Placebo-controlled comparison of effervescent acetylsalicylic acid, sumatriptan and ibuprofen in the treatment of migraine attacks.

Acetylsalicylic acid (ASA) in combination with metoclopramide has been frequently used in clinical trials in the acute treatment of migraine attacks. Recently the efficacy of a new high buffered formulation of 1000 mg effervescent ASA without metoclopramide compared to placebo has been shown. To further confirm the efficacy of this new formulation in comparison with a triptan and a nonsteroidal anti-inflammatory drug (ibuprofen) a three-fold crossover, double-blind, randomized trial with 312 patients was conducted in Germany, Italy and Spain. Effervescent ASA (1000 mg) was compared to encapsulated sumatriptan (50 mg), ibuprofen (400 mg) and placebo. The percentage of patients with reduction in headache severity from moderate or severe to mild or no pain (primary endpoint) was 52.5% for ASA, 60.2% for ibuprofen, 55.8% for sumatriptan and 30.6% for placebo. All active treatments were superior to placebo (P < 0.0001), whereas active treatments were not statistically different. The number of patients who were pain-free at 2 h was 27.1%, 33.2%, 37.1% and 12.6% for those treated with ASA, ibuprofen, sumatriptan or placebo, respectively. The difference between ASA and sumatriptan was statistically significant (P = 0.025). With respect to other secondary efficacy criteria and accompanying symptoms no statistically significant differences between ASA and ibuprofen or sumatriptan were found. Drug-related adverse events were reported in 4.1%, 5.7%, 6.6% and 4.5% of patients treated with ASA, ibuprofen sumatriptan or placebo. This study showed that 1000 mg effervescent ASA is as effective as 50 mg sumatriptan and 400 mg ibuprofen in the treatment of migraine attacks regarding headache relief from moderate/severe to mild/no pain at 2 h. Regarding pain-free at 2 h sumatriptan was most effective.

Interictal lack of habituation of mismatch negativity in migraine.

The aim was to study mismatch negativity features and habituation during the interictal phase of migraine. In migraine patients, a strong negative correlation has been found between the initial amplitude of long latency auditory-evoked potentials and their amplitude increase during subsequent averaging. We studied 12 outpatients with a diagnosis of migraine without aura recorded in a headache-free interval and 10 gender- and age-matched healthy volunteers not suffering from any recurrent headache. The experiment consisted of two sequential blocks of 2000 stimulations, during which 1800 (90%) recordings for standard tones and 200 (10%) for target tones were selected for averaging. The latency of the N1 component was significantly increased in migraine patients in respect of controls in both the first and second repetitions; the MMN latency was increased in the second repetition. In the control group the MMN amplitude decreased on average by 3.2 +/- 1.4 microV in the second trial, whereas in migraine patients it showed a slight increase of 0.21 +/- 0.11 microV in the second repetition. The MMN latency relieved in the second trial was significantly correlated with the duration of illness in the migraine patients (Spearman correlation coefficient: 0.69; P < 0.05). The increases in N1 latency and MMN latency and amplitude, the latter correlated with duration of illness, seemed to be due to a reduced anticipatory effect of stimulus repetition in migraine patients. This suggests that such hypo-activity of automatic cortical processes, subtending the discrimination of acoustic stimuli, may be a basic abnormality in migraine, developing in the course of the disease.

The Migraine Disability Assessment (MIDAS) questionnaire: translation and reliability of the Italian version.

We have developed and tested an Italian version of the Migraine Disability Assessment (MIDAS) questionnaire, an established instrument for assessing headache-related disability. A multistep process was used to translate and adapt the questionnaire into Italian, which was then tested on 109 Italian migraine without aura patients, 86 (78.9%) of whom completed the form a second time 21 days later. Overall MIDAS score had good test-retest reliability (Spearman's correlation 0.77), closely similar to that found in English-speaking migraineurs, and individual responses were also satisfactorily reliable. Internal consistency was good (Cronbach's alpha 0.7). These findings support the use of the MIDAS questionnaire as a clinical and research tool with Italian patients.

EEG spectral analysis in migraine without aura attacks.

In 16 patients suffering from migraine without aura, we examined quantitative EEG and steady-state visual evoked potentials (SSVEPs) at 27 Hz stimulation during the critical phase of migraine and in attack-free periods. The main spontaneous EEG abnormalities found during the critical phase were the slowing and asymmetry of the dominant frequency in the alpha range. The amplitude of the SSVEP F1 component was significantly reduced during the attack phase compared with the intercritical phase; in the latter condition the visual reactivity to 27 Hz stimulus was increased over almost the entire scalp compared with normal subjects. The EEG abnormalities confirm a fluctuating modification of alpha activity during the migraine attack, probably related to a functional disorder. The suppression of visual reactivity during the migraine attack could be related to a phenomenon of neuronal depolarization such as spreading depression, occurring in a situation of central neuronal increased excitability predisposing to migraine attacks.

