PubMed Health⌕ Search

Biomedical subjects

R Kohnen

Publications and source records attributed to R Kohnen.

At least 37 records · Page 2Linked to original sources
PubMed2000

Comparison of moclobemide with selective serotonin reuptake inhibitors (SSRIs) on sexual function in depressed adults. The Australian and German Study Groups.

OBJECTIVE: To compare the emergent sexual effects of moclobemide and selective serotonin reuptake inhibitors (SSRIs) during acute and maintenance therapy in routine practice. METHOD: 268 patients were evaluated for sexual function at baseline, 6 weeks, 3 and 6 months of treatment using physician ratings and self-rating questionnaires. Patients received moclobemide, an reversible monoamine oxidase A inhibitor (RIMA), or a SSRI (fluoxetine, fluvoxamine, paroxetine, sertraline). RESULTS: Baseline values were similar in all groups. Incidences of impairments of sexual functioning with treatment, whether clinically relevant or not, were 24.3% with moclobemide and 61.5% with SSRIs (physician ratings), with no significant tolerance to these effects. There was a suggestion of differences between the SSRIs in their specific dysfunctions they cause. SSRIs (21.6% of patients) had about ten times the moclobemide rate (1.9%) of sexual dysfunction reported as adverse events. Antidepressant efficacy was comparable between treatments. CONCLUSION: In patients for whom sexual function is important or sexual dysfunction is present, moclobemide should be considered a first line antidepressant.

Adult↗
PubMed2000

Mirtazapine compared with paroxetine in major depression.

BACKGROUND: The aim was to compare the efficacy and tolerability of mirtazapine with those of paroxetine. METHOD: 275 outpatients with a diagnosis of major depressive episode (DSM-IV) and a score > or = 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) were randomly assigned to 6 weeks of treatment with mirtazapine (15-45 mg/day) or paroxetine (20-40 mg/day). Efficacy was assessed by the HAM-D-17, Hamilton Rating Scale for Anxiety (HAM-A), and Clinical Global Impressions scales (Severity and Improvement), and analyses were performed on the intent-to-treat sample (127 mirtazapine-treated patients and 123 paroxetine-treated patients). RESULTS: Mean daily doses were 32.7 mg of mirtazapine and 22.9 mg of paroxetine. Thirty patients in the mirtazapine group and 33 in the paroxetine group dropped out. Both drugs were equally effective in reducing symptoms of depression. At week 1, the mean HAM-D-17 total score was significantly lower in mirtazapine- than paroxetine-treated patients (16.5 vs. 18.8, p = .0032). Similarly, significantly more mirtazapine-treated patients were HAM-D-17 responders (> or = 50% decrease from baseline) at weeks 1 (23.2% vs. 8.9%, p = .002) and 4 (58.3% vs. 44.5%, p = .04). Both treatments were equally effective in reducing anxiety. However, the reduction in mean HAM-A total score was significantly greater with mirtazapine than with paroxetine at week 1 (-5.1 vs. -3.5, p = .0435). Tolerability of both treatments was good, with more nausea, vomiting, tremor, and sweating in the paroxetine group and more weight increase and influenza-like symptoms in the mirtazapine group. CONCLUSION: Mirtazapine and paroxetine were equally effective after 6 weeks of therapy and were both well tolerated. A potentially faster onset of overall therapeutic efficacy of mirtazapine was suggested by significant differences between treatments after 1 week of therapy that were due to slightly larger improvements of several core symptoms of depression as well as distinct prevention of treatment-emergent worsening of anxiety and physical components of depression.

Adult↗
PubMed1999

Rapid onset of action of levodopa in restless legs syndrome: a double-blind, randomized, multicenter, crossover trial.

