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The Journal of Headache and Pain
Published in: The Journal of Headache and Pain 1/2017

Open Access 01-12-2017 | Research article

OnabotulinumtoxinA effectiveness on chronic migraine, negative emotional states and sleep quality: a single-center prospective cohort study

Authors: Elif Ilgaz Aydinlar, Pinar Yalinay Dikmen, Seda Kosak, Ayse Sagduyu Kocaman

Published in: The Journal of Headache and Pain | Issue 1/2017

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Abstract

Background

OnabotulinumtoxinA (OnabotA) is considered effective in in patients with chronic migraine (CM) who failed on traditional therapies. This study was designed to evaluate the effect of OnabotA injection series on migraine outcome, negative emotional states and sleep quality in patients with CM.

Methods

A total of 190 patients with CM (mean (SD) age: 39.3 (10.2) years; 87.9% were female) were included. Data on Pittsburgh sleep quality index (PSQI), headache frequency and severity, number of analgesics used, Migraine Disability Assessment Scale.
(MIDAS) scores and Depression, Anxiety and Stress Scale (DASS-21) were evaluated at baseline (visit 1) and 4 consecutive follow up visits, each conducted after OnabotA injection series; at week 12 (visit 2), week 24 (visit 3), week 36 (visit 4) and week 48 (visit 5) to evaluate change from baseline to follow up.

Results

From baseline to visit 5, significant decrease was noted in least square (LS) mean headache frequency (from 19.5 to 8.4, p = 0.002), headache severity (from 8.1 to 6.1, p = 0.017), number of analgesics (from 26.9 to 10.4, p = 0.023) and MIDAS scores (from 67.3 to 18.5, p < 0.001). No significant change from baseline was noted in global PSOI and DASS-21 scores throughout the study.

