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PubMed1985

Atenolol versus bendroflumethiazide in middle-aged and elderly hypertensives.

The antihypertensive effect and patient tolerability during 12 weeks' treatment with atenolol and bendroflumethiazide were evaluated in an open, randomized, between-patient trial. Out of a total of 162 patients, aged 50-75 years, with previously untreated hypertension, 151 completed the trial. They were randomly allocated to two groups. Forty-nine patients, aged 50-64 years (middle-aged), and 23, aged 65-75 years (elderly), were treated with atenolol. Forty middle-aged and 39 elderly were treated with bendroflumethiazide. Significant reductions in blood pressure (BP) were observed during treatment with each drug (p less than 0.001). The change in diastolic BP in middle-aged patients was significant in favour of atenolol (p less than 0.01), but otherwise no difference was found between the two drugs. Uric acid increased during treatment with both drugs (p less than 0.001). Serum potassium decreased during bendroflumethiazide treatment (p less than 0.001). Subjective side-effects of both drugs were few and expected. The results of this study indicate that atenolol and bendroflumethiazide are equally effective in reducing BP in patients aged 50-75 years.

Aged↗

PubMed1987

A controlled study of the nephrotoxicity of mezlocillin and gentamicin plus ampicillin in the neonate.

The nephrotoxicity of the aminoglycoside gentamicin was evaluated in an open, controlled study of newborn infants randomly allocated to receive either combination drug therapy with gentamicin and ampicillin or single drug therapy with mezlocillin for treatment of presumed neonatal sepsis. There were no significant differences in initial clinical characteristics between the groups. Neonates receiving gentamicin, in contrast to those receiving mezlocillin, had significant nephrotoxicity manifested by a smaller postnatal fall in mean serum creatinine concentration (-9%, P NS vs -21%, P less than 0.005, respectively) and a diminished postnatal rise in mean creatinine clearance (+ 21%, P NS vs + 51%, P less than 0.01, respectively). In neonates with a fall in creatinine clearance, the mean decline was significantly greater in those receiving gentamicin (44% vs 20%, P less than 0.01). There was no relationship between the incidence of gentamicin nephrotoxicity and either peak or trough gentamicin levels. For treatment of presumed neonatal sepsis, gentamicin proved more nephrotoxic than mezlocillin.

Ampicillin↗

PubMed1989

A comparison of moclobemide and imipramine in treatment of depression.

Moclobemide, a new reversible anti-MAO drug, was compared to imipramine in forty patients with major depression or dysthymic disorder. After a one-week wash-out period, patients were randomly allocated to the two treatment groups, receiving imipramine 25 mg tablets or Moclobemide 50 mg capsules for 28 days. Efficacy and tolerability were investigated by means of HRSD, CGI and VAS at baseline and thereafter at days 3, 7, 14 and 28. All patients completed the study, mean daily doses were 112.5 mg imipramine and 215 mg Moclobemide at day 28. Both treatments had similar antidepressant efficacy and a very good tolerability profile. Moclobemide was superior to imipramine in mean time to onset of effect (7.3 days versus 11.6 days: p less than 0.05) and in mean time to peak effect (13.5 days versus 18.5 days: 0.10 greater than p greater than 0.05. It is concluded that Moclobemide is a safe and effective anti-MAO drug, with an increasing rapid onset of therapeutic activity.

Adult↗

PubMed1986

Ineffectiveness of levamisole in prolonging remission or survival of women treated with cyclophosphamide, doxorubicin, and 5-fluorouracil for good-risk metastatic breast carcinoma: a Southeastern Cancer Study Group Trial.

A total of 97 women with good-risk metastatic breast cancer received therapy with cyclophosphamide, doxorubicin, and 5-FU; half of these patients were randomly allocated to receive levamisole, 2.5 mg/kg, 2 days of each week in addition to chemotherapy, while the other half received an identical placebo. Good-risk patients consisted of those with bone-only metastasis, or local chest wall recurrence with or without bone metastasis. No significant difference in response rate, duration of disease control, or survival was observed between the groups. No major toxicity was associated with levamisole.

Antineoplastic Combined Chemotherapy Protocols↗

PubMedDate not supplied

Safety of central venous catheter change over guidewire for suspected catheter-related sepsis. A prospective randomized trial.

