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PubMed1995

Ritanserin, a central 5-HT2 antagonist, in heavy social drinkers: desire to drink, alcohol intake and related effects.

Ritanserin, a 5-HT2 receptor antagonist, decreased alcohol intake in some, but not all, animal studies and in an open clinical study. We tested the short-term effects of ritanserin in 39 (35 male, four female) heavy social drinkers (consuming at least 28 drinks/week), aged 19-63 years, who were not seeking treatment. After an intake assessment, they received placebo for 7 days in a single-blind baseline. They were then randomly assigned to one of three double-blind treatments for 14 days: ritanserin 5 mg/day (n = 12), ritanserin 10 mg/day (n = 13) or placebo (n = 14). Subjects recorded daily outpatient alcohol intake. Feelings of intoxication and interest, desire, craving and liking for alcohol were rated retrospectively at each weekly study visit. Experimental drinking sessions were conducted after baseline (EDS1) and treatment (EDS2); in each session subjects were offered 18 mini-drinks (total = six standard) and rated their desire to drink, intoxication and mood (POMS). Outpatient results: ritanserin 5 mg/day decreased desire and craving for alcohol (vs. baseline, p < 0.05) but not alcohol intake. Liking of alcohol decreased from baseline with ritanserin 10 mg/day (p = 0.01) and placebo (p = 0.05). Changes in alcohol intake from baseline with ritanserin 10 mg/day (increase, p > 0.05) and placebo (decrease, p > 0.05) were different (p < 0.05). EDS results: in EDS2, desire ratings for the first three mini-drinks were lower after ritanserin 5 mg/day than after ritanserin 10 mg/day (p < 0.05), but the decreases were not statistically significant when EDS1 desire ratings were controlled for. Ritanserin 10 mg/day increased alcohol-induced feelings of intoxication and friendliness, compared with placebo (p < 0.05). Both ritanserin 5 mg/day and 10 mg/day enhanced alcohol-induced decreases in fatigue, compared with placebo (p < 0.05). These results indicate that ritanserin may have differential effects on alcohol intake, desire, craving and liking, intoxication and some of alcohol's effects on mood. However, they suggest that ritanserin has limited efficacy in reducing alcohol intake in heavy drinkers.

Adult↗
PubMedDate not supplied

Effects of the beta-adrenoceptor blocking agent sotalol on CNS: sleep, EEG, and psychophysiological parameters.

Sotalol (Sotalex), 320 or 960 mg, was administered to 12 healthy subjects daily for a period of four days in a double-blind trial over 11 days. The effects of sotalol on heart rate, blood pressure, EEG, subjective quality of sleep, polygraphically determined sleep pattern, and psychophysiological parameters such as psychomotor performance, memory, perception, vigilance, and general condition were studied and were related to dosage and plasma levels. Steady-state plasma levels of sotalol were reached within 24 hours after a single dose; 960 mg resulted in plasma levels three times higher than those reached with 320 mg, which indicates first-order linear absorption. The effects of sotalol on EEG, sleep, and performance in psychological tests were equivocal and do not yield evidence for CNS activity of sotalol.

Adolescent↗
PubMed1990

Diurnal blood pressure in patients with mild-to-moderate hypertension treated with once-daily benazepril hydrochloride.

This study evaluated the blood pressure effects of administration of once daily oral benazepril hydrochloride, a new angiotensin-converting enzyme (ACE) inhibitor, for mild-to-moderate hypertension. After a 2 to 4 week placebo baseline period, patients with diastolic blood pressure between 95 and 114 mm Hg, were randomized to receive either placebo or benazepril hydrochloride, 5, 10, 20, or 40 mg, once daily in double-blind fashion for 28 days. Blood pressure was measured predose and at 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours after the dose during inpatient observation days at the end of the placebo baseline period, and on the first and last day of the double-blind treatment period; and 24 hours after the dose at weekly outpatient visits. All doses of benazepril hydrochloride resulted in clinically important reductions in diastolic and systolic blood pressures that lasted between 12 and 24 hours after both the first dose, and following the last dose after 4 weeks of treatment. The findings indicate that benazepril hydrochloride may be clinically useful as once-daily monotherapy in many patients with hypertension.

