{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T04:08:31Z","timestamp":1768536511993,"version":"3.49.0"},"reference-count":19,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,12,2]],"date-time":"2018-12-02T00:00:00Z","timestamp":1543708800000},"content-version":"vor","delay-in-days":335,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Scientific Research Funding of Jiangxi Jiangzhong Pharmaceutical (group) Co., Ltd.","award":["2016918"],"award-info":[{"award-number":["2016918"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Evidence-Based Complementary and Alternative Medicine"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:p><jats:italic>Background.<\/jats:italic> 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. <jats:italic>Objectives<\/jats:italic>. 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. <jats:italic>Methods\/Design.<\/jats:italic> This study is a multicenter, randomized, double\u2010blinded, parallel, and placebo\u2010controlled 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\u201017, the negative <jats:italic>Helicobacter pylori<\/jats:italic> 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\u2010related AEs and withdrawal due to AEs. <jats:italic>Discussion.<\/jats:italic> 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\u2010based clinical research model for dietary TCM formulas. <jats:italic>Ethics<\/jats:italic>. The protocol was approved by Ethics Committee of five research hospitals and was registered in Clinicaltrials.gov (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03019042\">NCT03019042<\/jats:ext-link>).<\/jats:p>","DOI":"10.1155\/2018\/1980491","type":"journal-article","created":{"date-parts":[[2018,12,2]],"date-time":"2018-12-02T23:31:42Z","timestamp":1543793502000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo\u2010Controlled Trial"],"prefix":"10.1155","volume":"2018","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0677-6021","authenticated-orcid":false,"given":"Xiaofan","family":"Chen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9146-5836","authenticated-orcid":false,"given":"Heyun","family":"Nie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2322-5283","authenticated-orcid":false,"given":"Wenjun","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9541-4796","authenticated-orcid":false,"given":"Xu","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3507-3085","authenticated-orcid":false,"given":"Jianhua","family":"Nie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2034-0160","authenticated-orcid":false,"given":"Bin","family":"Xie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2987-9819","authenticated-orcid":false,"given":"Dongping","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6838-3023","authenticated-orcid":false,"given":"Yiping","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3568-0600","authenticated-orcid":false,"given":"Kunhe","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6069-6618","authenticated-orcid":false,"given":"Ying","family":"Fu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0303-237X","authenticated-orcid":false,"given":"Deping","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4691-8103","authenticated-orcid":false,"given":"Yan","family":"Xiong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4652-1971","authenticated-orcid":false,"given":"Zhangyang","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6537-2559","authenticated-orcid":false,"given":"Xin","family":"Sun","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0679-0691","authenticated-orcid":false,"given":"Weifeng","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,12,2]]},"reference":[{"key":"e_1_2_10_1_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.12.015"},{"key":"e_1_2_10_2_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.08.002"},{"key":"e_1_2_10_3_2","first-page":"5","article-title":"Chronic disease prevalence and disease burden analysis of typical urban residents","volume":"30","author":"Qin J. M.","year":"2014","journal-title":"Chinese Journal of Public Health"},{"key":"e_1_2_10_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1746.2008.05774.x"},{"key":"e_1_2_10_5_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12020-015-0584-z"},{"key":"e_1_2_10_6_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.032"},{"key":"e_1_2_10_7_2","first-page":"738","article-title":"Consensus on integrated traditional Chinese and Western medicine in the treatment of chronic gastritis (Tianjin, 2011)","volume":"32","author":"Digestive System Disease Professional Committee in Integrated Traditional Chinese and Western Medicine Association in China","year":"2011","journal-title":"Chinese Journal of Integrated Traditional and Western Medicine"},{"key":"e_1_2_10_8_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.028"},{"key":"e_1_2_10_9_2","doi-asserted-by":"publisher","DOI":"10.11622\/smedj.2015109"},{"key":"e_1_2_10_10_2","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2017.15.3.266"},{"key":"e_1_2_10_11_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2007.119446"},{"key":"e_1_2_10_12_2","first-page":"1325","article-title":"Traditional Chinese medicine syndrome distribution and neuroendocrine mechanisms of irritable bowel syndrome: cross-sectional study","volume":"41","author":"Hou Z. K.","year":"2016","journal-title":"China Journal of Chinese Materia Medica"},{"key":"e_1_2_10_13_2","volume-title":"Clinical Guideline of New Drugs for Traditional Chinese Medicine","author":"Zheng X.","year":"1993"},{"key":"e_1_2_10_14_2","unstructured":"Tai Ping Hui Min He Ji Ju. Tai Ping Hui Min He Ji Ju Fang Juan 3 (Imperial Grace Formulary of the Tai Ping Era Volume 3). Song Dynasty (1102 AD)."},{"key":"e_1_2_10_15_2","first-page":"939","article-title":"Meta-analysis of Shenling Baizhu San for Treatment of Functional Dyspepsia","volume":"31","author":"Wang M.","year":"2014","journal-title":"Chinese Journal of Health Statistics"},{"key":"e_1_2_10_16_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"e_1_2_10_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(00)02799-9"},{"key":"e_1_2_10_18_2","first-page":"51","article-title":"How to calculate sample size in randomized controlled trial?","volume":"1","author":"Zhong B.","year":"2009","journal-title":"Journal of Thoracic Disease"},{"key":"e_1_2_10_19_2","doi-asserted-by":"publisher","DOI":"10.1201\/9780367805326"}],"container-title":["Evidence-Based Complementary and Alternative Medicine"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/downloads.hindawi.com\/journals\/ecam\/2018\/1980491.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/downloads.hindawi.com\/journals\/ecam\/2018\/1980491.xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1155\/2018\/1980491","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T05:10:56Z","timestamp":1722921056000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1155\/2018\/1980491"}},"subtitle":[],"editor":[{"given":"Carmen","family":"Mannucci","sequence":"additional","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2018,1]]},"references-count":19,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,1]]}},"alternative-id":["10.1155\/2018\/1980491"],"URL":"https:\/\/doi.org\/10.1155\/2018\/1980491","archive":["Portico"],"relation":{},"ISSN":["1741-427X","1741-4288"],"issn-type":[{"value":"1741-427X","type":"print"},{"value":"1741-4288","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,1]]},"assertion":[{"value":"2018-08-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-11-14","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-12-02","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"1980491"}}