The Spanish Pancreatic Club recommendations for the diagnosis and treatment of chronic pancreatitis: part 1 (diagnosis).

Chronic pancreatitis (CP) is a relatively uncommon, complex and heterogeneous disease. The absence of a gold standard applicable to the initial phases of CP makes its early diagnosis difficult. Some of its complications, particularly chronic pain, can be difficult to manage. There is much variability in the diagnosis and treatment of CP and its complications amongst centers and professionals. The Spanish Pancreatic Club has developed a consensus on the management of CP. Two coordinators chose a multidisciplinary panel of 24 experts on this disease. A list of questions was drafted, and two experts reviewed each question. Then, a draft was produced and shared with the entire panel of experts and discussed in a face-to-face meeting. This first part of the consensus addresses the diagnosis of CP and its complications.

The Spanish Pancreatic Club's recommendations for the diagnosis and treatment of chronic pancreatitis: part 2 (treatment).

Chronic pancreatitis (CP) is a complex disease with a wide range of clinical manifestations. This range comprises from asymptomatic patients to patients with disabling symptoms or complications. The management of CP is frequently different between geographic areas and even medical centers. This is due to the paucity of high quality studies and clinical practice guidelines regarding its diagnosis and treatment. The aim of the Spanish Pancreatic Club was to give current evidence-based recommendations for the management of CP. Two coordinators chose a multidisciplinary panel of 24 experts on this disease. These experts were selected according to clinical and research experience in CP. A list of questions was made and two experts reviewed each question. A draft was later produced and discussed with the entire panel of experts in a face-to-face meeting. The level of evidence was based on the ratings given by the Oxford Centre for Evidence-Based Medicine. In the second part of the consensus, recommendations were given regarding the management of pain, pseudocysts, duodenal and biliary stenosis, pancreatic fistula and ascites, left portal hypertension, diabetes mellitus, exocrine pancreatic insufficiency, and nutritional support in CP.

[Standardization of the Alzheimer's Disease Assessment Scale in a Spanish population]. / Estandarización en una población española de la escala ADAS (Alzheimer's Disease Assessment Scale).

We describe a Spanish adaptation and standardization of the Alzheimer's Disease Assessment Scale (ADAS) carried out as part of a prospective, coordinated study performed simultaneously in two Spanish health centers. Three diagnostic groups were defined: 21 healthy volunteers (normal group); 22 patients with cognitive deterioration but no dementia (CDND group); and 20 patients with Alzheimer type dementia (ATD group). The subjects were examined at the start of the study and after 3 and 6 months. The mean cognitive ADAS scores were significantly different in the 3 groups (F = 67.2, p = 0.0001), as follows: normal group, 7.6 +/- 2.1; CDND group, 12.4 +/- 4.5; and ATD group, 21.0 +/- 4.7. Likewise, the ADAS proved sensitive to the course of deterioration in the ATD group, while the other groups' scores improved. We conclude that the ADAS, and in particular the cognitive subscale, is useful for evaluating ATD patients, especially in the early phases of deterioration. It discriminates between ATD and CDND patients well.

A multicenter double-blind study of three different doses of the new cAMP-phosphodiesterase inhibitor rolipram in patients with major depressive disorder.

A multicenter randomized 4-week interindividual double-blind study was carried out in 58 hospitalized patients with major depressive disorder (DSM III 296.23, 296.22, 296.33, 296.32, 296.53 and 296.52) to test the dose-effect relationship of three different doses of the new cAMP-phosphodiesterase inhibitor rolipram: 3 x 0.25 mg, 3 x 0.50 mg and 3 x 1.00 mg rolipram/day. With respect to the desired effect, the 3 x 0.50 mg dosage stood out from the others in almost all relevant parameters. With respect to the response rate, the efficacy of the 3 x 0.25 mg dosage was about the same as that reported in the literature for placebo. The inferior performance of the 3 x 1.00 mg dosage compared to the 3 x 0.50 mg dosage might indicate a reverse U-shaped dose-effect relationship. There was good tolerance to all three dosages. There were no findings that might cast doubt on the safety of the dosages tested.

Rolipram in major depressive disorder: results of a double-blind comparative study with imipramine.

Rolipram improves signal transmission in central noradrenergic neurones at a pre- and postsynaptic level, and is thus a novel approach in antidepressant therapy. In order to prove efficacy, tolerance, and safety, several controlled studies are underway. Results of a randomized double-blind comparative trial versus imipramine involving 64 in-patients with Major Depressive Disorder (DSM III) in six independent centers will be presented and discussed. The chosen biometric model provided evidence that towards the end of the study imipramine was superior to Rolipram. The particular clinical relevance of this difference is discussed. As regards tolerance, nausea emerged as the typical side-effect of Rolipram, whereas imipramine precipitated mainly anticholinergic side-effects.

Rolipram versus imipramine in inpatients with major, "minor" or atypical depressive disorder: a double-blind double-dummy study aimed at testing a novel therapeutic approach.

