{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T05:21:12Z","timestamp":1787980872305,"version":"build-2784847793"},"reference-count":36,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2018,3,2]],"date-time":"2018-03-02T00:00:00Z","timestamp":1519948800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100008899","name":"Waksman Foundation of Japan","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100008899","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Neurogastroenterology Motil"],"published-print":{"date-parts":[[2018,7]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>Functional dyspepsia (FD<\/jats:styled-content>), a heterogeneous disorder, involves multiple pathogenetic mechanisms. Developing treatments for FD<\/jats:styled-content> has been challenging. We performed a randomized, placebo\u2010controlled, double\u2010blind clinical trial to determine the efficacy of rikkunshito, a Japanese herbal medicine, in FD<\/jats:styled-content> patients.<\/jats:p><\/jats:sec>Methods<\/jats:title>FD<\/jats:styled-content> patients (n\u00a0=\u00a0192) who met the Rome III<\/jats:styled-content> criteria without Helicobacter pylori<\/jats:italic> infection, predominant heartburn, and depression were enrolled at 56 hospitals in Japan. After 2\u00a0weeks of single\u2010blind placebo treatment, 128 patients with continuous symptoms were randomly assigned to 8\u00a0weeks of rikkunshito (n\u00a0=\u00a064) or placebo (n\u00a0=\u00a061). The primary efficacy endpoint was global assessment of overall treatment efficacy (OTE<\/jats:styled-content>). The secondary efficacy endpoints were improvements in upper gastrointestinal symptoms evaluated by the Patient Assessment of Upper Gastrointestinal Disorders\u2010Symptom Severity Index (PAGI<\/jats:styled-content>\u2010SYM<\/jats:styled-content>), the Global Overall Symptom scale (GOS<\/jats:styled-content>), and the modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (m\u2010FSSG<\/jats:styled-content>), and psychological symptoms evaluated by the Hospital Anxiety and Depression Scale (HADS<\/jats:styled-content>).<\/jats:p><\/jats:sec>Key Results<\/jats:title>Rikkunshito increased OTE<\/jats:styled-content> compared to placebo at 8\u00a0weeks (P<\/jats:italic>\u00a0=\u00a0.019). Rikkunshito improved upper gastrointestinal symptoms (PAGI<\/jats:styled-content>\u2010SYM<\/jats:styled-content>, GOS<\/jats:styled-content>, and m\u2010FSSG<\/jats:styled-content>) at 8\u00a0weeks, especially postprandial fullness\/early satiety (P<\/jats:italic>\u00a0=\u00a0.015 and P<\/jats:italic>\u00a0=\u00a0.001) and bloating (P<\/jats:italic>\u00a0=\u00a0.007 and P<\/jats:italic>\u00a0=\u00a0.002) of the PAGI<\/jats:styled-content>\u2010SYM<\/jats:styled-content> subscales at 4\u00a0weeks and 8\u00a0weeks. Improvement of HADS<\/jats:styled-content> at 8\u00a0weeks (P<\/jats:italic>\u00a0=\u00a0.027) correlated with those of PAGI<\/jats:styled-content>\u2010SYM<\/jats:styled-content> (r<\/jats:italic>\u00a0=\u00a0.302, P<\/jats:italic>\u00a0=\u00a0.001), GOS<\/jats:styled-content> (r<\/jats:italic>\u00a0=\u00a0.186, P<\/jats:italic>\u00a0=\u00a0.044), and m\u2010FSSG<\/jats:styled-content> (r<\/jats:italic>\u00a0=\u00a0.462, P<\/jats:italic>\u00a0<\u00a0.001), postprandial fullness\/early satiety (r<\/jats:italic>\u00a0=\u00a0.226, P<\/jats:italic>\u00a0=\u00a0.014), dyspepsia (r<\/jats:italic>\u00a0=\u00a0.215, P<\/jats:italic>\u00a0=\u00a0.019), and PDS<\/jats:styled-content> (r<\/jats:italic>\u00a0=\u00a0.221, P<\/jats:italic>\u00a0=\u00a0.016).<\/jats:p><\/jats:sec>Conclusion & inferences<\/jats:title>Rikkunshito may be beneficial for FD<\/jats:styled-content> patients to simultaneously treat gastrointestinal and psychological symptoms.<\/jats:p><\/jats:sec>","DOI":"10.1111\/nmo.13319","type":"journal-article","created":{"date-parts":[[2018,3,2]],"date-time":"2018-03-02T10:26:43Z","timestamp":1519986403000},"source":"Crossref","is-referenced-by-count":84,"title":["Rikkunshito simultaneously improves dyspepsia correlated with anxiety in patients with functional dyspepsia: A randomized clinical trial (the DREAM<\/scp> study)"],"prefix":"10.1111","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1337-3140","authenticated-orcid":false,"given":"K.","family":"Tominaga","sequence":"first","affiliation":[{"name":"Premier Developmental Research of Medicine Osaka Medical College Osaka Japan"},{"name":"Second Department of Internal Medicine Osaka Medical College Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y.","family":"Sakata","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Saga Medical School Saga 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University Shizuoka Hospital Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Premier Developmental Research of Medicine Osaka Medical College Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y.","family":"Fujikawa","sequence":"additional","affiliation":[{"name":"Premier Developmental Research of Medicine Osaka Medical College Osaka Japan"},{"name":"Second Department of Internal Medicine Osaka Medical College Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Oshima","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology Department of Internal Medicine Hyogo College of Medicine Hyogo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Kato","sequence":"additional","affiliation":[{"name":"National Hospital Organization Hakodate Hospital Hakodate 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