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Randomised controlled trial of a no-added-sodium diet for mild hypertension.

90 patients on medication for mild hypertension were randomly allocated to diet and control groups and kept under surveillance by their own doctors every 2 weeks for 12 weeks to test the short-term effectiveness of a diet free from sodium additives as an alternative to medication. Mean urinary sodium excretion was reduced 37.0 mmol/24 h in the diet group and 161.0 mmol/24 h in the control group, with average K/Na ratios of 3.9 and 0.50. Both groups had a fall in mean systolic and diastolic blood pressure, but the diet group finished on half of the initial amount of medication, with 1 patient in 3 off medication and 4 out of 5 having either stopped or reduced the dose. The control group remained on almost the full amount of medication, with 2 patients out of 3 having made no reduction. The diet group had a mean weight loss of 2.1 kg, a rise in serum potassium, and a fall in serum bicarbonate. There was no increase in overall frequency of muscle cramp, and the diet group reported feeling happier, less depressed, and less dependent on analgesics. Two-thirds of the diet group intend to continue to diet indefinitely. Reduction of sodium intake permitted drug treatment to be substantially reduced without side-effects or loss of blood-pressure control.

Adult↗

Effect of ranitidine on healing of peptic ulcer: a 2-month study.

A multicenter trial of oral ranitidine 150 mg bid was conducted in 41 patients with duodenal and 30 with gastric ulcers. Patients were randomly allocated in double-blind fashion to 4 wk treatment with either ranitidine or placebo, after which all unhealed patients were given 4 wk on the active drug without breaking the original allocation code. After 4 wk of treatment the healing rate associated with ranitidine was significantly superior to that of placebo in both duodenal and gastric ulcer patients. Further improvement in cumulative healing rates was observed after the 2nd month of the study. After the allocation code was broken and all patients had had the opportunity of up to 8 wk on the active drug, there remained only a single unhealed pyloric ulcer. No serious adverse effects or biochemical abnormalities were observed. Ranitidine is a potent and well-tolerated H2 antagonist. Therapy for 4 or 8 wk is highly effective in the treatment of uncomplicated gastroduodenal ulcer.

Adult↗

Effect of spectacle use and accommodation on myopic progression: final results of a three-year randomised clinical trial among schoolchildren.

Two hundred and forty mildly myopic schoolchildren aged 9-11 years were randomly allocated to three treatment groups and the progression of myopia was followed-up for three years. The treatment groups were: (1) minus lenses with full correction for continuous use (the reference group), (2) minus lenses with full correction to be used for distant vision only, and (3) bifocal lenses with +1.75 D addition. Three-year refraction values were received from 237 children. The differences in the increases of the spherical equivalents were not statistically significant in the right eye, but in the left eye the change in the distant use group was significantly higher (-1.87 D) than in the continuous use group (-1.46 D) (p = 0.02, Student's t test). There were no differences between the groups in regard to school achievement, accidents, or satisfaction with glasses. In all three groups the more the daily close work done by the children the faster was the rate of myopic progression (right eye: r = 0.253, p = 0.0001, left eye: r = 0.267, p = 0.0001). Myopic progression did not correlate positively with accommodation, but the shorter the average reading distance of the follow-up time the faster was the myopic progression (right eye: r = 0.222, p = 0.0001, left eye: r = 0.255, p = 0.001). It seems that myopic progression is connected with much use of the eyes in reading and close work and with short reading distance but that progression cannot be reduced by diminishing accommodation with bifocals or by reading without spectacles.

Accommodation, Ocular↗

Neonatal maintenance solution--is neonatalyte safe?

Newborns in the neonatal unit at Ga-Rankuwa Hospital who required intravenous fluids were randomly allocated, after 24 hours of life, to receive either Neonatalyte (Sabax) or a control solution. Biochemical monitoring was performed every 12 hours for a period of 5 days. Neonatalyte does not cause hyperkalaemia or hypocalcaemia in the early neonatal period.

Calcium↗

Dosage and time effects of inhaled budesonide on bronchial hyperreactivity.

