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Biomedical subjects

P Bech

Publications and source records attributed to P Bech.

At least 19 recordsLinked to original sources
PubMed1992

Issues of concern in the standardization and harmonization of drug trials in Europe: health-related quality of life, ESCT meeting, Strasbourg, 23-24 May 1991.

Overviews of the development of the concept of quality of life from a medical viewpoint, and the need for new models and methods to assess health-related quality of life were presented, along with WHO, FDA and European regulatory viewpoints and a discussion on the measurement and valuation of health by social judgement, at the health-related quality of life session at an ESCT meeting on issues of concern in the standardization and harmonization of drug trials in Europe. It was concluded that, for the present, all three types of measurements of quality of life--individual, disease-specific, and generic scales--should be used in research to look for convergent versus divergent validity.

Clinical Trials as Topic↗
PubMed1992

Combined treatment with imipramine and mianserin. A controlled pilot study.

The effect of imipramine plus mianserin and imipramine plus a placebo was compared in 40 depressed patients with a median age of 60 years. The imipramine dosage was flexible to give a plasma concentration around 200 nmol/l and mianserin was given at a fixed dosage of 30 mg daily. After six weeks of treatment the results showed that the scores on the Hamilton Depression Scale as well as on the Melancholia Scale were significantly more improved in the imipramine-plus-minaserin group than in the group of patients receiving imipramine alone (P less than 0.01). In terms of percentage of improvement (a reduction of baseline rating scores of 50% or more) 77% of the imipramine-plus-mianserin group had improved, compared with 27% of the imipramine group. The combination of imipramine and mianserin was well tolerated both as regards clinical side-effects and laboratory tests.

Adult↗
PubMed1992

Treatment of generalized anxiety disorder: comparison of a new beta-blocking drug (CGP 361 A), low-dose neuroleptic (flupenthixol), and placebo.

In an attempt to evaluate an alternative drug treatment to benzodiazepines in generalized anxiety disorders, a placebo controlled trial was carried out with a new beta-adrenergic blocker (CPG 361 A). A low-dosage neuroleptic (flupenthixol) was included as a reference drug. Depending on the clinical assessment scales the placebo treatment resulted in moderate to excellent improvement in 36% to 56% of the patients after four weeks of treatment. The active drugs generally had a higher improvement range (from 31% to 80%). The global improvement scale was found to be better than the other scales in discriminating between placebo (50% improvement) and the active drugs (CGP 361 A brought about 78% improvement and flupenthixol brought about 80% improvement). However, only for flupenthixol was the difference of statistical significance.

Adrenergic beta-Antagonists↗
PubMed1992

Citalopram in depression--meta-analysis of intended and unintended effects.

An updated qualitative meta-analysis of controlled clinical trials is presented. When compared to reference drugs, especially tricyclics, citalopram after 6 weeks of treatment showed a similar intended effect on the depression index of the Hamilton scale. However, on the sleep index of the scale citalopram was weaker than tricyclics. When compared to placebo, citalopram after 6 weeks of treatment showed to be significantly superior on the Hamilton scale and on the global assessment scales. Analysis of unintended effects showed that citalopram had fewer side-effects than tricyclics, especially of anticholinergic types. In conclusion, citalopram has been found to be a non-sedating antidepressant which is well accepted by the patients due to its lack of unintended effects.

Adult↗
PubMed1992

The Hamilton scales and the Hopkins Symptom Checklist (SCL-90). A cross-national validity study in patients with panic disorders.

The HRSD, HRSA, SCL-90 scales were psychometrically investigated in a cross-national sample of patients with varieties of non-psychotic symptoms of anxiety and depression. Across the cultural backgrounds the scores obtained from the original versions of these scales are not sufficient statistics. However, latent structure analysis has identified homogeneous subscales for depression (the HRSD) and for discomfort (an SCL subscale). High concurrent validity was found between the subscales of depression, anxiety and discomfort. In international research, inhomogeneity among scale items can be confounded with group differences which are usually ascribed to drug differences.

Adult↗
PubMed1992

Platelet paroxetine binding in alcoholics.

Platelet paroxetine binding was analysed in 24 abstinent alcoholics and 18 control persons. The alcoholics had significantly more binding sites than the control persons. Most of the alcoholics showed affective symptoms and the increased platelet paroxetine binding was predominantly observed among those who had the lowest Newcastle score, indicating the presence of non-endogenous depression.

