PREVENTION OF NSAID-INDUCED GASTRIC ULCER WITH MISOPROSTOL: MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
A double-blind, placebo-controlled study was carried out to see whether the synthetic E prostaglandin, misoprostol, would prevent gastric ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs). 420 patients with osteoarthritis and NSAID-associated abdominal pain were studied; they were rece...
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Veröffentlicht in: | The Lancet (British edition) 1988-12, Vol.332 (8623), p.1277-1280 |
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description | A double-blind, placebo-controlled study was carried out to see whether the synthetic E prostaglandin, misoprostol, would prevent gastric ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs). 420 patients with osteoarthritis and NSAID-associated abdominal pain were studied; they were receiving ibuprofen, piroxicam, or naproxen. Endoscopy was done at entry and after 1, 2, and 3 months of continuous treatment with 100 μg or 200 μg misoprostol or placebo, given four times daily with meals and at bedtime, concurrently with the NSAID. Abdominal pain was rated independently by patients and physicians. A treatment failure was defined as development of a gastric ulcer. Gastric ulcers (0·3 cm in diameter or greater) occurred less frequently (p |
doi_str_mv | 10.1016/S0140-6736(88)92892-9 |
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Endoscopy was done at entry and after 1, 2, and 3 months of continuous treatment with 100 μg or 200 μg misoprostol or placebo, given four times daily with meals and at bedtime, concurrently with the NSAID. Abdominal pain was rated independently by patients and physicians. A treatment failure was defined as development of a gastric ulcer. Gastric ulcers (0·3 cm in diameter or greater) occurred less frequently (p <0·001) in both misoprostol treatment groups (5·6% 100 μg and 1·4% 200 μg) than in the placebo group (21·7%). The significant difference in ulcer formation between the placebo and the misoprostol treatment groups remained when comparisons were restricted to ulcers greater than 0·5 cm in diameter (12·3% placebo, 4·2% 100 μg misoprostol, and 0·7% 200 μg misoprostol). Mild to moderate, self-limiting diarrhoea was the most frequently reported adverse effect attributed to misoprostol. These results provide the first clear indication that NSAID-induced ulcers are preventable.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(88)92892-9</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Anti-inflammatory agents ; Biological and medical sciences ; Drug toxicity and drugs side effects treatment ; Drugs ; Health care ; Medical research ; Medical sciences ; Nonsteroidal anti-inflammatory drugs ; Osteoarthritis ; Pain ; Pharmacology. Drug treatments ; Toxicity: digestive system ; Ulcers</subject><ispartof>The Lancet (British edition), 1988-12, Vol.332 (8623), p.1277-1280</ispartof><rights>1988</rights><rights>1989 INIST-CNRS</rights><rights>Copyright Lancet Ltd. Dec 3, 1988</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c330t-712b7f96a553ae29d5c0f2b7a731b165e467b69e35e1122ad6c0e9abd109e0013</citedby><cites>FETCH-LOGICAL-c330t-712b7f96a553ae29d5c0f2b7a731b165e467b69e35e1122ad6c0e9abd109e0013</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673688928929$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=7175253$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>Graham, DavidY</creatorcontrib><creatorcontrib>Agrawal, NaurangM</creatorcontrib><creatorcontrib>Roth, SanfordH</creatorcontrib><title>PREVENTION OF NSAID-INDUCED GASTRIC ULCER WITH MISOPROSTOL: MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL</title><title>The Lancet (British edition)</title><description>A double-blind, placebo-controlled study was carried out to see whether the synthetic E prostaglandin, misoprostol, would prevent gastric ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs). 420 patients with osteoarthritis and NSAID-associated abdominal pain were studied; they were receiving ibuprofen, piroxicam, or naproxen. Endoscopy was done at entry and after 1, 2, and 3 months of continuous treatment with 100 μg or 200 μg misoprostol or placebo, given four times daily with meals and at bedtime, concurrently with the NSAID. Abdominal pain was rated independently by patients and physicians. A treatment failure was defined as development of a gastric ulcer. Gastric ulcers (0·3 cm in diameter or greater) occurred less frequently (p <0·001) in both misoprostol treatment groups (5·6% 100 μg and 1·4% 200 μg) than in the placebo group (21·7%). The significant difference in ulcer formation between the placebo and the misoprostol treatment groups remained when comparisons were restricted to ulcers greater than 0·5 cm in diameter (12·3% placebo, 4·2% 100 μg misoprostol, and 0·7% 200 μg misoprostol). Mild to moderate, self-limiting diarrhoea was the most frequently reported adverse effect attributed to misoprostol. These results provide the first clear indication that NSAID-induced ulcers are preventable.