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PubMed1981

Metoprolol and atenolol administered once daily in primary hypertension. A clinical comparison of the efficacy of two selective beta-adrenoceptor blocking agents.

To compare the antihypertensive effect of two beta-blocking agents, metoprolol (Seloken) and atenolol (Tenormin), a double-blind study was performed in 55 patients. Following a six-week placebo period the patients, who all had mild to moderate essential hypertension (WHO I-II), were randomly allocated to treatment with either metoprolol (n = 28) or atenolol (n = 27). During a six-week period they received 100 mg of either drug once daily. For patients who at the end of that period did not reach a diastolic blood pressure (BP) of less than 95 mmHg the daily dose was increased to 200 mg. Patients who responded (diastolic BP less than 95 mmHg) continued on the initial dosage regimen. When comparing the two groups with regard to the reduction of BP, there was no difference either 24 hours after the last dose or 5-9 hours after drug administration. The decrease in supine systolic/diastolic BP was 18/16 mmHg on metoprolol and 20/16 on atenolol. The decrease in heart rate was comparable in the two groups. Eight patients in the metoprolol and 7 in the atenolol group had their dose increased to 200 mg at the end of the first six-week period. This means that the number of patients not responding to 100 mg daily was comparable in the two groups. We did not observe any differences in side-effects of the two drugs. The results clearly suggest that atenolol and metoprolol are equipotent following once daily administration in patients with mild to moderate hypertension.

Adult↗

PubMed1990

Argon laser trabeculoplasty with standard and long duration.

A prospective study of 0.1 sec and 0.2 sec duration argon laser trabeculoplasty was undertaken in 33 patients with chronic simple glaucoma. Patients were randomly allocated to receive 0.1 sec trabeculoplasty to the eye and 0.2 sec trabeculoplasty to the other. No difference was found in the fall in intra-ocular pressure or in glaucoma control between the two durations over the six months of the study. However, 0.2 sec argon laser trabeculoplasty was reported to be more uncomfortable of 60% of patients.

Aged↗

PubMed1987

Comparison of endotracheal and peripheral intravenous adrenaline in cardiac arrest. Is the endotracheal route reliable?

Twelve patients presenting to an accident and emergency department in asystolic cardiac arrest were randomly allocated to treatment with endotracheal adrenaline (five patients) or peripheral intravenous adrenaline (seven patients). Femoral-artery blood samples were taken for assay of adrenaline and noradrenaline. After intravenous adrenaline there was a good clinical and biochemical response, but after endotracheal adrenaline there was no change in serum adrenaline and no measurable clinical response. The endotracheal route of adrenaline administration is not reliable in out-of-hospital cardiac arrest.

Aged↗

PubMed1982

Peripheral vasodilatation in the treatment of hypertension. Prazosin compared with hydralazine in patients not responding to beta-receptor blockade.

Prazosin was compared with hydralazine in 39 patients (mean age 49 years), who were already on beta-blockade for arterial hypertension. They all had a resting DBP greater than 100 mm Hg on propranolol 80 mg b i d. They were randomly allocated to prazosin or hydralazine treatment. Blood pressure was measured after 4, 8 and 12 weeks. We noted a significant fall in blood pressure in both groups, in most cases to normotensive levels. Side-effects and other variables of interest are discussed. Together with beta blockade, i e propranolol, both prazosin and hydralazine give good blood-pressure control and no important differences could be found.

Adult↗

PubMed1983

A randomised multicentre single blind comparison of a cannabinoid anti-emetic (levonantradol) with chlorpromazine in patients receiving their first cytotoxic chemotherapy.

One hundred and eight patients selected to receive combinations of highly emetic cytotoxic chemotherapy for malignant disease were included in a study of anti-emetic therapy. The patients were randomly allocated to receive levonantradol (0.5, 0.75 or 1 mg) or chlorpromazine (25 mg) prior to receiving their first course of cytotoxic therapy. The appropriate anti-emetic was administered 2 hr prior to the start of chemotherapy, 2 hr after chemotherapy and subsequently at 4-hourly intervals for a further 8 hr. The extent of anorexia, nausea and vomiting along with other side-effects were assessed at regular intervals by physicians and nursing staff during the 24 hr following chemotherapy. In addition, a self-assessment questionnaire was completed by the patients. Levonantradol (0.5 mg) was superior to chlorpromazine (25 mg) as an anti-emetic. Both were reasonably well tolerated, although at this dose of levonantradol 22% of patients experienced dysphoric reactions. At higher doses of levonantradol the proportion of patients experiencing these reactions rose to 50%, but without a concomitant increase in antiemetic activity. Neither drug achieved satisfactory control of vomiting in patients receiving combinations containing cis-platinum. We conclude that levonantradol (0.5 mg) is a more effective anti-emetic than chlorpromazine (25 mg) in patients receiving cytotoxic chemotherapy. However, its use cannot be recommended due to its high incidence of unacceptable central nervous system side-effects.

