Enhancing antiepileptic drug adherence: a randomized controlled trial. A randomised trial of strategies to improve patient compliance with anticonvulsant therapy. A psychosocial self-management program for epilepsy: a randomized pilot study in adults. A structured, nurse-led intervention program improves quality of life in patients with epilepsy: a randomized, controlled trial. Topiramate in medically intractable partial epilepsies: double-blind placebo-controlled randomized parallel group trial. Korean Topiramate Study Group. Neuropsychological assessment of subjects with uncontrolled epilepsy: effects of EEG feedback training. A randomized, double-blind, placebo-controlled trial of topiramate in adults with epilepsy and intellectual disability: impact on seizures, severity, and quality of life. Treatment of refractory epilepsy with intravenous immunoglobulins. Results of the first double-blind/dose finding clinical study. Cognitive-behavior therapy with adult patients with epilepsy: a controlled outcome study.
Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (P<0.01). The implementation intention intervention may be an easy-to-administer and effective means of promoting AED adherence. Fifty-three hospital outpatients with epilepsy were randomly allocated to either a control or an intervention group. Patients in the intervention group were subjected to a combination of compliance-improving strategies: patient counselling, a special medication container, self-recording of medication intake and seizures, and mailed reminders to collect prescription refills and attend clinic appointments. Compliance with anticonvulsant therapy (as measured by plasma anticonvulsant levels and prescription refill frequencies), and seizure frequency, were evaluated in each patient prior to intervention and 6 months afterwards. Patient compliance and clinical control improved significantly in the intervention group patients. Seizure frequency was, on average, halved following intervention. Compliance and seizure frequency were unaltered in the control group. Intervention failed to improve clinic appointment keeping. Poor compliance with drug therapy commonly confounds the treatment of epilepsy. This study shows that compliance can be improved and seizure frequency lessened by strategies that are easily incorporated into the routine management of epileptic patients. The goal of the work described here was to develop and pilot a theoretically based self-management intervention in adults with epilepsy.
                A randomized, controlled trial examined intervention effectiveness of a 6-week psychosocial intervention designed to improve self-efficacy and quality of life for 61 adults with diagnosed epilepsy. Measures included the Quality of Life in Epilepsy-89 inventory (QOLIE-89), the Washington Psychosocial Seizure Inventory (WPSI), a locus of control scale (LOC), and the Epilepsy Self-Efficacy Scale-2000 (ESES). Group differences were examined between groups using analysis of covariance.
                There was a significant improvement in the QOLIE-89 Role Limitations-Emotional score in the treatment group at follow-up, but no significant differences in overall quality of life. Strong and significant correlations were observed between outcome measures.
                Although the intervention had little effect on improving overall quality of life, we observed promising trends in postintervention group comparisons linking self-efficacy and other psychosocial factors with quality of life. Intervention material can be modified for stage-based behavior change and retested in another study. We tested the hypothesis that structured epilepsy nursing improves quality of life (QOL). One hundred fourteen adult patients with uncontrolled epilepsy were randomly assigned to either an intervention group or a control group. The intervention group was offered an interactive, 1-day group education program followed by extended nurse follow-up and counseling. The nurse was present at as many outpatient consultations as possible and performed repeated consultations by telephone. All patients completed the QOLIE-89 before randomization and after 2 years. QOL was significantly improved from inclusion to completion of study in the intervention group (P=0.019), mainly in the subitems for Health Discouragement (P=0.01), Medication Effects (P=0.035), and Physical Role Limitations (P=0.05). To our knowledge, this is the first study to demonstrate a significant effect of a structured nurse-led intervention program in QOL of patients with epilepsy. To evaluate the efficacy and safety of topiramate (TPM) as add-on therapy in medically intractable partial epilepsies.
                We used a multicenter double-blind placebo-controlled randomized parallel-group trial consisting of 12 weeks of baseline phase, 10 weeks of titration phase, and 8 weeks of stabilization phase. The primary efficacy variable was the median seizure frequency reduction rate (MSFRR), and the other efficacy variables included responder rate, seizure-free rate, and global evaluations by the patient and the physician. The patient should have partial epilepsies refractory to the maximally tolerable doses of one to two antiepileptic drugs (AEDs) and should have two or more episodes of clinical seizures every 4 weeks during the baseline phase. The target dose of study drugs was 600 mg/day. The study drugs were started at the initial dose of 50 mg/day and gradually increased to the target dose over a 10-week period.
                A total of 177 patients was randomized into the TPM group (n = 91) and the placebo (PLC) group (n = 86). Baseline median seizure frequencies were 5.6 episodes/4 weeks in the TPM and the PLC groups. Among those who were randomized, 174 patients (TPM, 89 patients; PLC, 85 patients) were available for the efficacy measurement by intention-to-treat analysis. The MSFRR was 51.3% for TPM and 9.1% for PLC, which was highly in favor of TPM (p = 0.0001). The responder rate was 50.6% for TPM and 12.9% for PLC (p = 0.001). Seven (7.9%) of 89 patients taking TPM became seizure free compared with one (1.2%) of 85 patients taking PLC (p = 0.004). The global evaluation greatly favored TPM (p = 0.001). The incidence of adverse events (AEs) was higher in the TPM (81.3%) than in the PLC (48.9%) group, with central nervous system (CNS)-related AEs being the most frequent. Among individual AEs, anorexia (20.9%) and abdominal pain or discomfort (20.9%) were the most common AEs in the TPM group. AEs precipitated early drop-out in seven (7.6%) patients taking TPM and three (3.5%) patients taking PLC. No serious systemic AEs were observed.
