Effect of preventive (β blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial

Objective To determine if the addition of preventive drug treatment (β blocker), brief behavioural migraine management, or their combination improves the outcome of optimised acute treatment in the management of frequent migraine.Design Randomised placebo controlled trial over 16 months from July 20...

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Veröffentlicht in:BMJ 2010-09, Vol.341 (7776), p.769-769
Hauptverfasser: Holroyd, Kenneth A, Cottrell, Constance K, O’Donnell, Francis J, Cordingley, Gary E, Drew, Jana B, Carlson, Bruce W, Himawan, Lina
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container_end_page 769
container_issue 7776
container_start_page 769
container_title BMJ
container_volume 341
creator Holroyd, Kenneth A
Cottrell, Constance K
O’Donnell, Francis J
Cordingley, Gary E
Drew, Jana B
Carlson, Bruce W
Himawan, Lina
description Objective To determine if the addition of preventive drug treatment (β blocker), brief behavioural migraine management, or their combination improves the outcome of optimised acute treatment in the management of frequent migraine.Design Randomised placebo controlled trial over 16 months from July 2001 to November 2005.Setting Two outpatient sites in Ohio, USA.Participants 232 adults (mean age 38 years; 79% female) with diagnosis of migraine with or without aura according to International Headache Society classification of headache disorders criteria, who recorded at least three migraines with disability per 30 days (mean 5.5 migraines/30 days), during an optimised run-in of acute treatment.Interventions Addition of one of four preventive treatments to optimised acute treatment: β blocker (n=53), matched placebo (n=55), behavioural migraine management plus placebo (n=55), or behavioural migraine management plus β blocker (n=69).Main outcome measure The primary outcome was change in migraines/30 days; secondary outcomes included change in migraine days/30 days and change in migraine specific quality of life scores.Results Mixed model analysis showed statistically significant (P≤0.05) differences in outcomes among the four added treatments for both the primary outcome (migraines/30 days) and the two secondary outcomes (change in migraine days/30 days and change in migraine specific quality of life scores). The addition of combined β blocker and behavioural migraine management (−3.3 migraines/30 days, 95% confidence interval −3.2 to −3.5), but not the addition of β blocker alone (−2.1 migraines/30 days, −1.9 to −2.2) or behavioural migraine management alone (−2.2 migraines migraines/30 days, −2.0 to −2.4), improved outcomes compared with optimised acute treatment alone (−2.1 migraines/30 days, −1.9 to −2.2). For a clinically significant (≥50% reduction) in migraines/30 days, the number needed to treat for optimised acute treatment plus combined β blocker and behavioural migraine management was 3.1 compared with optimised acute treatment alone, 2.6 compared with optimised acute treatment plus β blocker, and 3.1 compared with optimised acute treatment plus behavioural migraine management. Results were consistent for the two secondary outcomes, and at both month 10 (the primary endpoint) and month 16.Conclusion The addition of combined β blocker plus behavioural migraine management, but not the addition of β blocker alone or behavioural migraine management alone,
doi_str_mv 10.1136/bmj.c4871
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The addition of combined β blocker and behavioural migraine management (−3.3 migraines/30 days, 95% confidence interval −3.2 to −3.5), but not the addition of β blocker alone (−2.1 migraines/30 days, −1.9 to −2.2) or behavioural migraine management alone (−2.2 migraines migraines/30 days, −2.0 to −2.4), improved outcomes compared with optimised acute treatment alone (−2.1 migraines/30 days, −1.9 to −2.2). For a clinically significant (≥50% reduction) in migraines/30 days, the number needed to treat for optimised acute treatment plus combined β blocker and behavioural migraine management was 3.1 compared with optimised acute treatment alone, 2.6 compared with optimised acute treatment plus β blocker, and 3.1 compared with optimised acute treatment plus behavioural migraine management. Results were consistent for the two secondary outcomes, and at both month 10 (the primary endpoint) and month 16.Conclusion The addition of combined β blocker plus behavioural migraine management, but not the addition of β blocker alone or behavioural migraine management alone, improved outcomes of optimised acute treatment. Combined β blocker treatment and behavioural migraine management may improve outcomes in the treatment of frequent migraine.Trial registration Clinical trials NCT00910689.