Adolescent↗

PubMed1990

Single fraction per day versus two fractions per day versus radiochemotherapy in the treatment of head and neck cancer.

From January 1978 to January 1988, 859 patients with T3-T4, NO-3, MO were randomly allocated to receive either: Group A--60Co 60, 60 Gy in 30 fractions; Group B--60Co, 70.4 Gy in 64 fractions; Group C--60Co, 60 Gy in 30 fractions plus chemotherapy (5 Fu, 250 mg/m2/IV every 2 days). Chemotherapy and radiotherapy were combined simultaneously. The average age was 56 years; the male/female ratio was 802/57. Median performance status (ECOG scale) was 1 (range 0-2). The TNM distribution as UICC criteria was T3 529 patients; T4 330 patients; No 217 patients; N1 52 patients; N2 319 patients; and N3 271 patients. The primary sites were nasopharynx 92, oral cavity 252, hypopharynx 119, larynx 310, and others (sinuses and unknown primary)86. Complete response was achieved in 188/277 patients in Group A (67.8%), 254/282 patients in Group B (90%), and 289/300 in Group C (96.3%). All patients were followed and statistical analysis shows a significant improvement in median duration of response, as well as survival for Groups B and C compared with Group A. No significant differences were seen between Group B and C. The acute toxicity was mucositis, skin toxicity, bone marrow depression. A mean temporary weight loss of 4.9 Kg was observed with a range of 2.3-10.5 Kg.

Adult↗

PubMed1986

Plasma catecholamines following exercise in hypertensives treated with pindolol: comparison with placebo and metoprolol.

This study re-examines the proposal that beta-adrenoceptor blockers with intrinsic sympathomimetic activity decrease plasma noradrenaline levels. Thirteen patients (aged 29-65 years) with uncomplicated essential hypertension were randomly allocated to a three period, double-blind cross-over trial. The treatment periods, each of 3 weeks duration, were composed of placebo, pindolol (5 mg twice daily) and metoprolol (100 mg twice daily), dispensed in identical capsules. At the end of each treatment period, patients were exercised on a bicycle ergometer to a predetermined workload. Blood pressure and heart rate were measured before, immediately on completion of exercise and after 10 min post-exercise rest. Blood samples for plasma noradrenaline and adrenaline determination were also collected at these times. Blood pressures were similar during treatment with pindolol and metoprolol. As expected, heart rate was consistently lower during metoprolol treatment. Basal, pre-exercise plasma noradrenaline and adrenaline were similar at the end of each treatment period. However, the increase following exercise was significantly greater during metoprolol treatment. The post-exercise increase during pindolol treatment was indistinguishable from that in the placebo period. These findings, in a randomised placebo-controlled study, therefore demonstrate that pindolol does not influence basal or exercise-stimulated plasma noradrenaline and adrenaline concentrations. This is best explained by a lack of effect of pindolol on the plasma clearance of catecholamines, which is impaired by beta-adrenoceptor blockers devoid of intrinsic sympathomimetic activity.

Adult↗

PubMed1989

Cyclophosphamide-cisplatin versus cyclophosphamide-carboplatin in stage III-IV ovarian carcinoma: a comparison of equally myelosuppressive regimens.

Between March 1985 and January 1987, 103 women with histologically proven stage III-IV ovarian carcinoma were randomly allocated to groups receiving monthly intravenous regimens of 1 g of cyclophosphamide/m2 plus either 60 mg of cisplatin (CDDP)/m2 or 150 mg of carboplatin (CBDCA)/m2 for 1 year unless disease progressed earlier. The groups were well balanced according to the stratification factors (age, histologic differentiation, extent of residual disease, and performance score), and both treatments were well tolerated and produced similar median first-course leukopenia (2,200 and 2,000 cells/microL) and thrombocytopenia (220,000 and 202,500 cells/microL). The CBDCA regimen was less emetogenic. After an interim analysis in January 1987 revealed superior progression-free survival for the group of 53 patients receiving CDDP (P = .005), the study was closed to further accrual. Those 24 patients still receiving CBDCA were encouraged to cross over to the CDDP-based regimen and 21 of them did. Following treatment crossover, the relative risk of death associated with original allocation to CBDCA receded from 1.79 to 0.97, indicating success of the salvage treatment using the CDDP-based regimen. This aborted study demonstrated the superiority of CDDP over CBDCA when the two platinum compounds were compared at equally myelosuppressive low doses in combination with 1 g of cyclophosphamide/m2. If CDDP is to be supplanted by CBDCA, larger, more myelosuppressive doses of CBDCA will be required. The platinum drug antitumor effect is a critically important therapeutic feature of this combination.

