Guidelines for controlled trials of drugs in migraine: second edition.
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Controlled Clinical Trials as Topic↗
Biomedical subjects
G Sandrini
Publications and source records attributed to G Sandrini.
Asymmetrical reduction of the nociceptive flexion reflex threshold in cluster headache.
The nociceptive flexion reflex (NFR) of the lower limbs (RIII reflex) was examined bilaterally in 54 cluster headache (CH) patients suffering from episodic CH (ECH) and chronic CH (CCH). Fifteen ECH patients were examined in both remission and active phases. The RIII reflex threshold (Tr) and the threshold of pain sensation (Tp) were significantly reduced on the symptomatic side in patients with episodic CH during the bout. During the active phase of episodic CH an inverse correlation was found between the severity of CH (ratio: number of cluster periods/years of illness duration) and the Tp, which may suggest a role for secondary central sensitization in pain pathways. The lower Tr and Tp on the symptomatic side is in keeping with previous observations exploring pain mechanisms using different methods (i.e. corneal reflex, pain pressure threshold). On the whole, these data tie in with the view of an impairment of the pain control system, which parallels the periodicity of the disorder in the episodic form.
Adult↗
Headache in the Diagnosis-Related Groups (DRG) era: management and appropriateness of admission.
Headache is an extremely common disorder which has a marked impact on the utilisation of healthcare resources and constitutes a considerable socio-economic burden. The related costs, both direct and indirect, are especially high in developed countries, since headache predominantly affects an economically-active section of the population. The Diagnosis-Related Groups (DRG) system, a method for reimbursing healthcare structures for patient admissions, was introduced in Italy in 1995. The aim of the system was to control public health expenditure and to promote better distribution of financial resources. Here, we report the results of the application of the DRG system to headache patients admitted to the Department of Neurology of the University of Pavia in 1996 and 1998. The financial analysis revealed high fixed costs (hospital running costs per days of hospitalisation); by contrast, the impact of the variable costs (those relating to the direct management of the individual patient, i.e. examinations, therapeutic interventions etc.) was low. It was found that reducing the number of days of hospitalisation increases the hospital's income and reduces the mean loss incurred in each DRG. It is therefore suggested that a complete approach to the management of headache must include educational programmes for patients and general practitioners, and that access to headache centres and to hospital care should be restricted to cases of acute, severe headache, or recurrent, chronic headache with/without drug abuse or dependence.
Costs and Cost Analysis↗
Clinical and para-clinical tests in the routine examination of headache patients.
Para-clinical examinations in the diagnosis and treatment control of headache patients vary considerably between clinics and headache centers. Among the neurological societies in Europe there has been a consensus that some common procedures and recommendations should be created. In the Fall of 1998, the European Federation of Neurological Societies (EFNS) commissioned a Task Force on Neurophysiological Tests and Imaging Procedures in Headache Patients. Members of the Task Force are the present authors and we have reviewed the literature on 1) neurophysiological tests (EEG and evoked potentials), 2) autonomic nervous system and clinical tests and 3) imaging and cerebrovascular tests (X-ray, CT, MR, fMRI, PET, SPECT and transcranial Doppler). The literature was carefully evaluated with respect to validity and strength of the data. The task was to reach conclusions about each technique in the form of guidelines for clinical use. Finally, selected areas for future research will be outlined. The extensive review and the guidelines will be published by the EFNS during 2000.
Electroencephalography↗
Different effect of high doses of naloxone on spinal reflexes in normal subjects and chronic paraplegic patients.
There is still controversy over the effects of naloxone on spinal reflexes in view of the fact that both facilitatory and inhibitory activities have been observed. Dosage, supraspinal influences and interactions with different opiate receptors may account for the different findings. We investigated the effect of placebo (saline) and high doses of naloxone (1.66 mg/kg) on the monosynaptic (H reflex) and nociceptive polysynaptic reflex (RIII reflex) in five normal subjects and three chronic paraplegic subjects. Following the administration of naloxone, there were no changes in the RIII reflex threshold in either group. By contrast, there was a marked facilitation of the H reflex amplitude in the normal subjects, but not in the spinal cord-injured subjects after treatment with naloxone. Saline induced no changes in the RIII reflex threshold or the H reflex amplitude in either of the two groups. Our data suggest that under normal conditions the opiatergic modulation of the nociceptive reflex is not functionally active whereas the tonic inhibitory modulation of the monosynaptic reflex is mediated by descending pathways.
