Showing papers on "Randomized controlled trial published in 1975"

A controlled trial of azathioprine in Crohn's disease.

Abstract: To determine the efficacy of azathioprine in the treatment of Crohn's disease, a 26-week double-blind trial was performed 20 patients with Crohn's disease, requiring at least 10 mg of prednisone/day over the 3 months prior to entering the study were randomized into placebo (10 patients) and azathioprine (10 patients) treatment groups Reduction of steroids was the major criterion of success in the trial There were 7 relapses in the placebo group (5 patients) and 2 relapses in the azathioprine group (2 patients) Complications including fistulae were not affected by the medications The mean reduction in steroid dosage in the azathioprine group at the end of the trial (−155 mg) was greater than in the placebo group (−61 mg) These results suggest that azathioprine may permit reduction or discontinuation of steroids without the worsening of symptoms in some patients who appear to require steroids for control of their symptoms The clinical features of this “AZA-responsive subgroup” remain to be defined

Medical versus surgical therapy for acute coronary insufficiency. A randomized study

Abstract: Forty patients with acute coronary insufficiency, including continued angina at rest and reversible ischemic electrocardiographic changes after hospitalization ("high-risk" subgroup), were randomly allotted to medical therapy or urgent surgical coronary bypass groups. In four months there were no deaths and two myocardial infarctions in 19 medical patients and one death and three myocardial infarctions in 21 surgical patients. Left ventricular ejection fraction did not change significantly in either group. The surgical patients had significantly higher functional capacities at four months as judged by lower symptomatic functional class (P less than 0.01), higher exercise angina threshold (P less than 0.001), higher pacing angina threshold (P less than 0.0001), and higher myocardial lactate extraction during pacing (P less than 0.0001). Initial medical management of patients with acute coronary insufficiency followed by elective coronary bypass in patients with continued disabling angina pectoris is a reasonable alternative to emergency bypass.

Azathioprine plus prednisone compared with prednisone alone in the treatment of systemic lupus erythematosus. Report of a prospective controlled trial in 24 patients.

Abstract: A prospective, randomized drug trial compared prednisone (60 mg per day initially) to azathioprine (3 to 4 mg/kg of body weight - day initially) plus prednisone in 24 patients with life-threatening systemic lupus erythematosus. Each group contained patients matched for age, sex, disease duration, previous therapy, and clinical and laboratory features of lupus erythematosus. During a mean follow-up period of 18 to 24 months, there were no significant differences between the two groups in number of deaths, renal or extrarenal manifestations of disease, serum complement levels, DNA antibodies, antinuclear antibody titers, lupus erythematosus cells, or Coombs' antibodies. There was no convincing evidence of a steroid-sparing effect of azathioprine. Side effects attributable to steroids were equally common in both groups; infections were not increased in the combination therapy group. Azathioprine was hepatotoxic in doses of 200 mg daily or more. Azathioprine was not a useful adjunct to corticosterolds in short-term therapy of a small number of patients with severe systemic lupus.

A controlled, randomized trial of highly selective vagotomy versus selective vagotomy and pyloroplasty in the treatment of duodenal ulcer.

Abstract: The results of highly selective vagotomy without drainage and selective vagotomy with pyloroplasty for duodenal ulcer were compared in a randomized, controlled trial of a series of 100 patients. The frequency of dumping, diarrhoea, and epigastric fullness was significantly lower after highly selective (6, 6, and 8 percent) than after selective vagotomy (30, 20, and 28 percent) one year after the operations. Recurrent and persisting duodenal ulcers appearing from one to four years after the operations were significantly more frequent after highly selective (22 percent) than after selective vagotomy (8 percent). No significant relationships were found between recurrent ulceration and gastric acid secretion measurements after the two operations. The Hollander response was early positive in 28 percent and late positive in 30 percent of the patients subjected to highly selective vagotomy, while the corresponding figures after selective vagotomy were 26 and 32 percent. The overall clinical results of the two operations were not different according to the classification of Visick. Excluding the patients with recurrence resulted in significantly better clinical results after highly selective vagotomy.

Controlled Trial of Methylphenidate in Preschool Children with Minimal Brain Dysfunction

Abstract: (1975). Controlled Trial of Methylphenidate in Preschool Children with Minimal Brain Dysfunction. International Journal of Mental Health: Vol. 4, Recent Advances in Child Psychopharmacology, pp. 61-74.

Disodium cromoglycate in the treatment of chronic proctitis.