Conclusions

Our findings revealed that OnabotA therapy was associated with significant improvement in migraine outcome leading to decrease in headache frequency and severity, number of analgesics used and MIDAS scores. While no significant change was noted in overall sleep quality and prevalence of negative emotional states, patients without negative emotional states at baseline showed improved sleep quality throughout the study.
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Literature
1.
2.
Natoli JL, Manack A, Dean B, Butler Q, Turkel CC, Stovner L, Lipton RB (2010) Global prevalence of chronic migraine: a systematic review. Cephalalgia 30:599–609CrossRefPubMed
3.
Bigal ME, Rapoport AM, Lipton RB, Tepper SJ, Sheftell FD (2003) Assessment of migraine disability using the Migraine Disability Assessment (MIDAS) questionnaire. A comparison of chronic migraine with episodic migraine. Headache 43:336–342CrossRefPubMed
4.
Blumenfeld AM, Varon SF, Wilcox TK, Buse DC, Kawata AK, Manack A, Goadsby PJ, Lipton RB (2011) Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the international burden of migraine study (IBMS). Cephalalgia 31:301–315CrossRefPubMed
5.
Buse DC, Manack A, Serrano D, Turkel C, Lipton RB (2010) Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry 81:428–432CrossRefPubMed
6.
Stewart WF, Wood GC, Manack A, Varon SF, Buse DC, Lipton RB (2010) Employment and work impact of chronic migraine and episodic migraine. J Occup Environ Med 52:8–14CrossRefPubMed
7.
Meletiche DM, Lofland JH, Young WB (2001) Quality of life differences between patients with episodic and transformed migraine. Headache 41:573–578CrossRefPubMed
8.
Bigal ME, Serrano D, Reed M, Lipton RB (2008) Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment. Neurology 71:559–566CrossRefPubMed
9.
Katsarava Z, Buse DC, Manack AN, Lipton RB (2012) Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep 16:86–92CrossRefPubMed
10.
Bigal ME, Rapoport AM, Sheftell FD, Tepper SJ, Lipton RB (2004) Transformed migraine and medication overuse in a tertiary headache centre–clinical characteristics and treatment outcomes. Cephalalgia 24:483–490CrossRefPubMed
11.
Jette N, Patten S, Williams J, Becker W, Wiebe S (2008) Comorbidity of migraine and psychiatric disorders: a national population-based study. Headache 48:501–516CrossRefPubMed
12.
Lanteri-Minet M, Radat F, Chautard M-H, Lucas C (2005) Anxiety and depression associated with migraine: influence on migraine subjects’ disability and quality of life, and acute migraine management. Pain 118:319–326CrossRefPubMed
13.
Buse DC, Silberstein SD, Manack AN, Papapetropoulos S, Lipton RB (2013) Psychiatric comorbidities of episodic and chronic migraine. J Neurol 260:1960–1969CrossRefPubMed
14.
Zwart JA, Dyb G, Hagen K, Ødegård KJ, Dahl AA, Bovim G, Stovner LJ (2003) Depression and anxiety disorders associated with headache frequency. The Nord-Trøndelag Health Study. Eur J Neurol 10:147–152CrossRefPubMed
15.
Juang KD, Wang SJ, Fuh JL, Lu SR, Su TP (2000) Comorbidity of depressive and anxiety disorders in chronic daily headache and its subtypes. Headache 40:818–823CrossRefPubMed
16.
Peterlin BL, Tietjen G, Meng S, Lidicker J, Bigal M (2008) Post-traumatic stress disorder in episodic and chronic migraine. Headache 48:517–522CrossRefPubMed
17.
Seidel S, Hartl T, Weber M, Matterey S, Paul A, Riederer F, Gharabaghi M, Wöber-Bingöl C, Wöber C, PAMINA Study Group (2009) Quality of sleep, fatigue and daytime sleepiness in migraine—a controlled study. Cephalalgia 29:662–669CrossRefPubMed
18.
Sadeghniiat K, Rajabzadeh A, Ghajarzadeh M, Ghafarpour M (2013) Sleep quality and depression among patients with migraine. Acta Med Iran 51:784–788PubMed
19.
Morgan I, Eguia F, Gelaye B, Peterlin BL, Tadesse MG, Lemma S, Berhane Y, Williams MA (2015) Sleep disturbances and quality of life in Sub-Saharan African migraineurs. J Headache Pain 16:18CrossRefPubMedPubMedCentral
20.
Zhu Z, Fan X, Li X, Tan G, Chen L, Zhou J (2013) Prevalence and predictive factors for poor sleep quality among migraineurs in a tertiary hospital headache clinic. Acta Neurol Belg 113:229–235CrossRefPubMed
21.
Lin YK, Lin GY, Lee JT, Lee MS, Tsai CK, Hsu YW, Lin YZ, Tsai YC, Yang FC (2016) Associations between sleep quality and migraine frequency: a cross-sectional case-control study. Medicine (Baltimore) 95:e3554CrossRef
22.
23.
Dodick DW (2005) Triptan nonresponder studies: implications for clinical practice. Headache 45:156–162CrossRefPubMed
24.
Lionetto L, Negro A, Palmisani S, Gentile G, Del Fiore MR, Mercieri M, Simmaco M, Smith T, Al-Kaisy A, Arcioni R, Martelletti P (2012) Emerging treatment for chronic migraine and refractory chronic migraine. Expert Opin Emerg Drugs 17:393–406CrossRefPubMed
25.