</description><identifier>ISSN: 0959-8138</identifier><identifier>ISSN: 0959-535X</identifier><identifier>EISSN: 1468-5833</identifier><identifier>EISSN: 1756-1833</identifier><identifier>DOI: 10.1136/bmj.c4871</identifier><identifier>PMID: 20880898</identifier><identifier>CODEN: BMJOAE</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Adolescent ; Adrenergic beta-Antagonists - therapeutic use ; Adult ; Aged ; Antidepressants ; Attention deficit disorder ; Behavior Therapy - methods ; Behaviour therapy ; Beta blockers ; Classification ; Cleveland Clinic CME ; Clinical medicine ; Clinical trials ; Clinical trials (epidemiology) ; Combined Modality Therapy - methods ; Drug abuse ; Evidence-based medicine ; Experimentation ; Female ; Headache ; Headache (including migraine) ; Headaches ; Humans ; Male ; Medication Adherence ; Middle Aged ; Migraine ; Migraine Disorders - prevention &amp; control ; Pain (neurology) ; Pharmaceutical preparations ; Placebos ; Primary care ; Quality of Life ; Secondary Prevention ; Sociology ; Statistical analysis ; Substance abuse treatment ; Treatment ; Treatment Outcome ; Young Adult</subject><ispartof>BMJ, 2010-09, Vol.341 (7776), p.769-769</ispartof><rights>Holroyd et al 2010</rights><rights>2010 BMJ Publishing Group Ltd</rights><rights>Copyright: 2010 © Holroyd et al 2010</rights><rights>Holroyd et al 2010 2010 Holroyd et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b556t-aaf6084ee113f8bcdb681faf1d8fe1b154f83a0dfc98c6172790f55147ab82823</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmj.com/content/341/bmj.c4871.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmj.com/content/341/bmj.c4871.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>114,115,230,314,780,784,803,885,3196,23571,27924,27925,31000,58017,58250,77600,77631</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20880898$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Holroyd, Kenneth A</creatorcontrib><creatorcontrib>Cottrell, Constance K</creatorcontrib><creatorcontrib>O’Donnell, Francis J</creatorcontrib><creatorcontrib>Cordingley, Gary E</creatorcontrib><creatorcontrib>Drew, Jana B</creatorcontrib><creatorcontrib>Carlson, Bruce W</creatorcontrib><creatorcontrib>Himawan, Lina</creatorcontrib><title>Effect of preventive (β blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial</title><title>BMJ</title><addtitle>BMJ</addtitle><description>Objective To determine if the addition of preventive drug treatment (β blocker), brief behavioural migraine management, or their combination improves the outcome of optimised acute treatment in the management of frequent migraine.Design Randomised placebo controlled trial over 16 months from July 2001 to November 2005.Setting Two outpatient sites in Ohio, USA.Participants 232 adults (mean age 38 years; 79% female) with diagnosis of migraine with or without aura according to International Headache Society classification of headache disorders criteria, who recorded at least three migraines with disability per 30 days (mean 5.5 migraines/30 days), during an optimised run-in of acute treatment.Interventions Addition of one of four preventive treatments to optimised acute treatment: β blocker (n=53), matched placebo (n=55), behavioural migraine management plus placebo (n=55), or behavioural migraine management plus β blocker (n=69).Main outcome measure The primary outcome was change in migraines/30 days; secondary outcomes included change in migraine days/30 days and change in migraine specific quality of life scores.Results Mixed model analysis showed statistically significant (P≤0.05) differences in outcomes among the four added treatments for both the primary outcome (migraines/30 days) and the two secondary outcomes (change in migraine days/30 days and change in migraine specific