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PubMed1984

Prenalterol as long-term therapy for chronic congestive heart failure. A randomized cross-over trial.

Ten patients with severe chronic congestive heart failure (CHF) due to ischaemic heart disease treated with digitalis and diuretics were randomly allocated to oral treatment with prenalterol (100-200 mg daily in addition to their basal treatment) or to intensified treatment with diuretics in a cross-over trial. A wash-out period of 1-4 weeks was allowed between the two modes of treatment. Most of the patients demonstrated subjective improvement during prenalterol therapy, but this improvement could not be verified objectively by exercise test, echocardiography, chest X-ray or weight measurements. No serious side-effects of either mode of treatment were observed. Heart rate was significantly lower during exercise when the patients were treated with prenalterol than during the control periods or during intensified conventional treatment, indicating that prenalterol acts as a beta-adrenergic receptor blocker during exercise in this patient group. The results indicate that prenalterol is a partial beta-receptor agonist without superior beneficial effects compared to those of intensified conventional treatment in patients with chronic, severe CHF.

Adrenergic beta-Agonists↗

PubMed1987

High dose versus low dose medroxyprogesterone acetate: a randomized trial in advanced breast cancer.

One hundred and twenty-four patients with advanced breast cancer were randomly allocated to treatment with either low dose (300 mg/day) or high dose (1000 mg/day) oral medroxyprogesterone acetate. The objective response rate was 24% for both treatment groups. For premenopausal patients, responses were achieved in two out of four on low dose and three out of six on high dose therapy (overall 5 out of 10 responders). No significant differences in response were seen in relation to previous endocrine therapy or site of disease. Both treatments were associated with a high incidence of bone pain relief (43 and 52%) but a low objective response rate (13%) in bone. Median response duration (10 vs. 11 months) and survival (13 vs. 11 months) were not significantly different for the two treatments. Both treatments were in general well tolerated, but toxicity was greater with the high dose treatment. Low dose oral medroxyprogesterone acetate is as effective as high dose therapy in the treatment of advanced breast cancer, and is cheaper and less toxic.

Adult↗

PubMed1982

A randomized trial of continuing medical education.

To determine whether continuing medical education affects the quality of clinical care, we randomly allocated 16 Ontario family physicians to receive or not receive continuing-education packages covering clinical problems commonly confronted in general practice. Over 4500 episodes of care, provided before and after study physicians received continuing education, were compared with preset clinical criteria and classified according to quality. Although objective tests confirmed that the study physicians learned from the packages, there was little effect on the overall quality of care. When the topics were of relatively great interest to the physicians, the control group (who did not receive the packages) showed as much improvement as did the study group. When the topics were not preferred, however, the documented quality of care provided by study physicians rose (P less than 0.05) and differed from that provided by control physicians (P = 0.01). Finally, there was no spillover effect on clinical problems not directly covered by the program. In view of the trend toward mandatory continuing education and the resources expended, it is time to reconsider whether it works.

Canada↗

PubMed1987

Hydrochlorothiazide with or without amiloride for hypertension in the elderly. A dose-titration study.

The blood pressure response to increasing doses of hydrochlorothiazide with or without amiloride was examined in 130 elderly hypertensive patients. After four weeks of placebo, patients were randomly allocated to increasing doses of hydrochlorothiazide or hydrochlorothiazide with amiloride for 12 weeks using a parallel, double-blind study design. Both hydrochlorothiazide and hydrochlorothiazide with amiloride significantly reduced mean (+/- SEM) baseline supine and standing blood pressure (171 +/- 2/102 +/- 1 and 167 +/- 2/102 +/- 1 mm Hg) to 148 +/- 2/84 +/- 1 and 146 +/- 3/85 +/- 1 mm Hg, respectively, at week 16. Amiloride did not exert any additional antihypertensive effect. Only eight patients required hydrochlorothiazide at 100 mg/d, with the remainder responding to 25 to 50 mg/d. Hydrochlorothiazide decreased mean serum potassium level from 4.3 +/- 0.1 mEq/L (4.3 +/- 0.1 mmol/L) during placebo to 4.0 +/- 0.1 mEq/L (4.0 +/- 0.1 mmol/L) at week 16. Ten patients receiving hydrochlorothiazide developed hypokalemia compared with only two receiving hydrochlorothiazide with amiloride. Relatively low doses of hydrochlorothiazide (25 to 50 mg/d) effectively reduce blood pressure in elderly hypertensive patients. Hypokalemia may occur with hydrochlorothiazide alone but is much less common when hydrochlorothiazide is combined with amiloride.

