Abstract

Background

Spleen qi deficiency (SQD), a syndrome based on traditional Chinese medicine (TCM) theory, is common in patients after radical gastrectomy. SQD manifests with chronic gastrointestinal disorders and systemic symptoms and is challenging to manage. Hou Gu Mi Xi (HGMX) is a dietary TCM formula for SQD. This study aims to evaluate the efficacy and safety of HGMX in patients with SQD who have undergone radical gastrectomy for gastric cancer.

Methods and design

This study is a multicenter, randomized, double-blind, placebo-controlled trial. One hundred thirty patients with SQD who have undergone radical gastrectomy for gastric cancer will be assigned to receive either HGMX or placebo for 2 years. The main outcome will be changes in SQD symptoms assessed by the Spleen Qi Deficiency Symptoms Grading and Quantifying Scale. The secondary outcomes will be changes in quality of life assessed by the Short Form 36 scale, performance status as assessed by the Eastern Cooperative Oncology Group Performance Status scale, body weight, and body mass index. Progression-free survival will also be assessed as a secondary outcome. Adverse events (AEs), severe AEs, and study withdrawal due to AEs will be recorded to evaluate the safety of HGMX.

Discussion

The results of this trial will provide initial evidence for the use of HGMX as an alternative and complementary intervention to manage chronic postoperative complications in patients who have undergone radical gastrectomy for gastric cancer.

Trial registration

ClinicalTrials.gov, NCT03025152. Registered on 17 January 2017.

Details

Title
Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial
Author
Zhou, Xu 1 ; Yan, Dong-mei 1 ; Zhu, Wei-feng 1 ; Liu, Wen-jun 2 ; Nie, He-yun 1 ; Xu, Sheng 1 ; Jiang, Yi-ping 3 ; Zhang, Kun-he 4 ; Fu, Ying 5 ; Wan, Yi-ye 6 ; Yu, Xin-yu 1 ; Li, Hong 1 ; Sun, Xin 7 ; Chen, Xiao-fan 1   VIAFID ORCID Logo 

1  Jiangxi University of Traditional Chinese Medicine, Evidence-based Medicine Research Center, School of Basic Medical Sciences, Nanchang, China (GRID:grid.411868.2) (ISNI:0000 0004 1798 0690) 
2  Inner Mongolia Agricultural University, School of Food Science and Engineering, Inner Mongolia, China (GRID:grid.411638.9) (ISNI:0000 0004 1756 9607) 
3  Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Department of Spleen, Stomach, Liver and Gallbladder Diseases, Jiangxi, China (GRID:grid.478032.a) 
4  First Affiliated Hospital of Nanchang University, Department of Gastroenterology, Jiangxi, China (GRID:grid.478032.a) 
5  Second Affiliated Hospital of Nanchang University, Department of Traditional Chinese Medicine, Jiangxi, China (GRID:grid.478032.a) 
6  Jiangxi Provincial Cancer Hospital, Third Department of Oncology, Jiangxi, China (GRID:grid.452533.6) (ISNI:0000 0004 1763 3891) 
7  Jiangxi University of Traditional Chinese Medicine, Evidence-based Medicine Research Center, School of Basic Medical Sciences, Nanchang, China (GRID:grid.411868.2) (ISNI:0000 0004 1798 0690); West China Hospital, Sichuan University, Chinese Evidence-based Medicine Center, Sichuan, China (GRID:grid.412901.f) (ISNI:0000 0004 1770 1022) 
Pages
343
Publication year
2019
Publication date
Dec 2019
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-019-3429-x
ProQuest document ID
2795393966
Copyright
© The Author(s). 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.