Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized controlled trial

Shengsheng Zhang,Shengsheng Zhang,Lin Tao,Hongbing Wang,Hongbing Wang,Wei Wei,Suiping Huang,Luqing Zhao,Luqing Zhao,Chuijie Wang,Hong Shen,Tao Zhou,Tao Zhou

doi:10.1186/1472-6882-13-54

Abstract

BackgroundChinese herbal medicine (CHM) has been used in China and some other countries for the treatment of patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatments in patients with FD are lacking. In this trial, we aimed to assess the efficacy and safety of modified LiuJunZi decoction in patients with FD of spleen-deficiency and qi-stagnation syndrome.MethodsWe performed a randomized, double-blind, placebo-controlled trial with patients from five centers. Patients with FD of spleen-deficiency and qi-stagnation syndrome (n = 160) were randomly assigned to groups given CHM modified LiuJunZi decoction or placebo in a 2:1 ratio. Herbal or placebo granules were dissolved in 300 ml of boiled water cooled to 70°C. Patients in both groups were administered 150 ml (50°C) twice daily. The trial included a 4-week treatment period and a 4-week follow-up period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4 and 8. The secondary outcome was the change of radiopaque barium markers emptied from the stomach between week 0 and week 4 of treatment.ResultsCompared with patients in the placebo group, patients in the CHM group showed significant improvements according to the scores of total dyspepsia symptoms and single dyspepsia symptoms obtained from patients (P < 0.01) and investigators (P < 0.01). They also showed an improvement in the number of radiopaque barium markers emptied from the stomach (P < 0.05).ConclusionsCHM modified LiuJunZi decoction appears to offer symptomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome.Trial registrationChinese Clinical Trial Registry (ChiCTR): http://ChiCTR-TRC-10001074

Highlights

Chinese herbal medicine (CHM) has been used in China and some other countries for the treatment of patients with functional dyspepsia (FD)
In Traditional Chinese Medicine (TCM), FD is considered nearly equivalent to the TCM term “stuffiness and fullness” [12], which is divided into different syndromes according to the clinical symptoms and signs
We studied the distribution of the different syndromes in 565 cases of FD and found that “spleen-deficiency and qi-stagnation” is the most common syndrome in FD patients [13]

Summary

Introduction

Chinese herbal medicine (CHM) has been used in China and some other countries for the treatment of patients with functional dyspepsia (FD). Controlled studies supporting the efficacy of such treatments in patients with FD are lacking In this trial, we aimed to assess the efficacy and safety of modified LiuJunZi decoction in patients with FD of spleen-deficiency and qi-stagnation syndrome. The Chinese consensus on diagnosis and treatment of functional dyspepsia defines spleen-deficiency and qi-stagnation as a prominent syndrome in FD [14]. LiuJunZi decoction is a traditional Chinese compound herbal recipe for invigorating the spleen and regulating qi. We added the related herbal medicines Cortex Mangnoliae officinalis, Common Vladimiria Root, Rhizoma Corydalis, and Villous amomrum fruit to the recipe, and found a modified LiuJunZi decoction with a satisfactory clinical effect. Previous studies had shown that the active ingredients in the modified LiuJunZi decoction can improve gastrointestinal motility, regulate gastrointestinal function and have anti-Helicobacter pylori and anti-inflammatory action [15,16,17,18,19,20,21]

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