Aged↗

PubMed1983

Pharmacodynamic and pharmacokinetic study of oral and intravenous penbutolol.

The present study was done to establish the dose-response relationships for effects on heart rate and systolic and diastolic blood pressure, tolerance and plasma disappearance kinetics after large intravenous and oral doses of penbutolol. Twelve healthy volunteers were randomly allocated to receive penbutolol (n = 8) or placebo (n = 4) in this single blind, placebo-controlled investigation. The degree of beta-blockade was measured by standarized exercise tests at work loads selected to produce a heart rate of 150/min without treatment. Penbutolol was given as single i.v. doses of 3, 6 and 12 mg and as 40, 80 and 120 mg once daily for one week, measurements being made 2 and 24 h after the last dose. Penbutolol i.v. did not influence the resting heart rate but it did reduce resting systolic blood pressure in a non-dose dependent manner. Exercise heart rate and systolic pressure were lowered by all the intravenous doses. All oral doses of penbutolol lowered exercise heart rate and systolic blood pressure to the same extent. The reductions in exercise tachycardia was still present after 24 h. After i.v. administration t1/2 was approximately 1.2 h and the volume of distribution was 32-421. All doses were well tolerated.

Administration, Oral↗

PubMed1990

The influence of midazolam on the plasma concentrations of bupivacaine and lidocaine after caudal injection of a mixture of the local anesthetics in children.

Twenty children undergoing surgery received a caudal block using 1 ml per kg of a mixture of 50% lidocaine (1%) and 50% bupivacaine (0.25%). They were randomly allocated to two groups, one of which received midazolam 0.4 mg/kg rectally as premedication. Midazolam administration resulted in a significantly lower AUC value for lidocaine but did not influence the plasma concentrations of bupivacaine.

Anesthesia, Caudal↗

PubMed1988

Rapid development of tolerance to the antihypertensive effect of nisoldipine.

Antihypertensive efficacy and tolerability of the dihydropyridine calcium antagonist nisoldipine were examined in a double-blind, placebo-controlled study. Twenty patients with hypertension (greater than 140/95 mmHg) uncontrolled by bendrofluazide plus atenolol were randomly allocated to receive nisoldipine, 10-20 mg daily, or placebo for six weeks. Nisoldipine, compared with placebo, lowered blood pressure (BP) by 31/21 mmHg (P less than 0.02/P less than 0.002) after two weeks. Thereafter its antihypertensive effect declined to 20/9 mmHg (NS/NS) at four weeks and 8/3 mmHg at six weeks (NS/NS). Compared with placebo, the rise in BP with nisoldipine during the last four weeks of the trial was highly significant (P less than 0.005). During this period BP rose by 14/11 mmHg (P less than 0.05/P less than 0.02) in the nisoldipine group so the apparent loss of effect was not attributable to a fall of BP in the placebo group. Compliance, as assessed by tablet counts, was satisfactory and nisoldipine treatment did not cause significant weight gain. The drug was not well tolerated and three patients withdrew from treatment because of side-effects. Tolerance to the antihypertensive effect of nisoldipine appears to develop rapidly and further studies should be performed to confirm this, and evaluate the mechanism.

Adolescent↗

PubMed1981

A randomised controlled trial of the effect of low fat diet advice on dietary response in insulin independent diabetic women.

Type 2 (insulin independent) diabetic women were randomly allocated to receive advice for low fat diets or low carbohydrate diets. By 24 h weighted dietary intakes before and after a mean interval of six months, patients in the low fat group had reduced their fat intake from 41% to 31% of total energy, while carbohydrate percentage of total energy intake increased from 38% to 46%. Percentage energy intake from fat and carbohydrate in the control group remained unchanged. Body weight fell in both groups especially for patients in the low fat group who were obese (weight/height2 greater than or equal to 28 kg/m2). Mean plasma glucose, HbA1, and triglycerides were unchanged. Mean plasma total cholesterol fell significantly in the low fat group compared with the controls (p less than 0.001), but there was no significant difference in the small reduction of high density lipoprotein cholesterol observed in both groups. Thus, adherence to low fat diets occurred without deterioration of diabetes and with benefit for weight and total cholesterol.