OBJECTIVE: To investigate the efficacy and safety of levodopa plus benserazide in the treatment of restless legs syndrome (RLS), in terms of the frequency of periodic limb movements (PLMs), objective and subjective criteria of sleep, onset of action, and withdrawal effects. DESIGN: A randomized, double-blind, placebo-controlled, multicenter, crossover trial, with two 4-week treatment periods. SETTING: Outpatient units of three specialist centers in Germany. PATIENTS: Eligible patients had to fulfill the diagnostic criteria of the International RLS Study Group and have sleep disturbances and PLMs during sleep shown on polysomnography at screening. Thirty-five patients were recruited, of whom 32 (13 men, 19 women) completed the study. INTERVENTIONS: Patients received a single dose of standard-release levodopa/benserazide 100/25 mg or placebo at bedtime each night for 4 weeks, before crossing over to receive the alternative treatment for a further 4 weeks; the dose could be doubled if required. The average dosages were 159 +/- 31 mg of levodopa and 1.56 +/- 0.29 capsules of placebo. RESULTS: Levodopa/benserazide significantly reduced the number of PLMs per hour (p<0.0001), increased the time in bed without limb movements (p<0.0001), and improved subjective quality of sleep (p=0.0004). The onset of action was rapid after the first dose, and full efficacy was achieved within the first few days of therapy; these improvements disappeared immediately when treatment was discontinued. Levodopa/benserazide treatment was well tolerated and safe. CONCLUSIONS: Levodopa/benserazide is effective and safe in the treatment of RLS. Objective and subjective measures of sleep improved rapidly after the first dose. RLS symptoms recurred immediately after treatment was discontinued.

Adult↗
PubMed1999

Hypericum extract versus imipramine or placebo in patients with moderate depression: randomised multicentre study of treatment for eight weeks.

OBJECTIVES: To assess the efficacy and safety of hypericum extract (STEI 300, Steiner Arzneimittel, Berlin) compared with imipramine and placebo in patients in primary care with a current episode of moderate depression. DESIGN: Randomised, double blind, multicentre, parallel group trial for 8 weeks. SETTING: Trained panel of 18 general practitioners from four German states: Bavaria, Berlin, Rhineland Palatinate, and Saxony. PARTICIPANTS: 263 patients (66 men, 197 women) with moderate depression according to ICD-10 (international classification of diseases, 10th revision) codes F32. 1 and F33.1. INTERVENTIONS: 1050 mg hypericum extract (350 mg three times daily), 100 mg imipramine (50 mg, 25 mg, and 25 mg daily), or placebo three times daily. MAIN OUTCOME MEASURES: Change from baseline score on the 17 item version of the Hamilton depression scale, the Hamilton anxiety scale, the clinical global impressions scale, Zung's self rating depression scale, and SF-36, and adverse events profile. RESULTS: Hypericum extract was more effective at reducing Hamilton depression scores than placebo and as effective as imipramine (mean -15.4 (SD 8.1), -12.1 (7.4), and -14.2 (7.3) respectively). Comparable results were found for Hamilton anxiety and clinical global impressions scales and were most pronounced for the Zung self rating depression scale. Quality of life was more improved in the standardised mental component scale of the SF-36 with both active treatments than with placebo but in the physical component scale was improved only by hypericum extract compared with placebo. The rate of adverse events with hypericum extract was in the range of the placebo group but lower than that of the imipramine group (0.5, 0.6, and 1.2 events per patient respectively). CONCLUSIONS: At an average dose of 350 mg three times daily hypericum extract was more effective than placebo and at least as effective as 100 mg imipramine daily in the treatment of moderate depression. Treatment with hypericum extract is safe and improves quality of life.

Adult↗
PubMed1999

A controlled study of additional sr-L-dopa in L-dopa-responsive restless legs syndrome with late-night symptoms.

OBJECTIVE: To investigate whether a combination treatment of regular-release levodopa (rr-L-dopa) and sustained-release levodopa (sr-L-dopa) compared with monotherapy of rr-L-dopa improves sleep quality and reduces periodic limb movements (PLM) in patients with restless legs syndrome (RLS) and problems with maintaining sleep. BACKGROUND: Reappearance of RLS symptoms during the second half of the night while being treated with rr-L-dopa is a common problem in the treatment of sleep disturbances caused by RLS. METHODS: A randomized, controlled, double-blind crossover trial was undertaken. Eligible patients fulfilled the diagnostic criteria of the International RLS Study Group, and met an actigraphically confirmed higher number of PLM per hour time in bed (PLM index) during the second half compared with the first half of the night under treatment with rr-L-dopa. During the crossover periods the patients received 100 to 200 mg rr-L-dopa plus either placebo or 100 to 200 mg sr-L-dopa at bedtime for 4 weeks each period. RESULTS: Thirty patients with RLS (11 men and 19 women) were assessed by actigraphy and subjective sleep quality, and showed a significant improvement in PLM index (p < 0.0001), in "time in bed without movements" (p < 0.0001), and in subjective sleep quality (p < 0.001). Eight of 30 patients reported an altered pattern of RLS symptoms, characterized by a time shift of RLS symptoms into the afternoon or evening, five of these during monotherapy with rr-L-dopa. CONCLUSIONS: A combination therapy of rr-L-dopa and sr-L-dopa is better than monotherapy with rr-L-dopa in reducing the frequency of PLM and problems maintaining sleep, even in patients who are severely affected.

