Cephalalgia : an international journal of headache
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To quantify and compare the responsiveness within the meaning of clinical relevance of efficacy endpoints in a clinical trial with over the counter (OTC) analgesics for headache. Efficacy endpoints and observed differences in clinical trials need to be clinically meaningful and mirror the change in the clinical status of a patient. This must be demonstrated for the specific disease indication and the particular patient population based on the application of treatments with proven efficacy. ⋯ When global assessment of efficacy by the patient was used as external criterion, ROC curve calculations confirmed a high responsiveness for all efficacy endpoints included in this study. Clinically relevant differences between patients satisfied and non-satisfied with the treatment were observed. The endpoint '%SPIDweighted' proved slightly but consistently superior to the other endpoints. SPID and %SPIDweighted are not easy to interpret and the time course of pain reduction is of high importance for the patients in the treatment of acute pain, including headache. The endpoint 'pain-free at 2 hours' showed the expected high specificity, but at the cost of a concurrently low sensitivity and clearly makes less use of the available information than the endpoint 'time to 50% pain reduction', which combines the highly relevant aspects of time course and extent of pain reduction. Responsiveness, the ability of an outcome measure to detect clinically important changes in a specific condition of a patient, should be added in future revisions of IHS guidelines for clinical trials in headache disorders.
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Previous cross-sectional studies evaluating the relationship between diabetes prevalence and migraine status have found conflicting results. We examined the relationship between migraine and incident type 2 diabetes (T2D) in a cohort of adult women. ⋯ Results of this prospective study in women do not support an association between migraine and incident T2D.
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Migraine is a prevalent neurological disorder with a complex genetic background characterized by recurrent episodes of headache. The disease is subclassified into migraine with aura (MA) and migraine without aura (MO). Many association studies have been performed to date to identify genetic risk variants for common migraine, most of them focusing on selected candidate genes, with variable and often inconsistent results. Recently, a clinic-based genome-wide association study for migraine reported a functionally relevant risk variant (SNP rs1835740), involved in glutamate homeostasis, which showed a significant association with MA. We aimed to replicate this finding in a clinic-based study of a Spanish cohort with MA and MO patients. ⋯ No association was found between the assayed SNP and any of the clinical groups considered.
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Case Reports
Bilateral paroxysmal cephalalgia: a novel indomethacin-responsive primary headache syndrome?
Paroxysmal hemicrania (PH) is a primary headache disorder characterised by frequent, short-lasting, very severe, strictly unilateral attacks occurring in association with cranial autonomic features. A striking feature of this disorder is its clear response to indomethacin. ⋯ There have been several case reports of patients presenting with short-lasting, frequent, bilateral headaches responding to indomethacin, without cranial autonomic features. These cases have been described as representing bilateral PH although strict unilaterality of pain and cranial autonomic phenomena are cardinal features of PH. These cases may represent a novel indomethacin-responsive syndrome and therefore, for now, should be studied separately from PH until their pathophysiological basis is better understood.
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Analysis of habituation patterns in patients with primary headache disorders allows the detection of changes to the excitability level of the trigeminal nociceptive system. Previous studies demonstrated a habituation deficit to painful stimuli in migraine and it was suggested that similar observations could be made in cluster headache (CH). ⋯ Our results did not detect an altered habituation in CH patients. Despite clinical similarities, migraine and CH seem not to share the same pathophysiological mechanisms in this regard.