[Show abstract][Hide abstract] ABSTRACT: Chronic migraine is associated with significant headache-related disability and psychiatric comorbidity. OnabotulinumtoxinA (BOTOX(®)) is effective and well tolerated in the prophylactic treatment of chronic migraine. This study aimed to provide preliminary data on the efficacy and safety of prophylactic onabotulinumtoxinA in patients with chronic migraine and comorbid depressive symptoms.
This was a prospective, open-label, multicenter pilot study. Eligible patients met International Classification of Headache Disorders 2nd edition Revision criteria for chronic migraine and had associated depressive symptoms, including Patient Health Questionnaire depression module scores of 5-19. Eligible participants received 155 units of onabotulinumtoxinA, according to the PREEMPT protocol, at baseline and week 12. Assessments included headache frequency, the Headache Impact Test™, the Migraine Disability Assessment, the Beck Depression Inventory(®)-II, the nine-item Patient Health Questionnaire depression module, and the seven-item Generalized Anxiety Disorder questionnaire. Adverse events were also monitored.
Overall, 32 participants received treatment. At week 24, there were statistically significant mean (standard deviation [SD]) improvements relative to baseline in the number of headache/migraine-free days (+8.2 [5.8]) (P<0.0001) and in the number of headache/migraine days (-8.2 [5.8]) (P<0.0001) per 30-day period. In addition, there were significant improvements in Headache Impact Test scores (-6.3 [6.9]) (P=0.0001) and Migraine Disability Assessment scores (-44.2 [67.5]) (P=0.0058). From baseline to week 24, statistically significant improvements were also seen in Beck Depression Inventory-II (-7.9 [6.0]) (P<0.0001), Patient Health Questionnaire depression module (-4.3 [4.7]) (P<0.0001), and Generalized Anxiety Disorder questionnaire (-3.5 [5.0]) (P=0.0002) scores. No serious adverse events were reported. Adverse events considered related to treatment occurred in 30% of patients and were mild or moderate.
Prophylactic onabotulinumtoxinA was well tolerated in patients with chronic migraine and comorbid depression, and was effective in reducing headache frequency, impact, and related disability, which led to statistically significant improvements in depression and anxiety symptoms.
International Journal of General Medicine 02/2015; 9:79-86. DOI:10.2147/IJGM.S70456
[Show abstract][Hide abstract] ABSTRACT: To describe the use of peripheral nerve blocks in a case series of pregnant women with migraine.
A retrospective chart review of all pregnant patients treated with peripheral nerve blocks for migraine over a 5-year period was performed. Injections targeted greater occipital, auriculotemporal, supraorbital, and supratrochlear nerves using local anesthetics.
Peripheral nerve blocks were performed 27 times in 13 pregnant women either in a single (n=6) or multiple (n=7) injection series. Mean patient age was 28 years and gestational age was 23.5 weeks, and all women had migraine, including 38.5% who had chronic migraine. Peripheral nerve blocks were performed for status migrainosus (51.8%) or short-term prophylaxis of frequent headache attacks (48.1%). Before peripheral nerve blocks were performed, oral medications failed for all patients and intravenous medications failed for most. In patients with status migrainosus, average pain reduction was 4.0 (±2.6 standard deviation) (P<.001) immediately postprocedure and 4.0 (±4.4 standard deviation) (P=.007) 24 hours postprocedure in comparison to preprocedure pain. For patients receiving peripheral nerve blocks for short-term prophylaxis, immediate mean pain score reduction was 3.0 (±2.1 standard deviation). No patients had any serious immediate, procedurally related adverse events, and the two patients who had no acute pain reduction ultimately developed preeclampsia and had postpartum headache resolution.
Peripheral nerve blocks for treatment-refractory migraine may be an effective therapeutic option in pregnancy.
Obstetrics and Gynecology 12/2014; 124(6):1169-74. DOI:10.1097/AOG.0000000000000555 · 5.18 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective
In this review, we focus on migraine as a chronic disorder with episodic attacks (CDEA). We aim to review methodological approaches to studying trigger factors and premonitory features that often precede a migraine attack.Background
Migraine attacks are sometimes initiated by trigger factors, exposures which increase the probability of an attack. They are heralded by premonitory features, symptoms which warn of an impending attack.Design/Methods
We review candidate predictors of migraine attack and discuss the methodological issues and approaches to studying attack prediction and suggest that electronic diaries may be the method of choice.Conclusion
Establishing the relationship between antecedent events and headaches is a formidable challenge. Successfully addressing this challenge should provide insights into disease mechanisms and lead to new strategies for treatment. In the second paper in this series, we review the available literature on trigger factors and premonitory features.