</description><subject>Anti-inflammatory agents</subject><subject>Biological and medical sciences</subject><subject>Drug toxicity and drugs side effects treatment</subject><subject>Drugs</subject><subject>Health care</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Nonsteroidal anti-inflammatory drugs</subject><subject>Osteoarthritis</subject><subject>Pain</subject><subject>Pharmacology. Drug treatments</subject><subject>Toxicity: digestive system</subject><subject>Ulcers</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1988</creationdate><recordtype>article</recordtype><recordid>eNqFkM1q3DAUhU1podMkj1AQpYsWokSSLcnqpng8TmJQRoN_2u6ERpbBIRmn0qSQt4-SCdl2deHe75zDPUnyGaMzjDA7bxHOEGQ8Zd_y_LsguSBQvEsWOOMZpBn_8z5ZvCEfk08h3CCEMoboIpk3TfWrWne1WgN1AdZtUa9gvV71ZbUCl0XbNXUJellWDfhdd1fgum7VplFtp-QPcN3Lri6juqlOwUr1S1nBpYzqU7CRRVktFSxVvCopo1u0KuRx8mE0t8GdvM6jpL-ouvIKSnVZl4WENk3RHnJMtnwUzFCaGkfEQC0a48rwFG8xoy5jfMuES6nDmBAzMIucMNsBI-EQwulR8uXge-_nvw8u7PXN_OB3MVJjkQtKCKIRogfI-jkE70Z976c74x81Rvq5Wv1SrX7uTee5fqlWi6j7-mpugjW3ozc7O4U3McecEppG7OcBc_HRf5PzOtjJ7awbJu_sXg_z9J-gJ6_Jgzc</recordid><startdate>19881203</startdate><enddate>19881203</enddate><creator>Graham, DavidY</creator><creator>Agrawal, NaurangM</creator><creator>Roth, SanfordH</creator><general>Elsevier Ltd</general><general>Lancet</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>ASE</scope><scope>C1K</scope><scope>FPQ</scope><scope>H94</scope><scope>K6X</scope><scope>K9.</scope><scope>KB~</scope><scope>M7N</scope><scope>NAPCQ</scope></search><sort><creationdate>19881203</creationdate><title>PREVENTION OF NSAID-INDUCED GASTRIC ULCER WITH MISOPROSTOL: MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL</title><author>Graham, DavidY ; Agrawal, NaurangM ; Roth, SanfordH</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c330t-712b7f96a553ae29d5c0f2b7a731b165e467b69e35e1122ad6c0e9abd109e0013</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1988</creationdate><topic>Anti-inflammatory agents</topic><topic>Biological and medical sciences</topic><topic>Drug toxicity and drugs side effects treatment</topic><topic>Drugs</topic><topic>Health care</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Nonsteroidal anti-inflammatory drugs</topic><topic>Osteoarthritis</topic><topic>Pain</topic><topic>Pharmacology. Drug treatments</topic><topic>Toxicity: digestive system</topic><topic>Ulcers</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Graham, DavidY</creatorcontrib><creatorcontrib>Agrawal, NaurangM</creatorcontrib><creatorcontrib>Roth, SanfordH</creatorcontrib><collection>Pascal-Francis</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>British Nursing Index</collection><collection>Environmental Sciences and Pollution Management</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Newsstand Professional</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Graham, DavidY</au><au>Agrawal, NaurangM</au><au>Roth, SanfordH</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>PREVENTION OF NSAID-INDUCED GASTRIC ULCER WITH MISOPROSTOL: MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL</atitle><jtitle>The Lancet (British edition)</jtitle><date>1988-12-03</date><risdate>1988</risdate><volume>332</volume><issue>8623</issue><spage>1277</spage><epage>1280</epage><pages>1277-1280</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>A double-blind, placebo-controlled study was carried out to see whether the synthetic E prostaglandin, misoprostol, would prevent gastric ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs). 420 patients with osteoarthritis and NSAID-associated abdominal pain were studied; they were receiving ibuprofen, piroxicam, or naproxen. Endoscopy was done at entry and after 1, 2, and 3 months of continuous treatment with 100 μg or 200 μg misoprostol or placebo, given four times daily with meals and at bedtime, concurrently with the NSAID. Abdominal pain was rated independently by patients and physicians. A treatment failure was defined as development of a gastric ulcer. Gastric ulcers (0·3 cm in diameter or greater) occurred less frequently (p <0·001) in both misoprostol treatment groups (5·6% 100 μg and 1·4% 200 μg) than in the placebo group (21·7%). The significant difference in ulcer formation between the placebo and the misoprostol treatment groups remained when comparisons were restricted to ulcers greater than 0·5 cm in diameter (12·3% placebo, 4·2% 100 μg misoprostol, and 0·7% 200 μg misoprostol). Mild to moderate, self-limiting diarrhoea was the most frequently reported adverse effect attributed to misoprostol. These results provide the first clear indication that NSAID-induced ulcers are preventable.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><doi>10.1016/S0140-6736(88)92892-9</doi><tpages>4</tpages></addata></record> |
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subjects | Anti-inflammatory agents Biological and medical sciences Drug toxicity and drugs side effects treatment Drugs Health care Medical research Medical sciences Nonsteroidal anti-inflammatory drugs Osteoarthritis Pain Pharmacology. Drug treatments Toxicity: digestive system Ulcers |
title | PREVENTION OF NSAID-INDUCED GASTRIC ULCER WITH MISOPROSTOL: MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL |
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