Administration, Oral↗
PubMed2002

A prospective randomized study: day 2 versus day 5 embryo transfer.

BACKGROUND: This randomized controlled study was performed in an unselected IVF/ICSI population to test the hypothesis that blastocyst transfers result in higher clinical pregnancy rates (CPR) per oocyte retrieval when compared with day 2 transfers. METHODS: Blind randomization for transfer on day 2 (group 1) or day 5/6 (group 2) was performed before stimulation. Oocytes and embryos were cultured in sequential media in 5.5% CO(2), 5% O(2), 89.5% N(2) and 90% humidity. A maximum of two embryos was transferred. RESULTS: The two groups were similar for age, IVF indication, number of treatment cycles, rate of ICSI/IVF, number of fertilized oocytes and number of embryos transferred. The CPR/oocyte retrieval was comparable in group 1 (32%) and in group 2 (44%), while the CPR/embryo transfer was significantly higher (P < 0.01) in group 2 (60%) than in group 1 (35%). Similarly, the implantation rate per embryo transferred was significantly higher (P < 0.03) in group 2 (46%) than in group 1 (29%). The cryo-augmented delivery rate/oocyte retrieval was comparable in group 2 (36.3%) and in group 1 (28.6%). CONCLUSION: This randomized study in an unselected population showed a significantly higher CPR/embryo transfer and a tendency toward a higher CPR/oocyte retrieval in patients receiving blastocysts when compared with day 2 transfers.

Adult↗
PubMed1986

Comparison of the efficacy and tolerance of isoxicam and piroxicam following surgery for skiing accidents.

1 A 10 day double-blind study was carried out comparing isoxicam (300 mg day-1) and piroxicam (40 mg day-1 for the first two days and 20 mg day-1 for the remaining days) following surgery in patients who had sustained skiing accidents. There were 20 patients in each group. The isoxicam-treated group had a slightly greater mean pain score prior to treatment. 2 Both isoxicam and piroxicam reduced pain and nocturnal awakening at days 5 and 10, but isoxicam was significantly superior to piroxicam in producing improvement in pain (at day 5, P less than 0.05) and in nocturnal awakenings (at day 10, P less than 0.05). 3 Both agents facilitated rehabilitation and there was no significant difference between them in this regard. 4 All patients in both groups considered themselves 'better' or 'much better' on day 5 of treatment. 5 Both agents were well tolerated by most patients but one patient in each group left the trial because of abdominal pain. One patient stopped isoxicam when she was found to be pregnant.

Adolescent↗
PubMed2005

Mood and affect during detoxification of opiate addicts: a comparison of buprenorphine versus methadone.

Twenty-six in-patients with Diagnostic and Statistical Manual version IV (DSM-IV) criteria for opioid dependence were selected at random to receive either a combination of an 11-day low-dose buprenorphine and a 14-day carbamazepine regimen (n = 14) or a combination of an 11-day methadone and a 14-day carbamazepine regimen (n = 12) in a double-blind, randomized 14-day in-patient detoxification treatment. Patients with buprenorphine and carbamazepine showed a significantly better psychological state after the first and second weeks of treatment. Above all, the buprenorphine-treated patients demonstrated a less marked tiredness, sensitiveness and depressive state as well as a more prominent elevated mood during the detoxification process. Seven non-completers (after 7 days: four of 12 = 33.3%; after 14 days: seven of 12 = 58.3%) were treated with methadone and carbamazepine and five non-completers (after 7 days: two of 14 = 14.3%; after 14 days: five of 14 = 35.7%) received buprenorphine and carbamazepine. The difference in the overall dropout rate after day 14 was not significant. The present study supports the hypothesis that the combination of buprenorphine and carbamazepine leads to a better clinical outcome than does a combination of methadone and carbamazepine in the detoxification of opioid addicts with additional multiple drug abuse. The buprenorphine and carbamazepine-regimen provides a more effective short-term relief of affective disturbances than does methadone and carbamazepine. No severe side effects occurred during the treatment period in both groups.

