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Biomedical subjects

R Spiegel

Publications and source records attributed to R Spiegel.

At least 91 records · Page 5Linked to original sources
PubMed1986

Significance of slow wave sleep: considerations from a clinical viewpoint.

Previous experimental observations, almost exclusively carried out with young healthy subjects, have been interpreted as showing a particular restorative role for human slow wave sleep (SWS). This article considers whether findings from polygraphic sleep studies in patients and elderly subjects lead to similar inferences about the meaning or "function" of SWS. The question was approached in three different ways: (a) by presenting results from a long-term study in elderly subjects whose SWS data were correlated with baseline medical and psychometric findings and with 5-year follow-up results; (b) by correlating nonmanipulated wake-time during days with parameters of SWS on subsequent nights in a group of 30 demented inpatients undergoing 72-h continuous sleep-wake recording; (c) by reviewing and comparing published polygraphic sleep studies for a number of psychiatric conditions. None of these three approaches provided unequivocal evidence for a clinically significant role for SWS. Reasons for the different outcome of SWS studies in young experimental subjects and clinical populations are discussed.

Age Factors↗
PubMed1986

Effects of long-term ergoloid mesylates ('Hydergine') administration in healthy pensioners: 5-year results.

Five-year results are reported of a controlled long-term comparative study to assess the effects of ergoloid mesylates (1.5 mg 3-times daily) and placebo on medical, psychological and electrophysiological variables. Initially, 148 healthy elderly volunteers of both sexes were included. Eighty-nine subjects (48 on ergoloid mesylates and 41 on placebo) are still in the double-blind study; 39 subjects have left the trial for various reasons (6 deaths, 25 drop-outs due to disease, and 8 withdrawals) and 20 subjects are participating under 'open' conditions. Formal statistical comparison of the two groups in terms of 10 medical and psychometric outcome variables did not produce significant differences. However, a number of relevant findings and trends with regard to the effects of ergoloid mesylates were established: the drug was well tolerated objectively and subjectively; subjective complaints such as frequent dizziness, cardiac symptoms and leg cramps were improved; there was less increase than on placebo in the number of subjects with pathological ECG findings; there was less increase than on placebo in the number of subjects taking digitalis; fewer subjects than in the placebo group had an increase in the number of major diagnoses; the decrease in some lipid fractions was more pronounced than on placebo; and performance in some psychometric tests (WAIS Vocabulary, WAIS Performance) was better in the ergoloid mesylates group. None of these findings, by itself, would be evidence of a dramatic effect of ergoloid mesylates on the participants in the double-blind trial. Taken together, however, they fall into a pattern, suggesting that ergoloid mesylates was partly effective in maintaining physical and mental health in these healthy elderly individuals. The finding of more disease-related and symptom-related drop-outs in the placebo group (25 vs. 20 in the ergoloid mesylates group) supports this assumption. Furthermore, the fact that a number of subjects who had left the double-blind trial for medical reasons improved on subsequent ergoloid mesylates administration may be seen as a further argument in favour of a prophylactic effect of ergoloid mesylates on pathological concomitants of ageing.

Aged↗
PubMed1986

Alpha-2-interferon/melphalan/prednisone in previously untreated patients with multiple myeloma: a phase I-II trial.

Alpha-2-interferon (IFN) has demonstrable activity in advanced, relapsing, or refractory multiple myeloma. Because of the in vitro synergism between the IFNs and cytotoxic agents, we conducted a trial of 30 previously untreated patients with multiple myeloma utilizing various doses of alpha-2-IFN in combination with standard oral doses of melphalan and prednisone. The combination was well-tolerated without unusual or unexpected toxic effects. The limiting toxicity included dose-related myelosuppression, and alpha-2-IFN induced flu-like symptoms and fatigue. Response was seen in at least as many patients as would be expected with melphalan and prednisone alone. The maximal tolerated dose for a phase II-III trial was 5.0 X 10(6) IU/m2 of alpha-2-IFN in combination with standard doses of melphalan and prednisone. Future trials should utilize this dose of alpha-2-IFN with dose de-escalation according to tolerance.

