Background The SIMS‐Trial (ISRCTN81072971) proved the effectiveness, in terms of patient’s knowledge and care satisfaction, of an add‐on information aid (personal interview with a physician using a ...navigable CD and take‐home booklet) in 120 newly diagnosed patients with multiple sclerosis (MS) from five Italian centres.
Objective To scrutinize the experience of SIMS‐Trial participants in order to gain better understanding of the effectiveness of the information aid and its components.
Design We performed (i) nine individual semi‐structured interviews with a purposeful sample of SIMS‐Trial patients who received the information aid, (ii) focus group meeting (FGM) with the physicians who conducted the personal interview, and (iii) FGM with patients’ caring neurologists.
Results Patients’ experience with the information aid was positive as it enhanced their understanding of their disease, being viewed as a guided tour of their medical condition. The physicians who conducted the personal interviews were also positive in their overall evaluation but noted an initial difficulty in using the CD. The caring neurologists had limited direct experience of the aid, and their views were confined to utility of the information aid in general. All participants considered the combination of personal interview, CD navigation and take‐home booklet essential, but urged a more flexible scheduling of the personal interview. It also emerged that some content required revision and that the aid was unsuitable for patients with primary progressive MS.
Conclusions The results of the study further support the value of the aid and also provide important indications for improving it and refining indications for use.
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.
Objective: The aim of the present study was to evaluate how hormone replacement therapy (HRT) could influence the course of primary headaches in postmenopausal women.
Methods: Fifty patients ...presenting for clinical evaluation of menopausal status and suffering from headache were enrolled. The observational period lasted 7 months during which women filled in a diary with the clinical characteristics of headache attacks (frequency, days with headache, severity) and the analgesic use (no. of analgesic/month). Climacteric symptoms and both anxiety and depression were also measured. At the first visit the patients were divided into two groups: those suffering from migraine without aura (MwA) and those suffering from episodic tension-type headache (ETTH) and separately randomized. After a month of run-in period, they received two different HRT regimen, either: (1) transdermal estradiol 50 mcg every 7 days for 28 days plus medroxyprogesterone acetate (MAP) 10 mg/day from 15th to 28th day, or (2) oral conjugated estrogens 0.625 mg/day for 28 days plus MAP 10 mg/day for the last 14 days. Follow up evaluations were planned after 1, 3 and 6 months of treatment.
Results: While we did not observe any significance change regarding headache parameters in ETTH patients during both transdermal and oral treatment, the course of migraine was significantly affected by the route of HRT. Both frequency of attacks (
F=8.5;
P<0.000) and days with headache (
F=6.9;
P<0.000) significantly increased during HRT in the subgroup assuming oral formulation. On the contrary, no changes in the same parameters were found in the group taking transdermal treatment. Moreover, while severity of migraine was unaffected by HRT, analgesic consumption was significantly increased in the subgroup on oral treatment (
F=6.3;
P=0.001).
Conclusions: HRT significantly affects the course of headache in postmenopausal migraine sufferers. Indeed, while the clinical pattern of ETTH remained stable throughout the observational period, patients suffering from MwA worsened their symptoms within the first 3 months of treatment. In particular, the oral route of administration significantly worsened migraine in comparison to the transdermal route.
A retrospective study was conducted on 1300 women suffering from migraine without aura referred to the Headache Centers of Parma and Pavia from 1984 to 1990. All the data concerning their ...reproductive life, and the modifications induced by it on the course of headache were obtained from record-charts. Migraine frequently started at menarche (10.7%); in 60% of cases the migraine attacks occurred mostly or exclusively in the perimenstrual period, in 67% of cases disappeared during pregnancy, and in 24.1% significantly (P < 0.0001) worsened with "pill" intake. This study also designated a migraine subgroup which is more influenced by changes in sexual hormones, i.e. migraine with onset at menarche. This form of migraine shows more frequently a menstrual periodicity, and usually improves during pregnancy. Furthermore, menstrual migraine patients show social and cultural characteristics with distinguish them from other women.
Objective.-To measure plasma and platelet levels of dopamine in patients with migraine with aura, migraine without aura, and cluster headache. Background.-Clinical, genetic, and pharmacological ...evidences suggest that an abnormality of dopaminergic system plays a role in migraine pathogenesis. Direct evidence of an abnormal metabolism of dopamine in migraine, however, is lacking. Methods.-Plasma and platelet levels of dopamine were measured in patients with migraine with aura or migraine without aura during headache-free periods and in patients with cluster headache during the remission and active periods, as compared with healthy control subjects, using a multichannel electrochemical high-performance liquid chromatography system. Results.-Plasma levels of dopamine were not detectable with our methodology. Platelet levels of dopamine were higher in both types of migraine (migraine without aura = .20 plus or minus .17 ng-10 super(8) platelets; migraine with aura = .16 plus or minus .19 ng-10 super(8) platelets) than in control subjects (.10 plus or minus .11 ng-10 super(8) platelets), although in migraine with aura patients the difference was not significant. Patients with cluster headache showed the highest levels of platelet dopamine (.34 plus or minus .36 ng-10 super(8) platelets). Conclusions.-Our results support the hypothesis that the dopaminergic system is impaired in migraine and cluster headache and suggest that high platelet levels of dopamine may represent an abnormal biochemical phenotypic trait of these primary headaches.
Background.—Platelets are activated in patients with cluster headache, during both the remission period and the active cycles.
Objective.—To delineate more clearly the origin of platelet activation ...in cluster headache.
Methods.—Platelet aggregation induced by collagen (0.5 μg/mL and 2 μg/mL), adenosine diphosphate (10−5 M and 10−6 M), and platelet‐activating factor (10−6 M and 10−7 M) was determined by the Born's method in 26 patients with cluster headache and 24 sex‐ and age‐matched controls.
Results.—The platelets of patients with cluster headache aggregated significantly less to collagen at a concentration of 0.5 μg/mL compared to those of controls (P = .04). The extent of platelet aggregation obtained with a higher dose of collagen (2 μg/mL) was in the same range in both groups. Platelet aggregation obtained via adenosine diphosphate at a concentration of 10−6 M was significantly reduced in patients with cluster headache in comparison to controls (P = .002), but no differences were found at a concentration of 10−5 M. In contrast, the platelets of patients with cluster headache aggregated significantly more to platelet‐activating factor at both the concentrations of 10−6 M (P = .001) and 10−7 M (P = .00001) compared to those of controls.
Conclusions.—This study suggests that platelet aggregation is impaired in patients with cluster headache during the active phase of the disease. We found hypoaggregation in response to low doses of collagen and adenosine diphosphate, and hyperaggregation when platelets were stimulated with platelet‐activating factor. Any interpretation of these results can only be speculative. It may be that impairment of platelet aggregation with collagen and adenosine diphosphate may indicate a derangement of nitric oxide function, while the hypersensitivity to platelet‐activating factor may be due to fluctuations in its plasma levels.
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