A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation
Background: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. Aims: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life...
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| Veröffentlicht in: | Gut 2005-12, Vol.54 (12), p.1707-1713 |
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| creator | Tack, J Müller-Lissner, S Bytzer, P Corinaldesi, R Chang, L Viegas, A Schnekenbuehl, S Dunger-Baldauf, C Rueegg, P |
| description | Background: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. Aims: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. Patients: Women (⩾18 years of age) with IBS-C according to the Rome II criteria. Methods: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. Results: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p |
| doi_str_mv | 10.1136/gut.2005.070789 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_1774790</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>4014121741</sourcerecordid><originalsourceid>FETCH-LOGICAL-b522t-c24595f8f3582de7ea4eb5fed7b2345c7b710c88b02ff3e5d4e103b388ab7d0d3</originalsourceid><addsrcrecordid>eNqFkVFrFDEUhQdR7Fp99k0C4kthtjeTySTzIpTFWqFWBO1rSGZudrPOTrZJ1rp_xN9rlllaffIlCZzv3HvCKYrXFOaUsuZ8uUvzCoDPQYCQ7ZNiRutGlqyS8mkxA6Ci5KJuT4oXMa4BQMqWPi9OaAMV1LKdFb8vSNBj7zcuYk86P6bghyE_U3B6IDpGjNGNS5JWSNBa1-luT7KDRG0x7Ym3JOAWdTp4cKkjBt8f6KC3e-JGcu83mE-XVsSF4JI2AxLj73EgcT_2IcuTmpfH5LY6OT--LJ5ZPUR8dbxPi--XH74trsrrLx8_LS6uS8OrKpVdVfOWW2kZl1WPAnWNhlvshalYzTthBIVOSgOVtQx5XyMFZpiU2ogeenZavJ_mbndmg32H-f96UNvgNjrslddO_auMbqWW_qeiQtSihTzg7XFA8Hc7jEmt_S6MOfMBaRmjHGimzieqCz7GgPZhAwV1KFLlItWhSDUVmR1v_g72yB-by8C7I6BjpwebW-xcfORE1YgG6syVE-diwl8Pug4_VCOY4OrmdqGuoP58w9pb9TXzZxNvNuv_pvwDXMfH_g</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1779331501</pqid></control><display><type>article</type><title>A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Tack, J ; Müller-Lissner, S ; Bytzer, P ; Corinaldesi, R ; Chang, L ; Viegas, A ; Schnekenbuehl, S ; Dunger-Baldauf, C ; Rueegg, P</creator><creatorcontrib>Tack, J ; Müller-Lissner, S ; Bytzer, P ; Corinaldesi, R ; Chang, L ; Viegas, A ; Schnekenbuehl, S ; Dunger-Baldauf, C ; Rueegg, P</creatorcontrib><description>Background: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. Aims: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. Patients: Women (⩾18 years of age) with IBS-C according to the Rome II criteria. Methods: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. Results: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p<0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p<0.05). Conclusion: Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.</description><identifier>ISSN: 0017-5749</identifier><identifier>EISSN: 1468-3288</identifier><identifier>EISSN: 1458-3288</identifier><identifier>DOI: 10.1136/gut.2005.070789</identifier><identifier>PMID: 16020489</identifier><identifier>CODEN: GUTTAK</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd and British Society of Gastroenterology</publisher><subject>Abdomen ; Adolescent ; Adult ; Aged ; Biological and medical sciences ; CHMP ; Clinical trials ; Committee for Medicinal Products for Human Use ; Constipation ; Constipation - drug therapy ; Constipation - rehabilitation ; Double-Blind Method ; Drug Administration Schedule ; efficacy ; Efficiency ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Gastrointestinal Agents - adverse effects ; Gastrointestinal Agents - therapeutic use ; Humans ; IBS-C ; IBS-C women ; Indoles - adverse effects ; Indoles - therapeutic use ; Irritable bowel syndrome ; Irritable Bowel Syndrome - drug therapy ; Irritable Bowel Syndrome - rehabilitation ; irritable bowel syndrome with constipation ; Laxatives ; Medical sciences ; Middle Aged ; Neurogastroenterology ; Other diseases. Semiology ; Pain ; Patient Satisfaction ; Prospective Studies ; QoL ; Quality of Life ; repeated treatment ; safety ; Serotonin Receptor Agonists - adverse effects ; Serotonin Receptor Agonists - therapeutic use ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; tegaserod ; TFI ; treatment free interval ; Treatment Outcome</subject><ispartof>Gut, 2005-12, Vol.54 (12), p.1707-1713</ispartof><rights>Copyright 2005 by Gut</rights><rights>2006 INIST-CNRS</rights><rights>Copyright: 2005 Copyright 2005 by Gut</rights><rights>Copyright © Copyright 2005 by Gut 