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106 women between 24 and 33 weeks' gestation and in preterm labour, rigidly defined to include cervical dilatation plus regular uterine contractions, were randomly allocated to receive either intravenous ritodrine hydrochloride or no tocolytic treatment. Ritodrine treatment significantly delayed delivery for 24 hours or less but did not significantly modify the ultimate perinatal consequences of preterm labour.
One hundred and thirty patients scheduled for ENT surgery were randomly allocated to one of the four groups: 3 to 5 minutes before anesthesia the first group (n = 19) received 5 mg of droperidol I.V., the second group (n = 30) 2.5 mg, the third group (n = 32) 0.5 mg and the fourth group (n = 49) received 2 ml of normal saline. Normal saline or droperidol were administered in a double blind manner from 2 ml coded ampules. The postanesthetic incidence of vomiting in the control group was 59% and was found to be significantly higher when compared with the droperidol treated groups (chi2 = 19.5228, P less than 0.0005). The incidence of vomiting in the groups treated with high, moderate or low dose of droperidol varied between 16 and 21% and did not differ significantly between them (chi2 = 0.26035, P greater than 0.80).
Three hundred and seventy one patients with extensive or limited small cell cancer of the lung took part in a randomised trial to evaluate irradiation of the primary tumour in patients treated with combination chemotherapy. They were randomly allocated to treatment either with chemotherapy alone (198) or with both chemotherapy and radiotherapy (173). All 371 initially received 12 weeks of chemotherapy after which they were categorised according to response. Only those with stable or responding disease continued with their allotted treatment. Thus 144 received chemotherapy alone and 135 received both chemotherapy and radiotherapy. The design of the study permitted analysis of the effect of radiotherapy according to initial extent of disease and quality of early response to chemotherapy. Radiotherapy (40 Gy (4000 rad), one fraction a day over 20 days) did not improve the survival of patients in any category of initial extent of disease or early response to chemotherapy and was not effective in preventing local relapse.
A randomized, controlled clinical trial, of sequential design, was undertaken to determine whether fine catheter aspiration cytology of the peritoneal cavity, using the percentage of neutrophils in the sample as the main test marker, reduces errors about urgent laparotomy in patients admitted to a surgical unit with acute abdominal pain. One hundred and forty-four patients with acute abdominal pain were studied. Of these, 26 were excluded because the test was unlikely to be useful and 20 did not consent. Conventional clinical assessment was undertaken and then the subjects were randomly allocated to have a peritoneal cytology test or not. After the test result was made available, the surgeon(s) decided whether to operate or continue conservative treatment. The correct decision was later ascertained by a blinded clinical referee. With the entry of the 98th patient the difference between the groups achieved the 5% significance level. The groups were well-matched in regard to demographic and other variables. The decision about urgent laparotomy was incorrect in only 8.2% of the test patients, compared with 28.6% of the others. It is concluded that fine catheter aspiration cytology of the peritoneal cavity is likely to reduce the numbers of unnecessary or delayed laparotomies when used in most patients admitted with acute abdominal pain.
Thirty-four children with upper or lower respiratory tract infections were randomly allocated to receive either a twice daily or four times daily dose of 50 mg amoxycillin/kg body-weight/day. Mean duration of therapy was identical in both groups. Peak and trough antibiotic concentrations were determined. Eradication of bacteria, clinical improvement and side-effects were comparable in both groups.
The effect of continuous thoracic epidural analgesia (TEA) on the occurrence of postoperative deep vein thrombosis (DVT) was studied with the [125I]-fibrinogen uptake test in patients undergoing elective gallbladder surgery. The 98 patients were randomly allocated to three groups, viz. TEA for 24 hours, TEA plus general anesthesia with intermittent positive-pressure ventilation (IPPV) and general anaesthesia with IPPV but no TEA. The frequency of DVT was 13% in the group with general anaesthesia only and 7% in both of the other groups.
