The analysis of oral nutritional supplements related aspects among patients with digestive system cancer.

OBJECTIVE: Malnutrition-related disease particularly occur in patients with digestive system cancer. The administration of oral nutritional supplements (ONSs) is one of the methods of nutritional support recommended for oncological patients. The primary aim of this study was to assess the consumption-related aspects of ONSs among patients with digestive system cancer. The secondary aim was to assess the impact of ONSs consumption on the quality of life of these patients. PATIENTS AND METHODS: The current study included 69 patients with digestive system cancer. The assessment of ONSs-related aspects among cancer patients was conducted using a self-designed questionnaire, which has been accepted by Independent Bioethics Committee. RESULTS: Among all patients, 65% of participants declared that they consumed ONSs. Patients consumed various types of ONSs. However, the most common were protein products (40%) and standard products (37.78%). Only 4.44% of patients consumed products with immunomodulatory ingredients. Nausea was the most commonly (15.56%) observed side effect after ONSs consumption. Considering particular types of ONSs, side effects were the most commonly declared by patients who consumed standard products (p=0.157). The easy product availability in the pharmacy was noted by 80% of participants. However, 48.89% of patients assessed the cost of ONSs as not acceptable (48.89%). 46.67% of studied patients did not observe the improvement of quality of life after ONSs consumption. CONCLUSIONS: We have demonstrated that patients with digestive system cancer consumed various period, amount, and types of ONSs. Side effects after ONSs consumption occur rarely. However, the improvement of quality of life related to ONSs consumption was not noted in almost half of participants. ONSs are easily available in pharmacy.

Increasing the dosage of pregabalin in patients with focal epilepsy decreases the frequency of seizures and ameliorates symptoms of anxiety, depression and insomnia.

OBJECTIVE: The effectiveness of the treatment depends on the adequate dosage of medications. In clinical practice, drugs are often used at doses that are too low, which results in suboptimal levels of clinical improvement. The aim of the study was to evaluate the effects of increasing the dose of previously taken pregabalin in a group of patients with focal epilepsy and generalized anxiety disorder (GAD). PATIENTS AND METHODS: This open study involved 993 patients (46 ± 14 years old) suffering from epilepsy with focal seizures and concomitant GAD treated with pregabalin add-on therapy. The severity of anxiety was assessed with GAD-7 Scale. The number of epileptic seizures was monitored before and after the increase of the pregabalin dose. RESULTS: On the initial visit, the mean daily dose of pregabalin was 159 ± 82 mg. During the study period (nine months) the mean dose was increased to 327 ± 163 mg. After nine months, based on the intention-to-treat analysis, 27.1% (N = 253) of the subjects experienced seizure resolution, and 57.8% (N = 539) reduction in seizure frequency by at least 50%. At the beginning of the study, despite pregabalin administration, 60.7% of patients were above the diagnostic threshold for GAD diagnosis. The add-on therapy resulted in the improvement of the depressive and anxiety symptoms, and insomnia, greater in those that experienced seizure resolution or reduction in their frequency. CONCLUSIONS: (1) Patients with focal epilepsy with concomitant anxiety disorder experience reduction in seizure frequency, improvement of anxiety, depressive symptoms and insomnia using PGB as an add-on therapy. (2) Our data suggest that pregabalin as an add-on treatment is a reasonable choice for patients with focal epilepsy who have concomitant symptoms of an anxiety disorder.

Convulsive status epilepticus management in adults and children: Report of the Working Group of the Polish Society of Epileptology.