Headache The Journal of Head and Face Pain 11/2014; 54(10). DOI:10.1111/head.12464 · 2.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Tension-type headache (TTH) is the most prevalent headache type in all age groups worldwide, including patients with advanced age. Because of its high prevalence and possible association with medical and psychiatric co-morbidities, TTH has a major socioeconomic impact. The lifetime prevalence of TTH ranges between 30 and 78 %, and the 1-year prevalence in individuals over the age of 55 years is 35.8 % (27.8 % in men, 42.4 % in women). Since the prevalence of secondary headache disorders increases in the elderly, the initial evaluation of this group of patients with a new-onset headache or a change in a pre-existing headache pattern should be directed towards their exclusion. This article reviews the diagnostic and treatment dilemmas encountered in elderly patients with tension-type headaches, highlighting both pharmacological and non-pharmacological interventions.
[Show abstract][Hide abstract] ABSTRACT: Objective/Background
To review the existing literature and describe a standardized methodology by expert consensus for the performance of trigger point injections (TPIs) in the treatment of headache disorders. Despite their widespread use, the efficacy, safety, and methodology of TPIs have not been reviewed specifically for headache disorders by expert consensus.Methods
The Peripheral Nerve Blocks and Other Interventional Procedures Special Interest Section of the American Headache Society over a series of meetings reached a consensus for nomenclature, indications, contraindications, precautions, procedural details, outcomes, and adverse effects for the use of TPIs for headache disorders. A subcommittee of the Section also reviewed the literature.ResultsIndications for TPIs may include many types of episodic and chronic primary and secondary headache disorders, with the presence of active trigger points (TPs) on physical examination. Contraindications may include infection, a local open skull defect, or an anesthetic allergy, and precautions are necessary in the setting of anticoagulant use, pregnancy, and obesity with unclear anatomical landmarks. The most common muscles selected for TPIs include the trapezius, sternocleidomastoid, and temporalis, with bupivacaine and lidocaine the agents used most frequently. Adverse effects are typically mild with careful patient and procedural selection, though pneumothorax and other serious adverse events have been infrequently reported.Conclusions
When performed in the appropriate setting and with the proper expertise, TPIs seem to have a role in the adjunctive treatment of the most common headache disorders. We hope our effort to characterize the methodology of TPIs by expert opinion in the context of published data motivates the performance of evidence-based and standardized treatment protocols.
Headache The Journal of Head and Face Pain 09/2014; 54(9). DOI:10.1111/head.12442 · 2.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Although peripheral nerve blocks are an established and safe treatment option, we describe their use for the first time in a case series of pregnant women.
A retrospective chart review of all pregnant patients treated with peripheral nerve blocks between July 2009 and April 2013 was performed including occipital nerve blocks with lidocaine.
Peripheral nerve blocks were performed 24 times in 11 pregnant women, either in isolation (n=5) or repetitively (n=6). Mean gestational age was 24.0 weeks (range 7-37 weeks), and 81.8% (n=9) had a previous migraine history. Peripheral nerve blocks were performed for status migrainosus (n=11 [45.8%]) or transitional or bridge therapy (n=13 [54.1%]) in both inpatient (n=10 [41.6%]) and ambulatory (n=14 [58.3%]) settings. Average preprocedure pain was 8.3 (range 5-10) and postprocedure pain was 4.7 (range 0-10) for status migrainosus patients, and for transitional treatment, average preprocedure pain was 3.5 (range 0-7) and postprocedure pain was 0.8 (range 0-5). All patients failed standard treatments. A total of 72.7% (n=8) did not have obstetric complaints after the procedure. The two patients who did not respond to peripheral nerve blocks were ultimately diagnosed with preeclampsia. Of the 11 patients, four (36.3%) delivered after 37 weeks of gestation, three (27.2%) delivered between 35 and 37 weeks of gestation for preterm premature rupture of membranes and poorly controlled diabetes, two (18.1%) delivered preterm at 29 weeks of gestation (n=1) for preeclampsia and (n=1) placental abruption, and two (18.1%) patients delivered in different hospitals and were lost to follow-up.
Peripheral nerve blocks for headache can be performed safely during pregnancy for patients who failed standard regimens, because most patients experienced rapid pain relief or attack frequency reduction.
[Show abstract][Hide abstract] ABSTRACT: To test whether level of perceived stress and reductions in levels of perceived stress (i.e., "let-down") are associated with the onset of migraine attacks in persons with migraine.
