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Results for “Randomized trial”

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At least 217 records · Page 12Linked to original sources

PubMed1988

Beneficial effects of early hypocaloric enteral feeding on neonatal gastrointestinal function: preliminary report of a randomized trial.

In a prospective randomized trial, we studied the effects of early hypocaloric enteral feedings (PO) begun at 48 hours of age in 19 infants compared with 20 infants who received no enteral feedings (NPO) for at least the first 9 days of life. Both groups initially received the majority of their calories by parenteral alimentation. The groups were similar with respect to birth weight, gestational age, sex, Apgar score, and major neonatal diagnoses. The early enteral feeds proved to be significantly beneficial without an increased incidence of complications. The PO group reached full enteral feedings faster than the NPO group (31.2 vs 47.3 days). The PO group had a greater decline in serum bilirubin concentration over the first 2 weeks of life and spent less time under phototherapy (6.8 vs 9.5 days). Less cholestasis was observed among the PO infants (6.7% vs 33%), and peak direct bilirubin levels were also lower (0.7 vs 2.5 mg/dL). Osteopenia of prematurity, manifested by significantly lower alkaline phosphatase activity, was also decreased in the PO group, perhaps because of greater calcium intake during the first month among PO infants (1.3 vs 0.8 g). Compared with complete bowel rest, early onset of hypocaloric enteral feedings has beneficial effects on indirect hyperbilirubinemia, cholestatic jaundice, and metabolic bone disease of very low birth weight infants.

Alkaline Phosphatase↗

PubMed1986

CABG: lessons from the randomized trials.

Three large cooperative randomized trials have evaluated the effects of medical and surgical management of ischemic heart disease on survival and other secondary end points. Both randomized and observational data from these trials show increased survival following coronary artery bypass grafting (CABG) in patients with left main coronary artery stenosis, triple-vessel disease, double-vessel disease, left ventricular (LV) functional impairment, or LV aneurysm. The incidence of fatal, but not nonfatal, myocardial infarction is reduced by CABG. Results in patients 65 years of age or older are similar to those in younger patients but are influenced by associated disease. Gainful employment and risk factors are uninfluenced by treatment. Symptoms of congestive heart failure were not improved by CABG alone but were improved by LV aneurysmectomy when this was performed.

Adult↗

PubMed1986

Leuprolide versus diethylstilbestrol for previously untreated stage D2 prostate cancer. Results of a prospectively randomized trial.

In a randomized, prospective trial, 199 previously untreated patients with Stage D2 prostatic cancer were treated with 3 mg/day diethylstilbestrol (DES) or 1 mg/day leuprolide acetate, a luteinizing hormone releasing hormone analog. Both DES and leuprolide suppressed testosterone to the desired castrate levels. Objective measures of disease, such as acid phosphatase levels, and subjective measures, such as bone pain, performance status, and mobility, showed similar decreases in both groups. No progression of disease was seen in 86 per cent of the leuprolide-treated group, compared with 85 per cent of the DES-treated group. The time to disease progression, development of adverse reaction requiring discontinuation of treatment, or death was identical for the two groups. Hot flashes were more common with leuprolide than with DES. Gynecomastia and breast tenderness, nausea and vomiting, and peripheral edema occurred more often in the DES group. Of those taking DES, 13 per cent discontinued treatment because of side effects, compared with 3 per cent of those taking leuprolide.

Acid Phosphatase↗

PubMed1981

Parietal cell vagotomy and truncal vagotomy as treatment of duodenal ulcer. A prospective randomized trial.