Adult↗
PubMed1986

Recombinant interferon alpha-2 (INTRON A) in a phase II study of renal cell carcinoma.

Because two of five patients with renal cell carcinoma in a Phase I study had partial response to recombinant alpha-2 interferon (IFN), we treated 26 patients with advanced renal cell carcinoma with a 3-month regimen of IFN. Patients were randomized to receive IFN either subcutaneously (2 X 10(6) IU/m2 3 times a week) or intravenously (3 X 10(7) IU/m2 for 5 consecutive days every 2-3 weeks). Patients whose disease was responding or stable were treated further, while those with progressive disease on subcutaneous treatment were offered intravenous therapy. Sites of metastasis included lung (14 patients), bone (7 patients), soft tissue (7 patients) and liver (2 patients). Twenty patients were evaluable for response. One patient had a partial response at the end of the third course of intravenous IFN and subsequently had complete disappearance of a 12 X 7 cm subcutaneous mass after the seventh course of treatment. The disease was stable in 13 patients including two minor responses, and six patients had progressive disease (5 with subcutaneous treatment; 1 with intravenous treatment) including one mixed response. All patients experienced early flu-like symptoms of fever, chills, and rigors during the first few days of treatment and most had mild to moderate fatigue. Three patients left the study because of fatigue, and one had an urticarial rash. From these results and our previous experience, it appears that IFN has activity against renal cell carcinoma with acceptable toxicity.

Adult↗
PubMed1984

Clinical trials with the cholinergic drug RS 86 in Alzheimer's disease (AD) and senile dementia of the Alzheimer type (SDAT).

The muscarinic agonist RS 86 was administered to patients with Alzheimer's disease (AD) and senile dementia of the Alzheimer type (SDAT) in a series of controlled clinical trials. Daily doses were up to 3.0 mg orally for a maximum duration of 18 weeks. RS 86 produced typical peripheral cholinergic effects, but appeared to be better tolerated than similar drugs, such as physostigmine and arecoline. Positive clinical changes with regard to cognitive functions, mood, and social behavior were seen in a minority of AD and SDAT patients. Psychometric tests suggested improvement of functions entailing a speed component. RS 86 is a suitable drug for further clinical experiments in AD and SDAT.

Aged↗
PubMed1984

Effects of RS 86, an orally active cholinergic agonist, on sleep in man.

The effect of four oral doses of RS 86, a direct-acting cholinergic agonist, on polygraphic sleep parameters was studied in two groups of 12 healthy male volunteers. Subjects received placebo, 0.25 and 0.50 mg (Study I), or placebo, 0.75 and 1.50 mg (Study II), in a double-blind, balanced, crossover design. While 0.25 and 0.50 mg RS 86 had no effect on electrophysiological correlates of sleep, 0.75 and 1.50 mg altered polygraphic sleep parameters in a dose-dependent fashion: the latency of rapid eye movement (REM) sleep was shortened, REM sleep duration in the first third of the sleep period increased, and slow wave sleep reduced in the first and second thirds of the sleep period. Pulse rate was dose-dependently and significantly increased after RS 86. Subjective sleep experience and the subjects' condition in the morning were not altered. These results suggest that RS 86, in well-tolerated oral doses, has central effects that are partly similar to and partly different from those of other cholinomimetic agents.

Adult↗
PubMed1984

[Prediction of treatment outcome with antidepressants: are short REM latencies diagnostically and prognostically reliable indicators?].