Adult↗
PubMed2004

The effects of remifentanil and sufentanil on the quality of recovery after day case laparoscopic cholecystectomy: a randomized blinded trial.

BACKGROUND: Duration of hospitalization after laparoscopic cholecystectomy (LC) is mainly determined by temporary side effects such as pain, nausea, and vomiting. In this study we compared remifentanil, a short acting opioid, and sufentanil, a longer acting opioid, on their ability to reduce these postoperative effects and facilitate LC in day case surgery. METHOD: Seventy patients scheduled for elective LC were randomized in two groups. Remifentanil was used in group 1 as part of the anesthetic protocol, sufentanil was used in group 2. After surgery, patients were asked to evaluate pain and nausea on a verbal rate scale (VRS). Frequency of vomiting and analgesic medication consumption was registered. Time between surgery and to the start of micturition, drinking, mobilization, dressing, and discharge was recorded. Patients registered their satisfaction on a VRS. Details of any other adverse events throughout the study were recorded. RESULTS: Twenty-two patients (63%) of group 1 were treated as day cases vs. 27 (77%) in group 2 (P = NS). All patients who were not discharged as day cases left the hospital one day postoperatively. Immediately after surgery, patients in group 2 reported significantly less pain. There were no other significant differences between groups. CONCLUSION: The majority of patients scheduled for LC can be safely discharged on the day of surgery. Reported satisfaction one week postoperatively was high for all patients. We found no major relevant differences between the two anesthetic protocols.

Adult↗
PubMed1976

[New strategies in psychiatric diagnosis through the use of audio-visual technics. 2. Importance of verbal and non-verbal information for assessment of depressive patients].

Sections of 150 seconds duration were taken on a random basis out of TV stored interviews of day 0, 10 and 20 of a double-blind antidepressive drug trial. Not identical sections were selected for the isolated audio and video channel and for the combined presentation in such a way that for each of the 20 patients three times three parts were presented for evaluation. It was the two rater's task to rank each patient's tapes in terms of the degree of depression. They were blind regarding the day of recording the interview (day 0, 10 or 20). The best results were reached with the combined presentation of the audio-video-channel while each channel taken seperately rendered less diagnostic information. The raters evaluated the material in two different modifications: a) Video, audio and than audio-video-channel or b) audio, video and audio-video-channel. The first version (a) was evaluated in a better way than the second one with respect to the content of diagnostic information. Furthemore we found that the evaluation of the visual information became less safe if the audio presentation preceded as in version b.

Amitriptyline↗
PubMedDate not supplied

Short-term double-blind trial of pipothiazine palmitate and haloperidol in the acute phase of schizophrenia.

A 22-day double-blind study of 53 acutely ill, recently admitted schizophrenic patients aged 18-45 years is described. Twenty-seven patients received 20 mg of haloperidol i.m. on the first day and 200 drops of haloperidol (20 mg) p.o. in a single dose in a glass of milk with grenadine, daily at 8:00 A.M. from the 2nd to the 21st day. Twenty-six other patients received 100 mg of pipothiazine palmitate i.m. on the first day and a glass of milk with grenadine daily at 8:00 A.M. from the 2nd to the 21st day. The two groups responded similarly to the drugs as indicated by both BPRS scores and CGI ratings. Extrapyramidal side effects were not significantly different for the two groups. Although a single injection of pipothiazine palmitate was as effective as the daily administration of haloperidol in a 22-day study of recently admitted schizophrenic patients, in the acute phase, a general recommendation for the use of long-acting neuroleptics cannot be made because more information on side effects is needed and a larger number of patients must be studied. However, long-lasting neuroleptics can be recommended for special situations such as when the patient is severely disturbed and/or refuses treatment.

Acute Disease↗
PubMed1988

Ketoprofen versus indomethacin in patients with acute gouty arthritis: a multicenter, double blind comparative study.

