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1.
The objective of this study was to assess the prevalence of fibromyalgia (FM) in patients with episodic migraine and to evaluate the relationship between migraine characteristics and FM. One hundred and eighteen consecutive patients (mean age?=?38 years, 75 % women) fulfilling the International Classification of Headache Disorders-II criteria for migraine with (n?=?22) and without (n?=?96) aura from an outpatient headache clinic of a university hospital were evaluated. The diagnosis of FM was made based on the 1990 American College of Rheumatology classification criteria. Participants completed some self-administered questionnaires ascertaining sociodemographics, headache severity, frequency and duration, headache-related disability (Headache Impact Test [HIT-6]) and Migraine Disability Assessment Scale, widespread musculoskeletal pain (visual analog scale), depression (Beck depression inventory), anxiety (Beck anxiety inventory), sleep quality (Pittsburgh Sleep Quality Index), fatigue (Multidimensional Assessment of Fatigue), and quality of life (Short Form-36 Health Survey [SF-36]). In patients with FM, the tender point count and the Fibromyalgia Impact Questionnaire were employed. FM was diagnosed in 37 (31.4 %) of the patients. FM comorbidity was equally distributed across patients with and without aura. Severity of migraine headache, HIT-6, and anxiety were especially associated with FM comorbidity. Patients suffering from migraine plus FM reported lower scores on all items of the SF-36. This study indicates that the assessment and management of coexisting FM should be taken into account in the assessment and management of migraine, particularly when headache is severe or patients suffer from widespread musculoskeletal pain.  相似文献   

2.
IntroductionExposure to extreme stress can result in a variety of clinical sequelae, in terms of severity and type, of which post-traumatic stress disorder (PTSD) is the prototype. PTSD was previously associated with chronic pain and primary pain disorders.ObjectiveTo evaluate the prevalence of PTSD among migraine patients and to assess its relation to migraine severity.MethodsWe evaluated 92 consecutive patients fulfilling the international headache society criteria for migraine with and without aura treated in the Headache Clinic of the Soroka University Medical Center in Beer-Sheva using the Clinician Administered PTSD Scale (CAPS), and headache severity scales (HIT-6 and MIDAS).ResultsThe prevalence of specific traumatic events in migraine patients was 16.3% (n = 15). Six patients (6.5%) of the 92 patients met the DSM-IV criteria for PTSD. Migraine patients with co-morbid PTSD had higher MIDAS scores than other migraine patients.ConclusionsMigraine patients do not suffer from PTSD more than the general population. When they do suffer from PTSD they report high levels of disability.  相似文献   

3.
BACKGROUND: Existing criteria for the diagnosis of headache do not indicate which clinical features are most important to establish or exclude primary headache diagnoses. OBJECTIVE: To determine the value of history taking in the evaluation of patients with primary headache syndromes. METHODS: A MEDLINE search of English-language studies published since 1966 and a hand search of bibliographies from retrieved articles. Included studies cited the sensitivity of clinical and historical features for the diagnosis of migraine, tension-type, and cluster headaches. Studies were classified according to their use of the International Headache Society criteria or other criteria as the reference standard for diagnosis. RESULTS: The features most predictive of migraine, when compared with tension-type headache, are nausea, photophobia, phonophobia, and exacerbation by physical activity. Positive likelihood ratios (95% confidence intervals) are 19.2 (15.0-24.5), 5.8 (5.1-6.6), 5.2 (4.5-5.9), and 3.7 (3.4-4.0), respectively. Headache precipitants are present equally in patients with migraine and tension-type headache, with the exception of food triggers, which confer a positive likelihood ratio of 3.6 (2.8-4.6) for the diagnosis of migraine. Visual aurae are present in 84% of patients with migraine with aura. Cluster headache is strictly unilateral, is periorbital in 80% of patients, and lasts less than 1 hour in 54% of patients. CONCLUSIONS: The features most predictive of the diagnosis of migraine, when compared with tension-type headache, are nausea, photophobia, phonophobia, exacerbation by physical activity, and an aura. Cluster headache is a distinct clinical syndrome.  相似文献   

