[Assessment of quality of life and treatment adherence in patients with dizziness treated with vasobral]. / Otsenka kachestva zhizni i priverzhennosti lecheniiu preparatom vazobral patsientov s golovokruzheniem.

AIM: To study indicators of quality of life and adherence to treatment with vazobral in patients with dizziness of vascular genesis. MATERIAL AND METHODS: Vazobral was administered to 330 patients with vertigo due to cerebrovascular disease for 3 months during a non-inferiority, open-label study. Quality of life (measured using VAS and the second part of the EQ-5D questionnaire), severity and frequency of dizziness attacks (using VAS), the overall effectiveness of treatment on the basis of objective (according to the doctor) and subjective (using CGI) assessments, treatment adherence were evaluated. RESULTS AND CONCLUSION: The positive effect of vazobral was reported by 320 patients (97.0%), 223 of them (67.6%) indicated a decrease in the frequency of episodes of dizziness by at least 50%, and 95 patients (28.8%) had complete relief of dizziness. Two hundred and sixty-two (79.4%) patients took the drug in full accordance with recommendations. Patients living alone missed drug intake more often. Improvement of quality of life was noted in 326 (98.8%) patients, scores for all domains of the questionnaire EQ-5D at baseline and in the end of the study were 50.8±18.1 and 78.8±14.7%, respectively (p<0.001). The tolerability of treatment was characterized by good tolerability.

Miscellaneous treatments for antipsychotic-induced tardive dyskinesia.

BACKGROUND: Antipsychotic (neuroleptic) medication is used extensively to treat people with chronic mental illnesses. Its use, however, is associated with adverse effects, including movement disorders such as tardive dyskinesia (TD) - a problem often seen as repetitive involuntary movements around the mouth and face. This review, one in a series examining the treatment of TD, covers miscellaneous treatments not covered elsewhere. OBJECTIVES: To determine whether drugs, hormone-, dietary-, or herb-supplements not covered in other Cochrane reviews on TD treatments, surgical interventions, electroconvulsive therapy, and mind-body therapies were effective and safe for people with antipsychotic-induced TD. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials including trial registers (16 July 2015 and 26 April 2017), inspected references of all identified studies for further trials and contacted authors of trials for additional information. SELECTION CRITERIA: We included reports if they were randomised controlled trials (RCTs) dealing with people with antipsychotic-induced TD and schizophrenia or other chronic mental illnesses who remained on their antipsychotic medication and had been randomly allocated to the interventions listed above versus placebo, no intervention, or any other intervention. DATA COLLECTION AND ANALYSIS: We independently extracted data from these trials and we estimated risk ratios (RR) or mean differences (MD), with 95% confidence intervals (CIs). We assumed that people who left early had no improvement. We assessed risk of bias and created 'Summary of findings' tables using GRADE. MAIN RESULTS: We included 31 RCTs of 24 interventions with 1278 participants; 22 of these trials were newly included in this 2017 update. Five trials are awaiting classification and seven trials are ongoing. All participants were adults with chronic psychiatric disorders, mostly schizophrenia, and antipsychotic-induced TD. Studies were primarily of short (three to six6 weeks) duration with small samples size (10 to 157 participants), and most (61%) were published more than 20 years ago. The overall risk of bias in these studies was unclear, mainly due to poor reporting of allocation concealment, generation of the sequence, and blinding.Nineteen of the 31 included studies reported on the primary outcome 'No clinically important improvement in TD symptoms'. Two studies found moderate-quality evidence of a benefit of the intervention compared with placebo: valbenazine (RR 0.63, 95% CI 0.46 to 0.86, 1 RCT, n = 92) and extract of Ginkgo biloba (RR 0.88, 95% CI 0.81 to 0.96, 1 RCT, n = 157), respectively. However, due to small sample sizes we cannot be certain of these effects.We consider the results for the remaining interventions to be inconclusive: Low- to very low-quality evidence of a benefit was found for buspirone (RR 0.53, 95% CI 0.33 to 0.84, 1 RCT, n = 42), dihydrogenated ergot alkaloids (RR 0.45, 95% CI 0.21 to 0.97, 1 RCT, n = 28), hypnosis or relaxation, (RR 0.45, 95% CI 0.21 to 0.94, 1 study, n = 15), pemoline (RR 0.48, 95% CI 0.29 to 0.77, 1 RCT, n = 46), promethazine (RR 0.24, 95% CI 0.11 to 0.55, 1 RCT, n = 34), insulin (RR 0.52, 95% CI 0.29 to 0.96, 1 RCT, n = 20), branched chain amino acids (RR 0.79, 95% CI 0.63 to 1.00, 1 RCT, n = 52), and isocarboxazid (RR 0.24, 95% CI 0.08 to 0.71, 1 RCT, n = 20). There was low- to very low-certainty evidence of no difference between intervention and placebo or no treatment for the following interventions: melatonin (RR 0.89, 95% CI 0.71 to 1.12, 2 RCTs, n = 32), lithium (RR 1.59, 95% CI 0.79 to 3.23, 1 RCT, n = 11), ritanserin (RR 1.00, 95% CI 0.70 to 1.43, 1 RCT, n = 10), selegiline (RR 1.37, 95% CI 0.96 to 1.94, 1 RCT, n = 33), oestrogen (RR 1.18, 95% CI 0.76 to 1.83, 1 RCT, n = 12), and gamma-linolenic acid (RR 1.00, 95% CI 0.69 to 1.45, 1 RCT, n = 16).None of the included studies reported on the other primary outcome, 'no clinically significant extrapyramidal adverse effects'. AUTHORS' CONCLUSIONS: This review has found that the use of valbenazine or extract of Ginkgo biloba may be effective in relieving the symptoms of tardive dyskinesia. However, since only one RCT has investigated each one of these compounds, we are awaiting results from ongoing trials to confirm these results. Results for the remaining interventions covered in this review must be considered inconclusive and these compounds probably should only be used within the context of a well-designed evaluative study.

