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PubMed1989

Leg blood flow during total hip replacement under spinal or general anaesthesia.

Calf blood flow was studied using venous occlusion impedance plethysmography during 122 total hip arthroplasties. Patients were randomly allocated to receive spinal or general anaesthesia. Blood flow was measured nine times perioperatively. In the non-surgical leg, mean blood flow rose by over 50% in both groups following anaesthetic induction, remaining significantly elevated with spinal but falling back gradually to baseline with general anaesthesia. In the surgical leg, surgical manipulations produced marked falls in flow in many patients, particularly with femoral component insertion. If this occurred, hyperaemia was commonly seen with spinal anaesthesia but rarely with general anaesthesia once the joint was relocated. Venous outflow resistance rose slightly during anaesthesia in both groups, more so with general anaesthesia. In the surgical leg, marked rises occurred with surgical manipulations, but resistance fell abruptly once the joint was relocated. No clear relationship between these observations and the occurrence of deep vein thrombosis postoperatively was established.

Anesthesia, General↗

PubMed1989

MOPP chemotherapy versus extended-field radiotherapy in the management of pathological stages I-IIA Hodgkin's disease.

In order to assess whether mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) chemotherapy (CT), which is less expensive and more easily available than radiotherapy (RT), is at least as effective as RT in terms of cure rate and has less iatrogenic damage, 89 consecutive patients with Hodgkin's disease (HD) (pathological stage I-IIA) were randomly allocated to receive mantle plus lumbar bar RT (36-45 Gy) or CT (six courses of MOPP). Forty-five patients were entered in the RT group and 44 in the CT group. The median follow-up was 60 months. Complete remission (CR) was obtained in all patients in the RT group and in 40 of 44 patients in the CT group. Overall survival (OS) and disease-free survival (DFS) were, respectively, 87.2% and 72.7% in the CT group and 93.5% and 74% in the RT group. Survival probability of relapsing patients was 76% for the patients in the RT group and 45% in the CT group. Treatment-related complications were more severe in the CT group as compared with the RT group.

Adolescent↗

PubMed1986

Initial antihypertensive therapy. Comparison of prazosin and hydrochlorothiazide.

Increasing awareness of the hazards of diuretic therapy has cast doubt on the appropriateness of its uniform use as initial treatment for hypertension. To establish the relative efficacy and acceptability of alternative forms of initial therapy, prazosin and hydrochlorothiazide were prospectively compared. In a one-year study, 62 patients with a diastolic blood pressure greater than or equal to 100 mm Hg were randomly allocated to receive one of the two agents. Twenty of 32 (63 percent) patients receiving prazosin and 17 of 30 (57 percent) receiving hydrochlorothiazide satisfied the year-long study requirements. For the most part, the dropout rate was not drug related. The percentages of subjects completing the study with the initial drug, without addition of a second drug, were identical in both groups (prazosin: 10 of 32 [31 percent] and hydrochlorothiazide: nine of 30 [30 percent]). In both treatment groups, blood pressure declined similarly and significantly (p less than 0.001) by the end of the study. The blood pressure of subjects receiving prazosin decreased from 150.3/105.8 mm Hg to 135.3/90.3 mm Hg, whereas the blood pressure of subjects receiving hydrochlorothiazide declined from 147.3/103.8 to 130.0/89.1 mm Hg. A reduction in diastolic blood pressure to less than 95 mm Hg was achieved in 80.0 percent of patients started with prazosin and in 78.6 percent of those started with hydrochlorothiazide. A further reduction to less than 90 mm Hg was achieved in 45.0 and 64.3 percent, respectively (not significant). Patients who completed the study with single-drug therapy in both treatment groups showed nonsignificant decreases in mean potassium levels from initial to final readings when compared with baseline readings (prazosin: 0.21 meq; hydrochlorothiazide: 0.41 meq). However, patients receiving prazosin had 11.5 percent of their readings less than or equal to 4.0 meq, whereas those receiving hydrochlorothiazide had 38.1 percent of their readings similarly distributed (p less than 0.05). Furthermore, four patients receiving hydrochlorothiazide had potassium levels less than or equal to 3.5 meq; none of those receiving prazosin had levels in that range. At baseline, no patient in the study had potassium levels of less than 4.0 meq. Prazosin-treated patients whose initial fasting blood glucose was less than 110 mg/dl had 3.7 percent (one of 27) of subsequent measurements greater than or equal to 110 mg/dl. These abnormal levels were found 18.2 percent (six of 33) (not significant) of the time in similar hydrochlorothiazide-treated subjects. Symptomatic side effects were primarily mild and transient in those receiving either drug alone.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗

PubMed1986

Otoscopic, impedance, and audiometric findings in glue ear treated by adenoidectomy and tonsillectomy. A prospective randomised study.

150 children aged between 2 and 9 years (mean 5.25 years) with chronic bilateral otitis media with effusion were randomly allocated to three groups who, in addition to unilateral myringotomy and grommet insertion, would have an adenotonsillectomy, an adenoidectomy, or neither. The contralateral ear was assessed. Otoscopic, impedance, and audiometric findings were recorded preoperatively and at six and twelve months postoperatively. Subtraction of the no-surgery results indicates that at twelve months adenoidectomy produces otoscopic resolution of OME in 41.7% and no-peak/peak conversion of impedance in 29.8%. The hearing gain from adenoidectomy alone was similar to that resulting from insertion of a grommet alone, but the children having adenoidectomy required fewer reinsertions to maintain adequate subjective hearing thresholds in the treated ear (26% versus 54%). Tonsillectomy conferred no additional benefit. Without treatment there was a small but significant improvement in all indices at twelve months but not at six months postoperatively.

Acoustic Impedance Tests↗

PubMed1987

Prehospital administration of anisoylated plasminogen streptokinase activator complex in acute myocardial infarction.

25 patients have been included in a randomised trial aimed to compare prehospital and hospital administration of anisoylated plasminogen streptokinase activator complex (AP-SAC). Patients were first seen, at home, by a noncardiologist doctor working in a mobile-care unit and were then evaluated for entry into the study. If they had evidence of myocardial infarction lasting for less than 3 hours and if there was no contraindication to thrombolytic therapy they were randomly allocated to APSAC 30U or placebo. They were next referred to an intensive coronary unit (ICU). On arrival in the ICU patients were reevaluated and received APSAC if they had previously received placebo. For 24 patients, diagnosis of myocardial infarction was confirmed. One patient died at home after having received placebo. There was 1 hospital death. At-home injection was made within a median of 124 minutes after the beginning of pain, whereas hospital administration was made after a median of 180 minutes. On a clinical basis reperfusion occurred in 16 out of 21 evaluable patients. Four patients had coronary artery bypass graft surgery and 9 had angioplasty. We conclude that prehospital administration of APSAC is feasible, well-tolerated and is a good way to shorten the delay of thrombolytic treatment in myocardial infarction.

Adult↗

PubMed1987

Hearing aids and tinnitus--an experimental group study.

From a waiting list consisting of hearing-impaired patients waiting for hearing aids to be fitted, 39 subjects who at interview also stated that they had tinnitus took part in an experimental group study with the aim of investigating the effect of a hearing aid on tinnitus. No subject had any previous experience of hearing aids. The subjects were randomly allocated to a treatment and a waiting list control group. After an initial interview, the routine programme for the fitting of hearing aids started in the treatment group, while the waiting list control group had to wait for 6 weeks before starting the same hearing aid rehabilitation programme. The hearing aids were fitted exclusively for hearing purposes. As expected, the hearing aids improved the hearing capacity, but they did not reduce tinnitus as recorded on a visual analogue scale. According to information obtained at the final interview, there were significant differences in tinnitus between subjects who used their aid for more than 2 hours daily and those who used it for less than 2 hours. However, the results of scaling (pre- and post-fitting) did not support this finding. The discrepancy between the scaling and interview data is probably due to demand characteristics.

Aged↗

PubMed1982

Use of glycerol in peripheral parenteral nutrition.