4.
The aim of the study is to determine the prevalence of and factors associated with major depression among those with Fibromyalgia Syndrome (FMS) in a Canadian representative sample. The study was a secondary analysis of a large, nationally representative sample from the Canadian Community Health Survey. The full sample (n = 126,805) was used to determine the prevalence of FMS and odds ratio of depression among those with FMS (n = 1,635) compared to those without (n = 125,170). A subsample of those with FMS (n = 1,635) was used to determine the prevalence of major depression and the demographic, psychosocial and health-related factors associated with it. Those with FMS had approximately three times higher odds of depression in comparison with those without FMS, even when controlling for important socio-demographic characteristics (OR = 2.90; 95% CI = 2.52, 3.33). Based on the subsample of those with FMS, it was found that 22% had current major depression. A multivariate logistic regression model of those with FMS showed depression was associated with younger age, female gender, being unmarried, food insecurity, number of chronic conditions, and limitations in activities. Two-fifths of those with depression and FMS had not discussed mental health concerns with any health professionals in the previous year, highlighting the underuse of mental health services and the need for health professionals to increase screening within this population. The findings may help clinicians target mental health assessments and interventions for their patients with fibromyalgia.  相似文献   

5.
Aim of the workTo screen for the new development of fibromyalgia syndrome (FMS) and anxiety in rheumatic diseases (RDs) patients and control who recovered from coronavirus disease 2019 (COVID-19).Patients and methodsThe study included 200 RDs patients and 100 matched controls with no previous history of FMS and who recovered from COVID-19. The patients’ RDs included rheumatoid arthritis (RA) (n = 50), systemic lupus erythematosus (SLE) (n = 50), juvenile idiopathic arthritis (JIA) (n = 40) and spondyloarthritis (SpA) (n = 60). The fibromyalgia symptom scale (FS), fibromyalgia impact questionnaire (FIQ) and Hamilton Anxiety rating scale were assessed.ResultsThe mean age of patients was 35.9 ± 8.5 years with female: male 2.6:1. Fibromyalgia and anxiety were significantly higher in cases than control (22.5 % vs 12 % and 27 % vs16 %, p = 0.002, p = 0.03 respectively). Hypertension, obesity, anxiety, severe COVID-19, frequency of SLE and SpA were significantly higher in patients with FMS compared to those without (31.1 % vs 11.6 %, 68.9 % vs 21.9 %, 84.4 % vs 10.3 %, 48.9 % vs 16.8 %, 31.1 % vs 23.2 % and 40 % vs 27.1; p = 0.002, p < 0.001, p < 0.001, p < 0.001, p = 0.014, p = 0.004 respectively).Severity of COVID-19, diabetes and anxiety were significant predictors of FMS(β = 1.1, p = 0.007; β = 3.03, p = 0.001 and β = 4.44, p < 0.001 respectively). Fibromyalgia increases with increase anxiety grade; the percentage of fibromyalgia was 4.7 %, 50 %, 90 % and 100 % among patients with no anxiety, mild, moderate, and severe anxiety respectively (p < 0.001).ConclusionFibromyalgia is common in RDs patients post-COVID-19. Diabetes, COVID-19 infection severity and anxiety predict the risk of developing post-COVID-19 fibromyalgia. Post-COVID-19 fibromyalgia occurred more in hypertensive, obese, anxious and patients with severe COVID infection.  相似文献   

