Effect of carbon monoxide on exercise performance in chronic obstructive pulmonary disease . We evaluated the effect of breathing 100 ppm of carbon monoxide versus compressed , purified air for 1 hour on exercise performance in 10 patients with chronic obstructive pulmonary disease in a double-blind , randomized , crossover study . The mean arterial carboxyhemoglobin was 1.48 per cent in the carbon monoxide control period and increased from 1.43 to 4.08 per cent after breathing carbon monoxide ( P less than 0.001 ) . The mean arterial carboxyhemoglobin level was 1.52 percent in the air control period and decreased from 1.47 to 1.34 per cent after purified air ( P less than 0.001 ) . The mean exercise time until marked dyspnea decreased from 218.5 seconds in the carbon monoxide control period to 146.6 seconds after breathing carbon monoxide ( P less than 0.001 ) . The mean exercise time was 219.9 seconds in the air control period and 221.3 seconds after purified air ( P not significant ) . Breathing 100 ppm of carbon monoxide for 1 hour caused a significant reduction in exercise performance in patients with chronic obstructive pulmonary disease .

carbon monoxide

breathing 100 ppm of carbon monoxide

compressed , purified air

carbon monoxide

exercise performance

mean arterial carboxyhemoglobin

mean arterial carboxyhemoglobin level

mean exercise time until marked dyspnea

chronic obstructive pulmonary disease

chronic obstructive pulmonary disease

chronic obstructive pulmonary disease


A double blind trial of terfenadine and placebo in hay fever using a substitution technique for non-responders . A double-blind study of terfenadine and placebo in 110 patients suffering from hay fever ( confirmed by skin tests ) was conducted . A novel technique was applied using an escape envelope containing a reference drug which could be taken under controlled conditions if , after 48 hours , the patient experienced no relief . Significantly more patients on placebo opened the envelope than patients taking the active drug . Terfenadine was demonstrated to be an effective drug in hay fever and produced no more drowsiness than placebo .

terfenadine

placebo

terfenadine

placebo

placebo

Terfenadine

relief

opened the envelope

effective drug

drowsiness

hay fever


Double-blind comparison of ketazolam , diazepam and placebo in once-a-day vs t.i.d . dosing . Comparison of ketazolam given once-a-day with diazepam given three times a day and placebo given either once or 3 times a day in 101 anxious outpatients showed ketazolam to be significantly better than placebo in alleviating the symptoms of anxiety and , on several measures of efficacy , better than diazepam as well . Significantly fewer patients on ketazolam dropped out of the study due to ineffective medication than on the other 3 treatments . The incidence of side effects was lowest in the ketazolam group . Of particular note , drowsiness was reported twice as often by diazepam patients as by ketazolam patients .

ketazolam

diazepam

placebo

ketazolam

diazepam

placebo

ketazolam

diazepam

ketazolam

incidence of side effects was lowest

drowsiness

anxious outpatients


A comparative trial of fixed ratio beta-adrenoceptor blocker and diuretic combination products in moderate hypertension . Two fixed ratio combination tablets , 10 mg pindolol combined with 5 mg clopamide and 100 mg metoprolol combined with 12.5 mg hydrochlorothiazide , were compared at two dose levels in a double-blind crossover trial in 10 previously untreated hypertensive patients . No significant difference was observed between resting blood pressure on the two combinations at either dose level . Exercise systolic pressure was lower after the pindolol/clopamide combination at low dose ( p less than 0.05 ) . The incidence of side-effects in this trial was high but proper comparison of the two products could not be made because of the small number of patients . It is suggested that combination products should be used only after patients have failed to respond adequately to a single agent .

beta-adrenoceptor blocker

diuretic combination products

pindolol combined with 5 mg clopamide

pindolol/clopamide

resting blood pressure

Exercise systolic pressure

incidence of side-effects

moderate hypertension


Schizophrenia . A follow-up study of the results of five forms of treatment . Two hundred twenty-eight first-admission schizophrenic patients were randomly assigned to the following five treatments : psychotherapy alone , drug alone , psychotherapy plus drug , electroconvulsive therapy ( ECT , and milieu . A there- to five-year follow-up examined their course after release from the hospital . The drug alone and ECT groups tended to have the best outcome and the psychotherapy alone group the worst . The positive effect from prior drug treatment began to dissipate after three years postadmission . For the in-hospital treatment successes , the advantage from drug treatment and the disadvantage from psychotherapy were less apparent . Overall , the follow-up outcome is far from reassuring , whatever the type of treatment . Even though a few patients may do well , much remains to be done in and out of the hospital .

psychotherapy alone

drug alone

psychotherapy plus drug

outcome

positive effect

advantage

disadvantage


A double-blind comparison of bromperidol and haloperidol in newly admitted schizophrenic patients .

bromperidol

haloperidol


Acute intervention studies in patients with myocardial infarction using atenolol , propranolol , oxprenolol and disopyramide phosphate . The value of beta-blockade and of disopyramide phosphate in the immediate treatment of patients with suspected acute myocardial infarction was assessed in two placebo controlled trials . In the first study 388 patients with suspected acute myocardial infarction were randomly allocated to treatment with propranolol , atenolol , or placebo , and when analysed on an initial intention to treat basis there was no significant difference between the three groups in respect of the mortality at one year . In addition , there was no evidence to suggest that either atenolol , or propranolol reduced the incidence of 'serious ' ventricular arrhythmias in the coronary care unit . In the second study 473 patients with suspected acute myocardial infarction were randomly allocated to treatment with oxprenolol , disopyramide phosphate , or placebo . Again no significant differences were seen with respect to the mortality at six weeks . There was , however , a significantly increased incidence of heart failure in the group which received disopyramide phosphate . Patients who received this drug also showed a reduced number of dysrhythmic episodes on 24-hour ECG recordings , but this trend did not achieve statistical significance . These results suggest that none of the three beta-blockers tested nor disopyramide phosphate is likely to reduce the mortality from acute myocardial infarction when given prophylactically , although disopyramide phosphate does reduce the incidence of 'serious ' ventriicular arrhythmias .

atenolol

propranolol

oxprenolol

disopyramide phosphate

beta-blockade

disopyramide phosphate

propranolol , atenolol

placebo

atenolol

propranolol

oxprenolol , disopyramide phosphate

placebo

disopyramide phosphate

three beta-blockers

disopyramide phosphate

disopyramide phosphate

mortality

of 'serious ' ventricular arrhythmias

no significant differences

mortality

incidence of heart failure

myocardial infarction

acute myocardial infarction

388 patients

473 patients

acute myocardial infarction


Comparison of the antihypertensive effect of metipranolol , butizide and torrat in Kenyan Africans .

metipranolol

butizide

torrat

antihypertensive effect

Kenyan Africans .


An assessment of beta-adrenoceptor blockade in man by prizidilol hydrochloride . 1 Prizidilol hydrochloride ( SK & F 92657 ) is a new compound which causes both arteriolar dilatation and beta-adrenoceptor blockade . The effect of a single oral dose on the responses of heart rate and blood pressure to isoprenaline infusion has been studied in healthy volunteers . 2 Isoprenaline heart rate dose-response curves showed parallel shifts to the right after oral prizidilol , indicating antagonism by this compound at beta-adrenoceptors in the heart . 3 Isoprenaline dose-response curves for decreases in diastolic blood pressure also showed shifts to the right after oral prizidilol , providing evidence of beta-adrenoceptor antagonism by this drug in peripheral resistance vessels . 4 The peak effect of a 40 mg dose of propranolol was greater than that of a 200 mg dose of prizidilol but both drugs caused persistent beta-adrenoceptor blockade for at least 7 h after ingestion .

prizidilol hydrochloride .

Prizidilol hydrochloride

Isoprenaline

prizidilol

prizidilol

propranolol

prizidilol

beta-adrenoceptor blockade .

heart rate dose-response curves

diastolic blood pressure

beta-adrenoceptor blockade

healthy volunteers


Clobazam in catamenial epilepsy . A model for evaluating anticonvulsants . The cyclical exacerbations of epilepsy ( catamenial epilepsy ) were used to assess the antiepileptic effect of a benzodiazepine , clobazam . Doses of 20 mg , and in some cases 30 mg , per day were compared with placebo over predetermined ten-day periods in a double-blind cross-over study . The results were evaluated by preference in a sequential procedure . In 14 of 18 patients who received both treatments clobazam was superior to placebo , and in 4 patients no preference was established . Clobazam completely prevented seizures in most of the patients , and toxic effects were of low frequency and severity .

Clobazam

benzodiazepine , clobazam .

placebo

clobazam

placebo

Clobazam

seizures

frequency and severity

catamenial epilepsy


Neuroleptics and depression .

Neuroleptics

depression .

Neuroleptics and depression .


The influence of beta-adrenoceptor blockade on left ventricular function . 1 This study was designed to compare in a randomized cross-over trial pindolol , a beta-adrenoceptor blocking agent with intrinsic sympathomimetic activity and metoprolol , a cardioselective beta-adrenoceptor blocker lacking sympathomimetic activity in hypertensives with incipient heart failure . Cardiac function was investigated by M-Mode and 2D-echo-cardiography . 2 Both pindolol and metoprolol in equipotent doses lowered blood pressure to the same extent . 3 There was no difference in overall left ventricular function in ventricular geometry or in wall dynamics after either drug . 4 In comparison to metoprolol , pindolol produced less reduction in resting heart rate , cardiac index and ejection velocity reflecting the intrinsic sympathomimetic activity of the drug .

beta-adrenoceptor

pindolol

beta-adrenoceptor blocking agent

metoprolol

pindolol

metoprolol

metoprolol

pindolol

Cardiac function

M-Mode and 2D-echo-cardiography

blood pressure

incipient heart failure


The effect of Naftidrofuryl on ethanol-induced liver damage in chronic alcoholic patients . A prospective double-blind placebo-controlled trial of intramuscular Naftidrofuryl was carried out on 32 randomly selected hospitalized male alcoholic patients with clinical , biochemical and histological evidence of hepatic damage . Seventeen patients received the drug ( 40 mg in 5 ml i.m . three times daily for 6 days ) and 15 patients received a placebo ( 5 ml in normal saline i.m . three times daily for 6 days ) . The drug was well tolerated and there were no adverse side-effects . Naftidrofuryl significantly improved the physiological function of the liver cells as reflected by indocyanine green ( ICG ) clearance by the liver ( t = 2.61 ; p less than or equal to 0.02 ) and also caused a larger fall in raised serum levels of gamma glutamyl transpeptidase ( GGT ) than did the placebo injections . Overall clinical improvement ( e.g . appetite , body weight , reduced liver size , general sense of well-being ) was more clearly evident in patients of the treated group than in those of the placebo group . Naftidrofuryl , therefore , appears to be of benefit in ethanol-induced liver damage and more extensive long-term trials are suggested in patients with alcoholic liver disease ( ALD ) .

