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PubMed1988

Effect of UVB therapy and a coal tar bath on short contact dithranol treatment for psoriasis.

The effect of UVB therapy after short contact dithranol therapy (SCDT) was examined in 53 patients with psoriasis. After dithranol application, patients were randomly allocated to receive either a tar bath and UVB therapy (27 patients) or an emulsifying ointment bath only (26 patients). Forty eight patients completed the study; 16 of the 21 dithranol only patients cleared in a mean of 19.5 days compared with 20 of the 27 dithranol + UVB patients who cleared in a mean of 20.3 days. These differences were not significant. Similarly there was no significant difference in response between the dithranol only and dithranol UVB group as measured by the change in plaque thickness measured using Harpenden calipers, and the severity of psoriasis assessed by the extent of the rash, the degree of scaling, redness and induration. Thirteen of the 16 dithranol only patients who cleared relapsed in a mean of 10.6 weeks compared with 14 of the 20 dithranol UVB patients who relapsed after a mean of 18.9 weeks (P less than 0.05). Comparison of pre- and post-treatment full blood count, biochemical screen and urinalysis showed no evidence of systemic toxicity due to SCDT. This study shows that UVB therapy does not improve the clearance of psoriasis in SCDT, but does significantly postpone relapse.

Adolescent↗

PubMed1989

Superiority of sequential methotrexate, fluorouracil, and leucovorin to fluorouracil alone in advanced symptomatic colorectal carcinoma: a randomized trial.

A total of 249 patients with advanced, symptomatic colorectal cancer who received no previous cytostatic therapy were randomly allocated to receive either fluorouracil (5-FU), 600 mg/m2, for 2 days or the following regimen: sequential methotrexate, 250 mg/m2, during the first 2 hours and 5-FU, 500 mg/m2, at hours 3 and 23 followed by leucovorin rescue initiated at hour 24 (15 mg x 8) (MFL). Treatment was repeated every 14 days for eight courses and then continued every 3 to 4 weeks. Five patients were unevaluable. In these groups the objective response could be evaluated in 69% and 73%, respectively, of the patients who received at least four treatment courses, whereas other outcomes were assessed in all randomized patients. The sequential MFL treatment was more effective than 5-FU alone, as indicated by the former's clinically and statistically highly significant advantage regarding the objective (complete [CR] plus partial [PR]) response rates (24% v 3%; P less than .001), subjective response rate (45% v 23%; P less than .001), and survival (median, 8.5 v 6 months; P less than .02). If all patients were considered for objective response, the figures were lower, 17% v 2%, but the difference was still statistically significant (P less than .001). All responses had a minimum duration of 4 months. Overall, the toxicity was low and comparable between the groups, but stomatitis and conjunctivitis were more common after sequential treatment. Our data suggest that the experimentally observed synergistic cell kill between methotrexate and 5-FU has clinical relevance and that the sequential MFL regimen is a superior alternative to 5-FU alone in the treatment of patients with advanced symptomatic colorectal cancer.

Adult↗

PubMed1988

The effect of transdermal estradiol on hormone and metabolic dynamics over a six-week period.

Seventeen healthy postmenopausal women who had subjectively noted eight or more hot flashes per day and who objectively demonstrated four or more vasomotor flushes of 1.0C or more during eight hours of continuous thermography were studied. They were randomly allocated in a double-blind fashion to either 50 micrograms/day of transdermal estradiol (E2) patch or placebo. Application of the first patch was followed immediately by repeat eight-hour thermography, with hourly measurements of E2 and luteinizing hormone (LH). In the transdermal E2 group only, significant elevations of E2 (mean 91 pg/mL) were noted at two hours, and LH was suppressed after eight hours (P less than .05). There was no immediate effect on vasomotor flushes. Treatment was continued for six weeks, with daily subjective recording of hot flash frequency. Patients on transdermal E2 reported a significant (P less than .001) fall in hot flashes over four weeks, after which the rate stabilized. An initial decline in the placebo group was not statistically different from baseline. Eight-hour thermography was repeated after six weeks of treatment. Patients on transdermal E2 demonstrated an 85% decrease from baseline in vasomotor flushes (P less than .01). No effect on total cholesterol or its subfractions, renin substrate, or aldosterone was found. Serum E2 levels fell by 50% in 24 hours after patch removal. Endometrial histology and vaginal cytology showed an estrogen effect.