6.
H. pylori infection has recently been associated with various vascular disorders. The aim of this study was to investigate its role in primary headache, a pathology strictly associated with vascular alterations. A total of 200 subjects affected by primary headache were evaluated. H. pylori infection was diagnosed by the 13C urea breath test. Headache was classified in tension-type headache, cluster headache, and migraine with or without aura. Prevalence of H. pylori infection and gastrointestinal (GI) symptoms were evaluated. H. pylori infection was found in 40% of the patients; prevalence of migraine without aura was found to be significantly greater in infected patients. The positive group showed no significant differences in the prevalence of the GI symptoms evaluated. In 30 infected patients, it was assessed whether the eradication of the bacterium was able to reduce frequency, intensity, and duration of clinical attacks of headache. After eradication, clinical attacks of headache completely disappeared in 17% of patients. Moreover, intensity, duration, and frequency of headache attacks were reduced in 69% of the remaining subjects. In conclusion, H. pylori infection is common in primary headache; bacterium eradication appears to be related to a significant reduction in clinical attacks of the disease.  相似文献   

7.
Digital palpation, myalgic scoring and dolorimetry are frequently used to count tender points in fibromyalgia syndrome. We aimed to investigate the probable relation between tender points count and fibromyalgia impact questionnaire and to assess which of the tender point counting methods is the most successful in predicting the severity of the disease. Tender point areas of 36 patients with fibromyalgia syndrome were assessed with three methods which are myalgic scoring, digital and dolorimetric tender points counting methods. Fibromyalgia impact questionnaire was used to measure the disease severity. The correlation between each of the assessment methods and fibromyalgia impact questionnaire was investigated. The mean count of digitally evaluated tender points was 14.86 ± 2.67 and by dolorimetry was 11.81 ± 4.48. The mean total myalgic score was found to be 24.61 ± 8.91. All of the tender point evaluation methods correlated positively with each other (P < 0.01). Fibromyalgia impact questionnaire score was also correlated with only digital palpation tender point count of these three evaluation methods (r = 0.427, P < 0.05). Digital tender point count seemed to be sufficient for assessment, and there is no need for an additional instrument for tender point evaluation.  相似文献   

8.
This study was set to investigate whether fibromyalgia increased cataract risk.Fibromyalgia patients were the case group and controls were people who never had a history of fibromyalgia. We estimated the hazard ratio of cataract by Cox proportional-hazards model. The adjusted hazard ratios were obtained by controlling variables of age, sex, and comorbidities. Stratification analysis was also performed to ensure the association of fibromyalgia and cataract.We included 6949 participants in each groups. The incidence rate of cataract in patients with fibromyalgia (108.9 per 1000 person-years) was higher than that of control group (58.9 per 1000 person-years). The risk of cataract in fibromyalgia patients was 2.48 (95% confidence interval = 2.34–2.63) times higher than subjects without fibromyalgia.Fibromyalgia is associated with higher risk of cataract.  相似文献   

9.
Studies on the prevalence of headache in systemic lupus erythematosus (SLE) have shown that it varies from 32 to 78%. The purpose of our study was to determine the prevalence and characteristics of headache in SLE compared with patients with different types of diffuse connective tissue diseases (DCTD) and its relationship with clinical and laboratory manifestations of SLE. We studied patients with SLE (SLE group) and patients with DCTD (control group). All patients were made to answer questionnaire to assess the presence of headache, characterized by at least five episodes of headache during the last year, which was classified according to the International Headache Society criteria. A total of 207 patients were studied, 115 in SLE group and 92 in the control group. The 1-year prevalence of headache was 75.7% in SLE group and 66% in the control group. When the groups were analyzed, 66.1% met the diagnostic criteria for migraine in the SLE group compared with 52.2% in the control group (p=0.04) and 13.9% for tension-type headache in SLE group compared with 16.3% in the control group. The former was the only variable that reached statistical significance comparing the two groups. Both headache and migraine were associated with Raynaud’s phenomenon in SLE patients (odds ratio of 2.80, 95% confidence interval: 1.11–7.05, p=0.02 and odds ratio of 2.34, 95% confidence interval: 1.04–5.23, p=0.03, respectively). These results suggest that headache is a common manifestation in SLE and in other DCTD and we cannot exclude the possibility that it may be related to the emotional stress induced by such clinical situations.  相似文献   