INTRODUCTION: The Working Group was established at the initiative of the General Board of the Polish Society of Epileptology (PSE) to develop an expert position on the treatment of convulsive status epilepticus (SE) in adults and children in Poland. Generalized convulsive SE is the most common form and also represents the greatest threat to life, highlighting the importance of the choice of appropriate therapeutic treatment. AIM OF GUIDELINE: We present the therapeutic options separately for treatment during the early preclinical (>5-30min), established (30-60min), and refractory (>60min) SE phases. This division is based on time and response to AEDs, and indicates a practical approach based on pathophysiological data. RESULTS: Benzodiazepines (BZD) are the first-line drugs. In cases of ineffective first-line treatment and persistence of the seizure, the use of second-line treatment: phenytoin, valproic acid or phenobarbital is required. SE that persists after the administration of benzodiazepines and phenytoin or another second-line AED at appropriate doses is defined as refractory and drug resistant and requires treatment in the intensive care unit (ICU). EEG monitoring is essential during therapy at this stage. Anesthesia is typically continued for an initial period of 24h followed by a slow reversal and is re-established if seizures recur. Anesthesia is usually administered either to the level of the "burst suppression pattern" or to obtain the "EEG suppression" pattern. CONCLUSIONS: Experts agree that close and early cooperation with a neurologist and anesthetist aiming to reduce the risk of pharmacoresistant cases is an extremely important factor in the treatment of patients with SE. This report has educational, practical and organizational aspects, outlining a standard plan for SE management in Poland that will improve therapeutic efficacy.

Christianity and epilepsy.

Epileptic seizures have been known from time immemorial. Throughout the ages, however, ideas concerning the aetiology and treatment of epilepsy have changed considerably. Epilepsy is mentioned many times in the Pentateuch, where it is portrayed as a mysterious condition, whose symptoms, course and contingencies evade rational laws and explanations. In the Middle Ages, the accepted view which prevailed in social consciousness was that patients with epilepsy were possessed by Satan and other impure spirits. One common method of treatment of epileptic seizures was to submit the patient to cruel exorcisms. Patients were frequently injured in the process and some of them even died. Our understanding of epilepsy and its social consequences has improved considerably within the last century. The most significant progress as far as diagnosis and treatment of epilepsy is concerned took place in the last four decades of the twentieth century. Although we now know much more about epilepsy than we used to, this knowledge is still insufficiently popularized.

An observational study of first-line valproate monotherapy in focal epilepsy.

The objective of this multinational open-label, prospective study was to collect, under naturalistic conditions, data on the effectiveness and tolerability of first-line monotherapy with valproate in subjects newly or recently diagnosed with focal onset epilepsy. Patients were treated with sustained release sodium valproate. Seizure control and occurrence of adverse events were assessed after 6 months. Around 1192 adults and 792 children were included. The mean daily valproate dose was 683 mg in children and 987 mg in adults. The retention rate at 6 months was 90.0%. At this time, 77% of subjects were seizure free (83.7% of children and 72.7% of adults). Adverse events possibly related to treatment were observed in 10.2% of subjects, leading to treatment modification for 1.7%. The most common adverse events were weight gain, gastro-intestinal, neurological and skin disorders. Sustained release sodium valproate is effective and shows acceptable tolerability as first-line monotherapy in focal onset epilepsy.

Current approaches to the use of generic antiepileptic drugs.

Generic substitution is encouraged as a cost containment strategy for the management of health care resources. However, in epilepsy, the consequences of loss of symptom control are important, and antiepileptic drugs have narrow therapeutic indices. For this reason, generic substitution may be problematic, and certain health authorities have excluded antiepileptic drugs from overall policy recommendations on generic prescribing. The absence of bioequivalence data among generic forms and the relatively broad criteria for bioequivalence with the branded drug allow differences in drug exposure to arise that may be clinically relevant and necessitate monitoring of plasma levels when switching formulations to avoid loss of seizure control or emergence of side effects. Management of these issues carries a significant cost, which should be weighed carefully against the cost savings acquired when purchasing the drug. Both physicians and patients have a right to be informed and approve before pharmacists make a generic substitution or switch between generics.

Tiagabine as add-on therapy may be more effective with valproic acid--open label, multicentre study of patients with focal epilepsy.