In a prospective randomized trial parietal cell vagotomy (PCV) was compared with truncal vagotomy with drainage (TV) in the treatment of duodenal ulcer. The material consists of 106 patients, 50 TV and 56 PCV. Basal and maximal acid output (BAO, MAO) were measured preoperatively, 6 weeks and 12 months postoperatively. The clinical results were judged from a modified Visick grading system 1-6 years postoperatively. BAO 6 weeks after PCV was reduced with 60% in average and 12 months postoperatively with 45%. After TV the BAO was reduced with 53% 6 weeks postoperatively and 34% 12 months postoperatively. MAO was reduced with 47% 6 weeks after PCV and with 31% 12 months postoperatively. After TV the reduction of MAO was 50% and 44%, respectively. After PCV 62% of the patients were insulin positive at the first postoperative examination and 78% one year later. After TV 46% of the patients had a positive insulin test at the first postoperative examination and 50% one year later. In the PCV group 9 patients (16%) have got recurrences during the 1-6 years observation time, in the TV group there were 4 recurrences (8%). In the PCV group 24% of the patients with pyloric or prepyloric ulcer got recurrences and 13% of the patients with duodenal ulcer. In the TV group the number of recurrences was 13% and 6%, respectively. At the modified Visick classification 71% of the patients in the PCV group were graded as I and II, 4% as III and 25% graded as IV. After TV 83% of the patients were graded as I and II, 4% as III and 13% graded as IV. The results from this study do not allow us to recommend PCV before TV and it should be seriously questioned if it shall at all be performed on prepyloric ulcers.

Adult↗

PubMed2006

Multilevel analysis of group-randomized trials with binary outcomes.

OBJECTIVES: Many dental studies have assessed the effectiveness of community- or group-based interventions such as community water fluoridation. These cluster trials, of which group-randomized trials (GRTs) are one type, have design and analysis considerations not found in studies with randomization of treatments to individuals (randomized controlled trials, RCTs). The purpose of this paper is to review analytic methods used for the analysis of binary outcomes from cluster trials and to illustrate these concepts and analytical methods using a school-based GRT. METHODS: We examine characteristics of GRTs including intra-class correlation (ICC), their most distinctive feature, and review analytical methods for GRTs including group-level analysis, adjusted chi-square test and multivariable analysis (mixed effect models and generalized estimating equations) for correlated binary data. We consider two- and three-level modeling of data from a cross-sectional cluster design. We apply the concepts reviewed using a GRT designed to determine the effect of incentives on response rates in a school-based dental study. We compare the results of analyses using methods for correlated binary data with those from traditional methods that do not account for ICC. RESULTS: Application of traditional analytic methods to the dental GRT used as an example for this paper led to a substantial overstatement of the effectiveness of the intervention. CONCLUSIONS: Ignoring the ICC among members of the same group in the analysis of public health intervention studies can lead to erroneous conclusions where groups are the unit of assignment. Special consideration is needed in the analysis of data from these cluster trials. Randomization of treatments to groups also should receive more consideration in the design of cluster trials in dental public health.

Algorithms↗

PubMed2004

High-dose intravenous melphalan and autologous stem cell transplantation as initial therapy or following two cycles of oral chemotherapy for the treatment of AL amyloidosis: results of a prospective randomized trial.

SUMMARY: A prospective randomized trial was conducted to study the timing of high-dose intravenous melphalan and autologous stem cell transplantation (HDM/SCT) in AL amyloidosis. In all, 100 newly diagnosed patients were randomized to receive HDM/SCT, either as initial therapy (Arm-1) or following two cycles of oral melphalan and prednisone (Arm-2). The objectives of the trial were to compare survival and hematologic and clinical responses. With a median follow-up of 45 months (range 24-70), the overall survival was not significantly different between the two treatment arms (P=0.39). The hematologic response and organ system improvements after treatment did not differ between the two groups. Fewer patients received HDM/SCT in Arm-2 because of disease progression during the oral chemotherapy phase of the study, rendering them ineligible for subsequent high-dose therapy. This affected patients with cardiac involvement particularly, and led to a trend for an early survival disadvantage in Arm-2. Hence, newly diagnosed patients with AL amyloidosis eligible for HDM/SCT did not benefit from initial treatment with oral melphalan and prednisone, and there was a survival disadvantage for patients with cardiac involvement if HDM/SCT was delayed by initial oral chemotherapy.

Amyloidosis↗

PubMed1994

Intravesical instillation chemotherapy of adriamycin with or without verapamil for the treatment of superficial bladder cancer: the final results of a collaborative randomized trial.