Naftidrofuryl

placebo-controlled

Naftidrofuryl

placebo

Naftidrofuryl

adverse side-effects .

clinical improvement ( e.g . appetite

body weight

reduced liver size

general sense of well-being

chronic alcoholic

male

alcoholic

hepatic damage

ethanol-induced liver damage

alcoholic liver disease ( ALD )


Ceftriaxone versus ampicillin and chloramphenicol for treatment of bacterial meningitis in children . 78 patients with bacterial meningitis were evaluated in a prospective , randomised study comparing twice-daily ceftriaxone as single-drug therapy with ampicillin and chloramphenicol given every 6 h. The groups were comparable in age , sex , days of illness before admission , and bacterial colony counts in cerebrospinal fluid ( CSF ) . The pathogens were Haemophilus influenzae type b ( 54 cases ) , streptococci ( 9 cases ) , meningococci ( 9 cases ) , and unknown ( 6 cases ) . In 40 CSF specimens obtained 4-12 h after initiation of therapy , cultures were negative in 57 % of the ceftriaxone patients and in 42 % of the others . The mean falls in the CSF bacterial colony counts were 4.7 and 5.0 log10 colony-forming units/ml , respectively . Mean bactericidal activity in CSF was significantly greater in the ceftriaxone than in the conventional treatment group at the beginning and end of therapy . There were no significant differences in clinical responses or in frequency of complications , except for mild diarrhoea , which occurred in 16 ceftriaxone patients and in 8 in the other group ( p less than 0.05 ) .

Ceftriaxone

ampicillin and chloramphenicol

ceftriaxone

ampicillin and chloramphenicol

ceftriaxone

ceftriaxone

bacterial meningitis

cultures were negative

Mean bactericidal activity in CSF

clinical responses

frequency of complications

mild diarrhoea


Gradual withdrawal of diazepam after long-term therapy . 41 outpatients who were long-term consumers of diazepam in therapeutic dosage were gradually withdrawn from the drug over 3 months by stepwise reduction . In a double-blind procedure half the patients began withdrawal immediately and half after 8 weeks . Of 36 patients who completed treatment , 16 ( 44.4 % ) experienced true withdrawal phenomena on reducing their drugs , but 8 other patients had pseudo-withdrawal reactions at a time when their drug treatment was unchanged . The pseudo-withdrawal reactions consisted of an increase in anxiety symptoms only , whereas true withdrawal symptoms also included perceptual changes and psychotic symptoms . Examination of pharmacological and clinical predictors of withdrawal phenomena and later relapse showed that personality factors were the most important , patients with passive-dependent traits having a significantly greater prevalence of withdrawal reactions .

diazepam

diazepam

true withdrawal phenomena

pseudo-withdrawal reactions

pseudo-withdrawal reactions

anxiety symptoms

true withdrawal symptoms

perceptual changes

and

psychotic symptoms

relapse

withdrawal reactions .

drug


Effect of beta-blocking drugs on beta-cell function and insulin sensitivity in hypertensive non-diabetic patients . The effects of two beta-blocking drugs on endogenous insulin secretion and insulin sensitivity were investigated in a double-blind cross-over study in 13 hypertensive patients . The patients were randomly allocated to each of three 2-week treatment periods with propranolol 80 mg b.i.d. , atenolol 50 mg b.i.d . and placebo b.i.d . Endogenous insulin secretion was assessed by measuring serum insulin and C-peptide before and 6 min after iv administration of glucagon ; insulin sensitivity was determined by measuring insulin binding to erythrocytes , and as the glucose disappearance rate ( KITT ) after i.v . insulin . Fasting concentrations of serum free fatty acids ( S-FFA ) and plasma gastric inhibitory polypeptide ( P-GIP ) were also recorded during the three study periods . Both propranolol and atenolol reduced blood pressure , heart rate and S-FFA concentrations compared to placebo , and all patients showed measurable plasma concentrations of propranolol and atenolol . The results can be considered representative , therefore , of clinical beta-blockade . The two drugs did not significantly influence the fasting blood glucose level . There was an increase in fasting and glucagon-stimulated serum C-peptide concentration during propranolol therapy compared with placebo ( p = 0.037 and p = 0.030 , respectively ) , although this was not reflected by a significant change in serum insulin . Propranolol and atenolol did not significantly influence insulin binding to erythrocytes , but they clearly reduced the glucose disappearance rate KITT was compared to placebo ( p = 0.0036 and p = 0.0003 ) , respectively ) . The findings support the view that beta-blocking drugs can influence glucose metabolism by mechanisms other than inhibition of endogenous insulin secretion .

propranolol 80 mg b.i.d.

atenolol 50 mg b.i.d .

and placebo b.i.d .

propranolol

atenolol

placebo

Propranolol

clinical beta-blockade

fasting blood glucose level .

serum insulin

insulin binding to erythrocytes

glucose disappearance rate KITT

glucose metabolism

endogenous insulin secretion .

hypertensive non-diabetic patients .

13 hypertensive patients .


Comparison between the central effects of camazepam and temazepam . Computerized analysis of sleep recordings . The effects of acute administration per os of 30 mg camazepam and the same dose of temazepam , were compared with placebo in 8 young male volunteers , fully adapted to the laboratory environment by 6 nights of adaptation . The study was double-blind , in a random order , 10 days separating each session . Spectral analysis was performed on the all-night records ( 1-min epochs ) , and the relative power of six frequency bands calculated . Concerning sleep parameters , temazepam induces a statistically significant reduction of : phase shifts ; number of awakenings ; percent duration of sleep stages I and IV . A significant increase of the percent duration of stage II and sleep efficiency was also found . Camazepam shows modification , with the same trend , but not reaching statistical significance . Concerning spectral analysis , temazepam induces a light increase of the relative power of the slowest frequencies , paralleled by an increase of the fast bands , while major effects are found on the characteristic periodicity of delta activities , which appear disrupted by the drug . These effects are not evident with camazepam , which does not seem to distort the normal sleep pattern .

camazepam and temazepam

camazepam

temazepam

placebo

temazepam

Camazepam

temazepam

camazepam

sleep parameters

percent duration of stage II

sleep efficiency

Camazepam shows modification

temazepam


Thyroid stimulating antibodies : an aid to the strategy of treatment of Graves ' disease ? In 1976 we initiated a prospective study to specify the usefulness of thyroid stimulating antibody ( TSAb ) determinations in predicting the outcome of post-antithyroid drug treatment for Graves ' disease . This study was carried out on 55 patients , who were either treated for six ( n = 16 ) or 18 months ( n = 39 ) and followed up for an additional two-year period . TSAb was determined on whole serum in 29 patients before and at the end of treatment , and in 26 patients at the end of treatment only . These determinations were carried out using a sensitive and reproducible microassay based on cAMP accumulation in human thyroid cell cultures . Before treatment , TSAb ranging from 170 to 1529 % was present in 28/29 patients and reached significantly low levels at the end of treatment whatever its duration . TSAb was undetectable in 24/55 patients at the end of treatment . 8/16 'short-treated ' and 18/39 'long-treated ' patients remained in remission . As expected , initial TSAb levels had no predictive value . End-treatment TSAb values , when low ( less than 350 % ) or negative did not correlate with later evolution : in these 39 patients , relapse rate was 41 % . In contrast , 13/16 patients with end-treatment TSAb greater than 350 % relapsed . Relapses tended to occur earlier in patients with the highest TSAb levels . TSAb determined again during follow-up was negative in each of the 18 patients in remission , and positive in 8/10 patients at the time of relapse , whatever its level at the end of the drug course . This study confirms that only end-treatment TSAb levels are predictive of relapse . ( ABSTRACT TRUNCATED AT 250 WORDS )

Thyroid stimulating antibodies

thyroid stimulating antibody ( TSAb )

post-antithyroid drug treatment

TSAb

TSAb

TSAb

TSAb

remission .

initial TSAb levels

End-treatment TSAb values

relapse rate

end-treatment TSAb

Relapses

TSAb levels

TSAb

Graves ' disease


A comparison of propranolol and nadolol pharmacokinetics and clinical effects in thyrotoxicosis . For a comparison of propranolol and nadolol pharmacokinetics and clinical effects , 20 newly diagnosed patients with thyrotoxicosis were randomly selected to receive as sole therapy , either propranolol , 40 mg every 6 hours for 14 days , or nadolol , 80 mg each morning for 14 days . The study was repeated when the patients were in the euthyroid state . There was a similar and highly significant degree of beta blockade and amelioration of symptoms of thyrotoxicosis at the end of the dosage interval ( trough ) , i.e. , 24 hours after nadolol or 6 to 8 hours after propranolol . Trough and peak serum levels of propranolol were significantly lower when the patients were in a thyrotoxic state than when they were in a euthyroid state , whereas the pharmacokinetics of nadolol were not appreciably altered by thyrotoxicosis . In thyrotoxicosis , trough levels of propranolol and nadolol were significantly inversely correlated with derived creatinine clearance values . In the symptomatic treatment of thyrotoxicosis , nadolol , a once-daily nonmetabolized beta blocker , has certain advantages compared with propranolol . It is preferred by patients , is more convenient , and probably aids compliance .

propranolol

nadolol pharmacokinetics

propranolol

nadolol

propranolol

nadolol

nadolol

propranolol

propranolol

propranolol

nadolol

nadolol

nonmetabolized beta blocker

propranolol

pharmacokinetics

clinical effects

thyrotoxicosis

pharmacokinetics

clinical effects

degree of beta blockade

and

amelioration of symptoms

of thyrotoxicosis

pharmacokinetics

derived

creatinine clearance values

thyrotoxicosis

compliance

thyrotoxicosis .

symptomatic treatment of thyrotoxicosis


[ The somatostatin infusion test for the evaluation of glucose utilization in bezafibrate medication ] . The utilisation of blood glucose may be used for definition of insulin resistance in type II diabetes mellitus . To evaluate this possibility we adapted an infusion test of somatostatin in 10 normal persons ( age 26 +/- 3 years , relative body weight 26 +/- 10 % according to Broca ) in a randomized cross-over therapy with bezafibrate ( 3 X 200 mg/die ) . As the coefficient of variation ( VC ) of measured blood glucose continuously increased the best time of a steady state was between 90 and 130 min after beginning the infusion ( mean VC 8.9 % ) . While insulin remained nearly constant ( 41 ( 45 ; 38 ) microU/ml ) blood glucose dropped by about 14 % and reached a steady state of 89 ( 134 ; 45 ) mg/dl . During the therapy of bezafibrate blood glucose was significantly decreased by 36 % 130 min after beginning the infusion . Although the effect was not significant during the whole time of the steady state it became evident by a negative correlation with lactate ( r = -0.687 ) and pyruvate ( r = -0.843 ) . A correlation with a concomitant decrease of triglyceride and cholesterol also induced by bezafibrate could not be proven . The results show that the infusion test of somatostatin is fitted to measure a steady state of blood glucose and insulin and that it is possible by this technique to quantify a changed utilisation of blood glucose induced by specific therapy .

somatostatin infusion test

bezafibrate medication

blood glucose

infusion test of somatostatin

bezafibrate

bezafibrate

bezafibrate

infusion test of somatostatin

glucose utilization

blood glucose

blood glucose

insulin

blood glucose

blood glucose

triglyceride

cholesterol

blood glucose

insulin

type II diabetes mellitus .


