{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T19:29:59Z","timestamp":1793215799540,"version":"4.5.0"},"reference-count":64,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,9,27]],"date-time":"2022-09-27T00:00:00Z","timestamp":1664236800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurogastroenterology Motil"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pharmacological trials in functional dyspepsia (FD) are associated with high placebo response rates. We aimed to identify the magnitude and contributing factors to the placebo response.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a systematic review and meta\u2010analysis including randomized controlled trials (RCTs) with a dichotomous outcome in adult patients with FD that compared an active pharmacotherapeutic treatment with placebo. Our main outcome was identification of the magnitude of the pooled placebo response rate for the following endpoints: symptom responder, symptom\u2010free responder, adequate relief responder, and combined endpoint responder (i.e., the primary endpoint of each specific trial regarding treatment response). Several putative moderators (i.e., patient, disease, and trial characteristics) were examined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Key Results<\/jats:title>\n                    <jats:p>We included 26 RCTs in our analysis. The pooled placebo response rate was 39.6% (95% CI 30.1\u201350.0) using the symptom responder definition, 20.5% (12.8\u201331.0) using the symptom\u2010free responder definition, 38.5% (33.8\u201343.6) using the adequate relief responder definition, and 35.5% (31.6\u201339.7) using the combined endpoint responder definition. A lower overall baseline symptom score was significantly associated with a higher placebo response rate. No other moderators were found to significantly impact the placebo response rate. Due to the lack of data, no analyses could be performed according to individual FD subtypes or symptoms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions and Inferences<\/jats:title>\n                    <jats:p>The pooled placebo response rate in pharmacological trials in FD is about 39%, depending on which responder definitions is used. Future trials should consider applying an entry criterion based on minimal level of symptom severity to decrease the placebo response. We also suggest separate reporting of core FD symptoms pending more concrete harmonization efforts in FD trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/nmo.14474","type":"journal-article","created":{"date-parts":[[2022,9,28]],"date-time":"2022-09-28T00:44:30Z","timestamp":1664325870000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Placebo response in pharmacological trials in patients with functional dyspepsia\u2014A systematic review and meta\u2010analysis"],"prefix":"10.1111","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2040-2520","authenticated-orcid":false,"given":"Michelle","family":"Bosman","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM) Maastricht University Medical Center  Maastricht The 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Gastrointestinal Disorders (TARGID) Catholic University of Leuven  Leuven Belgium"},{"name":"Division of Gastroenterology and Hepatology University Hospitals Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magnus","family":"Simr\u00e9n","sequence":"additional","affiliation":[{"name":"Department of Molecular and Clinical Medicine, Institute of Medicine Sahlgrenska Academy, University of Gothenburg  Gothenburg Sweden"},{"name":"Centre for Functional GI and Motility Disorders University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2537-3092","authenticated-orcid":false,"given":"Nicholas","family":"Talley","sequence":"additional","affiliation":[{"name":"NHMRC Center of research Excellence in Digestive Health University of Newcastle  Newcastle New South Wales 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