A collaborative randomized clinical trial on the intravesical administration of Adriamycin (ADM) with or without verapamil (VR), a calcium-channel blocker, as chemotherapy of superficial bladder cancer (Ta, T1) was carried out at two universities, Okayama and Kagoshima, and their affiliated hospitals. Arm A consisted of ADM given at 50 mg/50 ml saline, and arm B consisted of ADM given at 50 mg/40 ml saline plus five ampules (25 mg/10 ml saline) of injectable VR. The drugs were instilled into the bladder for 3 consecutive days, and three such courses were given with a 4-day interval between each course for a total of nine instillations. A total of 96 patients (48 in arm A and 48 in arm B) were entered into this study. The two treatment groups showed no significant difference in background factors. Of the 40 evaluated arm-A patients, 24 (60.0%) showed a response (CR + PR), whereas 19 (48.7%) of the 39 patients in arm B responded. The difference between these response rates was not statistically significant. As for adverse reactions to the intravesical chemotherapy, local inflammatory symptoms were observed in half of the patients, although no systemic reaction was observed. No significant difference was found between arm A and arm B, except for urinary turbidity. In conclusion, at the dose employed in the present clinical trial, there was no clear enhancement of the effect of ADM combined with VR in patients with superficial bladder cancer. Further clinical studies are required to determine the optimal doses of ADM and VR for their combination in intravesical chemotherapy.

Administration, Intravesical↗

PubMedDate not supplied

Value of second-look endoscopy after injection therapy for bleeding peptic ulcer: a prospective and randomized trial.

A prospective and randomized trial involving 104 patients was performed to assess whether second-look endoscopy could improve the efficacy of injection therapy for bleeding ulcers. The inclusion criteria were the presence of active arterial bleeding or a non-bleeding visible vessel at emergency endoscopy. All the patients received emergency injection of 1:10,000 adrenaline and were subsequently randomized (52 patients in each group) according to whether or not they would receive a second elective endoscopy within the first 24 hours with repeated injection if a visible vessel was still identified. Both groups were well matched for clinical and endoscopic data. A tendency towards better results was noted in the group that received a second-look endoscopy; the two groups were compared in regard to further bleeding (21% versus 29%, 95% confidence interval of the difference = -24.3 to 8.5), need for emergency surgery (8% versus 15%, 95% confidence interval of the difference = -19.9 to 4.5), transfusion requirements (1.7 +/- 1.9 versus 2.5 +/- 2.5 units, 95% confidence interval of the difference = -1.6 to 0.07), length of hospital stay (9.3 +/- 8.6 versus 11.8 +/- 10.8 days, 95% confidence interval of the difference = -6.2 to 1.4), and mortality rate (2% versus 4%). Although these trends did not achieve statistical significance, a type II error cannot be ruled out. However, according to our results, several hundred patients would be required to demonstrate statistically these relatively small differences.(ABSTRACT TRUNCATED AT 250 WORDS)

Emergencies↗

PubMed2004

[Efficacy of a smoking relapse prevention program by postdischarge telephone contacts: a randomized trial].

OBJECTIVES: This randomized controlled trial assessed the efficacy of a smoking relapse prevention program featuring 3 postdischarge telephone contacts with subjects who had quit smoking on hospitalization. METHODS: Patients were randomly assigned to public health nurse-mediated behaviorally oriented in-patient counseling focused on relapse prevention (control group, n = 49), or the same inpatient counseling with postdischarge telephone contacts at 7, 21 and 42 days after discharge (intervention group, n = 57). The main outcome measure, smoking cessation rate, was obtained from self-reports at 3, 6 and 12 months after discharge. Smoking cessation at 12 months after discharge was confirmed by urinary nicotine concentration. RESULTS: At 3, 6 and 12 months smoking cessation rates were 83%, 63% and 56% for the intervention group, and 76%, 65% and 51% for control group. After adjustment for sex, age, having any complication, number of family members, smoking status on admission, strength of nicotine dependence and self confidence to quit smoking, the odds ratio of cessation among the intervention group were 1.46 (95% confidence interval (CI): 0.48-4.47), 0.82 (95% CI: 0.31-2.17) and 0.99 (95% CI: 0.40-2.45) at 3, 6 and 12 months after discharge, respectively. CONCLUSION: This program had limited efficacy to maintain postdischarge smoking abstinence. We should re-consider the modality of smoking cessation program for relapse prevention among hospitalized patients.

Adult↗

PubMed1979

Hypertrophic scarring: Dexon suture in a randomized trial.