Administration, Cutaneous↗

PubMed1985

Day and full time psychiatric treatment: a controlled comparison.

Ninety-one patients admitted as emergencies, suffering from neurosis, personality disorder, or adjustment reaction, were randomly allocated to day hospital or to continued in-patient care. Follow-up was for up to one year. Clinical outcome was similar in the day care and in-patient groups, but patient satisfaction was significantly greater in day patients. Day hospital care was only about two-thirds of the cost of the cheaper of the two in-patient regimes, even though contact with it was on average twice as long as for in-patients.

Adjustment Disorders↗

PubMed1981

To strip or not to strip the long saphenous vein? A varicose veins trial.

A double blind controlled trial of surgery for varicose veins was conducted on the legs of patients with bilateral symmetrical varicose veins. The two treatments, saphenofemoral ligation and avulsion of varices, with and without stripping of the long saphenous vein from ankle to groin, were randomly allocated among the legs of individual patients. At follow-up, between 2.5 and 3.5 years, an objective (observer) assessment was that stripping conferred a significant advantage, but the incidence of paraesthesia and pain biased patient's opinion against stripping.

Adult↗

PubMed1988

A randomized trial on the effect of mannitol on postoperative renal function in patients with obstructive jaundice.

A randomized trial was undertaken to reassess the effectiveness of mannitol in preventing postoperative renal impairment in patients with obstructive jaundice. The study included 31 patients with obstructive jaundice (bilirubin, 3 mg/dl or higher) randomly allocated in two groups to receive (n = 17) or not receive (n = 14) preoperative mannitol. Sixty-five percent of patients had a creatinine clearance below 70 ml/min before surgery. Serum bilirubin and bacteribilia had no relation with preoperative renal function. No relation was found between serum bilirubin value and the percentage fall in postoperative creatinine clearance. Compared with the preoperative values, the postoperative creatinine clearance was significantly impaired in the mannitol group (p = 0.03) and remained almost unaltered in the no-mannitol group. Three patients (9.7%) died of acute renal failure; two were in the mannitol group and one was in the no-mannitol group. Serum fibrin degradation products were not sensitive markers for impending renal failure. There was no significant difference in postoperative serum sodium concentration or in the urinary sodium excretion. Administration of mannitol did not improve the postoperative renal function of jaundiced patients, nor did it prove beneficial in preventing renal failure. Our results suggest that severe disturbances of body-fluid compartments may be the basic mechanism underlying kidney dysfunction in obstructive jaundice and that further water depletion induced by mannitol may indeed prove detrimental.

Acute Kidney Injury↗

PubMed1989

Metabolic effects of continuous estradiol-progestin therapy in postmenopausal women.

Sixty postmenopausal women with climacteric complaints were randomly allocated to four treatment groups. Without interruption, each patient was given one tablet daily containing 2 mg 17 beta-estradiol along with either norethisterone acetate 1 mg and 0.5 mg or megestrol acetate 5 mg and 2.5 mg. Blood samples were obtained before treatment and then after 1, 4, and 12 months of treatment. Serum was analyzed for cholesterol and triglycerides in serum and for cholesterol in the ultracentrifugally separated lipoprotein fractions of very low-density lipoproteins, low-density lipoproteins, and high-density lipoproteins. Significant reductions of serum cholesterol were found in all treatment groups except for that given 2.5 mg megestrol acetate. After 1 and 4 months of treatment, low-density lipoprotein cholesterol decreased 7-22%, whereas high-density lipoprotein cholesterol was reduced by 2-16% in the four groups. No significant differences could be demonstrated among the groups in low-density lipoprotein cholesterol or high-density lipoprotein cholesterol during treatment, as assessed by analysis of variance. Thus, cholesterol metabolism was equally influenced by both progestin types. Accordingly, the clinical efficacy and acceptance would decide the preparation to be advocated for women in need of hormone replacement therapy.

Adult↗

PubMed1985

The effects of hospital admission for bed rest on the duration of twin pregnancy: a randomised trial.