quality of life scores). The addition of combined β blocker and behavioural migraine management (−3.3 migraines/30 days, 95% confidence interval −3.2 to −3.5), but not the addition of β blocker alone (−2.1 migraines/30 days, −1.9 to −2.2) or behavioural migraine management alone (−2.2 migraines migraines/30 days, −2.0 to −2.4), improved outcomes compared with optimised acute treatment alone (−2.1 migraines/30 days, −1.9 to −2.2). For a clinically significant (≥50% reduction) in migraines/30 days, the number needed to treat for optimised acute treatment plus combined β blocker and behavioural migraine management was 3.1 compared with optimised acute treatment alone, 2.6 compared with optimised acute treatment plus β blocker, and 3.1 compared with optimised acute treatment plus behavioural migraine management. Results were consistent for the two secondary outcomes, and at both month 10 (the primary endpoint) and month 16.Conclusion The addition of combined β blocker plus behavioural migraine management, but not the addition of β blocker alone or behavioural migraine management alone, improved outcomes of optimised acute treatment. Combined β blocker treatment and behavioural migraine management may improve outcomes in the treatment of frequent migraine.Trial registration Clinical trials NCT00910689.</description><subject>Adolescent</subject><subject>Adrenergic beta-Antagonists - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Antidepressants</subject><subject>Attention deficit disorder</subject><subject>Behavior Therapy - methods</subject><subject>Behaviour therapy</subject><subject>Beta blockers</subject><subject>Classification</subject><subject>Cleveland Clinic CME</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Clinical trials (epidemiology)</subject><subject>Combined Modality Therapy - methods</subject><subject>Drug abuse</subject><subject>Evidence-based medicine</subject><subject>Experimentation</subject><subject>Female</subject><subject>Headache</subject><subject>Headache (including migraine)</subject><subject>Headaches</subject><subject>Humans</subject><subject>Male</subject><subject>Medication Adherence</subject><subject>Middle Aged</subject><subject>Migraine</subject><subject>Migraine Disorders - prevention &amp; control</subject><subject>Pain (neurology)</subject><subject>Pharmaceutical preparations</subject><subject>Placebos</subject><subject>Primary care</subject><subject>Quality of Life</subject><subject>Secondary Prevention</subject><subject>Sociology</subject><subject>Statistical analysis</subject><subject>Substance abuse treatment</subject><subject>Treatment</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0959-8138</issn><issn>0959-535X</issn><issn>1468-5833</issn><issn>1756-1833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><sourceid>7QJ</sourceid><recordid>eNqFkt2K1DAYhoso7rDugRegBBR0wa5J2zSJB4KM6w8uK8K6pyHNfJnJbJuMaTrobXnuLXhNptvdWRVEWuhH3ydvvr8su0_wESFl_bzp1ke64ozcymakqnlOeVnezmZYUJFzUvK97KDv1xjjomRc1PRutldgzjEXfJb9ODYGdETeoE2ALbhot4Ce_vyOmtbrCwiHKAZQsUvKM9TASm2tH4JqUWeXQVkHqFNOLWECfEBxBTYg7bvGOhWtd2h8h5j-QD_e4zfRdraHBVJ6iHDjj6xDJsCXYYyv7V-goNzCTwe0dzH4tk1hDFa197I7RrU9HFx997PPb47P5u_yk49v389fneQNpXXMlTI15hVAapjhjV40NSdGGbLgBkhDaGV4qfDCaMF1TVjBBDaUkoqphhe8KPezl5PvZmg6WOiUYGqB3ATbqfBNemXln4qzK7n0W1mIitUFSQZPrgyCT_X1UaaCNLStcuCHXvKiqASjaXT_IxmtC8HLeiQf_UWu02Rc6oMkYpy-YJfU4UTp4Ps-gNllTbAcF0imBZKXC5TYh7-XuSOv1yUBDyZg3UcfbnTKSp6epOeTbvsIX3e6CheyZiWj8vR8Lj_gT-evxWklzxL_eOLHHP6d1y8EQuwS</recordid><startdate>20100929</startdate><enddate>20100929</enddate><creator>Holroyd, Kenneth A</creator><creator>Cottrell, Constance K</creator><creator>O’Donnell, Francis J</creator><creator>Cordingley, Gary E</creator><creator>Drew, Jana B</creator><creator>Carlson, Bruce W</creator><creator>Himawan, Lina</creator><general>British Medical Journal Publishing Group</general><general>BMJ Publishing Group</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group Ltd</general><scope>9YT</scope><scope>ACMMV</scope><scope>BSCLL</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>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>7QJ</scope><scope>5PM</scope></search><sort><creationdate>20100929</creationdate><title>Effect of preventive (β blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial</title><author>Holroyd, Kenneth