Short term effect of methotrexate in severe steroid-dependent asthma

The steroid-sparing capacity of methotrexate in asthmatics is still being debated. The present study was undertaken to evaluate the effect of low-dose methotrexate on steroid consumption in patients with severe asthma, who require very high doses of systemic corticosteroids. We conducted a randomized, double-blind, parallel clinical trial in 24 patients with long-standing asthma. After a 3-week run-in period, patients received a 16-week course of either 15 mg of oral methotrexate weekly or matched placebo in addition to their previous asthma therapy. The daily steroid dose (at run-in 30 ± 14 mg/day in the methotrexate group; 25 ± 9 mg/day in the placebo group (NS)) decreased by 24% in the methotrexate group (p < 0.01) and by 5% in the placebo group (NS) during weeks 9–16 of the treatment period when compared with run-in values. However, there was no difference in steroid consumption between the two groups at any time. We conclude that in patients with severe asthma who require very high doses of systemic corticosteroids, short-term treatment with methotrexate allows only a marginal steroid reduction. Our study does not support the use of methotrexate as a steroid-sparing agent in asthmatics. Offprint requests to: H. Magnussen     

Fatigue in patients with systemic lupus erythematosus: lack of associations to serum cytokines, antiphospholipid antibodies, or other disease characteristics

OBJECTIVE: To determine if fatigue in patients with systemic lupus erythematosus (SLE) is associated with levels of serum cytokines, antiphospholipid antibodies (aPL), or other disease features. METHODS: In a cross sectional study 57 Caucasian patients with SLE were subjected to clinical neurological examination and cerebral magnetic resonance imaging (MRI). Fatigue was evaluated by Fatigue Severity Scale (FSS) and disease activity by SLE Disease Activity Index (SLEDAI). Serum levels of tumor necrosis factor-alpha (TNF-alpha), interleukin 2 (IL-2), IL-6, IL-10, transforming growth factor-beta (TGF-beta), interferon-alpha (IFN-alpha), anticardiolipin antibody (aCL) IgG and IgM, as well as anti-beta2-glycoprotein I antibody (anti-beta2-GPI) IgG and IgM were analyzed by ELISA. RESULTS: Four of 5 patients with SLE had fatigue (FSS score > or = 3). There were no associations between fatigue and any sociodemographic variables, medication for SLE, disease activity, cerebral infarcts, serum cytokines, aCL or beta2-GPI antibodies, or any routine hematological, biochemical, or immunological tests. CONCLUSION: Fatigue is a common phenomenon in patients with SLE. There is no association to disease activity or other markers of disease or inflammation. Fatigue is a complex phenomenon, and cytokine involvement in brain tissue not reflected by cytokine serum concentrations in this study cannot be excluded. Alternatively, psychosocial factors may well be the dominant predictor of fatigue in patients with SLE.     

Patient satisfaction with a neurological specialist consultation for headache

OBJECTIVE: To evaluate patient satisfaction with a specialist consultation for headache and thus identify subgroups of headache patients more satisfied than others. DESIGN: A survey of consecutive patients referred to a neurologist for headache. SETTING: Neurological outpatient clinics in North Norway. PATIENTS: We included 889 consecutive patients referred to a specialist centre for headache during a period of 2 years. Using a questionnaire, we recorded patients' satisfaction with the potential treatment initiated by the specialist. RESULTS: Sixty-three percent of migraine patients (95% CI, 0.58 to 0.68) were satisfied with the consultation, compared to 44% of patients with non-migrainous headache (95% CI, 0.40 to 0.70), (p = 0.01). Altogether 481 patients had some kind of measure recommended by the neurologist, and 317 of these (66%) were satisfied (95% CI, 0.62 to 0.70). Patients with tension-type headache and those who were not prescribed specific treatment modalities were less satisfied. CONCLUSION: The study confirms that patients with headache are satisfied with a neurological specialist consideration, especially in the case of migraine.     

Aspects of referral care for headache associated with improvement

OBJECTIVE: To assess which aspects of referral care for headache are associated with improvement of pain and subjective quality of life. BACKGROUND: In managed care, referrals to a specialist are sometimes kept to a minimum. It has been questioned whether patients with headache do better after consultation with a specialist. METHODS: We mailed a questionnaire to all patients referred for headache to a neurologic center in northern Norway during a 2-year period (n = 1403). The questionnaire included items concerning diagnosis and treatment, along with simple visual analog scales to assess whether the patient's headache syndrome and self-perceived quality of life had changed after seeing the specialist. RESULTS: There were 1052 responders (75%). Headache generally decreased after consultation with a specialist; it decreased significantly more in the 527 patients who were assigned a diagnosis compared to the 344 patients who claimed they were not. Reduction of headache also was significantly more obvious in the 483 patients who had treatment prescribed, as compared to the 385 patients not receiving any therapeutic measure. Self-perceived quality of life was generally improved, significantly more when the patient was given a diagnosis, and even when the diagnosis did not lead to treatment. CONCLUSIONS: Patients referred to a neurologic center for evaluation of headache generally experience a significantly greater improvement in their headache syndrome and quality of life. This appears particularly so when they receive a diagnosis, even if no treatment is prescribed.     

Reproducibility of quantitative coronary analysis

Because of limited storage capacity for digital images, angiographic laboratories without cinefilm are dependent on locally performed quantitative coronary angiography (QCA) in clinical studies. In the present study the intra-and interobserver variability, as well as variability between different laboratories and variability due to frame selection was analyzed. A total of 20 coronary lesions were studied in two different digital laboratories 12±8 days apart. Images were analyzed on-line and after being transferred to a Cardiac Work Station (CWS). There was no significant difference between the measurement situations. For minimal luminal diameter (MLD) precision (SD of signed errors) ranged from 0.12 mm to 0.20 mm, for reference diameter (RD) from 0.15 mm to 0.28 mm, and for percent diameter stenosis (DS) from 4.2% to 5.8%. Overall relative precision was obtained by normalizing the QCA parameters, and was 11.9% for MLD, 7.0% for RD and 8.5% for DS (p<0.001, RD and DS compared to MLD). The overall variability in the interobserver and in the interlaboratory comparisons was 11.2% and 10.4%, respectively (n.s.) (n.s.). Thus the variability of QCA performed in cinefilmless, digital laboratories is small, and within a range making it an useful tool for clinical practice and group comparisons in clinical studies. However, the error range of QCA measurements must be taken into consideration when judging results from individual patients.