Fifty-nine patients with acute gouty arthritis entered into a 7-day multicenter, double blind trial of ketoprofen versus indomethacin. Patients were randomly assigned to receive 100 mg of ketoprofen (n = 29 patients) or 50 mg of indomethacin (n = 30 patients) 3 times a day. More than 90% of the patients in each group reported pain relief within the 1st day of treatment. By Day 5, 7 patients in the ketoprofen group and 6 in the indomethacin group discontinued treatment because of complete or substantial pain relief. At the end of the study, most patients in both groups were rated as having marked improvement both by the investigators and by self-assessment. Three patients in each group withdrew prematurely because of drug related gastrointestinal disorders. Ketoprofen compared favorably for efficacy and safety with indomethacin in the treatment of gouty arthritis.

Administration, Oral↗
PubMed1986

Clinical and psychometric evaluation of two doses of loprazolam and placebo in geriatric patients.

A double-blind, parallel group, randomized trial was carried out to compare the hypnotic efficacy, tolerance and psychometric effects of two doses of loprazolam and placebo in 89 elderly hospital in-patients. All had disturbed sleep patterns, which were not the result of serious psychiatric or physical illness and, after a 1 or 2 day single-blind placebo baseline period, they received either 0.5 mg or 1.0 mg loprazolam or placebo administered double-blind for 5 days. The sleep of patients in all three treatment groups, as measured by patient self-rating scales, substantially improved during the study, with loprazolam being superior to placebo for measures of sleep latency, satisfaction with sleep, number of nocturnal awakenings and feeling refreshed on waking. Differences in hypnotic efficacy between the 0.5 mg and 1.0 mg loprazolam groups were not significant. The incidence of side-effects was low and, although there was a significant relationship with loprazolam treatment, this was not dose-related. Performance tests for residual effects (critical flicker fusion threshold and choice reaction time) showed no difference between the placebo and active treatment groups, suggesting that loprazolam, even in a dose of 1.0 mg, is unlikely to produce hangover effects. It is concluded that the findings confirm that loprazolam is an effective and well-tolerated hypnotic in the elderly and that a 0.5 mg dose would be an appropriate initial dose for older patients.

Aged↗
PubMed2000

Antianginal and anti-ischaemic efficacy of tedisamil, a potassium channel blocker.

OBJECTIVE: To determine the efficacy and safety of the potassium channel blocker tedisamil versus placebo in the treatment of patients with stable angina. DESIGN: Prospective, double blind, placebo controlled study. 203 patients first completed a seven day placebo run in. They were then randomised to receive 50 mg, 100 mg or 150 mg tedisamil twice daily, or placebo. Treadmill exercise testing was carried out at baseline and after 14 days of double blind treatment. MAIN OUTCOME MEASURES: Primary efficacy parameters were an increase in total exercise duration and a reduction of the sum of ST segment depression using six ECG leads at maximum workload at trough (12 hours after last medication). Secondary aims included increase in exercise time to onset of 0.1 mV ST segment depression, increase in exercise time to onset of any anginal pain, and reduction in ST segment depression in any of the six specified leads at maximum workload. These were all at trough. The same parameters were also assessed at peak concentrations (two hours after administration). Overall attacks of angina and the use of short acting nitrates were assessed from patient diaries. RESULTS: Tedisamil led to a dose dependent prolongation of exercise duration (significant at all concentrations), an effect that was greater at peak than at trough. Treatment also led to a significant dose dependent reduction in the sum of ST segment depression at both trough and peak concentrations. Tedisamil also decreased (in a dose dependent way) the frequency of anginal attacks and the consumption of short acting nitrates, an improvement that became significant for all doses in the second treatment week. Adverse events with tedisamil were few. There was a pronounced rise in the incidence of diarrhoea with the 150 mg twice daily regimen. Bradycardic effects and increases in QT interval were dose dependent, but were no more evident at exercise than at rest. CONCLUSIONS: Tedisamil, at doses of 50-100 mg twice daily, was found to be an effective antianginal and anti-ischaemic agent. At doses above 100 mg twice daily its main side effect, diarrhoea, becomes pronounced; therefore the 50-100 mg twice daily regimen appears to be appropriate.

Aged↗
PubMed1982

Adaptative response of alpha- and beta-glucosidase kinetics along the villi of rat self-filling jejunal blind loops.

