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PubMed1981

Blood pressure reduction in elderly: a randomised controlled trial of methyldopa.

A total of 123 out of 549 elderly residents of local authority welfare homes in Nottinghamshire were found at screening to have a standing or lying diastolic blood pressure of 100 mm Hg or more. These 123 subjects were randomly allocated to simple observation or to treatment with methyldopa. The cumulative mortality was similar in the observed and treated groups and in the normotensive group from which the subjects had been separated. Thus moderate hypertension, whether treated or not, was not a major risk predictor in the elderly population studied.

Aged↗

PubMed1989

Ticlopidine in the treatment of intermittent claudication: a 21-month double-blind trial.

After a 3-month, single-blind, run-in period, 151 patients with intermittent claudication were randomly allocated to receive the antiplatelet agent ticlopidine (250 mg twice per day) or an identical placebo. One hundred and twenty patients completed the double-blind phase of the trial, which lasted 21 months. The primary analysis was performed according to the "intention-to-treat principle" in all 151 enrolled patients. There was, continuing on from the third month after randomization, a progressive and sustained improvement of the pain-free and maximum walking distances in the two treatment groups that was significantly greater in the ticlopidine group. The ankle-arm systolic blood pressure ratio at rest and after exercise increased in a significant manner in the ticlopidine group only. In a secondary analysis, with exclusion of 25 patients because of protocol violations at selection, consistently significant differences in favor of the ticlopidine group were still observed for maximum walking distance and systolic ankle-arm blood pressure ratio, both at rest and after exercise. No major side effects were reported in the treated group. It is concluded that long-term treatment with ticlopidine improves walking ability and ankle systolic blood pressure in patients with claudication.

Blood Pressure↗

PubMed1988

Tympanoplasty surgery and prophylactic antibiotics: surgical results.

This paper reports a multicentre, controlled, blind, prospective, randomized study into the use of prophylactic systemic antibiotics in myringoplasty surgery. A total of 130 individuals were randomly allocated to either an antibiotic or a non-antibiotic group. Each individual was clinically and audiometrically assessed preoperatively, and 8 weeks postoperatively. It was found that systemic prophylactic antibiotics did not influence either the success rate of myringoplasty surgery or the audiometric result.

Adolescent↗

PubMed1979

Randomized clinical trials in the evaluation of surgical innovation.

Randomized clinical trials are widely accepted as the standard for evaluation of therapeutic innovation in many fields of medicine. The three basic components of such trials (concurrent comparison, random allocation, and objective observation) are designed to control four forms of bias (chronology bias, susceptibility bias, compliance bias, and observation bias) that may interfere with the interpretation of the results of a study. Only 2% of the articles evaluating therapeutic maneuvers published in the Journal of Neurosurgery have attempted to use concurrent controls. Only one of 863 such articles met the criteria for a randomized clinical trial. Reasons for underutilization of such trials in neurosurgery are discussed and suggestions for their wider use are offered.

Clinical Trials as Topic↗

PubMed1987

Detection method, tumour size and node metastases in breast cancers diagnosed during a trial of breast cancer screening.

The relationship between tumour size and lymph node metastases was examined in screening-detected and clinically detected breast cancers. The data used were from a randomized trial of breast cancer screening with mammography. 964 cancers were reviewed, in both arms of the trial, in women aged 40-74. Lymph node status was significantly related to detection method (P less than 0.001), metastases being less common in screening-detected cancers. Node status was also significantly related to tumour size (P less than 0.001), metastases being commoner in larger tumours. Similarly, tumour size was significantly associated with detection method (P less than 0.001), smaller tumours being detected by screening. No significant interaction was observed among all three factors, indicating that the relationship between node status and tumour size did not change with detection method. When detection method was replaced with randomly allocated study (invited to screening) and control (not invited to screening) groups, the same results were observed. It is concluded that if screening detects tumours with a different natural history to that of those which surface clinically, this is not reflected in the relationship between tumour size and lymph node metastases.

Adult↗

PubMed1987

Controlled multicentre therapeutic trial of an unrefined carbohydrate, fibre rich diet in Crohn's disease.

Between 1 September 1980 and 31 August 1983, 352 patients with inactive or mildly active Crohn's disease but not taking drug treatment apart from sulphasalazine were entered from 40 hospitals into a prospective trial to assess the effects of two different diets on disease activity over two years. One hundred and sixty two patients were randomly allocated to take a diet unrestricted in sugar and low in fibre and 190 to a diet with little or no sugar and high in unrefined carbohydrate. No clear difference in clinical course was detected among patients who accepted the two different types of dietary advice.