Adult↗
PubMed1999

[Prospective double-blind study of prophylaxis of radioxerostomia with Coumarin/Troxerutine in patients with head and neck cancer].

AIM: Prospective, randomized placebo-controlled double-blind study to prove the efficacy of Coumarin/Troxerutine (Venalot Depot) for protection of salivary glands during a head and neck irradiation. PATIENTS AND METHOD: Forty-eight radiotherapy patients (60 Gy) with head and neck cancer were included in this trial. During radiotherapy the salivary glands were located in the core irradiation field. Primary efficacy parameters were sialometry, quantitative salivary gland scintigraphy and clinical evaluation of early effects of radiotherapy (RTOG-score, Table 1). All data were collected at 6 assessments: 1 week pre-radiation (U1), at start (U2), half time (U3) and end (U4) of irradiation, 8 days (U5) and 28 days (U6) after the end of irradiation (Figure 1). RESULTS: Twenty-three patients (11 verum, 12 placebo) completed the study with all assessments. Sialometrically, all patients were severely (half of radiotherapy) or completely (end of radiotherapy) xerostomatic (Figure 2). In a global efficacy measure according to O'Brien combining scintigraphy and RTOG there was a tendency for a higher efficacy of verum compared to placebo (p = 0.068). After start of irradiation therapy, the RTOG-score showed continuously and significantly lower early radiation effects under verum than under placebo (U3 vs U6: p < 0.05, area under curve: p = 0.032; Table 2, Figure 3). The scintigraphically determined excretion fraction was slightly less impaired in the verum group compared to the placebo treatment (p = 0.12. Figure 4). There was no difference in drug safety between placebo and verum for adverse events, changes in the activity of liver enzymes and for global impression of tolerability. CONCLUSIONS: The results give support for an advantageous effect of Venalot Depot in the treatment of radiogenic sialadenitis and mucositis. In even a small number of evaluable patients, early clinical effects of irradiation (RTOG-score) were less pronounced in the active treatment group than in the placebo group, but the sample size was too low to prove statistically also the benefit of coumarin/troxerutine with the scintigraphic method. Sialometry seems not suitable for the assessment of early radiation effects.

Adult↗
PubMed1999

Undesirable blood pressure changes under naturalistic treatment with moclobemide, a reversible MAO-A inhibitor--results of the drug utilization observation studies.

Blood pressure decrease, associated with postural hypotension, as well as spontaneous hypertension are considered to be typical side-effects of conventional, irreversible and nonselective MAO (A+B) inhibitors. The new generation of reversible MAO-A inhibitors is, however, expected to have negligible cardiovascular effects and low propensity to induce either blood pressure increases or decreases. But, the true incidence of such changes is largely unknown since observation studies, specifically assessing the frequency of blood pressure changes, in unselected population of patients treated in the practice, are lacking.

Adult↗
PubMed1999

Efficacy and safety of a fixed combination phytomedicine in the treatment of the common cold (acute viral respiratory tract infection): results of a randomised, double blind, placebo controlled, multicentre study.

