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
Xu Zhou,
Dong-mei Yan,
Wei-feng Zhu,
Wen-jun Liu,
He-yun Nie,
Sheng Xu,
Yi-ping Jiang,
Kun-he Zhang,
Ying Fu,
Yi-ye Wan,
Xin-yu Yu,
Hong Li,
Xin Sun,
Xiao-fan Chen
Affiliations
Xu Zhou
Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine
Dong-mei Yan
Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine
Wei-feng Zhu
Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine
Wen-jun Liu
School of Food Science and Engineering, Inner Mongolia Agricultural University
He-yun Nie
Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine
Sheng Xu
Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine
Yi-ping Jiang
Department of Spleen, Stomach, Liver and Gallbladder Diseases, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Kun-he Zhang
Department of Gastroenterology, First Affiliated Hospital of Nanchang University
Ying Fu
Department of Traditional Chinese Medicine, Second Affiliated Hospital of Nanchang University
Yi-ye Wan
Third Department of Oncology, Jiangxi Provincial Cancer Hospital
Xin-yu Yu
Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine
Hong Li
Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine
Xin Sun
Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine
Xiao-fan Chen
Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine
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.
