title: Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized controlled trial.
abstract: BACKGROUND
  Chinese 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.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  Compared 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).
  
  
  CONCLUSIONS
  CHM modified LiuJunZi decoction appears to offer symptomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry (ChiCTR): http://ChiCTR-TRC-10001074.
authors: Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, No, 23 Meishuguan Back Street, Dongcheng District, Beijing, 100010, China. zhss2000@163.com
authors: Shengsheng
authors: S
authors: Zhang
authors: Luqing
authors: L
authors: Zhao
authors: Hongbing
authors: H
authors: Wang
authors: Chuijie
authors: C
authors: Wang
authors: Suiping
authors: S
authors: Huang
authors: Hong
authors: H
authors: Shen
authors: Wei
authors: W
authors: Wei
authors: Lin
authors: L
authors: Tao
authors: Tao
authors: T
authors: Zhou
mesh_terms: D000328:Adult; D003937:Diagnosis, Differential; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000494:pharmacology / Q000627:therapeutic use*; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005746:Gastric Emptying / Q000187:drug effects*; D005765:Gastrointestinal Agents / Q000494:pharmacology / Q000627:therapeutic use*; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D008517:Phytotherapy; D019413:Qi; D012720:Severity of Illness Index; D013154:Spleen; D013270:Stomach / Q000187:drug effects*; D013577:Syndrome; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D005765:Gastrointestinal Agents; C521739:liujunzi