Adult↗
PubMed1991

[Treatment of hypertension in general practice, consequences of therapeutic changes. A multipractice study of the therapeutic patterns, blood pressure control, drug administration schedule and incidence of side effects].

The antihypertensive treatment schedules were investigated in 1,153 consecutive patients in 65 general practices. Treatment consisted mainly of diuretics or betablockers singly or combined. In a sample of 303 of these patients, treatment was altered in a randomised, single-blind, cross-over design to consist of a single daily dose of metoprolol, or a single daily dose of metoprolol plus a single dose of a placebo. The effect of multiple dosages on the quality of life was investigated simultaneously with investigation of the efficacy of single drug treatment with a beta-blocker on blood-pressure control as compared with the previous treatment. A slight increase in side-effects was observed which might be ascribed to increased awareness by the patient and also by the doctor. The more simplified regimen with a single daily dose of the betablocker showed the same blood-pressure levels as in the previous more complicated regimen.

Adult↗
PubMed1991

An epidemiological study of REM latency and psychiatric disorders.

In an epidemiological population study 87 subjects were studied with home sleep recordings. Nineteen subjects had minor psychiatric disorders: six subjects had a minor depression, six subjects had a generalized anxiety disorder, and seven subjects had a mild vegetative discomfort syndrome. Syndrome profiles of the three groups, using the AMDP system, showed a significantly higher degree of insomnia in the anxiety group than in the depressive group. The mean rapid eye movement (REM) latency in the anxiety group was significantly longer than in the other groups, including normals. The study showed a slight tendency towards a reduced REM latency in the minor depressives, but no statistical significance was obtained.

Adult↗
PubMed1991

Validation criteria for panic disorder as a nosological entity.

Panic disorder (DSM-III, DSM-III-R) has been thoroughly studied in recent years. The main evidence for panic disorder as a nosological entity is reviewed, to delineate some important questions for future research. Validation criteria include epidemiological, phenomenological, genetic, neurobiological, pharmacological and behavioral findings. Biological, behavioral and psychodynamic considerations on etiology, pathogenesis and treatment are presented.

Alprazolam↗
PubMed1991

Efficacy and safety of alprazolam, imipramine and placebo in treating panic disorder. A Scandinavian multicenter study.

As part of the cross-national collaborative panic study, a double-blind comparison of alprazolam, imipramine and placebo was performed in Scandinavian outpatients with panic disorder according to DSM-III; 41 patients were randomly allocated to each drug. Doses were increased for 3 weeks to an average of about 6 mg alprazolam, 150 mg imipramine and a corresponding number of placebo capsules, which were then given for 5 weeks. No more than supportive psychotherapy was given. Key symptoms were rated weekly. The drugs were tapered for 4 or 8 weeks and the patients were followed up for 6 months. Compliance at 3 weeks was 95% for alprazolam, 83% for imipramine and 88% for placebo; at 8 weeks 95% for alprazolam, 73% for imipramine and 46% for placebo. At 3 weeks plasma determination showed that the proportion taking diazepam outside the protocol was 0% for alprazolam, 19% for imipramine and 31% for placebo; at 8 weeks the corresponding proportions were 3%, 11% and 16%. Intention-to-treat analysis showed that freedom from panic attacks was obtained for 68% with alprazolam, 61% with imipramine and 34% with placebo. Alprazolam was more effective than imipramine and placebo on anticipatory anxiety and phobic symptoms. Globally rated by physicians and patients, about 60% had complete remission with alprazolam and imipramine and 30% on placebo. At least partial remission was obtained in about 85% with alprazolam, 70% with imipramine and 40% with placebo. Alprazolam had a more rapid onset of action than imipramine on all symptoms. Side effects were generally mild, with a preponderance of drowsiness for alprazolam and anticholinergic effects for imipramine. Tapering was uneventful without significant discontinuation phenomena. During taper and follow-up, several patients in remission relapsed, leaving approximately 30% patients in complete remission in all groups. To obtain more stable improvement, either long-term drug treatment or combinations of drug treatment and psychotherapy should be evaluated.

Adolescent↗
PubMed1991

A trend analysis of changes during treatment of panic disorder with alprazolam and imipramine.

