Psychological distress and adjustment to disease in patients before and after radical prostatectomy. Results of a prospective multi-centre study.

The aim of this prospective multi-centre study was to evaluate the level of psychological distress (PD) and adjustment to disease in patients who underwent radical prostatectomy. Furthermore, the impact of urinary incontinence and erectile dysfunction on PD was assessed. Anxiety, depression and PD were evaluated using the Hospital Anxiety and Depression Scale in 329 prostate cancer patients before surgery as well as 3, 6 and 12 months after surgery. These results were compared with those of a male German general population reference group. Adjustment to disease was assessed using the Perceived Adjustment to Chronic Illness Scale. Patients reported low levels of PD at all points of assessment similar to population norms of age-matched German men. Persistent PD was seen in about 8% of the patients and 20% had PD at least two of the measurement points. Relevant predictors for PD after surgery were urinary symptoms and baseline PD. Adjustment to disease was highest before surgery and had significantly reduced at 3 and 6 months after surgery. In general, men are resilient to the experience of localised prostate cancer and adjust well psychologically after surgery. However, between 8% and 20% of patients could possibly benefit from mental health support.

Erectile dysfunction after radical prostatectomy: the impact of nerve-sparing status and surgical approach.

The core question of the study was whether the nerve-sparing status and surgical approach affected the patients' sexual life in the first year after surgery. In addition, determinants of erectile function (EF) and the extent of sexual activity were investigated. We conducted a multicentric, longitudinal study in seven German hospitals before, 3, 6 and 12 months after radical prostatectomy (RP). A total of 329 patients were asked to self-assess the symptoms associated with erectile dysfunction (ED). These symptoms were assessed using the International Index of Erectile Function and EORTC QLQ-PR25 questionnaires. A multiple regression model was used to test the influence of clinical, socio-demographic and quality-of-life-associated variables on the patients' EF 1 year after RP. Before surgery, 39% of patients had a severe ED (complete impotence). At 3, 6 and 12 months after surgery, it was 80, 79 and 71%, respectively. Although the surgical approach had no significant effect on EF, patients who had undergone nerve-sparing surgery had significantly lower ED rates. Nevertheless, 1 year after RP, 66% of these patients had severe ED. Age, nerve-sparing status and the burden of urinary symptoms had the greatest impact on the patients' EF. Regardless of nerve-sparing status and surgical approach, postsurgical improvement of EF does not mean a full convalescence of presurgical EF. Instead, it may rather reduce the degree of postsurgical ED in time. Consequently, urologists should disclose to the patient that ED is a likely side effect of RP.

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.

Assessment of sexual dysfunction in depressed patients and reporting attitudes in routine daily practice: Results of the postmarketing observational studies with moclobemide, a reversible MAO-A inhibitor.

OBJECT: The aim of this study was to assess the effect of moclobemide on sexual dysfunction in depressed patients treated under routine conditions in private practice and hospital settings. METHOD: sexual function was systematically assessed by a specific questionnaire and by recording spontaneously reported adverse events during large prospective postmarketing surveillance studies with moclobemide, carried out in Germany between 1992 and 1995. The data of 4333 patients were collected in two different settings: (a) specialized psychiatric and neurological private practices and (b) psychiatric hospitals. RESULTS: Up to 70% of depressed patients suffered from Some type of sexual dysfunction at baseline and in about two thirds the dysfunction was rated as moderate to severe. The severity and frequency of sexual dysfunction corresponded well to the severity of depressive syndrome. Sexual functions improved during treatment with moclobemide and the extent of improvement corresponded to the favourable outcome of antidepressant treatment. Deterioration of sexual functions under moclobemide treatment was infrequent and experienced by less than 3% of patients. The frequency of spontaneously reported sexual dysfunction, reported as adverse event, was lower than 0.1%. For a considerable proportion of patients included in the studies sexual function was not systematically recorded: up to 10-20% of data for variables related to sexual function were missing. Unreported sexual functioning varied in dependence of the type of function, age and gender of the patient and treatment settings. CONCLUSION: The results of the observational studies with moclobemide do not provide evidence that moclobemide induces or intensifies sexual dysfunction in depressed patients under routine daily treatment. The results also demonstrate that the assessment of sexual function in the practice is clearly influenced by the reporting attitudes of patients and physicians.

Management of hypoparathyroidism during pregnancy--report of twelve cases.