In a randomized prospective trial of three methods of skin suture an increased incidence of hypertrophic scarring in paramedian and inguinal wounds has been found to be associated with the use of 2/0 Dexon suture subcuticularly. However, the variance associated with the type of suture was less than that associated with the sex of the patient. The patient's opinion of the appearance of the scar was the same for all three suture methods used in skin closure.

Abdomen↗

PubMed2003

Pacemaker mode selection: the evidence from randomized trials.

The evidence base for pacing, specifically with regards to outcome-based randomized trials, is only beginning to emerge. At present, the guidelines for pacing in sinus node dysfunction (SND), atrioventricular block (AVB), and vasovagal syncope are largely based on observational, not randomized studies. The findings from observational studies that physiological pacing was associated with reduced mortality, fewer strokes, less heart failure, and less AF when compared with ventricular pacing, were not uniformly supported by the early randomized trials of a relatively small sample size. Thus, it has become increasingly clear that large scale randomized trials are necessary to measure reliably the benefit, if any, of progressively more expensive and complex pacemakers. To provide reliable answers to these important questions, three large multicenter randomized trials in Canada, the United Kingdom, and the United States have been designed and conducted. The present review analyzed the results of completed randomized trials on pacemaker mode selection. To date, > 6,000 patients requiring permanent pacing to prevent bradycardia have been randomized; among these, dual chamber pacing did not prevent stroke or improve survival when compared with ventricular pacing. However, dual chamber pacing led to a moderate reduction of incident and chronic AF, reduced symptoms of heart failure in patients with SND, prevented pacemaker syndrome, and modestly improved quality-of-life. Further, a 5-10% reduction in mortality by atrial-based pacing cannot be excluded based on the results of the analyzed trials. The availability of data from ongoing randomized trials and their meta analysis should complete the totality of evidence during the next several years.

Cardiac Pacing, Artificial↗

PubMed1999

Comparison of general and regional anesthesia for cesarean section: success rate, blood loss and satisfaction from a randomized trial.

OBJECTIVE: A prospective randomized trial was organized to compare the effectiveness of general and regional anesthesia for cesarean section (C/S). METHOD: Three hundred and forty-one patients were randomized into the general anesthesia group (GA), epidural anesthesia group (EA) and spinal anesthesia group (SA). The effectiveness of interest was success rate, blood loss and patient satisfaction. RESULT: We found that the success rates of EA and SA were lower than GA. Success in EA should be improved by using an epidural catheter to add more local anesthetic drug instead of a single shot; and the surgeon should allow more time for the block to work adequately. Success in SA should be improved by using bupivacaine instead of lidocaine. GA resulted in significantly more blood loss, lower postoperative hematocrit, and higher proportion of patients who had postoperative hematocrit < 30 per cent than EA and SA. The patients' satisfaction scores were not different among the 3 techniques. This meant that, given adequate explanation and perioperative care, Thai women were satisfied with regional anesthesia. CONCLUSION: Regional anesthesia is a better choice of anesthesia for C/S than general anesthesia. However, the availability of different techniques and ability to change the technique when needed were very useful and important. If GA is chosen, all safety procedures must be followed. Oxygen supplement and endotracheal intubation facilities must be available in all techniques. Guidelines of anesthesia for C/S at a national level should be agreed upon, including the type of personnel, monitoring equipment and postoperative care.

Adult↗

PubMed2006

Impact of cyclooxygenase inhibitors in the Women's Health Initiative hormone trials: secondary analysis of a randomized trial.