Statistical aspects of early termination in the beta-blocker heart attack trial . The Beta-Blocker Heart Attack Trial was a randomized double blind controlled trial comparing propranolol with placebo in 3837 patients with a recent myocardial infarction . The trial was terminated on recommendation of the Policy and Data Monitoring Board 9 months before the scheduled closing date . The propranolol group , at the time of the decision , had a 26 % lower mortality ( z = 2.82 ) . Many issues were considered in this decision . These included the magnitude of the overall results ; consistency of results across subgroups , clinical centers , and cause of death ; and completeness of follow-up . Two basic statistical methods were used in declaring the overall mortality results significant . The first method evaluated the current survival data taking into account the issue of repeated significance testing . The second method evaluated whether the observed trend was so impressive that the conclusion was unlikely to change even if the trial should continue to the scheduled end . These two methods , as well as other considerations led to the recommendation to discontinue the trial .

propranolol

placebo

propranolol

mortality

overall mortality

survival data


Anti-IgG antibodies during immunotherapy with purified grass pollen extracts . In a double blind study 40 patients were allocated specific immunotherapy ( hyposensitization ) with partially purified timothy extract or two timothy major allergens 19 , 25 . All patients had typical grass pollen hay fever , in 27 % associated with grass pollen asthma and in 13 % with birch pollen allergy . Serum IgG anti-IgG antibodies were determined after dithiothreitol treatment . Before hyposensitization , IgG anti-IgG titres greater than or equal to 9 were demonstrated in 45 % of the patients . During hyposensitization IgG anti-IgG titres showed a slight initial increase followed by a decrease below pretreatment level . Neither increase nor decrease was statistically significant . Reactions to rabbit IgG F ( ab ' ) 2 fractions were only obtained during hyposensitization . The occurrence of anti-IgG antibodies did no correlate with symptoms , side effects , or the level of allergen-specific IgG . In a previous study it was demonstrated that patients with multiallergy hyposensitized with combined allergen extracts showed a statistically significant increase in IgG anti-IgG titres during treatment . The increase failed to appear in the present patients allergic only to pollen and treated with purified allergen extracts . It is therefore suggested that a multiallergic condition and the combination and/or purification of allergen extracts administered during hyposensitization may influence the production of IgG anti- IgG antibodies .

partially purified timothy extract

two timothy major allergens 19 , 25

Serum IgG anti-IgG antibodies

IgG anti-IgG titres

IgG anti-IgG titres

Reactions to rabbit IgG F ( ab ' ) 2

anti-IgG antibodies

symptoms

side effects ,

the level of allergen-specific IgG

IgG anti-IgG titres

IgG anti- IgG antibodies


Effect of betamethasone valerate on the normal human facial skin flora . Eighteen volunteers were randomly divided into two groups and allocated either an active corticosteroid preparation ( Betamethasone valerate ) or the basal formulation only ( placebo ) . The cream was applied to the face twice daily for one month . The treated area was sampled by the scrub-wash method immediately before treatment began and after 2 and 4 weeks , and microorganisms were enumerated and identified . Application of either cream produced a very slight increase ( less than or equal to 0.5 log cycle ) in the skin flora during the first 2 weeks of treatment . There were no significant differences in the changes occurring between volunteers treated with placebo and those on the steroid formulation . The results are discussed in relation to theories of pathogenesis of perioral dermatitis and steroid acne .

betamethasone valerate

basal formulation only ( placebo ) .

human facial skin flora .

skin flora

perioral dermatitis and steroid acne

normal human facial skin flora

Eighteen


[ Local application of anti-cancer drugs for the treatment of malignant pleural and pericardial effusion ] . Pleural effusion is a common complication in patients with malignant neoplasm . A randomized controlled study of intrapleural instillation of Adriamycin ( control group , 30 patients ) and Adriamycin Nocardia rubra cell wall skeleton ( N-CWS group , 26 patients ) with tube thoracostomy was performed in 55 patients with malignant pleural effusion due to primary lung cancer . The response rates for control of pleural effusion were 73.4 % in the N-CWS group and 46.1 % in the N-CWS group . These results suggest that intrapleural instillation using a combination of anti-cancer agent and immunopotentiator is an effective treatment for malignant pleurisy . Cardiac tamponade secondary to cancer is a life-threatening complication requiring immediate treatment . Twenty-four patients with malignant pericardial effusion were treated by intrapericardial instillation of anti-cancer drugs , such as Carbazilquinone , Mitomycin-C or ACNU , with pericardial drainage . The range of survival time from the instillation of anti-cancer drug was 3-365 days ( average days ) . In only 4 patients , reaccumulation of pericardial effusion was recognized . There were no serious complications with this procedure . It was considered that local instillation of anti-cancer agents with pericardial drainage was a useful therapeutic modality for malignant pericarditis .

anti-cancer drugs

Adriamycin

tube thoracostomy

N-CWS group

N-CWS group

anti-cancer agent and immunopotentiator

anti-cancer drugs

Carbazilquinone , Mitomycin-C

ACNU

anti-cancer drug

anti-cancer agents

control of pleural effusion

range of survival time

reaccumulation of pericardial effusion

patients with malignant neoplasm .


Effects of nutritional supplementation on IQ and certain other variables associated with Down syndrome . In a double-blind study , 24 Down syndrome children , ages 6 to 17 years living at home , were given a megadose multi-vitamin/mineral supplement for 4 months . A matched group of 23 children received a placebo in identical form . The children 's IQ , vision , and visual-motor integration were tested before and after supplementation , and weekly checks were made to monitor behavioral changes . No differences were found on any measures as a result of supplementation .

nutritional supplementation

placebo

Effects

IQ

IQ

vision

visual-motor integration

Down syndrome .

Down syndrome

6 to 17


Metabolic and circulatory effects of oral salbutamol in the third trimester of pregnancy in diabetic and non-diabetic women . Metabolic and cardiovascular effects of 4 mg oral salbutamol were studied in ten non-diabetic , ten chemical diabetic and five juvenile diabetic women in late pregnancy . None of the women had been treated with beta-sympathomimetic drugs earlier in their pregnancy . Heart rate and blood pressure were recorded and blood samples for measurement of plasma cyclic AMP , insulin , C-peptide , glucose , lactate , glycerol , non-esterified fatty acids ( NEFA ) and 3-hydroxybutyrate ( 3-HB ) were collected every 30 minutes for 120 minutes after salbutamol . All women underwent the same procedure at random without salbutamol . There were significant cardiovascular effects of salbutamol in all the groups but no differences in these effects between the groups . Salbutamol caused significant increases of glycogenolysis and lipolysis in all the groups , significantly larger in the juvenile diabetic than the non-diabetic and chemical diabetic women . This observation could be explained by the inability of the juvenile diabetics to secrete insulin , shown by their non-measureable plasma C-peptide levels . The metabolic responses following salbutamol in the chemical diabetics were intermediate between the non-diabetic and juvenile diabetic groups . The results show that diabetes does not alter the sensitivity of beta-receptors involved in cardiovascular regulation , while the metabolic responses to oral salbutamol are enhanced , especially in juvenile diabetics . We suggest that during treatment with beta-sympathomimetic drugs , blood glucose should be monitored in all patients showing criteria of potential diabetes .

salbutamol

4 mg oral salbutamol

beta-sympathomimetic drugs

salbutamol

salbutamol

Salbutamol

salbutamol

salbutamol

beta-sympathomimetic drugs

Metabolic and cardiovascular effects

Heart rate

blood pressure

cardiovascular effects

glycogenolysis and lipolysis

metabolic responses

diabetic

non-diabetic

women .

ten

non-diabetic

ten

chemical diabetic

five

juvenile diabetic

women

women

juvenile diabetic

non-diabetic

chemical diabetic

women

diabetes


Bronchoscopic findings in patients with a complete radiographic regression of small cell bronchogenic carcinoma . Fibre-optic bronchoscopy was performed in 21 patients with small cell bronchogenic carcinoma who demonstrated a complete radiographic regression of their chest lesions after 3-4 months of combination chemotherapy . Fifteen patients showed abnormalities at the site of the original tumour consisting of nodular elevations , narrowing of bronchi and/or fibrous strands or membranes . Microscopic evidence of residual cancer was obtained in 3 cases . In 3 out of 8 patients who underwent a further bronchoscopy after 18 months of treatment , disappearance of nodules was noted at the later examination . Persistent bronchial narrowing was observed in patients who became disease-free 2-yr survivors . It is concluded that tumour regression may be accompanied by scar formation , which complicate the interpretation of post-treatment abnormalities , and that further regression of intrabronchial lesions may occur beyond 3-4 months .

Fibre-optic bronchoscopy

bronchoscopy

Bronchoscopic

small cell bronchogenic carcinoma .

small cell bronchogenic carcinoma

abnormalities

site

tumour

bronchoscopy

nodules

Persistent bronchial narrowing

scar formation

post-treatment abnormalities


[ Long-term treatment of cerebrovascular changes in the elderly ( author 's transl ) ] . A prospective study over 15 months in 100 elderly patients with signs of cerebro-vascular impairment demonstrated by psychometric testing that Hydergine ( an ergot alkaloid preparation : 4.5 mg daily ) compensated the signs of dementia , present in the placebo group , and in some patients actually brought about a significant improvement in mental activity . Similar compensatory effect was also demonstrable in cerebral haemodynamics : in the placebo group there was a progressive increase in cerebral circulation time , an expression of decreased cerebral blood flow , while with Hydergine cerebral circulation time was shortened and stabilized . Serial EEGs , obtained in parallel with psychometric and circulation time tests , demonstrated a marked increase in the 8-10 Hz pattern which corresponds to the physiological alpha activity in this age group . Furthermore , there was a diminished variability in performance in the tested frequency bands with Hydergine , the opposite tendency being obtained in the placebo group .