[Efficacy of the combination drug vasobral in chronic vascular encephalopathy].

OBJECTIVE: Despite the high prevalence of chronic vascular encephalopathy, its diagnosis and treatment remain understudied. This observational multicenter trial assessed the efficacy and safety of vasobral in patients with cerebral ischemia. MATERIAL AND METHODS: The open observational study was carried out in 37 centers in 11 Russian cities and included 300 patients with confirmed diagnosis of chronic vascular encephalopathy, stages 1 and 2, without dementia. The patients received 1 tablet (4 mg α-dihydroergocryptine and 40 mg caffeine) 2 times a day during 3 months. RESULTS AND CONCLUSION: There was an improvement of cognitive and affective status as well as quality of life and a decrease of subjective signs of chronic vascular encephalopathy. Vasobral did not cause significant fluctuations of arterial pressure and was safe for patients with chronic vascular encephalopathy and arterial hypertension.

[Vasobral in the treatment of brain lesions: views of physicians and patients].

A study was based on the survey of 419 neurologists and 1189 their patients with different forms of cerebrovascular diseases using a specially developed questionnaire. In most cases, vasobral was used as a monotherapy or in a complex treatment. Twenty-two percent of physicians reported that vasobral was the most effective compared to other drugs. The good tolerability of treatment (18%) and the broad spectrum of indications and clinical effects (17%) were reported as well. The large percentage (75%) of patients indicated the positive effect of vasobral on memory, reasoning, vertigo etc The maximal effect was identified in the treatment of mild cognitive impairment caused by chronic brain ischemia and vertebrobasilar insufficiency. Vasobral is recommended for a use in a complex therapy in patients with more severe brain lesions and cognitive deficit.

[Preventive treatment of migraine with vasobral: a multicenter trial].

The results of an open prospective trial on the treatment of migraine with vasobral which was conducted in 170 medical centers (27 cities) of the Russian Federation are summarized. The trial included 5475 patients treated with vasobral in dosage 2 ml (1 ml contains 1 mg of alpha-dihydroergocryptine and 10 mg of caffeine) twice a day during 2 months. Assessment criteria of treatment efficacy were frequency and duration of migraine seizures, pain syndrome severity, presence of concomitant syndromes, general state and working capacity of patients and side-effects. Vasobral was effective and safe medication for the prevention of migraine. Its preventive effect is due to the decrease of frequency and duration of migraine seizures, pain severity and to the overall improvement of patient's state. Vasobral can be recommended to many migraine patients, in particular to those in the young age and with short disease duration.

[Early diagnosis and treatment of Alzheimer's disease. Implementation in the doctor's office]. / Frühdiagnostik und Therapie der Alzheimer-Krankheit. Zum Vorgehen in der Praxis.