Antineoplastic Agents↗

PubMed1983

Concurrent or sequential use of cytotoxic chemotherapy and hormone treatment in advanced breast cancer: report of the Swiss Group for Clinical Cancer Research.

In a trial of combined hormone treatment and cytotoxic chemotherapy 464 patients with advanced breast cancer were randomly allocated to either concurrent or sequential treatment. Cytotoxic drugs were given only if the antitumour activity of the hormone treatment was inadequate. Hormone treatment consisted of oophorectomy for premenopausal and tamoxifen administration for postmenopausal patients. Length of survival was better, though not significantly, in premenopausal patients (p = 0.29) treated concurrently and in postmenopausal women (p = 0.17) treated sequentially; the difference was highly significant (p = 0.003) only for postmenopausal women in the low-risk category. The findings suggest that postmenopausal women with metastatic breast cancer should probably be treated primarily by carefully monitored hormone treatment.

Antineoplastic Agents↗

PubMed1990

The value of pulmonary artery and central venous monitoring in patients undergoing abdominal aortic reconstructive surgery: a comparative study of two selected, randomized groups.

One hundred two patients undergoing abdominal aortic reconstructive surgery were prospectively, randomly allocated to two groups, one of which was monitored with a central venous catheter and the other with a pulmonary artery catheter. Patients with uncompensated cardiopulmonary or renal disease were excluded from the study. General anesthesia was administered for the surgical procedure, and the patients were followed through hospital discharge. No statistically significant differences occurred between the two groups with regard to morbidity (perioperative cardiac, pulmonary or renal sequelae), mortality rate, duration of intensive care, postoperative hospital stay, or cost of hospitalization. The one statistically significant difference between groups was the professional fee charged for anesthetic care, which was higher for patients with pulmonary artery catheters than for those with central venous catheters. In conclusion, we prospectively gathered data from most patients presented for abdominal aortic reconstructive surgery. Our data seem to indicate that the choice of central venous catheter or pulmonary artery catheter monitoring makes little difference in outcome after abdominal aortic reconstructive surgery, and that for many patients pulmonary artery catheters are not necessary to give appropriate, adequate care. Because of the size of the sample, however, declarations of epidemiologic significance would be unfounded. Therefore large-scale, multicenter studies addressing such outcomes remain necessary.

Anesthesia, General↗

PubMed2003

Efficacy and safety of topical administration of selamectin for treatment of ear mite infestation in rabbits.

OBJECTIVE: To evaluate the efficacy and safety of topical administration of selamectin in rabbits naturally infested with Psoroptes cuniculi. DESIGN: Randomized controlled trial. ANIMALS: 48 mixed-breed domestic rabbits with active P. cuniculi mite populations and clinical ear lesions. PROCEDURES: Rabbits were randomly allocated to 1 of 6 treatment groups. On day 0, rabbits in groups 1 and 2 were given vehicle, rabbits in groups 3 and 4 were given selamectin at a dose of 6 mg/kg (2.7 mg/lb), and rabbits in groups 5 and 6 were given selamectin at a dose of 18 mg/kg (8.2 mg/lb). On day 28, rabbits in groups 2, 4, and 6 were given a second dose of vehicle or selamectin. Otoscopic examinations were performed and ear lesion size was measured weekly for 8 weeks. Quantitative viable mite counts were performed on day 56. RESULTS: On days 7 through 56, lesion sizes for all selamectin-treated groups were significantly lower than sizes for control groups; there were no significant differences in lesion sizes among selamectin-treated groups. All rabbits in the 2 control groups had viable adult P. cuniculi mites for the duration of the study, as determined by otoscopic examination, whereas all rabbits in the 4 selamectin-treated groups were free from P. cuniculi mites on days 7 through 56. No adverse reactions associated with selamectin treatment were observed. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggest that topical application of selamectin at a dose of 6 or 18 mg/kg can completely eliminate mites from rabbits naturally infested with P. cuniculi.