Negro A, Curto M, Lionetto L, Martelletti P (2015) A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience. J Headache Pain 17:1CrossRefPubMed
26.
Rothrock JF (2012) Botox-A for suppression of chronic migraine: commonly asked questions. Headache 52:716–717CrossRefPubMed
27.
Sanassi LA (2016) Botulinum toxin: a lift for chronic migraines. JAAPA 29:1–4, ReviewPubMed
28.
Aurora SK, Dodick DW, Turkel CC, DeGryse RE, Silberstein SD, Lipton RB, Diener HC, Brin MF, PREEMPT 1 Chronic Migraine Study Group (2010) OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia 30:793–803CrossRefPubMed
29.
Diener HC, Dodick DW, Aurora SK, Turkel CC, DeGryse RE, Lipton RB, Silberstein SD, Brin MF, PREEMPT 2 Chronic Migraine Study Group (2010) OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia 30:804–814CrossRefPubMed
30.
Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF (2010) OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized placebo-controlled phases of the PREEMPT clinical program. Headache 50:921–936CrossRefPubMed
31.
Aurora SK, Dodick DW, Diener HC, DeGryse RE, Turkel CC, Lipton RB, Silberstein SD (2014) OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program. Acta Neurol Scand 129:61–70CrossRefPubMed
32.
Allergan Inc (2013) BOTOX (onabotulinumtoxinA) full prescribing information. Allergan Inc, Irvine
33.
Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ (2010) Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache 50:1406–1418CrossRefPubMed
34.
Sawyer J (2001) Development and testing of the migraine disability assessment (MIDAS) questionnaire to assess headache-related disability. Neurology 15:20–28
35.
Ertas M, Siva A, Dalkara T, Uzuner N, Dora B, Inan L, Idiman F, Sarica Y, Selcuki D, Sirin H, Oguzhanoglu A, Irkec C, Ozmenoglu M, Ozbenli T, Ozturk M, Saip S, Neyal M, Zarifoglu M, Turkish MIDAS group (2004) Validity and reliability of the Turkish migraine disability assessment (MIDAS) questionnaire. Headache 15:786–793CrossRef
36.
Lovibond SH, Lovibond PF (1995) Manual for the depression anxiety stress scales, 2nd edn. Psychology Foundation, Sydney
37.
Brown TA, Chorpita BF, Korotitsch W, Barlow DH (1997) Psychometric properties of the depression anxiety stress scales (DASS) in clinical samples. Behav Res Ther 35:79–89CrossRefPubMed
38.
Antony MM, Bieling PJ, Brian J, Cox BJ, Enns MW, Swinson RP (1998) Psychometric properties of the 42-item and 21-item versions of the depression anxiety stress scales in clinical groups and a community sample. Psychol Assess 10:176–181CrossRef
39.
Hekimoglu L, Altun ZO, Kaya EZ, Bayram N, Bilgel N (2012) Psychometric properties of the Turkish version of the 42 item depression anxiety stress scale (DASS-42) in a clinical sample. Int J Psychiatry Med 44:183–198CrossRefPubMed
40.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ (1998) The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res 28:193–213CrossRef
41.
Agargun MY, Kara H, Anlar O (1996) Pittsburgh Uyku kalitesi indeksi’nin gecerliliği ve güvenilirligi. Turk Psikiyatri Derg 7:107–115 [Turkish]
42.
Kollewe K, Escher CM, Wulff DU, Fathi D, Paracka L, Mohammadi B, Karst M, Dressler D (2016) Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting. J Neural Transm (Vienna) 123:533–540CrossRef
43.
Cernuda-Morollón E, Ramón C, Larrosa D, Alvarez R, Riesco N, Pascual J (2015) Long-term experience with onabotulinumtoxinA in the treatment of chronic migraine: what happens after one year? Cephalalgia 35:864–868CrossRefPubMed
44.
Jackson JL, Kuriyama A, Hayashino Y (2012) Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: a meta-analysis. JAMA 307:1736–1745CrossRefPubMed
45.
Harwood RH, Sayer AA, Hirschfeld M (2004) Current and future worldwide prevalence of dependency, its relationship to total population, and dependency ratios. Bull World Health Organ 82:251–258PubMedPubMedCentral
46.
Menken M, Munsat TL, Toole JF (2000) The global burden of disease study: implications for neurology. Arch Neurol 57:418–420CrossRefPubMed
47.
Deiner HC, Limmroth V (2004) Medication overuse headache: a worldwide problem. Lancet Neurol 3:475–483CrossRef
48.
Silberstein SD, Blumenfield AM, Cady RK, Turner IM, Lipton RB, Deiner HC, Aurora SK, Sirimanne M, DeGryse RE, Turkel CC, Dodick DW (2013) OnabotulinumtoxinA for treatment of chronic migraine: PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline. J Neurol Sci 331:48–56CrossRefPubMed
49.
Saper JR, Dodick D, Gladstone JP (2005) Management of chronic daily headache: challenges in clinical practice. Headache 45(Suppl 1):S74–S85, ReviewCrossRefPubMed
50.
Finkel AG (2015) Botulinum toxin and the treatment of headache: a clinical review. Toxicon 107:114–119CrossRefPubMed
51.
Negro A, Curto M, Lionetto L, Crialesi D, Martelletti P (2015) OnabotulinumtoxinA 155 U in medication overuse headache: a two years prospective study. Springerplus 4:826CrossRefPubMedPubMedCentral