The efficacy of antidemential agents proven in comprehensive studies and by clinical experience, now justifies an active and positive approach by the general physician to the diagnosis and treatment of patients with dementia. The proposals on how to implement diagnostic and therapeutic measures in the doctor's office comply both with medical quality criteria and the requirements for appropriateness of treatment and considerations of economy stipulated by German law. They therefore provide the basis for a modern diagnostic work-up and treatment strategy, which will also meet economical demands.

Treatment of restless legs syndrome with the dopamine agonist alpha-dihydroergocryptine.

An open pilot study with the dopamine agonist alpha-dihydroergocryptine (DHEC) was conducted in 16 patients with idiopathic restless legs syndrome (RLS) over a period of 5 weeks. Following a drug-free interval of 1 week, the patients were treated with daily doses of 10 to 40 mg DHEC. As compared to baseline values, treatment led to a statistically significant reduction of subjective RLS symptoms. Overall complaints at night decreased significantly by 63.9 +/- 38.1% as measured by a visual analogue scale. Detailed evaluation of sensory discomfort, motor restlessness, involuntary movements, as well as sleep quality also showed significant improvement. Side effects were mostly mild and affected mainly the gastrointestinal tract. Five patients needed domperidone for treatment of concomitant nausea. One patient stopped the study due to nausea. In conclusion, the results of this open study suggest a role for DHEC in the treatment of RLS.

[Experience in the administration of vasobral in sensorineural vascular hypoasusis]. / Obosnovanie primeneniia élasticheskoi tamponady posleoperatsionnykh polostei srednego ukha.

24 patients with neurosensory hypoacusis of vascular genesis related to chronic cerebral vascular deficiency in the vertebrobasillar bed combined with cervical osteochondrosis were given basobral. The drug produced positive changes in neurological symptoms, lowered hearing thresholds in the range of high frequencies, improved cerebral hemodynamics and hearing afferentation at the stem level of the acoustic analyzer.

[The influence of alpha-dihydroergocryptine derivatives on psychomotor manifestations in Parkinson disease]. / Vliianie proizvodnogo al'fa-digidroérgokriptina na psikhicheskie i dvigatel'nye proiavleniia parkinsonizma.

The paper presents the results of administration of alpha-dihydroergocryptine preparation (vasobral) to parkinsonic patients. It was prescribed to 20 patients with parkinsonism together with the specific therapy. Clinical state as well as the level of anxiety and depression was estimated using standard scales both before and after treatment. A high efficiency of vasobral was found as regards such symptoms as disorders of memory, headache, vertigo, a noise in ears and head, asthenic state. In some patients functional activity increased, in 4 patients a dose of dopaminergic preparations was successfully decreased by 25%. An important aspect of vasobral activity was also a decrease of anxious-depressive symptoms. A conclusion was made about efficiency of vasobral in combined treatment of parkinsonic patients.

[The effect of pharmacological treatment in the compensation of vertigo]. / Efecto de un tratamiento farmacológico en la compensación del vértigo.

From the age of sixty, vertigo is mainly due to vertebro-basilar insufficiency. It has been described that the association of Dihydroergocristine-Piracetam (D-P) is a useful treatment for vertebro-basilar insufficiency. That is why we have designed a comparative study between D-P an a Placebo, so that to prove if this association can be usefull in the treatment of vertigo occasioned by cerebrovascular insufficiency. Fifty patients complaining of vertigo were included in the study after an untreated term. 19 received a daily capsule of Placebo, and the other 31, treated with D-P, were divided in two groups: 16 patients received a dose of 3 mg Dihydroergocristine + 1.6 g Piracetam every 12 hours per os; and 15 other were treated with 1.5 mg Dihydroergocristine + 0.8 g Piracetam every 8 hours during 90 days. The patients were evaluated at the beginning of the study and 90 days later, with anamnesis and vestibular tests. In the last consultation the patients autoevaluated themselves the effect and the tolerance to the drugs received. In the Placebo group it was observed an improvement or disappearance of vertiginous symptoms in the 68.5% of the cases, while with D-P was 93.7% at the dose of 3 mg Dihydroergocristine + 1.6 g Piracetam each 12 hours and 100% with the dose 1.5 mg Dihydroergocristine + 0.8 g Piracetam each 8 hours. None of the treated patients with D-P worsened their symptoms. We observe a considerable decrease in the number of patients with vegetative symptoms in the group treated with D-P related to the Placebo group, though the symptoms persisted more time in the group treated with D-P that in the Placebo group. The group treated with D-P get a higher percentage of improvements and disappearance of auditive and cervical symptoms that the groups treated with Placebo. In the vestibulo-spinal and cerebellous tests it was observed a better improvement with D-P at the dose of 1.5 mg of Dihydroergocristine + 0.8 g Piracetam each hours compared with the other two groups. It can be concluded that the association D-P is an effective treatment for vertigo, getting also a higher normalization of the vestibular tests than Placebo.