Administration, Topical↗

PubMedDate not supplied

A community trial strategy for evaluating treatment for symptomatic conditions.

A method has been developed for simultaneously comparing the usefulness of many treatments of established value for symptomatic medical conditions. Medical assessment of outcome is not employed. Instead patients are required to assess treatments prescribed during the course of ordinary general practice rather than under the strictly controlled settings of most clinical trials. Outcome incorporates patient compliance and treatment acceptability and is based on patients' subjective judgments of the usefulness of randomly allocated treatments as recorded in self-completed diaries, which are mailed directly to a trial centre. Thus large and more representative samples are achieved through minimizing the efforts required, both of participating doctors and of patients. Although the approach was originally developed and tested for the comparison of hay fever treatment regimens, we believe that it can be adapted to compare many other treatments where patient-reported symptoms validly describe the outcome of interest. The feasibility of the approach was tested in two pilot studies, and it has been employed successfully in a two-year trial comparing seven hay fever treatments. Aspects of analysing such trials are discussed.

Clinical Trials as Topic↗

PubMed1992

An electroencephalographic comparison of effects of propofol and methohexital.

Thirty-eight patients were randomly allocated to receive propofol 1 mg/kg (group A, N = 10), methohexital 0.7 mg/kg (group B, N = 9), propofol 2 mg/kg (group C, N = 10), methohexital 1.5 mg/kg (group D, N = 9). They were all male with a mean age of 65.8 years (range, 46-85) and a mean weight of 76.2 kg (range, 50-109). Patients received no premedication. All drugs were administered as a single i.v. bolus. After baseline EEG recordings were obtained, i.v. bolus doses were given and the recording continued until the patients became fully responsive to verbal commands. The EEGs were visually analyzed and classified into 4 phases: phase 0, the wake physiologic pattern; phase 1, initial changes after i.v. bolus doses; phase 2, state of deep anesthesia; and phase 3, stage of recovery. The main change during phase 1 was increase in the amplitude of the background rhythms. Phase 2 was characterized by theta and delta activity and burst suppression in some patients. During phase 3 beta activity was seen following methohexital. Propofol produced a much deeper level of anesthesia compared to methohexital. The stage of deep anesthesia was prolonged following propofol. The clinical and EEG recoveries were prolonged after induction doses of propofol. The quality of recovery, however, was far superior with propofol. Methohexital produces a "hang over" effect which delays full recovery.

Aged↗

PubMed1984

Relation between osmolality of diet and gastrointestinal side effects in enteral nutrition.

One hundred and eighteen patients with normal gastrointestinal function were randomly allocated to one of three feeding regimens in a double blind study to determine the relation between the tonicity of the diet and gastrointestinal side effects related to the diet and to evaluate the efficacy of "starter" regimens in reducing gastrointestinal side effects during enteral nutrition. Patients received a hypertonic diet with an osmolality of 430 mmol (mosmol)/kg (group 1), the same diet but with the osmolality increasing from 145 to 430 mmol/kg over the first four days (group 2), or an isotonic diet (300 mmol/kg) (group 3). All diets were prepared aseptically and administered by 24 hour nasogastric infusion. The mean daily nitrogen intake in group 1 was significantly greater (p less than 0.05) than that in both groups 2 and 3, and the mean overall daily nitrogen balance was significantly better (p less than 0.05) in group 1 than groups 2 and 3. The incidence of side effects related to the diet was similar in all three groups, but diarrhoea was significantly (p less than 0.001) associated with concurrent treatment with antibiotics. These findings show that undiluted hypertonic diet results in significantly better nitrogen intake and balance, that starter regimens reduce nutrient intake but not symptoms, and that diarrhoea is significantly related to treatment with antibiotics and not to administration of an undiluted hypertonic polymeric diet.

Clinical Trials as Topic↗

PubMed1984

A single-blind comparative study of auranofin and hydroxychloroquine in patients with rheumatoid arthritis.

