Effects of onabotulinumtoxinA treatment on efficacy, depression, anxiety, and disability in Turkish patients with chronic migraine

Demiryürek, Bekir Enes; Ertem, Devrimsel Harika; Tekin, Atilla; Ceylan, Mustafa; Aras, Yeşim Güzey; Güngen, Belma Doğan

doi:10.1007/s10072-016-2665-z

Cited by 27 publications

(20 citation statements)

References 27 publications

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“…In terms of monthly headache frequency, headache severity, number of analgesics used and MIDAS scores our findings support the association of OnabotA therapy with rapid improvement in migraine parameters usually after the first session as reported in past studies [26, 27, 30, 51–53]. …”

Section: Discussionsupporting

confidence: 90%

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

et al. 2017

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BackgroundOnabotulinumtoxinA (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.MethodsA 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.ResultsFrom 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.ConclusionsOur 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s10194-017-0723-4) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 90%

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

et al. 2017

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“…The rationale for the exclusion of botox, nerve blocks, and IV infusion was to ensure there would be enough attacks during the run‐in phase of the study. Due to the temporal pattern of botox treatment, in which the positive effect of the treatment shows a tendency to wane between the first and third months after the treatment, we specifically excluded those who used botox 1 month prior to enrollment.…”

Section: Methodsmentioning

confidence: 99%

Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double‐Blind, Placebo‐Controlled, Multicenter Trial

et al. 2019

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Objective To assess the efficacy and safety of a remote electrical neuromodulation (REN) device for the acute treatment of migraine. Background There is a significant unmet need for novel effective well‐tolerated acute migraine treatments. REN is a novel acute migraine treatment that stimulates upper arm peripheral nerves to induce conditioned pain modulation – an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions. A recent pilot study showed that REN can significantly reduce headache. We have conducted a randomized, double‐blind, sham‐controlled study to further evaluate the efficacy and safety of REN for the acute treatment of migraine. Methods This was a randomized, double‐blind, sham‐controlled, multicenter study conducted at 7 sites in the United States and 5 sites in Israel. Two hundred and fifty‐two adults meeting the International Classification of Headache Disorders criteria for migraine with 2‐8 migraine headaches per month were randomized in a 1:1 ratio to active or sham stimulation. A smartphone‐controlled wireless device was applied for 30‐45 minutes on the upper arm within 1 hour of attack onset; electrical stimulation was at a perceptible but non‐painful intensity level. Migraine pain levels were recorded at baseline, 2, and 48 hours post‐treatment. Most bothersome symptoms (MBS) were also recorded. The primary efficacy endpoint was the proportion of participants achieving pain relief at 2 hours post‐treatment (improvement from severe or moderate pain to mild or none, or from mild pain to none). Relief of MBS and pain‐free at 2 hours were key secondary endpoints. Results Active stimulation was more effective than sham stimulation in achieving pain relief (66.7% [66/99] vs 38.8% [40/103]; therapeutic gain of 27.9% [CI95%, 15.6‐40.2]; P < .0001), pain‐free (37.4% vs 18.4%, P = .003), and MBS relief (46.3% vs 22.2%, P = .0008) at 2 hours post‐treatment. The pain relief and pain‐free superiority of the active treatment was sustained 48 hours post‐treatment. The incidence of device‐related adverse events was low and similar between treatment groups (4.8% [6/126] vs 2.4% [3/126], P = .499). Conclusions REN provides superior clinically meaningful relief of migraine pain and MBS compared to placebo, offering a safe and effective non‐pharmacological alternative for acute migraine treatment.

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“…So the improvement in anxiety and depression symptoms may either be an effect of drugs specifically targeting these symptoms, or be an effect of improvement in headache outcome, and a different study design would be needed to approach such a relation. Anyway, addressing symptoms of anxiety and depression may be one of the keys to success, as shown in studies who specifically address it in the treatment of CM with onabotulinumtoxin‐A 50,51 . In particular, the study of Blumenfeld and colleagues 51 showed that a considerable part of subjects who showed relevant depression and anxiety at baseline significantly improved over the 108 weeks of the study (respectively, 78% of those with relevant depression and 82% of those with relevant anxiety).…”

Section: Discussionmentioning

confidence: 99%

“…Anyway, addressing symptoms of anxiety and depression may be one of the keys to success, as shown in studies who specifically address it in the treatment of CM with onabotulinumtoxin‐A. 50 , 51 In particular, the study of Blumenfeld and colleagues 51 showed that a considerable part of subjects who showed relevant depression and anxiety at baseline significantly improved over the 108 weeks of the study (respectively, 78% of those with relevant depression and 82% of those with relevant anxiety). However, the vast majority of these patients improved by 12 weeks (respectively, 62% of those with relevant depression and 69% of those with relevant anxiety).…”

Section: Discussionmentioning

confidence: 99%

Withdrawal failure in patients with chronic migraine and medication overuse headache

et al. 2021

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Objectives The management of chronic migraine (CM) with Medication Overuse Headache (MOH) consists of withdrawal therapy, education on medications’ use and prescription of prophylaxis. Little attention has been given to patients who fail in achieving a successful short‐term outcome after withdrawal: we aim to describe predictors of failure. Methods Patients with CM and MOH were enrolled at the Neurological Institute C. Besta of Milano, and included if they completed the three months follow‐up. Withdrawal failure was defined as the situation in which patients either did not revert from chronic to episodic migraine (EM), were still overusing acute medications, or both did not revert to EM and kept overusing acute medications. Predictors of failure were addressed with a logistic regression, and for all variables, the longitudinal course in the two groups was described. Results In 39, out of 137 patients, withdrawal was unsuccessful: the predictors included day‐hospital‐based withdrawal (OR: 2.37; 95% CI: 1.06–5.29), emergency room (ER) access before withdrawal (OR: 2.81; 95% CI: 1.13–6.94) and baseline headache frequency >69 days/three months (OR: 2.97; 95% CI: 1.32–6.65). Patients who failed withdrawal did not improve on medications intake, use of prophylactic and non‐pharmacological treatments, symptoms of anxiety and depression. Conclusions Patients who were treated in day‐hospital, those who recently attended ER for headache, and those with more than 69 headache/3 months, as well as to those with relevant symptoms of anxiety and depression who did not improve should be closely monitored to reduce likelihood of non‐improvement after structured withdrawal.

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Effects of onabotulinumtoxinA treatment on efficacy, depression, anxiety, and disability in Turkish patients with chronic migraine

Cited by 27 publications

References 27 publications

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

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

Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double‐Blind, Placebo‐Controlled, Multicenter Trial

Withdrawal failure in patients with chronic migraine and medication overuse headache

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