PMID- 30622590 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240413 IS - 1741-427X (Print) IS - 1741-4288 (Electronic) IS - 1741-427X (Linking) VI - 2018 DP - 2018 TI - Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial. PG - 1980491 LID - 10.1155/2018/1980491 [doi] LID - 1980491 AB - BACKGROUND: There is a worldwide epidemic of nonorganic gastrointestinal disorders (NOGDs), which are a class of disorders that cause various discomforts and ultimately progress into organic gastrointestinal diseases. Because of the unsatisfactory efficacy of Western medical treatments, traditional Chinese medicine (TCM) is becoming a promising complementary and alternative treatment to manage NOGDs. OBJECTIVES: To investigate the efficacy and safety of Hou Gu Mi Xi (HGMX), a newly developed dietary TCM formula, on the syndrome of spleen qi deficiency (SQD) in patients with NOGDs. METHODS/DESIGN: This study is a multicenter, randomized, double-blinded, parallel, and placebo-controlled trial that will last for 2 years. All qualified subjects with NOGDs and SQD will be included. The study population will be divided into the HGMX and placebo groups. To assess the efficacy of HGMX, we will mainly focus on changes in SQD symptoms scored by a Spleen Qi Deficiency Symptoms Grading and Quantifying Scale and evaluate changes in gastrin-17, the negative Helicobacter pylori conversion rate, body weight, body mass index, and gastroscopy findings. The safety of HGMX will be assessed by recording adverse events (AEs), severe AEs, treatment-related AEs and withdrawal due to AEs. DISCUSSION: This trial is part of our study series that intends to validate the potential of HGMX in the management of chronic gastrointestinal diseases. This series of RCTs is the first committed to the evaluation of a dietary TCM formula and will hopefully establish an evidence-based clinical research model for dietary TCM formulas. ETHICS: The protocol was approved by Ethics Committee of five research hospitals and was registered in Clinicaltrials.gov (NCT03019042). FAU - Chen, Xiaofan AU - Chen X AUID- ORCID: 0000-0003-0677-6021 AD - Evidence-Based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. FAU - Nie, Heyun AU - Nie H AUID- ORCID: 0000-0002-9146-5836 AD - Evidence-Based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. FAU - Liu, Wenjun AU - Liu W AUID- ORCID: 0000-0002-2322-5283 AD - School of Food Science and Engineering, Inner Mongolia Agricultural University, Inner Mongolia, China. FAU - Zhou, Xu AU - Zhou X AUID- ORCID: 0000-0002-9541-4796 AD - Evidence-Based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. FAU - Nie, Jianhua AU - Nie J AUID- ORCID: 0000-0003-3507-3085 AD - Evidence-Based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. FAU - Xie, Bin AU - Xie B AUID- ORCID: 0000-0003-2034-0160 AD - Evidence-Based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. FAU - Chen, Dongping AU - Chen D AUID- ORCID: 0000-0002-2987-9819 AD - Evidence-Based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. FAU - Jiang, Yiping AU - Jiang Y AUID- ORCID: 0000-0002-6838-3023 AD - Department of Spleen, Stomach, Liver and Gallbladder Diseases, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. FAU - Zhang, Kunhe AU - Zhang K AUID- ORCID: 0000-0003-3568-0600 AD - Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Jiangxi, China. FAU - Fu, Ying AU - Fu Y AUID- ORCID: 0000-0001-6069-6618 AD - Department of Traditional Chinese Medicine, The Second Affiliated Hospital of Nanchang University, Jiangxi, China. FAU - Yang, Deping AU - Yang D AUID- ORCID: 0000-0002-0303-237X AD - Department of Gastroenterology, Nanchang Hospital of Integrated Traditional Chinese and Western Medicine, Jiangxi, China. FAU - Xiong, Yan AU - Xiong Y AUID- ORCID: 0000-0002-4691-8103 AD - Department of Internal medicine, Nanchang Hongdu Hospital of Traditional Chinese Medicine, Jiangxi, China. FAU - Zhao, Zhangyang AU - Zhao Z AUID- ORCID: 0000-0003-4652-1971 AD - Evidence-Based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. FAU - Sun, Xin AU - Sun X AUID- ORCID: 0000-0001-6537-2559 AD - Evidence-Based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. AD - Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Sichuan, China. FAU - Zhu, Weifeng AU - Zhu W AUID- ORCID: 0000-0003-0679-0691 AD - Evidence-Based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Jiangxi, China. LA - eng SI - ClinicalTrials.gov/NCT03019042 PT - Journal Article DEP - 20181202 PL - United States TA - Evid Based Complement Alternat Med JT - Evidence-based complementary and alternative medicine : eCAM JID - 101215021 PMC - PMC6304527 EDAT- 2019/01/10 06:00 MHDA- 2019/01/10 06:01 PMCR- 2018/12/02 CRDT- 2019/01/10 06:00 PHST- 2018/08/16 00:00 [received] PHST- 2018/10/19 00:00 [revised] PHST- 2018/11/14 00:00 [accepted] PHST- 2019/01/10 06:00 [entrez] PHST- 2019/01/10 06:00 [pubmed] PHST- 2019/01/10 06:01 [medline] PHST- 2018/12/02 00:00 [pmc-release] AID - 10.1155/2018/1980491 [doi] PST - epublish SO - Evid Based Complement Alternat Med. 2018 Dec 2;2018:1980491. doi: 10.1155/2018/1980491. eCollection 2018.