In a double-blind study of 2 parallel groups of 15 allergic asthmatic patients each, we investigated whether treatment with inhaled budesonide has a dose- and time-dependent effect on the degree of bronchial hyperreactivity. The patients were randomly allocated to treatment with either 200 or 800 micrograms budesonide per day for a period of 8 wk. The active treatment period was preceded by a selection period of 3 wk, and a single-blind placebo period of 2 wk. During these initial 5 wk the maintenance treatment of the patients, including cromolyn sodium and inhaled corticosteroids, was withheld. Spirometry and inhalation provocation tests with methacholine were carried out, and the symptom score was recorded every 2 wk. The methacholine provocation concentrations (geometric mean) causing a decrease in FEV1 of 20% (PC20) in the 200 and 800 micrograms/day treatment groups just before the active treatment period were 0.90 and 0.91 mg/ml, respectively. These values increased significantly to 1.21 and 1.84 mg/ml after 2 wk of treatment (p less than 0.05 and p less than 0.001, respectively) and to 1.55 and 2.74 mg/ml after 8 wk of treatment (p less than 0.01 and p less than 0.001). During the whole study period budesonide in a dosage of 800 micrograms/day induced a significantly larger change in PC20 than in a dosage of 200 micrograms/day. The FEV1 before treatment was 91 +/- 3% (SEM) and 84 +/- 2% of the predicted value in the 200 and 800 micrograms/day treatment groups, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗

Effect of captopril at two different dosage regimens in hypertensive non-insulin dependent patients.

Thirty patients (21 F, 9 M) of mean age 55.3 years with non-insulin dependent diabetes mellitus of mean duration 10.8 years and hypertension (blood pressure 160/95 mm Hg) of 0.3 to 4.0 years were randomly allocated to either a twice daily regimen of captopril (50 mg twice daily, Group A) or a once daily captopril schedule (50 mg once daily, Group B). Good glycaemic control (HbA1c, mean 7.63%) had been achieved with sulphonylureas in 22 patients and insulin in 8 patients. There were no statistical differences in baseline values between the two groups. For the 15 patients in Group A, blood pressure fell significantly from a baseline of 177 +/- 13.2/106 +/- 7.8 mm Hg to 161 +/- 14.3/91 +/- 6.9 after one month (P less than 0.05) and continued to decrease at 3 and 6 months. In Group B the blood pressure changed from 179 +/- 19.0/110 +/- 15.6 to 169 +/- 21.0/98 +/- 7.2 at 1 month (P less than 0.05) with further reductions again seen at 3 and 6 months. Nine patients had poorer response than the other 21 but there were no demographic differences between these subgroups nor were there any differences in plasma renin activity or aldosterone responses. There were no statistically significant changes in haematological or biochemical values in either group during treatment. In particular, HbA1c and fasting glucose were unaffected by captopril treatment. No side effects were encountered during the 6 months of follow-up. In conclusion, captopril is an effective antihypertensive in non-insulin dependent diabetes mellitus with mild to moderate hypertension and a once daily regimen could improve compliance.

Captopril↗

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.

Adrenergic beta-Antagonists↗

Ultrasonic localization of the porta hepatis prior to percutaneous transhepatic cholangiography.

Sixtyfour jaundiced patients were randomly allocated to have fine needle PTC performed with or without prior ultrasonographical localization of the porta hepatis. The general success rate was 97% and complications occurred in two patients (3%). Ultrasonography prior to PTC did not significantly reduce the number of needle passes in the liver parenchyma, the failure rate or the number of complications. Ultrasonic scanning, however, should precede PTC to disclose patients with obstructive jaundice and reveal hepatic and perihepatic abnormalities.

Adult↗

Dietary-induced changes in the fatty acid composition of human cheek cell phospholipids: correlation with changes in the dietary polyunsaturated/saturated fat ratio.

Healthy normotensive volunteers aged 20 to 59 yr were randomly allocated either to a control group or to one of two experimental groups. The control group ate a low P/S ratio diet for 12 wk while the first experimental group ate a high P/S ratio diet for 6 wk followed by a low P/S ratio diet for the next 6 wk. The second experimental group ate a low P/S ratio diet in the first 6 wk followed by a high P/S ratio diet for the next 6 wk. Dietary P/S ratio, plasma linoleic acid (18:2), and cheek cell phospholipid 18:2 levels were compared in each dietary group at the end of the 1st and 2nd 6 wk. On change from a low to a high P/S ratio diet, there was a 36% increase in the proportion of 18:2 in the cheek cell phospholipids in comparison with the proportion existing before the change. This was associated with an increase in the proportion of 18:2 in the plasma lipids of this group. No reduction in the proportion of 18:2 in the cheek cell phospholipids was apparent in the control group or the group which changed from a high to a low P/S ratio diet, although in the latter group there was a reduction in the proportion of 18:2 in the plasma lipids. As the phospholipid fatty acid composition of human cheek cells reflects dietary lipid status under certain conditions, this observation may be useful in dietary and nutritional studies, particularly as human cheek cells can be obtained in a noninvasive manner.