52.
Guerzoni S, Pellesi L, Baraldi C, Pini LA (2015) Increased efficacy of regularly repeated cycles with onabotulinumtoxinA in MOH patients beyond the first year of treatment. J Headache Pain 17:48CrossRefPubMed
53.
Demiryurek BE, Ertem DH, Tekin A, Ceylan M, Aras YG, Gungen BD (2016) Effects of onabotulinumtoxinA treatment on efficacy, depression, anxiety, and disability in Turkish patients with chronic migraine. Neurol Sci 37:1779–1784CrossRefPubMed
54.
Silberstein SD, Dodick WD, Aurora SK, Dienere H-C, DeGryse RE, Lipton RB, Turkel CC (2015) Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry 86:996–1001CrossRefPubMed
55.
Khalil M, Zafar HW, Quarshie V, Ahmed F (2014) Prospective analysis of the use of onabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, UK. J Headache Pain 15:54CrossRefPubMedPubMedCentral
56.
Lipton RB, Varon SF, Grosberg B, McAllister PJ, Freitag F, Aurora SK, Dodick DW, Silberstein SD, Diener HC, DeGryse RE, Nolan ME, Turkel CC (2011) OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine. Neurology 77:1465–1472CrossRefPubMed
57.
Baney J (2011) How effective is long-term use of botox for chronic migraine? Neurol Rev 19:18A
58.
Blumenfeld AM, Inocelda A, Purdy C, Dalfonso L, Magar R (2015) The durability of onabotulinumtoxinA for the treatment of chronic migraine: CLARITY Pilot Study. Toxicon 93(Suppl):S11CrossRef
59.
Bigal M (2009) Migraine chronification-concept and risk factors. Discov Med 8:145–150PubMed
60.
Ashina S, Buse DC, Maizels M, Manack A, Serrrano D, Turkel CC, Lipton RB (2010) Self-reported anxiety as a risk factor for migraine chronification: results from the American Migraine Prevalence and Prevention (AMPP) study. Headache 50(Suppl 1):4
61.
Fishbain DA, Cutler R, Rosomoff HL, Rosomoff RS (1997) Chronic pain-associated depression: antecendent or consequence of chronic pain? A review. Clin J Pain 13:116–137CrossRefPubMed
62.
Boudreau GP, Grosberg BM, McAllister PJ, Lipton RB, Buse DC (2015) Prophylactic onabotulinumtoxinA in patients with chronic migraine and comorbid depression: an open-label, multicenter, pilot study of efficacy, safety and effect on headache-related disability, depression, and anxiety. Int J Gen Med 8:79–86CrossRefPubMedPubMedCentral
63.
Parsaik AK, Mascarenhas SS, Hashmi A, Prokop LJ, John V, Okusaga O, Singh B (2016) Role of botulinum toxin in depression. J Psychiatr Pract 22:99–110CrossRefPubMed
64.
Silberstein SD, Dodick D, Freitag F, Pearlman SH, Hahn SR, Scher AI, Lipton RB (2007) Pharmacological approaches to managing migraine and associated comorbidities—clinical considerations for monotherapy versus polytherapy. Headache 47:585–599CrossRefPubMed
65.
Blier P, Abbott FV (2001) Putative mechanisms of action of antidepressant drugs in affective and anxiety disorders and pain. J Psychiatry Neurosci 26:37–43PubMedPubMedCentral
66.
Ghajarzadeh M, Jalilian R, Togha M, Azimi A, Hosseini P, Babaei N (2014) Depression, poor sleep, and sexual dysfunction in migraineurs women. Int J Prev Med 5:1113–1118PubMedPubMedCentral
67.
Kelman L, Rains JC (2005) Headache and sleep: examination of sleep patterns and complaints in a large clinical sample of migraineurs. Headache 45:904–910CrossRefPubMed
68.
69.
Shim YJ, Lee MK, Kato T, Park HU, Heo K, Kim ST (2014) Effects of botulinum toxin on jaw motor events during sleep in sleep bruxism patients: a polysomnographic evaluation. J Clin Sleep Med 10:291–298PubMedPubMedCentral
70.
Gori S, Lucchesi C, Baldacci F, Bonuccelli U (2015) Preferential occurrence of attacks during night sleep and/or upon awakening negatively affects migraine clinical presentation. Funct Neurol 30:119–123PubMedPubMedCentral
71.
Gori S, Morelli N, Maestri M, Fabbrini M, Bonanni E, Murri L (2005) Sleep quality, chronotypes and preferential timing of attacks in migraine without aura. J Headache Pain 6:258–260CrossRefPubMedPubMedCentral
72.
Gori S, Lucchesi C, Maluccio MR, Morelli N, Maestri M, Bonanni E, Murri L (2012) Inter-critical and critical excessive daily sleepiness in episodic migraine patients. Neurol Sci 33:1133–1136CrossRefPubMed
73.
Walters AB, Hamer JD, Smitherman TA (2014) Sleep disturbance and affective comorbidity among episodic migraineurs. Headache 54:116–124CrossRefPubMed
Metadata
Title
OnabotulinumtoxinA effectiveness on chronic migraine, negative emotional states and sleep quality: a single-center prospective cohort study
Authors
Elif Ilgaz Aydinlar
Pinar Yalinay Dikmen
Seda Kosak
Ayse Sagduyu Kocaman
Publication date
01-12-2017
Publisher
Springer Milan
Published in
The Journal of Headache and Pain / Issue 1/2017
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI
https://doi.org/10.1186/s10194-017-0723-4

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