Adolescent↗

PubMed1980

Adenoidectomy for middle ear disorders: a randomized controlled trial.

Repeated tympanometric screening of a regionally defined population of 3-year-old children defined a group of 42 children with middle ear disease which had persisted for at least 6 months. These children were treated by either myringotomy with adenoidectomy or myringotomy without adenoidectomy decided by random allocation. Postoperative observation during 6 months failed to disclose any difference in middle ear status between the two groups.

Adenoidectomy↗

PubMed1980

Effects of anti-mite measures on children with mite-sensitive asthma: a controlled trial.

Mite counts and tests for mite antigen were performed on samples of dust taken from the bedding of 53 children with mite-sensitive asthma. The samples from damp houses and the beds or enuretic children had markedly more mites and mite-antigen than those from dry houses. although the predominant species was usually Dermatophagoides pteronyssinus, some of the beds in the damp houses were heavily infested with another pyroglyphid mite Euroglyphus maynei, so that this was the species found in the greatest numbers. D pteronyssinus antigen was found to be correlated broadly with the total mite count, but more antigen was present for a given number of mites in the mattresses than in the blankets. The children were randomly allocated into two groups, one of which carried out rigorous anti-mite measures. The amounts of dust and mite antigen were reduced, though not the numbers of mites. Peak flow readings were monitored in the two groups for eight weeks and a final assessment made by a paediatrician who was unaware of the allocation of each patient in the trial. No significant differences emerged in the progress of the two groups, both tending to improve. Measures designed to remove mites from bedding do not greatly benefit the majority of children with mite-sensitive asthma.

Adolescent↗

PubMed1986

Potassium supplementation does not lower blood pressure in normotensive women.

Forty-four normotensive females, who were selected on the basis of lower prevailing potassium intake, participated in a two-period crossover study to assess the effects of potassium supplementation on blood pressure. They were randomly allocated to one of two groups who took either 80 mmol/day of KCl (Slow-K, Ciba Geigy), or matching placebo, for the first of two 4-week treatment periods. The treatments were reversed during the second 4-week period. Despite significant increases in both urinary and plasma potassium no consistent fall in blood pressure was seen during 80 mmol/day potassium intake.

Adult↗

PubMed2004

Dynamical influence of Cordyceps sinensis on the activity of hepatic insulinase of experimental liver cirrhosis.

BACKGROUND: Cordeceps sinensis (CS) is a herb which can inhibit the liver fibrosis. Hyperinsulinemia is common in liver cirrhosis patients. The activity of insulin degrading enzyme could reflect the metabolism of insulin. This study was to detect the dynamical effects and mechanisms of CS on the activity of hepatic insulinase in CCl4 induced liver cirrhosis in rats. METHODS: Rats were randomly allocated into three groups: normal group, model group and CS group. The rats in the normal group were sacrificed at the beginning of experiment, and the other two groups were sacrificed randomly at the end of the third, sixth and ninth weeks. Blood and tissue specimens were taken. Biochemical assays were used to determine the changes of alanine transaminase (ALT), albumin levels in serum. And radioimmunological assays were used to determine the changes of hyaluronic acid (HA), insulin levels in serum and the activity of hepatic insulinase. RESULTS: No significant differences were seen in the serum levels of ALT, albumin, HA between the CS group and the model group at the third and sixth weeks (P>0.05). The serum levels of ALT, HA in the CS group were lower than those in the model group at the ninth week (P<0.05), but the serum level of albumin in the CS group was higher than that in the model group at the ninth week (P<0.05). No significant differences were observed in the serum levels of insulin and the activity of hepatic insulinase between the CS and model groups at the third week and the normal group (P>0.05). The serum levels of insulin in the CS and model groups at the sixth and ninth weeks were higher than those in the normal group (P<0.05). But the activity of hepatic insulinase was lower than that in the normal group (P<0.05 or P<0.01). No significant differences were found in the serum levels of insulin and the activity of hepatic insulinase between the CS and model groups at the third, sixth and ninth weeks (P>0.05). CONCLUSIONS: CS may decrease the damage to hepatocyte by CCl4, and inhibit hepatic fibrogenesis. Six weeks after CCl4 administration, the activity of hepatic insulinase began decreasing. CS could not inhibit the decrease of the activity of hepatic insulinase.

Alanine Transaminase↗

PubMed1990

Phenytoin sodium and magnesium sulphate in the management of eclampsia.