                TPM was highly effective and safe as add-on therapy in medically intractable partial epilepsies. Slower titration of TPM might be responsible for the lesser drop-out rate than previous trials, but the incidence of AEs was still high. The AE profile of TPM in Koreans was different from that in whites. A battery of neuropsychological tests was administered at baseline, postcontrol period, and posttraining period to 24 drug-refractory subjects with epilepsy participating in a study of sensorimotor electroencephalographic (EEG) normalization feedback training. Results revealed the following. First, subjects exhibited significant baseline deficits in psychosocial, cognitive and motor functioning. Second, certain tests discriminated subjects before training who were subsequently above and below the median in seizure reduction following EEG training. Subjects who showed the greatest seizure reduction performed better on a test of general problem-solving ability but not on other cognitive tests and worse on tests involving strong motor components and were more intact psychosocially. These subjects also took significantly fewer medications in combination than did less successful subjects. Third, improvement on several measures occurred following participation in the study. Cognitive and motor functioning improved only in subjects with the greatest seizure reduction and only after actual training as opposed to control conditions. Psychological functioning, as measured by the Minnesota Multiphasic Personality Inventory (MMPI) improved in both outcome groups. MMPI improvement, unlike cognitive improvement, was as likely to occur after control conditions, when seizure reduction had not yet occurred, as after EEG training. Thus, MMPI changes apparently reflected the nonspecific benefits of participation in this study. This randomized, double-blind, placebo-controlled UK trial evaluated the effect of topiramate as add-on therapy on seizure frequency, seizure severity, and quality of life in patients with epilepsy and intellectual disability. There were three phases: 4 weeks baseline, 18 weeks titration to 200-400 mg topiramate/day (adults) or 5-9 mg/kg/day (children), 12 weeks maintenance. Recruitment was low (88/120); analyses were underpowered. Seizure frequency varied enormously (median 17.7, maximum 1706.2). There was no significant difference in reduction in mean total seizure frequency or number of responders between the groups. Topiramate reduced seizure frequency by >30% from baseline (placebo 1%); post hoc analyses showed a trend toward significance (R ratio, P=0.052). There were no significant differences between the groups with respect to mean seizure severity or other outcome measures. Topiramate was generally well tolerated; body weight (P=0.015) and systolic blood pressure (P=0.043) were reduced. The study suggests that topiramate reduces seizure frequency in patients with epilepsy and intellectual disability without the added burden of behavior effects, and was potentially advantageous to physical well-being. Sixty-one refractory epileptic patients (46 with partial epilepsy) were treated with intravenous immunoglobulins in a controlled double-blind/dose finding clinical trial; 18 (7 females, mean age 18.5 years) received placebo, while 14 (3 females, mean age 26.2 years, 2 excluded), 14 (4 females, mean age 24.6 years, 1 excluded) and 15 (5 females, mean age 24.4 years) patients received 100, 250 and 400 mg/kg per infusion of intravenous immunoglobulins, respectively. Seven perfusions were scheduled, four the 1st week, and thereafter one during the 2nd, 3rd and 6th week. The patients were followed for 6 months. An optional infusion was given at the end of the study. A comparison of the mean number of seizures per day was made between the baseline (4 weeks before the first infusion) and the 6th month after the first infusion. Patients were considered responders if they had a decrease of at least 50% in daily seizure frequency at the end of the study compared with the baseline. We did not find severe adverse events. One patient had to stop infusions for possible related side effects (vomiting). When all patients were analyzed together, we found a positive trend in favor of intravenous immunoglobulin treatment, but this was not significant (P = 0.095). There was no relationship between dose and efficacy (P = 0.31). When the largest group with partial epilepsy was analyzed separately, we noted 19 responders in the test group, compared with 2 in the placebo.(ABSTRACT TRUNCATED AT 250 WORDS) The present study evaluated the efficacy of group cognitive-behavior therapy for the alleviation of psychosocial problems and reduction of seizures with adult epileptic patients. Twenty-seven outpatients were randomly assigned to one of three groups: Cognitive-Behavior Therapy, Supportive Counseling (attention-placebo control), and Waiting list (no treatment control). The major outcome measures used were: patient's, neurologist's, and therapist's global ratings of psychological adjustment, patient's target complaints and weekly seizure frequency, patient's and neurologist's ratings of seizure control, the Minnesota Multiphasic Personality Inventory, the Washington Psychosocial Seizure Inventory, and the Beck Depression Inventory. No significant differences were found among the three groups on these measures except for therapist's global ratings of psychological adjustment, on which both the Cognitive-Behavior Therapy and Supportive Counseling groups improved significantly after therapy, but the Waiting List control group did not. Overall, little support was found for the efficacy of group cognitive behavior therapy (eight 2-h weekly sessions) for the reduction of psychosocial difficulties or seizures. Implications of the present findings are discussed, with the need for further controlled outcome research stressed.
It is not possible to draw any conclusions about the role of immunomodulatory interventions in reducing seizure frequency or the safety of these agents in adults with epilepsy. Further randomised controlled trials are needed.