Peripheral parenteral nutrition avoids the use of central lines and is a useful means of nutritional support for selected patients. Amino acids alone have been used for peripheral parenteral nutrition and have been shown to give near nitrogen equilibrium. The addition of small amounts of dextrose to amino acids further improves nitrogen balance, but at the expense of making the solutions unsterilizable and unstable by standard techniques. Glycerol is a nonprotein calorie source that can be autoclaved with amino acids and stored. Fasting patients about to undergo major abdominal surgery were randomly allocated to receive 3% amino acids with or without 3% glycerol. The solution was infused by peripheral vein for 5 days, starting the morning following surgery. Routine monitoring, blood tests, and nitrogen balance tests were performed during this time. No adverse reactions to either solution were encountered. Liver function tests, electrolytes, and hematologic values were similar in both groups. The cumulative nitrogen balance was better in the amino acid plus glycerol group (+5 +/- 3.3 gm) than in the amino acid group (-9.7 +/- 3 gm) (P less than 0.02). Serum insulin levels were higher and serum free fatty acids lower in the amino acid plus glycerol group. Glycerol levels rose and plateaued by the third day in the amino acid plus glycerol patients. Amino acids plus glycerol is safe solution to administer by peripheral vein. The addition of glycerol improves nitrogen balance as compared to amino acids alone.

Amino Acids↗

PubMed1982

Propranolol does not inhibit sulphonylurea-stimulated insulin secretion in patients with non-insulin dependent diabetes mellitus.

In a double-blind cross-over trial we compared the effects of placebo and propranolol on iv tolbutamide and oral glipizide-stimulated insulin secretion in 10 non-insulin dependent diabetics. The patients were randomly allocated for 2 weeks treatment with placebo and propranolol 80 mg twice daily. At the end of each period an iv tolbutamide test and an oral glipizide-glucose-test were performed. Tolbutamide-stimulated insulin secretion was not affected by propranolol. There was no change in blood glucose levels during the iv tolbutamide test (IVTT), which excluded an effect of blood glucose on insulin secretion. During the oral glipizide-glucose challenge propranolol decreased blood glucose at 60 min (P less than 0.01) and increased C-peptide at 0 min (P less than 0.01) and 30 min (P less than 0.05) compared with placebo. In contrast to earlier results obtained in animals and healthy subjects propranolol does not inhibit insulin- or C-peptide responses to sulphonylurea in patients with non-insulin dependent diabetes mellitus.

Aged↗

PubMed1988

Measurement of spinal or peripheral bone mass to estimate early postmenopausal bone loss?

This report presents data from 153 healthy, early postmenopausal women who were randomly allocated to two years of treatment with estrogen or placebo. Bone mineral content in the forearms was measured by single-photon absorptiometry, and bone mineral density of the lumbar spine and total-body bone mineral by dual-photon absorptiometry, before and after one and two years of treatment. At the end of the two years, there were highly significant differences of 6 to 7 percent between the estrogen and the placebo groups at all sites measured. The range of the changes of the spine measurement was twice that of the forearm and total-body measurements. It is concluded that measurement of the forearm by single-photon absorptiometry is superior to measurement of the spine by dual-photon absorptiometry both in clinical studies and in the individual patient for detecting estrogen-dependent bone loss and its treatment by estrogen replacement.

Double-Blind Method↗

PubMed1983

The Bacon Chow study: maternal supplementation and infant growth.

The effect of maternal supplementation during both gestation and lactation on infant growth from birth to 12 mth was investigated in the double-blind, randomly allocated control trial conducted in Taiwan by the late Bacon F. Chow. The supplement was a milk-based formula providing 800 kcal and 40 g protein daily. The placebo provided less than 40 kcal per diem but resembled the supplement in appearance. Supplementation was limited to mothers and began after birth of one infant and continued without interruption until weaning of a second infant. Supplement effects were tested by comparing both supplement and placebo groups and first- and second-infant groups with respect to weight, length and head circumference. Both comparisons of growth curves and analyses of variance were carried out. Both strategies agreed in failing to detect differences in growth between supplement and placebo groups. However, differences were found between first and second infants in the supplement group.

Adult↗

PubMed1982

A comparison of phenytoin and valproate in previously untreated adult epileptic patients.