Patients with migraine from a tertiary headache center were invited to participate in a 3-month electronic diary study. Participants entered data daily regarding migraine attack experience, subjective stress ratings, and other data. Stress was assessed using 2 measures: the Perceived Stress Scale and the Self-Reported Stress Scale. Logit-normal, random-effects models were used to estimate the odds ratio for migraine occurrence as a function of level of stress over several time frames.
Of 22 enrolled participants, 17 (median age 43.8 years) completed >30 days of diaries, yielding 2,011 diary entries including 110 eligible migraine attacks (median 5 attacks per person). Level of stress was not generally associated with migraine occurrence. However, decline in stress from one evening diary to the next was associated with increased migraine onset over the subsequent 6, 12, and 18 hours, with odds ratios ranging from 1.5 to 1.9 (all p values < 0.05) for the Perceived Stress Scale. Decline in stress was associated with migraine onset after controlling for level of stress for all time points. Findings were similar using the Self-Reported Stress Scale.
Reduction in stress from one day to the next is associated with migraine onset the next day. Decline in stress may be a marker for an impending migraine attack and may create opportunities for preemptive pharmacologic or behavioral interventions.
[Show abstract][Hide abstract] ABSTRACT: Nummular headache (NH) is a rare headache disorder characterized by focal and well-circumscribed pain fixed within a rounded or oval/elliptical-shaped area of the head, typically 2 to 6 cm in diameter (Grosberg et al. Curr Pain Headache Rep 11:310-2, 2007). The disorder most commonly affects the parietal region and is almost always unilateral and side-locked. The pain is typically characterized as pressure-like, sharp, or stabbing and is usually mild to moderate in intensity. Many patients experience superimposed exacerbations of pain, lasting from seconds to days (Grosberg et al. Curr Pain Headache Rep 11:310-2, 2007). Distortions of sensation including hyperesthesia, hypoesthesia, allodynia, and paresthesias are frequently reported in the affected area. The temporal pattern may be episodic or chronic. Rarely, the disorder may be bifocal or multifocal, affecting various regions of the head simultaneously or in sequence. Treatment with gabapentin, tricyclic antidepressants, or botulinum toxin may be helpful. In this review of the more than 250 cases now reported in the literature, the epidemiology, clinical features, pathogenesis, differential diagnosis, and management of this disorder are discussed.
Current Pain and Headache Reports 06/2013; 17(6):340. DOI:10.1007/s11916-013-0340-0 · 2.26 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: In contrast to migraine and tension-type headache, the psychiatric comorbidities of cluster headache (CH) have not been well-studied.
We assessed the presence of depression and anxiety in groups of episodic CH (ECH) and chronic CH (CCH) patients and compared CH patients with and without depression and anxiety.
Sociodemographics, comorbidities, and selected headache features were ascertained from a clinic-based sample in a cross-sectional fashion from January 2007 to July 2010. Active depression and anxiety were assessed using the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7) scales.
Of 49 CH patients, ECH patients (n=32) had an earlier age of onset and consumed less caffeine than CCH patients (n=17). Rates of depression as defined by a PHQ-9 score ≥10 were low in both ECH (6.3%) and in CCH (11.8%) with similar mean PHQ-9 scores (3.1 vs 3.7, P=.69). Rates of anxiety as defined by a GAD-7 score ≥10 were also low in both ECH (15.6%) and CCH (11.8%) with similar mean GAD-7 scores (3.8 vs 3.4, P=.76). ECH patients in and out of active attack periods had similar levels of depression and anxiety. Depression and anxiety usually occurred together in ECH and CCH patients. CH patients who were depressed or anxious were more likely to present at a younger age and have attack-related nausea and prodromal symptoms. Depressed CH patients were also more likely to have another pain disorder and had undertaken twice as many prophylactic medication trials.
In this clinic-based cross-sectional study, ECH and CCH patients had similarly low rates of depression and anxiety. Rates were lower than those reported for both episodic and chronic migraine.
Headache The Journal of Head and Face Pain 11/2011; 52(4):600-11. DOI:10.1111/j.1526-4610.2011.02024.x · 2.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To assess the effects of treatment with onabotulinumtoxinA (Botox, Allergan, Inc., Irvine, CA) on health-related quality of life (HRQoL) and headache impact in adults with chronic migraine (CM).
The Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program (PREEMPT 1 and 2) included a 24-week, double-blind phase (2 12-week cycles) followed by a 32-week, open-label phase (3 cycles). Thirty-one injections of 5U each (155 U of onabotulinumtoxinA or placebo) were administered to fixed sites. An additional 40 U could be administered "following the pain." Prespecified analysis of headache impact (Headache Impact Test [HIT]-6) and HRQoL (Migraine-Specific Quality of Life Questionnaire v2.1 [MSQ]) assessments were performed. Because the studies were similar in design and did not notably differ in outcome, pooled results are presented here.
