Effectiveness of oral phloroglucinol as a premedication for unsedated esophagogastroduodenoscopy: A prospective, double-blinded, placebo-controlled, randomized trial
Anti-spasmodic agents are commonly injected during esophagogastroduodenoscopy (EGD) to improve visualization of the gastric mucosa by inhibiting gastrointestinal (GI) peristalsis. The availability of oral anti-spasmodic agents would increase convenience. In this study, we evaluated the effectiveness...
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| creator | Jung, HyeIn Kim, Hyun Jung Choi, Eun Sung Lee, Ju Yup Park, Kyung Sik Cho, Kwang Bum Lee, Yoo Jin |
| description | Anti-spasmodic agents are commonly injected during esophagogastroduodenoscopy (EGD) to improve visualization of the gastric mucosa by inhibiting gastrointestinal (GI) peristalsis. The availability of oral anti-spasmodic agents would increase convenience. In this study, we evaluated the effectiveness of oral phloroglucinol (Flospan.sup.®) as a premedication for unsedated EGD. A prospective, double-blinded, placebo-controlled, randomized controlled trial was conducted in a tertiary hospital. Individuals scheduled to undergo unsedated EGD were randomly assigned to receive either oral phloroglucinol or matching placebo 15 min before EGD. The primary outcome was the rate of complete gastric peristalsis suppression. Outcomes were assessed by independent investigators according to the classification of gastric peristalsis and ease of intragastric observation at the beginning (Period A) and end (Period B) of EGD. Overall, 71 phloroglucinol-treated and 71 placebo-treated participants (n = 142 total) were included. The phloroglucinol group showed significantly higher proportions of participants with complete gastric peristalsis suppression than the placebo group (22.5% vs. 9.9%, P = 0.040). The ease of intragastric observation was significantly better in the phloroglucinol group than in the placebo group at Periods A (P < 0.001) and B (P = 0.005). Patients in both groups had comparable adverse events and showed willingness to take the premedication at their next examination. Oral phloroglucinol significantly suppressed gastrointestinal peristalsis during unsedated EGD compared with placebo (Clinical trial registration number: NCT03342118). |
| doi_str_mv | 10.1371/journal.pone.0255016 |
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The availability of oral anti-spasmodic agents would increase convenience. In this study, we evaluated the effectiveness of oral phloroglucinol (Flospan.sup.®) as a premedication for unsedated EGD. A prospective, double-blinded, placebo-controlled, randomized controlled trial was conducted in a tertiary hospital. Individuals scheduled to undergo unsedated EGD were randomly assigned to receive either oral phloroglucinol or matching placebo 15 min before EGD. The primary outcome was the rate of complete gastric peristalsis suppression. Outcomes were assessed by independent investigators according to the classification of gastric peristalsis and ease of intragastric observation at the beginning (Period A) and end (Period B) of EGD. Overall, 71 phloroglucinol-treated and 71 placebo-treated participants (n = 142 total) were included. The phloroglucinol group showed significantly higher proportions of participants with complete gastric peristalsis suppression than the placebo group (22.5% vs. 9.9%, P = 0.040). The ease of intragastric observation was significantly better in the phloroglucinol group than in the placebo group at Periods A (P < 0.001) and B (P = 0.005). Patients in both groups had comparable adverse events and showed willingness to take the premedication at their next examination. Oral phloroglucinol significantly suppressed gastrointestinal peristalsis during unsedated EGD compared with placebo (Clinical trial registration number: NCT03342118).</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0255016</identifier><identifier>PMID: 34347808</identifier><language>eng</language><publisher>San Francisco: Public Library of Science</publisher><subject>Adverse events ; Anesthesia ; Biology and Life Sciences ; Clinical trials ; Complications and side effects ; Endoscopy ; Enrollments ; Evaluation ; Gastric mucosa ; Internal medicine ; Medicine ; Medicine and Health Sciences ; Motility ; Patient outcomes ; Performance evaluation ; Peristalsis ; Phenols ; Phloroglucinol ; Physical Sciences ; Placebos ; Research and Analysis Methods ; Smooth muscle</subject><ispartof>PloS one, 2021-08, Vol.16 (8), p.e0255016-e0255016</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Jung et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 Jung et al 2021 Jung et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c669t-bc2d10a243bf1a75987bd47cd74c4a1510f8f45d794607206325f621635e5b453</citedby><cites>FETCH-LOGICAL-c669t-bc2d10a243bf1a75987bd47cd74c4a1510f8f45d794607206325f621635e5b453</cites><orcidid>0000-0003-1799-0146</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8336830/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8336830/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793</link.rule.ids></links><search><contributor>Gluud, Lise Lotte</contributor><creatorcontrib>Jung, HyeIn</creatorcontrib><creatorcontrib>Kim, Hyun Jung</creatorcontrib><creatorcontrib>Choi, Eun Sung</creatorcontrib><creatorcontrib>Lee, Ju Yup</creatorcontrib><creatorcontrib>Park, Kyung Sik</creatorcontrib><creatorcontrib>Cho, Kwang Bum</creatorcontrib><creatorcontrib>Lee, Yoo Jin</creatorcontrib><title>Effectiveness of oral phloroglucinol as a premedication for unsedated esophagogastroduodenoscopy: A prospective, double-blinded, placebo-controlled, randomized trial</title><title>PloS one</title><description>Anti-spasmodic agents are commonly injected during esophagogastroduodenoscopy (EGD) to improve visualization of the gastric mucosa by inhibiting gastrointestinal (GI) peristalsis. The availability of oral anti-spasmodic agents would increase convenience. In this study, we evaluated the effectiveness of oral phloroglucinol (Flospan.sup.