Adult↗

PubMed1983

Nifedipine in hypertensive emergencies.

The effects and safety of using oral nifedipine 10-20 mg as acute antihypertensive treatment were studied in a single-blind placebo-controlled study of 25 consecutive patients with very high blood pressure requiring emergency reduction. In addition the effect of this treatment on cerebral blood flow was investigated using xenon-133 in 10 patients randomly allocated to receive oral nifedipine or intravenous clonidine. Whereas placebo did not alter the blood pressure, oral nifedipine significantly reduced the systolic and diastolic blood pressures in all 25 patients (from 221 +/- 22/126 +/- 14 mm Hg to 152 +/- 20/89 +/- 12 mm Hg after 30 minutes, p less than 0.001). Heart rate increased from 74 +/- 11 to 84 +/- 11 beats/minute (p less than 0.01); this effect was inversely related to age (r = -0.65, p less than 0.01). The falls in systolic and diastolic blood pressures were closely related to the blood pressures before treatment ) r = 0.67, p less than 0.001 for systolic, and r = -0.58, p less than 0.01 for diastolic values). No serious unwanted effects were observed. Measurement of cerebral blood flow after nifedipine showed an increase in flow in four out of five patients. Clonidine, by contrast, reduced cerebral blood flow in all patients by up to 28%. Nifedipine is a simple, effective, and safe alternative drug for managing hypertensive emergencies, especially when continuous monitoring of the patient cannot be guaranteed.

Adult↗

PubMed1990

Relation between dose of bendrofluazide, antihypertensive effect, and adverse biochemical effects.

OBJECTIVE: To determine the relevant dose of bendrofluazide for treating mild to moderate hypertension. DESIGN: Double blind parallel group trial of patients who were given placebo for six weeks and then randomly allocated to various doses of bendrofluazide (1.25, 2.5, 5, or 10 mg daily) or placebo for 12 weeks. SETTING: General practices in Zealand, Denmark. PATIENTS: 257 Patients with newly diagnosed or previously treated hypertension, aged 25-70, who had a mean diastolic blood pressure of 100-120 mm Hg after receiving placebo for six weeks. MAIN OUTCOME MEASURES: Reduction in diastolic blood pressure and changes in biochemical variables (potassium, urate, glucose, fructosamine, total cholesterol, apolipoprotein A I, apolipoprotein B, and triglyceride concentrations). RESULTS: All doses of bendrofluazide significantly reduced diastolic blood pressure to the same degree (10-11 mm Hg). Clear relations between dose and effect were shown for potassium, urate, glucose, total cholesterol, and apolipoprotein B concentrations. The 1.25 mg dose increased only urate concentrations, whereas the 10 mg dose affected all the above biochemical variables. CONCLUSION: The relevant range of doses of bendrofluazide to treat mild to moderate hypertension is 1.25-2.5 mg a day. Higher doses caused more pronounced adverse biochemical effects including adverse lipid effects. Previous trials with bendrofluazide have used too high doses.

Adult↗

PubMed1985

Coeliac plexus block versus pancreaticogastrostomy for pain in chronic pancreatitis. A controlled randomized trial.

Seventeen patients with chronic pancreatitis and dilated pancreatic ducts were randomly allocated to coeliac plexus block or pancreaticogastrostomy. The number of patients with pain relief after coeliac plexus block and pancreaticogastrostomy did not differ at discharge. Pain score and use of analgesics before coeliac plexus block and 6 months later were unaffected but were significantly less after pancreaticogastrostomy. Operation decreased pancreatic tissue pressure significantly. This pressure decrease is believed to explain pain relief.

Adult↗

PubMed1988

Intermittent versus long-term tapering prednisolone for initial therapy in children with idiopathic nephrotic syndrome.