Eighty-eight patients with the onset of epilepsy in adult life were randomly allocated to treatment with sodium valproate (600 mg/day), or phenytoin (300 mg/day), and followed up for at least 12 months. Both drugs were highly effective in the control of tonic-clonic seizures, irrespective of whether they were accompanied by focal features, but were markedly less effective in the control of partial seizures. Two patients exhibited acute allergic reactions to phenytoin. No significant differences have yet emerged in the efficacy of the two drugs, and valproate may be considered as a "fist-line" anticonvulsant in the treatment of adult onset epilepsy.

Adolescent↗

PubMed1989

The Tromsø Heart Study: family approach to intervention on CHD. Feasibility of risk factor reduction in high-risk persons--project description.

Intervention on high risk persons for CHD has shown varying results depending on the effectiveness of the intervention. Most studies have concentrated on the high-risk person only. The present study focuses on the high-risk family as an entity. 1,373 high-risk men, 30-55 years, were identified on the basis of high total cholesterol and/or low relative HDL (HDL-cholesterol/tot. cholesterol) in the Tromsø II screening in 1979/80, and randomly allocated to intervention or control group. The 673 men in the intervention group and their families, were offered advice to reduce their risk during two home visits and later by quarterly newsletters. Follow-up blood samples drawn 1.5 years following the home-visit, show a small reduction in total cholesterol and an increase in the ratio of HDL cholesterol/total cholesterol. Both the intervention and control group were invited to the examination in connection with the Tromsø III screening in 1986/87 and are being followed for 10 years on cardiovascular morbidity and mortality.

Adult↗

PubMed1986

A single night time dose of ranitidine in the acute treatment of gastric ulcer: a European multicentre trial.

Four hundred and twenty eight patients with endoscopically diagnosed gastric ulcers, randomly allocated to treatment with ranitidine 300 mg at night or ranitidine 150 mg twice daily, were evaluated in a double blind multicentre trial conducted in 10 European countries. After four weeks, complete ulcer healing was observed in 138 of 211 patients (65%) treated with ranitidine 300 mg nocte and in 155 of 217 patients (71%) receiving 150 mg bd. Cumulative healing rates at eight weeks were 90% and 93%, respectively. There was no statistically significant difference between the healing rates at either four or eight weeks. The treatment regimens were equally effective at rapidly reducing the incidence of ulcer related symptoms. Adverse events reported were minor and equally distributed between the two groups. The results of this trial show that 300 mg of ranitidine administered at night is an effective and safe alternative to the current twice daily regimen for the short term treatment of gastric ulcer.

Administration, Oral↗

PubMed1987

Oxytocin titration to achieve preset active contraction area values does not improve the outcome of induced labour.

The value of controlling oxytocin titration in induction of labour by a present uterine activity, assessed as active contraction area, was examined in a randomized study in 60 nulliparae and 54 multiparae. Each parity group was divided into two groups according to the cervical score (less than or equal to 5 and greater than 5) and within those four groups the women were randomly allocated to oxytocin titration against a present frequency of 6-7 uterine contractions every 15 min, or to a preset uterine activity equivalent to the 75th centile for spontaneous labour. The length of labour was slightly, but not significantly, longer in the frequency group. The mode of delivery, Apgar scores at 1 and 5 min and cord artery blood pH values were similar with the two modes of oxytocin titration. The mean maximum dose rate of oxytocin infusion was not significantly different except in the nulliparous group with a poor cervical score. The given mean total dose of oxytocin was similar in the different groups when controlled for parity and cervical score. The results suggest that oxytocin titration to achieve uterine activity values equivalent to the 75th centile of those observed in spontaneous labour does not confer any advantage compared with the traditional practice of titrating the oxytocin infusion to achieve a preset frequency of uterine contractions.

Apgar Score↗

PubMed1985

Near-UV radiation from the operating microscope and pseudophakic cystoid macular edema.

