{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T22:23:23Z","timestamp":1790807003196,"version":"4.1.0"},"reference-count":44,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2017,5,2]],"date-time":"2017-05-02T00:00:00Z","timestamp":1493683200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Lisa O'Rourke at Cello Health Communications"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2017,6]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Symptomatic breakthrough in proton pump inhibitor (\n                      <jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>\n                      )\u2010treated gastro\u2010oesophageal reflux disease (\n                      <jats:styled-content style=\"fixed-case\">GERD<\/jats:styled-content>\n                      ) patients is a common problem with a range of underlying causes. The nonsystemic, raft\u2010forming action of alginates may help resolve symptoms.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>\n                      To assess alginate\u2010antacid (Gaviscon Double Action,\n                      <jats:styled-content style=\"fixed-case\">RB<\/jats:styled-content>\n                      , Slough,\n                      <jats:styled-content style=\"fixed-case\">UK<\/jats:styled-content>\n                      ) as add\u2010on therapy to once\u2010daily\n                      <jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>\n                      for suppression of breakthrough reflux symptoms.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In two randomised, double\u2010blind studies (exploratory, n=52; confirmatory, n=262), patients taking standard\u2010dose\n                      <jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>\n                      who had breakthrough symptoms, assessed by Heartburn Reflux Dyspepsia Questionnaire (\n                      <jats:styled-content style=\"fixed-case\">HRDQ<\/jats:styled-content>\n                      ), were randomised to add\u2010on Gaviscon or placebo (20 mL after meals and bedtime). The exploratory study endpoint was change in\n                      <jats:styled-content style=\"fixed-case\">HRDQ<\/jats:styled-content>\n                      score during treatment vs run\u2010in. The confirmatory study endpoint was \u201cresponse\u201d defined as \u22653 days reduction in the number of \u201cbad\u201d days (\n                      <jats:styled-content style=\"fixed-case\">HRDQ<\/jats:styled-content>\n                      [heartburn\/regurgitation] &gt;0.70) during treatment vs run\u2010in.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In the exploratory study, significantly greater reductions in\n                      <jats:styled-content style=\"fixed-case\">HRDQ<\/jats:styled-content>\n                      scores (heartburn\/regurgitation) were observed in the Gaviscon vs placebo (least squares mean difference [95%\n                      <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\n                      ] \u22122.10 [\u22123.71 to \u22120.48];\n                      <jats:italic>P<\/jats:italic>\n                      =.012). Post hoc \u201cresponder\u201d analysis of the exploratory study also revealed significantly more Gaviscon patients (75%) achieved \u22653 days reduction in \u201cbad\u201d days vs placebo patients (36%),\n                      <jats:italic>P<\/jats:italic>\n                      =.005. In the confirmatory study, symptomatic improvement was observed with add\u2010on Gaviscon (51%) but there was no significant difference in response vs placebo (48%) (\n                      <jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content>\n                      (95%\n                      <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\n                      ) 1.15 (0.69\u20101.91),\n                      <jats:italic>P<\/jats:italic>\n                      =.5939).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Adding Gaviscon to\n                      <jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>\n                      reduced breakthrough\n                      <jats:styled-content style=\"fixed-case\">GERD<\/jats:styled-content>\n                      symptoms but a nearly equal response was observed for placebo. Response to intervention may vary according to whether symptoms are functional in origin.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.14064","type":"journal-article","created":{"date-parts":[[2017,5,2]],"date-time":"2017-05-02T13:28:06Z","timestamp":1493731686000},"page":"1524-1533","source":"Crossref","is-referenced-by-count":40,"title":["Randomised clinical trial: addition of alginate\u2010antacid (Gaviscon Double Action) to proton pump inhibitor therapy in patients with breakthrough symptoms"],"prefix":"10.1111","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3190-8460","authenticated-orcid":false,"given":"C.","family":"Coyle","sequence":"first","affiliation":[{"name":"RB Slough Berkshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Crawford","sequence":"additional","affiliation":[{"name":"CPS Research Glasgow UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Wilkinson","sequence":"additional","affiliation":[{"name":"RB Slough Berkshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. 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