{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:05:54Z","timestamp":1790726754642,"version":"4.1.0"},"reference-count":45,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T00:00:00Z","timestamp":1714608000000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100020306","name":"Steigerwald Arzneimittelwerk","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020306","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["JGH Open"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Aim<\/jats:title><jats:p>Herbal products are widely used to treat patients with disorders of gut brain interaction but clinical efficacy and safety data for treatments lasting &gt;4\u2009weeks are widely lacking. We evaluated the efficacy and safety of 8\u2009weeks of treatment with the herbal combination product STW 5\u2010II for patients with functional dyspepsia (FD) meeting Rome II criteria. We also conducted a post hoc analysis including patients meeting Rome IV criteria for FD and evaluated the effect of the G\u2010protein beta 3 (GNB3) subunit polymorphism (C825T) on therapeutic response.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicenter, placebo\u2010controlled, double\u2010blind study included 272 FD patients meeting Rome II criteria in the intention\u2010to\u2010treat cohort and 266 meeting Rome IV criteria. We used the validated Gastrointestinal Symptom Score (GIS) to assess GI symptoms, defining response rate as the proportion of patients with \u226550% GIS improvement in at least three of four assessments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>After 8\u2009weeks, the response rate was significantly higher in the STW 5\u2010II group <jats:italic>versus<\/jats:italic> placebo (61.2% <jats:italic>vs<\/jats:italic> 45.1%, <jats:italic>P<\/jats:italic>\u2009=\u20090.008). Mean GIS non\u2010significantly improved with STW 5\u2010II treatment (7.9\u2009\u00b1\u20094.41 <jats:italic>vs<\/jats:italic> 6.7\u2009\u00b1\u20094.91 with placebo; <jats:italic>P<\/jats:italic>\u2009=\u20090.07). In the Rome IV subgroup analysis, STW 5\u2010II yielded a better response rate (<jats:italic>P<\/jats:italic>\u2009=\u20090.01) <jats:italic>versus<\/jats:italic> placebo and greater postprandial distress symptom improvement (<jats:italic>P<\/jats:italic>\u2009=\u20090.04) <jats:italic>versus<\/jats:italic> placebo. Safety parameters did not differ between groups, and GNB3 status was not linked with therapeutic response.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>STW 5\u2010II is efficacious, with no observed safety signals at up to 8\u2009weeks of treatment in patients with FD meeting Rome II or IV criteria.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jgh3.13054","type":"journal-article","created":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T06:08:17Z","timestamp":1714630097000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Double\u2010blind, randomized, 8\u2010week multicenter study of the efficacy and safety of <scp>STW 5\u2010II<\/scp><i>versus<\/i> placebo in functional dyspepsia"],"prefix":"10.1002","volume":"8","author":[{"given":"Bettina","family":"Vinson","sequence":"first","affiliation":[{"name":"Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH  Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Careen","family":"Fink","sequence":"additional","affiliation":[{"name":"Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH  Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manfred","family":"Wargenau","sequence":"additional","affiliation":[{"name":"M.A.R.C.O. 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