Sodium-Glucose Cotransporter 2 Inhibitors Improve Body Composition by Increasing the Skeletal Muscle Mass/Fat Mass Ratio in Patients with Type 2 Diabetes: A 52-Week Prospective Real-Life Study.

Background: Sodium-glucose cotransporter 2 inhibitors (SGLT2is) induce body weight loss, but their effect on skeletal muscle mass (SMM) and strength needs to be better elucidated.

Objectives: This study aimed to evaluate the effects of SGLT2i on SMM in a real-life population setting of patients with type 2 diabetes (T2D). Secondary outcomes included changes in liver steatosis and in anthropometric and glucometabolic parameters.

Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study.

Background: While monoclonal antibodies (mAbs) targeting the CGRP pathway have revolutionized migraine management due to their improved tolerance and adherence, concerns remain about their potential impact on blood pressure (BP), especially in older patients, due to CGRP-mediated vasodilation blockade. Given the growing use of these therapies in older populations, assessing their cardiovascular (CV) safety is of paramount importance.

Methods: This multicentric observational prospective study focused on migraine sufferers aged ≥ 60 who began erenumab, galcanezumab, or fremanezumab for prevention.

Migraine chronification as an allostatic disorder: a proof-of-concept study.

Objective: The underpinning biologics of migraine chronification are not well understood. We aim to investigate the role of the cumulative burden of stress, namely the allostatic load, in migraine chronification.

Methods: This was a cross-sectional study.

The evolutionary meaning of migraine.

Introduction: Migraine's astonishing prevalence and preserved genetic background contrast with the definition of a disease and the biological meaning of experiencing recurrent, severe headache attacks is still puzzling.

Methods: To provide a comprehensive explanation of the migraine evolutionary meaning, we review (i) the putative role of the autonomic nervous system in migraine attacks, (ii) the inter-ictal autonomic, functional, and metabolic signature of migraine patients, (iii) the bio-behavioral perspective of pain, and (iv) the allostatic perception of migraine chronification.

Results: Migraineurs have inter-ictal cortical hyperexcitability and metabolic dysfunction that predisposes to brain energetic imbalance.

Is physiotherapy in migraines known to sufferers? A cross-sectional study.

Background: Migraine, a prevalent neurological condition, often impairs daily functioning and quality of life. While medications are the primary treatment, the potential of physiotherapy as an integrative approach remains underexplored. The aim of the study was to explore the awareness and experience of migraine patients regarding physiotherapy as a complementary treatment.

Gender-related stress factors and emotional perception in migraine: a structured online questionnaire in migraine patients and controls.

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.

Prevalence, natural history and dynamic nature of chronic headache and medication overuse headache in Italy: The SPARTACUS study.

Background: Chronic headaches and medication overuse headache are common and burdening conditions. No studies have evaluated the prevalence of chronic headache and medication overuse headache in an unselected Italian population.

Methods: We performed a three-year cross-sectional and longitudinal population-based study to investigate prevalence, natural history, and prognostic factors of chronic headache.

Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study.

Background: A novel formulation of diclofenac, complexed with hydroxypropyl-β-cyclodextrin (HPβCD) as a solubility enhancer, in a prefilled syringe for self-administered subcutaneous injection may overcome the limitations of acute migraine treatments administered by oral, rectal, intramuscular, or intravenous routes.

Methods: This multicentre, phase 2, double-blind, randomized, placebo-controlled, dose-finding pilot study evaluated the efficacy, safety and tolerability of three different doses (25/50/75 mg/1 mL) of subcutaneous diclofenac sodium in the treatment of an acute migraine attack in 122 subjects. The primary efficacy endpoint was the percentage of patients pain-free at 2 hours after the study drug injection.

Vessel-wall MRI in primary headaches: The role of neurogenic inflammation.

Objective: The purpose of this study was to investigate if vessel-wall magnetic resonance imaging (VW-MRI) could differentiate among primary headaches disorders, such as migraine and cluster headache (CH), and detect the presence of neurogenic inflammation.

Background: The pathophysiology of primary headaches disorders is complex and not completely clarified. The activation of nociceptive trigeminal afferents through the release of vasoactive neuropeptides, termed "neurogenic inflammation," has been hypothesized.

Detoxification vs non-detoxification before starting an anti-CGRP monoclonal antibody in medication overuse headache.

Background: Medication overuse headache significantly contributes to the chronification process and treatment refractoriness of migraine. Currently, abrupt discontinuation of the overused medication still represents the best management strategy for these patients, challenging public health system resources.

Methods: In this prospective study, chronic migraine and medication overuse headache sufferers with at least 28 days of analgesic consumption per month were included.

