{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T08:08:30Z","timestamp":1791533310364,"version":"4.3.4"},"reference-count":17,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,8,9]],"date-time":"2024-08-09T00:00:00Z","timestamp":1723161600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>There is little information on the effectiveness of therapies for severe chronic constipation. In a phase 3 trial, we previously demonstrated that a vibrating capsule was significantly more efficacious than a placebo in chronic constipation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To examine the effects of a vibrating capsule and placebo on symptoms and health\u2010related quality of life (HRQoL) in patients with severe chronic constipation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a post hoc analysis of phase 3, multicentre, randomised, double\u2010blind, and placebo\u2010controlled 8\u2010week clinical trial of a vibrating capsule to specifically assess outcomes among subjects who reported 0 complete spontaneous bowel movements (CSBMs) during the 2\u2010week baseline period. We assessed effects of treatment on bowel symptoms, patient satisfaction, and HRQoL. CSBM responders were defined as subjects with increases of \u22651 or \u22652 or \u22653 weekly CSBMs (CSBM1 or CSBM2, CSBM3, respectively) over baseline for \u22656 out of 8\u2009weeks of treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The severe chronic constipation subgroup comprised 175 (56%) of the 312 subjects. Significantly more subjects with severe chronic constipation who received the vibrating capsule than those who received the placebo were CSBM1 (44.9% vs. 20.9%, <jats:italic>p<\/jats:italic>\u2009=\u20090.007), CSBM2 (29.2% vs. 11.6%, <jats:italic>p<\/jats:italic>\u2009=\u20090.004), and CSBM3 (19.10% vs 6.98%, <jats:italic>p<\/jats:italic>\u2009=\u20090.017) responders. Straining effort, stool consistency, patient satisfaction, and HRQoL significantly improved in the severe chronic constipation subgroup. A mild vibrating sensation was reported in 10%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The vibrating capsule significantly improved constipation\u2010related symptoms and HRQoL in patients with severe constipation, affirming its efficacy and safety across the spectrum of chronic constipation.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.18198","type":"journal-article","created":{"date-parts":[[2024,8,10]],"date-time":"2024-08-10T06:19:40Z","timestamp":1723270780000},"page":"855-862","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Clinical trial: Effects of treatment with a vibrating capsule in patients with severe chronic constipation"],"prefix":"10.1111","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4479-1188","authenticated-orcid":false,"given":"Anthony","family":"Lembo","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Nutrition Cleveland Clinic, Digestive Disease Institute  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madison","family":"Simons","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Nutrition Cleveland Clinic, Digestive Disease Institute  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jack","family":"Loesch","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Nutrition Cleveland Clinic, Digestive Disease Institute  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eyad","family":"Hamza","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Nutrition Cleveland Clinic, Digestive Disease Institute  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica Loren","family":"Graff","sequence":"additional","affiliation":[{"name":"Department of Medicine University Hospital  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4151-7180","authenticated-orcid":false,"given":"Eamonn","family":"Quigley","sequence":"additional","affiliation":[{"name":"Lynda K. and David M. Underwood Center for Digestive Disorders Houston Methodist Hospital and Weill Cornell Medical College  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4446-8452","authenticated-orcid":false,"given":"Satish S. C.","family":"Rao","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology\/Hepatology Augusta University  Augusta Georgia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,8,9]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.04.014"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468\u20101253(21)00111\u20104"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/JXX.0000000000000760"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2017.95"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001708"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15657"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325\u2010017\u20100633\u20105"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.02.013"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2022.101407"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/00365520510012208"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.3109\/00365529709011203"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477\u20107525\u20102\u201012"},{"issue":"513","key":"e_1_2_9_14_1","first-page":"1078","article-title":"Complete spontaneous bowel movement frequency as primary outcome measure in patients with chronic constipation treated with linaclotide","volume":"102","author":"Johnston J","year":"2007","journal-title":"Off J Am Coll Gastroenterol ACG"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0800670"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102036.2008.03884.x"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.7326\/M15\u20103118"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15642"}],"container-title":["Alimentary Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.18198","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,17]],"date-time":"2024-11-17T12:08:30Z","timestamp":1731845310000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.18198"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,9]]},"references-count":17,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2024,10]]}},"alternative-id":["10.1111\/apt.18198"],"URL":"https:\/\/doi.org\/10.1111\/apt.18198","archive":["Portico"],"relation":{},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"value":"0269-2813","type":"print"},{"value":"1365-2036","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,9]]},"assertion":[{"value":"2024-05-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-08-09","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}