Forty-six children with steroid-responsive nephrotic syndrome were randomly allocated to receive two different prednisolone regimens for initial therapy. Twenty-nine children (group 1) received an intermittent regimen (60 mg/m2/day for 4 weeks, followed by 40/mg/m2/day on 3 days a week for 4 weeks); 17 children (group 2) had a long-term regimen (60 mg/m2/day for 4 weeks, followed by the same dose on alternate days for 4 weeks and the doses tapered by 10 mg/m2, given on alternate days every 4 weeks for 5 months). There was no difference between the two groups in the regimen used to treat relapses, steroid responsiveness, number of patients with relapses, and frequency of toxic reactions to steroids. However, the number of patients with a relapse within 6 months after initial therapy and the number of those with frequent relapses or steroid dependence were significantly higher in group 1 than in group 2 (P less than 0.05 for both). The data indicate that the long-term tapering regimen appears to be both safe and preferable to the intermittent regimen for initial therapy in children with idiopathic nephrotic syndrome.

Child↗

PubMed1987

Treatment of hypertension in pregnancy with methyldopa: a randomized double blind study.

Twenty-five patients whose pregnancies were complicated by chronic hypertension were entered in a double-blind study and randomly allocated to treatment with methyldopa (Aldomet) or placebo. Thirteen patients were in the treatment group and 12 in the placebo group. The two groups showed no significant difference in demographic and pretreatment laboratory profiles. Methyldopa-treated patients registering in the first trimester had a significant reduction in the mean arterial pressure (MAP) during the second and third trimesters (P less than 0.025). No significant differences in birth weight (BW), ponderal index (PI) were found when results were corrected for gestational age (GA), race, and sex. The mean GA was significantly prolonged in the methyldopa-treated group by 10.3 days (P less than 0.05). The frequency of superimposed pre-eclampsia was similar in both groups (33.3% vs. 38.4%). However, 75% of the superimposed pre-eclampsia occurred antepartum in the placebo group, while 80% of the methyldopa-treated group developed superimposed pre-eclampsia intrapartum. The results of this small study suggest that the treatment of hypertension in pregnancy may reduce MAP and possibly delay the occurrence of superimposed pre-eclampsia and thus afford a prolongation of the pregnancy.

Chronic Disease↗

PubMed1989

Estrogen-induced gallstone formation in males. Relation to changes in serum and biliary lipids during hormonal treatment of prostatic carcinoma.

To assess if and by which mechanisms pharmacological estrogen treatment induces gallstone disease, we examined patients with recently diagnosed prostatic cancer randomly allocated to estrogen therapy (n = 37) or orchidectomy (n = 35). According to gallbladder ultrasonography, after 1 yr new gallstones had developed in 5 of 28 estrogen-treated patients, compared with 0 of 26 orchidectomized patients (P = 0.03). Estrogen therapy for 3 mo increased the relative concentration of cholesterol and cholesterol saturation of bile by approximately 30% (n = 10). Serum LDL cholesterol was reduced by approximately 40%, and its relative change related inversely to that of bile cholesterol (Rs = -0.77). There were no changes in biliary or serum lipids after orchidectomy (n = 9). Secretion rates of biliary lipids were measured with a duodenal perfusion technique. Patients on chronic estrogen therapy (n = 5) had approximately 40% higher biliary excretion rates of cholesterol than age-matched controls (n = 7). Phospholipid secretion was also higher, but no difference in bile acid secretion was found. We conclude that an increased hepatic secretion of cholesterol results in increased cholesterol saturation of bile and an enhanced rate of gallstone formation during estrogen treatment. The changes in bile cholesterol seem to be related to the induced changes in serum lipoprotein metabolism.

Aged↗

PubMed1990

Cognitive and functional competence after anaesthesia in patients aged over 60: controlled trial of general and regional anaesthesia for elective hip or knee replacement.

OBJECTIVE: To determine the influence of general or regional anaesthesia on long term mental function in elderly patients. DESIGN: Prospective study of patients randomly allocated to receive general or regional anaesthesia. SETTING: The patients' homes and a large teaching hospital in Cardiff. SUBJECTS: 146 Patients aged 60 and over scheduled for elective hip or knee replacement. MAIN OUTCOME MEASURES: Scores achieved in tests of cognitive function and functional competence. RESULTS: 72 Patients were allocated to receive general anaesthesia and 74 regional anaesthesia. Anaesthetic technique did not influence the duration of the operation, time to mobilisation postoperatively, requirements for analgesia after the operation, or duration of stay in hospital. Three months after the operation there was an improvement in the score for the recognition component (76 ms, 95% confidence interval 9 to 144) and the response component (82 ms, 5 to 158) of the choice reaction time in the group receiving general anaesthesia compared with the group receiving regional anaesthesia. This was the only significant difference between the two groups in the assessments of cognitive and functional competence. Eleven patients receiving regional anaesthesia and 12 receiving general anaesthesia reported that their memory and concentration were worse than before the operation, but this was not confirmed by testing. CONCLUSION: Cognitive and functional competence in elderly patients was not detectably impaired after either general or regional anaesthesia when attention was paid to the known perioperative influences on mental function.