OBJECTIVE: The common cold (acute viral respiratory tract infection) is one of the most frequent diseases in man, world-wide. Clinically relevant efficacy should include early improvement of all symptoms. Results of a clinical trial of a commercially available fixed combination herbal remedy (Radix echinaceae, Radix baptisiae, Herba thujae) are reported here. The aim of this study was to verify clinical efficacy shown in recent studies under (i) good clinical practice (GCP) quality assurance and (ii) common situations at family doctors. METHODS: Patients attending one of 15 study centres (practitioners) as a result of an acute common cold were randomised to the double-blind placebo-controlled study. Three tablets of study medication were applied t.i.d. for 7 to 9 days. Patients daily documented the intensity of 18 cold symptoms, as well as the cold overall, using a 10-point scale and estimated their general well-being using the Welzel-Kohnen colour scales. Additionally, the severity of illness was assessed by the physician on days 4 and 8 (CGI-1). The main and confirmatory outcome measure was expressed as a total efficacy value. This was gauged from the z-standardised AUC values of the primary endpoints (rhinitis score, bronchitis score, CGI-1 and general well-being). Adverse events, overall tolerability, vital signs and laboratory parameters were documented. RESULTS: 263 patients were included. For safety analysis, all patients were used. 259 patients were evaluable for primary efficacy analysis (ITT). Results were confirmed analysing only the 238 valid cases (VCs). The primary efficacy parameters showed the superiority of the herbal remedy over placebo (p < 0.05). Effect size was 20.6% of the standard deviation (90% CI: 0.04-41.1%; ITT) and 23.1% (1.7-44.5%; VC). In relation to the general well-being, the effect size was 33.9% of the standard deviation (12.5-55.3%; VC). Patients who suffered from at least moderate symptom intensity at baseline showed response rates (at least 50% improvement of the global score, day 5) of 55.3% in the herbal remedy group and 27.3% in the placebo group (p = 0.017; NNT = 3.5). In the subgroup of patients who started therapy at an early phase of their cold, the efficacy of the herbal remedy was most prominent (p = 0.014 for the primary efficacy parameter). The therapeutic benefit of the herbal remedy had already occurred on day 2 and reached significance (p < 0.05) on day 4, and continued until the end of the treatment in the totdl score of symptoms, bronchitis score and rhinitis score, as well as in the patients' overall rating of the cold intensity. At that time, equal levels of improvement were reached three days earlier in the verum group than in the placebo group. In 26 patients receiving the herbal remedy and 23 patients receiving placebo, adverse events were reported. Adverse drug reactions were suspected in two patients in the verum group and in four patients in the placebo group. Serious adverse events did not occur. CONCLUSIONS: This study shows that the herbal remedy is effective and safe. The therapeutic benefit consists of a rapid onset of improvement of cold symptoms. If patients with colds are able to start the application of the herbal remedy as soon as practical after the occurrence of the initial symptoms, the benefit would be expected to increase (e.g. self-medication).

Adult↗
PubMed1998

Polysomnographic sleep measures in patients with uremic and idiopathic restless legs syndrome.

In the present study, the nocturnal electroencephalographic sleep pattern, the number of periodic leg movements (PLM) during sleep and wakefulness, and the subjective sleep parameters of patients with uremic (n = 10) and idiopathic (n = 17) restless legs syndrome (RLS) were compared. The main finding was that the total number of PLM (p = 0.019), the PLM index (p = 0.018), and the PLM index while awake (p = 0.003) were significantly higher in patients with uremic RLS compared with patients who had idiopathic RLS. Additionally, both groups showed a distinct time-of-night pattern of PLM activity. Polysomnographic measures of sleep continuity (total sleep time, sleep efficiency, sleep onset latency, time awake) and sleep architecture (amount of nonrapid eye movement sleep stages 1, 2, 3, and 4 and the amount of rapid eye movement sleep) did not differ between uremic and idiopathic RLS patients. With regard to subjective parameters, sleep quality was estimated to be worse in uremic RLS (p = 0.033), whereas other parameters (for example, severity of RLS, quality of life) did not differ between the two groups. It is suggested that uremia itself worsens the motor symptoms of RLS, probably as a result of increased excitability.

Adult↗
PubMed1998

[Quality of life in chronic venous insufficiency (CVI). Results of a study with the newly developed Tübingen Questionnaire for measuring quality of life of patients with chronic venous insufficiency].