Alpha-dihydroergocryptine in Parkinson's disease: a multicentre randomized double blind parallel group study.

INTRODUCTION: A multicentre randomized double-blind parallel group study was carried out on 68 patients suffering from idiopathic Parkinson's disease (PD) treated with L-dopa for at least 1 year with inadequate therapeutic responsiveness. The aim of the study was to compare the efficacy of alpha-dihydroergocryptine (alpha-DHEC) vs lisuride as an adjunct therapy to L-dopa on dyskinesias and clinical fluctuations (Unified Parkinson's Disease Rating Scale [UPDRS] part IV), on the symptoms pattern (Columbia University Rating Scale [CURS]), on disability (Northwestern University Disability Scale [NUDS]), and to evaluate the incidence of adverse events. PATIENTS AND METHODS: Thirty-two patients (18 males, 14 females with a mean age of 64.5+/-1.5 SEM) were randomized to alpha-dihydroergocryptine and 36 (16 males, 20 females with a mean age of 61.8+/-1.4) to lisuride. The treatment lasted 3 months and the dosage was increased until it reached 60 mg/day of alpha-dihydroergocryptine and 1.2 mg/day of lisuride, while the L-dopa dosage was kept constant in both groups. Per protocol and intention to treat analyses were performed on response variables. RESULTS: The adjunctive treatment with the two dopamine agonists determined a significant improvement of PD symptoms in both groups. Alpha-dihydroergocryptine showed a superior efficacy in reducing the clinical complications (P < 0.01 by ANOVA). The number of patients complaining of adverse events was 8 out of 32 (25%) for alpha-dihydroergocryptine and 24/36 (67%) for lisuride (P < 0.05). CONCLUSION: Alpha-dihydroergocryptine effect seems to be superior to that of lisuride both in terms of reduction of L-dopa therapy long term motor complications (UPDRS part IV) as well as in terms of the incidence and severity of adverse events.

Alpha-dihydroergocryptine in the prophylaxis of migraine: a multicenter double-blind study versus flunarizine.

This multicenter, double-blind, clinical study was designed to compare the efficacy and safety of alpha-dihydroergocryptine and flunarizine in the prophylaxis of migraine without aura. One hundred thirty-five patients fulfilling the diagnostic criteria of the International Headache Society were enrolled at five neurologic centers. The study design included a 1-month pretreatment phase with placebo; a 6-month, double-blind, double-dummy treatment phase with alpha-dihydroergocryptine (10 mg twice daily) or flunarizine (5 mg once daily); a further 3-month follow-up phase without treatment. Efficacy was assessed using the patient's diary. Laboratory tests, vital signs, and adverse events were monitored. Analysis of covariance for repeated measures was performed on the intent-to-treat sample. Both treatments led to a significant reduction in the frequency of migraine, days with headache, and use of relief medication. Overall, 51% of those treated with alpha-dihydroergocryptine and 49% of those treated with flunarizine were responders (50% or greater reduction in attack frequency), the average percentage of reduction being 64% with alpha-dihydroergocryptine and 51% with flunarizine. There was no significant difference between the two groups in terms of incidence of adverse events; dizziness and weight gain were the most frequent observed adverse events with alpha-dihydroergocryptine and flunarizine, respectively. Based on the overall improvement in migraine parameters, alpha-dihydroergocryptine can be recommended for use in migraine prophylaxis.

The effect of topical dihydroergocristine on the intraocular pressure in alpha-chymotrypsin-induced ocular hypertensive rabbits.