Hydergine

placebo

placebo

Hydergine

Hydergine

placebo

improvement in mental activity

compensatory effect

cerebral haemodynamics

8-10 Hz pattern

performance

elderly


[ Metastatic breast cancer : a comparative study of the efficacy of tamoxifen and the sequential administration of tamoxifen and medroxyprogesterone acetate ] . Seventy-nine patients with an histologically proven disseminated breast cancer , never treated before with additive hormonal therapy , entered into a randomized trial between june 1981 and december 1982 . In the first group 44 patients were given continually a daily dose of tamoxifen ( TAM ) of 20 mg/m2 . In the 2nd group 35 patients were given a daily dose of TAM of 20 mg/m2 for 15 days and then an oral daily dose of medroxyprogesterone acetate of 350 mg/m2 for the next 15 days . In both groups I and II , the treatment was stopped at the first manifestation of progression of the disease . The hormonal receptor status was determined in 30 patients of the group I and 23 patients of the group II . An objective response to treatment was observed in 48 per cent of the patients of the group I and 60 per cent of the group II . This difference is not significant ( X2 = 1,05 ) . However , the mean duration of therapeutic response is significantly higher in the group II ( p = 0,01 ) .

tamoxifen

tamoxifen

medroxyprogesterone acetate

tamoxifen ( TAM )

TAM

medroxyprogesterone acetate

Metastatic breast cancer

mean

duration of therapeutic response

[ Metastatic breast cancer

Seventy-nine


A dose-response study of the effect of levobunolol on ocular hypertension . We conducted a randomized , double-masked , dose-response study of the ocular hypotensive effect of the beta-adrenergic blocker , levobunolol . A single drop of placebo or levobunolol ( at concentrations of 0.03 % , 0.3 % , 0.6 % , 1 % , and 2 % ) was administered to one eye of each of 48 patients with ocular hypertension . The 0.3 % and 0.6 % concentrations decreased intraocular pressure significantly from baseline levels compared to placebo at one , two , and four hours after treatment . The 1 % and 2 % concentrations decreased intraocular pressure significantly from baseline compared to placebo at one , two , four , six , eight , and 12 hours after administration . No objective or subjective side effects were noted , and no substantial changes in visual acuity , pupil diameter , pulse rate , or blood pressure were recorded during the study . These results appear to justify long-term studies of levobunolol for the treatment of increased intraocular pressure .

levobunolol

placebo

levobunolol

levobunolol

ocular hypertension .

ocular hypotensive effect

intraocular pressure

intraocular pressure significantly

objective or subjective side effects

intraocular pressure

ocular hypertension


Comparison of hypnotherapy with systematic relaxation in the treatment of cigarette habituation . Because of the methodological deficiencies in this area of research , it is impossible to make any valid conclusions about whether hypnosis itself is effective in the treatment of cigarette habituation . In this study , 87 volunteers who wanted to quit cigarette smoking were assigned randomly to the experimental hypnosis group , the comparison relaxation group , and the waiting list control group . Ss in the treatment groups had four weekly 50-minute , individual sessions . Four months after the completion of treatment , Ss were administered a questionnaire and a hypnotic susceptibility scale . Ss in the hypnosis group who were in the upper two-thirds of the group in terms of hypnotic susceptibility reduced their cigarette consumption substantially more than Ss in the relaxation group who were in the upper two-thirds of the group in terms of hypnotic susceptibility . Therefore , the hypnotic state appears to be therapeutic for individuals who can enter medium or deep states of hypnosis .

hypnotherapy

systematic relaxation

experimental hypnosis group ,

the

comparison relaxation group

waiting list control group

hypnosis

questionnaire

hypnotic susceptibility scale

cigarette consumption

hypnotic susceptibility

cigarette smoking


Caries preventive effects of toothpastes containing monofluorophosphate and trimetaphosphate : a 3-year clinical trial . The caries-preventive effects of two toothpastes were tested in a 3-year clinical trial involving 1319 children aged 11-13 years . The test toothpastes were : 1 ) a low abrasion paste containing 0.8 % sodium monofluorophosphate ( MFP ) , and 2 ) a paste containing 3 % sodium trimetaphosphate ( TMP ) . The control toothpaste was a conventional , moderately abrasive paste containing 0.8 % sodium monofluorophosphate . The children were examined clinically and radiologically each year . Toothpaste was supplied to the children 's homes , and its use was unsupervised . Caries increments after 3 years , in terms of DMF teeth and DMF surfaces , showed no significant differences between the MFP test group ( 444 children ) and the MFP control group ( 450 children ) . However , the TMP test group ( 425 children ) had significantly higher caries increments than the MFP control group . All three groups of children showed some improvement in oral hygiene and in gingival health , but there were no significant differences between the groups .

monofluorophosphate

trimetaphosphate

MFP

MFP control

TMP

MFP control

Caries preventive effects

caries-preventive effects

Caries increments

caries increments

oral hygiene and in gingival health

11-13 years

( 444


A comparison of once and twice daily atenolol for angina pectoris . We have studied the effects of four doses of atenolol in 11 patients with stable angina pectoris using a symptom-limited exercise test and angina diaries . The doses 100 mg twice daily and 50 mg , 100 mg and 200 mg once daily were given double-blind and randomised within patients following run-in on placebo . Measurements were made 12 hours after the last twice daily dose and 24 hours after the last once daily dose . Exercise tolerance was improved by 40-74 % and exercise duration before the onset of angina by 61-94 % ( P less than 0.01 ) . Maximal heart rate was reduced further by a total daily dose of 200 mg than by lower doses , but no extra benefit was derived by giving the drug twice daily . The largest increase in exercise tolerance was obtained during treatment with 50 mg once daily . Atenolol was shown to be an effective anti-anginal agent when given once daily , and there were no major differences between the doses studied .

atenolol

atenolol

placebo

Atenolol

Exercise tolerance

Maximal heart rate

exercise tolerance

angina pectoris


The role of the MA-sensitive leukocyte chemotaxis in rheumatoid arthritis . A randomized double-blind clinical trial of griseofulvin treatment . Polymorphonuclear leukocyte ( PMN ) chemotaxis is thought to play an essential role in the pathogenesis of rheumatoid arthritis . PMN chemotaxis is in part sensitive to microtubule antagonists ( MAs ) , e.g . colchicine . The antimycotic antibiotic griseofulvin inhibits the MA-sensitive PMN chemotaxis in vitro in concentrations far below those obtained in serum during antimycotic therapy . The role of the MA-sensitive chemotaxis in rheumatoid arthritis could thus be elucidated by a clinical trial of griseofulvin treatment . Griseofulvin ( n = 20 ) was tested in a randomized double-blind study versus placebo ( m = 19 ) during one year in patients with rheumatoid arthritis of mild-moderate activity . No beneficial effect of griseofulvin treatment was noted on clinical symptoms or laboratory parameters of rheumatoid arthritis . Moreover , the placebo-treated patients showed more improvement than the griseofulvin-treated patients . It is therefore suggested that the MA-sensitive chemotaxis plays a reparative role in the inflammatory lesions of rheumatoid arthritis .

griseofulvin

griseofulvin

antimycotic therapy

griseofulvin

Griseofulvin

placebo

griseofulvin

placebo-treated

griseofulvin-treated

beneficial effect

improvement

rheumatoid arthritis

rheumatoid arthritis

mild-moderate activity


Double-blind comparison of liquid antacid and placebo in the treatment of symptomatic reflux esophagitis . Although antacids have been the mainstay of pharmacologic therapy for reflux esophagitis , their effectiveness has not been tested in a placebo-controlled double-blind trial . We report a double-blind comparison of liquid antacid vs placebo in the treatment of reflux esophagitis in 32 patients with chronic heartburn . Entry criteria included the presence of symptomatic gastroesophageal reflux confirmed by both an acid perfusion ( Bernstein ) test and by intraesophageal pH probe . Drug treatment consisted of 15 ml ( 80 mEq ) doses of antacid ( Maalox Therapeutic Concentration , William H. Rorer ) or placebo taken 7 times daily , ie , 1 and 3 hr after meals and at bedtime . Both groups showed significant improvement ( P less than 0.05 ) in both frequency and severity of heartburn . The time to reproduce heartburn with the timed Bernstein test was increased with both active drug and placebo therapy . The mean increase was 402 % ( 41 +/- 20 sec to 169 +/- 66 sec ) for the placebo group and 286 % ( 42 +/- 16 to 120 +/- 57 sec ) in the antacid group . Both the antacid and placebo groups showed improvement in the degree of esophagitis as assessed endoscopically . The current study asked : does regular antacid therapy have a favorable influence on the natural history of symptomatic reflux esophagitis , ie , does therapy heal or otherwise change esophagitis so that painful episodes are either less frequent , less severe , or both ? We found that the natural history of symptomatic reflux esophagitis was to improve with either antacid or placebo . There was no significant difference in antacid or placebo on the ( short-term ) natural history of the disease .

liquid antacid

placebo

antacids

liquid antacid

placebo

placebo

active drug

antacid

antacid

antacid

frequency and severity of heartburn

time to reproduce heartburn

degree of esophagitis

symptomatic reflux esophagitis

natural history of the disease

symptomatic reflux esophagitis

chronic heartburn


Recurrent ulcer after successful treatment with cimetidine or antacid . This study was designed to compare the rates of duodenal ulcer healing and recurrence after treatment with cimetidine or antacid . Patients with endoscopically documented duodenal ulcer received cimetidine , 1200 mg daily , or Mylanta II , 7 oz daily , in a randomized , double-blind trial . For the 69 patients in each group who completed the healing phase of the trial , endoscopic ulcer healing was almost identical . At 2 , 4 , and 6 wk , the cumulative percent healed on antacid was 33 % , 64 % , and 80 % , and on cimetidine it was 25 % , 62 % , and 86 % . The 114 patients with healed ulcer were observed on no therapy and underwent additional endoscopy to detect recurrences when symptomatic or at 3 , 6 , and 12 mo . There was no difference in the frequency of recurrences between treatments . At 3 and 6 mo , the cumulative percentages of patients with recurrence were 29 % and 56 % after antacid therapy and 36 % and 55 % after cimetidine therapy . Some patient variables were associated with delayed ulcer healing or ulcer recurrence . These included sex , pain frequency , smoking , disease duration , and acid secretion .

cimetidine

antacid .

cimetidine

antacid

cimetidine

Mylanta II

antacid

cimetidine

antacid

cimetidine

frequency of recurrences

delayed ulcer healing

ulcer recurrence

endoscopically

duodenal ulcer

ulcer


[ Effect on pressure after instillation of a drop of depot-pilocarpine . Clinical results of its medium-term action ] . A clinical comparison of an emulsion containing a new pilocarpine polymer ( Polym ) compound to that of a traditional pilocarpine salt solution ( Plc ) on the intraocular pressure ( IOP ) has been performed in 40 open-angle patients treated with the long acting pilocarpine-complex for 120 days . The treatment protocol was divided into 3 stages : Stage 1 is a single dose treatment where 12 patients were divided randomly into 2 groups of 6 each . The patients of each group were given 1 drop into each eye : 1 drop every 12 hours for Polym , 1 drop every 6 hours for Plc . The patients were observed for a period of 24 hours . After 24 hours without medication , the treatments were crossed over and nycthemeral graph curves were registered for both groups . Stage 2 is a medium term study were the 12 patients used in Stage 1 were added to another 28 patients . All 40 were then assigned to 1 of 2 treatment groups ( 2 groups of 20 patients each ) according to a table of random numbers . Treatments were administered during one month , then cross-overed again during 4 weeks . Stage 3 : finally , every patient could choose his treatment ( either Polym or Plc ) for the rest of the period ( 2 months ) . The clinical study shows that the polymer complex ( Polym ) produced a prolonged therapeutic effect , this being consistant with a slow release pattern and maintained a more effective around-the-clock control than pilocarpine solution . These results were accomplished by two applications per day as compared to the four necessary applications of Plc , on a half daily pilocarpine dose with Polym . The medium term results confirmed the efficacity noted in the short term survey . Most patients preferred Polym to Plc when they were asked . Throughout the 4 months study period , no adverse side effects were reported . Visual disturbances characteristic of pilocarpine eye-drops were reduced from 3 times a day on pilocarpine salt solution to once a day on pilocarpine polymer complex .

depot-pilocarpine .

new pilocarpine polymer ( Polym )

