Information about migraine disability influences physicians' perceptions of illness severity and treatment needs.

OBJECTIVE: To assess physician-patient communication about headache-related disability and to evaluate the influence of information about disability on physicians' perceptions of illness severity and the treatment needs of migraineurs. BACKGROUND: Evidence suggests that migraine is suboptimally treated in clinical practice, partly due to poor communication between physicians and their patients. METHODS: One hundred five neurologists and primary care physicians with an interest in headache participated in two interactive surveys, one in North America (n=42) and one in Europe (n=63). Each survey focused on the evaluation of four videotaped migraine cases. The first case was evaluated twice, initially after a typical symptom history that centered on diagnosis and then following a fuller history of migraine disability. Additional questions assessed the extent of the collection of migraine disability information in clinical practice. RESULTS: Physicians reported that they recorded symptoms relating to diagnosis (eg, pain location/intensity, associated symptoms) rather than information on headache-related disability. Only about one third of patients volunteered disability information. When made available to them, physicians rated information on disability as one of the most important factors in assessing treatment needs. In particular, when physicians knew the patient's disability history: (1) the proportion of physicians who rated the patient's illness as "severe" increased by 128% in North America, 27% in Europe; (2) the proportion of physicians who recommended immediate treatment increased by 63% in North America, 37% in Europe; and (3) the proportion of patients recommended for a follow-up visit increased by 15% in North America, 18% in Europe. CONCLUSIONS: Physicians and patients often fail to discuss headache-related disability during consultation. This information has a powerful influence on physicians' perceptions of illness severity, treatment choice, and the need for follow-up. Tools to improve communication about headache-related disability, such as the Migraine Disability Assessment questionnaire, may favorably improve migraine management.

Stratified care vs step care strategies for migraine: the Disability in Strategies of Care (DISC) Study: A randomized trial.

CONTEXT: Various guidelines recommend different strategies for selecting and sequencing acute treatments for migraine. In step care, treatment is escalated after first-line medications fail. In stratified care, initial treatment is based on measurement of the severity of illness or other factors. These strategies for migraine have not been rigorously evaluated. OBJECTIVE: To compare the clinical benefits of 3 strategies: stratified care, step care within attacks, and step care across attacks, among patients with migraine. DESIGN AND SETTING: Randomized, controlled, parallel-group clinical trial conducted by the Disability in Strategies Study group from December 1997 to March 1999 in 88 clinical centers in 13 countries. PATIENTS: A total of 835 adult migraine patients with a Migraine Disability Assessment Scale (MIDAS) grade of II, III, or IV were analyzed as the efficacy population; the safety analysis included 930 patients. INTERVENTIONS: Patients were randomly assigned to receive (1) stratified care (n = 279), in which patients with MIDAS grade II treated up to 6 attacks with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg, and patients with MIDAS grade III and IV treated up to 6 attacks with zolmitriptan, 2.5 mg; (2) step care across attacks (n = 271), in which initial treatment was with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg. Patients not responding in at least 2 of the first 3 attacks switched to zolmitriptan, 2.5 mg, to treat the remaining 3 attacks; and (3) step care within attacks (n = 285), in which initial treatment for all attacks was with aspirin, 800 to 1000 mg, plus metoclopramide, 20 mg. Patients not responding to treatment after 2 hours in each attack escalated treatment to zolmitriptan, 2.5 mg. MAIN OUTCOME MEASURES: Headache response, achieved if pain intensity was reduced from severe or moderate at baseline to mild or no pain at 2 hours; and disability time per treated attack at 4 hours for all 6 attacks, compared among the 3 groups. RESULTS: Headache response at 2 hours was significantly greater across 6 attacks in the stratified care treatment group (52.7%) than in either the step care across attacks group (40.6%; P<.001) or the step care within attacks group (36.4%; P<.001). Disability time (6 attacks) was significantly lower in the stratified care group (mean area under the curve [AUC], 185.0 mm. h) than in the step care across attacks group (mean AUC, 209.4 mm. h; P<.001) or the step care within attacks group (mean AUC, 199.7 mm. h; P<.001). The incidence of adverse events was higher in the stratified care group (321 events) vs both step care groups (159 events in across-attack group; 217 in within-attack group), although most events were of mild-to-moderate intensity. CONCLUSION: Our results indicate that as a treatment strategy, stratified care provides significantly better clinical outcomes than step care strategies within or across attacks as measured by headache response and disability time. JAMA. 2000;284:2599-2605.

A double-blind, multicentre, placebo-controlled study of tiludronate in Paget's disease of bone.

A multicentre, randomised, placebo-controlled, dose-ranging study was conducted to investigate the therapeutic activity and sustained efficacy of tiludronate (200 mg, 400 mg and 600 mg once daily) taken orally for 12 weeks in patients with Paget's disease. Serum alkaline phosphatase concentrations were compared with baseline at weeks 12 and 24; treatment success was defined as a 50% reduction compared with baseline. Changes in the hydroxyproline: creatinine ratio were also measured. Pain was assessed using the Huskisson Visual Analogue Scale and by questionnaire. Patients completing at least 11 weeks of treatment were followed-up 18 months later by postal questionnaire. Significantly greater numbers of patients in the tiludronate groups successfully responded to treatment compared with the placebo group. A dose-response was observed; the percentage of patients responding to treatment being 31% (200 mg), 52% (400 mg) and 82% (600 mg) at week 12 and 45% (200 mg), 70% (400 mg) and 82% (600 mg) at week 24. Tiludronate treatment also significantly reduced hydroxyproline: creatinine ratios compared with placebo, again showing a dose response. Dose-related gastrointestinal symptoms were the commonest adverse events, occurring in 2.4%, 11.0%, 5.5% and 18.9% of patients receiving placebo and tiludronate 200, 400 and 600 mg daily, respectively. The response to oral tiludronate was sustained for more than 18 months in some patients and there was evidence of a reduction in the longer term complications of the disease. These results show that oral tiludronate is an effective, well-tolerated treatment for Paget's disease; the 400 mg once daily dose appears to offer the optimum balance of efficacy and tolerance.