Twenty-two patients with eclampsia were randomly allocated to receive either intravenous phenytoin sodium or intravenous magnesium sulphate. The groups were comparable. No side-effects occurred and therapeutic levels were obtained in both groups. While none of the 11 patients managed with magnesium sulphate had further convulsions, four of the 11 treated with phenytoin sodium did and were subsequently effectively treated with magnesium sulphate. These results suggest that phenytoin sodium is not as effective an anticonvulsant in eclampsia as is magnesium sulphate.

Adolescent↗

PubMed1988

IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis.

Despite the development of newer generation of antibiotics, mortality from neonatal sepsis remains high. In a prospective, randomized study, we investigated the use of IgM-enriched immunoglobulin therapy in neonatal sepsis. Two groups of 30 infants each (matched for gestational age, sex, weight, and other variables) were randomly allocated to receive either antibiotics alone (control group) or antibiotics plus 5 mL/kg/d for four days of IgM-enriched immunoglobulin intravenously (immunotherapy group). Mortality from sepsis in the control group was 20% (6/30), while in the immunotherapy group it was 3.3% (1/30). We conclude that IgM-enriched immunoglobulin therapy in conjunction with antibiotic therapy significantly reduces mortality from neonatal sepsis.

Anti-Bacterial Agents↗

PubMed1988

A double-blind, randomised, placebo-controlled trial of fish oil in psoriasis.

28 patients with stable chronic psoriasis completed a trial in which they were randomly allocated to receive either 10 fish-oil capsules ('MaxEPA') or 10 placebo capsules (olive oil) daily. Patients were specifically instructed not to change their normal diet. After 8 weeks' treatment there was a significant lessening of itching, erythema, and scaling in the active treatment group, with a trend towards an overall decrease in body surface area affected. No change occurred in the placebo group.

Administration, Oral↗

PubMed1984

A double-blind randomized trial of cimetidine in acute upper gastrointestinal bleeding.

Two hundred and thirteen patients were studied in a double-blind trial of cimetidine versus placebo in the treatment of acute upper gastrointestinal haemorrhage. One hundred and six patients were randomly allocated to receive cimetidine and 107 to receive placebo. There was no significant reduction in transfusion requirements, incidence of further haemorrhage, length of stay in hospital, or mortality in the treated group. There was no subgroup of patients with acute upper gastrointestinal bleeding which appeared to benefit from treatment with cimetidine.

Adolescent↗

PubMed1986

Anti-ulcer drugs and intrinsic factor secretion.

Twelve healthy volunteers were randomly allocated to take two of the following treatments; cimetidine, misoprostol (a prostaglandin E1 analogue) and carbenoxolone, for two weeks. A further four subjects took ranitidine. Gastric aspirates were collected before and on the 14th day of therapy for each drug, and analysed for intrinsic factor concentration and total output. Both randitine and cimetidine inhibited pentagastrin stimulated output by 47% and 27% respectively in comparison to control, but had no effect on stimulated mean intrinsic factor concentrations. No changes were observed with misoprostol and carbenoxolone treatment.

Adult↗

PubMed1988

No effect of continuous passive motion after arthroplasty of the knee.

We randomly allocated 54 patients to active physical therapy only or this combined with 2 hours of passive knee motion twice daily from 2-12 days after total knee arthroplasty. The range of knee motion was measured on the 14th postoperative day. We found no difference between the groups. We concluded that 4 hours' passive motion daily in addition to early, active physical therapy does not improve the range of knee motion or promote mobilization after arthroplasty.

Adult↗

PubMed1979

Anticoagulants in the treatment of small cell carcinoma of the bronchus.

The object of this study was to see if the addition of anticoagulants to a regimen of cytotoxic drugs would improve the prognosis in patients with small cell carcinoma of the bronchus. Twenty-four patients were randomly allocated to receive chemotherapy or chemotherapy plus anticoagulants. The median survival in the group receiving the anticoagulants was not improved.

Antineoplastic Agents↗

PubMed1981

A randomized study of misonidazole and radiotherapy for grade 3 and 4 cerebral astrocytoma.

The results are reported of a small clinical trial carried out to assess the potential value of the hypoxic cell radiosensitizer misonidazole in the radiation treatment of Grade 3 and 4 supratentorial astrocytomas. A total of 55 patients were randomly allocated to one of 3 treatment groups. No significant differences were seen between the median survivals of patients in the 2 control radiation groups and that of the third group in which oral misonidazole at a dose of 3 g/m2 preceded each of 4 weekly radiation doses. Possible reasons why no improvement was seen are discussed in detail.

Adolescent↗