Polym

Plc

pilocarpine

Plc

pilocarpine

Polym

Polym

Plc

pilocarpine

pilocarpine salt

pilocarpine polymer

intraocular pressure ( IOP )

prolonged therapeutic effect

efficacity

adverse side effects

Visual disturbances


A comparative study of netilmicin-cefoxitin and gentamicin-cefoxitin in surgical patients with serious systemic infection . A double-blind , randomized study of gentamicin and netilmicin , each in combination with cefoxitin , was done to compare their respective efficacy and toxicity in patients with serious systemic infection . Thirty-seven surgical patients were evaluated for efficacy and 46 patients were evaluated for toxicity . The most frequently cultured organisms were Escherichia coli ( 15 ) , Klebsiella sp ( 9 ) , Proteus sp ( 6 ) , and Bacteroides sp ( 4 ) . For 23 patients treated with gentamicin-cefoxitin ( G-C ) , the clinical response was favorable in 20/21 ( 95.2 % ) evaluable cases , and elimination or marked reduction of 33/34 ( 97.1 % ) organisms was achieved . For 14 patients treated with netilmicin-cefoxitin ( N-C ) , the clinical response was favorable in 13/13 ( 100 % ) evaluable cases , and 19/20 ( 95 % ) organisms were eliminated or markedly reduced . Nephrotoxicity was defined as an increase in serum creatinine to greater than 25 % over baseline with an absolute rise of at least 0.5 mg/100 ml to a value greater than or equal to 1.3 mg/100 ml . Based on these criteria , nephrotoxicity was seen in 2/27 ( 7.4 % ) patients treated with G-C and in 3/19 ( 15.8 % ) patients treated with N-C. Ototoxicity was defined as a greater than 20 dB loss at any frequency . Based on these criteria , ototoxicity was seen in 5/27 ( 18.5 % ) patients treated with G-C and 2/19 ( 10.5 % ) patients treated with N-C . The data show no significant difference in toxicity and suggest that netilmicin and gentamicin are both highly effective in combination with cefoxitin in patients who have serious infections after surgery .

netilmicin-cefoxitin

gentamicin-cefoxitin

gentamicin

netilmicin

cefoxitin

gentamicin-cefoxitin

netilmicin-cefoxitin

efficacy and toxicity

efficacy

clinical response

clinical response

Nephrotoxicity

serum creatinine

nephrotoxicity

Ototoxicity

ototoxicity

toxicity

serious systemic infection

serious systemic infection .

Thirty-seven

serious infections after surgery .


Fat embolism prophylaxis with corticosteroids . A prospective study in high-risk patients . The efficacy of corticosteroid treatment in the prophylaxis of the fat embolism syndrome was evaluated in a prospective , randomized , double-blind study of high-risk patients with long-bone fractures . Using a set of objective diagnostic criteria , we saw a significant difference in the incidence of the syndrome between corticosteroid- ( 0 of 21 ) and placebo-treated patients ( 9 of 41 ) ( p less than 0.05 ) . There were no complications related to corticosteroid treatment . No routine laboratory or physical findings reliably predicted the development of the fat embolism syndrome except petechial rash , which occurred only in 5 placebo-treated patients who developed the syndrome . Complement activation was present in all patients studied who had the syndrome ( 5 of 27 ) but also in many patients who did not meet our diagnostic criteria , suggesting a multifactorial cause . These data support the prophylactic value of corticosteroid treatment in patients at high risk for the fat embolism syndrome , particularly if several unfavorable predictors are present .

corticosteroids .

corticosteroid

corticosteroid-

placebo-treated

corticosteroid

corticosteroid

efficacy

fat embolism syndrome

syndrome

petechial rash

Complement activation

fat embolism syndrome

fat embolism syndrome


Comparison of short-term efficacy of diltiazem and propranolol in unstable angina at rest -- a randomized trial in 70 patients . The short-term efficacy of diltiazem ( D ) has been compared to that of propranolol ( P ) , in a group of 70 patients hospitalized in the Coronary Care Unit for unstable angina , defined as recent ( less than one month ) appearance or aggravation of spontaneous chest pains . Among the 70 patients , 24 had angina only at rest . The patients have been divided into two groups according to ST-T changes during chest pain : 29 with ST elevation ( group A ) and 41 with other repolarization abnormalities ( group B ) . Treatment was then randomized in each group . Treatment Treatment was considered successful only if spontaneous chest pains disappeared completely . Thirty-four patients were treated with D ( 282 +/- 102 mg/day ) and 36 with P ( 158 +/- 81 mg/day ) . In the whole group and in groups A and B considered individually , responses to D and P did not differ . Among the 24 patients with angina exclusively at rest , nine successes and four failures were observed with D. There was no symptomatic relief among the 11 patients treated by P ( P = 0.001 ) . Moreover , the number of episodes of angina was decreased by D and unchanged by P , while eight out of the 11 failures with P were immediate successes when treatment was replaced with D. These results suggest that D is preferable to P for management of unstable angina in patients with angina which is exclusively spontaneous .

diltiazem and propranolol

diltiazem ( D )

propranolol ( P )

D

P

D

P

D.

P

D

P

P

D.

D

P

chest pains

angina

no symptomatic relief

number of episodes of angina

unstable angina

chest pains .

angina

chest pain

angina

angina

angina


Effect of cicloxilic acid on bile lipid composition in patients with gallstones : a multicenter trial . 24 gallstone patients were treated with cicloxilic acid , an agent endowed with choleretic activity , at the dose of 240 mg/day for 1 month . 24 comparable patients on placebo treatment acted as controls . Bile lipid composition was determined and the saturation index calculated before and after treatment , on samples collected by duodenal siphonage after caerulein stimulation , in both groups . In the cicloxilic group there was little or no change in bile salts and phospholipids , whereas biliary cholesterol concentration was significantly reduced ( p less than 0.05 ) and consequently the lithogenic index lowered ( from 1.5 to 1.2 , p less than 0.01 ) . Cicloxilic acid can have a place in gallstone disease therapy in association with the litholytic bile acids or in the prevention of gallstone formation in high-risk populations .

cicloxilic acid

cicloxilic acid

placebo

bile lipid composition

Bile lipid composition

bile salts and phospholipids

biliary cholesterol concentration

lithogenic index

gallstone formation

gallstones

gallstone patients


A controlled study of the effect of indomethacin in uremic pericarditis . To determine the impact of indomethacin on the course of uremic pericarditis we performed a prospective , double blind study in which 24 patients with endstage chronic renal failure and pericarditis randomly received indomethacin , 25 mg four times daily , ( 11 patients ) or a placebo ( 13 patients ) for a 3-week period . All patients received peritoneal or hemodialysis treatment concurrently with the study drug . In contrast to the placebo , indomethacin produced an immediate and sustained reduction of fever in all but one patient . On the other hand , indomethacin had no effect on the duration of chest pain ( mean days +/- SE : placebo 1.4 +/- 0.6 , indomethacin 5.5 +/- 3.3 ) , duration of pericardial friction rub ( placebo 10.3 +/- 1.7 , indomethacin 16.0 +/- 3.8 ) , or on the amount of pericardial effusion . Further , indomethacin did not diminish the need for invasive surgical procedures for relief of tamponade ( three of 13 placebo patients , two of 11 indomethacin patients ) or result in decreased mortality rate . Death ( not due to pericarditis ) occurred in two patients treated with indomethacin and one patient who received the placebo . In our patients pericarditis encompassed a wide spectrum ranging from a mild illness of several days duration to a painful and debilitating disease lasting weeks and requiring surgical intervention . Although the size of our population prohibits definitive conclusions , it would appear that , except for fever , the manifestations and natural history of this illness are unaffected by indomethacin .

indomethacin

indomethacin

indomethacin

placebo

placebo

indomethacin

indomethacin

placebo

indomethacin

indomethacin

placebo

indomethacin

effect

uremic pericarditis .

reduction of fever

duration of chest pain

pericardial friction rub

pericardial effusion .

need for invasive surgical procedures

tamponade

mortality rate . Death

mild illness of several days duration

surgical intervention

illness


Suppression of immediate and late anti-IgE-induced skin reactions by topically applied alcohol/onion extract . In a double blind study , alcohol/onion extract ( 5 % ethanol ) was injected simultaneously with 20 IU and 200 IU rabbit anti-human-IgE intradermally in 12 adult volunteers ( 6 atopics , 6 non-atopics ) . Diameters of wheals and flares were measured 10 min after and compared with control sites challenged with 20 IU and 200 IU anti-IgE in a 5 % ethanol solution . The skin sites were then treated epidermally with 45 % alcohol/onion extract and 45 % ethanol under occlusion . Diameters of late cutaneous reactions were measured hourly . Oedema formation was clinically estimated according to an arbitrary scale and skin thickness measured with a calliper . In the onion-treated skin sites the wheal areas were significantly reduced ( 20 IU : control : 108 +/- 53 mm2 ; onion 69 +/- 42 mm2 , P less than 0.05 ; 200 IU anti-IgE : control : 152 +/- 25 mm2 , onion : 138 +/- 26 mm2 , P less than 0.02 ) . The oedema formation during the late phase skin reaction was markedly depressed ( P less than 0.005 at 2 h , P less than 0.01 at 4 and 6 h , P less than 0.02 at 8 h ) . The extent of late skin reactions was slightly , but not significantly reduced . Obviously , onions contain pharmacologically active substances with anti-inflammatory and/or allergic properties .

alcohol/onion extract .

alcohol/onion extract ( 5 % ethanol )

anti-IgE in a 5 % ethanol

45 % alcohol/onion extract

45 % ethanol

onion-treated

onions

anti-IgE-induced skin reactions

wheal areas

oedema formation

skin reactions

adult volunteers (

atopics ,

non-atopics ) .


Netilmicin versus tobramycin in multi-centre studies . In two prospective , randomized studies conducted in West Germany and involving 80 patients , netilmicin-ticarcillin was compared to tobramycin-ticarcillin in the treatment of serious systemic infections . Both regimens were essentially identical with respect to the clinical and bacteriological results they produced . The netilmicin group developed significantly less nephrotoxicity than the tobramycin group ( 0 % versus 15 % , P = 0.03 ) . Ototoxicity also occurred less frequently in the netilmicin-treated patients ( 3 % versus 10 % , P = 0.4 ) . In a large collaborative study involving 15 centres , 254 patients were enrolled . Clinical and bacteriological responses were excellent , with netilmicin and tobramycin equally effective , but the incidences of nephrotoxicity and ototoxicity were lower in patients treated with netilmicin than those receiving tobramycin .