OBJECTIVES: We evaluated the hypothesis that cyclooxygenase (COX) inhibitor use might have counteracted a beneficial effect of postmenopausal hormone therapy, and account for the absence of cardioprotection in the Women's Health Initiative hormone trials. Estrogen increases COX expression, and inhibitors of COX such as nonsteroidal anti-inflammatory agents appear to increase coronary risk, raising the possibility of a clinically important interaction in the trials. DESIGN: The hormone trials were randomized, double-blind, and placebo-controlled. Use of nonsteroidal anti-inflammatory drugs was assessed at baseline and at years 1, 3, and 6. SETTING: The Women's Health Initiative hormone trials were conducted at 40 clinical sites in the United States. PARTICIPANTS: The trials enrolled 27,347 postmenopausal women, aged 50-79 y. INTERVENTIONS: We randomized 16,608 women with intact uterus to conjugated estrogens 0.625 mg with medroxyprogesterone acetate 2.5 mg daily or to placebo, and 10,739 women with prior hysterectomy to conjugated estrogens 0.625 mg daily or placebo. OUTCOME MEASURES: Myocardial infarction, coronary death, and coronary revascularization were ascertained during 5.6 y of follow-up in the estrogen plus progestin trial and 6.8 y of follow-up in the estrogen alone trial. RESULTS: Hazard ratios with 95% confidence intervals were calculated from Cox proportional hazard models stratified by COX inhibitor use. The hazard ratio for myocardial infarction/coronary death with estrogen plus progestin was 1.13 (95% confidence interval 0.68-1.89) among non-users of COX inhibitors, and 1.35 (95% confidence interval 0.86-2.10) among continuous users. The hazard ratio with estrogen alone was 0.92 (95% confidence interval 0.57-1.48) among non-users of COX inhibitors, and 1.08 (95% confidence interval 0.69-1.70) among continuous users. In a second analytic approach, hazard ratios were calculated from Cox models that included hormone trial assignment as well as a time-dependent covariate for medication use, and an interaction term. No significant interaction was identified. CONCLUSIONS: Use of COX inhibitors did not significantly affect the Women's Health Initiative hormone trial results.

Journal Article↗

PubMed1991

Randomized trials of induction chemotherapy. A critical review.

There are nine prospective randomized trials comparing induction chemotherapy with standard therapy published in either final form or as preliminary abstract reports. Only one of the six randomized trials critiqued was designed to account for all known prognostic factors, utilized an effective chemotherapy regimen, and had excellent compliance such that the numbers of patients completing the protocol were adequate to provide a valid statistical interpretation of the data. This was the VA cooperative group trial to preserve the larynx. Although this trial did not show a difference in survival between surgically treated patients and those who received induction chemotherapy, the larynx was preserved in two thirds of patients. The results of the other published trials cannot be considered conclusive owing to the flaws in design and interpretation noted in this review. These trials do confirm the feasibility of administering chemotherapy prior to surgery and RT and do confirm the prognostic importance of various factors suggested by the results of single institution trials. Induction chemotherapy has been tested for almost two decades. During this time we have learned the importance of treating intensively to obtain a high complete response rate. At one primary site, the larynx, it has been shown that 64% of patients can be rendered histologically disease-free after three courses of cisplatin and 5-FU. The results of three randomized trials indicate that induction chemotherapy can change the expected pattern of recurrence by decreasing the rate of distant metastases. This early systemic treatment of micrometastases may also reduce the mutation rate theorized for the development of drug resistance. The goals of future randomized trials should include the use of dose-intensive multidrug regimens to increase complete response rates, improve locoregional control, and decrease distant metastases. Induction chemotherapy trials with cisplatin and 5-FU should explore organ preservation at sites other than the larynx where significant functional impairment results from standard surgical approaches. Randomized trials must be carefully designed and rigorously conducted to ensure that the results and conclusions are valid. New regimens, perhaps incorporating growth factors, need to be identified and tested in this group of patients. Finally, improvement in survival must remain a primary goal of multimodality therapy for advanced head and neck cancer.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2007

Experimental test of the affect-regulation theory of bulimic symptoms and substance use: a randomized trial.

OBJECTIVE: Conduct a randomized trial to test whether a cognitive behavioral intervention designed to decrease depressive symptoms produces subsequent decreases in bulimic and substance use symptoms. METHOD: Female participants (N = 145) with elevated depressive symptoms were randomly assigned to a 4-session depression intervention or a measurement-only condition and assessed through 6-month follow-up. RESULTS: Relative to control participants, intervention participants showed decreases in depressive symptoms. Intervention participants also showed significantly greater reductions in bulimic symptoms, but not substance use, and change in depressive symptoms mediated this effect for bulimic symptoms. CONCLUSION: The results provide experimental support for the theory that affect disturbances contribute to bulimic pathology, but do not support the affect regulation theory of substance use.

Adolescent↗

PubMed1993

Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial.