10.
Reduced labor force participation among primary care patients with headache   总被引:3,自引:0,他引:3  
OBJECTIVE: To assess the long-term impact of headache on labor force participation among primary care patients with headache. DESIGN: A 2-year cohort study comparing employment status of primary care patients with headache and that of patients with back pain. PARTICIPANTS: Patients with headache (n=662) or back pain (n=1,024) sampled from persons visiting a primary care physician who completed baseline, 1-year and 2-year follow-up interviews. MEASUREMENTS AND MAIN RESULTS: The percentage of subjects unemployed at baseline, 1 year or 2 years was determined, excluding the retired and homemakers. Among all patients, the percentage unable to obtain or keep full-time work in the year prior to each interview because of headache or back pain was also assessed. Over the 3-year period covered by the study interviews, 13% of headache and 18% of back pain patients were unable to obtain or keep full-time work because of their pain condition. Among those in the labor force, 12% of headache patients and 12% of back pain patients were unemployed for any reason at one or more interviews. Among the one in five headache patients with a poor longterm outcome, 36% were unable to obtain or keep full-time work because of headache at some time compared with 4% of headache patients with a good outcome. Among headache patients, women, persons aged 18 to 24 years, those with lower levels of education, persons with depressive symptoms, and migraineurs were more likely to have reduced labor force participation owing to headache. CONCLUSIONS: The likelihood of reduced labor force participation among primary care patients with headache was considerable and concentrated among the one in five patients with a poor long-term outcome. Headache patients at a social disadvantage in attaining occupational role stability (e.g., younger women or poorly educated patients) were more likely to report reduced labor force participation. Supported by grants from the Agency for Health Care Policy and Research (RO1 HS06168) and the National Institute of Dental Research (PO1 DE08773), and Glaxo Research Institute. The contributions of Kathleen Saunders to this research are gratefully acknowledged.  相似文献   

11.
Aim: The aim of this study was to analyze the effect of 18-week functional training (FT) program consisting in two sessions a week of in-water exercise and one of on-land exercise on pain, strength, and balance in women with fibromyalgia.

Methods: A sample consisting of 36 fibromyalgia patients was included in the study. The patients were allocated randomly into the experimental group (EG, n = 20), and control group (CG, n = 16). Standardized field-based fitness tests were used to assess muscle strength (30-s chair stand and handgrip strength) and agility/dynamic balance and static balance. Fibromyalgia impact and pain were analyzed by Fibromyalgia Impact Questionnaire (FIQ), tender points (TPs), visual analog scale (VAS).

Results: We observed a significant reduction in the FIQ (p = 0.042), the algometer scale of TP (p = 0.008), TP (p < 0.001), and VAS (p < 0.001) in the EG. The EG shows better results in leg strength (p < 0.001), handgrip strength (p = 0.025), agility/dynamic balance (p = 0.032) and balance (p = 0.006).

Conclusions: An 18-week intervention consisting in two sessions of in-water exercise and one session of on-land exercise of FT reduces pain and improves functional capacity in FM patients. These results suggested that FT could play an important role in maintaining an independent lifestyle in patients with FM.  相似文献   

12.
Fibromyalgia is a complex problem in which symptoms of anxiety and depression feature prominently. Low levels of vitamin D have been frequently reported in fibromyalgia, but no relationship was demonstrated with anxiety and depression. Seventy-five Caucasian patients who fulfilled the ACR criteria for fibromyalgia had serum vitamin D levels measured and completed the Fibromyalgia Impact Questionnaire (FIQ) and Hospital Anxiety and Depression Score (HADS). Deficient levels of vitamin D was found in 13.3% of the patients, while 56.0% had insufficient levels and 30.7% had normal levels. Patients with vitamin D deficiency (<25 nmol/l) had higher HADS [median, IQR, 31.0 (23.8–36.8] than patients with insufficient levels [25–50 nmol/l; HADS 22.5 (17.0–26.0)] or than patients with normal levels [50 nmol/l or greater; HADS 23.5 (19.0–27.5); Kruskal–Wallis ANOVA on ranks p<0.05]. There was no relationship with global measures of disease impact or musculoskeletal symptoms. Vitamin D deficiency is common in fibromyalgia and occurs more frequently in patients with anxiety and depression. The nature and direction of the causal relationship remains unclear, but there are definite implications for long-term bone health.  相似文献   