Brief REM latencies, i.e. abnormally short intervals between sleep onset and the occurrence of the first REM period in polygraphic recordings of night sleep, have been proposed in recent years to be of diagnostic value for primary and endogenous depressions. It was also postulated that therapeutic success of antidepressant drugs can be predicted from this characteristic. Analysis of recent studies shows, however, that none of these claims can be maintained: although brief REM latencies do occur more frequently in middle-aged and elderly depressed patients than in healthy controls, this--strongly age-dependent-feature is neither sensitive to nor specific of depressions and therefore unlikely to facilitate their diagnosis. Similarly, there are no valid indications that brief REM latencies might predict success or failure of antidepressant drug treatment. Heterogeneous results of the studies reviewed are probably due to inhomogeneous selection of patient and control groups, variable periods of withdrawal of previous medication and other procedural differences.

Adult↗
PubMed1984

A long-term study with co-dergocrine mesylate (Hydergine) in healthy pensioners. Results after 3 years.

Started in 1976, a long-term study in healthy pensioners is now in progress in Basel, Switzerland, to investigate medical, psychological, and electrophysiological aspects of the normal aging process and to establish whether these can be influenced by drug treatment. The subjects are receiving co-dergocrine mesylate (Hydergine) 1.5 three times daily or placebo orally under double-blind conditions. At 1-year intervals each subject's case history is reviewed, a clinical examination and laboratory tests are carried out, an ECG and an EEG are recorded, and a shortened form of the Hamburg-Wechsler Intelligence Test for Adults (German version of the WAIS, i.e., the Wechsler Adult Intelligence Scale), the Raven Coloured Progressive Matrices Test, and the Maudsley Personality Inventory are administered. Treatment compliance is being monitored by pill counting and determination of drug plasma levels. The results after 3 years of the study are presented. The subjects included in this evaluation are those who have undergone all examinations under double-blind conditions (n = 99). During the 3-year period, 27 of the 148 subjects (64 women and 84 men, mean age 63 years) initially recruited for the study have withdrawn, mainly because serious illness has supervened. Three subjects in the placebo group and 1 in the co-dergocrine mesylate group have died. The double-blind code has been broken for medical reasons in 18 cases; these subjects have continued to participate under open conditions. During this 3-year period, the following changes have been observed: A slight but statistically significant rise in systolic and diastolic blood pressure in the sample as a whole (mean increase 12 mm Hg). A decrease in systolic blood pressure in subjects with high initial values (mean decrease 6 mm Hg in the placebo group, and 18 mm Hg in the co-dergocrine mesylate group). An increase in systolic blood pressure in subjects with low initial values (mean increase 17 mm Hg in the placebo group and 16 mm Hg in the co-dergocrine mesylate group). A significant decrease in pulse rate in all subjects (mean decrease 7 beats/min). An increase in the number of subjects with pathological ECGs. A significant decrease in mean serum creatinine and lipid levels (all subjects) and a decrease of about 70% in the number of subjects with pathologically raised values. A decrease in the number of subjects from both groups with pathological signs in the EEG.(ABSTRACT TRUNCATED AT 400 WORDS)

Aged↗
PubMed1984

An effective therapy for both undifferentiated (including Burkitt's) lymphomas and lymphoblastic lymphomas in children and young adults.