Abstract: The effect of topical disodium cromoglycate (DSCG) has been examined in 30 patients with chronic active proctitis using a double-blind crossover trial. Each treatment period was four weeks and patients were given DSCG 200 mg by enema twice daily and 100 mg orally three times each day. Twenty-six patients completed the trial successfully, 14 responded to DSCG treatment, two improved with placebo, and 10 responded to neither. Patients who responded to DSCG had significantly more eosinophils in their rectal biopsies than those who failed to respond and in some instances the counts were very high. The findings support the hypothesis than an allergic reaction is important in the pathogenesis of proctitis.

Comparison of two occupational therapy approaches for treating the young cerebral-palsied child

Abstract: This pilot study compared the results of facilitation and functional treatment approaches on the overall development of 12 cerebral-palsied children aged 1 to 5 years. The Denver Developmental Screening Test and the Bayley Motor Scale were used to evaluate the subjects. Pairs of children with similar developmental ages were identified and randomly assigned to the two treatment programs. Posttests and subsequent statistical analyses indicated that the group of children receiving the facilitation treatment approach showed significant improvement then did the group receiving the functional treatment approach in computed developmental age. Results suggest that comparative and evaluative studies should be continued on these approaches, as well as on other areas of clinical practice, to validate the effectiveness of occupational therapy treatment.

Brief Group Therapy following Myocardial Infarction: Eighteen-Month Follow-up of a Controlled Trial

Abstract: Sixty post-myocardial infarction (MI) subjects have been followed for up to eighteen months' time following their MI. Thirty-eight of these subjects completed a brief series of four to six group therapy sessions during their early rehabilitation phase; the others received no group therapy. Both groups were placed on otherwise identical schedules of outpatient follow-up. Group therapy patients have, to date, experienced significantly fewer cardiac complications than controls. Only one death has occurred, and that one patient was in the control group. A coronary heart disease teaching evaluation questionnaire was given to a sample of group therapy patients, a sample of controls, and a comparison group of men without MI. Following their group therapy sessions, these men demonstrated significantly greater knowledge of their disease and its optimal rehabilitation than did control or comparison subjects. Control patients' questionnaire results proved to be insignificantly different from those of the comparison group.

Management of hypertension. Effect of improving patient compliance for follow-up care.

Abstract: A randomized controlled trial was conducted in a metropolitan teaching hospital to determine whether improving follow-up of emergency room patients who had hypertension led to improvements in their medical care and blood pressure control. One hundred forty-four patients were randomly assigned into an intervention group and a control group. In the former, a follow-up clerk assisted patients in returning for follow-up care. Eighty-four percent of patients in this group and 63% of control patients returned to the clinic ( P ( JAMA 233:242-244, 1975)

Chemotherapy of advanced breast cancer: a controlled randomized trial of cyclophosphamide versus a four-drug combination.

Abstract: Ninety-nine patients with advanced breast cancer were randomized to receive either cyclophosphamide continuously or a combination of cyclophosphamide, methotrexate, 5-fluorouracil and vinblastine given intermittently. The number and duration of objective responses were greater in patients receiving the combination but the differences between the two treatments did not achieve formal significance. The combination was logistically easier to manage and produced less toxicity.

A comparison of sodium picosulphate ("Laxoberal") with standardised senna ("Senokot") in geriatric patients.

Abstract: SummaryA comparison was made between the effectiveness of sodium picosulphate and that of standardised senna in a group of 50 long-stay geriatric patients. Both were found to be equally effective as laxatives, but there were wide variations in the responses of individual patients to these agents. Side-effects were uncommon. They may well have been reduced further if a small starting dose of sodium picosulphate had been used.

Naproxen in Rheumatoid Arthritis: A Controlled Trial

Abstract: The efficacy of naproxen in treating rheumatoid arthritis patients was evaluated in a double-blind clinical trial using aspirin as the control drug. The study was conducted at seven centers and involved 80 patients. After an unequivocal increase in disease activity during a drug-free period, patients were randomly assigned to either drug and continued in the trial for 16 weeks. Some patients took low maintenance doses of corticosteroids, or gold salts, or both throughout the trial. Both test drugs significantly decreased disease activity as measured by a number of ways. By objective measurements, naproxen was as effective as aspirin, although patients in the naproxen-treated group entered the trial with more severe disease. By some subjective evaluations, naproxen was considered more effective than aspirin. Although patients taking naproxen had less frequent gastrointestinal side effects and fewer symptoms VIIIth nerve toxicity, the differences were not statistically significant. We conclude that naproxen is a useful addition to the physician's armamentarium for the treatment of rheumatoid arthritis.

A double-blind trial of methocarbamol versus placebo in painful muscle spasm.

Abstract: A double-blind trial of methocarbamol versus placebo was carried out in 59 matched pairs of patients suffering from painful muscle spasm. Methocarbamol (1500 mg. q.d.s.) was found to be effective in approximately 60% of patients compared with 30% of patients receiving placebo (p less than 0.01). Side-effects were of almost equal incidence in the two groups.