Netilmicin versus tobramycin

netilmicin-ticarcillin

tobramycin-ticarcillin

nephrotoxicity

Ototoxicity

Clinical and bacteriological responses

effective

nephrotoxicity

ototoxicity

serious systemic infections


Histologic conversion in the non-Hodgkin 's lymphomas . Between July 1 , 1971 and December 31 , 1978 , 150 patients with favorable subtypes of non-Hodgkin 's lymphoma [ nodular poorly differentiated lymphocytic ( NLPD ) , nodular mixed , or diffuse well differentiated lymphocytic ] were entered into prospective randomized clinical trials at Stanford University . Treatments included involved field , total lymphoid , or whole body irradiation , single alkylating agent chemotherapy , combination chemotherapy with cyclophosphamide , vincristine and prednisone ( CVP ) or with cyclophosphamide , vincristine , procarbazine , and prednisone ( C-MOPP ) , or various combinations of chemotherapy and irradiation . The initial complete response rate ( CR ) was 79 % . Among patients who achieved a CR , 31 % later relapsed . There were 78 patients who either failed to achieve a CR or achieved a CR and later relapsed . Histologic conversion ( change from initially favorable to an unfavorable subtype of non-Hodgkin 's lymphoma ) was documented in 22/78 patients ( 28 % ) . However , the actuarial risk for conversion was actually much greater ( 60 % at 8 yr ) . The median time to documentation of conversion was 51 mo . The most common type of histologic conversion was from NLPD to diffuse histiocytic lymphoma . Documented histologic conversion was often associated with a more aggressive clinical behavior of the lymphoma , and the median survival after conversion was less than 1 yr . However , those patients who achieved a CR after conversion had a more favorable outcome ( actuarial survival 75 % at 5 yr ) . No specific risk factors predictive of histologic conversion could be identified .

single alkylating agent chemotherapy

vincristine and prednisone ( CVP )

cyclophosphamide

Histologic conversion

complete response rate ( CR )

achieved a CR

relapsed .

achieve a CR

achieved a CR

relapsed . Histologic conversion

actuarial risk for conversion

greater

most common

histologic conversion

histiocytic lymphoma .

histologic conversion

aggressive clinical behavior

median survival

conversion

achieved a CR

conversion

favorable outcome ( actuarial survival

risk factors

histologic conversion

non-Hodgkin 's lymphomas

non-Hodgkin 's lymphoma


The treatment of localized non-Hodgkin 's lymphoma in children : a report from the Children 's Cancer Study Group . Investigators of the Children 's Cancer Study Group entered 73 children with previously untreated localized non-Hodgkin 's lymphoma on a prospective randomized trial of systemic treatment with either a four-drug program ( cyclophosphamide , vincristine , methotrexate , prednisone [ COMP ] ) or a 10-drug ( LSA2-L2 modified ) program of 18 months duration . All patients received central nervous system prophylaxis with intrathecal methotrexate and most received local or regional radiation treatment . The three-year relapse-free survival rate for all patients ( N = 73 ) was 84 % ; for COMP ( N = 42 ) was 85 % , and for LSA2-L2 ( N = 31 ) was 84 % . Of the 12 patients who suffered adverse events eight relapsed and four died of toxicity . Histopathology was reviewed centrally . Of 32 patients with nonlymphoblastic disease treated with COMP only one relapsed . Of 26 patients treated with LSA2-L2 , four relapsed . Patients with localized lymphoblastic disease were uncommon . None of three patients treated with LSA2-L2 relapsed compared with three of nine treated with COMP . COMP is an excellent treatment for patients with localized disease of nonlymphoblastic type , but the relative value of the two regimens for patients with localized lymphoblastic disease is uncertain .

10-drug ( LSA2-L2 modified )

local or regional radiation treatment

COMP

COMP

three-year relapse-free survival rate

adverse events

relapsed

died of toxicity

relapsed

relapsed

localized lymphoblastic disease


Adjuvant therapy of breast cancer : the Southwest Oncology Group experience . The Southwest Oncology Group in a prospective randomized study compared one year of adjuvant combination chemotherapy with continuous CMFVP ( cyclophosphamide , methotrexate , 5-fluorouracil , vincristine , and prednisone ) to two years of intermittent L-phenylalanine mustard ( L-PAM ) in women with operable breast cancer with histologically positive axillary lymph nodes . In fully and partially evaluable patients with a 68-month median follow-up , treatment failures have occurred in 27 % of 172 receiving CMFVP and 47 % of 186 women given L-PAM ( p = 0.002 ) . The advantage for women receiving CMFVP was seen for all subsets regardless of menopausal status except among women who were premenopausal and had 1-3 positive nodes . Based on this study , a second study was implemented using both the estrogen-receptor ( ER ) content of the primary tumor and axillary nodal status to select therapy .

Adjuvant therapy

CMFVP

L-PAM

CMFVP

treatment failures

women

premenopausal


A comparison of an aqueous and a pressurized nasal spray of beclomethasone dipropionate in the management of seasonal rhinitis . A multi-centre , double-blind , parallel group study was carried out in 38 patients with seasonal rhinitis to compare a new aqueous nasal spray of beclomethasone dipropionate with the conventional pressurized nasal spray . Beclomethasone dipropionate ( 200 micrograms ) was administered twice daily for a treatment period of 2 weeks . Both treatments were found to be equally effective and well tolerated . It is suggested , therefore , that the new aqueous nasal spray provides an alternative method of intranasal administration of the steroid for patients who may prefer an aqueous product .

aqueous

pressurized nasal spray

beclomethasone dipropionate

conventional pressurized nasal spray

Beclomethasone dipropionate

aqueous nasal spray

management of seasonal rhinitis

effective and well tolerated

seasonal rhinitis

seasonal rhinitis


Treatment of adult asthma : controlled double-blind clinical trial of oxitropium bromide . Sixteen young adult sufferers from extrinsic paroxysmal asthma with pollen hypersensitivity took part in a therapeutic trial of the synthetic anticholinergic agent oxitropium bromide administered by a metered dose inhaler . The study comprised three 3-week periods . The first , run-in period was carried out to confirm the ability of the patients to maintain a daily record of symptoms . During the second and third periods , the patient received 3 X 2 inhalations of drug or placebo in a cross-over design . The medical staff was blind to the nature of the aerosol ( drug or placebo ) , which was given in random order . The run-in clinical score was high . Asymptomatic days were relatively infrequent and daily drug consumption was high . Functional studies between the cross-over periods showed flow-rate values close to normal , with an increase in residual volume and functional residual capacity . During treatment either with placebo or oxitropium , there was a statistically significant decrease in clinical scores . Results for oxitropium bromide treatment were significantly better than the run-in values ( p less than 0.005 ) and the placebo period ( p less than 0.02 ) . There was no significant change in non-trial drug consumption . Functional values showed no difference in terms of flow rate , although oxitropium did cause a significant improvement in the RV/TLC ratio ( p less than 0.05 ) . No adverse reactions were reported .

oxitropium bromide

placebo

drug

placebo )

placebo

oxitropium

oxitropium bromide

placebo

Asymptomatic days

daily drug consumption

flow-rate values

clinical scores

significantly better

run-in values

non-trial drug consumption

flow rate

RV/TLC ratio

adverse reactions

adult asthma :


Effect of oral diuretics on pulmonary mechanics in infants with chronic bronchopulmonary dysplasia : results of a double-blind crossover sequential trial . In a randomized double-blind crossover trial with sequential analysis , the effects of oral diuretics were compared with the effects of placebo on pulmonary mechanics in ten infants with bronchopulmonary dysplasia ( BPD ) . Pulmonary mechanics were measured before and at the end of a week of treatment with oral diuretics ( chlorothiazide , 20 mg/kg/dose and spironolactone , 1.5 mg/kg/dose ) given twice daily , or placebo . Mean airway resistance decreased 35.3 cm H2O/L/s , mean specific airway conductance increased 0.095 1/L/s/cm H2O , and mean dynamic pulmonary compliance increased 1.74 mL/cm H2O during treatment with diuretics ( all P less than .001 ) , but not during treatment with placebo . The infants ' rate of weight gain decreased on the first three days of diuretic treatment , but was thereafter comparable with weight gain during treatment with placebo . Fluid intake was similar in infants receiving diuretics and placebo . But , infants receiving diuretics not only had significantly increased urine output , osmolal clearance , and potassium and phosphorus excretion , but these infants also retained less fluid , and , in addition , excreted less calcium than infants receiving placebo . It is concluded that oral diuretics improve lung function in infants with chronic bronchopulmonary dysplasia ; however , potassium and phosphorus depletion are potential complications of treatment .

diuretics

diuretics

placebo

oral diuretics

chlorothiazide , 20 mg/kg/dose

spironolactone , 1.5 mg/kg/dose )

placebo

placebo

placebo

diuretics

Mean airway resistance

specific airway conductance

mean dynamic pulmonary compliance

weight gain

weight gain

Fluid intake

urine output

osmolal clearance

potassium and phosphorus excretion

retained less fluid

excreted less calcium

lung function


Double-blind efficacy study of selenium sulfide in tinea versicolor . Selenium sulfide ( 2.5 % ) lotion applied daily for 10 minutes for 7 consecutive days was found to be an effective therapeutic agent , significantly superior to the vehicle , in a double-blind study in the treatment of tinea versicolor . Mild transitory contact dermatitis of the primary irritant type occurred in all the treatment groups and was apparently due to the detergent base .

selenium sulfide

Selenium sulfide ( 2.5 % ) lotion

Mild transitory contact dermatitis


Treatment of bladder cancer with intravesical instillation of adriamycin . Intravesical treatment with adriamycin has been extensively employed in the last decade . In the treatment of carcinoma in situ complete responses have been reported in about 60 % of cases . Its efficacy is probably lower in the therapy of multiple or diffuse low stage transitional cell carcinoma that is too extensive to be completely resected by conventional transurethral surgery . In such circumstances , including cancer in situ , adriamycin compares favorably with other local forms of treatment . The prophylactic use of intravesical instillation of Adriamycin has been studied more extensively . Preliminary results of controlled randomized trials implemented from the EORTC Urological Group show that adriamycin instillations significantly reduce recurrence rate after TUR . The treatment is well tolerated . Systemic absorption is virtually absent , and no severe drug-related side effects have ever been reported . Chemical cystitis is occasionally observed , especially if multiple instillations are started immediately after TUR , or in the presence of additional inflammatory conditions , such as previous irradiation or bacterial cystitis .

adriamycin

adriamycin

adriamycin

Adriamycin

adriamycin

efficacy

recurrence rate after TUR .

tolerated .

Systemic absorption

no severe drug-related side effects

Chemical cystitis

bladder cancer


Fentanyl supplementation to inhalation anaesthesia . In eight out of 15 healthy patients undergoing body surface surgery , the effect of a fentanyl infusion on a conventional thiopentone , nitrous oxide , oxygen and halothane anaesthetic was studied . The fentanyl infusion ( 2 micrograms/kg/hour ) reduced the induction dose of thiopentone and caused marked respiratory depression with a reduction in the patients ' response to surgery . The mean arterial pressures and pulse rates were not significantly different in each group throughout the course of the operation . The fentanyl made no difference to the patients ' postoperative analgesic requirements or to their recovery in the first 24 hours .

