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PubMedDate not supplied

Medical ethics and controlled clinical trials.

The controlled clinical trial is a relatively new phenomenon; the first large clinical trial on evaluation of streptomycin in therapy of pulmonary tuberculosis occurred in 1946. In such a study, two or more groups of patients with similar characteristics are chosen by random allocation to receive one or more therapies. The essential ethical dilemma is based on the risk-benefit ratio of the new therapy. Ethical factors that must be considered in the design of controlled clinical trials include provision for informed consent, nature of alternate therapy, confidentiality of data, source of funding and potential conflict of interest, remuneration of subjects, criteria for ending participation of the subject, criteria for concluding the trial, compensation of injured subjects, compliance with institutional, municipal, state and federal regulations and provisions for special groups such as the fetus and pregnant woman, infants and young children, institutional patients and prisoners. Federal guidelines for research in specific areas are now available through the reports of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. To date, commission reports include recommendations for research in fetuses and pregnant women and in children. Protection of the subject is best provided by the the quality of the protocol, integrity of the investigator, valid informed consent, and review of the research program by an independent committee composed of scientists and consumers.

Child↗
PubMed1978

Chlorambucil dosage in frequently relapsing nephrotic syndrome: a controlled clinical trial.

A controlled clinical trial was performed using two dosage regimens of chlorambucil to treat children with frequently relapsing nephrotic syndrome. All children concurrently received prednisone (60 mg/m2 on alternate days). Ten children (Group I) were given chlorambucil as a stable dose (0.2 mg/kg/day) for 56 to 60 days, and 11 children (Group II) received increasing doses (0.2 to 0.63 mg/kg/day) for 42 to 77 days. Two children in each group subsequently relapsed. Follow-up averaged 28.6 and 27.2 months in Groups I and II, respectively. Three children in Group II developed infectious complications. The data indicate that a stable dosage regimen for chlorambucil is as effective as an increasing dose regimen in achieving long-term remission of frequently relapsing nephrotic syndrome.

Adolescent↗
PubMed1977

Long-term treatment with sulphamethoxazole/trimethoprim (Bactrim) and nitrofurantoin in chronic urinary tract infections. A controlled clinical trial.

In a controlled clinical trial based on 30 geriatric patients with recurrent urinary tract infection, 12 out of 17 patients fulfilled a 12-month treatment with sulphamethoxazole/trimethoprim (Bactrim) with continuous sterile urine compared to 1 out of 13 patients treated with nitrofurantoin (p less than 0.05). There was a slight but statistically significant increase in serum creatinine during treatment for 12 months in the sulphamethoxazole/trimethoprim group, but this probably does not reflect any deterioration in kidney function. The remaining laboratory values showed no significant changes whatsoever.

Aged↗
PubMed1979

3-Methoxy-4-hydroxyphenylglycol excretion in acutely schizophrenic patients during a controlled clinical trial of the isomers of flupenthixol.

Urinary MHPG excretion in patients with acute schizophrenia was studied before and during a trial of the isomers of flupenthixol and placebo. Pretrial MHPG excretion was not related to severity of illness before the trial or to other pretrial clinical variables. In male subjects higher pretrial MHPG excretion was associated with a better outcome 1 year post-trial. However in females no relationship between MHPG excretion and outcome was established. During the trial there was a reduction in MHPG excretion in patients treated with beta-flupenthixol but no decrease in the group treated with alpha-flupenthixol or chlorpromazine. In patients on placebo there was a reduction in MHPG excretion in those who did well clinically, but not in those who did poorly. Thus low MHPG excretion may be a predictor of poor outcome in schizophrenia, but MHPG excretion also changes both as a function of clinical state and of neuroleptic drug administration.

Adult↗
PubMed1979

Preoperative prophylactic cephalothin fails to control septic complications of colorectal operations: results of controlled clinical trial. A Veterans Administration cooperative study.

Data obtained from a survey of the membership of the Society for Surgery of the Alimentary Tract and the American Society of Colon and Rectal Surgeons indicated that concomitant administration of oral neomycin-erythromycin base and systemic cephalothin, together with mechanical colon cleansing, was the most popular method of colon preparation. We designed a prospective double blind clinical trial to compare administration of intravenous cephalothin, oral neomycin-erythromycin base, and the combination of both the intravenous and oral antibiotics. Intake of patients to the intravenous cephalothin group was stopped because the data indicated that this method of prophylaxis resulted in significantly higher numbers of septic complications. The incidence of wound infection was 30 per cent and the overall incidence of septic complications was 39 per cent in patients receiving only intravenous cephalothin combined with mechanical colon cleansing. The incidence of wound infection and the overall incidence of septic complications was only 6 per cent in the comparison group, and the differences are highly significant.

Aminoglycosides↗
PubMed1978

Controlled clinical trial of arginine for infertile men with oligozoospermia.

64 infertile men with oligozoospermia took part in a double blind cross-over trial. Each patient received matching capsules of a placebo and arginine for periods of 12 weeks. There was no difference in the conception rates of the wives or changes in the quality of the semen during each period of treatment.

Arginine↗
PubMed1977

Prophylactic treatment of migraine with clonidine. A controlled clinical trial.