13.
Fibromyalgia may present with widespread pain and tenderness, fatigue, anxiety, and depression and is associated with a low pain threshold. The etiology of fibromyalgia is yet to be ascertained, although both genetic and environmental factors may play a role in the susceptibility of patients to fibromyalgia. Various genetic variations have been investigated to explain fibromyalgia susceptibility and differences in pain sensitivity, pain threshold, and tolerance. The A118G rs1799971 polymorphism in the opioid receptor μ1 gene (OPRM1) is one of the candidate genes. We hypothesized that the OPRM1 polymorphism may play a role in fibromyalgia susceptibility and impact the pain intensity and pain-related symptoms in fibromyalgia patients. This study comprised of 108 patients with fibromyalgia and 100 healthy controls. Overall, the 118G allele frequency was 16.3 % and was significantly lower in patients with fibromyalgia than in the control group (13.9 and 19 %, respectively). No difference was observed between fibromyalgia patients with and without the A118G allele with regard to the Beck Depression Inventory, widespread pain index, symptom severity, and Fibromyalgia Impact Questionnaire scores. All body parts of patients with fibromyalgia demonstrated lower pressure pain thresholds (PPT) compared to controls. The PPTs were higher in the 118 A/A genotype carrier fibromyalgia patients than in 118*/G carriers; however, the differences were not significant. As the A118G polymorphism frequency was lower in fibromyalgia patients, this polymorphism may exert a protective effect against fibromyalgia in Turkish women. However, the OPRM1 polymorphism does not have a significant effect on pressure pain and fibromyalgia severity.  相似文献   

14.
OBJECTIVE: Headaches--especially of migrainous type--have been considered part of the disease spectrum of systemic lupus erythematosus (SLE). We wished to characterize prevalence and types of headaches in SLE and find out if headache is associated with disease, personality traits, or other psychological factors. METHODS: Fifty-eight consecutive Caucasian patients with SLE were given a clinical examination. We recorded SLE disease activity according to the SLE Disease Activity Index, types of headache according to International Headache Society criteria, and personality traits and emotional status according to Minnesota Multiphasic Personality Inventory-2 and Beck Depression Inventory (BDI). RESULTS: Thirty-eight SLE patients (66%) were headache sufferers; of these, 22 patients (38%) had migraine and 21 (36%) had tension-type headache. Headaches were not associated with disease activity or any other disease associated variable, including tests for antiphospholipid antibodies. Migraine was associated only with a tendency to social isolation and anxiety, while tension-type headache was associated with psychological distress, such as anxiety, somatic complaints, reduced energy, mental tension, social discomfort and withdrawal, and depressive mood according to the BDI. CONCLUSION; Migraine and tension-type headaches occur frequently in patients with SLE. Migraine shows the same clinical presentation as in a non-SLE population, and may not be part of a neuropsychiatric disease spectrum. This also applies to tension-type headache, which in contrast to migraine shows some associations with emotional and personality traits, and could represent components of a chronic pain syndrome.  相似文献   

15.
Fibromyalgia is a disorder characterized by chronic widespread pain. In this study, we investigated the effect of intravenous infusions of lidocaine in pain and quality of life of patients with fibromyalgia. Twenty-three consecutive patients were included in the study, which consisted on five sequential intravenous 2% lidocaine infusions with rising dosages (2–5 mg/kg, days 1–5). Fibromyalgia Impact Questionnaire (FIQ), Health Assessment Questionnaire, and a visual analog scale (VAS) for pain were applied before the first lidocaine infusion, immediately after the fifth infusion and 30 days after the fifth infusion. A significant improvement was observed in the FIQ scores after the fifth infusion (73.52 ± 16.56 vs 63.29 ± 21.21, p = 0.02), which was maintained after 30 days (73.52 ± 16.56 vs 63.85 ± 24.59, p = 0.04). Similar results were seen concerning the VAS: 8.19 ± 1.76 vs 6.84 ± 2.44, p = 0.01 and 8.19 ± 1.76 vs 7.17 ± 2.35, p = 0.05, respectively. Intravenous lidocaine infusions are safe and effective in the management of fibromyalgia.  相似文献   