We have used a single intensive chemotherapy regimen in the treatment of young patients with diffuse, aggressive, malignant lymphomas. There were two major histologic types of lymphoma in our series: lymphoblastic lymphomas, which presented most often with mediastinal tumor (64%), and undifferentiated lymphomas (mostly Burkitt's lymphomas), which occurred predominantly in the abdomen (86%). Our objective was to examine the determinants of prognosis in a uniformly treated patient group that included 31 children (2-16 yr) and 34 young adults 17-35 yr). Patients with extensive bone marrow involvement (greater than 50% replacement by tumor cells) were included in the study. Treatment consisted essentially of a 4-drug combination (cytoxan, adriamycin, vincristine, and prednisone) alternating with a 42-hr methotrexate infusion, followed by leukovorin rescue, and included intrathecal prophylactic therapy against central nervous system (CNS) disease. Patients with localized or resected undifferentiated lymphoma received 6 therapy cycles; all other patients received 15 cycles. Radiation therapy was used only in exceptional circumstances. Fifty-eight of 65 patients (89%) achieved complete remission: 97% of children and 82% of adults. The estimated 3-yr survival was 60% (SE 6.4%) with a median follow-up of 3 yr. Analysis of factors associated with remission duration and survival indicated that bone marrow involvement at referral and extensive disease were poor prognostic variables. Patients with lymphoblastic lymphomas and patients with completely resected undifferentiated lymphomas had the best prognosis (81% +/- 12% and 94% +/- 6% estimated 3-yr survival, respectively). Patients with extensive intraabdominal undifferentiated lymphoma (stage D) had the worst prognosis (33% +/- 11% estimated 3 yr survival), but even in this subgroup, bone marrow involvement was an adverse factor (estimated survival in stage D patients with and without bone marrow involvement was 14% +/- 13% and 43% +/- 15%, respectively). Elevated uric acid and/or lactic dehydrogenase (LDH) were also of prognostic significance, but predominantly reflected state, i.e., extent of disease. Age did not significantly influence prognosis. In the undifferentiated lymphoma subgroup, histology (i.e., Burkitt's lymphoma versus non-Burkitt's lymphoma) was not of prognostic significance. Total white count was below 1,000/cu mm in 39% of cycles, and fever associated with granulocytopenia occurred in 17% of cycles. Stomatitis of moderate to severe extent occurred in 50% of cycles.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed1983

EEG and sleep in aged hospitalized patients with senile dementia: 24-h recordings.

Polygraphic recordings of wake and sleep were performed on 10 partly bed-ridden, severely deteriorated patients with senile dementia. Compared with healthy elderly persons these subjects showed less SWS (slow wave sleep, characterized by high amplitude, slow EEG waves), less REM sleep (rapid eye movement sleep, usually accompanied by dream activity) and poorly organized stage 2 sleep (no sleep spindles, i.e. phasic EEG activity with a frequency of 12-14 Hz). Six of the 10 patients had no dominant alpha rhythm during wakefulness; this seemed to be related to their more deteriorated clinical state, to still less SWS and REM sleep and more time spent in stage 2. The basic NREM-REM cycle of sleep, i.e. the regular alternation between non-REM- and REM-periods, could still be distinguished, however, and showed similar average temporal characteristics as in healthy old and younger people. Similarly, although sleep was severely fragmented in most patients and many sleep episodes occurred during the day, the day-night alternation of wakefulness and sleep was maintained in the sample as a whole.

Aged↗
PubMed1983

A controlled long-term study with ergoloid mesylates (Hydergine) in healthy, elderly volunteers: results after three years.

A long-term clinical comparison of the effects of ergoloid mesylates and placebo on 148 healthy elderly volunteers of both sexes was analyzed after three years of study. At that point, 99 subjects (53 receiving ergoloid mesylates and 46, placebo) were still being treated under double-blind conditions, while the remainder either had dropped out or continued to participate under open conditions. Many subjects in both groups were healthier after the three years than they had been at the onset of the study: subjective symptoms such as tiredness and dizziness were reduced, performances on tests of intelligence were improved, and some abnormal laboratory values had normalized. Blood pressures increased on the average during the investigational period and pulse rates became slower. The ergoloid mesylate regimen was well tolerated objectively and subjectively. Additional medical and psychologic improvements were noted in the group treated with ergoloid mesylates concerning cardiovascular parameters, cholesterol levels, subjective symptoms, and performances on tests of intelligence. These intermediate findings are interpreted as showing a preventive effect of ergoloid mesylates against some of the debilitating physical and psychologic concomitants of aging.

Aged↗
PubMed1982

Human EEG slow-wave sleep increased by a serotonin antagonist.