Across the boundaries of the medical specialties we have realized how important the concepts of quality of life and disease-related coping behavior are to understand the patients' subjective perception of the medical condition and its treatment. Although standardized instruments are already available for different medical indications and even in the related fields of peripheral vascular and cardiac diseases, phlebology still lacks standardized concepts for evaluating quality of life and/or disease-related coping behavior in patients with chronic venous insufficiency (CVI). We report on a newly developed instrument specifically designed for recording quality of life in patients with CVI. It not only meets the requirements of psychometric standards, but has also proven its applicability in clinical use. The "Tübingen Questionnaire for measuring Quality of Life in patients with CVI (TLQ-CVI)" and the results of a study on quality of life in 142 patients with various stages of chronic venous insufficiency are presented. It was possible to distinguish between Stage I/II and Stage III CVI patients with respect to parameters such as "leg complaints" and "day-to-day fears and worries". These convey clinically relevant insights into the patient's subjective perception of the disease and how they cope. The information gathered provides a set of reasonable target scores for clinical studies presently being carried out at various study centers in Germany incorporating the TLQ-CVI.

Activities of Daily Living↗
PubMed1998

Clinical and biochemical findings in uremic patients with and without restless legs syndrome.

The restless legs syndrome (RLS) is one of the most common and unpleasant complaints of uremic patients. The pathophysiology of the RLS is still unclear. Various factors, including anemia and iron deficiency, are proposed to play a major role. We determined the prevalence of RLS in all stable hemodialysis patients under long-term treatment in two dialysis centers (n = 136) and compared the clinical and biochemical findings of patients with RLS and without RLS. Twenty-three percent of all patients investigated fulfilled the diagnostic criteria of RLS according to the International Restless Legs Syndrome Study Group. There were no statistical differences between the two groups regarding age, duration of uremia and need for dialysis, time on dialysis per week, hemoglobin, hematocrit, erythrocytes, s-ferritin, s-transferrin, s-iron, calcium, and standard biochemical indices, except for intact parathyroid hormone (iPTH) levels. Uremic patients with RLS showed significantly lower iPTH (P < 0.01) concentrations. In addition, the RLS group received a significantly higher number and dosage of psychopharmacological drugs, (ie, L-DOPA), than patients without RLS. These biochemical findings suggest that neither the severity of anemia nor that of iron deficiency has to be considered a major pathophysiological factor in established RLS. The significantly lower iPTH secretion in uremic patients with RLS, however, is a new finding, and further investigations will be necessary to determine whether this result is of any clinical significance to this group of patients. The significantly higher number of psychopharmacological drugs prescribed to uremic patients with RLS may be related to the symptoms of RLS.

Adult↗
PubMed1998

Evaluation of sedative effects of single and repeated doses of 50 mg and 150 mg tolperisone hydrochloride. Results of a prospective, randomized, double-blind, placebo-controlled trial.

Sedative effects of single and repeated doses of 50 mg and 150 mg tolperisone hydrochloride (Mydocalm), a centrally active muscle-relaxing agent, were evaluated in a placebo-controlled double-blind clinical trial. A total of 72 healthy young adults balanced by sex were randomized to receive 50 mg or 150 mg tolperisone hydrochloride or placebo t.i.d. for a period of 8 days. Control examinations were performed in the mornings of days 1 and 8 before intake of the morning dose and at 1.5, 4 and 6 hours postdose. The psychomotoric test battery used in this trial revealed no sedative effects of tolperisone hydrochloride in the given doses at any control examination. Subjective mood ratings quantified by the Welzel Colored Scales were not impaired either. The lack of differences in sedative potentials of tolperisone hydrochloride and placebo was confirmed by tests on differences and by tests on equivalence using 95% CI. The present study substantiates clinical experience and previous clinical trials demonstrating that tolperisone hydrochloride, though being a centrally active muscle relaxant, does not cause any sedation and does not impair reaction times.

Adult↗
PubMed1997

What happens to patients after the end of a clinical trial? Systematic follow-up observational study of an open moclobemide trial in major depression.