A total of 123 Scandinavian patients participated in a cross-national study of panic disorder. Twelve outcome measures, including number of panic attacks and phobias, have been used to describe changes in symptoms during treatment. This article gives a trend analysis of remission for each variable, analysing changes through the total period from baseline to week 8 and also changes in first and second half of this period, separately. Important differences between treatments are demonstrated. Alprazolam had an early effect on variables relating to panic attacks, such as severity of spontaneous attacks and avoidance, whereas imipramine showed a more delayed effect on global measures. Duration of illness, sex and the occurrence of depression in patients' history all affected the sequence of improvement.

Alprazolam↗
PubMed1991

Secondary depression in panic disorder: an indicator of severity with a weak effect on outcome in alprazolam and imipramine treatment.

Depressive symptoms are frequent in panic disorder. Among 123 Scandinavian patients participating in a placebo-controlled multicenter study of the efficacy of alprazolam and imipramine treatment in panic disorder, 21% and 23% fulfilled the DSM-III criteria of current and past major depressive episode, respectively, and 17% had dysthymia, even when melancholia and depressive episode with onset prior to the panic symptoms were excluded. According to a subscale of the Hamilton Rating Scale for Depression (HRSD) with higher validity than the full scale, 18% were classified as major depression and 57% as minor depression. A major finding was that patients with affective symptoms had higher scores on many psychopathological measures, including several Symptom Checklist-90 factors. Accordingly, secondary depression was suggested as an indicator of the severity of panic disorder. Depressed and nondepressed patients significantly improved on major outcome measures, but patients with current minor or major depression improved less. Although the sample was too small for detailed analysis of differences in drug efficacy, there was no indication that imipramine was more effective than alprazolam, considering scores on an HRSD subscale.

Alprazolam↗
PubMed1991

Alprazolam, imipramine and placebo treatment of panic disorder: predicting therapeutic response.

Factors that predicted the outcome of drug treatment (alprazolam or imipramine) of panic disorder were studied in a sample of 123 Scandinavian patients participating in a multicenter placebo-controlled 8-week trial. The attrition rate was 95% for alprazolam, 73% for imipramine and 46% for placebo. For the intention-to-treat and 3-week-completer samples, drugs and anxiety symptoms at baseline were the best predictors of improvement on the Global Improvement Scale and on symptom scales focusing on panic attacks, phobic behavior and anticipatory anxiety. For completers of the 8-week trial, only baseline scores predicted outcome. Generally, more severe symptoms at baseline predicted a worse outcome. A subsample of patients had a marked placebo response. Avoidance, sex, age, childhood psychopathology and previous treatment experience had no or only a weak impact on the outcome. The relationship between panic disorder and mood disorder is presented elsewhere.

Adult↗
PubMed1991

The Cronholm-Ottosson Depression Scale: the first depression scale designed to rate changes during treatment.

In 1960 Ottosson published the first specific depression rating scale (the Cronholm-Ottosson Depression Scale) designed to be sensitive in measuring change during antidepressive therapy. Ottosson and his group have never used factor analysis to validate the scale, as the items of the scale were used factor analysis to validate the scale, as the items of the scale were selected on a preconceived idea for homogeneity, i.e. having a monotonic correspondence to the underlying dimension of severity of depression. The most appropriate method of testing the construct validity of the Cronholm-Ottosson Depression Scale is latent structure analysis. Using the original Ottosson data, a latent structure analysis has been made showing that the 8 items of the scale are homogeneously related, i.e. can be ordered on one dimension of severity of depression. The descriptive statistic of a 50% reduction of pretreatment score (or more) equaled the global clinical score of moderate to excellent improvement. Both scales showed that, already after 4 electroconvulsive treatments, about 80% of depressed patients who received adequate fits had moderate to excellent improvement, whereas only around 40% of depressed patients who received inadequate fits improved moderately or excellently.

Affective Disorders, Psychotic↗
PubMed1991

The Panic-Associated Symptom Scale: measuring the severity of panic disorder.

The Panic-Associated Symptom Scale (PASS) is presented as a new measurement of the severity of the core symptoms of panic disorder. This first description addresses the rationale for its design and its scoring, score distributions, test-retest reliability, correlations within the PASS and with other scales, principal component structure, and response to drug therapy. Data are presented from a large study group of patients with panic disorder (n = 1168). Problems in measuring panic disorder are discussed.

Adult↗