Forty patients with rheumatoid arthritis were randomly allocated to treatment with auranofin 3 mg b.d. or hydroxychloroquine 200 mg b.d. Twenty patients received each drug. Efficacy was analysed by comparing patients with available data at weeks 12, 24, 36 and 48 with baseline within each treatment group, and between treatment groups at each of these same time points. There were statistically significant improvements in all measured parameters of clinical efficacy among hydroxychloroquine treated patients, and in all efficacy parameters except one (time to onset of fatigue) in the auranofin treatment group. There were no significant differences between the treatment groups for any parameter of clinical efficacy. Of the laboratory parameters measured, only auranofin treatment produced statistically significant decreases in the concentration of IgA, IgG and IgM, with significant differences between treatments being detected in the case of IgA and IgG. Eight auranofin-treated and three hydroxychloroquine-treated patients were withdrawn because of adverse reactions before completing 48 weeks treatment. The commonest reason for stopping auranofin treatment was diarrhoea (5 cases). Three hydroxychloroquine-treated and two auranofin-treated patients were withdrawn from the study because of inefficacy of the trial drug. Auranofin had a more 'potent' biochemical profile than hydroxychloroquine, although more patients tolerated one year of treatment with the latter drug.

Adult↗

PubMed1988

A randomized placebo-controlled comparison of amlodipine and atenolol in mild to moderate systemic hypertension.

Amlodipine, a new long-acting dihydropyridine calcium antagonist, was compared with placebo and atenolol in 125 patients with mild to moderate systemic hypertension [supine diastolic blood pressure (DBP) 90-114 mm Hg]. Patients received placebo for 4 weeks, followed by a random allocation to an 8-week double-blind, once-daily treatment with amlodipine (n = 41), atenolol (n = 43), or placebo (n = 41). The changes in 24-h post-dose blood pressure (BP) from baseline to final visit for amlodipine (mean daily dose 8.8 mg, range 5-10 mg) were -12.8 +/- 2.0/ -10.1 +/- 1.2 mm Hg in supine BP and -11.5 +/- 2.3/-9.8 +/- 1.1 mm Hg in standing BP (p less than 0.001); for atenolol (mean daily dose 83.7 mg, range 50-100 mg), the changes from baseline were -11.3 +/- 2.3/-11.7 +/- 1.3 mm Hg in supine BP and -13.3 +/- 3.1/-12.3 +/- 1.5 mm Hg in standing BP (p less than 0.001); for placebo, the changes from baseline were -0.9 +/- 2.8/-3.5 +/- 0.9 mm Hg in supine BP and -1.6 +/- -2.6/-4.0 +/- 1.0 mm Hg in standing BP. In the study, goal response was defined as a supine DBP of less than 90 mm Hg or its decrease by greater than or equal to 10 mm Hg. The response rates were similar for atenolol (65%) and amlodipine (61%). Both active therapies were significantly more effective than placebo. Heart rate was significantly lowered by atenolol only.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1983

Randomized trial of 3 different regimens of combination chemotherapy in patients receiving simultaneously a hormonal treatment for advanced breast cancer.

We report the results of a randomized trial carried out by the Swiss Group for Clinical Cancer Research (SAKK) and in which 230 patients with advanced breast cancer receiving concurrently a hormonal treatment (oophorectomy for pre- and tamoxifen for postmenopausal women) were randomly allocated to three different regimens of combination chemotherapy. The therapeutic results registered with the two more intensive combinations (LMP/FVP and LMFP/ADM) were similar with regard to response rates, time to progression and survival. The patients receiving the low-dose chemotherapy lmfp showed a statistically significant lower response rate (32%, P less than 0.001) and a shorter survival (P = 0.03) than the results observed in patients treated with the two other regimens. This difference was particularly pronounced, at least regarding survival, in the following subgroups: postmenopausal women, patients with a poor performance status, dominant visceral lesions, two sites of disease and a disease-free interval longer than 12 months. Patients with bony metastases as dominant lesion fared similarly with all three regimens of chemotherapy. This latter subset of advanced breast cancer patients should probably be spared too intensive cytotoxic treatment. This is, to our knowledge, the first report of a randomized trial showing an evident correlation between response rate and survival in various subgroups of patients with advanced breast cancer treated with different chemotherapeutic regimens.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1986

Failure of a pure anti-platelet drug to decrease the number of attacks more than placebo in patients with Raynaud's phenomenon.

Fifty-eight patients with Raynaud's phenomenon were randomly allocated in a six week double-blind clinical trial in parallel groups to compare the efficacy of a pure antiplatelet agent, ticlopidine (250 mg b.i.d.) with that of a placebo. There was no significant difference between the two treatments in percent reduction of weekly number of attacks and in subjective improvement assessed by both patient and investigator. It is unlikely that platelets are involved in the mechanisms of Raynaud's crisis.

Adult↗