Controlled clinical drug trials typically last several weeks. At the end of this fixed time period approximately two-thirds of the patients in trials with antidepressant drugs are classified as responders, i.e. the initial severity score is reduced by about fifty percent. In a clinical perspective this means that many patients, even among the responders, are still quite ill and require further treatment. Nevertheless, to date there do not appear to have been any studies on treatment and course of illness after the termination of controlled clinical trials. In a "naturalistic" follow-up surveillance study of 202 patients who had taken part in a controlled trial with the antidepressant moclobemide for six weeks, treatment and clinical status were monitored through questionnaires sent out to their treating physicians (n = 78) at two assessment points four weeks and six months later. Results showed that sixty percent of patients continued to receive the study drug moclobemide after the completion of the clinical trial. Twenty percent were switched to other antidepressants and twelve percent received no further psychotropic drugs. In the course of six months a considerable variation in treatment modes could be observed. Patients under ongoing active treatment made considerable additional progress. A correlation was found between insufficient response and repeated switching of medication. Patients who had been taken off antidepressant medication because of early good response did not experience early relapse after the end of treatment.

Antidepressive Agents↗
PubMed1997

Guidelines for the implementation of drug utilization observation (DUO) studies in psychopharmacological therapy. The "Phase IV Research" Task-Force of the Association for Neuropsychopharmacology and Pharmacopsychiatry (AGNP).

The task-force on Phase-IV-Research of the Association for Neuropharmacology and Pharmacopsychiatry (AGNP) has developed guidelines for the implementation of scientifically sound drug utilisation observation studies (DUO studies). These guidelines have been adopted by the executive committee as the position of the association. DUO studies are prospective pharmacoepidemiological studies, by which prescription, illness, and patient data of individual patients are collected without interference with the routine course of treatment. They can answer questions on the interaction of treatment modalities with positive and negative treatment outcome. Scientific standards require that there is a study protocol which describes the epidemiological, statistical, procedural, and quality assurance methodology and states who is responsible for what. As such studies can violate data protection regulations or can be used for sales instead of scientific purposes, consultation of an ethics committee is recommended.

Clinical Trials, Phase IV as Topic↗
PubMed1996

[Decision to use complementary medicine: fact oriented or irrational?].

PROBLEM AND OBJECTIVE: Complementary medicine is being used to varying extent in all industrial countries. There are incomplete data concerning efficacy, safety and costs of such treatment, while little is known about special features and motivation of those persons who choose complementary medicine. The aim of the study was to ascertain, among patients who use complementary medicine and those who prefer traditional medicine, any differences with regard to sociodemographic, disease-related and psychological characteristics and their life-style. PATIENTS AND METHODS: A total of 419 patients were studied by a standardised interview and questionnaire (168 items) and divided into two groups (group 1: those using conventional treatment [n - 197; 91 women, 106 men; average age 43.2 +/- 16.9 years]; group 2: those preferring complementary medicine [n = 222; 159 women, 63 men; average age 43.2 +/- 15.0 years]). They were recruited from specialist internal medical or generalist medical practice with or without offer of complementary medicine (additional term: natural healing methods). Statistical analysis was with Student's-t-test and the chi(2)-test [correction of gamma-test]. RESULTS: Those patients who chose to be treated by complementary medicine clearly differed from the others with respect to sociodemographic, disease-related and psychological characteristics, as well as life-style. The patient-doctor relationship also differed between the two groups. On average those of group 2 had a higher educational level (higher education: 10.3% in group 1; 15.9 in group 2) and lower risk factors (68.9% nonsmokers in group 1, 77.8% in group 2; alcohol abstinence: 33.2 vs 46.4%). Patients in both groups preferred conventional medicine for serious diseases (cardiac infarct; tumour; AIDS). CONCLUSIONS: In general, those patients who choose complementary medicine have a healthier life-style. As the number of these patients is on the increase. Since as yet the efficacy, risks and costs of complementary medicine have been inadequately investigated, research in this area should be intensified.

Adult↗
PubMed1996

[ICD diagnoses in university polyclinic naturopathy consultation].

In a special consulting office for complementary medicine, ambulatory patients interested in receiving adjuvant treatment with complementary medicine can obtain a relevant advice and critical information regarding non-evaluated therapies. Within the framework of a retrospective statistical analysis, the diagnosis documented over a period of 24 months in accordance with the 4-digit ICD code were evaluated. In particular patients with chronic and/or functional illnesses had additional treatment needs. The exponential growth in the numbers of patients during the course of the observation period illustrates the increasing importance of complementary medical measures. However, in view of the considerable political significance of the cost factor and the possible risks of the treatment, only properly evaluated complementary medical therapies should be employed.

Adolescent↗