We made an open comparison of lignocaine and mexiletine in the treatment of ventricular arrhythmias occurring after open-heart surgery. Thirty patients whose arrhythmia did not respond to correction of metabolic disturbances were randomly allocated to receive treatment either with lignocaine or with mexiletine in fixed dosage schedules (15 in each group). Failure to control the rhythm or recurrent abnormality led to administration of a further dose and, if this was unsuccessful, to crossover to the alternative agent. The two drugs were comparable in efficacy, but mexiletine was slightly more effective when administered after lignocaine than the converse.
Mifepristone (RU 486; Roussel-Uclaf, Paris, France) is an antiprogesterone used for termination of very early pregnancy. The ripening effect of Mifepristone on the human pregnant cervix was studied in 42 healthy women from 7 to 11 weeks gestation. The women were randomly allocated to oral treatment of either 100 mg Mifepristone or placebo for 24 and 12 hours before vacuum aspiration. An objective method has been designed to measure the force necessary to step-wise dilate the cervix from 4 to 11 mm. Significant (p less than 0.05) changes in the stiffness of the cervix were demonstrated in patients treated with Mifepristone, reflecting ripeness. The treatment was simple and had no side effects.
The therapeutic effectiveness of combining tamoxifen with a combination chemotherapy regimen was tested in 135 patients with advanced breast cancer previously treated with chemotherapy. Patients were randomly allocated to received dibromodulcitol + Adriamycin (DA, 55 patients) or DA + tamoxifen (DAT, 67 patients). An additional 13 patients less than 50 years of age were assigned to DAT (DATN). Pretreatment characteristics were similar across both regimens. DAT and DATN yielded similar results in the less than 50-year-old cohort. DAT tended to be superior to DA with respect to response rate (55% versus 36%, p = 0.004), time to treatment failure (medians: 170 days versus 110 days, log rank p = 0.001), responders' time to treatment failure (360 days versus 220 days, p = 0.035), and survival (340 days versus 270 days, p = 0.18). Toxicity was similar in both regimens. Thus, addition of tamoxifen to a second-line DA regimen appears to increase the therapeutic effectiveness. It is suggested that the addition of this antiestrogen to other chemotherapy regimens would also be beneficial.
The effect of clonidine, an alpha 2 agonist, on sensory and motor blockade during spinal anesthesia was studied in 44 ASA physical status I II patients scheduled for orthopedic surgery. The patients were randomly allocated into three groups given 15 mg of 0.5% hyperbaric tetracaine (HT), within group I (N = 14) 1 ml isotonic saline, in group II (N = 15) 0.5 ml saline solution and 0.5 ml clonidine (75 micrograms), and in group III (N = 15) 1 ml clonidine (150 micrograms). Sensory blockade (SB) was evaluated by pinprick and motor blockade (MB) according to Bromage's scale. The level of SB was comparable in the three groups but the duration was different. The 75 micrograms clonidine was associated with 25% prolongation of SB at L2 and 29% prolongation of grade 3 MB Clonidine 150 micrograms prolonged the time of SB at L2 by 72% and grade 3 MB by 96%. Colloid infusion and the decrease in diastolic blood pressure were significantly greater in the clonidine 150 micrograms group compared to group I. A dose related prolongation of spinal anesthesia is demonstrated with clonidine.