®) as a premedication for unsedated EGD. A prospective, double-blinded, placebo-controlled, randomized controlled trial was conducted in a tertiary hospital. Individuals scheduled to undergo unsedated EGD were randomly assigned to receive either oral phloroglucinol or matching placebo 15 min before EGD. The primary outcome was the rate of complete gastric peristalsis suppression. Outcomes were assessed by independent investigators according to the classification of gastric peristalsis and ease of intragastric observation at the beginning (Period A) and end (Period B) of EGD. Overall, 71 phloroglucinol-treated and 71 placebo-treated participants (n = 142 total) were included. The phloroglucinol group showed significantly higher proportions of participants with complete gastric peristalsis suppression than the placebo group (22.5% vs. 9.9%, P = 0.040). The ease of intragastric observation was significantly better in the phloroglucinol group than in the placebo group at Periods A (P < 0.001) and B (P = 0.005). Patients in both groups had comparable adverse events and showed willingness to take the premedication at their next examination. Oral phloroglucinol significantly suppressed gastrointestinal peristalsis during unsedated EGD compared with placebo (Clinical trial registration number: NCT03342118).</description><subject>Adverse events</subject><subject>Anesthesia</subject><subject>Biology and Life Sciences</subject><subject>Clinical trials</subject><subject>Complications and side effects</subject><subject>Endoscopy</subject><subject>Enrollments</subject><subject>Evaluation</subject><subject>Gastric mucosa</subject><subject>Internal medicine</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Motility</subject><subject>Patient outcomes</subject><subject>Performance evaluation</subject><subject>Peristalsis</subject><subject>Phenols</subject><subject>Phloroglucinol</subject><subject>Physical Sciences</subject><subject>Placebos</subject><subject>Research and Analysis Methods</subject><subject>Smooth 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of oral phloroglucinol as a premedication for unsedated esophagogastroduodenoscopy: A prospective, double-blinded, placebo-controlled, randomized trial</title><author>Jung, HyeIn ; Kim, Hyun Jung ; Choi, Eun Sung ; Lee, Ju Yup ; Park, Kyung Sik ; Cho, Kwang Bum ; Lee, Yoo Jin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c669t-bc2d10a243bf1a75987bd47cd74c4a1510f8f45d794607206325f621635e5b453</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>Anesthesia</topic><topic>Biology and Life Sciences</topic><topic>Clinical trials</topic><topic>Complications and side effects</topic><topic>Endoscopy</topic><topic>Enrollments</topic><topic>Evaluation</topic><topic>Gastric mucosa</topic><topic>Internal medicine</topic><topic>Medicine</topic><topic>Medicine and Health Sciences</topic><topic>Motility</topic><topic>Patient outcomes</topic><topic>Performance 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Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jung, HyeIn</au><au>Kim, Hyun Jung</au><au>Choi, Eun Sung</au><au>Lee, Ju Yup</au><au>Park, Kyung Sik</au><au>Cho, Kwang Bum</au><au>Lee, Yoo Jin</au><au>Gluud, Lise Lotte</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of oral phloroglucinol as a premedication for unsedated esophagogastroduodenoscopy: A prospective, double-blinded, placebo-controlled, randomized trial</atitle><jtitle>PloS one</jtitle><date>2021-08-04</date><risdate>2021</risdate><volume>16</volume><issue>8</issue><spage>e0255016</spage><epage>e0255016</epage><pages>e0255016-e0255016</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Anti-spasmodic agents are commonly injected during esophagogastroduodenoscopy (EGD) to improve visualization of the gastric mucosa by inhibiting gastrointestinal (GI) peristalsis. The availability of oral anti-spasmodic agents would increase convenience. In this study, we evaluated the effectiveness of oral phloroglucinol (Flospan.sup.®) as a premedication for unsedated EGD. A prospective, double-blinded, placebo-controlled, randomized controlled trial was conducted in a tertiary hospital. Individuals scheduled to undergo unsedated EGD were randomly assigned to receive either oral phloroglucinol or matching placebo 15 min before EGD. The primary outcome was the rate of complete gastric peristalsis suppression. Outcomes were assessed by independent investigators according to the classification of gastric peristalsis and ease of intragastric observation at the beginning (Period A) and end (Period B) of EGD. Overall, 71 phloroglucinol-treated and 71 placebo-treated participants (n = 142 total) were included. The phloroglucinol group showed significantly higher proportions of participants with complete gastric peristalsis suppression than the placebo group (22.5% vs. 9.9%, P = 0.040). The ease of intragastric observation was significantly better in the phloroglucinol group than in the placebo group at Periods A (P < 0.001) and B (P = 0.005). Patients in both groups had comparable adverse events and showed willingness to take the premedication at their next examination. Oral phloroglucinol significantly suppressed gastrointestinal peristalsis during unsedated EGD compared with placebo (Clinical trial registration number: NCT03342118).</abstract><cop>San Francisco</cop><pub>Public Library of Science</pub><pmid>34347808</pmid><doi>10.1371/journal.pone.0255016</doi><tpages>e0255016</tpages><orcidid>https://orcid.org/0000-0003-1799-0146</orcidid><oa>free_for_read</oa></addata></record> |
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| source | DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adverse events Anesthesia Biology and Life Sciences Clinical trials Complications and side effects Endoscopy Enrollments Evaluation Gastric mucosa Internal medicine Medicine Medicine and Health Sciences Motility Patient outcomes Performance evaluation Peristalsis Phenols Phloroglucinol Physical Sciences Placebos Research and Analysis Methods Smooth muscle |
| title | Effectiveness of oral phloroglucinol as a premedication for unsedated esophagogastroduodenoscopy: A prospective, double-blinded, placebo-controlled, randomized trial |
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