We conducted a study to determine the safety of guidewire exchange of central venous catheters suspected of causing catheter-related sepsis (CRS). Out of a total of 146 patients studied prospectively 41 (28%) suspected of having CRS, were randomly allocated to have their catheters changed over a guidewire (group I) or replaced by a new contralateral venipuncture (group II). One hundred and five patients (group III) requiring only one catheterization served as a control group. Positive semiquantitative cultures (greater than or equal to 15 colonies per plate) of the catheter tip constituted a reliable index of CRS (positive and negative predictive value of 100%). No significant difference in catheter contamination rate and CRS rate was found between group I and II (p = 0.13) and between group I and II versus group III. Nevertheless, there were fewer problems of insertion in the guidewire group (p = 0.03). We conclude that changing a central venous catheter over a guidewire is as safe and has better patient acceptability than inserting a new one, as the proven CRS rate is low (2%) despite a high (27%) suspected rate.

Catheterization, Central Venous↗

PubMed1986

The influence of early intervention in acute myocardial infarction on long-term mortality and morbidity as assessed in the Göteborg metoprolol trial.

The mortality and morbidity were assessed during a 2-year follow-up in an acute intervention trial in suspected acute myocardial infarction with metoprolol (a selective beta 1-blocker). On admission to the trial, the 1395 participating patients were randomly allocated to metoprolol or placebo for 3 months. Thereafter, if there was no contraindication, patients with infarction and/or angina pectoris were continued on metoprolol for 2 years. A lower mortality was observed after 3 months in patients randomised to metoprolol. The difference remained after 2 years. The difference in 2-year mortality rate was restricted to patients randomised early after onset of pain. Late infarction was observed more often in the placebo group during the first 3 months. When the two groups thereafter were treated similarly, the difference successively declined and did not remain after 2 years. A similar incidence of angina pectoris was observed in the two groups at each check up. During the early recovery period, more patients in the metoprolol group returned to work. No such difference was observed later on.

Adult↗

PubMed1988

Studies on the effects of nitrendipine on oxytocin-, angiotensin II- and ergometrine-induced contraction of pregnant human myometrium in vitro.

Calcium channel blockers inhibit myometrial contractility by preventing the increase in intracellular free calcium which follows stimulation. They could thus be useful in treating premature labour. The effect of nitrendipine, a dihydropyridine calcium channel antagonist, on the contractile response of strips of pregnant human myometrium to oxytocin, angiotensin II (AII) and ergometrine has been examined. A total of 68 tissue strips were studied, with random allocation to treatment group. Initial concentration: response curves to one of the three agonists were determined; the concentration:response determinations were repeated in the presence or absence of nitrendipine at 10(-9)M. The initial EC50S for tissues exposed to oxytocin and AII were 8.2 X 10(-10)M and 3.4 X 10(-8)M respectively. The contractile response to both agonists was significantly blunted in the presence of nitrendipine (ANOVA; P less than 0.001 for both agents). This effect was greatest at high agonist concentrations. The initial EC50S for tissues exposed to ergometrine was 3.9 X 10(-8)M. Exposure to nitrendipine blunted the response (ANOVA; P less than 0.001), an effect most marked at low concentrations of ergometrine. The effect of nitrendipine on myometrial responses to the naturally occurring hormones oxytocin and AII supports suggestions of a role for it in inhibiting premature labour.

Angiotensin II↗

PubMed1986

An investigation of the effectiveness of bupivacaine applied to the abdominal wall and fallopian tubes in reducing pain after laparoscopic tubal ligation.

Sixty women having laparoscopic sterilisation performed under general anaesthesia were randomly allocated to one of two groups. Intraoperatively, one group had bupivacaine applied topically to the fallopian tubes and injected into the skin wounds, while the other group received no local anaesthetic. A double-blind investigation utilising a visual analogue scale failed to demonstrate a statistically significant difference in postoperative pain between the two groups. In both groups there was a significant reduction in mean pain scores between 1/2 and 7 hours, but there was no further reduction between 7 hours and 17 hours. At 7 hours, only 10% of patients scored their pain as 3 or greater (out of a possible 10). It is concluded that the use of bupivacaine as described is not a useful adjuvant to general anaesthesia and that the low incidence of even moderate pain at 7 hours confirms the view that these patients are suitable for management in the day-stay unit.

Bupivacaine↗

PubMed1988

Treatment with cimetidine, antacid, or placebo in patients with dyspepsia of unknown origin.

Patients with dyspepsia of unknown origin were randomly allocated to a controlled double-blind study to examine the symptomatic effect of cimetidine and antacid especially on the relief of pain, nausea, and bloating. Two hundred and twenty-two patients with no previous history of peptic ulcer disease and no evidence of other organic causes of dyspepsia were treated for 6 weeks with placebo, cimetidine, or antacid. The results showed that cimetidine was superior to both placebo and antacid in relieving pain and nausea but not bloating. Certain background factors, such as epigastric pain and symptoms relieved by solid food, had a significant positive influence on the outcome of treatment. When the impact of background factors was taken into account, cimetidine was found to be more effective than both placebo and antacid also with regard to the number of patients who improved in general well-being.

