Effect of the transcutaneous electrical stimulation system on esophageal-acid exposure in patients non-responsive to once-daily proton-pump inhibitor: proof-of-concept study

Effect of the transcutaneous electrical stimulation system on esophageal-acid exposure in patients non-responsive to once-daily proton-pump inhibitor: proof-of-concept study

Background Gastroesophageal reflux disease (GERD) is a common disorder. Overall, ≤35% of GERD patients fail the standard dose of proton-pump-inhibitor (PPI) treatment. Due to the high prevalence and low satisfaction rate with treatment failure, there is an unmet need for new treatment. Our aim was t...

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Veröffentlicht in:Gastroenterology Report 2021-08, Vol.9 (4), p.323-328
Hauptverfasser: Dickman, Ram, Levy, Sigal, Perets, Tsachi Tsadok, Hazani-Pauker, Maor, Boltin, Doron, Schmilovitz-Weiss, Hemda, Nidal, Issa, Siterman, Matan, Carter, Dan, Fass, Ronnie, Gingold-Belfer, Rachel
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Care and treatment
Gastroesophageal reflux
Original
Patient outcomes
Proton pump inhibitors
Testing
Transcutaneous electrical nerve stimulation
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container_end_page 328
container_issue 4
container_start_page 323
container_title Gastroenterology Report
container_volume 9
creator Dickman, Ram
Levy, Sigal
Perets, Tsachi Tsadok
Hazani-Pauker, Maor
Boltin, Doron
Schmilovitz-Weiss, Hemda
Nidal, Issa
Siterman, Matan
Carter, Dan
Fass, Ronnie
Gingold-Belfer, Rachel
description Background Gastroesophageal reflux disease (GERD) is a common disorder. Overall, ≤35% of GERD patients fail the standard dose of proton-pump-inhibitor (PPI) treatment. Due to the high prevalence and low satisfaction rate with treatment failure, there is an unmet need for new treatment. Our aim was to evaluate whether the use of the transcutaneous electrical stimulation system (TESS) can reduce esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI. Methods We enrolled 10 patients suffering from heartburn and regurgitation with an abnormal esophageal-acid exposure (off PPIs) who failed standard-dose PPI. After the placement of a wireless esophageal pH capsule, all patients were treated with TESS. The primary end point was the reduction in the baseline (pretreatment) 24-hour percent total time pH
doi_str_mv 10.1093/gastro/goab002
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Overall, ≤35% of GERD patients fail the standard dose of proton-pump-inhibitor (PPI) treatment. Due to the high prevalence and low satisfaction rate with treatment failure, there is an unmet need for new treatment. Our aim was to evaluate whether the use of the transcutaneous electrical stimulation system (TESS) can reduce esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI. Methods We enrolled 10 patients suffering from heartburn and regurgitation with an abnormal esophageal-acid exposure (off PPIs) who failed standard-dose PPI. After the placement of a wireless esophageal pH capsule, all patients were treated with TESS. The primary end point was the reduction in the baseline (pretreatment) 24-hour percent total time pH &lt;4 and/or DeMeester score by 50%. Results Seven GERD patients (five females and two males, aged 49.3 ± 10.1 years) completed the study. At baseline, the mean percent total time pH &lt;4 was 12.0 ± 4.9. Following TESS, the mean percent total time pH &lt;4 dropped to 5.5 ± 3.4, 4.5 ± 2.6, 3.7 ± 2.9, and 4.4 ± 2.5 on Days 1, 2, 3, and 4, respectively. At baseline, the mean DeMeester score was 39.0 ± 18.5. After TESS, the mean DeMeester score dropped to 15.8 ± 9.2, 13.2 ± 6.8, 11.2 ± 9.4, and 12.0 ± 6.8 on Days 1, 2, 3, and 4, respectively. Conclusion TESS is a safe and potentially effective modality in reducing esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI. A larger and prospective controlled study is needed to verify these preliminary results.</description><identifier>ISSN: 2052-0034</identifier><identifier>EISSN: 2052-0034</identifier><identifier>DOI: 10.1093/gastro/goab002</identifier><identifier>PMID: 34567564</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Care and treatment ; Gastroesophageal reflux ; Original ; Patient outcomes ; Proton pump inhibitors ; Testing ; Transcutaneous electrical nerve stimulation</subject><ispartof>Gastroenterology Report, 2021-08, Vol.9 (4), p.323-328</ispartof><rights>The Author(s) 2021. Published by Oxford University Press and Sixth Affiliated Hospital of Sun Yat-sen University 2021</rights><rights>The Author(s) 2021. Published by Oxford University Press and Sixth Affiliated Hospital of Sun Yat-sen University.