The aim of the current study was to review the efficacy of tiagabine (TGB) as add-on therapy in patients with drug-resistant focal epilepsy under normal daily clinical practice, and try to identify those who had improvement. This was an open multicentre study conducted in Poland. A group of 330 patients were analysed. Patients received TGB up to 30-50 mg/day with adjustment within the therapeutic range and titration period. For statistical evaluation chi-square test and logistic analysis were used. At the 16-week follow-up visit, 71.4% patients were reported as responders, i.e. had a 50% or greater decrease in seizure frequency compared with baseline (P<0.001). One-third of patients were seizure-free at 16-week evaluation (P<0.001). The beneficial effect of TGB on seizure reduction was most marked in patients with partial seizures (P<0.001). Patients who used valproic acid (mean dose 1307 mg/day) had 61-85% higher chances for disappearance of seizures or reduction of their number by 50% or more. Patients who used carbamazepine (mean dose 800 mg/day) at a dose 1000 mg or higher mg/day had twice lower chance for reduction of seizures by 50% or more (OR=0.45; 95 CI 0.25-0.82). There was no statistical impact of sex, age and aetiology on probability of therapeutic effect.

[Economic aspects of drug-resistant epilepsy]. / Ekonomiczne aspekty padaczek opornych na leczenie.

Drug-resistant epilepsy is a serious source of indirect and direct public expenses. American studies have shown that the total cost per patient of treating drug-resistant epilepsy is 138,600 USD a year whereas the annual cost of treating effectively-treated epilepsy is 4,272 USD. Although the proportion of drug-resistant cases does not exceed 20% of all registered cases of epilepsy these cases are responsible for 48% of the total direct costs and 90% of indirect costs of treatment. Frequent hospitalizations and introduction of more and more complicated polytherapies contribute to the increase in direct costs whereas the main factor responsible for indirect costs is the incapacity to work. Open clinical studies on the optimization of antiepileptic treatment have shown that a considerable number of patients are still diagnosed as apparently drug-resistant. In the case of these patients frequent modification of the methods of treatment are associated with patients' justified or unjustified fear of the adverse effects of antiepileptic drugs. This leads to mood deterioration in the patients themselves and, as a consequence, to poorer quality of life of the patients and their families. Another serious economic problem is the presence of psychogenic pseudo-epileptic seizures. The factors discussed in this article increase the measurable and immeasurable psycho-social costs of epileptic seizures.

Patients with coexistent psychogenic pseudoepileptic and epileptic seizures: a psychological profile.

Despite significant advances in epileptology, the differential diagnosis of epileptic and pseudoepileptic seizures continues to be a considerable challenge. The problem becomes even more complicated when epileptic and psychogenic pseudoepileptic seizures coexist in the same patient. Appropriate psychological measures may be helpful in the diagnosis and may improve knowledge about aetiological factors which can provoke psychogenic pseudoepileptic seizures. The purpose of this paper is to present the psychological profile of patients with mixed seizures (epileptic and psychogenic pseudoepileptic) developed on the basis of the Minnesota Multiphasic Personality Inventory (MMPI) and to discuss the personality differences between patients with psychogenic epileptic seizures and epileptic patients. In patients with diagnosed epilepsy and/or suspected psychogenic pseudoepileptic seizures long-term video-monitoring was performed. On the basis of the gathered data the patients were divided into three groups: group I (N= 32 : 25 F and 7 M) had coexistent psychogenic pseudoepileptic and epileptic seizures, group II (N= 38 : 30 F and 8 M) had psychogenic pseudoepileptic seizures only and group III (N= 36 : 18 F and 8 M) had epileptic seizures only and was treated as the control group. All three groups were given the MMPI. Comparison of the averaged personality profiles of the three groups revealed significant differences (P< 0.0001) in hypochondriasis (Hs) and hysteria (Hy), similarity of the profiles of groups I and II, and significantly higher Hs and Hy scores than D (Depression) scores (P< 0.001). Unlike groups I and II, group III (the epileptic group) had significantly higher D scores than Hs and Hy scores (P< 0.01). Our findings suggest that conversion, manifested in the typically elevated Hs and Hy scores as compared to D scores, is present in both groups of patients demonstrating pseudoepileptic seizures but absent in the patients with epilepsy where the Hs and Hy to D ratio is reversed. Patients with mixed seizures and patients with psychogenic pseudoepileptic seizures only have similarly shaped profiles.

