RESUMEN
BACKGROUND: While migraine is markedly prevalent in women, gender-related phenotype differences were rarely assessed. For this reason, we investigated, through a multicenter observational cross-sectional study, based on an online questionnaire, gender-related differences in stress factors, emotions, and pain perception in migraine patients and controls and their impact on migraine severity. METHODS: The study was designed as an online questionnaire. The link was emailed to healthy subjects (C) and migraine patients (MIG) (age 18-75, education ≥ 13 years) recruited during the first visit in 8 Italian Headache Centers adhering to Italian Society for Headache Study (SISC). The questionnaire included personal/social/work information, the Perceived Stress Scale, the Romance Quality Scale, the Emotion Regulation Questionnaire, the Beck Anxiety Inventory, the Body Perception Questionnaire, the pain perception, and a self-assessment of migraine severity in the last 3 months. RESULTS: 202 MIG and 202 C completed the survey. Independently from gender, migraine was characterized by higher pain sensitivity and more severe partner relationships. The female gender, in MIG, exhibited higher anxiety scores, body awareness, and reduced emotional suppression. Body awareness and emotional suppression were discriminating factors between genders in control and migraine groups without relevant influence on disease features. Perceived perception of migraine severity was similar between genders. CONCLUSION: Gender-related emotional and stress factors did not contribute to delineate a distinct phenotype in migraine men and women. The possible impact of emotional and stress factors characterizing genders could be considered for a single case-tailored therapeutic approach.
Asunto(s)
Trastornos Migrañosos , Pruebas Psicológicas , Autoinforme , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Estudios Transversales , Emociones , Cefalea , Trastornos Migrañosos/psicología , Percepción del Dolor , Encuestas y CuestionariosRESUMEN
BACKGROUND: The Cluster Headache Impact Questionnaire (CHIQ) is a specific and easy-to-use questionnaire to assess the current impact of cluster headache (CH). The aim of this study was to validate the Italian version of the CHIQ. METHODS: We included patients diagnosed with episodic CH (eCH) or chronic CH (cCH) according to the ICHD-3 criteria and included in the "Italian Headache Registry" (RICe). The questionnaire was administered to patients through an electronic form in two sessions: at first visit for validation, and after 7 days for test-retest reliability. For internal consistency, Cronbach's alpha was calculated. Convergent validity of the CHIQ with CH features and the results of questionnaires assessing anxiety, depression, stress, and quality of life was evaluated using Spearman's correlation coefficient. RESULTS: We included 181 patients subdivided in 96 patients with active eCH, 14 with cCH, and 71 with eCH in remission. The 110 patients with either active eCH or cCH were included in the validation cohort; only 24 patients with CH were characterized by a stable attack frequency after 7 days, and were included in the test-retest cohort. Internal consistency of the CHIQ was good with a Cronbach alpha value of 0.891. The CHIQ score showed a significant positive correlation with anxiety, depression, and stress scores, while showing a significant negative correlation with quality-of-life scale scores. CONCLUSION: Our data show the validity of the Italian version of the CHIQ, which represents a suitable tool for evaluating the social and psychological impact of CH in clinical practice and research.
Asunto(s)
Cefalalgia Histamínica , Humanos , Cefalalgia Histamínica/diagnóstico , Cefalalgia Histamínica/psicología , Calidad de Vida/psicología , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Italia , PsicometríaRESUMEN
BACKGROUND: Chronic migraine is a disabling condition that is currently underdiagnosed and undertreated. In this narrative review, we discuss the future of chronic migraine management in relation to recent progress in evidence-based pharmacological treatment. FINDINGS: Patients with chronic migraine require prophylactic therapy to reduce the frequency of migraine attacks, but the only currently available evidence-based prophylactic treatment options for chronic migraine are topiramate and onabotulinumtoxinA. Improved prophylactic therapy is needed to reduce the high burden of chronic migraine in Italy. Monoclonal antibodies that target the calcitonin gene-related peptide (CGRP) pathway of migraine pathogenesis have been specifically developed for the prophylactic treatment of chronic migraine. These anti-CGRP/R monoclonal antibodies have demonstrated good efficacy and excellent tolerability in phase II and III clinical trials, and offer new hope to patients who are currently not taking any prophylactic therapy or not benefitting from their current treatment. CONCLUSIONS: Treatment of chronic migraine is a dynamic and rapidly advancing area of research. New developments in this field have the potential to improve the diagnosis and provide more individualised treatments for this condition. Establishing a culture of prevention is essential for reducing the personal, social and economic burden of chronic migraine.
Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Trastornos Migrañosos/tratamiento farmacológico , Toxinas Botulínicas Tipo A/uso terapéutico , Enfermedad Crónica , Personas con Discapacidad , Humanos , Trastornos Migrañosos/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Topiramato/uso terapéuticoRESUMEN
BACKGROUND: Case-finding tools, such as the Identify Chronic Migraine (ID-CM) questionnaire, can improve detection of CM and alleviate its significant societal burden. We aimed to develop and validate the Italian version of the ID-CM (ID-EC) in paper and as a smart app version in a headache clinic-based setting. METHODS: The study investigators translated and adapted to the Italian language the original ID-CM questionnaire (ID-EC) and further implemented it as a smart app. The ID-EC was tested in its paper and electronic version in consecutive patients referring to 9 Italian tertiary headache centers for their first in-person visit. The scoring algorithm of the ID-EC paper version was applied by the study investigators (case-finding) and by patients (self-diagnosis), while the smart app provided to patients automatically the diagnosis. Diagnostic accuracy of the ID-EC was assessed by matching the questionnaire results with the interview-based diagnoses performed by the headache specialists during the visit according to the criteria of International Classification of Headache Disorders, III edition, beta version. RESULTS: We enrolled 531 patients in the test of the paper version of ID-EC and 427 in the validation study of the smart app. According to the clinical diagnosis 209 patients had CM in the paper version study and 202 had CM in the smart app study. 79.5% of patients returned valid paper questionnaires, while 100% of patients returned valid and complete smart app questionnaires. The paper questionnaire had a 81.5% sensitivity and a 81.1% specificity for case-finding and a 30.7% sensitivity and 90.7% specificity for self-diagnosis, while the smart app had a 64.9% sensitivity and 90.2% specificity. CONCLUSIONS: Our data suggest that the ID-EC, developed and validated in tertiary headache centers, is a valid case-finding tool for CM, with sensitivity and specificity values above 80% in paper form, while the ID-EC smart app is more useful to exclude CM diagnosis in case of a negative result. Further studies are warranted to assess the diagnostic accuracy of the ID-EC in general practice and population-based settings.
Asunto(s)
Trastornos Migrañosos/diagnóstico , Traducción , Adulto , Enfermedad Crónica , Femenino , Encuestas Epidemiológicas , Humanos , Italia , Masculino , Tamizaje Masivo , Persona de Mediana Edad , Trastornos Migrañosos/psicología , Desarrollo de Programa , Sensibilidad y Especificidad , Encuestas y Cuestionarios/normas , Adulto JovenRESUMEN
BACKGROUND: Real-world studies on fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for migraine prevention, are few and with limited follow-up. OBJECTIVE: We aimed to evaluate the long-term (up to 52 weeks) effectiveness and tolerability of fremanezumab in high-frequency episodic migraine and chronic migraine. METHODS: This s an independent, prospective, multicenter cohort study enrolling outpatients in 17 Italian Headache Centers with high-frequency episodic migraine or chronic migraine and multiple preventive treatment failures. Patients were treated with fremanezumab 225 mg monthly. The primary outcomes included changes from baseline (1 month before treatment) in monthly headache days, response rates (reduction in monthly headache days from baseline), and persistence in medication overuse at months 3, 6, and 12 (all outcome timeframes refer to the stated month). Secondary outcomes included changes from baseline in acute medication intake and disability questionnaires scores at the same timepoints. A last observation carried forward analysis was also performed. RESULTS: A total of 90 patients who received at least one dose of fremanezumab and with a potential 12-month follow-up were included. Among them, 15 (18.0%) patients discontinued treatment for the entire population, a reduction in monthly headache days compared with baseline was reported at month 3, with a significant median [interquartile range] reduction in monthly headache days (- 9.0 [11.5], p < 0.001). A statistically different reduction was also reported at month 6 compared with baseline (- 10.0 [12.0]; p < 0.001) and at 12 months of treatment (- 10.0 [14.0]; p < 0.001). The percentage of patients with medication overuse was significantly reduced compared with baseline from 68.7% (57/83) to 29.6% (24/81), 25.3% (19/75), and 14.7% (10/68) at 3, 6, and 12 months of treatment, respectively (p < 0.001). Acute medication use (days and total number) and disability scores were also significantly reduced (p < 0.001). A ≥ 50% response rate was achieved for 51.9, 67.9, and 76.5% of all patients at 3, 6, and 12 months, respectively. Last observation carried forward analyses confirmed these findings. Fremanezumab was well tolerated, with just one patient discontinuing treatment because of adverse events. CONCLUSIONS: This study provides evidence for the real-world effectiveness of fremanezumab in treating both high-frequency episodic migraine and chronic migraine, with meaningful and sustained improvements in multiple migraine-related variables. No new safety issue was identified.