There is no established therapeutic regimen for treatment of hypoparathyroidism during pregnancy. This is due particularly to uncertainty about the use of vitamin D or its analogues, as in animal experiments teratogenic side-effects have been reported. Nevertheless, vitamin D or its analogues are required to control tetany predisposing to abortion and preterm labour. We herein report the course of two pregnancies in a hypoparathyroid woman treated with calcitriol (1,25(OH)2D3). Additionally, we describe the outcome of pregnancy in ten women receiving calcitriol, reported to the Drug Safety Department (DSD), Hoffmann-La Roche AG. A 29-year-old hypoparathyroid woman receiving chronic treatment with calcitriol (0.25 microg/day) and calcium (1.5 g/day) was referred in the 6th week of her first pregnancy. Calcitriol was initially discontinued, but during the 20th week of pregnancy recurrent tetany occurred (serum calcium 1.74 mmol/l). Calcitriol (0.25 microg/day) was added, stabilizing serum calcium around 2.15 mmol/l with 1,25(OH)2D3 concentrations around 60 ng/l (normal range 35-80 ng/l). To maintain normocalcaemia the calcitriol dose was increased to 0.5 microg/day during the 33rd week and to 0.75 microg/day shortly before delivery of a healthy girl in the 3 7th week. During her second pregnancy calcitriol was given initially at a dose of 0.25 microg/day with further adaptation to 0.5 microg/day during the 20th and to 1.00 microg/day in the 31st week. Serum calcium and 1,25(OH)2D3 were continually within the lower normal range. She gave birth to another healthy girl during the 39th week. In eight of the ten pregnancies reported to the DSD no adverse effects of calcitriol (0.25-3.25 microg/day) were seen and healthy babies were delivered. In two retrospectively reported cases, serious adverse events were described: premature closure of the frontal fontanelle, and stillbirth in the 20th week due to complex fetal malformation respectively. However, in both cases the causative role of calcitriol administration remains highly questionable. We conclude that, during pregnancy, management of maternal hypoparathyroidism with calcitriol and calcium is feasible, if the 1,25(OH)2D3 concentrations are adapted to the physiological needs during pregnancy and serum calcium levels are kept in the lower normal range.

The efficacy of tenoxicam in patients suffering from rheumatoid arthritis (including assessments of quantified articular scintigraphic data).

Every doctor faced with the task of testing a drug is well aware of the difficulty of making his or her results objective. In designing test procedures, methods need to be found which are unaffected by the subjective views of either the testing doctor or the patients undergoing the treatment. This study was designed taking this into account, using scintigraphic joint measurements in patients with chronic rheumatoid arthritis (RA) to record comparable data. Even this method, however, despite its indisputable scientific accuracy, requires clinical interpretation.

[Influence of the anti-inflammatory agent tenoxicam on gastric potential difference]. / Einfluss der antiinflammatorisch wirkenden Substanz Tenoxicam auf die gastrische Potentialdifferenz.

Tenoxicam (Ro 12-0068), a thienothiacine derivate which belongs to the oxicam class, has been developed for the treatment of rheumatic diseases. Standard antiinflammatory compounds are known for their irritative potency on the gastric mucosa. For this purpose a study was carried out with 15 volunteers after receipt of their informed consent, using the gastric potential difference model. The results of the study showed that tenoxicam is a compound with a low irritative potency on the gastric mucosa and that it is slightly superior to standard therapeutics.

[Interaction of the analgesic substance tenoxicam with alcohol and its influence on psychometrically measurable performance]. / Untersuchungen zur Interaktion der analgetisch wirkenden Substanz Tenoxicam mit Alkohol und der Einfluss auf die psychometrisch messbare Leistungsfähigkeit.

Tenoxicam (Ro 12-0068) is a thienothiacine derivate, which proved to be a potent analgesic in preclinical and clinical trials. An interaction of analgesics, especially those with a possible central origin, with the simultaneous intake of alcohol can never be excluded. For this purpose a study was carried out with 12 volunteers, who had given their informed consent, investigating the influence of alcohol on psychometric parameters like reaction time, memory, ability to concentrate, psychomotor skills. The study led to the result that the simultaneous intake of a realistic volume of alcohol has no influence on the psychometrically measurable performance of the volunteers.

Pilot clinical trial with a new beta 2-sympathomimetic bronchodilator, mabuterol.