212 women with twin pregnancies were randomly allocated either to receive advice to rest in hospital from 32 weeks' gestation until delivery, or to be part of a control group in which hospital admission was offered selectively (and, on average, 5 weeks later). Preterm delivery was more common among women admitted routinely for bed rest than among controls, and this difference was unlikely to have occurred by chance. There is at present no scientifically acceptable evidence that this common, disruptive, and expensive obstetric policy does more good than harm.

Adult↗

PubMed1983

Conditions for tracheal intubation using atracurium compared with pancuronium.

Intubating conditions were compared using atracurium 0.6 and 0.8 mg kg-1 and pancuronium 0.08 and 0.1 mg kg-1 in 96 patients. They were randomly allocated and studied at 30, 45, 60 or 75 s after injection of the drug. Smooth intubation was not possible before 60 s with either drug and in 11 patients intubation could not be achieved at the chosen time. Atracurium 0.6 mg kg-1 and pancuronium 0.08 mg kg-1 gave comparable results. Atracurium 0.8 mg kg-1 gave intubating conditions comparable to those obtained with pancuronium 0.1 mg kg-1 at 45 and 75 s and slightly better conditions at 30 and 60 s.

Adolescent↗

PubMed1981

Inhibitory effect of KWD 2131, terbutaline, and DSCG on the immediate and late allergen-induced bronchoconstriction.

Beta-adrenoceptor stimulants exhibit both bronchodilating and anti-allergic activities. KWD 2131 is a new beta-agonist with preferably anti allergic property. In an earlier study, nebulized KWD 2131 in a non-bronchodilating dose (0.25--0.50 mg) did not give significant protection against immediate reaction. The present study evaluated whether an increased nebulized dose of the new compound (5 mg) could protect against either immediate and/or late responses. The response was compared with a nebulized dose of terbutaline (5 mg) and with twice the recommended dose DSCG (40 mg). The study included 10 patients with known allergic asthma. It was designed as a single-blind cross-over trial with randomized allocation of the drugs. Lung functions were measured spirometrically and by body-plethysmograph; flow volume curves were drawn. KWD 2131 gave no significant protection against immediate reaction. Both terbutaline and DSCG did so, terbutaline being more efficient. Contrary to the beta-agonists, DSCG also gave protection against late response.

Adrenergic beta-Agonists↗

PubMed1981

Contact lens effects on ametropia: a current example of the clinical trial.

This paper describes the basic features of an ongoing double masked, randomized, controlled clinical trial which studies the changes in corneal and visual function that result when contact lenses are fitted in a manner designed to alter myopic refractive error. Subjects are randomly allocated to either a treatment or control group. Corneal and visual changes resulting from wearing lenses of these designs are compared to the effects of wearing contact lenses fitted in a standard clinical manner. Comparative analysis of the treatment and control groups is based on (1) visual acuity, (2) refractive error, (3) corneal thickness, (4) endothelial cell density, (5) external eye health, (6) corneal curvature, (7) duration of effect, and (8) predictive factors such as ocular rigidity and corneal topography. Essential parts of the experimental design and some results from the first phase of the study are reported.

Clinical Trials as Topic↗

PubMed1984

A comparison of sustained-release terbutaline with ordinary salbutamol in bronchial asthma.

The effects of a sustained-release preparation of terbutaline, depot tablets, 7.5 mg 2 times/day were compared with ordinary salbutamol tablets 4 mg 3 times/day. The study, performed for 2 weeks, one week on each treatment, was double-blind, double-dummy, crossover with randomized allocation of the drugs. Twenty-five patients with chronic bronchial asthma completed the trial. The morning Peak-Flow was higher during the period on the depot tablets compared to that on the ordinary tablets (p less than 0.05). No differences were found in side effects.

Adult↗

PubMed2003

Hemodynamic and bispectral index responses to tracheal intubation during isoflurane or sevoflurane anesthesia.

