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Biomedical subjects

M Skreta

Publications and source records attributed to M Skreta.

6 recordsLinked to original sources
PubMed1988

Multi-centre general practitioner comparative study of controlled-release ('Valrelease') and conventional ('Valium') forms of diazepam in patients suffering from anxiety.

A multi-centre, double-blind, parallel group study was carried out in 114 patients with an anxiety disorder to compare the effectiveness of diazepam given as 5 mg 3-times daily or as a once-daily 10 mg dose of a controlled-release formulation designed to provide smooth drug concentrations over about 24 hours, without the heavy sedation caused by a high initial peak. Patients were allocated at random to receive one or other dosage regimen for 1 week and treatment could be continued for a further week if necessary. Clinical assessments of response to treatment showed that whilst both formulations were equally effective in providing symptomatic improvement, a much higher proportion of patients on controlled-release diazepam were ready to terminate treatment after 1 week, having attained the desired relief of symptoms. Moreover, as indicated by patient diary records, significantly fewer patients on the controlled-release formulation complained of drowsiness in the morning and evening.

Anxiety Disorders↗
PubMed1986

Comparison of controlled-release diazepam capsules and placebo in patients in general practice.

A multi-centre, randomized double-blind parallel study was carried out to compare the efficacy and tolerance of a single daily dose of controlled-release (CR) capsules of diazepam (10 mg and 15 mg) with placebo under conditions close to those of general practice. All patients between 16 and 60 years of age, presenting an anxiety syndrome as a result of neurotic disturbance, for whom benzodiazepine treatment was indicated for at least 3 weeks, were accepted for the study. The results from 231 patients (119 on placebo, 55 on 10 mg and 57 on 15 mg diazepam) were analyzed after 1 and 3 weeks of treatment. Complaints were found to have improved after 1 week and 3 weeks in the controlled-release diazepam groups whereas the corresponding results with placebo were clearly less favourable. After 1 week, and even more strikingly after 3 weeks, evaluation of the general effects of treatment showed better results with diazepam than with placebo. The obviously higher rate of drop-outs on placebo confirmed its less reliable effect. The controlled-release capsules were well tolerated and notably better than placebo. The most frequent side-effect reported on diazepam was fatigue, and this was probably due to a relative overdosage from use of a standardized dose throughout treatment. Other reported side-effects could not definitely be ascribed to the drug. At the end of a week, successful results were achieved in 48.2% of the patients on controlled-release diazepam compared with only 14.3% of those on placebo. After 3 weeks, these figures were 73.2% and 30.3%, respectively.

Adolescent↗
PubMed1982

The subacute effect of bromazepam on psychomotor activity and subjective mood.

In a double-blind study, fifty-five healthy, male medical students received a tranquilizer (bromazepam, 'Lexotanil') or placebo according to dosage group (placebo, 1.5 mg and 3 mg bromazepam). The subjects were randomly allocated to three groups (placebo: n = 19; 1.5 mg: n = 19; and 3 mg: n = 17). Dependent variables tested were the subjective assessment of performance and the level of activation (self-rating), and aspects of psychomotor function were assessed using the standard testing devices. The medication was administered for a total of 14 days. The testing times reported here were: before start, and after 7 and 14 days of administration of serum or placebo. The subjective evaluation (self-rating) such as performance assessment and level of activation demonstrated no changes related to either the medication or the length of time elapsed. The objective measures of performance revealed two main effects: lengthening of time of reaction to optical stimuli during the course of the study, especially in the higher bromazepam dosage group (sedative effect). This sedative effect was, however, relatively weak since, despite this observation, there was a significant training effect in the 3 mg group with regard to attentiveness and alertness testing. The results were also evaluated for a possible effect on driving ability. In the group studied here and at the relatively low dosage administered, any possible negative influence can be disregarded.

Adult↗
PubMed1981

The effect of bromazepam on psychomotor activity and subjective mood.

The effects of short-term (acute) doses of bromazepam were studied in a double-blind trial with the aid of three dosage groups comprising a total of fifty-five healthy male medical students (who received placebo, and 1.5 mg or 3.0 mg bromazepam, respectively). Subjective well-being was recorded through self-ratings by the volunteers, and the variables of psychomotor function by standard testing instruments. In terms of subjective well-being, fatigue and decreased performance (statistically confirmed throughout) were reported by the probands in all three dosage groups after they were administered either the drug or placebo. None of the dose-effect relationships were statistically significant, although this trend was more pronounced, purely in quantitative terms, in the group that received 3 mg bromazepam than in either the placebo or the 1.5 mg bromazepam group. In the reaction time and in critical flicker-frequency (CFF) testing, the trend mentioned above was confirmed. In the attentiveness and memory span test, learning effects were statistically confirmed in equally uniform fashion. The action of the substance was again not statistically significant. It may be concluded from this that subjective, and also in part objective, fatigue and decreased performance were related to the type of trial design employed, and not, generally speaking, to the action of the substance. However, again independently of the drug's activity, statistical confirmation was obtained of improved performance and/or learning activity in three variables of the alertness testing apparatus. Variables of driving ability were not adversely affected, but--if anything--stabilized. Our investigation studied the single-dose schedules of bromazepam--viz. 1.5 mg and 3 mg--that are most commonly prescribed for patients. The subacute and personality-related effects of the drug will be the subject of a later report.

Adult↗