Randomized trial of transfer factor treatment of human warts.

Abstract: Dialysed transfer factor, prepared from the leucocytes of a donor whose warts had undergone recent spontaneous regression, was used in the treatment of a child with the Wiskott--Aldrich syndrome. The child then had a spontaneous regression at multiple warty areas. A similar relationship was seen in four otherwise healthy patients in a pilot study. A randomized double-blind study of thirty patients failed to confirm a causal relationship between the transfer factor therapy (equivalent to 2-1 X 10(8) leucocytes) and wart regressions. The need for randomized trials of transfer factor therapy for diseases with a variable natural history is emphasized.

[Randomised study on histaminelike side-effects of 5 common plasmasubstitutes in orthopedic surgery (author's transl)].

Abstract: Preceding anaesthesia 750 randomised patients, sub-divided into 5 different age groups, were given 500 ml of a standard plasma-substitute at a flow rate of 25-30 ml/min. There was direct correlation (p=0.1%) of the frequency of side-effects to the substance used; none, however, to the age or general surgical risk. Side-effects were observed in 21.3% with derivates of gelatin as compared to 3.7% with Macrodex and Plasmasteril combined. The rate of more serious anaphylactoid reactions was 6% with Haemaccel, 1.3% with Gelifundol-S, 0.67% with Macrodex and less than 0.67% with Neo-Plasmagel. The study reveals that serious side-effects may be expected in orthopaedictic patients after application of plasma substitutes. As a prophylactic procedure for those patients we recommend, therefore, the application of these substances only after careful consideration of the indications for their use.

A double-blind comparison of naproxen with indomethacin in osteoarthrosis.

Abstract: Twenty-two patients with osteoarthrosis of one or both knee joints and 28 patients with osteoarthrosis of one or both hips completed a double-blind trial of 500 mg naproxen daily versus 100 mg indomethacin daily. All patients had been on other active medication up to the start of the trial. Identical trial designs were followed with both classes of patients, namely, a crossover pattern of four weeks on each drug with patients being assessed at -2, 0, 2, 4, 6, and 8 weeks. Assessments made included objective measurement of joint range, stair climbing and walking times, and subjective grading of pain present during normal activity, of which the patient kept a daily record. Patients were also questioned at each clinic visit regarding possible side effects. Study groups were comparable for both drugs. In the majority of subjective and objective parameters, there were significant improvements from baseline on both drugs of statistically comparable magnitude. Significantly fewer side effects were noted during the period on naproxen compared with those on indomethacin. There were no abnormalities discovered in hematologic or biochemical tests performed during the course of the trial.

Double-blind cross-over comparison of clenbuterol and salbutamol tablets in asthmatic out-patients

Abstract: A double-blind cross-over comparison of a newβ 2-sympathomimetic bronchodilator, clenbuterol, with salbutamol and placebo has been made during a 24 day period of out-patient treatment of 19 adults with moderately severe asthma. Oral clenbuterol (10 µg 3 times a day) and salbutamol (4 mg 3 times a day) were equally and significantly (p<0.001) more effective than placebo, when daily records of peak expiratory flow or use of isoprenaline inhalations were the criteria of activity. Daily records of symptoms according to a questionnaire also suggested relief of the subjective effects of asthma during treatment with both active drugs (p<0.01).

Suppression of lactation with high doses of pyridoxine.

Abstract: Administration of high doses of vitamins B6, B1 and B12 successfully inhibited lactation without any untoward side-effects or discomfort in 96% of patients who had not yet established lactation, compared with 76,5% of control patients who received placebo.

Comparison of dopa decarboxylase inhibitor (carbidopa) combined with levodopa and levodopa alone on the cardiovascular system of patients with Parkinson's disease

Abstract: The effects of carbidopa combined with levodopa (carbidopa/levodopa) and levodopa alone on the cardiovascular system of patients with Parkinson's disease were evaluated Thirty-eight patients who had been on stable doses of levodopa underwent a complete cardiac examination, including measurement of recumbent and erect blood pressure and 24 hour ambulatory electrocardiographic monitoring Patients were classified with respect to the presence or absence of clinically significant heart disease and ventricular arrhythmias Nineteen of the 38 patients (50 percent) had heart disease, and 12 (32 percent) had significant ventricular arrhythmias Eleven of the 12 with arrhythmias had underlying heart disease The incidence of arrhythmias did not correlate with the dose of levodopa The patients were subsequently randomly assigned to treatment groups receiving either carbidopa/levodopa or levodopa alone There was no significant difference in the severity of ventricular arrhythmias or in the incidence of orthostatic hypotension in the group assigned to carbidopa/levodopa compared with the group receiving levodopa