PURPOSE: The effects of volatile anesthetics on change in the bispectral index (BIS) due to tracheal intubation are unclear. We investigated hemodynamic and BIS responses to intubation during isoflurane or sevoflurane anesthesia. METHODS: After obtaining Institutional Review Board approval and informed consent, we randomly allocated 40 patients of American Society of Anesthesiologists (ASA) physical status I to receive either isoflurane (ISO group; n = 20) or sevoflurane (SEV group; n = 20). The patients were anesthetized with thiamylal and were ventilated with 100% oxygen, using a mask. The inspired concentrations of isoflurane and sevoflurane were gradually increased and maintained at end-tidal anesthetic concentrations of 2 minimum alveolar concentration (MAC) during the study period. Tracheal intubation was performed 15 min after the end-tidal anesthetic concentrations had reached 2 MAC. Mean arterial pressure (MAP), heart rate (HR), and BIS were recorded before induction, at the loss of consciousness, before laryngoscopy, and at 1, 3, and 5 min after intubation. RESULTS: Anesthesia with 2 MAC volatile anesthetics increased HR in the ISO group, and decreased MAP in the SEV group. The BIS value decreased from 95 +/- 3 and 96 +/- 2 before thiamylal to 39 +/- 9 and 38 +/- 10 before intubation in the ISO and SEV groups, respectively. MAP and HR were significantly increased in both groups 1 and 3 min after intubation, but BIS remained unchanged. CONCLUSION: Anesthesia with 2 MAC of isoflurane and sevoflurane was effective to suppress the change in BIS due to intubation but was not sufficient to prevent changes in hemodynamic responses.

Adult↗

PubMed1985

Concentration and composition of serum lipoproteins during a low-fat diet at two levels of polyunsaturated fat.

A 12-week dietary intervention was carried out among 40 families from North Karelia, a county in Finland with an exceptionally high rate of coronary heart disease and high serum cholesterol values. The proportion of dietary energy derived from fat was reduced during the 12-week intervention period from about 39% to 23% in all families. The families were randomly allocated into two groups. Twenty families consumed a diet with a polyunsaturated to saturated fat (P/S) ratio of 0.9 (group I), while the other 20 families had a diet with a P/S ratio of 0.4 (group II). Total serum cholesterol decreased by 16% and 9% in men of groups I and II, respectively, and by 16% in women of both groups. These changes were due to a decrease in both low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol. LDL cholesterol and phospholipid reached minimum values after 6 weeks on both intervention diets, but LDL protein responded more slowly. Thus, after 6 weeks LDL had an altered composition containing less cholesterol and phospholipids and more protein and triglycerides than during the baseline diet. During the intervention, the linoleic acid content in the serum cholesteryl ester fraction increased, and the magnitude of this change correlated negatively with the changes in total and LDL cholesterol. The decrease in HDL cholesterol during the two intervention diets was due to a fall in the HDL2 cholesterol (29% and 24% in men, and 26% and 25% in women in groups I and II, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1987

Controlled study of exclusion of dietary vasoactive amines in migraine.

To assess the effects of dietary vasoactive amines in the aetiology of childhood migraine, 39 children were randomly allocated to either a high fibre diet low in these substances or a high fibre diet alone. Both groups of children showed a significant decrease in the number of headaches and there was no significant difference between the two groups. Dietary vasoactive amines have not been shown in this study to influence childhood migraine. The improvement seen in both groups emphasises the need for a control diet in studies designed to show that dietary manipulation improves disease.

Adolescent↗

PubMed1981

Induction of labor with and without primary amniotomy. A randomized study of prostaglandin E2 tablets and intravenous oxytocin.

