Digital cognitive behavioral therapy for insomnia - The first Georgian version. Can we use it in practice?

Insomnia is a common sleep disorder which has a 5-6% prevalence rate and shows high social impact. At least 10% of patients with insomnia will see a medical specialist. Hence, 20,000-40,000 people in Georgia require medical help for insomnia. Treatment of insomnia is very effective. Pharmacotherapy is common, but it is recognized that cognitive behavioral therapy (CBT) is a better choice, since it is safe for patients and shows sustainable improvement. CBT of insomnia is not currently available in Georgia. The aim of our study was to evaluate a Georgian version of an innovative, internet-delivered digital CBT (dCBT) for insomnia in terms of therapeutic efficacy, adherence, and ease of handling. The Georgian digital cognitive behavioral therapy for insomnia was developed as an analogue of Dutch dCBT "i-Sleep." All online materials were made applicable for the Georgian population through translation, validation by translation back to the original language, and adaptation to the Georgian reality, in order to avoid linguistic, cultural, and social pitfalls. Fifty-two adult patients with insomnia were recruited for the study: 34 women and 18 men, aged 18-64 years (mean: 33.5 years). Inclusion criteria included: age over 18, access to internet, and sufficient skills to use electronic devices. The patients who were treated pharmacologically continued their usual medication and received dCBT in addition to this treatment. DCBT was guided by a therapist. Clinical efficacy was evaluated on the basis of Insomnia Severity Index (ISI), measured before the dCBT and one month after its completion. 25 out of 52 patients (48%) completed a full dCBT course. Mean ISI in this group dropped from 22.88 to 8.24 (P < 0.01), showing significant therapeutic effect one month after CBT completion. 27 patients (52%) stopped treatment for various reasons at different stages of dCBT. Sixteen patients dropped out from the first module (31%). 7 patients older than 50 years encountered problems with handling electronic devices and the platform itself. 9 patients stopped therapy, showing bad adherence for different reasons, mostly related to finding the sessions time-consuming and being disappointed by the absence of immediate therapeutic effect. Eleven more patients (21%) stopped at sleep restriction, finding it difficult to accomplish sleep restriction-related tasks. In general, patients found dCBT quite comprehensive and easy to handle. This data suggests that the Georgian version of dCBT for insomnia is a promising therapeutic tool, comparable with international analogues in terms of efficacy and adherence. Further studies, involving a greater number of patients and long-term follow-up are required for the final assessment of therapeutic efficacy and sustainability of results.

Fasting insulin and HOMA-index changes in patients treated with valproic acid.

Our study was carried out to ascertain the role of valproic acid for inducing metabolic disorders like hyperinsulinemia, insulin resistance and metabolic syndrome. Seventy-nine subjects were enrolled into the study. They were divided in 3 groups: 26 patients with epilepsy on VPA monotherapy and 28 patients with epilepsy on CBZ monotherapy and 25 healthy controls. Blood samples for fasting insulin, glucose, C-peptide, TG and HDL were collected. We compared insulin, C-peptide, C-peptide/insulin ratio, HOMA-IR, BMI, central obesity and metabolic syndrome in patients treated with VPA, patients treated with CBZ and in healthy controls. VPA treatment was associated with insulin resistance (30.8%) in opposite to CBZ treatment (7.1%). Metabolic syndrome existed in 34,6%, 14,3% and 12% among VPA, CBZ and control groups, respectively. There was no difference in C peptide/insulin ratio between study groups. Interestingly lean VPA treated patients showed high frequency of insulin resistance and metabolic syndrome compared to lean CBZ treated patients and controls. Therefore we suppose that obesity should not be an obligatory factor for VPA induced metabolic disturbances. VPA treatment is associated with insulin resistance and metabolic syndrome. This metabolic disorders were not connected with diminished hepatic insulin extraction. Although VPA treated patients showed central obesity predominance, we suggest that VPA can induce such metabolic and endocrine changes without obesity.

Valproic Acid related metabolic syndrome in patients with epilepsy.

Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug for the long-term treatment. It is established that VPA has number of side effects affecting metabolic and endocrine system, like weight gain, hyperinsulinemia, changes in sex hormones, dyslipidemia, hyperleptinemia and etc. But the data are not sufficient to judge if VPA treatment can induce metabolic syndrome. Our aim was to investigate metabolic syndrome frequency in VPA-treated (n=11) and CBZ-treated (n=13) patients with epilepsy and in drug-free healthy subjects (n=11). We diagnosed metabolic syndrome according to Adult Treatment Panel III criteria (ATP III). We took blood samples for analysing triglyceride, HDL cholesterol and fasting glucose. Waist circumference and blood pressure was measured as well. Our data revealed that metabolic syndrome is relatively frequent in VPA-treated patients group (45,5%) compared with CBZ group and controls (15.4% and 27.3% respectively) (p<0,5). BMI did not differ between study groups. According to our preliminary data VPA monotherapy increases the risk of metabolic syndrome in patients with epilepsy, but BMI did not differ between VPA monotherapy study group, CBZ monotherapy study group and controls.

Interaction of carbamazepine and phenobarbital in rabbits.

The interaction of carbamazepine and phenobarbital in rabbits was investigated. The drugs were administered to the rabbit orally as a single dose. By simultaneous administration the sequence of drugs was varied, with an interval between doses of 15 min. The doses of carbamazepine and phenobarbital were 100 and 25 mg, respectively. It was established that phenobarbital appears to be an inductor for carbamazepine independently sequence of administration of the drugs. Carbamazepine reveals inductive properties for phenobarbital in the case where phenobarbital enteres in the organism first. It was ascertained also that, by simultaneous administration, these drugs reduce absorption of each other in plasma.

Possibilities of non-pharmacological conservative treatment of epilepsy.

This study set out to assess the effect of non-pharmacological conservative (NPC) interventions as alternatives to antiepileptic pharmacotherapy. A prospective follow-up cohort study was conducted in an outpatient seizure clinic of a referral center for epilepsy. Twenty-five patients (nine males, 16 females) aged 16-45, with at least two well-described epileptic seizures, were included who had rejected antiepileptic pharmacotherapy. Twelve had idiopathic generalized epilepsy, 11 had symptomatic or cryptogenic localization-related epilepsy, and two had epilepsy with generalized and focal signs. Twenty-three of the patients were followed for more than 2 years. The patients were treated with arrest after focal seizure onset (2 cases), sensory protection against reflex seizures (3 cases), avoidance of non-specific seizure-precipitating factors ('life hygiene', 16 cases), and/or miscellaneous interventions (8 cases). The main outcome measures were complete seizure control (more than 2 years) or sufficient improvement to continue with NPC treatment alone. Eight of the 23 patients were completely seizure free for more than 4 years, and three were sufficiently improved to continue NPC treatment without drugs. Trends were observed for patients with idiopathic generalized epilepsies with less than seven convulsive seizures, and with only one seizure type to respond better to NPC treatment. The duration of epilepsy, and the finding of generalized epileptiform discharge in the EEG had no influence on the outcome. Rational NPC treatments which are aimed at specific factors in the precipitation and development of epileptic seizures can be useful therapeutic alternatives for patients with milder forms of epilepsy. Apart from photosensitive patients, those most likely to profit are patients with idiopathic generalized epilepsy, a maximum of six generalized tonic-clonic seizures which were precipitated by lack of sleep or excessive alcohol intake, and with no or rare concomitant absences. In such cases, NPC treatment may be as effective as pharmacotherapy and gives the patient a positive experience of regained self-control.