Adult↗
Experimental models for the study of cluster headache.
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Animals↗
Neurophysiological approach to the study of cluster headache.
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Blinking↗
Psychiatric comorbidity and psychosocial stress in patients with tension-type headache from headache centers in Italy. The Italian Collaborative Group for the Study of Psychopathological Factors in Primary Headaches.
A multicenter study was carried out in 10 Italian Headache Centers to investigate the prevalence of psychosocial stress and psychiatric disorders listed by the IHS classification as the "most likely causative factors" of tension-type headache (TTH). Two hundred and seventeen TTH adult outpatients consecutively recruited underwent a structured psychiatric interview (CIDI-c). The assessment of psychosocial stress events was carried out using an ad hoc questionnaire. The psychiatric disorders that we included in the three psychiatric items of the fourth digit of the IHS classification were depressive disorders for the item depression, anxiety disorders for the item anxiety, and somatoform disorders for the item headache as a delusion or an idea. Diagnoses were made according to DSM-III-R criteria. At least one psychosocial stress event or a psychiatric disorder was detected in 84.8% of the patients. Prevalence of psychiatric comorbidity was 52.5% for anxiety, 36.4% for depression, and 21.7% for headache as a delusion or an idea. Psychosocial stress was found in 29.5% of the patients and did not differ between patients with and without psychiatric comorbidity. Generalized anxiety disorder (83.3%) and dysthymia (45.6%) were the most frequent disorders within their respective psychiatric group. The high prevalence of psychiatric disorders observed in this wide sample of patients emphasizes the need for a systematic investigation of psychiatric comorbidity aimed at a more comprehensive and appropriate clinical management of TTH patients.
Adult↗
Chronic daily headache. How should it be included in the IHS classification?
A number of patients attending specialty headache centers complain of very frequent, almost continuous or continuous headaches, which are usually grouped together under the term chronic daily headache, a category which does not appear in the International Headache Society (IHS) classification. On the basis of the IHS criteria, these patients can only be classified as having a chronic tension-type headache with the possible addition of migraine, if migrainous attacks are superimposed on the "background" headache. However, several studies have demonstrated that most patients with chronic daily headache originally suffered from migraine and that their migraine has transformed, in the course of time, into a chronic headache picture in which isolated migraine attacks may or may not persist. Despite some differences in the personal opinions of authors involved in the care of patients with chronic daily headache, some views seem to be generally accepted: (1) the great majority of chronic daily headaches are transformations of an original episodic migraine and cannot be included in the chronic tension-type headache category, (2) the current IHS classification does not allow many patients presenting with chronic daily headache to be classified correctly, (3) an important nosological category (transformed migraine) has emerged from all the studies on this subject, (4) it is impossible to diagnose transformed migraine merely by "photographing" the picture of single attacks. Although some theoretical problems remain unresolved, it seems to us that the next revision of the IHS classification can no longer ignore the existence of chronic daily headache.
Headache Disorders↗
[Pathogenesis of tension headache: role of temporomandibular disorders. A research protocol].
BACKGROUND: The purpose of this research is to verify through a blind, controlled study if there is a positive correlation between tension-type headache and the most likely causative factors. In accordance with the headache classification of the international headache society, they are: oro-mandibular dysfunction; psychosocial stress; anxiety; depression; headache as a delusion or an idea; muscular stress; drug overuse for tension-type headaches. METHODS: The subjects who participated in the study were selected from patients diagnosed as having tension-type headache. The patients were of both sexes and aged between 18 and 60 years. A control subject was joined to every case. 102 subjects entered the study. The protocol includes the following examinations: questionnaire about the headache's characteristics; questionnaire about muscular stress; questionnaire about sleep; physiologic and pathologic history; structured Clinical Interview for DSMIII-R (Diagnostic and Statistical Manual of Mental Disorders) for diagnosis of anxiety, depression and somatoform disorder; DSMIII-R questionnaire about psychosocial stressors; EMG; algometry; evaluation of the TMJ; evaluation of the muscles of mastication; evaluation of the denture. RESULTS AND CONCLUSIONS: A positive correlations between oro-mandibular dysfunction, anxiety, muscular stress and tension-type headache was found.