Having previously reported that topical dihydroergocristine dose-dependently reduces intraocular pressure in ocular normotensive rabbits with a maximum response and potency higher than those of timolol and pilocarpine, the aim of the present work was to assess the effect of this drug in alpha-chymotrypsin-induced ocular hypertensive rabbits. Intraocular pressure was measured with a pneumatonometer. The experiments examining the effects of dihydroergocristine on intraocular pressure were conducted in 10 albino rabbits in which ocular hypertension was induced by intracameral injection of alpha-chymotrypsin. Intraocular pressure responses to drug vehicle and 5 different doses of topical dihydroergocristine were studied in order to obtain a dose-response curve. Tonographies were also performed in ocular hypertensive rabbits 2 h after vehicle and dihydroergocristine instillation to ascertain the actions of this drug on aqueous humor dynamics. Topical dihydroergocristine was found to lower intraocular pressure in alpha-chymotrypsin-induced ocular hypertensive rabbits in a dose-related manner, with the ED50 of the concentration-response curve very similar to that previously obtained in ocular normotensive rabbits. Data from tonographic studies indicate that dihydroergocristine reduces intraocular pressure in this animal model for glaucoma by decreasing the aqueous humor inflow. Our findings suggest that topical dihydroergocristine may be useful in the treatment of ocular hypertension.

Combined cabergoline and recombinant human growth hormone treatment of an adolescent with a macroprolactinoma causing GH deficiency.

The rare macroprolactinomas seen in childhood frequently cause delayed puberty and GH deficiency. We report the combined use of cabergoline and recombinant human GH (rhGH) therapy in a male adolescent with macroprolactinoma and GH deficiency. Computed tomography and magnetic resonance imaging of the hypothalamic-pituitary region showed a macroadenoma with extrasellar extension. Neither bromocriptine nor dihydroergocryptine therapy was successful in decreasing serum PRL levels. On cabergoline treatment normal serum PRL levels were achieved within 3 months along with a marked shrinkage of the adenoma but growth rate did not increase nor did puberty start. The addition of exogenous rhGH therapy improved the growth rate, but complete pubertal development was obtained only after the administration of exogenous gonadotropins. During the combined treatment no expansion of the macroadenoma was observed. In conclusion, the combined therapy with cabergoline and rhGH seems to be safe and highly effective. Nevertheless, it warrants careful monitoring and on-going evaluation.

Alcohol-induced organic cerebral psychosyndromes: partial reversal of cognitive impairments assisted by dihydroergocristine.

Chronic alcohol abusers show a specific pattern of cerebral damage associated with cognitive and behavioral defects known as the organic cerebral psychosyndrome, which is partially reversible upon discontinuation of ethanol consumption. To assess the potential of nootropic drug therapy in alcohol rehabilitation in a double-blind study design, 56 consecutive patients who participated in routine rehabilitation therapy received 2 x 3 mg/day dihydroergocristine or placebo in tablet form over 6-13 weeks. Forty-nine patients completed the protocol. Although significant improvement was seen in both groups, we could document a specific cognitive restitution effect attributable to dihydroergocristine. Significant differences in favor of the active drug group were demonstrated by Mini-Mental State Examination, Syndrome Brief Test, Paired Words Test, in the neuropsychiatric Brief Cognitive Rating Scale assessments, and in the Clinical Global Impression of Change rating. No significant between-group differences were found in the Digit Symbol Test and the Block Design Test as well as in the Brief Psychiatric Rating Scale (BPRS). Dihydroergocristine was equivalent to placebo in terms of subjective drug tolerance, lack of side effects, and laboratory parameters. Based on this profile of efficacy and safety, we recommend dihydroergocristine as an adjuvant drug in alcohol rehabilitation.

Comparison of the efficacy and safety of daily dosages of 6 mg and 20 mg dihydroergocristine in the treatment of chronic cerebro-vascular disease.

The efficacy and safety of two different regimens of dihydroergocristine, in the treatment of patients with chronic cerebro-vascular disease, were compared in this double-blind study. Forty out-patients, 11 males and 29 females, aged 55-80 years were randomly assigned to treatment with 6 or 20 mg dihydroergocristine, daily, for 3 months. The Sandoz Clinical Assessment for Geriatrics (SCAG) scale was used to assess the efficacy of treatment. Both doses induced a statistically significant improvement (P < 0.01) in total SCAG scores after both 45 and 90 days of treatment. The higher dose produced a significantly greater improvement in total SCAG scores than did the lower dose after both 45 and 90 days. There were no statistically or clinically significant changes in any of the laboratory parameters after either treatment; neither were there any statistically significant changes in blood-pressure or pulse-rate except in the case of standing systolic pressure which decreased significantly (P < 0.01) in the 20 mg group. The only adverse event reported was a case of mild gastric pain at the end of treatment with 20 mg dihydroergocristine.