Four and 12 days after the construction of self-filling jejunal blind loops in the rat, the apparent Km- and Vmax-values of lactase/beta-glucosidase and neutral alpha-glucosidase were determined by in-situ quantitative enzyme histochemistry, and changes in the villus-crypt architecture of the mucosa were examined by microdissection. The results were compared with corresponding data from sham-operated controls. The kinetics data were obtained from the base and the transition zone between medium and apical villus third by the use of a microdensitometric technique. The apparent Vmax of lactase/beta-glucosidase is significantly smaller than in the control rats at both measuring sites of the villi and even decreases from day 4 to day 12. The apparent Vmax of neural alpha-glucosidase is not affected, and thus the same increase in enzyme activity along the villi as in the controls is observed. The apparent Km of this enzyme, however, is already significantly increased on day 4 at both villus positions in the blind loops. A pronounced increase in villus surface area is detected in the blind loops as a result of an increase in crypt cell proliferation. The results indicate that enzymatic adaptation in the self-filling blind loops of rat jejunum exhibits different patterns for brush border alpha- and beta-glucosidases and is at least in part accomplished independently of the pronounced mucosal transformation occurring in this experimental condition.

Animals↗
PubMed2000

Dose-response efficacy of a new estradiol transdermal matrix patch for 7-day application: a randomized, double-blind, placebo-controlled study. Italian Menopause Research Group.

New estradiol (E2) transdermal matrix patches developed for once-a-week application, releasing 25 micrograms E2 (7D-25) or 50 micrograms E2 (7D-50) daily, were investigated in comparison with a placebo patch and the twice-weekly parent patch releasing 50 micrograms E2 (Derm-50) daily. Three hundred and eleven postmenopausal patients suffering at least seven hot flushes daily were randomly assigned to the four parallel groups and treated continuously for 12 weeks without progestin opposition. The daily number of hot flushes significantly decreased in all groups. At the 12th week the decrease from a base-line average of eight to nine episodes per day was 78% with 7D-25, 93% and 97% respectively with 7D-50 and Derm-50, and significantly (p < 0.001) lower with placebo (59%). Comparable efficacy was observed in terms of severity of hot flushes, Kupperman Index and patient self-rated overall efficacy. Minor systemic adverse events occurred in 10.0%, 8.8%, 16.9% and 13.5% patients in the placebo, 7D-25, 7D-50 and Derm-50 groups respectively. Occasional mild and transient itching and/or erythema at the site of application was reported by a few patients, with no difference between groups or between once-weekly or twice-weekly application. In conclusion all E2 patches were significantly more effective than placebo in relieving climacteric symptoms in a dose-dependent fashion and all were well tolerated.

Administration, Cutaneous↗
PubMed1983

Plasma levels of disopyramide after administration of conventional capsules and sustained-release tablets.

A study was carried out in 33 patients with myocardial infarction and complicating arrhythmias to compare plasma levels of disopyramide attained after administration of conventional capsules or sustained-release tablets. On Day 1, 29 patients started treatment wtih 600 mg disopyramide in 3 divided doses of conventional capsules. In 18, disopyramide plasma concentrations of 3 mg/l or more were achieved within 300 minutes after the first dose. On the second day, patients were allocated at random to receive treatment double-blind for 11 days with 500 mg disopyramide daily given either as conventional capsules (17 patients) or as sustained-release tablets (16 patients). Plasma concentrations were measured just before and 3 hours after the morning dose. Mean maximum and minimum concentrations in the conventional capsule group were 4.4 mg/l and 2.8 mg/l, respectively, compared to 4.3 mg/l and 3.0 mg/l, respectively, in the sustained-release tablet group. For the next 30 days all patients continued treatment with sustained-release tablets. Mean disopyramide plasma concentration measured 15 to 18 hours after the last dose was 2.8 mg/l. Myocardial function was estimated during and 1 week after discontinuing disopyramide treatment. The mean fractional fibre shortening (echocardiography) during treatment was 23% less than that 1 week after discontinuation. The mean PEP/LVET (systolic time interval recording) was 7% higher during treatment compared with 1 week after discontinuation. In 4 cases, mean ejection fraction, measured by scintigraphic methods, during treatment was 10% less than 1 week after discontinuation. Anti-arrhythmic effect was investigated by continuous monitoring in the first 12 days and by Holter monitoring during the 30-day ambulant period and 1 week after discontinuing disopyramide. A significant reappearance of warning arrhythmias could be detected after discontinuing disopyramide sustained-release tablets. No anti-arrhythmic effect was detected in 4 patients. Six patients had to be withdrawn because of side-effects. It is concluded that disopyramide sustained-release tablets 500 mg per day in 2 divided doses gives therapeutic plasma concentrations of 3 mg/l comparable with conventional capsules. A myocardial depressive effect is noted of about 10%.