A ; 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control</topic><topic>Pain (neurology)</topic><topic>Pharmaceutical preparations</topic><topic>Placebos</topic><topic>Primary care</topic><topic>Quality of Life</topic><topic>Secondary Prevention</topic><topic>Sociology</topic><topic>Statistical analysis</topic><topic>Substance abuse treatment</topic><topic>Treatment</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Holroyd, Kenneth A</creatorcontrib><creatorcontrib>Cottrell, Constance K</creatorcontrib><creatorcontrib>O’Donnell, Francis J</creatorcontrib><creatorcontrib>Cordingley, Gary E</creatorcontrib><creatorcontrib>Drew, Jana B</creatorcontrib><creatorcontrib>Carlson, Bruce W</creatorcontrib><creatorcontrib>Himawan, Lina</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Istex</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>Nursing &amp; 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79% female) with diagnosis of migraine with or without aura according to International Headache Society classification of headache disorders criteria, who recorded at least three migraines with disability per 30 days (mean 5.5 migraines/30 days), during an optimised run-in of acute treatment.Interventions Addition of one of four preventive treatments to optimised acute treatment: β blocker (n=53), matched placebo (n=55), behavioural migraine management plus placebo (n=55), or behavioural migraine management plus β blocker (n=69).Main outcome measure The primary outcome was change in migraines/30 days; secondary outcomes included change in migraine days/30 days and change in migraine specific quality of life scores.Results Mixed model analysis showed statistically significant (P≤0.05) differences in outcomes among the four added treatments for both the primary outcome (migraines/30 days) and the two secondary outcomes (change in migraine days/30 days and change in migraine specific quality of life scores). The addition of combined β blocker and behavioural migraine management (−3.3 migraines/30 days, 95% confidence interval −3.2 to −3.5), but not the addition of β blocker alone (−2.1 migraines/30 days, −1.9 to −2.2) or behavioural migraine management alone (−2.2 migraines migraines/30 days, −2.0 to −2.4), improved outcomes compared with optimised acute treatment alone (−2.1 migraines/30 days, −1.9 to −2.2). For a clinically significant (≥50% reduction) in migraines/30 days, the number needed to treat for optimised acute treatment plus combined β blocker and behavioural migraine management was 3.1 compared with optimised acute treatment alone, 2.6 compared with optimised acute treatment plus β blocker, and 3.1 compared with optimised acute treatment plus behavioural migraine management. Results were consistent for the two secondary outcomes, and at both month 10 (the primary endpoint) and month 16.Conclusion The addition of combined β blocker plus behavioural migraine management, but not the addition of β blocker alone or behavioural migraine management alone, improved outcomes of optimised acute treatment. Combined β blocker treatment and behavioural migraine management may improve outcomes in the treatment of frequent migraine.Trial registration Clinical trials NCT00910689.</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>20880898</pmid><doi>10.1136/bmj.c4871</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record>
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subjects Adolescent
Adrenergic beta-Antagonists - therapeutic use
Adult
Aged
Antidepressants
Attention deficit disorder
Behavior Therapy - methods
Behaviour therapy
Beta blockers
Classification
Cleveland Clinic CME
Clinical medicine
Clinical trials
Clinical trials (epidemiology)
Combined Modality Therapy - methods
Drug abuse
Evidence-based medicine
Experimentation
Female
Headache
Headache (including migraine)
Headaches
Humans
Male
Medication Adherence
Middle Aged
Migraine
Migraine Disorders - prevention & control
Pain (neurology)
Pharmaceutical preparations
Placebos
Primary care
Quality of Life
Secondary Prevention
Sociology
Statistical analysis
Substance abuse treatment
Treatment
Treatment Outcome
Young Adult
title Effect of preventive (β blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial
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