</rights><rights>COPYRIGHT 2021 Oxford University Press</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c491t-ce3518da783a39f7c27415819b26f68e0adc9a08e38a4de16be2f14f43d695ae3</citedby><cites>FETCH-LOGICAL-c491t-ce3518da783a39f7c27415819b26f68e0adc9a08e38a4de16be2f14f43d695ae3</cites><orcidid>0000-0002-6477-2849</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/PMC8460107/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8460107/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,1604,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34567564$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dickman, Ram</creatorcontrib><creatorcontrib>Levy, Sigal</creatorcontrib><creatorcontrib>Perets, Tsachi Tsadok</creatorcontrib><creatorcontrib>Hazani-Pauker, Maor</creatorcontrib><creatorcontrib>Boltin, Doron</creatorcontrib><creatorcontrib>Schmilovitz-Weiss, Hemda</creatorcontrib><creatorcontrib>Nidal, Issa</creatorcontrib><creatorcontrib>Siterman, Matan</creatorcontrib><creatorcontrib>Carter, Dan</creatorcontrib><creatorcontrib>Fass, Ronnie</creatorcontrib><creatorcontrib>Gingold-Belfer, Rachel</creatorcontrib><title>Effect of the transcutaneous electrical stimulation system on esophageal-acid exposure in patients non-responsive to once-daily proton-pump inhibitor: proof-of-concept study</title><title>Gastroenterology Report</title><addtitle>Gastroenterol Rep (Oxf)</addtitle><description>Background Gastroesophageal reflux disease (GERD) is a common disorder. Overall, ≤35% of GERD patients fail the standard dose of proton-pump-inhibitor (PPI) treatment. Due to the high prevalence and low satisfaction rate with treatment failure, there is an unmet need for new treatment. Our aim was to evaluate whether the use of the transcutaneous electrical stimulation system (TESS) can reduce esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI. Methods We enrolled 10 patients suffering from heartburn and regurgitation with an abnormal esophageal-acid exposure (off PPIs) who failed standard-dose PPI. After the placement of a wireless esophageal pH capsule, all patients were treated with TESS. The primary end point was the reduction in the baseline (pretreatment) 24-hour percent total time pH &lt;4 and/or DeMeester score by 50%. Results Seven GERD patients (five females and two males, aged 49.3 ± 10.1 years) completed the study. At baseline, the mean percent total time pH &lt;4 was 12.0 ± 4.9. Following TESS, the mean percent total time pH &lt;4 dropped to 5.5 ± 3.4, 4.5 ± 2.6, 3.7 ± 2.9, and 4.4 ± 2.5 on Days 1, 2, 3, and 4, respectively. At baseline, the mean DeMeester score was 39.0 ± 18.5. After TESS, the mean DeMeester score dropped to 15.8 ± 9.2, 13.2 ± 6.8, 11.2 ± 9.4, and 12.0 ± 6.8 on Days 1, 2, 3, and 4, respectively. Conclusion TESS is a safe and potentially effective modality in reducing esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI. A larger and prospective controlled study is needed to verify these preliminary results.</description><subject>Care and treatment</subject><subject>Gastroesophageal reflux</subject><subject>Original</subject><subject>Patient outcomes</subject><subject>Proton pump inhibitors</subject><subject>Testing</subject><subject>Transcutaneous electrical nerve stimulation</subject><issn>2052-0034</issn><issn>2052-0034</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNqFUsFu1TAQjBCIVqVXjshHOKS1ncRJOCBVVVuQKnGBs7Vx1nlGTmxsp-r7KP4RP-VRygnZkle7M7Pe1RTFW0YvGO2rywliCu5ycjBQyl8Up5w2vKS0ql8-i0-K8xh_UEoZbXnDmtfFSVU3om1EfVr8utEaVSJOk7RDkgIsUa0JFnRrJGhzLRgFlsRk5tVCMm4hcR8TziRHGJ3fwYRgS1BmJPjoXVwDErMQn8G4pEgWt5QBo3dLNA-5h8tMheUIxu6JDy7lul9nn0k7M5jkwsdD2ukyX3XA-pT7r-P-TfFKg414fnzPiu-3N9-uP5f3X---XF_dl6ruWSoVVg3rRmi7Cqpet4q3NWs61g9caNEhhVH1QDusOqhHZGJArlmt62oUfQNYnRWfNl2_DjOOKo8RwEofzAxhLx0Y-W9lMTs5uQfZ1eKw5izw_igQ3M8VY5KziQqt3RYredOKnvFW0Ay92KATWJRm0S4rqnxGnE2eHrXJ-atWtJ1gXIi_BBVcjAH1078YlQdfyM0X8uiLTHj3fJon-B8XZMCHDeBW_z-x3wLdywE</recordid><startdate>20210801</startdate><enddate>20210801</enddate><creator>Dickman, Ram</creator><creator>Levy, Sigal</creator><creator>Perets, Tsachi Tsadok</creator><creator>Hazani-Pauker, Maor</creator><creator>Boltin, Doron</creator><creator>Schmilovitz-Weiss, Hemda</creator><creator>Nidal, Issa</creator><creator>Siterman, Matan</creator><creator>Carter, Dan</creator><creator>Fass, Ronnie</creator><creator>Gingold-Belfer, Rachel</creator><general>Oxford University Press</general><scope>TOX</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IAO</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-6477-2849</orcidid></search><sort><creationdate>20210801</creationdate><title>Effect