Adult↗
PubMed1995

Evaluation of antihypertensive effects of once-a-day isradipine and fosinopril: a double-blind crossover study by means of ambulatory blood pressure monitoring.

We compared the efficacy and tolerability of isradipine (ISR) and fosinopril (FOS) once-a-day administration in 17 outpatients, 9 men and 8 women, aged 35-65 years (mean +/- SD = 58 +/- 10 years), affected by mild to moderate primary systemic hypertension. The patients were given single-blind placebo for 2 weeks and thereafter, in double-blind, randomized, crossover sequence, ISR (5 mg) and FOS (20 mg), both for 4 weeks. At the end of each period, patients underwent 24-h noninvasive blood pressure (BP) monitoring by means of an A&D TM 2420 Monitor Model 7, with readings taken very 10 min during the day (from 7 A.M. to 11 P.M.), and every 20 min during the night (from 11 P.M. to 7 A.M.) Similarly, BP load (BPL) as percentage of systolic and diastolic BP reading > 140 and > 90 mmHg was investigated. Both ISR and FOS induced a highly significant (p < 0.0001) decrease in BP from 158/96 +/- 7/6 mmHg to 133/86 +/- 6/6 and to 132/83 +/- 10/7 mmHg, respectively. Mean BP decreased from 117 +/- 6 mmHg to 102 +/- 6 mmHg (ISR) (p < 0.0001) and to 99 +/- 8 mmHg (FOS) (p < 0.0001). Both ISR and FOS significantly (p < 0.0001) reduced systolic BPL from 78 +/- 16% to 44 +/- 13% and 28 +/- 12%, respectively, and diastolic BPL from 70 +/- 15% to 40 +/- 13% (p < 0.0001) and 35 +/- 13% (p < 0.0001), respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed2006

A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania.

OBJECTIVE: The efficacy and safety of divalproex sodium extended release (divalproex ER) were evaluated in patients hospitalized for acute mania associated with bipolar I disorder, manic or mixed type (DSM-IV-TR criteria). METHOD: Following screening and washout of psychotropic medications, 377 patients were randomly assigned in a 1:1 ratio to 21 days of double-blind treatment with divalproex ER (N = 192) or placebo (N = 185). Daily dosage was initiated at 25 mg/kg, increased 500 mg on day 3, and adjusted to serum valproate concentrations of 85 to 125 microg/mL. The Mania Rating Scale (MRS) was used to assess efficacy. Patients remained hospitalized at least 15 days during blinded treatment. The study was conducted from April 2003 to May 2004. RESULTS: Improvement from baseline on the MRS was significantly greater among patients who received divalproex ER compared with placebo at the first on-treatment rating assessment, day 5, and all subsequent ratings through day 21 (p = .013). Furthermore, the proportion of patients achieving at least 50% improvement from baseline in MRS was significantly higher in patients receiving divalproex ER (48%) than in patients receiving placebo (34%) (p = .012). Five of the 11 MRS items improved significantly more in patients receiving divalproex ER than placebo: less need for sleep (p <or= .01), more energetic (p <or= .05), increased activity (p <or= .05), generalized motor hyperactivity (p <or= .05), and racing thoughts (p <or= .001). Side effects associated with divalproex ER included somnolence, dizziness, and gastrointestinal complaints. CONCLUSION: The results indicate that dival-proex ER is effective and safe for the treatment of mania episodes in bipolar I patients. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00060905.

Acute Disease↗