Asunto(s)
Trastornos Migrañosos , Uso Excesivo de Medicamentos Recetados , Humanos , Estudios de Cohortes , Estudios Prospectivos , Resultado del Tratamiento , Método Doble Ciego , Trastornos Migrañosos/tratamiento farmacológico , Anticuerpos Monoclonales/efectos adversos , Cefalea/tratamiento farmacológicoRESUMEN
In this study, we compared the efficacy and tolerability of the combination of paracetamol 1,000 mg + caffeine 130 mg (PCF) with sumatriptan 50 mg (SUM) in migraine attacks. This was a multi-center randomized double-blind, double-dummy, cross-over controlled trial. The efficacy was assessed by the sum of pain intensity differences, the curve of mean pain intensity, the number of pain free at 2 h, and the total pain relief. Tolerability was assessed by recording adverse events within 4 h after drug assumption and evaluating the global judgement of patients. The comparison of these parameters did not show differences between the two drugs which resulted absolutely overlapping in pain relief and patients evaluation. In conclusion, we confirm the efficacy and safety of PCF such as SUM in the treatment of migraine attacks.
Asunto(s)
Acetaminofén/uso terapéutico , Analgésicos no Narcóticos/orina , Cafeína/uso terapéutico , Trastornos Migrañosos/tratamiento farmacológico , Sumatriptán/uso terapéutico , Vasoconstrictores/uso terapéutico , Adulto , Método Doble Ciego , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Masculino , Dimensión del Dolor , Resultado del TratamientoRESUMEN
The first edition of the Italian diagnostic and therapeutic guidelines for primary headaches in adults was published in J Headache Pain 2(Suppl. 1):105-190 (2001). Ten years later, the guideline committee of the Italian Society for the Study of Headaches (SISC) decided it was time to update therapeutic guidelines. A literature search was carried out on Medline database, and all articles on primary headache treatments in English, German, French and Italian published from February 2001 to December 2011 were taken into account. Only randomized controlled trials (RCT) and meta-analyses were analysed for each drug. If RCT were lacking, open studies and case series were also examined. According to the previous edition, four levels of recommendation were defined on the basis of levels of evidence, scientific strength of evidence and clinical effectiveness. Recommendations for symptomatic and prophylactic treatment of migraine and cluster headache were therefore revised with respect to previous 2001 guidelines and a section was dedicated to non-pharmacological treatment. This article reports a summary of the revised version published in extenso in an Italian version.
Asunto(s)
Cefaleas Primarias , Guías de Práctica Clínica como Asunto/normas , Bases de Datos Bibliográficas/estadística & datos numéricos , Cefaleas Primarias/diagnóstico , Cefaleas Primarias/tratamiento farmacológico , Cefaleas Primarias/prevención & control , Humanos , Italia , Metaanálisis como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Sociedades Médicas/normasRESUMEN
Headaches are among the most prevalent and disabling neurologic disorders and there are several unmet needs as current pharmacological options are inadequate in treating patients with chronic headache, and a growing interest focuses on nutritional approaches as non-pharmacological treatments. Among these, the largest body of evidence supports the use of the ketogenic diet (KD). Exactly 100 years ago, KD was first used to treat drug-resistant epilepsy, but subsequent applications of this diet also involved other neurological disorders. Evidence of KD effectiveness in migraine emerged in 1928, but in the last several year's different groups of researchers and clinicians began utilizing this therapeutic option to treat patients with drug-resistant migraine, cluster headache, and/or headache comorbid with metabolic syndrome. Here we describe the existing evidence supporting the potential benefits of KDs in the management of headaches, explore the potential mechanisms of action involved in the efficacy in-depth, and synthesize results of working meetings of an Italian panel of experts on this topic. The aim of the working group was to create a clinical recommendation on indications and optimal clinical practice to treat patients with headaches using KDs. The results we present here are designed to advance the knowledge and application of KDs in the treatment of headaches.