A clinical trial cannot be adequately interpreted without information about the methods used in the design of the study and the analysis of the results. To determine the frequency of reporting what we consider 11 important aspects of design and analysis, we surveyed all 67 clinical trials published in the New England Journal of Medicine, the Lancet, and the British Medical Journal from July through December 1979 and in the Journal of the American Medical Association from July 1979 through June 1980. Of all 11 items in the 67 trials published in all four journals, 56 per cent were clearly reported, 10 per cent were ambiguously mentioned, and 34 per cent were not reported at all. At least 80 per cent of the 67 trials reported information about statistical analyses, statistical methods used, and random allocation of subjects, yet only 19 per cent reported the method of randomization. Loss to follow-up was discussed in 79 per cent of the articles, treatment complications in 64 per cent, and admission of subjects before allocation in 57 per cent, but eligibility criteria for admission to the trial appeared in only 37 per cent. Although information about whether patients were blind to treatment was given in 55 per cent, information about whether there was blind assessment of outcome was reported in only 30 per cent. The statistical power of the trial to detect treatment effects was discussed in only 12 per cent of the articles. The clinical trials published in The New England Journal of Medicine reported 71 per cent of the 11 items, those in the Journal of the American Medical Association 63 per cent, those in the British Medical Journal 52 per cent, and those in the Lancet 46 per cent. These rates are significantly different (P less than 0.001). We recommend that editors improve the reporting of clinical trials by giving authors a list of the important items to be reported.
Thirty-three consecutive patients having restorative proctocolectomy since April 1986 were randomly allocated to reconstruction using a stapled J pouch (n = 18) or a sutured W pouch (n = 15). There were no deaths, but one patient required pouch excision for ischaemia (J). One patient developed a leak from the pouch necessitating loop ileostomy (J) and one patient had a low pouch vaginal fistula successfully treated by a seton (W). There were no other major complications. Median (range) operative time was 200 min (165-290) for J pouch and 255 min (220-330) for the W pouch (P less than 0.05). In 24 patients followed up for more than 4 months after restoring intestinal continuity, median frequency of defaecation over 24 h was 4 (3-6) for the J pouch and 4 (3-6) for the W pouch. There was no incontinence, urgency or soiling. These results indicate that the quicker J pouch provides identical functional results to the larger W pouch in this series of patients.
Prevention of aortocoronary bypass occlusion by aspirin (ASA, 1 X 100 mg per day) was studied in a prospective double-blind trial of 83 patients. 60 (72%) were randomly allocated to ASA or placebo starting 24 h after operation. 90% of grafts in the ASA group and 68% in the placebo group were patent at four months. At least one anastomosis was occluded in 62% of the patients on placebo and in 27% of those on aspirin. Ventricular arrhythmias increased after surgery in more patients on placebo (12/18) than in patients on ASA (5/17). Platelet thromboxane formation on collagen tested before operation was significantly higher in patients in whom bypass occlusion developed (occlusion: 40 +/- 19, no occlusion: 25 +/- 13 ng/ml). A 100 mg dose of ASA per day effectively blocked platelet thromboxane formation and thromboxane-supported aggregation on collagen and was safe in the postoperative phase. No side effects were reported throughout the trial. The reduced toxicity with full efficacy favours a low and infrequent dosage of aspirin.
The aim of this study was to determine the dose-response relationship of anisoylated plasminogen streptokinase activator complex (APSAC) by means of a between group double-blind comparison of the new agent and placebo. 50 patients with symptoms of acute myocardial infarction of less than 6 hours duration and whose coronary artery occlusion had been confirmed by coronary angiography were randomly allocated to 5 treatment groups (15, 20, 25 or 30U of APSAC, or placebo) and treatment was given as an intravenous injection over 2 minutes. Angiography was performed again at 15, 30, 45, 60 and 90 minutes and the films were assessed centrally by 2 independent cardiologists. Six patients were excluded from the angiographic analysis, 4 because their angiograms revealed patent arteries before APSAC was administered, 1 patient was excluded because streptokinase had been infused just after randomisation because of cardiogenic shock and 1 because the angiogram was not available due to problems in the film development. Clinical and laboratory examinations carried out for 72 hours after treatment showed that the drug was well tolerated. The reperfusion rates were as follows: placebo, 0/9; APSAC 15U, 5/8; APSAC 20U, 5/9; APSAC 25U, 6/9; APSAC 30U, 5/9. Reperfusion was achieved in 60% of treated patients but no dose relationship was revealed.
