On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study

Summary Background In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients’ quality of life (QoL). A randomised, double‐blind, placebo‐controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination fo...

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Veröffentlicht in:International journal of clinical practice (Esher) 2014-02, Vol.68 (2), p.245-254
Hauptverfasser: Ducrotte, P., Grimaud, J. C., Dapoigny, M., Personnic, S., O'Mahony, V., Andro-Delestrain, M. C.
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container_issue 2
container_start_page 245
container_title International journal of clinical practice (Esher)
container_volume 68
creator Ducrotte, P.
Grimaud, J. C.
Dapoigny, M.
Personnic, S.
O'Mahony, V.
Andro-Delestrain, M. C.
description Summary Background In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients’ quality of life (QoL). A randomised, double‐blind, placebo‐controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief. Aim As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on‐demand ACS treatment vs. that of usual treatments. Methods Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on‐demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6. Results A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p 
doi_str_mv 10.1111/ijcp.12333
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C. ; Dapoigny, M. ; Personnic, S. ; O'Mahony, V. ; Andro-Delestrain, M. C.</creator><creatorcontrib>Ducrotte, P. ; Grimaud, J. C. ; Dapoigny, M. ; Personnic, S. ; O'Mahony, V. ; Andro-Delestrain, M. C.</creatorcontrib><description>Summary Background In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients’ quality of life (QoL). A randomised, double‐blind, placebo‐controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief. Aim As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on‐demand ACS treatment vs. that of usual treatments. Methods Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on‐demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6. Results A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p &lt; 0.0008). The IBS‐severity symptom score (IBS‐SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS‐SSS &lt; 75 was more frequent in the ACS group (37.7% vs. 16.0%; p &lt; 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on‐demand ACS treatment, which was associated with both lower direct and indirect costs. Conclusions After 6 months, on‐demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments.</description><identifier>ISSN: 1368-5031</identifier><identifier>EISSN: 1742-1241</identifier><identifier>DOI: 10.1111/ijcp.12333</identifier><identifier>PMID: 24147869</identifier><language>eng</language><publisher>India: Blackwell Publishing Ltd</publisher><subject>Abdominal Pain - prevention &amp; control ; Antifoaming Agents - therapeutic use ; Clinical medicine ; Clinical outcomes ; Clinical trials ; Double-Blind Method ; Drug Combinations ; Drug therapy ; Female ; Gastroenterology ; Humans ; Irritable bowel syndrome ; Irritable Bowel Syndrome - drug therapy ; Male ; Middle Aged ; Propylamines - therapeutic use ; Quality of Life ; Serotonin Receptor Agonists - therapeutic use ; Simethicone - therapeutic use ; Treatment Outcome</subject><ispartof>International journal of clinical practice (Esher), 2014-02, Vol.68 (2), p.245-254</ispartof><rights>2013 The Authors International Journal of Clinical Practice Published by John Wiley &amp; Sons Ltd</rights><rights>2013 The Authors International Journal of Clinical Practice Published by John Wiley &amp; Sons Ltd.</rights><rights>Copyright © 2014 John Wiley &amp; Sons Ltd</rights><rights>2013 The Authors International Journal of Clinical Practice Published by John Wiley &amp; Sons Ltd 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4863-f7fbcbb0c4e6d47f85b1a22654551abf1e3d0be29b1d3415c3b81835b6a15dcf3</citedby><cites>FETCH-LOGICAL-c4863-f7fbcbb0c4e6d47f85b1a22654551abf1e3d0be29b1d3415c3b81835b6a15dcf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fijcp.12333$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fijcp.12333$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,315,782,786,887,1419,27933,27934,45583,45584</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24147869$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ducrotte, P.</creatorcontrib><creatorcontrib>Grimaud, J. C.</creatorcontrib><creatorcontrib>Dapoigny, M.</creatorcontrib><creatorcontrib>Personnic, S.</creatorcontrib><creatorcontrib>O'Mahony, V.</creatorcontrib><creatorcontrib>Andro-Delestrain, M. C.