Adult↗

Effectiveness and cost of different strategies for information feedback in general practice.

AIM: The aim of this study was to determine the effectiveness and relative cost of three forms of information feedback to general practices--graphical, graphical plus a visit by a medical facilitator and tabular. METHOD: Routinely collected, centrally-held data were used where possible, analysed at practice level. Some non-routine practice data in the form of risk factor recording in medical notes, for example weight, smoking status, alcohol consumption and blood pressure, were also provided to those who requested it. The 52 participating practices were stratified and randomly allocated to one of the three feedback groups. The cost of providing each type of feedback was determined. The immediate response of practitioners to the form of feedback (acceptability), ease of understanding (intelligibility), and usefulness of regular feedback was recorded. Changes introduced as a result of feedback were assessed by questionnaire shortly after feedback, and 12 months later. Changes at the practice level in selected indicators were also assessed 12 and 24 months after initial feedback. RESULTS: The resulting cost per effect was calculated to be 46.10 pounds for both graphical and tabular feedback, 132.50 pounds for graphical feedback plus facilitator visit and 773.00 pounds for the manual audit of risk factors recorded in the practice notes. The three forms of feedback did not differ in intelligibility or usefulness, but feedback plus a medical facilitator visit was significantly less acceptable. There was a high level of self-reported organizational change following feedback, with 69% of practices reporting changes as a direct result; this was not significantly different for the three types of feedback. There were no significant changes in the selected indicators at 12 or 24 months following feedback. The practice characteristic most closely related to better indicators of preventive practice was practice size, smaller practices performing significantly better. Separate clinics were not associated with better preventive practice. CONCLUSION: It is concluded that feedback strategies using graphical and tabular comparative data are equally cost-effective in general practice with about two thirds of practices reporting organizational change as a consequence; feedback involving unsolicited medical facilitator visits is less cost-effective. The cost-effectiveness of manual risk factor audit is also called into question.

Cost-Benefit Analysis↗

Clinical trial of deglycyrrhizinised liquorice in gastric ulcer.

Ninety-six patients with gastric ulcer were randomly allocated to treatment either with deglycyrrhizinised liquorice or placebo. After four weeks no differences were found between the treatment groups in the proportions with complete healing, whether assessed by gastroscopy or radiology, or in the percentage reduction in ulcer area, or in clinical improvement.

Antacids↗

The value of antenatal cardiotocography in the management of high-risk pregnancy: a randomized controlled trial.

The value of routine regular antenatal cardiotocography (CTG) in the management of high-risk pregnancy was assessed in a prospective randomized controlled study of 353 patients. All patients had a weekly CTG trace during the last 6 weeks of pregnancy and according to the random allocation the tracings were concealed from, or available to, the clinicians. Other methods of assessing fetal welfare were available to both groups. There was no significant difference between the concealed and revealed groups in the timing and mode of delivery, birthweights, Apgar score and neonatal morbidity. No apparent effect from the routine use of antenatal CTG in high-risk pregnancy was shown.

Adolescent↗

Prevention of atherosclerotic complications: controlled trial of ketanserin. Prevention of Atherosclerotic Complications with Ketanserin Trial Group.

