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Open Access Research article

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

Shengsheng Zhang1*, Luqing Zhao1, Hongbing Wang1, Chuijie Wang2, Suiping Huang3, Hong Shen4, Wei Wei5, Lin Tao1 and Tao Zhou1

Author Affiliations

1 Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, No. 23 Meishuguan Back Street, Dongcheng District, Beijing, 100010, China

2 The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 33 Beiling Street, Huanggu District, Shenyang, 110033, China

3 The Second Affiliated Hospital of Guangdong University of Traditional Chinese Medicine, No. 111 Dade Street, Baiyun District, Guangzhou, 510120, China

4 The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, No. 155 Hanzhong Street, Jianye District, Nanjing, 210029, China

5 Wangjing Hospital, Huajiadi Street, Chaoyang District, Beijing, 100102, China

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BMC Complementary and Alternative Medicine 2013, 13:54  doi:10.1186/1472-6882-13-54

Published: 2 March 2013

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.

Trial registration

Chinese Clinical Trial Registry (ChiCTR): http://ChiCTR-TRC-10001074 webcite

Keywords:
Functional dyspepsia; Chinese herbal medicine; Modified LiuJunZi decoction; Randomized controlled trial