Fentanyl

fentanyl infusion

thiopentone , nitrous oxide , oxygen

halothane anaesthetic

fentanyl infusion

fentanyl

induction dose of thiopentone

marked respiratory depression

mean arterial pressures

pulse rates

inhalation anaesthesia

eight

healthy

body surface surgery


[ Treatment of essential headache in developmental age with L-5-HTP ( cross over double-blind study versus placebo ) ] . Thirty patients ( mean age : 10.38 years ) affected by primary headache were selected for a double-blind cross-over clinical trial . The patients were randomized into 2 homogeneous groups of 15 and treated for 12 weeks with L-5-HTP ( 100 mg/day ) and placebo as per the following design : placebo - L-5-HTP ( group A ) and L-5-HTP - placebo ( group B ) . Evaluation was carried out every 3 weeks by the Migraine Index supplying a general assessment of the attacks , i.e . severity , duration and frequency . The decrease in mean score values was directly proportional to L-5-HTP treatment , and statistical significance ( Wilcoxon 's test ) was observed only for L-5-HTP in both groups , from 0.05 to 0.01 . Improvement , as evaluated by CGI on percentage distribution of the patients , was homogeneous in both groups .

placebo

placebo

placebo

placebo

essential headache

primary headache

Migraine Index

general assessment of the attacks

severity

duration

frequency

mean score values

Wilcoxon 's test

developmental age


Comparison of tocainide and prajmalium bitartrate for the treatment of ventricular arrhythmias . The antiarrhythmic efficacy of tocainide , a new antiarrhythmic substance , has been compared with that of prajmalium bitartrate , a drug in clinical use for many years in the German speaking countries . The investigation was performed as a double-blind cross-over study in 20 patients with ventricular arrhythmias ( VA ) of various origin . The efficacy was assessed by serial Holter monitoring . Plasma levels were measured to study the dose-effect relationship . Applying to the criterion of a reduction of VA of more than 75 % or an improvement according to the Lown grading 8 pts . under tocainide and 7 under prajmalium bitartrate were responders . Side effects were few and under tocainide only 2 pts . had to discontinue the therapy . From the present findings tocainide and prajmalium bitartrate have the same efficient antiarrhythmic effects in the majority of patients .

tocainide

prajmalium bitartrate

tocainide

prajmalium bitartrate

prajmalium bitartrate

tocainide

prajmalium bitartrate

efficacy

Holter monitoring .

Plasma levels

reduction of VA

Lown grading

Side effects

antiarrhythmic effects

ventricular arrhythmias

ventricular arrhythmias

VA


A prospective randomized clinical trial of melphalan and cis-platinum versus hexamethylmelamine , adriamycin , and cyclophosphamide in advanced ovarian cancer . From May 1978 until November 1980 , 169 previously untreated patients with advanced epithelial ovarian cancer were entered into a prospective randomized clinical trial comparing the combination of hexamethylmelamine , Adriamycin , and cyclophosphamide ( HAC ) to a combination of melphalan and cis-platinum . Eleven patients were excluded from analysis and another 5 patients were excluded from response analysis . Of 153 patients evaluable for response , there were 47 , or 30.7 % , complete responders ( all determined surgically ) , 6 partial responders , and 100 nonresponders . The response rate for the HAC group was 31 % and for the melphalan-platinum group was 37.8 % . The overall response rate was 34.6 % . Residual tumor diameter ( less than or greater than 2 cm ) exerted a statistically significant effect on response -- 47.8 vs 24.4 % . Of the 47 complete responders , 7 , or 14.9 % , have relapsed , with the median duration of remission of 44+ months . Of the 158 patients evaluable for survival , 90 patients have died , with a median survival time of 27.9 months ( HAC = 26.4 months , melphalan-platinum = 29.6 months ) . Age , FIGO stage , histologic grade , and residual disease all exerted a significant effect on survival time . Second-line therapy in the treatment failures was of no benefit . Hematologic toxicity was greater in the melphalan-platinum group . Gastrointestinal toxicity was severe in both groups . Other toxicities were minor and infrequent .

melphalan and cis-platinum

HAC

melphalan-platinum

HAC

melphalan-platinum

melphalan-platinum

complete responders

response rate

survival

median survival time

Hematologic toxicity

Gastrointestinal toxicity

Other toxicities

advanced ovarian cancer

previously untreated

advanced epithelial ovarian cancer

Eleven


[ Randomized controlled study of OK-432 in the treatment of cancerous pleurisy ] . A randomized controlled study was performed to evaluate the efficacy of intrapleural and systemic administration of OK-432 , streptococcus preparation , in patients with cancerous pleurisy . A total of 53 patients were accessed to the study : 29 patients for the OK-432 group and 24 patients for the control group . Intrapleural instillation of 50 mg of adriamycin and a combination chemotherapy of MFC ( mitomycin C 0.08 mg/kg , 5-FU 10 mg/kg , ara-C 0.8 mg/kg iv , weekly ) were administered in both groups . In the OK-432 group intrapleural instillation of 2 units of OK-432 was administered daily until disappearance of pleural effusion ; thereafter , 2 to 5 units of OK-432 were administered intradermally every other day . Patients with stage III in the OK-432 group survived significantly longer than those in the control group ( P less than 0.05 ) , but there was no significance between in patients with stage IV of both treatment groups . Also patients with PPD negative skin reaction at the time of beginning of treatment in the OK-432 group survived significantly longer than those in the control group ( P less than 0.001 ) , but there was no significance between both treatment groups in patients with PPD positive skin reaction at the time of beginning of treatment . Eighteen ( 62 % ) of 29 patients treated with OK-432 had a fever , but well tolerated .

OK-432 , streptococcus preparation

control group .

ara-C

cancerous pleurisy

survived significantly longer

skin reaction


Absence of central effects in man of the benzodiazepine antagonist Ro 15-1788 . The benzodiazepines are typified by a profile of side effects which includes drowsiness , ataxia and incoordination . Ro 15-1788 , an imidazodiazepine derivative , exhibits marked antagonism of the behavioural and biochemical effects of the benzodiazepines in animals and man . It is devoid of any behavioural activity in animals , except at very high doses . In the present study the effects of single rising oral doses of Ro 15-1788 on cognitive , psychomotor and subjective function in man have been assessed using a battery of psychometric tests designed to identify the sedative action of the benzodiazepines . At all doses up to 600 mg , Ro 15-1788 demonstrated none of the classical behavioural effects of the benzodiazepines .

benzodiazepine

Ro 15-1788

Ro 15-1788

Ro 15-1788

central effects

drowsiness

ataxia

incoordination

cognitive

psychomotor

subjective function

psychometric tests

sedative action

behavioural effects

in man


[ Randomized study on the long-term adjuvant chemotherapy with ftorafur and mitomycin C for stomach cancer : second report ] . In view of the usefulness of long-term adjuvant chemotherapy , the Cooperative Study Group of Surgical Adjuvant Chemotherapy for Gastric Cancer adopted as the second cooperative study a prospective randomized trial on three groups ; MMC alone , Futraful alone and a combination of MMC and Futraful . In the group of Futraful alone the survival and disease-free rate were improved in three years after operation , especially marked in patients with the advanced stage . Moreover , the survival and disease-free rate in the group of the combination therapy were higher than those in the group of Futraful alone , and the relapse rate was lower in the former . Therefore , a long-term combined adjuvant chemotherapy with MMC and Futraful seems to be one of the most effective chemotherapy regimens for resectable advanced gastric cancer .

long-term adjuvant chemotherapy

ftorafur

mitomycin C

long-term adjuvant chemotherapy

MMC alone

Futraful alone

MMC

Futraful

Futraful

combination therapy

Futraful

chemotherapy

survival

disease-free rate

survival

disease-free rate

relapse rate


Blood pressure control during weight reduction in obese hypertensive men : separate effects of sodium and energy restriction . The separate and combined effects of dietary energy and sodium restriction on regulation of blood pressure were investigated in 30 middle aged obese men with essential hypertension attending the outpatient department . In group 1 ( n = 15 ) a basal period with no dietary restriction was followed by a period taking an energy reduced diet ( 5.1 MJ ; 1230 kcal ) , the sodium intake being supplemented and hence unchanged ( 1 : ErSn ) . In group 2 ( n = 15 ) the basal period preceded a control period with no intervention , which was followed by taking a diet restricted in energy ( 5.1 MJ ; 1220 kcal ) and sodium ( 2 : ErSr ) . During period 1 : ErSn there were reductions in heart rate and urinary noradrenaline output but not in systolic or diastolic blood pressure . Body weight decreased by 4.9-11.7 kg and urinary sodium excretion did not change . In period 2 : ErSr urinary sodium output was reduced by 81.4 ( SEM 17.8 ) mmol ( mEq ) /24 h and there was a weight loss of 8.2 ( SEM 0.7 ) kg . Systolic and diastolic blood pressures fell significantly , as did the heart rate and urinary noradrenaline excretion . These results show that in hypertensive obese men a moderate weight reducing diet decreases indices of sympathetic nervous system activity . Reduction of blood pressure to the normotensive range was observed only when there was a concomitant restriction of sodium intake .

sodium restriction

no dietary restriction

sodium intake being supplemented

no intervention

sodium

blood pressure

heart rate

urinary noradrenaline output

systolic or diastolic blood pressure

Body weight

urinary sodium excretion

urinary sodium output

weight loss

Systolic and diastolic blood pressures

heart rate

urinary noradrenaline excretion

sympathetic nervous system activity

blood pressure

obese hypertensive

men

middle aged

obese

essential hypertension

hypertensive obese

men


The effect of surgical trauma and insulin on whole-body protein turnover in parenterally-fed undernourished patients . Ten undernourished patients receiving total parenteral nutrition and undergoing major intestinal surgery were restarted on intravenous feeds identical to their pre-operative regimens within 24 h of their operation . Five , chosen at random , received post-operatively 1-2 units insulin/kg body weight/24 h with their feed , while the other five received the feed only . Pre-operatively , and 2 h after commencing their post-operative feeds , rates of whole-body protein synthesis and breakdown were measured over a 9-h period following intravenous injection of a single tracer dose of 15N-glycine by the ammonia and urea end-product methods . During these 9-h study periods measurements were also made of blood glucose , plasma insulin and glucagon , urinary ammonia , nitrogen , creatinine and 3-methylhistidine . Blood glucose and plasma insulin and glucagon concentrations rose post-operatively whether or not insulin was given , but the increment in insulin concentration was significantly greater when insulin was given . Apparent nitrogen balance was positive pre-operatively and became less so post-operatively whether insulin was given or not . Similarly , post-operative increments in urinary excretion of ammonia , creatinine and 3-methylhistidine were not altered by addition of insulin . Protein turnover , as estimated by the ammonia end-product method , tended to rise post-operatively , but there was no significant difference between the increases observed with or without insulin . The urea end-product method suggested that there was no change in whole-body protein turnover after surgery , whether or not insulin was given . This study does not support the clinical use of insulin as a means of modifying protein metabolic losses after major surgery .

insulin

received the feed only

insulin

insulin

insulin

insulin

insulin

insulin

insulin

insulin

insulin

insulin

whole-body protein turnover

blood glucose

plasma insulin and glucagon

urinary ammonia

nitrogen

creatinine

Blood glucose

insulin concentration

Apparent nitrogen balance

urinary excretion of ammonia

creatinine and 3-methylhistidine

Protein turnover

ammonia end-product

whole-body protein turnover

insulin

Ten

undernourished


Endotracheal cuff pressure and tracheal mucosal blood flow : endoscopic study of effects of four large volume cuffs . Large volume , low pressure endotracheal tube cuffs are claimed to have less deleterious effect on tracheal mucosa than high pressure , low volume cuffs . Low pressure cuffs , however , may easily be overinflated to yield pressures that will exceed capillary perfusion pressure . Various large volume cuffed endotracheal tubes were studied , including Portex Profile , Searle Sensiv , Mallinkrodt Hi-Lo , and Lanz . Tracheal mucosal blood flow in 40 patients undergoing surgery was assessed using an endoscopic photographic technique while varying the cuff inflation pressure . It was found that these cuffs when overpressurised impaired mucosal blood flow . This impairment of tracheal mucosal blood flow is an important factor in tracheal morbidity associated with intubation . Hence it is recommended that a cuff inflation pressure of 30 cm H2O ( 22 mm Hg ) should not be exceeded .