Serotonin has been held to play a necessary role in EEG slow-wave sleep. A central serotonin antagonist, known as FU 29-245, 200 mg, was taken nightly for 6 nights by 10 volunteers, mean age 59 years. Compared with baseline sleep the drug significantly increased the duration of slow-wave sleep, with a significant rebound decrease below baseline after withdrawal. The drug also caused fewer transitions into stage 1 and less time in stage 1 and less time in stage 2. There were significant tolerance effects by the fifth and sixth nights. No subjective effects were present.

Adult↗
PubMed1982

Action of lysine-vasopressin on human electroencephalographic activity. Night sleep pattern, auditory evoked potential, contingent negative variation.

This study is an investigation of the central effects of vasopressin in man, as this hormone proved able to modify learning processes in animals and was applied successfully to post-traumatic, amnesic patients. Electrophysiological techniques were used to assess the effects of lysine-vasopressin (LVP) given by nasal spray (7 and 14 IU) on night sleep pattern (12 subjects), auditory evoked potentials (AEP; 26 subjects), and contingent negative variation (CNV; 26 subjects). Night sleep EEG was not modified to a great extent: in particular REM sleep did not undergo any change after LVP. Nor were AEPs modified, either in the 6-hour period following drug administration or 1 week after; CNV, however, reacted in a significant manner 6 h after drug intake, and the modifications were still present after 1 week. LVP did not affect CNV amplitude itself but its evolution through time, as CNV habituation was prevented. Such effects are discussed with regard to the neurochemical mechanisms of vasopressin action and CNV genesis.

Administration, Intranasal↗
PubMed1982

Aspects of sleep, daytime vigilance, mental performance and psychotropic drug treatment in the elderly.

As people grow older, their subjective and objective sleep patterns change: sleep is often experienced as less deep, more broken, less refreshing - and these alterations find their objective correlate in polygraphic sleep recordings. Reductions in high amplitude slow wave sleep, rapid eye movement (REM) sleep and sleep maintenance are the best documented of these. Besides, there are changes in the EEG pattern during sleep (fewer and slower sleep spindels, fewer K-complexes and other phasic events). Daytime EEG recordings in the elderly are characterized by slowing of the dominant alpha rhythm, diffuse or localized slow waves and reduced reactivity to stimuli. Only few studies, however, have addressed the question of how daytime EEG alterations are related to changes of the sleep polygram, and how these electrophysiological parameters relate to measures of mental performance which also undergo changes with aging. A review of published results and data from our own studies suggest that, within the non-pathological range, few correlations exist between polygraphic sleep, daytime EEG and mental performance data if age as an independent factor is kept constant. The only relations that were significant in some of the studies had opposite directions in different subjects' samples. Thus, until more is known, these 3 areas of assessment should be studied and conceptualized separately. Our lack of understanding in this field is further illustrated by results of drug studies: compounds with confirmed effects on mental performance and mood in young subjects, such as amphetamine, fail to be useful stimulants or antidepressants in the elderly, and drugs like co-dergocrine mesylate ((Hydergine) which are of use in mentally deteriorating old persons have no effects on vigilance and mental performance in young, healthy subjects. Therefore, extrapolations from one level of assessment to another and from experiments in young subjects to studies in the elderly appear unwarranted at the present time.

Aged↗
PubMed1981

CT of American Burkitt lymphoma.

One hundred abdominal and chest CT scans in 29 patients with American Burkitt lymphoma were reviewed. Abdominal and/or pelvic masses were the most common finding and were detected in 13 (45%) patients. Masses indicating relapse were noted in three (10%) additional patients. Ascites and retroperitoneal involvement were noted in seven and five patients, respectively. Other findings included hepatic lesions, splenomegaly, gastric wall abnormalities, renal enlargement, urate nephropathy, and bony involvement. Pleural effusions and two mediastinal masses were noted on chest scans. CT was found to be a rapid screening procedure and especially useful in delineating the size and intrathoracic extension of abdominal masses, defining deep pelvic diseases, assessing the response to therapy, and defining areas of relapse. Lack of retroperitoneal fat and inadequate opacification of bowel loops were frequent problems that limited the value of CT scans.

Adolescent↗