[Clinical analysis of the effectiveness and safety of vigabatrin]. / Analiza kliniczna skutecznosci i bezpieczenstwa stosowania wigabatryny.

The efficacy and safety of vigabatrin (VGB) has been extensively evaluated in preclinical and clinical studies but level of effectiveness in different type of seizures has yet to be established. The aim of our study is the prospective evaluation of anticonvulsant efficacy and toxicity of VGB. This long-term observation mainly focusing on efficacy of VGB in partial vs. secondarily generalized seizures were considered separately. In our study the criterion of drug resistance is occurrence per month of at least 1 tonic-clonic seizure or at least 2 complex partial seizures in 3 following months. The studies are based on 73 patients (39 F and 34 M), with average age of 26 years. After two weeks of treatment with sabril the drug was withdrawn in 5 patients because of side effects. The period of observation was 12 months. In group I--from total of 73 patients with partial seizures (including secondarily generalized)--31 (42%) of patients suffered only from partial seizures. Complex partial seizures occurred in 18 of patients; in this group were also 13 patients with simple partial seizures. Group II consisted of 42 patients (58%) who suffered from secondarily generalized tonic-clonic seizures. Number of seizures in group of patients with tonic-clonic seizures was from 1 to 16 per month (average 3.4) and in group of patients with complex partial seizures was from 1 to 70 per month (average 13.29). After titration period, Vigabatrin was given in doses of 500 to 3500 mg daily. Mean monthly fit frequency was calculated for over 3 months prior to the addition of vigabatrin and 12 months of therapy at the patient's maximum dose. Monthly fit frequency expressed as mean +/- standard error of the mean, and this statistical significance was determined using MANOVA for repeated measurement. Average monthly fit frequency of partial seizures has been reduced from 13.29 to 6.96 (p < 0.0001) and of generalized seizures from 3.38 to 1.38 (p < 0.0001). The percentage of patients achieving an increase of at least 75%--(Ratio < -0.6)--of seizures was greater in generalized seizures (27.3) than in partial ones (21.3). VGB is effective and well tolerated in refractory patients requiring add-on antiepileptic treatment and it has shown efficacy both in therapy of refractory partial seizures as well of secondarily generalized ones.

Effect of vigabatrin addition on carbamazepine blood serum levels in patients with epilepsy.

Because vigabatrin (VGB) is not metabolized by liver enzymes and does not bind with serum proteins, there is little theoretical chance of it interacting with other antiepileptic drugs. However, our observations have shown that if VGB is added to carbamazepine (CBZ) monotherapy, some patients respond with adverse, toxic symptoms suggesting possible carbamazepine-vigabatrin interaction. This article presents the results of a study of 66 epileptic patients (27 women and 39 men), age 10-66 years (mean, 28.2 years), with focal seizure onset with or without secondary generalization. In these patients, in addition to CBZ therapy with an average dose of 16.7 mg/kg per day (8.6-26.8), VGB, average dose 31.1 mg/kg per day (7.1-57.9), was added. CBZ concentration was measured twice: prior to VGB introduction and 5-12 weeks after the final dose of VGB was reached. In our study 69.7% of patients responded to VGB addition with a significant increase (by at least 10%) in CBZ concentration. A correlation between the value of the increase and the initial level of CBZ prior to VGB addition was found also. Correlational analysis (Pearson's r) revealed a negative correlation between CBZ concentration and increased concentration after VGB addition (r = -0.47, df = 64, P < 0.001). This negative correlation means that if the initial CBZ level is lower, its concentration value after VGB addition is higher.

