Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study
The effect of Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of H pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs. 285 patients were randomly as...
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Veröffentlicht in: | The Lancet (British edition) 1998-09, Vol.352 (9133), p.1016-1021 |
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creator | Hawkey, CJ Tulassay, Z Szczepanski, L van Rensburg, CJ Filipowicz-Sosnowska, A Lanas, A Wason, CM Peacock, RA Gillon, KRW |
description | The effect of
Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of
H pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs.
285 patients were randomly assigned omeprazole 20 mg, amoxycillin 1000 mg, and clarithromycin 500 mg, twice daily (n=142,
H pylori eradication treatment), or omeprazole with placebo antibiotics (n=143, controls) for 1 week. All patients received omeprazole 20 mg once daily for 3 weeks until endoscopy, and, if the ulcer was not healed, 40 mg once daily until repeat endoscopy at 8 weeks. Ulcer-free patients with mild dyspepsia continued NSAIDs but not antiulcer treatment. We investigated ulcers with endoscopy at 1, 3, and 6 months and with carbon-13-labelled urea breath test at 3 months.
The estimated probability of being ulcer-free at 6 months was 0.56 (95% CI 0.47–0.65) on eradication treatment and 0·53 (0·44–0·62) on on control treatment (p=0·80). Time to treatment failure did not differ between groups for ulcers or dyspepsia alone, per-protocol analysis, or final
H pylori status. 66% (58–74) of the eradication group compared with 14% (8–20) of the control group had a final negative
H pylori result (p |
doi_str_mv | 10.1016/S0140-6736(98)04206-8 |
format | Article |
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Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of
H pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs.
285 patients were randomly assigned omeprazole 20 mg, amoxycillin 1000 mg, and clarithromycin 500 mg, twice daily (n=142,
H pylori eradication treatment), or omeprazole with placebo antibiotics (n=143, controls) for 1 week. All patients received omeprazole 20 mg once daily for 3 weeks until endoscopy, and, if the ulcer was not healed, 40 mg once daily until repeat endoscopy at 8 weeks. Ulcer-free patients with mild dyspepsia continued NSAIDs but not antiulcer treatment. We investigated ulcers with endoscopy at 1, 3, and 6 months and with carbon-13-labelled urea breath test at 3 months.
The estimated probability of being ulcer-free at 6 months was 0.56 (95% CI 0.47–0.65) on eradication treatment and 0·53 (0·44–0·62) on on control treatment (p=0·80). Time to treatment failure did not differ between groups for ulcers or dyspepsia alone, per-protocol analysis, or final
H pylori status. 66% (58–74) of the eradication group compared with 14% (8–20) of the control group had a final negative
H pylori result (p<0·001). Fewer baseline gastric ulcers healed among eradication-treatment patients than among controls (72
vs 100% at 8 weeks, p=0·006).
H pylori eradication in long-term users of NSAIDs with past or current peptic ulcer or troublesome dyspepsia led to impaired healing of gastric ulcers and did not affect the rate of peptic ulcers or dyspepsia over 6 months.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(98)04206-8</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Anti-inflammatory agents ; Antibiotics ; Bacteria ; Carbon 13 ; Drug therapy ; Infections ; Nonsteroidal anti-inflammatory drugs ; Ulcers ; Urea</subject><ispartof>The Lancet (British edition), 1998-09, Vol.352 (9133), p.1016-1021</ispartof><rights>1998 Elsevier Ltd</rights><rights>Copyright Lancet Ltd. Sep 26, 1998</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c358t-2079ac5a02987b19a554ffc0344d0575e7f0777ce9b5841b858d4292187620ea3</citedby><cites>FETCH-LOGICAL-c358t-2079ac5a02987b19a554ffc0344d0575e7f0777ce9b5841b858d4292187620ea3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673698042068$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids></links><search><creatorcontrib>Hawkey, CJ</creatorcontrib><creatorcontrib>Tulassay, Z</creatorcontrib><creatorcontrib>Szczepanski, L</creatorcontrib><creatorcontrib>van Rensburg, CJ</creatorcontrib><creatorcontrib>Filipowicz-Sosnowska, A</creatorcontrib><creatorcontrib>Lanas, A</creatorcontrib><creatorcontrib>Wason, CM</creatorcontrib><creatorcontrib>Peacock, RA</creatorcontrib><creatorcontrib>Gillon, KRW</creatorcontrib><title>Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study</title><title>The Lancet (British edition)</title><description>The effect of
Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of
H pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs.
285 patients were randomly assigned omeprazole 20 mg, amoxycillin 1000 mg, and clarithromycin 500 mg, twice daily (n=142,
H pylori eradication treatment), or omeprazole with placebo antibiotics (n=143, controls) for 1 week. All patients received omeprazole 20 mg once daily for 3 weeks until endoscopy, and, if the ulcer was not healed, 40 mg once daily until repeat endoscopy at 8 weeks. Ulcer-free patients with mild dyspepsia continued NSAIDs but not antiulcer treatment. We investigated ulcers with endoscopy at 1, 3, and 6 months and with carbon-13-labelled urea breath test at 3 months.