16.
The aim of the present study was to assess the peripheral proenkephalin-A system in order to determine if it is related in any way to age and/or the type of headache. Our results show no significant change in plasma met-enkephalin (ME) and neutrophil met-enkephalin-containing peptide (NMECP) with aging in controls. Plasma ME levels and NMECP in patients suffering from migraine without aura and tension-type headaches were found to be similar in both groups, younger and older than 60 years old. When ME plasma levels were compared among the three groups of subjects in the two age-groups, only chronic tension-type headache patients differed ( [Formula: see text] ) from both controls and migraine without aura subjects.  相似文献   

17.
Objective. To study, for the first time, service utilization and costs in fibromyalgia, a prevalent syndrome associated with high levels of pain, functional disability, and emotional distress. Methods. Five hundred thirty-eight fibromyalgia patients from 6 rheumatology centers were enrolled in a 7-year prospective study of fibromyalgia outcome. Patients were assessed every 6 months with validated, mailed questionnaires which included questions regarding fibromyalgia symptoms and severity, utilization of services, and work disability. Results. Fibromyalgia patients averaged almost 10 outpatient medical visits per year, and when nontraditional treatments were considered, this number increased to ∼1 visit per month. Patients were hospitalized at a rate of 1 hospitalization every 3 years. In each 6-month study period, patients used a mean of 2.7 fibromyalgia-related drugs. Costs increased over the course of the study. The mean yearly per-patient cost in 1996 dollars was $2,274. However, results were skewed by high utilizers, and many patients used few services and had limited costs. Total costs and utilization were independently associated with the number of selfreported comorbid or associated conditions, functional disability, and global disease severity. Compared with patients with other rheumatic disorders, those with fibromyalgia were more likely to have lifetime surgical interventions, including back or neck surgery, appendectomy, carpal tunnel surgery, gynecologic surgery, abdominal surgery, and tonsillectomy, and were more likely than other rheumatic disease patients to report comorbid or associated conditions. Almost 50% of hospitalizations occurring during the study were related to fibromyalgia-associated symptoms. Conclusion. The average yearly cost for service utilization among fibromyalgia patients is $2,274. Fibromyalgia patients have high lifetime and current rates of utilization of all types of medical services. They report more symptoms and comorbid or associated conditions than patients with other rheumatic conditions, and symptom reporting is linked to service utilization and, to a lesser extent, functional disability and global disease severity.  相似文献   

18.
Oxidative stress is thought to play a role in the pathogenesis of fibromyalgia. We examined the hypothesis that oxidative stress was increased in patients with fibromyalgia and related to the severity of symptoms. Urinary F2-isoprostane excretion was measured in 48 patients with fibromyalgia and compared to those of 96 control subjects. In patients, we examined the association between oxidative stress and symptoms. Patients with fibromyalgia were significantly more symptomatic than control subjects, but urinary F2-isoprostane excretion did not differ significantly (2.3 ± 1.9 vs. 2.8 ± 2.2 ng/mg creatinine, p = 0.16). In patients with fibromyalgia, F2-isoprostane excretion was associated with fatigue visual analog scale (rho = 0.30, p = 0.04) but not with pain, quality of life, functional capacity, depression, number of tender points, or overall impact of fibromyalgia. Oxidative stress is not increased in patients with fibromyalgia, but as was previously found in patients with systemic lupus erythematosus, oxidative stress was associated with fatigue. Jason D. Morrow: deceased  相似文献   