We performed a prospective randomized study of 297 patients to determine the effect of a UV-blocking filter on the operating microscope on the angiographic incidence of cystoid macular edema in patients undergoing extracapsular surgery with implantation of a posterior chamber lens. Patients were randomly allocated preoperatively to two groups undergoing surgery with or without a UV filter in place. Of the 297 patients, 205 had angiograms readable for the presence or absence of cystoid macular edema. The incidence of aphakic cystoid macular edema in patients without the filter was 21% v 17.3% in the group with a filter. This difference was not significant. The presence of a UV-blocking filter on the operating microscope makes no difference in the angiographic incidence of cystoid macular edema or the visual outcome in these cases.

Cataract Extraction↗

PubMed1982

National Heart, Lung, and Blood Institute type II Coronary Intervention Study: design, methods, and baseline characteristics.

The Type II Coronary Intervention Study (Type II Study) is a double-blind, randomized, placebo-controlled clinical trial conducted by the Division of Intramural Research of the National Heart, Lung, and Blood Institute of Bethesda, Maryland. The study was designed to evaluate the 5-year treatment effect of cholestyramine on low density lipoprotein (LDL) cholesterol and on lesions in the coronary arteries. One hundred forty-three patients with Type II hyperlipoproteinemia (elevated LDL cholesterol) and coronary artery disease (CAD) were entered into the study between 1972 and 1976. Patients were stratified by sex and extent of coronary disease as defined angiographically and were randomly allocated to a daily dosage of 24 g cholestyramine and diet (treatment group) or placebo and diet (control group). Changes in the coronary arteries were evaluated by sequential coronary angiography carried out before and after five years of treatment. This report describes the trial design and baseline characteristics of the study patients.

Adult↗

PubMed1987

Adjuvant Bestatin immunotherapy in patients with transitional cell carcinoma of the bladder. Clinical results of a randomized trial.

The first clinical results of an ongoing, prospective trial to determine the value of adjuvant Bestatin immunotherapy in the management of bladder cancer are presented. Patients with nonmetastatic transitional cell carcinoma of the bladder, scheduled for full dose local radiation therapy (64 Gy), were randomly allocated to adjuvant oral Bestatin treatment (30 mg daily for at least 1 year), starting at completion of irradiation, or no Bestatin. The longest follow-up period of the 151 evaluable patients is 6 years. The results have shown that the disease-free survival of the patients taking Bestatin is significantly improved compared to the controls (p = 0.04). However, the overall survival of the patients was not affected by the Bestatin treatment. The beneficial effect of Bestatin seemed to be more marked among men than women. Furthermore, statistical analyses of the patient material according to T tumor categories suggested that compared to the controls, patients with less advanced disease (T1 and T2) benefitted more from Bestatin treatment than those with more advanced tumors (T3 and T4). The results of this ongoing trial thus show that patients with bladder cancer benefit from adjuvant Bestatin treatment in terms of disease-free survival.

Adjuvants, Immunologic↗

PubMed1999

The Misgav Ladach method for cesarean section compared to the Pfannenstiel method.

OBJECTIVE: The aim of the study was to evaluate the outcome of two different methods of cesarean section (CS). DESIGN: The study was designed as a prospective, randomized, controlled trial. SETTING: All CS were performed at the University Hospital in Uppsala, Sweden. POPULATION: Fifty women admitted to hospital for a first elective CS were consecutively included in the study. They were randomly allocated to two groups. METHODS: One group was operated on by the Misgav Ladach method for CS and the other group by the Pfannenstiel method. All operations were performed by the same surgeon. MAIN OUTCOME MEASURES: Duration of operation, amount of bleeding, analgesics required, scar appearance and length of hospitalization. RESULTS: Operating time was significantly different between the two methods, with an average of 12.5 minutes with the Misgav Ladach method and 26 minutes with the Pfannenstiel method (p<0.001). The amount of blood loss differed significantly, with 448 ml and 608 ml respectively (p=0.017). Significantly less analgesic injections and tablets (p=0.004) were needed after the Misgav Ladach method. CONCLUSION: The Misgav Ladach method of CS has advantages over the Pfannenstiel method by being significantly quicker to perform, with a reduced amount of bleeding and diminished postoperative pain. The women were satisfied with the appearance of their scars. In this study no negative effects of the new operation technique were discovered.

Adult↗