Stress, mood disorders and memory in headache.

Comorbidity between headache and other disorders such as psychological or memory problems is a topic of increasing scientific interest both for us diagnostic and therapeutic implications but also for pathogenetic advances. A central neurogenic mechanism such as a dysregulation of some neurotransmitter system might underlie not only headache but also other coexistent disorders; findings highlight the role of serotonin pathways.

Quality of life in shift work syndrome.

Air Force radar controllers represent an excellent example of night shift workers, as they are obliged to demonstrate perfect alertness during working hours. We set out: a) to assess the quality of life in these shift workers; b) to identify those with shift work syndrome and c) to evaluate the possible effects of triazolam both on their quality of life and sleep. The results reveal an impairment of the quality of life in shift workers, independently of the presence of a circadian rhythm sleep disorder. Quality of life was more severely impaired in subjects with circadian rhythm sleep disorder. Hypnotic therapy brought about an improvement both in the sleep disorder and in the quality of life of subjects affected by shift work syndrome. Selective alertness tests failed to demonstrate any "sedative carry-over" in the treated patients.

Photic driving in migraine: correlations with clinical features.

Fifty-eight migraineurs were studied by intermediate frequency steady-state visual evoked potentials (SSVEPs) during headache-free periods. Sex, age, age of onset of migraine, duration of illness, type of migraine, side of pain, sleep-wake disorders, and frequency of migraine attacks did not correlate with any SSVEP abnormalities. On the other hand, visual responsiveness was significantly increased in subjects with family history of migraine, and in those with autonomic symptoms. Our results may indicate that a genetic predisposition to migraine underlies the observed abnormal visual response in migraineurs.

Posatirelin in the treatment of vascular dementia: a double-blind multicentre study vs placebo.

INTRODUCTION: The usefulness of posatirelin (L-pyro-2-aminoadipyl-L-leucyl-L-prolinamide), a synthetic peptide having modulatory activity on the monoaminergic and cholinergic systems and neurotrophic effects, was evaluated in vascular dementia. PATIENTS AND METHODS: A multicentre, parallel groups, double-blind clinical study vs placebo was carried out with patients suffering from probable vascular dementia according to the NINDS-AIREN criteria. The study consisted of a two-week run-in of a once daily, orally administered, placebo phase, followed by 12 weeks of intramuscular treatment with posatirelin 10 mg/ml or placebo given once a day and a follow-up after one month's withdrawal. Efficacy was assessed using the Gottfries-Bråne-Steen (GBS) Rating Scale for dementia, the Randt Memory Test and the Toulouse-Piéron Attention Test. Data were evaluated using analysis of variance and covariance. RESULTS: As regards GBS scores, patients treated with posatirelin showed a significant improvement in intellectual performance, in orientation, motivation and memory as compared to controls. The improvement of memory performance was also confirmed by the acquisition score and memory index of the Randt Memory Test. At the end of the follow-up period the differences between treatments were still maintained. Tolerability was good. CONCLUSIONS: The significant improvement observed in cognitive functions, attention and motivation of demented patients treated with posatirelin suggests the potential usefulness of this drug in vascular dementia. Furthermore, the presence of a long-lasting effect after drug withdrawal suggests the possibility of administering the drug cyclically.

EEG features in juvenile migraine: topographic analysis of spontaneous and visual evoked brain electrical activity: a comparison with adult migraine.

Topographic analysis of spontaneous and steady-state visual evoked brain electrical activity was carried out between attacks in 82 migraine patients (40 youths and 42 adults). In adult migraine with aura a significant increase of delta rhythm percentage power was observed compared with migraine without aura and age-matched controls. Children suffering from migraine both with aura and without aura had an increased theta rhythm compared to normal controls. The presence of alpha interhemispheric asymmetry discriminated between migraine with aura and without aura, just as in adults. An increased amplitude of the SVEP F1 component with a tendency to the spread of visual reactivity was observed in juvenile migraine with and without aura; this pattern was not dissimilar from the one previously observed in adult migraine with and without aura. Abnormal photic driving in migraine is independent of age and type of migraine.

Topographic analysis of steady-state visual evoked potentials (SVEPs) in the medium frequency range in migraine with and without aura.

Topographic analysis of SVEPs in the medium frequencies range was performed in 30 migraineurs without aura, 20 migraineurs with aura and in 20 control subjects. The mean absolute power values of the fundamental component F1, the subharmonic F1/2 and the first harmonic F2, corrected by logarithmic transformation, were computed in each group and then compared using Student's t-test. The interhemispheric coherence of the F1 component was also evaluated. The 18, 21, and 27 Hz F1 components were increased in both migraineurs with and without aura, particularly in the temporo-parietal regions. The 24 Hz F1 component was augmented only in migraineurs without aura in the parieto-occipital regions in comparison with migraineurs with aura and controls. Migraine with aura patients had a reduced interhemispheric coherence mostly of 12 Hz and 15 Hz F1 components in frontal and temporo-parietal regions. Results of the study confirm abnormalities of SVEPs in migraineurs with and without aura. These consist of widespread increases of F1 components in the medium frequency range over the temporo-parietal regions.