Great occipital nerve long-acting steroid injections in cluster headache therapy: an observational prospective study.

Background: Injections targeting the occipital nerve are used to reduce headache attacks and abort cluster bouts in cluster headache patients. There is no widely accepted agreement over the optimal technique of injection, type and doses of steroids and/or anesthetics to use, as well as injection regimens. The aim of this study was to verify the effectiveness and safety of greater occipital nerve long-acting steroid injections in the management of episodic and chronic cluster headache.

Do catastrophizing and autonomic-reduced flexibility mediate pain outcomes in chronic headache?

Objectives: Maladaptive cognitive strategies and reduced autonomic flexibility have been reported in chronic pain conditions. No study to date addressed the effects of maladaptive coping and reduced autonomic flexibility, as indexed by heart rate variability (HRV), in chronic headaches. The present study aimed to assess the mediating role of pain catastrophizing and HRV on pain outcomes in patients with chronic headache.

Applications of Ketogenic Diets in Patients with Headache: Clinical Recommendations.

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.

Real-life assessment of erenumab in refractory chronic migraine with medication overuse headache.

Objective: To determine whether erenumab is effective and safe in refractory chronic migraine with medication overuse headache.

Methods: In this prospective, multicentric, real-life study, chronic migraine with medication overuse headache patients who received erenumab were recruited. Study inclusion was limited to patients who previously failed onabotulinumtoxinA in addition to at least three other pharmacological commonly used migraine preventive medication classes.

Insights into real-world treatment of cluster headache through a large Italian database: prevalence, prescription patterns, and costs.

: This study aimed at estimating the treated cluster headache (CH) prevalence and describing prescription patterns and direct costs paid by the Italian National-Health-System.: Through the ReS database (healthcare administrative data collection of a large sample of the Italian population), adults in treatment for CH (acute therapy with sumatriptan/subcutaneous or oxygen, associated with preventive therapy with verapamil or lithium) were selected. A cross-sectional analysis described the prevalence of CH-treated subjects repeated annually in 2013-2017.

Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study).

Background: The clinical benefit of galcanezumab, demonstrated in randomized clinical trials (RCTs), remains to be quantified in real life. This study aimed at evaluating the effectiveness, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic migraine (CM) in a real-life setting.

Methods: This multicenter prospective observational cohort study was conducted between November 2019 and January 2021 at 13 Italian headache centers.

Chronic Migraine and Medication Overuse Headache Worsening After OnabotulinumtoxinA Withdrawn Due to the Severe Acute Respiratory Syndrome-Coronavirus-2 Pandemic.

OnabotulinumtoxinA (BT-A) is a preventive treatment for chronic migraine (CM), which needs to be administered regularly by a trained clinician every 3 months. The spread of the severe acute respiratory syndrome coronavirus-2 pandemic has forced many patients to momentarily stop the scheduled BT-A injections. The goal of this study was to explore whether those patients experienced a worsening of their CM and, if any, the clinical predictors of migraine worsening after BT-A withdrawal.

A Randomized Clinical Trial on Acupuncture Versus Best Medical Therapy in Episodic Migraine Prophylaxis: The ACUMIGRAN Study.

A large corpus of evidence has reported encouraging results for acupuncture as a prophylaxis therapy for migraine. However, trials that investigated the efficacy of acupuncture in comparison with pharmacological treatment in episodic migraine showed conflicting results. The study aimed to evaluate if acupuncture is as effective as evidence-based pharmacological drugs in episodic migraine prophylaxis.

Vessel-wall MRI in thunderclap headache: A useful tool to answer the riddle?

Background: Finding an intracranial aneurysm (IA) during a thunderclap headache (TCH) attack, represents a problem because it is necessary to distinguish whether the aneurysm is responsible for the headache as a warning leak or as an incidental finding. High-Resolution Vessel-Wall (HRVW) MRI sequences have been proposed to assess the stability of the wall, as it permits to detect the presence of aneurysmal wall enhancement (AWE). In fact, AWE has been confirmed due to inflammation, recognizable preceding rupture.

Locking down the CGRP pathway during the COVID-19 pandemic lockdown: the PandeMig study.

Objectives: The COVID-19 pandemic and the consequent lockdown came as a storm disrupting people's everyday life. This study aimed at observing whether the COVID-19 related lockdown influenced migraine frequency and disability in migraine patients on therapy with monoclonal antibodies inhibiting the CGRP pathway.

Methods: In this longitudinal observational cohort study, 147 consecutive patients receiving monthly administration of erenumab or galcanezumab were enrolled in four Italian headache centers.