This prospective and randomized trial sought to compare large-bore plastic endoprostheses (14 French) and self-expanding metal stents (24 French) in the palliative treatment of obstructive jaundice due to biliary hilar malignancies. Twenty patients with Type II-IV (Bismuth classification) hilar obstruction were randomized to treatment with either plastic or metal stents. Both treatment groups were well matched with regard to all assessed clinical criteria before stenting. Stent placement was uniformly successful in the metal group and in 88.9% of the plastic group. Early stent failure (< 30 days) occurred in two patients of the plastic stent group. Longterm (> 30 days), stent failure was observed in 50% of the plastic group and 18.2% of the metal stent group. All differences were not statistically significant. The number of re-interventions required to manage stent-related problems proved to be significantly higher in the plastic group (2.4 +/- 2.6) compared to the metal group (0.4 +/- 0.5). Hospitalization for treatment of stent complications was also significantly higher in the plastic treatment group. The costs calculated for stents and hospital stay for required re-interventions were therefore higher in the plastic stent group. In conclusion, metal stent insertion for palliation of hilar malignancies does not only offer higher success rates and higher patency rates compared to plastic stent insertion, but is also cost-effective since patients require fewer re-interventions.

Aged↗

PubMed2006

The effect of epidural needle type on postdural puncture headache: a randomized trial.

PURPOSE: A prospective, randomized trial in labouring parturients was undertaken to assess whether the 18G Special Sprotte epidural needle is associated with a lower incidence of accidental dural puncture (ADP) in comparison with the 17G Tuohy needle. A secondary purpose was to determine if the incidence of postdural puncture headache (PDPH ) differed between groups when ADP occurred. METHODS: Following Institutional Review Board approval 1,077 parturients requesting epidural analgesia at three tertiary obstetrical units were randomized to epidural catheter insertion with a 17G Tuohy or 18G Special Sprotte needle. Patients were followed for seven days by a blinded assessor to determine the occurrence of PDPH using standardized criteria. If postural headache or neck ache presented, an ADP was diagnosed even if cerebrospinal fluid (CSF) was not observed at insertion. This subgroup was followed daily to assess headache characteristics and response to blood patch. RESULTS: Six Tuohy group patients, and two patients in the Sprotte group were excluded. One of the six excluded in the Tuohy group had an ADP. Twenty-eight ADPs occurred, nine unrecognized by CSF visualization (1.8% Tuohy, 3.4% Sprotte, P = 0.12). The incidence of unrecognized ADPs was higher in the Sprotte group (40% Sprotte vs 20% Tuohy, P < 0.05). If ADP occurred, the incidence of PDPH was lower in the Sprotte group (100% Tuohy vs 55% Sprotte, P = 0.025). The ease of use, and user satisfaction were higher in the Tuohy group (84 +/- 17.3% Tuohy vs 68.2 +/- 25.3% Sprotte, P < 0.001). CONCLUSION: The incidence of ADP was not reduced with the Special Sprotte epidural needle in comparison with the Tuohy needle, but PDPH after ADP occurred less frequently in the Sprotte group.

Adult↗

PubMed1995

The decision to enter a randomized trial of tamoxifen for the prevention of breast cancer in healthy women: an analysis of the tradeoffs.

OBJECTIVE: Interest in breast cancer prevention has led to the Breast Cancer Prevention Trial (BCPT), a controversial randomized trial of tamoxifen for women at risk for breast cancer. The goal of our study was to determine whether the potential benefits of enrolling in the randomized trial of prophylactic tamoxifen outweigh the potential risks. METHODS: We used a decision analytic model based on the available data on tamoxifen treatment benefits in women with breast cancer and extrapolated to its use in healthy women. RESULTS: For a 50-year-old woman with a breast cancer risk twice that of the average woman her age, the BCPT offers an increase in life expectancy of about 9 days, a gain that is modest compared with other health interventions. For women ages 35 to 60 who meet the minimum risk of breast cancer for trial eligibility, the trial increases life expectancy by about 8 or 9 days. Assumptions about the effect of tamoxifen on the incidence of endometrial and liver cancer and on quality of life associated with tamoxifen did not alter our findings. CONCLUSIONS: Advocates and opponents of the BCPT should temper their concerns to reflect the modest absolute benefits and harms associated with the trial. Although women at increased risk for breast cancer should be aware of the likely overall benefit associated with entry into the trial, for most women, entry into the BCPT is unlikely to alter substantially their length of life, in either a beneficial or harmful manner.

Adult↗