In a double-blind crossover trial of two 12-week treatment periods with a 4-week treatment free interval, to which 21 patients were admitted, there was no statistically significant difference between clonidine 75 microgram twice daily and placebo in the total number of headache days, migraine indices, duration of attacks, number of severe attacks and consumption of acute attack treatment. However, there was a marked reduction in number of headache days, migraine indices, duration of attacks and consumption of acute attack treatment during the second treatment period compared to the first treatment period, regardless of the treatment regime. This was presumably a result of prolonged treatment and frequent attention and not an effect of the active drug. 32 patients entered the trial, but 11 dropped out. Of the 21 patients completing the trial, 16 were women; the median age was 34 years (range 17-54 years) and the median duration of headaches 12 years (range 1-40 years). Only mild side-effects were registered and no laboratory abnormalities were seen.

Adolescent↗
PubMed1976

Glucagon and barium enema examinations: a controlled clinical trial.

In a double-blind crossover clinical trial, 10 healthy volunteers received placebo and 2 mg glucagon intramuscularly preceding barium enema examination on separate days. In addition, 50 patients were given either placebo or 2 mg glucagon prior to barium enema examination in a double-blind study. The results of 38 variables determined on each study population were similar. When glucagon was given, both the patients and examiners noted significantly less discomfort and more bowel relaxation. There were no significant changes in pulse, blood pressure, or electrocardiogram. Adverse reactions did not occur frequently enough to allow confident comparison of placebo and glucagon. It is concluded that the use of glucagon can provide a more comfortable barium examination with acceptable safety.

Adult↗
PubMed1979

[Advances in the conservative treatment of acute traumatic cerebral edema. Controlled clinical trial with follow-up examination (author's transl)].

Studies in 142 accident victims with severe craniocerebral trauma showed that the intravenous application of sodium escinate over several days considerably reduced the dangerous rise in intracranial pressure and also the total mortality in comparison with corticosteroid therapy alone. Both groups, each of 71 patients, were adjusted from an initial intraventricular pressure of 500--250 mm H2O to the same basic pressure of 150 mm H2O hydrostatically. In the same way, sodium escinate shortened the duration of unconsciousness. The renal function in patients was good. Follow-up examinations at least 2 to a maximum of 3.5 years after the accident and treatment showed a significantly higher rehabilitation rate in the sodium escinate group.

Adrenal Cortex Hormones↗
PubMed1975

[Results of a controlled clinical trial for evaluation of intensive preoperative irradiation in operable bronchial cancer (author's transl)].

To examine the value of an intensive preoperative irradiation on the bronchial carcinoma, 196 operable patients with tumors being histologically confirmed were divided into two groups by drawing the lot: 99 patients for preoperative irradiation, 97 for primary operation. The correspondence of the following criteria was tested and confirmed: age, sex, no symptons, histological tumor type. The preoperative irradiation dose amounted to 5,500 RHD (CO-60). Out of both groups the same number of patients was resected (83 and 85 respectively); within the preoperative irradiated group, however, 11 patients were omitted before the operation (information on reasons), while within the not irradiated group the number of thoracotomized but not resected cases was adequately greater (13). There is no statistically significant difference within the annual survival rate, although the mortality of the primarily operated patients is a bit more favourable. Quite the same is valid for postoperative mortality and complications. The local recurrences (in all cases of necropsy), however, are statistically significant reduced after preoperative irradiation. Since there is no influence on the rate of surviving, the conclusion is drawn that the majority of the operable cases has already developed small distant metastatic formations, being decisive for the prognosis before any therapy was performed. That is why a new prospective series with a low irradiation dose is started, where an increase of complications is not to be expected, but the possibility exists to influence local micrometastatic formations, that means an influence only to those cases with the probability of a low degree of remote metastatic formations.

Adenocarcinoma↗
PubMed1979

A placebo controlled clinical trial of transfer factor in lepromatous leprosy.

The effects of repeated injections of transfer factor over a period of 20 weeks were investigated in fourteen bacteriologically positive patients at the lepromatous side of the leprosy spectrum. All patients showed negative (0 mm induration) skin tests to M. leprae antigens (i.e. leprolin and lepromin). Of these patients, seven were treated with transfer factor with a total of 9 units (1 unit being equivalent to 5 x 10(8) lymphocytes) and seven with a placebo. Maintenance treatment with clofazimine was continued. Transfer factor was prepared from the lymphocytes of donors who showed positive skin tests to M. leprae antigens (i.e. leprolin greater than or equal to 12 mm induration, average 15.5 mm or lepromin greater than or equal to 8 mm induration, average 13.6 mm), as well as a positive lymphocyte transformation in vitro to M. leprae (the average transformation being higher than the average transformation of lymphocytes of tuberculoid leprosy patients). No differences were found between the two groups as regards the clinical course of the disease, the histopathological and bacteriological evaluation of skin biopsies, changes in skin test reactivity to various antigens (i.e. lepromin, leprolin, PPD, Mumps, C. albicans, Tr. rubrum and Varidase), as well as the lymphocyte transformation in vitro to various mitogens (i.e. PHA, PWM, Con A) and antigens (i.e. M. leprae, leprolin, PPD, BCG, Mumps, C. albicans, Trichophyton and Varidase). No evidence was found to suggest that transfer factor is a valuable adjuvant in the treatment of lepromatous leprosy patients or that it increases cell-mediated immune reactivity towards M. leprae.

Antigens, Bacterial↗