A multicentre trial to evaluate the efficacy and tolerability of alpha-glycerylphosphorylcholine versus cytosine diphosphocholine in patients with vascular dementia.

An open clinical trial was carried out to compare the efficacy and the tolerability of 1 g/day alpha-glycerylphosphorylcholine (alpha-GPC) with 1 g/day cytosine diphosphocholine (CDP) both given intramuscularly for 90 days in 120 patients with mild to moderate vascular dementia. The clinical evaluation, carried out at the start as well as halfway through (45 days) and at the end of treatment (90 days), was expressed by psychometric tests (modified Parkside behaviour rating scale, Sandoz clinical assessment geriatric scale, word fluency test, Hamilton's rating scale of depression, narration subtest of Wechsler memory scale). Both treatments produced a definite symptomatic improvement and showed a very good tolerability. The results suggest that in most tests alpha-GPC possessed a statistical higher efficacy and an overall more satisfactory activity assessed by both patients and investigators compared with CDP.

Clinical pharmacodynamics of acetyl-L-carnitine in patients with Parkinson's disease.

Two groups of 10 patients with Parkinson's disease received doses of either 1g acetyl-L-carnitine (ALC) per day for seven days or 2g. The effects of this drug on intermittent luminous stimulation and on nocturnal sleep patterns were studied. In both cases with either dose of ALC the effect was an improvement of the H response, sleep stages and spindling activity. However a further study of the complexity of action of acetyl-L-carnitine is necessary.

[Obstructive apnea syndrome during sleep in children: diagnosis and treatment]. / Sindrome apnoica ostruttiva del sonno nel bambino: diagnosi e trattamento.

Marked adeno-tonsillar hypertrophy is certainly the most common respiratory disturbance found among children. Most particularly obstructive sleep apnea (OSA) leads to serious, at times fatal, consequences on the cardio-respiratory apparatus. Thus opinion in the literature unanimously holds that said syndrome is one precise indication for tonsillectomy and/or adenotomy. The present case study was performed on 19 children, age range 21 months to 6 years, with serious obstructions of the respiratory tract due to tonsillar or adeno-tonsillar hypertrophy (14 cases) or to isolated adenoid hypertrophy (5 cases). The sample was divided into 4 groups, taking into consideration the severity of the nighttime sleep obstruction and the type of obstruction. Polygraphy performed during sleep recorded objective OSA in 10 subjects with tonsillar or adeno-tonsillar hypertrophy, but no case was recorded in any subject with solely adenoid hypertrophy. The severity of the obstruction was likewise shown, judged both on the basis of frequency and duration of the pauses as well as on the cardio-respiratory complications, especially in the smallest children (less than 3 years). Furthermore, in the most serious cases significant hematological alterations were recorded. Tonsillectomy, performed in 9 of the 10 children with OSA, completely resolved the sleep disturbances and improved, or normalized, the broncho-pneumonic picture as well the hematological findings in those cases where preoperative complications were present. Even for those children who did not manifest OSA, tonsillectomy and/or adenotomy led to a more uniform rhythm and quality of their sleep.(ABSTRACT TRUNCATED AT 250 WORDS)

Psychomotor dysfunctions in alcoholic and post-necrotic cirrhotic patients without overt encephalopathy.

Psychometric tests, visual reaction time tests and electroencephalograms were performed in 26 cirrhotic patients without overt portal-systemic encephalopathy and in 26 healthy individuals. Cirrhotics performed poorly, compared with controls, on intelligence, learning and memory, perceptual motor and spatial tests. Non-alcoholic scored lower than alcoholic cirrhotics compared with controls in most tests. Visual reaction time ability was lower in cirrhotics than controls, but the etiology of the cirrhosis did not influence the test results. EEG was normal in all subjects. We conclude that psychomotor tests are the most useful tool for the detection of latent encephalopathy and in the discrimination of different cirrhosis.

Psychologic factors in chronic headache: assessment by means of the SCL-90-R inventory.

A survey of the psychologic profile of 540 chronic headache cases, including migraine, tension, and mixed headache, has been carried out with the symptom check list (SCL)-90-R inventory. The results obtained were viewed in relation to sex, age, illness onset, and illness duration. Females showed a positive correlation of somatization with present age and with age at onset of illness and a negative correlation of interpersonal sensitivity, hostility, and paranoid ideation with present age and age at onset of illness. Men showed a negative correlation of obsessive-compulsive and paranoid scores with age and a positive correlation between onset of illness and somatization. Data were also analyzed by cluster analysis, which showed underpopulation with peculiar patterns of symptom profile. A prospective, long-term epidemiologic study could provide more conclusive results.