Double-Blind Method↗
Eye movement abnormalities in myotonic dystrophy.
We studied saccade and smooth pursuit eye movements in 31 patients suffering from myotonic dystrophy (MD). On the basis of mean value comparisons, saccades were slower and hypometric and smooth pursuit eye movements performed worse in MD patients than in controls. On an individual basis, saccade duration was prolonged in 67.7%, saccades were hypometric in 19.4%, saccade latency was delayed in 9.7%, and the smooth pursuit performance index was decreased in 9.7% of patients. Eye movement abnormalities did not correlate with those detectable by visual, brain-stem auditory and somatosensory evoked potentials. We attempted to classify eye movement abnormalities as myogenic or neurogenic on the basis of differences in combination of eye movement abnormalities and the occurrence of D5/D35 dissociation; the latter consists of a prolonged duration for large (35 degrees) but not for small (5 degrees) saccades. Since D5/D35 dissociation occurred in 26/33 multiple sclerosis patients with increased saccade duration, we considered it to be a neurogenic pattern attributable to a central nervous system (CNS) dysfunction. A prolonged duration without dissociation especially in combination with saccade hypometria, is interpreted as a myogenic pattern, although the lack of dissociation may also occur with CNS impairment in case of a marked increase in saccade duration. Accordingly we classified the oculomotor abnormalities detected as neurogenic in 11 MD patients and as myogenic in another 10, but in some subjects belonging to the second group concomitant CNS impairment is not to be excluded.
Adolescent↗
Long-term outcome of migraine.
Migraine prevalence increases from childhood up until 40 years of age, and thereafter declines. Several hypotheses can be advanced to explain the decrease in migraine with advancing age: (i) favorable effect of preventive treatments; (ii) increased mortality in migraineurs (due to higher vulnerability to other fatal diseases); (iii) cohort effect (increased incidence in young subjects); (iv) spontaneous remission. The first two theses are poorly supported by data in the literature. Although a cohort effect may exist, a spontaneous remission of migraine in middle and old age (at least partially due to the loss of sex hormone changes after the menopause in females) is the more likely hypothesis. In a small subgroup of patients (most of them drug abusers), migraine has a "malignant" course and changes into chronic daily headache. The risk factors for a poor outcome of migraine have been little studied. In a case-control study, we found that a history of head trauma and a long duration of contraceptive intake were risk factors for a bad outcome, whilst a long duration of prophylactic treatments had a protective effect.
Age Distribution↗
Psychiatric comorbidity in chronic daily headache.
Clinical evidence suggests that chronic daily headache (CDH) occurs in association with psychopathologies: previous studies have focused particularly on migraine. To evaluate this association, we studied, using the DSM-IIIR criteria, a population of 88 patients (18M, 70F) affected by CDH (mean duration 7.4 +/- 8.7 years). We documented the presence of a psychiatric disorder in 90% of this population. The most frequent diagnosis was a comorbidity of anxiety and mood disorders. The comorbidity of psychiatric disorders and headache has important implications as far as treatment is concerned.
Adult↗
Effectiveness of ibuprofen-arginine in the treatment of acute migraine attacks.
The purpose of this study was to evaluate the effectiveness of a new formulation of ibuprofen (ibuprofen-arginine [IA]) in the treatment of migraine attacks. This is a faster absorbed formulation as compared with ibuprofen alone. The rapidity of action is considered to be a crucial factor in the treatment of migraine attacks. Forty migraine patients participated in this multicenter, double-blind, crossover, randomized, placebo-controlled trial. Each patient was treated with a single oral dose of IA 400 mg or placebo during two consecutive migraine attacks. The results confirm the efficacy of IA, with a significant (p < 0.05) improvement in pain relief at 30 min after treatment. A statistically significant (p < 0.001) reduction in pain intensity was observed at 1, 2, 4 and 6 h after treatment with ibuprofen as compared with placebo. IA was well tolerated and our data indicate that this new formulation of ibuprofen is valuable in the treatment of acute migraine attacks.