An open pilot study was performed on 10 patients with chronic, reversible, obstructive lung disease and known good response to beta 2-bronchodilators. The effects of 40, 60 and 80 micrograms 1-(4-amino-3-chloro-5-trifluoromethyl-phenyl)-2-tert.-butylamino-ethanol hydrochloride (mabuterol) given orally and of 0.4 mg fenoterol (aerosol) were measured on airway resistance, thoracic gas volume, pulse rate and blood pressure. Side effects, ECG and laboratory values were recorded. Mabuterol was found to have a good, clinically useful, bronchodilating effect and to possess excellent tolerability at doses of 40-60 micrograms.

[The effect of indomethacin and carprofen on gastric prostaglandin biosynthesis]. / Wirkung von Indometacin und Carprofen auf die gastrale Prostaglandin-Biosynthese.

The effect of indometacin (3 X 50 mg daily), carprofen (Imadyl) (2 X 150 mg daily) and placebo (3 X daily) on gastric juice secretion, acidity, prostanoid concentration (PGE2, PGF2 alpha and TXB2) and excretion of the major urinary metabolite of PGF (PGF-MUM) were investigated in a single-blind cross-over study in nine healthy volunteers after 3-day treatment periods separated by one-week washout periods between treatments. Indometacin proved to be a classical cyclooxygenase inhibitor (strong inhibition of PGE2 and TXB2 before and after pentagastrin stimulation and of PGF-MUM) while carprofen was an atypical inhibitor (weak inhibition of PGE2 before pentagastrin stimulation and no inhibition after, strong inhibition of TXB2 but without influence on PGF-MUM). The weak inhibition of PGE2-biosynthesis by carprofen might be related to its low incidence of gastric side effects.

[Imadyl: gastric irritation in comparison with acetylsalicylic acid, indomethacin, piroxicam and diclofenac-Na]. / Imadyl(R): Die gastrische Irritation im Vergleich zu Acetylsalicylsäure, Indometacin, Piroxicam und Diclofenac-Na.

A study on 10 healthy male volunteers with the new non-steroidal antiphlogistic drug Carprofen is reported. Carprofen was tested versus Aspirin, Indomethacin, Piroxicam, and Diclofenac-Na using the model of measuring the gastric transmural potential difference (GPD). The lowest values of the relevant parameters concerning the gastric irritation were measured after administration of Carprofen.

[Stomach tolerance of non-steroid anti-rheumatic agents. Studies on gastric irritation caused by carprofen in comparison with acetylsalicyclic acid, indomethacin, piroxicam, and diclofenac]. / Magenverträglichkeit nicht-steroidaler Antirheumatika. Untersuchung zur gastrischen Irritation durch Carprofen im Vergleich zu Azetylsalizylsäure, Indometacin, Piroxicam und Diclofenac.

This is the report of a study on the new non-steroidal antiphlogistic substance Carprofen. In this comparative study Carprofen was tested versus acetylsalicylic acid, Indomethacin, Piroxicam and Diclofenac using the gastric irritation model, by means of a non invasive technique of measuring the gastric transmural potential difference. The study was carried out on a group of 10 healthy male volunteers and led to the following results: The most marked irritation was observed after administration of acetylsalicylic acid followed by Indomethacin. The lowest values of the relevant parameters concerning the gastric irritation were measured after the administration of Carprofen. The differences between acetylsalicylic acid and Indomethacin, and between Indomethacin and the other nonsteroidal substances which were tested could be proven statistically. There was no difference between Piroxicam, Diclofenac and Carprofen that could be proven statistically, nevertheless Carprofen showed the lowest irritation potency of the three non-steroidal antiphlogistics tested.

Leiomyomas of the larynx.

In a now 65 years old male patient a monochorditis of the left vocal cord was clinically observed over several years. Multiple exploratory excisions finally demonstrated a leiomyoma with atypically growing histological structures. The complaints of the patient permanently increased, and a hazel-nut-sized leiomyoma with atypically growing tissue structures, originating in the left vocal cord, was removed by laryngectomy. The exploratory specimen, which was diagnosed in our laboratory as proliferative pseudosarcomatous tissue 11 months before manifestation of the leiomyoma with atypical structures, is compared with analogous findings reported by Lane (1957) and Sherwin et al. (1963). Our observations, completing the results of these publications, allow the conclusion that pseudosarcomatous tissue structures do not only occur in the surroundings of carcinomas but also in the immediate neighbourhood of mesenchymal tumours. Choice of the adequate site for exploratory excision is decisive for correct histological diagnosis. A comparison with the literature concerned shows that leiomyomas and leiomyosarcomas rarely occur in the laryngeal region.