[Open multicenter study of the effectiveness and safety of gabitril in epileptic patients with partial seizures]. / Otwarte wieloosrodkowe badanie skutecznosci i bezpieczenstwa stosowania Gabitrilu u chorych z padaczka z napadami czesciowymi.

The paper presents the results obtained by 53 investigators implementing the first Polish multicentre study of the effectiveness and safety of tiagabine (Gabitril). The study included 81 patients with refractory epilepsy with partial seizures. The duration of the study was 16 weeks. For the initial 6 weeks, Gabitril was gradually introduced till a dose of 30 mg/day was achieved. Within the subsequent 10 weeks the treatment effectiveness was observed and monitored, with the provision that the dose could be increased. The final analysis included 62 patients, while in 12 subjects the treatment was discontinued in less than 16 weeks. The results indicate a very beneficial effect of Gabitril on the frequency of seizures in patients with drug-resistant epilepsy. Almost 1 of the analyzed patients were seizure free. The most beneficial effects with respect to seizure number and intensity reduction were noted in subjects with partial complex and partial seizures with secondary generalization. The dynamic character of the decrease in seizure frequency was best observed between the first and third month of therapy. In 2/3 of patients the recommended dose was achieved and maintained. Less than 15% of subjects were excluded from the study, mainly due to lack of therapeutic effects. The number and character of adverse effects observed in the course of the present study did not differ from these noted in long-term Gabitril trials. The drug was demonstrated to exert no effect on vital functions and laboratory parameters. The results confirm the high effectiveness of Gabitril in treatment of patients with partial seizures and a good tolerance of this agent.

[Evaluation of tiagabine efficacy in different groups of patients with epilepsy]. / Ocena skutecznosci tiagabiny w róznych grupach chorych z padaczka.

UNLABELLED: The aim of study is to discuss from a clinicians viewpoint the use of tiagabine in the clinical setting, in particular how we can relate our current knowledge to individuals in our clinics. The choice for individual and the clinician is multi-layered dependent on many factors. Namely is based on patient characteristics, their beliefs and wishes, age, seizure type or syndrome and comorbidity. The next factor influencing choice is drug characteristics; pharmacology, mode of action, efficacy, tolerability, practical use and cost. Very important is fear of unknown. Particularly important are new drugs, which can be safety use in groups of special concern like children, women of reproductive age, the elderly, patients with psychiatric illness and mental handicaps. In these cases the risk of fetal malformations, interactions with other drugs, safety profile should be taken into consideration. Tiagabine represents an important new therapeutic option for patients with drug resistant partial seizures. The role of tiagabine in the management of patients with intellectual disability is especially emphasised since tiagabine has a low side-effects profile in the cognitive area. Comparison of data for new antiepileptic drugs provide information for selection among treatments when a second drugs is needed to improve control of seizures. However, there are numerous caveats in use of these summary data. First, the data from clinical trials cannot be compared directly because of variability in placebo response and potentially in other population characteristics. Second, the needs of individual patients differ. CONCLUSION: There is important to stress that no controlled clinical trials have provided algorithm for the best add-on drug or combination of drugs. So there is need to describe the homogenic groups of patients and final choice should be based on the need of the individual patient (sex, age, pregnancy, mental status) for superior seizure control versus minimal adverse effects.

[Anaplastic oligoastrocytoma of the spinal cord: diagnostic difficulties. Case report]. / Oligoastrocytoma anaplasticum rdzenia kregowego: trudnosci diagnostyczne. Opis przypadku.

