The prophylactic effect of flunarizine and metoprolol was studied in a multi-center randomized, double-blind trial of 149 patients with migraine with or without aura. After a 4-week placebo run-in period, patients were randomly allocated to treatment with flunarizine 10 mg daily or metoprolol 200 mg daily for 16 weeks (parallel group design). Both drugs reduced the number of migraine days per month by 37% (95% confidence interval 21-53%) compared with the placebo run-in period. All efficacy parameters were significantly reduced by both drugs and no significant difference was found between the two drugs at any time of the treatment period. However, calculation of the 95% confidence limits showed that each drug may have a superiority of more than 100% on a single main effect parameter. The most common adverse experiences were day-time sedation (both drugs) and weight gain (flunarizine). Depression was the most serious side-effect occurring in 8% on flunarizine and 3% on metoprolol. We conclude that both drugs are effective in the prevention of migraine attacks but a higher number of dropouts occurred on flunarizine because of depression or weight gain.
Preference is a composite, patient-oriented endpoint incorporating efficacy, tolerability, formulation, and convenience of medications. The objective of this study was to compare patient preference for rizatriptan 10-mg wafer vs. eletriptan 40-mg tablet for acute treatment of migraine. In this multicentre, open-label, two-period, crossover study, out-patients were randomly assigned to treat the first of two moderate to severe migraines with rizatriptan or eletriptan and the second with the alternate therapy. Patients completed diary assessments at baseline and up to 24 h after taking study medication. At the last visit, patients completed a psychometrically validated preference questionnaire. A total of 372 patients (mean age 38 years, 85% female) treated two migraine attacks, and 342 patients (92%) expressed a preference for treatment. Significantly more (P < or = 0.001) patients preferred rizatriptan 10-mg wafer [61.1%; 95% confidence interval (CI) 55.7, 66.3] to eletriptan 40-mg tablet (38.9%; 95% CI 33.7, 44.3). The most common reason given for preference of either treatment was speed of headache relief. At 2 h, 80% and 69% of patients reported that rizatriptan and eletriptan, respectively, was convenient or very convenient to take (mean convenience score 1.99 vs. 2.31, respectively; P < or = 0.001). Both triptans were well tolerated. In this head-to-head study designed to evaluate global patient preference, significantly more patients preferred the rizatriptan 10-mg wafer to the eletriptan 40-mg tablet for acute treatment of migraine. The single most important reason for preference was speed of relief, consistent with results from previous preference studies.
We examined the effect of acupuncture on epileptic seizures in humans in a controlled clinical setting. Treatment was administered by two Chinese professors of acupuncture. Effect was measured by change in seizure frequency. Twenty-nine patients with chronic intractable epilepsy completed the study. They were randomized in two groups; 15 were given classical acupuncture and 14 were given sham acupuncture. There was a reduction in seizure frequency in both groups, which did not reach a level of statistical significance. There was also an increase in the number of seizure-free weeks in both groups, which reached a level of significance in the sham group. Thus, we have not been able to prove a beneficial effect of acupuncture in chronic intractable epilepsy.
Although few neurologists are formally trained in traffic medicine, they are frequently asked to assess whether a patient is medically fit to drive. For patients with epilepsy, the physician must assess the risk of the patient having a seizure while driving, and decide what is an acceptable risk. The legislation on this subject is aiming at finding a reasonable balance between two important considerations: public safety and a patient's individual need to drive. For the neurologist to explain and put into practice the legislation may be a demanding task and a challenge to the doctor-patient alliance. The decision on driving capability should be tailored to the individual patient and based on careful evaluation and informed judgement. In Norway, to qualify for a driver's license, a seizure-free interval of at least 12 months is currently required for group 1 drivers (passenger cars), whereas group 2 drivers (heavy motor vehicles, commercial driving) must have been seizure-free for at least 10 years and not have experienced epileptic seizures from the age of 18 years. Norwegian physicians are obliged to report patients with seizures to driving authorities, although this is an unpopular rule. In reviewing the available literature, it is apparent that despite there being relatively few sound studies, the risks of car accidents among persons with epilepsy may previously have been overestimated.
The objective of this study was to assess the effect on health-related quality of life of acupuncture and sham acupuncture as adjunctive treatment in intractable epilepsy. We performed a randomized controlled trail with two parallel treatment arms at The National Center for Epilepsy in Norway, a comprehensive epilepsy center. Thirty-four patients with long-standing drug resistant epilepsy completed the study. The intervention consisted of 20 acupuncture treatments (bilateral needling of three acupoints plus one or two individually chosen points) or sham acupuncture (bilateral needling with smaller needles of three points outside the traditional meridians) over 8 weeks. The main outcome measures were changes in mean health-related quality of life scores for the two groups after 8 weeks, using the 89-item Quality of Life in Epilepsy (QOLIE-89) questionnaire. We found no difference between the acupuncture and sham acupuncture groups in score changes in any dimension of the QOLIE-89 questionnaire, despite testing a large number of dimensions. We also found no change in QOLIE-89 scores between baseline and 8 weeks in either groups. In conclusion, we could not demonstrate a significant effect of traditional acupuncture or sham acupuncture on the health-related quality of life of patients with intractable epilepsy.
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