Activities of Daily Living↗

PubMed1995

Oxygen therapy reduces postoperative tachycardia.

Concomitant hypoxaemia and tachycardia in the postoperative period is unfavourable for the myocardium. Since hypoxaemia per se may be involved in the pathogenesis of postoperative tachycardia, we have studied the effect of oxygen therapy on tachycardia in 12 patients randomly allocated to blinded air or oxygen by facemask on the second or third day after major surgery. Inclusion criteria were arterial hypoxaemia (oxygen saturation < or = 92%) and increased heart rate (> 90 beat.min-1). Each patient responded similarly to oxygen therapy: an increase in arterial oxygen saturation and a decrease in heart rate (p < 0.002). Thus, postoperative supplementary oxygen has a positive effect on the cardiac oxygen delivery and demand balance.

Aged↗

PubMed1986

Fipexide, an effective cognition activator in the elderly: a placebo-controlled, double-blind clinical trial.

Forty geriatric in-patients with severe cognition disorders were randomly allocated to treatment with either 600 mg fipexide daily or placebo over a period of 3 weeks. Before and after treatment, the symptoms of cognitive performance (disorders of memory and attention, asthenia, apathy and disorders of coenaesthesia) were monitored and scored. Similarly, the Thurstone test (symbol matching test) was performed and time to completion, number of errors and exactitude index were recorded. Haemodynamics, haematology and haematochemistry investigations were made before and after treatment, and accessory symptoms of potential side-reactions were monitored by positive questioning. Treatment with fipexide was associated with a significant improvement in each and all monitored symptoms and signs to an average extent of 60%, whereas placebo was not. Similarly, the patients given fipexide experienced a significant improvement in the Thurstone test, in terms of time to completion (-22%), number of errors (-46%) and exactitude index (+60%); again, placebo was not associated with any significant improvement (variations, respectively, of -5%, -14%, and +24%). Overall, 85% of the patients given fipexide experienced clinical improvement to a greater or lesser degree, a significantly greater proportion than that associated with placebo (25%; p less than 0.001). Tolerance, both subjective and objective, was good in both treatment groups.

Aged↗

PubMed1988

A randomized, controlled trial to determine the effectiveness of fascial infiltration of bupivacaine in preventing respiratory complications after elective abdominal surgery.

A randomized, controlled trial was performed to determine whether infiltration of fascia with bupivacaine, a long-acting local anesthetic, at the time of closure after elective laparotomy, is effective in preventing postoperative respiratory complications. At the Toronto General Hospital 415 patients undergoing elective laparotomy were randomly allocated to receive bupivacaine 0.25% (2 ml/cm incision), infiltrated into the fascia evenly along both sides of the incision before wound closure (202 patients), or to have closure without infiltration (213 patients). Chest x-ray (CXR) films of all patients were obtained preoperatively and on the second postoperative day. Pulmonary function studies were performed preoperatively and for the first two consecutive days postoperatively. CXR films were scored by a blinded observer. Postoperatively, 64% of the treatment group and 56% of the control group had evidence of atelectasis on CXR films (p = NS, chi 2 test). Both groups had similar decrements in vital capacity and expiratory reserve volume on the first and second postoperative days. There was no significant difference in the amount of analgesic taken in the first 24 hours, although the time to first analgesic was significantly longer in the treatment group (2.2 vs 1.3 hours, p less than 0.055). We conclude that infiltration of the fascia with 0.25% bupivacaine at a dose of 2 ml/cm of incision is not effective in preventing postoperative atelectasis. It does not reduce use of an analgesic although it may delay its initial requirement.

Adult↗