of the transcutaneous electrical stimulation system on esophageal-acid exposure in patients non-responsive to once-daily proton-pump inhibitor: proof-of-concept study</title><author>Dickman, Ram ; Levy, Sigal ; Perets, Tsachi Tsadok ; Hazani-Pauker, Maor ; Boltin, Doron ; Schmilovitz-Weiss, Hemda ; Nidal, Issa ; Siterman, Matan ; Carter, Dan ; Fass, Ronnie ; Gingold-Belfer, Rachel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c491t-ce3518da783a39f7c27415819b26f68e0adc9a08e38a4de16be2f14f43d695ae3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Care and treatment</topic><topic>Gastroesophageal reflux</topic><topic>Original</topic><topic>Patient outcomes</topic><topic>Proton pump inhibitors</topic><topic>Testing</topic><topic>Transcutaneous electrical nerve stimulation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dickman, Ram</creatorcontrib><creatorcontrib>Levy, Sigal</creatorcontrib><creatorcontrib>Perets, Tsachi Tsadok</creatorcontrib><creatorcontrib>Hazani-Pauker, Maor</creatorcontrib><creatorcontrib>Boltin, Doron</creatorcontrib><creatorcontrib>Schmilovitz-Weiss, Hemda</creatorcontrib><creatorcontrib>Nidal, Issa</creatorcontrib><creatorcontrib>Siterman, Matan</creatorcontrib><creatorcontrib>Carter, Dan</creatorcontrib><creatorcontrib>Fass, Ronnie</creatorcontrib><creatorcontrib>Gingold-Belfer, Rachel</creatorcontrib><collection>OUP_牛津大学出版社OA刊</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale Academic OneFile Select</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Gastroenterology Report</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dickman, Ram</au><au>Levy, Sigal</au><au>Perets, Tsachi Tsadok</au><au>Hazani-Pauker, Maor</au><au>Boltin, Doron</au><au>Schmilovitz-Weiss, Hemda</au><au>Nidal, Issa</au><au>Siterman, Matan</au><au>Carter, Dan</au><au>Fass, Ronnie</au><au>Gingold-Belfer, Rachel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of the transcutaneous electrical stimulation system on esophageal-acid exposure in patients non-responsive to once-daily proton-pump inhibitor: proof-of-concept study</atitle><jtitle>Gastroenterology Report</jtitle><addtitle>Gastroenterol Rep (Oxf)</addtitle><date>2021-08-01</date><risdate>2021</risdate><volume>9</volume><issue>4</issue><spage>323</spage><epage>328</epage><pages>323-328</pages><issn>2052-0034</issn><eissn>2052-0034</eissn><abstract>Background Gastroesophageal reflux disease (GERD) is a common disorder. Overall, ≤35% of GERD patients fail the standard dose of proton-pump-inhibitor (PPI) treatment. Due to the high prevalence and low satisfaction rate with treatment failure, there is an unmet need for new treatment. Our aim was to evaluate whether the use of the transcutaneous electrical stimulation system (TESS) can reduce esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI. Methods We enrolled 10 patients suffering from heartburn and regurgitation with an abnormal esophageal-acid exposure (off PPIs) who failed standard-dose PPI. After the placement of a wireless esophageal pH capsule, all patients were treated with TESS. The primary end point was the reduction in the baseline (pretreatment) 24-hour percent total time pH &lt;4 and/or DeMeester score by 50%. Results Seven GERD patients (five females and two males, aged 49.3 ± 10.1 years) completed the study. At baseline, the mean percent total time pH &lt;4 was 12.0 ± 4.9. Following TESS, the mean percent total time pH &lt;4 dropped to 5.5 ± 3.4, 4.5 ± 2.6, 3.7 ± 2.9, and 4.4 ± 2.5 on Days 1, 2, 3, and 4, respectively. At baseline, the mean DeMeester score was 39.0 ± 18.5. After TESS, the mean DeMeester score dropped to 15.8 ± 9.2, 13.2 ± 6.8, 11.2 ± 9.4, and 12.0 ± 6.8 on Days 1, 2, 3, and 4, respectively. Conclusion TESS is a safe and potentially effective modality in reducing esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI. A larger and prospective controlled study is needed to verify these preliminary results.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>34567564</pmid><doi>10.1093/gastro/goab002</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-6477-2849</orcidid><oa>free_for_read</oa></addata></record>
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subjects Care and treatment
Gastroesophageal reflux
Original
Patient outcomes
Proton pump inhibitors
Testing
Transcutaneous electrical nerve stimulation
title Effect of the transcutaneous electrical stimulation system on esophageal-acid exposure in patients non-responsive to once-daily proton-pump inhibitor: proof-of-concept study
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