The estimated probability of being ulcer-free at 6 months was 0.56 (95% CI 0.47–0.65) on eradication treatment and 0·53 (0·44–0·62) on on control treatment (p=0·80). Time to treatment failure did not differ between groups for ulcers or dyspepsia alone, per-protocol analysis, or final
H pylori status. 66% (58–74) of the eradication group compared with 14% (8–20) of the control group had a final negative
H pylori result (p<0·001). Fewer baseline gastric ulcers healed among eradication-treatment patients than among controls (72
vs 100% at 8 weeks, p=0·006).
H pylori eradication in long-term users of NSAIDs with past or current peptic ulcer or troublesome dyspepsia led to impaired healing of gastric ulcers and did not affect the rate of peptic ulcers or dyspepsia over 6 months.</description><subject>Anti-inflammatory agents</subject><subject>Antibiotics</subject><subject>Bacteria</subject><subject>Carbon 13</subject><subject>Drug therapy</subject><subject>Infections</subject><subject>Nonsteroidal anti-inflammatory drugs</subject><subject>Ulcers</subject><subject>Urea</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1998</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkM1KJDEUhcOgMO3PIwjB1cyi9KYqqSSzEfGvhUaHUcFdSCcpiVQnPUla6BfwuY22uHV1z4VzzuV-CB0QOCJA-uM7IBSannf9Lyl-A22hb8QPNCGU04ZR_riFJl-Wn2gn52cAoD2wCXr9p4ONC5-dxSaGkuI4VlmS1yOOA5660Zs416a4hJfrMSaPXdLWG118DNgHvKzKhZJxXUMMTa7W6G3N61B848Mw6sVCl5jW2KbVU_6Dpxezv_jm7vT6PONcVna9h7YHPWa3_zl30cPlxf3ZtJndXl2fnc4a0zFRmha41IZpaKXgcyI1Y3QYDHSUWmCcOT4A59w4OWeCkrlgwtJWtkTwvgWnu110uOldpvh_5XJRz3GVQj2piJTQCt7JamIbk0kx5-QGtUx-odNaEVDvxNUHcfWOU0mhPogrUXMnm5yrH7x4l1Q2lYxx1idnirLRf9PwBtKZiVA</recordid><startdate>19980926</startdate><enddate>19980926</enddate><creator>Hawkey, CJ</creator><creator>Tulassay, Z</creator><creator>Szczepanski, L</creator><creator>van 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controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study</title><author>Hawkey, CJ ; Tulassay, Z ; Szczepanski, L ; van Rensburg, CJ ; Filipowicz-Sosnowska, A ; Lanas, A ; Wason, CM ; Peacock, RA ; Gillon, KRW</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c358t-2079ac5a02987b19a554ffc0344d0575e7f0777ce9b5841b858d4292187620ea3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1998</creationdate><topic>Anti-inflammatory agents</topic><topic>Antibiotics</topic><topic>Bacteria</topic><topic>Carbon 13</topic><topic>Drug therapy</topic><topic>Infections</topic><topic>Nonsteroidal anti-inflammatory drugs</topic><topic>Ulcers</topic><topic>Urea</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hawkey, CJ</creatorcontrib><creatorcontrib>Tulassay, Z</creatorcontrib><creatorcontrib>Szczepanski, 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edition)</jtitle><date>1998-09-26</date><risdate>1998</risdate><volume>352</volume><issue>9133</issue><spage>1016</spage><epage>1021</epage><pages>1016-1021</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>The effect of
Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of
H pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs.
285 patients were randomly assigned omeprazole 20 mg, amoxycillin 1000 mg, and clarithromycin 500 mg, twice daily (n=142,
H pylori eradication treatment), or omeprazole with placebo antibiotics (n=143, controls) for 1 week. All patients received omeprazole 20 mg once daily for 3 weeks until endoscopy, and, if the ulcer was not healed, 40 mg once daily until repeat endoscopy at 8 weeks. Ulcer-free patients with mild dyspepsia continued NSAIDs but not antiulcer treatment. We investigated ulcers with endoscopy at 1, 3, and 6 months and with carbon-13-labelled urea breath test at 3 months.
The estimated probability of being ulcer-free at 6 months was 0.56 (95% CI 0.47–0.65) on eradication treatment and 0·53 (0·44–0·62) on on control treatment (p=0·80). Time to treatment failure did not differ between groups for ulcers or dyspepsia alone, per-protocol analysis, or final
H pylori status. 66% (58–74) of the eradication group compared with 14% (8–20) of the control group had a final negative
H pylori result (p<0·001). Fewer baseline gastric ulcers healed among eradication-treatment patients than among controls (72
vs 100% at 8 weeks, p=0·006).
H pylori eradication in long-term users of NSAIDs with past or current peptic ulcer or troublesome dyspepsia led to impaired healing of gastric ulcers and did not affect the rate of peptic ulcers or dyspepsia over 6 months.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><doi>10.1016/S0140-6736(98)04206-8</doi><tpages>6</tpages></addata></record> |
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source | Elsevier ScienceDirect Journals Complete; EBSCOhost Business Source Complete |
subjects | Anti-inflammatory agents Antibiotics Bacteria Carbon 13 Drug therapy Infections Nonsteroidal anti-inflammatory drugs Ulcers Urea |
title | Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study |
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