Adolescent↗

PubMed1983

Controlled, randomised trial of the effect of dietary fat on blood pressure.

57 couples living in two communities of North Karelia, aged 30-50 years, were randomly allocated to three groups. After a 2-week baseline period group I followed a diet low in fat (23% of energy) with a high polyunsaturated/saturated (P/S) ratio (1 . 0), group II reduced daily salt intake from 192 mmol to 77 mmol, and group III (control group) continued the usual diet. After the 6-week intervention period groups I and II reverted to their usual diets. In group I systolic blood pressure declined from 138 . 4 to 129 . 5 mm Hg and diastolic blood pressure from 88 . 9 to 81 . 3 mm Hg during the intervention period; the values rose during switch-back. The fall was greater among hypertensive than among normotensive subjects. In groups II and III the mean blood pressure changed very little during the study.

Adult↗

PubMed1979

Childhood asthma. A controlled trial of family psychotherapy.

In an attempt to evaluate the effectiveness of family psychotherapy as an adjunct conventional treatment in childhood asthma, children with moderate to severe asthma were randomly allocated to a control group or to an experimental group; the latter group received 6 hours of family treatment during a 4-month period, and both groups had standard medical treatment. While there was no significant difference between the two groups on three parameters, the experimental group were significantly better in day-wheeze score and thoracic gas volume. These results suggest that family treatment in selected cases may have a place in the overall management of childhood asthma, and that more research with larger numbers of children is necessary.

Adolescent↗

PubMed1999

Stimulation of the noradrenergic system enhances and blockade reduces memory for emotional material in man.

BACKGROUND: It is clearly established that emotional events tend to be remembered particularly vividly. The neurobiological substrates of this phenomenon are poorly understood. Recently, the noradrenergic system has been implicated in that beta blockade has been shown to reduce significantly the delayed recall of emotional material with matched neutral material being unaffected. METHODS: In the present study, 36 healthy young adults were randomly allocated to receive either yohimbine, which stimulates central noradrenergic activity, metoprolol which blocks noradrenergic activity, or matched placebo. The three groups were well matched. All capsules were taken orally, prior to viewing a narrated 11 slide show described a boy being involved in an accident. RESULTS: Yohimbine significantly elevated, and metoprolol reduced mean heart rate during the slide show relative to placebo, thus confirming the efficacy of the pharmacological manipulation. One week later, in a surprise' test, memory for the slide show was tested. As predicted, yohimbine-treated subjects recalled significantly more and metoprolol subjects fewer slides relative to placebo. This result was confirmed via analysis of multiple-choice recognition memory scores. CONCLUSIONS: We conclude that stimulation of the noradrenergic system results in the enhancement and blockade in a reduction of recall and recognition of emotional material in man.

Adrenergic alpha-Agonists↗

PubMed1986

Venous thromboembolism after cerebral infarction and the prophylactic effect of dextran 40.

In a prospective study of the incidence of deep vein thrombosis (DVT) after stroke, and the prophylactic effect of dextran, 50 patients, admitted with a diagnosis of cerebral infarction with paresis of the lower extremity within the first 48 hours, were randomly allocated to treatment or non-treatment groups. The treatment group received 500 ml of dextran 40 on admission and on days 1 and 2, and 250 ml on days 4 and 6. Venesection was performed on admission and if necessary on day 1. The control group received no dextran or venesection. DVT was diagnosed with the 125I-fibrinogen test during the first ten days. The incidence of DVT was 54% in the treatment group and 50% in the control group. There were no statistically significant differences between the groups regarding number of DVTs needing treatment, number of positive scanning points or number of days for scan to become positive. Lethal pulmonary emboli occurred in one treated and in three control patients, respectively. Age and progress of neurologic symptoms predisposed for the development of DVT. The high incidence of DVT in stroke patients indicates the need for prophylactic routines.

Aged↗

PubMed1987

Functional status changes following medical or surgical treatment for cerebral ischemia. Results of the extracranial-intracranial bypass study.