Patients about to undergo cataract extraction were assessed clinically using several criteria to try and judge the necessity for biometry. The patients judged not to need biometry were allocated randomly to two groups, one of which had biometry. The only significant clinical criterion for biometry was found to be the wearing of glasses since before the age of 30 years. Several unexpectedly high refractive errors occurred in the group of patients who did not have biometry. In the group of patients judged not to need biometry but allocated to the biometry group, refractive results were significantly better (nearer to target refractions) than in the unmeasured group. Routine pre-operative biometry is probably the only way to avoid unexpected high ametropia, and it also improves the refractive results. There is however much room for improvement in the accuracy of biometry.
The night shiftwork on the one hand, the obesity on the other hand, are at the origin of sleep modifications. Is the overweight an aggravating factor which damages the recovering sleep? A study on sleep conducted in the laboratory on 7 reference subjects and 7 obese subjects, randomly allocated with regard to age, seniority and Body Mass Index, has shown only a small influence of the overweight on the slow wave sleep during the night shortened by shift work. Obesity does not seem to alter the REM sleep.
Dofetilide (UK-68,798) is a new class III antiarrhythmic agent. In animal experiments it selectively prolongs the refractory periods parallel to the action potential duration without any influence on upstroke velocity or conduction parameters. The present double-blind, placebo-controlled study was designed to show the effect of dofetilide on basic electrophysiologic parameters in patients with coronary artery disease. Eighteen patients (aged 31 to 64 years) with symptoms of stable angina pectoris admitted for routine coronary angiography were recruited. They were randomly allocated to receive either placebo or 1 of 2 dose levels of dofetilide intravenously with 6 patients in each group. Paired electrophysiologic variables were compared before and after administration of dofetilide. Both active dose levels produced significant prolongations (p less than 0.05) of 10 to 23% in atrial effective refractory period, 6 to 16% in ventricular effective refractory period and 11 to 15% in ventricular functional refractory period. Atrial functional refractory period was prolonged by 14 to 22% at the high-dose level (p less than 0.05). No effect was observed on conduction parameters (PA, AH, HV, PR or QRS intervals), sinus cycle length or sinus node recovery. The selective prolongation of the refractory periods in both atrium and ventricle, combined with a lack of effect on cardiac conduction parameters, indicates that this drug could be useful in the treatment of both atrial and ventricular reentrant tachyarrhythmias and fibrillation.
OBJECTIVE: To evaluate the efficacy of ceftiofur hydrochloride sterile suspension administered parenterally for treatment of acute postpartum metritis (APM) in dairy cows. DESIGN: Multilocation, randomized block, field trial. ANIMALS: 406 cows in the first 14 days postpartum. PROCEDURE: Cows with rectal temperatures > or = 39.5 degrees C (103.1 degrees F) without clinical signs of respiratory or gastrointestinal tract disease and with a fetid vaginal discharge were allocated randomly in blocks of 3 to 3 treatment groups: sterile saline (0.9% NaCl) solution administered at a dosage of 2 mL/45.4 kg (2 mL/100 lb), SC or IM, once daily for 5 days (control); or ceftiofur hydrochloride administered at a dosage of 1.1 or 2.2 mg of ceftiofur equivalents (CE)/kg (0.5 or 1 mg/lb, respectively), SC or IM, once daily for 5 days. Cows were evaluated on days 6, 10, and 14, and clinical cure or failure to cure was determined. Clinical cure was defined as no additional antimicrobial treatment administered, rectal temperature < 39.5 degrees C, and absence of a fetid vaginal discharge. RESULTS: On day 14, clinical cure rates were 77%, 65%, and 62% for the 2.2 mg of CE/kg, 1.1 mg of CE/kg, and control groups, respectively. No significant differences were detected in clinical cure rates between control and treatment groups on day 10 or 6. CONCLUSIONS AND CLINICAL RELEVANCE: Ceftiofur hydrochloride administered at a dosage of 2.2 mg of CE/kg, SC or IM, once daily for 5 days was efficacious for treatment of APM in dairy cows.