2005</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b522t-c24595f8f3582de7ea4eb5fed7b2345c7b710c88b02ff3e5d4e103b388ab7d0d3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1774790/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1774790/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17267604$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16020489$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tack, J</creatorcontrib><creatorcontrib>Müller-Lissner, S</creatorcontrib><creatorcontrib>Bytzer, P</creatorcontrib><creatorcontrib>Corinaldesi, R</creatorcontrib><creatorcontrib>Chang, L</creatorcontrib><creatorcontrib>Viegas, A</creatorcontrib><creatorcontrib>Schnekenbuehl, S</creatorcontrib><creatorcontrib>Dunger-Baldauf, C</creatorcontrib><creatorcontrib>Rueegg, P</creatorcontrib><title>A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation</title><title>Gut</title><addtitle>Gut</addtitle><description>Background: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. Aims: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. Patients: Women (⩾18 years of age) with IBS-C according to the Rome II criteria. Methods: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. Results: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p<0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p<0.05). Conclusion: Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.</description><subject>Abdomen</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>CHMP</subject><subject>Clinical trials</subject><subject>Committee for Medicinal Products for Human Use</subject><subject>Constipation</subject><subject>Constipation - drug therapy</subject><subject>Constipation - rehabilitation</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>efficacy</subject><subject>Efficiency</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Gastrointestinal Agents - adverse effects</subject><subject>Gastrointestinal Agents - therapeutic use</subject><subject>Humans</subject><subject>IBS-C</subject><subject>IBS-C women</subject><subject>Indoles - adverse effects</subject><subject>Indoles - therapeutic use</subject><subject>Irritable bowel syndrome</subject><subject>Irritable Bowel Syndrome - drug therapy</subject><subject>Irritable Bowel Syndrome - rehabilitation</subject><subject>irritable bowel syndrome with constipation</subject><subject>Laxatives</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neurogastroenterology</subject><subject>Other diseases. Semiology</subject><subject>Pain</subject><subject>Patient Satisfaction</subject><subject>Prospective Studies</subject><subject>QoL</subject><subject>Quality of Life</subject><subject>repeated treatment</subject><subject>safety</subject><subject>Serotonin Receptor Agonists - adverse effects</subject><subject>Serotonin Receptor Agonists - therapeutic use</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>tegaserod</subject><subject>TFI</subject><subject>treatment free interval</subject><subject>Treatment Outcome</subject><issn>0017-5749</issn><issn>1468-3288</issn><issn>1458-3288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFkVFrFDEUhQdR7Fp99k0C4kthtjeTySTzIpTFWqFWBO1rSGZudrPOTrZJ1rp_xN9rlllaffIlCZzv3HvCKYrXFOaUsuZ8uUvzCoDPQYCQ7ZNiRutGlqyS8mkxA6Ci5KJuT4oXMa4BQMqWPi9OaAMV1LKdFb8vSNBj7zcuYk86P6bghyE_U3B6IDpGjNGNS5JWSNBa1-luT7KDRG0x7Ym3JOAWdTp4cKkjBt8f6KC3e-JGcu83mE-XVsSF4JI2AxLj73EgcT_2IcuTmpfH5LY6OT--LJ5ZPUR8dbxPi--XH74trsrrLx8_LS6uS8OrKpVdVfOWW2kZl1WPAnWNhlvshalYzTthBIVOSgOVtQx5XyMFZpiU2ogeenZavJ_mbndmg32H-f96UNvgNjrslddO_auMbqWW_qeiQtSihTzg7XFA8Hc7jEmt_S6MOfMBaRmjHGimzieqCz7GgPZhAwV1KFLlItWhSDUVmR1v_g72yB-by8C7I6BjpwebW-xcfORE1YgG6syVE-diwl8Pug4_VCOY4OrmdqGuoP58w9pb9TXzZxNvNuv_pvwDXMfH_g</recordid><startdate>20051201</startdate><enddate>20051201</enddate><creator>Tack, J</creator><creator>Müller-Lissner, S</creator><creator>Bytzer, P</creator><creator>Corinaldesi, R</creator><creator>Chang, L</creator><creator>Viegas, A</creator><creator>Schnekenbuehl, S</creator><creator>Dunger-Baldauf, C</creator><creator>Rueegg, P</creator><general>BMJ Publishing Group Ltd and British Society of Gastroenterology</general><general>BMJ</general><general>BMJ Publishing Group LTD</general><general>Copyright 2005 by Gut</general><scope>BSCLL</scope><scope>IQODW</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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQGLB</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>5PM</scope></search><sort><creationdate>20051201</creationdate><title>A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation</title><author>Tack, J ; Müller-Lissner, S ; Bytzer, P ; Corinaldesi, R ; Chang, L ; Viegas, A ; Schnekenbuehl, S ; Dunger-Baldauf, C ; Rueegg, P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b522t-c24595f8f3582de7ea4eb5fed7b2345c7b710c88b02ff3e5d4e103b388ab7d0d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Abdomen</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>CHMP</topic><topic>Clinical trials</topic><topic>Committee for Medicinal Products for Human Use</topic><topic>Constipation</topic><topic>Constipation - drug therapy</topic><topic>Constipation - rehabilitation</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>efficacy</topic><topic>Efficiency</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Gastrointestinal Agents - adverse effects</topic><topic>Gastrointestinal Agents - therapeutic use</topic><topic>Humans</topic><topic>IBS-C</topic><topic>IBS-C women</topic><topic>Indoles - adverse effects</topic><topic>Indoles - therapeutic use</topic><topic>Irritable bowel syndrome</topic><topic>Irritable Bowel Syndrome - drug therapy</topic><topic>Irritable Bowel Syndrome - rehabilitation</topic><topic>irritable bowel syndrome with constipation</topic><topic>Laxatives</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neurogastroenterology</topic><topic>Other diseases. Semiology</topic><topic>Pain</topic><topic>Patient Satisfaction</topic><topic>Prospective Studies</topic><topic>QoL</topic><topic>Quality of Life</topic><topic>repeated treatment</topic><topic>safety</topic><topic>Serotonin Receptor Agonists - adverse effects</topic><topic>Serotonin Receptor Agonists - therapeutic use</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>tegaserod</topic><topic>TFI</topic><topic>treatment free interval</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tack, J</creatorcontrib><creatorcontrib>Müller-Lissner, S</creatorcontrib><creatorcontrib>Bytzer, P</creatorcontrib><creatorcontrib>Corinaldesi, R</creatorcontrib><creatorcontrib>Chang, L</creatorcontrib><creatorcontrib>Viegas, A</creatorcontrib><creatorcontrib>Schnekenbuehl, S</creatorcontrib><creatorcontrib>Dunger-Baldauf, C</creatorcontrib><creatorcontrib>Rueegg, P</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection (ProQuest)</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Applied & Life Sciences</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Gut</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tack, J</au><au>Müller-Lissner, S</au><au>Bytzer, P</au><au>Corinaldesi, R</au><au>Chang, L</au><au>Viegas, A</au><au>Schnekenbuehl, S</au><au>Dunger-Baldauf, C</au><au>Rueegg, P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation</atitle><jtitle>Gut</jtitle><addtitle>Gut</addtitle><date>2005-12-01</date><risdate>2005</risdate><volume>54</volume><issue>12</issue><spage>1707</spage><epage>1713</epage><pages>1707-1713</pages><issn>0017-5749</issn><eissn>1468-3288</eissn><eissn>1458-3288</eissn><coden>GUTTAK</coden><abstract>Background: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. Aims: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. Patients: Women (⩾18 years of age) with IBS-C according to the Rome II criteria. Methods: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. Results: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p<0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p<0.05). Conclusion: Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd and British Society of Gastroenterology</pub><pmid>16020489</pmid><doi>10.1136/gut.2005.070789</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Gut, 2005-12, Vol.54 (12), p.1707-1713 |
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| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Abdomen Adolescent Adult Aged Biological and medical sciences CHMP Clinical trials Committee for Medicinal Products for Human Use Constipation Constipation - drug therapy Constipation - rehabilitation Double-Blind Method Drug Administration Schedule efficacy Efficiency Female Gastroenterology. Liver. Pancreas. Abdomen Gastrointestinal Agents - adverse effects Gastrointestinal Agents - therapeutic use Humans IBS-C IBS-C women Indoles - adverse effects Indoles - therapeutic use Irritable bowel syndrome Irritable Bowel Syndrome - drug therapy Irritable Bowel Syndrome - rehabilitation irritable bowel syndrome with constipation Laxatives Medical sciences Middle Aged Neurogastroenterology Other diseases. Semiology Pain Patient Satisfaction Prospective Studies QoL Quality of Life repeated treatment safety Serotonin Receptor Agonists - adverse effects Serotonin Receptor Agonists - therapeutic use Stomach. Duodenum. Small intestine. Colon. Rectum. Anus tegaserod TFI treatment free interval Treatment Outcome |
| title | A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation |
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