Acute Disease↗
Pain pressure threshold in cluster headache patients.
Pain perception threshold (PPT) in the head was assessed with a pressure algometer in 58 cluster headache (CH) patients (52M, 6F; 41 episodic and 17 chronic). Fourteen patients in cluster period were retested in remission. Thresholds were assessed at 10 symmetrical points on each side of the head and at the deltoid. Compared with controls (n = 50), CH patients had lower PPT in the head and in the deltoid. PPT was lower on the symptomatic side than on the non-symptomatic side in patients with episodic CH during a cluster period (p < 0.001) and in patients with chronic CH (p < 0.05). This pattern was more evident during a cluster period than during remission (p < 0.05). A reduced PPT did not correlate with illness duration and pain side. The lowest PPT mean values were found at the anterior and intermediate levels of the temporal muscle on the symptomatic side. These results imply a central mechanism underlying the pathogenesis of CH.
Adult↗
Classification of chronic daily headache by International Headache Society criteria: limits and new proposals.
We conducted a retrospective study of 150 patients with chronic daily headache (CDH) to determine how to categorize their headache according to the classification of the International Headache Society (IHS). All patients were first evaluated at Parma and Pavia Headache Centres (from January 1992 to March 1993) and had had headache for at least 15 days a month during the previous 6 months. Four patients were thereafter excluded due to poor reliability. The 146 patients who met our CDH criteria (92 with and 54 without clear-cut migraine attacks) could be classified into four groups: (i) chronic tension-type headache (CTTH)--27 patients; (ii) coexisting migraine plus CTTH--65 patients; (iii) unclassifiable daily headache--27 patients; and (iv) migraine and an unclassifiable interval headache--27 patients. Seventy-two percent of patients with CDH had migraine as the initial form of their headache. We therefore propose to revise the IHS classification for migraine, taking into account its evolution, and add two subcategories, migraine with interparoxysmal headache and chronic migraine.
Adolescent↗
Comparative study with EMG, pressure algometry and manual palpation in tension-type headache and migraine.
According to International Headache Society classification criteria, the presence of pericranial muscle disorder in tension-type headache should be evaluated using one of the following methods: EMG, pressure algometry or manual palpation. The purpose of this study was to compare the results of these three methods in 15 patients with episodic tension-type headache, 29 with chronic tension-type headache and 22 presenting migraine without aura compared to those obtained in healthy individuals. Algometric and EMG recordings at the frontalis muscle during mental arithmetic were more impaired in episodic and chronic tension headache patients than in controls and migraine patients. Chronic tension headache patients were significantly impaired at the trapezius muscle in all three tests compared to controls. Our data indicate that when two or three tests were carried out the diagnostic capacity was significantly improved in comparison to only one test. Moreover, since a different pattern could be seen with pain and without pain, the existence of headache at the time of testing should be taken into consideration.
Adolescent↗
Neurophysiological studies in chronic paroxysmal hemicrania and hemicrania continua.
To explore the possible involvement of the pain control system, pain pressure threshold (PPT), nociceptive flexion reflex (RIII), blink and corneal reflexes have been studied for pain perception assessment in 12 patients with chronic paroxysmal hemicrania (CPH) and 12 patients with hemicrania continua (HC). PPT was found to be reduced in HC and CPH when separately compared to controls. In addition, a significant reduction of subjective pain perception (Tp) which was most marked on the symptomatic side, has been demonstrated after sural nerve stimulation in CPH. The RIII reflex threshold on the symptomatic side was significantly reduced when patients were compared to controls. No major differences between CPH and HC as regards blink reflex latencies were found; nor was any such difference observed when comparing the two headache groups to controls. The corneal reflex thresholds were found significantly reduced bilaterally in CPH, irrespective of whether the treatment was given or not.
Adult↗