19.
Aim: The purpose of this study was to compare the depression and quality of life (QOL) scores of fibromyalgia (FM) patients and control subjects. We also aimed to detect relationships between different QOL scales, depression and clinical symptoms. Method: Ninety‐eight fibromyalgia patients and 48 healthy volunteers were included in the study. Depression was evaluated by a psychiatrist according to the Hamilton Depression Rating Scale and Diagnostic and Statistical Manual for Mental Disorders Edition 4 (DSM‐IV) criteria. QOL of the FM patients was assessed according to the Nottingham Health Profile (NHP), Health Assessment Questionnaire (HAQ), and Fibromyalgia Impact Questionnaire (FIQ). Results: We found significantly higher scores of depression, NHP, FIQ and HAQ in FM patients compared with controls (P < 0.000). Pain, tender point count (TPC), pain intensity, skinfold tenderness, FIQ, HAQ, and NHP scores were higher in patients with depression than in those without depression. Depression scores correlated with FIQ (r = 0.39, P < 0.01), HAQ (r = 0.35, P < 0.01), NHP (r = 0.55, P < 0.01) scores, TPC (r = 0.34, P < 0.01) and duration of disease (r = 0.21, P < 0.05). Fibromyalgia Impact Questionnaire scores correlated with HAQ scores (r = 0.45, P < 0.01), NHP scores (r = 0.49, P < 0.01) and TPC (r = 0.21, P < 0.05). HAQ scores correlated with NHP scores (r = 0.40, P < 0.01) and TPC (r = 0.29, P < 0.05). Nottingham Health Profile scores correlated with TPC (r = 0.43, P < 0.01) and duration of disease (r = 0.22, P < 0.05). Conclusion: We found higher scores of TPC, pain intensity, skinfold tenderness, NHP, FIQ, and HAQ in depressive FM patients as compared with non‐depressive FM patients. Our study indicates that there is an important relationship between pain, depression and QOL scales in young FM patients. Therefore; these patients should be managed using a multidisciplinary approach including psychiatric support.  相似文献   

20.
Abstract. Objectives. To evaluate the efficacy of self-administered subcutaneous sumatriptan in the acute treatment of early-morning migraine attacks. Design. A double-blind, randomized, placebo-controlled, cross-over study. Setting. Thirteen neurology centres in France. Subjects. Patients of either sex, 18–65 years old, with two to six attacks of migraine (according to the International Headache Society (IHS) criteria, with or without aura) per month, of which at least two had to be early-morning migraine attacks. One-hundred-and-one patients were included, 96 being evaluable for the first attack and 81 for the cross-over design. Interventions. Two migraine attacks (grade 2/3) were treated with sumatriptan (6 mg) or placebo, with an optional second injection 1–24 h later. Main outcome measures. The primary end-point was headache relief: reduction in headache severity from grade 2/3 (moderate/severe) to grade 1/0 (mild/none) 2 h after treatment. Results. Sumatriptan was superior to placebo for headache relief (32 [78%] vs. 11 [28%] at the first attack; 29 [73%] vs. 8 [20%] at the second; P < 0.001). Because of a significant carry-over effect for some of the secondary end-points, a parallel-group analysis of the first attack was performed, which confirmed a significantly higher efficacy of sumatriptan for all end-points: pain-free rate (22 [46%] vs. 7 [15%]; P = 0.001) and use of a second injection (26 [53%] vs. 38 [81%]; P = 0.004). Sumatriptan was preferred by 74% of patients vs. 17% for placebo, and 9% expressed no preference (P < 0.0001). After complete relief, headache reappeared in 8/23 (35%) patients with sumatriptan and 3/7 (43%) with placebo. Adverse events were significantly more frequent with sumatriptan but they were minor and transient. Conclusion. Subcutaneous sumatriptan auto-injection is an effective and well-tolerated acute treatment of early-morning migraine attacks allowing earlier return to normal activity.  相似文献   

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