis trial will assess the efficacy and safety of Maekmoondong-tang in chronic dry cough.Trial registrationKorean Clinical Trial Registry (http://cris.nih.go.kr; registration number: KCT0001646). Date of registration: October 5 2015

Highlights

Chronic cough, defined it lasts more than 8 weeks
MMDT, which consists of six herbs, is widely used to treat cough caused by lung yin deficiency, which is a common pattern in chronic dry cough according to traditional Korean medicine (TKM) [11]
According to the Donguibogam, which was published in 1613 by the royal physician Heo Jun and has been a popular piece of TKM literature, MMDT is used for heat-induced asthma, which is caused by the lung or stomach yin deficiency [13]

Summary

Introduction

Chronic cough, defined it lasts more than 8 weeks. The symptom is common, but highly troublesome, and it reduces quality of life. Chronic cough, defined as lasting more than 8 weeks, is a common respiratory symptom among outpatients [1,2,3]. It is associated with a substantial deterioration in quality of life, with various effects on all aspects of health, such as. Studies into the efficacy of antitussive drugs to manage chronic cough have yielded inconsistent results. MMDT, which consists of six herbs, is widely used to treat cough caused by lung yin deficiency, which is a common pattern in chronic dry cough according to traditional Korean medicine (TKM) [11]. No clinical trials have studied the efficacy of MMDT on chronic dry cough with normal chest X-ray

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