Low pressure cuffs

large volume cuffed endotracheal tubes

Portex Profile

Searle Sensiv

Mallinkrodt Hi-Lo

Lanz

cuff inflation pressure

tracheal mucosa

impaired mucosal blood flow .

tracheal mucosal blood flow

tracheal morbidity

cuff inflation pressure

patients undergoing surgery


Short-term pulmonary effects of total parenteral nutrition in children with cystic fibrosis . Indices of respiratory muscle strength , pulmonary function , and pulmonary diffusing capacity were measured in 11 malnourished children ( age 10 to 17 years ) with cystic fibrosis , before and after improvement of nutritional status with supplemental parenteral nutrients for 1 month . During this time , the children received 120 % of estimated energy requirements ( either 3.75 % or 22.5 % as lipid ) and amino acids 2.5 gm/120 kcal by central venous catheter , plus as much of their usual diet as desired . With nutritional supplementation , body weight , triceps skinfold thickness , and mid-arm muscle circumference increased ( mean 15 % , 62 % , and 95 % , respectively ) . Maximum inspiratory airway pressure also increased ( mean 29 % ; P less than 0.01 ) , suggesting improvement in respiratory muscle strength . However , none of the indices of pulmonary function improved . Pulmonary diffusing capacity did not change during parenteral nutrition regardless of the amount of parenteral energy intake supplied by lipid , but arterial oxygen saturation decreased ( mean of 93.5 % to 91.5 % ; P less than 0.005 ) . During the month following parenteral nutrition , weight , skinfold thickness , and mid-arm muscle circumference , but not MIP , decreased and arterial oxygen saturation returned to the initial value ( P less than 0.01 ) .

total parenteral nutrition

supplemental parenteral nutrients

lipid

amino acids

nutritional supplementation

body weight

triceps skinfold thickness

mid-arm muscle circumference

respiratory muscle strength

indices of pulmonary function

Pulmonary diffusing capacity

parenteral energy intake

arterial oxygen saturation

children

cystic fibrosis

malnourished

cystic fibrosis


Cognitive effects of lithium carbonate and haloperidol in treatment-resistant aggressive children . The effects of lithium carbonate and haloperidol on cognition were examined in a placebo-controlled , double-blind study of 61 treatment-resistant , hospitalized school-aged children . They all had a DSM-III diagnosis of conduct disorder -- undersocialized , aggressive , with a profile of highly explosive and aggressive behavior . Children were assessed at the end of a two-week placebo-baseline period and again after four weeks of treatment . Drug effects on cognition were mild . Haloperidol ( mean dose , 2.95 mg/day ) caused significant decreases in Porteus Maze test quotient scores and a slowing of reaction time ( RT ) on a simple RT task . Lithium carbonate ( mean dose , 1,166 mg/day ) adversely affected qualitative scores on the Porteus Maze test . No significant treatment effects were found for the Matching Familiar Figures Test , short-term recognition memory and concept attainment tasks , or the Stroop Test .

lithium carbonate and haloperidol

lithium carbonate and haloperidol

placebo-controlled

placebo-baseline

Haloperidol

Lithium carbonate

Porteus Maze test quotient scores

slowing of reaction time ( RT )

Matching Familiar Figures Test

short-term recognition memory

concept attainment tasks

the Stroop Test


Ascorbic acid and performance in man . Effects on performance of 1 , 2 and 4 g ascorbic acid were studied from 0.5-5.5 h after ingestion in six healthy females . Diazepam ( 5 mg ) was included as an active control , and it impaired digit symbol substitution , visuomotor coordination and complex reaction time . There were no effects of any dose of ascorbic acid on performance .

Ascorbic acid

ascorbic acid

ascorbic acid

performance

performance

performance .

six

healthy

females


The treatment of acne vulgaris in general practice . A double-blind assessment of co-trimoxazole and tetracycline .

co-trimoxazole and tetracycline .

acne vulgaris


Relief of osteoporotic backache with fluoride , calcium , and calciferol . In a prospective randomized clinical trial comprising 22 postmenopausal women with backache and a halisteretic spine with crush fracture ( s ) , 12 women completed a 12-week therapy with sodium fluoride , calcium and calciferol and 10 with placebo . A statistically significant improvement ( p less than 0.05 ) , evaluated by a four-stage scale on pains , infirmity , and consumption of analgesics , was observed in the actively treated patients .

fluoride , calcium , and calciferol .

placebo .

osteoporotic backache

consumption of analgesics

osteoporotic backache

postmenopausal

women

women


Risk of infection after penetrating abdominal trauma . To identify the risk factors for the development of postoperative septic complications in patients with intestinal perforation after abdominal trauma , and to compare the efficacies of single-drug and dual-drug prophylactic antibiotic therapy , we studied 145 patients who presented with abdominal trauma and intestinal perforation at two hospitals between July 1979 and June 1982 . Logistic-regression analysis showed that a higher risk of infection ( P less than 0.05 ) was associated with increased age , injury to the left colon necessitating colostomy , a larger number of units of blood or blood products administered at surgery , and a larger number of injured organs . The presence of shock on arrival , which was found to increase the risk of infection when this factor was analyzed individually , did not add predictive power . Patients with postoperative sepsis were hospitalized significantly longer than were patients without infection ( 13.8 vs. 7.7 days , P less than 0.0001 ) . Both treatment regimens -- cefoxitin given alone and clindamycin and gentamicin given together -- resulted in similar infection rates , drug toxicity , duration of hospitalization , and costs .

cefoxitin

clindamycin

gentamicin

risk of infection

hospitalized significantly

infection rates , drug toxicity

duration of hospitalization , and costs

intestinal perforation

abdominal trauma

abdominal trauma

intestinal perforation

postoperative sepsis


Immunogenicity and safety of a plasma-derived heat-inactivated hepatitis B vaccine ( CLB ) . Studies in volunteers at a low risk of infection with hepatitis B virus . The safety and immunogenicity of a plasma-derived heat-inactivated hepatitis B vaccine ( CLB ) were evaluated in 471 healthy human volunteers , who , both in their occupations and in their private lives , had been at minimal risk of being infected with hepatitis B virus . The first 202 individuals received three 3-micrograms doses of heat-inactivated hepatitis B surface antigen ( HBsAg ) at one-month intervals ( trial A ) . A total of 42 % one month after the first injection , 84 % after two months , and 93 % after five months had become anti-HBs ( antibody to hepatitis B surface antigen ) positive . In a second randomized study ( trial B ) , the immunogenicity of five different dosages of the vaccine was compared in 269 volunteers . When the dose of HBsAg was diminished from 3 micrograms to 1.5 , 0.6 , and 0.25 microgram , no decrease of the anti-HBs response was observed . However , when the dose was diminished to 0.1 microgram of HBsAg , the anti-HBs response dropped significantly to 63 % ( p less than 0.001 ) . In the recipients of all five vaccine dosages , no influence of sex and age was found on the anti-HBs conversion rates . During the eight-month observation period , none of the vaccinees became HBsAg and/or anti-HBc ( antibody to hepatitis B core antigen ) positive , and none developed antibodies associated with autoimmune liver disease . No serious side effects were observed .

Immunogenicity

safety

safety

immunogenicity

immunogenicity

anti-HBs response

anti-HBs response

anti-HBs conversion rates .

antibodies

serious side effects

healthy

hepatitis B virus


Rational-emotive therapy and the reduction of interpersonal anxiety in junior high school students . This study evaluated the effectiveness of rational-emotive therapy and rational-emotive imagery . Fifty-nine junior high school students who volunteered to participate in treatment for interpersonal anxiety were randomly assigned to rational-emotive therapy without imagery ( RET ) , rational-emotive therapy with imagery ( REI ) , relationship-oriented counseling ( ROC ) , and waiting-list control ( WLC ) groups . Groups met for seven 50-minute treatment sessions during a three-week period . Assessments were conducted at pretreatment , posttreatment , and three-week follow-up . Both self-report and sociometric measures were used to evaluate treatment outcome . At postassessment , both the RET and REI groups were rated on sociometric measures as significantly less interpersonally anxious than the WLC group . Mean scores favored the RET and REI groups , but no significant differences between these groups and the ROC group were obtained . The self-report measure did not significantly differentiate between groups , but the REI group demonstrated significant pre- to follow-up changes . Both the RET and REI groups yielded greater reductions in irrational thinking than did the ROC and WLC groups . In addition , the pattern of the results supported the use of rational-emotive imagery as a component of rational-emotive therapy . The practical implications of these findings are discussed .

Rational-emotive therapy

rational-emotive therapy

rational-emotive imagery

rational-emotive imagery

rational-emotive therapy

interpersonal anxiety

interpersonal anxiety

self-report and sociometric measures

sociometric measures

anxious

Mean scores

self-report measure

reductions in irrational thinking

Fifty-nine

anxiety


Effects of antihypertensive drugs on cognitive function in adolescents . The effects of clonidine and hydrochlorothiazide on cognitive function were studied in hypertensive adolescents requiring pharmacologic therapy for blood pressure control . Twenty-four adolescents with persistent blood pressure elevation ( greater than 95th % ) on placebo were randomized double blind to clonidine or hydrochlorothiazide treatment . A battery of cognitive tests were performed during the placebo phase and after 16 weeks of active therapy . Antihypertensive therapy resulted in significant blood pressure reduction ( p less than .01 ) . A slight interactive effect was observed in arithmetic performance ( p less than .05 ) . All other parameters of cognitive function were not affected by either treatment .

antihypertensive

clonidine

hydrochlorothiazide

clonidine

hydrochlorothiazide

Antihypertensive therapy

cognitive function

cognitive function

blood pressure

cognitive tests

blood pressure reduction

arithmetic performance

cognitive function

adolescents

hypertensive

Twenty-four

adolescents


Failure of pyridoxine to suppress raised serum prolactin levels . Pyridoxine has been reported as having an antilactogenic effect , presumably by suppressing prolactin secretion . We have measured serum prolactin levels during pyridoxine administration in two groups of hyperprolactinaemic subjects . In normal postpartum women , the postdelivery fall in serum prolactin levels did not differ significantly in treated and control subjects . In patients with chlorpromazine-induced hyperprolactinaemia and galactorrhoea , pyridoxine did not reduce the elevated levels . In neither group was milk production suppressed .

pyridoxine administration

hyperprolactinaemic subjects

raised serum prolactin levels

prolactin secretion

serum prolactin levels

serum prolactin levels

milk production