A total of 1,384 subjects were included in the pooled analyses (onabotulinumtoxinA, n = 688; placebo, n = 696). Baseline mean total HIT-6 and MSQ v2.1 scores were comparable between groups; 93.1% were severely impacted based on HIT-6 scores ≥60. At 24 weeks, in comparison with placebo, onabotulinumtoxinA treatment significantly reduced HIT-6 scores and the proportion of patients with HIT-6 scores in the severe range at all timepoints including week 24 (p < 0.001). OnabotulinumtoxinA treatment significantly improved all domains of the MSQ v2.1 at 24 weeks (p < 0.001).
Treatment of CM with onabotulinumtoxinA is associated with significant and clinically meaningful reductions in headache impact and improvements in HRQoL.
This study provides Class 1A evidence that onabotulinumtoxinA treatment reduces headache impact and improves HRQoL.
[Show abstract][Hide abstract] ABSTRACT: Olfactory hallucinations (phantosmias) have rarely been reported in migraine patients. Unlike visual, sensory, language, brainstem, and motor symptoms, they are not recognized as a form of aura by the International Classification of Headache Disorders.
We examined the clinical features of 39 patients (14 new cases and 25 from the literature) with olfactory hallucinations in conjunction with their primary headache disorders.
In a 30-month period, the prevalence of phantosmias among all patients seen at our headache center was 0.66%. Phantosmias occurred most commonly in women with migraine, although they were also seen in several patients with other primary headache diagnoses. The typical hallucination lasted 5-60 minutes, occurred shortly before or simultaneous with the onset of head pain, and was of a highly specific and unpleasant odor, most commonly a burning smell. In the majority of patients, phantosmias diminished or disappeared with initiation of prophylactic therapy for headaches.
We propose that olfactory hallucinations are probably an uncommon but distinctive form of migraine aura, based on their semiology, timing and response to headache prophylaxis.
[Show abstract][Hide abstract] ABSTRACT: Cluster headache is a rare primary headache disorder characterized by recurrent, stereotyped short-lasting attacks of severe, unilateral head pain accompanied by autonomic symptoms.
Ophthalmic features such as conjunctival injection, lacrimation, ptosis and miosis occur in the vast majority of patients with cluster headache, whereas co-existent ocular movement disorders are rare.
To the best of our knowledge, only two documented cases of cluster headache with external ocular movement disorders have been reported. We describe herein an additional case with this unusual finding and discuss the putative pathophysiology of cluster headache associated with ophthalmoparesis.
[Show abstract][Hide abstract] ABSTRACT: This study assessed the efficacy of diclofenac potassium for oral solution, a novel water-soluble buffered powder formulation, versus placebo for the acute treatment of migraine. Diclofenac potassium for oral solution has a time to maximum plasma concentration (Tmax) of 15 minutes, suggesting the potential for a rapid onset of therapeutic effects.
This was a randomized, double-blind, parallel-group, placebo-controlled study conducted in 23 US centers. Adult sufferers with an established migraine diagnosis according to the International Classification of Headache Disorders, second edition (ICHD-II), treated one moderate or severe attack with 50 mg diclofenac potassium for oral solution (dissolved in approximately 2 ounces of water; N=343) or matching placebo (N=347). Four co-primary endpoints included the percentage of subjects who at two hours post-treatment reported no headache pain, no nausea, no photophobia and/or no phonophobia.
Significantly more subjects treated with diclofenac potassium for oral solution (N=343) achieved a two-hour pain-free response (25% vs. 10%, p<.001), no nausea (65% vs. 53%; p=.002), no photophobia (41% vs. 27%; p<.001) and no phonophobia (44% vs. 27%; p<.001) compared to placebo. Pain intensity differences between treatments were significantly lower in the diclofenac potassium oral solution group, starting at 30 minutes post-treatment (p=.013) with significant differences at all time points thereafter (p<.001). Twenty-four-hour sustained pain-free response favored diclofenac potassium oral solution treatment versus placebo (19% vs. 7%, p<.0001). The most common adverse event considered to be treatment related was nausea (diclofenac potassium for oral solution [4.6%]; placebo [4.3%]).
This study shows that this formulation of diclofenac potassium for oral solution is effective in reducing pain intensity within 30 minutes, which may be related to the 15-minute T(max) associated with this formulation. The rapid-onset benefits were sustained through 24 hours post-treatment.