</creatorcontrib><title>On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study</title><title>International journal of clinical practice (Esher)</title><addtitle>Int J Clin Pract</addtitle><description>Summary Background In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients’ quality of life (QoL). A randomised, double‐blind, placebo‐controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief. Aim As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on‐demand ACS treatment vs. that of usual treatments. Methods Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on‐demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6. Results A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p &lt; 0.0008). The IBS‐severity symptom score (IBS‐SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS‐SSS &lt; 75 was more frequent in the ACS group (37.7% vs. 16.0%; p &lt; 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on‐demand ACS treatment, which was associated with both lower direct and indirect costs. Conclusions After 6 months, on‐demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments.</description><subject>Abdominal Pain - prevention &amp; control</subject><subject>Antifoaming Agents - therapeutic use</subject><subject>Clinical medicine</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Drug Combinations</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Humans</subject><subject>Irritable bowel syndrome</subject><subject>Irritable Bowel Syndrome - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Propylamines - therapeutic use</subject><subject>Quality of Life</subject><subject>Serotonin Receptor Agonists - therapeutic use</subject><subject>Simethicone - therapeutic use</subject><subject>Treatment Outcome</subject><issn>1368-5031</issn><issn>1742-1241</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp9kc1u1DAURiMEoqWw4QGQJTYIKW38mwyLSmgEpaPRlEpQlpbt3LQekjjYTod5Fx4WD2lHhQXe2LLPPb5XX5a9xMUxTuvErs1wjAml9FF2iEtGckwYfpzOVFQ5Lyg-yJ6FsC4KwnlVPM0O0jMrKzE7zH5d9HkNneprFD2o2EEf0cbGG6TaW_C2B2Rs9CrCSbAdRGvc7sp1g_JQT2SIqVz5B4aAGueR9d5GpVtA2m2gRWHb19518A55CGObKNcghXyqdp0NSTd4dd2p9ElyjvX2efakUW2AF3f7Ufb144cv80_58uLsfP5-mRtWCZo3ZaON1oVhIGpWNhXXWBEiOOMcK91goHWhgcw0rinD3FBd4YpyLRTmtWnoUXY6eYdRd1CbNIFXrRy87ZTfSqes_Pultzfy2t1KRipCeJkEb-4E3v0YIUSZ5jHQtqoHNwaJ2YyIigtRJfT1P-jajb5P4-0oLLigrEjU24ky3oXgodk3gwu5C13uQpd_Qk_wq4ft79H7lBOAJ2BjW9j-RyXPF_PP99J8qrEhws99jfLfpShpyeW31Zm8vLparBarS7mkvwFoKcxC</recordid><startdate>201402</startdate><enddate>201402</enddate><creator>Ducrotte, P.</creator><creator>Grimaud, J. C.</creator><creator>Dapoigny, M.</creator><creator>Personnic, S.</creator><creator>O'Mahony, V.</creator><creator>Andro-Delestrain, M. C.</creator><general>Blackwell Publishing Ltd</general><general>Hindawi Limited</general><general>BlackWell Publishing Ltd</general><scope>BSCLL</scope><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7T5</scope><scope>7TK</scope><scope>7TS</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201402</creationdate><title>On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study</title><author>Ducrotte, P. ; Grimaud, J. C. ; Dapoigny, M. ; Personnic, S. ; O'Mahony, V. ; Andro-Delestrain, M. 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C.</au><au>Dapoigny, M.</au><au>Personnic, S.</au><au>O'Mahony, V.</au><au>Andro-Delestrain, M. C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study</atitle><jtitle>International journal of clinical practice (Esher)</jtitle><addtitle>Int J Clin Pract</addtitle><date>2014-02</date><risdate>2014</risdate><volume>68</volume><issue>2</issue><spage>245</spage><epage>254</epage><pages>245-254</pages><issn>1368-5031</issn><eissn>1742-1241</eissn><abstract>Summary Background In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients’ quality of life (QoL). A randomised, double‐blind, placebo‐controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief. Aim As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on‐demand ACS treatment vs. that of usual treatments. Methods Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on‐demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6. Results A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p &lt; 0.0008). The IBS‐severity symptom score (IBS‐SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS‐SSS &lt; 75 was more frequent in the ACS group (37.7% vs. 16.0%; p &lt; 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on‐demand ACS treatment, which was associated with both lower direct and indirect costs. Conclusions After 6 months, on‐demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments.</abstract><cop>India</cop><pub>Blackwell Publishing Ltd</pub><pmid>24147869</pmid><doi>10.1111/ijcp.12333</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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source MEDLINE; Access via Wiley Online Library
subjects Abdominal Pain - prevention & control
Antifoaming Agents - therapeutic use
Clinical medicine
Clinical outcomes
Clinical trials
Double-Blind Method
Drug Combinations
Drug therapy
Female
Gastroenterology
Humans
Irritable bowel syndrome
Irritable Bowel Syndrome - drug therapy
Male
Middle Aged
Propylamines - therapeutic use
Quality of Life
Serotonin Receptor Agonists - therapeutic use
Simethicone - therapeutic use
Treatment Outcome
title On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study
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