A comparative study of labor induction has been performed on 471 consecutive patients. Primary amniotomy was performed in 227 cases, and 103 of these patients were stimulated, 57 patients with PGE2 tablets and 46 with oxytocin. In the remaining 124 cases labor was induced within 4 hours without medical stimulation. Primary amniotomy was omitted in 244 cases, as the head was not engaged and the cervix was unripe. After random allocation to the treatment groups 125 patients received PGE2 tablets (ProstinR), and 119 patients received oxytocin intravenously. After 2 days of stimulation without primary amniotomy, delivery was induced in 83 per cent of the patients receiving PGE2 and in 84 per cent of the patients receiving oxytocin. All patients on whom primary amniotomy had been performed were delivered on the first day. There was no difference in the success rate between PGE2 and oxytocin treatments in patients with the same Bishop score. The performance of amniotomy at the beginning of induction led to a significantly lower total dose as well as a lower maximal dose of PGE2 and oxytocin. There was no difference in the duration of active labor in patients receiving PGE2 or oxytocin. There were no differences in the incidence of fetal distress and low Apgar scores between the different groups. No serious side effects occurred. Vomiting and diarrhea in 14 patients (8 per cent) receiving PGE2 was in contrast to 3 patients with these symptoms (2 per cent) in the oxytocin group. Oral administration of PGE2 is a convenient, effective and safe alternative to oxytocin for the induction of labor; however, PGE2 was not found superior to oxytocin in cases with a low Bishop score.

Adult↗

PubMed1988

Termination of second trimester pregnancy with laminaria and intramuscular 15-methyl PGF2 alpha or 16-phenoxy-omega-17,18,19,20-tetranor PGE2 methyl sulfonylamide. A randomized multicenter study.

The present study included 592 second trimester healthy informed patients admitted to the participating hospitals for termination of pregnancy. In each patient one medium size laminaria tent was introduced into the cervical canal. The laminaria was withdrawn 12 h later and the patients were randomly allocated to either intramuscular infections of 15-methyl-PGF2 alpha (Prostin 15M), 0.25 mg every second hour, or 16-phenoxy-omega-17,18,19,20-tetranor PGE2 methyl sulfonylamide (Nalodor), 0.5 mg every fourth hour. Both treatment schedules were equally effective. The success rate was 95.6% and 94.5% for the E and F analogs, respectively, within 24 h of prostaglandin treatment. The mean duration of prostaglandin treatment was for Nalodor 10.8 h and for Prostin 15M 11.3 h. The mean total dose given of the two analogs was 1.85 mg and 1.65 mg, respectively. With the E analog, the frequency of gastrointestinal side effects was significantly lower than with the F analog. With the former compound, 83.2% had no episodes of diarrhea and 58.9% no vomiting. The mean number of episodes of vomiting and diarrhea per patient was for the E analog 1.0 and 0.4, respectively. The corresponding figures for the F analog were 2.3 episodes of vomiting and 2.2 episodes of diarrhea per patient. Only in three patients (0.5%) cervical laceration was found. It may be concluded that intramuscular administration of either analog after pretreatment with laminaria would appear to be more effective than other methods presently in use for termination of second trimester pregnancy.(ABSTRACT TRUNCATED AT 250 WORDS)

Abortifacient Agents↗

PubMed1985

Is muscle lipoprotein lipase inactivated by ordinary amounts of dietary carbohydrates?

Lipoprotein metabolism was investigated in 12 patients, healthy except for renal stone disease, who received a high-protein experimental diet for 2 weeks under metabolic ward conditions. The results were compared with those after 2 weeks on a control diet of ordinary composition. The patients were randomly allocated to begin with the control or experimental diet. The energy contributions from protein, carbohydrate and fat were 12, 48 and 41 per cent in the control diet and 29, 31 and 41 per cent in the experimental diet, respectively. Fasting concentrations of very-low-density lipoprotein (VLDL) triglycerides and cholesterol were lower with the high-protein than with the control diet (0.69 vs 1.4 mmol/l, P less than 0.0001, and 0.33 vs 0.47 mmol/l P less than 0.01, respectively). High-density lipoprotein cholesterol tended to be higher (0.05 less than P less than 0.10) with the high-protein diet. Lipoprotein-lipase (LPL) activity in skeletal muscle and the fractional catabolic rate constant of an intravenous fat tolerance test were higher with the high-protein than with the control diet (38 vs 21 mU/l, P less than 0.01, and 5.1 vs 3.6 mU/l, P less than 0.001, respectively). Neither fasting blood glucose, intravenous glucose tolerance nor insulin concentrations differed between the two dietary periods. These findings indicate that an 'ordinary' intake of refined carbohydrates has an inhibitory effect on the muscle LPL activity, thereby increasing the VLDL level and slightly decreasing the level of high-density lipoproteins, which may be of relevance for the atherosclerotic process.

Adult↗