Unlike conventional antidepressants, rolipram stimulates both the presynaptic as well as the postsynaptic component of monoaminergic transmission. Several double-blind comparative trials are on the way to assess the clinical efficacy and safety of this novel compound. The present study was a randomized double-blind double-dummy comparison with imipramine in inpatients with major, "minor" and atypical depressions (DSM III). Results show no relevant differences between rolipram and imipramine regarding efficacy and safety.

Is phosphodiesterase inhibition a new mechanism of antidepressant action? A double blind double-dummy study between rolipram and desipramine in hospitalized major and/or endogenous depressives.

Unlike conventional antidepressants, rolipram (a new approach in the treatment of depression) stimulates both the presynaptic and the postsynaptic component of monoaminergic transmission. Several double blind trials are under way to assess the clinical efficacy and safety of this compound. The present study was a randomized, 4-week interindividual double blind double-dummy comparison with desipramine in inpatients with major (DSM-III) and/or endogenous (ICD-9) depressions. After a minimum washout period of three days the patients received either 0.50 mg rolipram or 25 mg desipramine orally t.i.d. for the first three days, then 0.75 mg rolipram or 50 mg desipramine t.i.d. until day 28. Rating tests were based principally on the AMDP-system and the HAMD scale. The study showed no differences between the two drugs as regards the efficacy, but a definite trend in favour of rolipram as regards the side effects and, in particular, anticholinergic effects.

Results of a phase II study of the antidepressant effect of rolipram.

The antidepressant effect of rolipram, believed to be based on a new mechanism of action, was investigated in an open phase II study in 10 depressive patients, most of whom had been refractory to previous antidepressant therapy. Five patients displayed a good to very good improvement of their depressive condition. Four patients failed to show any substantial improvement, and therapy had to be withdrawn in one case due to deterioration of the condition. In most cases, the antidepressant effect of the trial preparation became noticeable after 2-4 days of treatment only. Basing on the presented cases, the tolerance can be described as excellent compared to other antidepressants. Although, on the whole the trial yielded very encouraging results, only double-blind trials can determine the true antidepressant efficacy of rolipram.

Study with lormetazepam as a hypnotic in general practice.

Due to the increasing pressure to investigate new drugs under conditions met with in practice, Lormetazepam (0.5 mg) was investigated in nine general practices under the direction and collaboration of a psychiatrist used to investigations with psychopharmaceuticals. The results of a double-blind study, carried out in comparison to triazolam (0.5 mg), in a total of 94 ambulatory patients are presented.

[Drug therapy of sleep disorders in shift workers]. / Probleme der medikamentösen Behandlung von Schlafstörungen bei Schichtarbeitern.

The hypnotic action of a soporific may be of limited use in populations who live in contradiction to their "internal biological clock". In order to test the assumption 60 nurses who had a disturbance in their sleep-waking rhythm due to shift work participated in an one-week double blind study. Nurses were randomly assigned to receive either lormetazepam 1 mg (Noctamid) or placebo (n = 30 per group). In the nurses with disturbance of falling asleep, a normalization of the duration of falling asleep occurred in 15 of 17 cases under lormetazepam as compared to ten of 17 under placebo. In the nurses who slept too little the length of the sleeping time normalized in 15 of 16 cases under lormetazepam as compared to the nine of 16 under placebo. With simultaneous consideration of the duration of falling asleep, total duration of sleep and depth of sleep, a distinction was made between "normalization in all three parameters", "normalization in one or two parameters, but no deterioration in any parameter" and "no normalization" for evaluation of the therapy comparison. The action of lormetazepam was shown in higher improvement rates (p less than 0,05). Neurophysiological and social medical implications are being discussed.

[Lormetazepam in the treatment of sleep disorders in a medical practice; double-blind test on 100 patients (author's transl)]. / Lormetazepam bei der Behandlung von Schlafstörungen in der internistischen Praxis. Doppelblindprüfung an 100 Patienten.

Lormetazepam (1 mg) and diazepam (5 mg) were compared in a double-blind study of 100 patients with sleep disorders associated with a medical illness. Assignment to one of two treatment groups was at random. Lormetazepam had a greater hypnotic effect than diazepam in all significant variables (P less than 0.05). There was no hangover effect or other side effects with lormetazepam, which was thus superior to diazepam also in this respect (P less than 0.05).

Comparative efficacy of lormetazepam (Noctamid) and diazepam (Valium) in 100 out-patients with insomnia.

Lormetazepam (Noctamid) at a dosage of 1 mg was compared with diazepam (Valium) at a dosage of 5 mg in a 7-day double-blind study. The study involved fifty patients in the lormetazepam group and fifty patients in the diazepam group. All the patients were suffering from sleep disorders as a concomitant symptom of general diseases. Lormatazepam was significantly better than diazepam in the: -Reduction of the time taken to fall asleep (p less than 0.05) -Prolongation of the duration of uninterrupted sleep (p less than 0.05) -Reduction of the frequency of awakening (p less than 0.05). Lormetazepam displayed no hang-over effects or other side-effects and, in this respect too, was significantly superior to diazepam (p less than 0.05).