STUDY OBJECTIVE: To determine whether ketanserin, an antagonist at the serotonin receptor, prevents important vascular events such as death, myocardial infarction, major stroke, and amputation of a leg in patients with claudication. DESIGN: Double blind, randomised, placebo controlled trial after a single blind run in period of placebo treatment for one month. SETTING: One hundred and forty seven outpatient clinics in 14 countries. PATIENTS: Total of 3899 patients over 40 years old who had had documented intermittent claudication for at least two months and in whom the ratio of systolic blood pressure in the ankle to that in the arm was less than or equal to 0.85 in both arteries of at least one foot. INTERVENTION: After the one month placebo run in period patients were randomly allocated to take 20 mg ketanserin three times daily for the first month and 40 mg three times daily thereafter or to take the same number of placebo tablets. Five months after the onset of the trial, on the recommendation of the ethical and safety committee, four patients stopped taking ketanserin and two stopped taking placebo because they had a corrected QT interval greater than 500 ms. Four months later the committee recommended that all patients taking diuretics should stop receiving trial treatment (167 of those taking ketanserin and 144 of those taking placebo). END POINT: The first primary event after randomisation. Primary events were definite myocardial infarction, major stroke, amputation above the ankle, excision of ischaemic viscera, and death due to other vascular causes. MEASUREMENTS AND MAIN RESULTS: There were 136 study end points in the 1930 patients treated with ketanserin, who were followed up for 2063 patient years, and 132 study end points in the 1969 patients treated with placebo, who were followed up for 2129 patient years. A harmful interaction of ketanserin and potassium losing diuretics resulted in an increase in the number of deaths. After patients taking potassium losing diuretics or antiarrhythmic agents were excluded [corrected] a secondary analysis showed that there were 65 end points in 1514 patients taking ketanserin and 87 in 1557 patients taking placebo, a reduction of 23% in the number of study end points in those taking ketanserin. CONCLUSIONS: Ketanserin can prolong the corrected QT interval, and the combined use of ketanserin and potassium losing diuretics can be harmful. A secondary analysis suggested a protective effect of ketanserin against cardiovascular complications in patients with claudication.

Adult↗

The prevention of gastric inflation--a neglected benefit of cricoid pressure.

The ability of cricoid pressure to prevent inflation of the stomach during mask ventilation of a patient was studied. Fifty patients were randomly allocated to either have or not have cricoid pressure applied during a three-minute period of standardised mask ventilation. Patients who had had cricoid pressure applied had less gas in the stomach after mask ventilation (P less than 0.001). However, in a subgroup of patients considered difficult to ventilate, cricoid pressure seemed less successful in preventing gastric inflation. Cricoid pressure is a useful technique for reducing gastric inflation during mask ventilation, particularly in patients who are relatively easy to ventilate.

Cricoid Cartilage↗

A randomized study of fetal abdominal diameter and fetal weight estimation for detection of light-for-gestation infants in low-risk pregnancies.

A total of 2771 pregnant women with gestational age estimated by ultrasound measurement of the fetal biparietal diameter (BPD) before the 22nd week of gestation were re-examined by ultrasound in the 32nd and 37th week of pregnancy at which time the fetal BPD and abdominal diameter (AD) were measured. An additional examination was performed at 34 weeks if the fetal weight in the 32nd week was estimated to be less than 95% of the expected mean weight. Light-for-gestational age (LGA) was suspected if the estimated birth-weight was less than 85% of the expected mean birthweight. This applied to 186 uncomplicated pregnancies in which there was no clinical suspicion of poor intrauterine growth. These pregnancies were randomly allocated to a treatment group (AD and estimated weight reported) or to a control group (AD and estimated weight withheld). Induction of labour was significantly more common in the treatment group (41%) than in the control group (15%). No statistically significant difference was found in the use of instrumental vaginal delivery or caesarean section. There was a suggestion of marginal benefit in terms of neonatal morbidity but this was not statistically significant.

Abdomen↗

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

The effects and side effects in steady state of a sustained-release preparation of terbutaline 7.5 mg twice daily were compared with ordinary tablets 5 mg three times daily. The study performed for two weeks was double-blind, double-dummy, cross-over with randomized allocation of the drugs. 20 patients completed the trial and the results show higher mean morning PEFR values and a tendency to milder side effects with depot tablets.

Adult↗

[A letter to benzodiazepine users--an efficient way to reduce the prescription].

Eight general practitioners in Aust-Agder county (southern Norway) had 169 patients who were found to be suitable for receiving a letter arguing for reduction of daily benzodiazepine intake, or cessation of the drug. The patients were randomly allocated to an intervention or control group. 4-12 months after receiving the letter, the amount of benzodiazepines (DDD/six months) prescribed had decreased by 51% in the intervention group and by 24% in the control group. The impression of the participating doctors was that the patients appreciated the information and that it was easier than expected to get the patients to reduce benzodiazepine intake. The marked reduction in the control group too indicates that the doctors' active attitude towards dose reduction had been applied towards these patients as well.

Benzodiazepines↗