To determine the value of extracranial-intracranial arterial anastomosis (EC/IC bypass), we randomly allocated 1377 patients with symptomatic atherosclerosis of the internal carotid or middle cerebral arteries to medical care alone or to EC/IC bypass with continuing medical care. As previously reported, surgery did not reduce--or significantly increase--the risk of stroke. Functional status data collected during the trial provide new information. Six weeks following entry, surgical patients showed greater dysfunction in the following activities: fluency of speech, getting in and out of bed, sitting down and standing up, toileting, cutting food and pouring beverages, and dressing and undressing. At 4.5 months, surgical patients still exhibited greater dysfunction in toileting, with nonsignificant trends in several other activities. From six months onward, there were no significant differences between the groups. Thus, EC/IC bypass results in transient worsening of functional status beyond the immediate perioperative period.

Activities of Daily Living↗

PubMed1988

The effects of long term methyldopa in patients with hypoxic cor pulmonale.

Methyldopa (alpha-methyldopa) was given to patients with cor pulmonale secondary to chronic obstructive airways disease (COAD) to determine its effect on pulmonary haemodynamics. Twenty-five patients were randomly allocated to methyldopa (750 mg daily) or placebo. Pulmonary haemodynamics were measured twice, 12 months apart. Conventional therapies were continued unchanged. The effects of the drug on pulmonary haemodynamics were inconclusive when considered overall, but total pulmonary vascular resistance (TPVR) fell in all patients on active therapy in whom measurements were obtained both at rest and upon exercise. Only one patient in the placebo group achieved this. Over the trial period there was one death in the active but five in the placebo group. Survival was unrelated to abnormalities in pulmonary haemodynamics at the commencement of the trial in this study although the numbers of patients was small. Postural hypotension developed in patients receiving methyldopa and limited the dose that could be administered. The problems involved in long term trials of vasodilators in hypoxic cor pulmonale are discussed.

Aged↗

PubMed1986

Treatment of hypertension during pregnancy with hydralazine monotherapy or with combined therapy with hydralazine and pindolol.

Forty-four consecutive patients referred for treatment because of hypertension (greater than 150/90 mmHg) occurring during pregnancy were randomly allocated to one of two treatment groups, hydralazine alone (n = 21) or hydralazine combined with pindolol (n = 23). Satisfactory blood pressure control (diastolic pressure less than 90 mmHg) was achieved in 86% of patients receiving hydralazine alone and 91% of those on combined therapy. Although the treatment did not lower the overall incidence of hypertensive complications it appeared to delay the onset of such complications until successful surgical intervention was possible. Fetal outcome was similar in both groups and there was no perinatal mortality in this high-risk population. Although blood pressure control was similar in both groups of patients, combined therapy with hydralazine and pindolol can be considered to be superior to hydralazine monotherapy, since in patients treated with the combination the incidence and intensity of troublesome side-effects was markedly lower.

Adult↗

PubMed1981

Metoprolol and pindolol in hypertension: different effects on peripheral haemodynamics.

1. Thirty-six patients with essential hypertension, were randomly allocated to double-blind treatment with either metoprolol (100--200 mg/day) or pindolol (5--10 mg/day). The effects upon blood pressure and peripheral blood flow were determined. Both drugs reduced blood pressure significantly. 2. Heart rate was significantly reduced by metoprolol but not by pindolol. 3. Vascular resistance at maximal dilatation was not changed by either pindolol. 4. At rest, pindolol reduced vascular resistance in the calf by 14% (P less than 0.05) but metoprolol tended to increase the resistance slightly. The difference in effect was also significant (P less than 0.005). 5. During leg muscle work there were no changes in vascular resistance in the forearm with either compound. 6. We conclude that pindolol appears to reduce blood pressure at least partly through vascular mechanisms, in contrast to metoprolol. The response to sympathetic stimulation induced by physical exercise does not differ between metoprolol- and pindolol-treated patients.

Double-Blind Method↗

PubMed1981

Double-blind cross-over investigation of the effectiveness and safety of two doses of indoprofen compared with an ASA preparation and placebo in patients suffering from osteoarthritis.

Eighty patients suffering from osteoarthritis of the large joints were admitted to the study and randomly allocated to a 4-treatment sequence, according to a multiple replication of a 4 x 4 Latin square design, with proper balancing of treatments, of periods and of the residual effects of drugs. Each treatment (indoprofen 300 or 600 mg/day, ASA 1500 + diazepam 6 mg/day, and matching placebo) was administered for 7 days. Examinations were carried out on admission, after a 3-4 day wash-out period, and then repeated at the end of each treatment period. Treatment with active drugs was significantly better than placebo in relieving overall pain, and in patient's and investigator's opinion on effectiveness. Treatment with indoprofen, at both dosages, was preferred more frequently than others. The incidence of adverse events during each period did not seem to depend either on the treatment being given during that period or on the previous one.

Aged↗