The authors report a rare case of 49-years old woman with rapidly progressing anaplastic oligoastrocytoma primarily localized in the spinal cord. Increasing spastic paresis of the right lower limb was concomitant with decrease in superficial sensibility in this limb and the right side of the trunk below Th10 level, suggested a lesion within the spinal cord. However, it was the difficult confirming the diagnosis by spinal MR imaging, and the negative result of the first MR examination (performed 5 weeks after manifestation of first clinical symptoms of the disease) delayed surgical treatment. During the next 3 weeks the neurological syndrome increased to spastic paraparesis with sphincters dysfunction and decrease in superficial and vibratory sensibility within the lower limbs and the trunk below the Th10 level. The second MR examination of the spine revealed an intraspinal tumour at Th8-Th10 levels. Surgical (partial excision of the tumour) and radiation treatment was given. Histopathological examination of tumour tissue showed the presence of anaplastic oligoastrocytoma. During the follow-up of our patient we found cerebral foci, probably of metastatic origin ascending with cerebrospinal fluid. More than 5 months after the diagnosis was established the patient died of primary disease. The imaging parameters of both spinal MR examinations were similar, however, on second examination narrower field of vision was used. In both cases Magnevist was administered. Discussing factors which might be responsible for the false-negative result of spinal MR examination--the examination of choice for detection of proliferative transformation--the authors take artefacts connected with respiratory and circulatory function, peristaltic movements, and with field of vision into consideration.

Psychological approach of non-epileptic to epileptic patients: the dynamics of attitude changes during hospitalization.

Measures of interpersonal relations of non-epileptic patients to epileptic patients were studied in search of answers to two questions: what is the initial attitude of non-epileptic patients to epileptic patients; and, do any changes in attitude occur during time spent together in hospital? In order to study these personal relations, a formal analysis of preferences was carried out. Twenty-two non-epileptic patients admitted to the Neurology and Epileptology Department, Medical Centre for Postgraduate Education, Warsaw were studied. Subjects were asked to rank-order (from 1 to 9 points) suggested ways of distributing the profits of a hypothetical joint (e.g., with a room-mate) money-earning venture. The experimental procedure for each patient was repeated for all three room-mates. Preferences were assessed three times - the day after admission to hospital, after 11 days and after 21 days in hospital. Following this procedure, it was possible to trace the dynamics of the patients' interpersonal relations. The data were correlated (Spearman's r(s)) and submitted to analysis of variance (MANOVA) with repeated measures. Analysis of the attitudes of patients with non-epileptic neurological disorders towards epileptic patients revealed a dynamic tendency - from negative (measures one and partly two) to positive attitudes after three weeks spent together in hospital (measure three).

Psychogenic pseudoepileptic seizures: clinical and electroencephalogram (EEG) video-tape recordings.

This paper presents a clinical and electrophysiological analysis of type and duration of seizures recorded by means of long-term video electroencephalogram (EEG) monitoring, a method which enables accurate diagnosis of psychogenic pseudoepileptic seizures occurring with or without epileptic seizures. Analysis is based on 1083 patients, hospitalized at our department between 1990 and 1997, with a preliminary diagnosis of epilepsy. Psychogenic pseudoepileptic seizures were diagnosed in 85 patients (7.8%). In 48 patients, pseudoepileptic seizures alone were diagnosed (group 1), whereas 37 patients had a mixed condition in which pseudoepileptic seizures were accompanied by epileptic seizures (group 2). For comparison of duration of pseudo- and epileptic seizures a control group (group 3), consisting of 55 patients randomly selected from the population of patients suffering from epileptic seizures alone, was parceled out. Long-term video EEG monitoring was performed in 70 patients. In 55 (79%) of these patients 230 seizures (221 pseudoepileptic and nine epileptic) were recorded. In 30 patients (32%), the diagnosis was based on clinical observation of the seizures and on the number of EEG recordings, including activating procedures such as sleep deprivation, photostimulation, hyperventilation and anti-epileptic drug withdrawal. We found that the duration of epileptic seizures was significantly shorter than the duration of psychogenic pseudoepileptic seizures. Our study has exposed the difficulties involved in the diagnosis of psychogenic pseudoepileptic seizures and the negligible value of neuroimaging techniques and interictal EEG recordings in the differential diagnosis of epileptic versus nonepileptic seizures. In this study, psychogenic seizures were significantly more frequent in women than in men; patient history analysis did not confirm the hypothesis that sexual abuse may cause psychogenic seizures.