Asunto(s)
Dieta Cetogénica/métodos , Cefalea/dietoterapia , Guías de Práctica Clínica como Asunto , Dieta Cetogénica/normas , HumanosRESUMEN
Most of the studies about chronic insomnia focused only on specific features, providing in this way a partial outlook of the problem. The aim of this study was to examine a sample of chronic insomniacs from different points of view, by estimating the prevalence of stress, psychopathological symptoms, psychiatric disorders, changes in quality of life and illness behaviour. Forty-three patients (54.4%) experienced some psychosocial stressors in the last 6 months preceding the enrollment in the study. More than 55% of insomniacs reported symptoms of psychopathology. One or more than one psychiatric disorder was diagnosed in 61.5% of insomniacs. Life events could play a role in facilitating the transformation of a psychopathological symptom in a psychiatric disorder, since patients with a psychiatric diagnosis showed a higher percent of stress. The more noticeable disability in the group of insomniacs with psychiatric disorders and the absence of a corresponding worsening in illness behaviour suggests that insomniacs feelings about their health status are so negative to be not fatherly worsen by comorbidity in spite of a worsen disability. The evaluation of insomniacs should be as much detailed as possible, without neglecting tests for the evaluation of disability and illness behaviour, which are important not only for a correct diagnosis but also for monitoring the effects of therapies.
Asunto(s)
Calidad de Vida/psicología , Trastornos del Inicio y del Mantenimiento del Sueño/fisiopatología , Trastornos del Inicio y del Mantenimiento del Sueño/psicología , Adulto , Distribución de Chi-Cuadrado , Femenino , Humanos , Masculino , Trastornos Mentales/fisiopatología , Trastornos Mentales/psicología , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica/estadística & datos numéricosRESUMEN
The main aim of this study was to confirm in an Italian population affected by tension-type headache (TTH) the good profile of safety and tolerability of the combination paracetamol 1,000 mg-caffeine 130 mg (PCF) observed in previous studies, by a comparison with naproxen sodium 550 mg (NAP) and placebo (PLA). A secondary objective was to assess the efficacy of PCF in the acute treatment of TTH. This was a multicentre, randomised, double-blind, double-dummy, crossover, placebo-controlled trial. Tolerability was assessed by recording adverse events by the patient in the 4-h post-dose treatment. To assess the efficacy, the sum of pain intensity differences (SPID) and the total pain relief (TOTPAR) were calculated. Comparing PCF and NAP and PCF and PLA for tolerability, the difference was nonsignificant but the result regarding noninferiority was inconclusive, whilst NAP was noninferior to PLA. As regards SPID and TOTPAR, both PCF and NAP were better than placebo (P < 0.05), but not significantly different from each other. In conclusion, PCF was well-tolerated and effective in the treatment of acute TTH.
Asunto(s)
Acetaminofén/uso terapéutico , Analgésicos no Narcóticos/uso terapéutico , Antiinflamatorios no Esteroideos/uso terapéutico , Cafeína/uso terapéutico , Estimulantes del Sistema Nervioso Central/uso terapéutico , Naproxeno/uso terapéutico , Cefalea de Tipo Tensional/tratamiento farmacológico , Adolescente , Adulto , Anciano , Estudios Cruzados , Método Doble Ciego , Evaluación de Medicamentos , Quimioterapia Combinada , Femenino , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Umbral del Dolor/efectos de los fármacos , Estudios Retrospectivos , Adulto JovenRESUMEN
Literature data concerning the comorbidity of migraine and hypertension are conflicting and lacking in consistency. This study was designed to evaluate the distribution of hypertension in a sample of migraineurs in comparison with a group of tension type headache (TTH) patients. Hypertension prevalence was more elevated in headache sufferers than in the general population. This finding might be due to a Berkson's bias; in fact individuals seeking medical care often show a high rate of association between two medical conditions which may be independent in the general population. The highest hypertension prevalence was found in patients with TTH, supporting the hypothesis that this type of headache might be based upon vascular mechanisms.
Asunto(s)
Hipertensión/epidemiología , Migraña con Aura/epidemiología , Migraña sin Aura/epidemiología , Adulto , Comorbilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Distribución por Sexo , Cefalea de Tipo Tensional/epidemiologíaRESUMEN
The presence of significant and confounding psychiatric comorbidity is greater in patients attending headache clinics than in headache patients from the general population. The frequent comorbidity of headache with generalized anxiety disorder can take advantage of the administration of benzodiazepines. With regard to depression-related headache, it's wellknown that the antidepressive drugs can improve migraine as well as tension-type headache. Antiepileptic drugs give one more good opportunity. The recognition of a psychiatric comorbidity is mandatory for an accurate management of the patient because prevents the clinicians from using any drug that might be dangerous for a mysdiagnosed psychiatric disturbance and often permits to administer medications that can efficaciously control both headache and psychiatric disorders.