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Results for “randomized controlled trial”

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PubMed1987

A randomized control trial of cardiac rehabilitation.

A randomized trial using controls tested whether psycho-social rehabilitation of acute myocardial infarction (MI) patients would improve significantly their return to work rate and assessed the importance of various psychological, social, occupational, socio-demographic, and medical factors in facilitating or impeding rapid return to work. Eighty-nine patients were assigned randomly to participate in an experimental cardiac rehabilitation program (rehab care), and 91 patients were controls who received conventional hospital rehabilitation (usual care). By the first follow-up interview at three months, patients assigned to experimental treatment were significantly less distressed psychologically and less dependent on family support than controls (P = 0.04 and P = 0.05, respectively). By the final follow-up interview at 13 months, there was a marginally significant difference in favor of the experimental group in the frequency of reported deterrents to work resumption (P = 0.07). However, the intervention did not result in a statistically significant difference in the return to work rate (P greater than 0.10). In each group, 88% were back at work by approximately the first year after infarction. In addition, the two groups were similar in the amount of time patients remained out of the workforce (median days rehab care = 75, usual care = 81; P greater than 0.10). A multi-stage data analysis procedure utilizing the Cox regression technique indicated that while several independent variables had significant univariate associations with the length of time patients convalesced, outcome was most influenced by the patient's initial cardiological status and clinical course, by the patterns of family support, and by the several variables measuring the presence of obstacles to resuming work. Our findings suggest that rehabilitation programs intervening on multiple levels (psychological, social, occupational, and physical) may best meet the needs of chronically ill cardiac patients. Results indicate that implementing measures addressing the patient's general psycho-social adjustment to MI may improve existing programs.

Adolescent↗

PubMed2026

Effects of an internet-based combined exercise and cognitive-behavioral therapy intervention on endocannabinoid system biomarkers and physical fitness in adults with mild-to-moderate depression: a SONRIE randomized controlled trial.

BACKGROUND: This SONRIE randomized controlled trial (NCT05849792) examined the effects of a 12-week combined physical exercise and internet-based cognitive-behavioral therapy (iCBT) intervention on endocannabinoid system (ES) biomarkers and physical fitness in adults with mild-to-moderate depression. METHODS: Eighty adults were randomly assigned 1:1 to an intervention (IG) or control (CG) group. Outcomes included nine ES biomarkers (2-arachidonoylglycerol, 2-AG; anandamide, AEA; seven analogues) and physical fitness, including cardiorespiratory fitness (CRF; 6-minute walking test) and muscular strength. Measurements were taken at baseline, post-intervention and 8-week follow-up. Primary analysis performed 2 × 3 repeated-measures ANOVA on completers; mixed-effects intention-to-treat model as sensitivity analysis. RESULTS: No significant time × group interaction was detected for any ES biomarker, including 2-AG (F(2,88) = 0.17, p = 0.844) and AEA (F(2,88) = 1.20, p = 0.306); both groups showed comparable within-group decreases in 2-AG, 2-LG and 2-OG. The intervention significantly improved CRF [between-group difference + 81.6 m at 12 weeks (F(2,78) = 7.88, p = 0.001)], exceeding the established minimal clinically important difference. None of the exploratory muscular fitness outcomes reached statistical significance; the arm curl test showed a borderline non-significant interaction (F(2,78) = 2.83, p = 0.065). CONCLUSION: A 12-week internet-based combined exercise and iCBT intervention significantly improved CRF in adults with mild-to-moderate depression. We did not find evidence of an intervention-specific effect on plasma ES biomarkers. These findings support the inclusion of internet-delivered exercise and psychological interventions in comprehensive treatment strategies for depression. TRIAL REGISTRATION: ClinicalTrials.gov NCT05849792 (registered 6 May 2023).

Humans↗

PubMed1989

On randomized controlled trials and lifestyle interventions.

Randomized controlled trials (RCT) are viewed as the ultimate method for evaluation. The author claims that RCT do not enable full evaluation of lifestyle interventions in particular. Lifestyle interventions usually affect several diseases not measured by RCTs and the people who have undergone these interventions also have an impact on the lifestyle in their immediate environment. These potential biases indicate that RCTs underestimate the value of lifestyle interventions.

Bias↗

PubMed2026

Effectiveness of Embedded Social Media Content on E-cigarette Attitudes and Behaviors: Results from a Randomized Control Trial.

BACKGROUND: This longitudinal randomized controlled trial examined the effects of anti-vaping social media content on e-cigarette attitudes and intentions among U.S. young adults (ages 18-24; n=3,400). METHODS: Targeted content was embedded directly into participants' social media feeds, with varying levels of impressions. RESULTS: Results indicate that increased exposure to anti-vaping messages significantly elevated perceived risk of harm (β=0.11, 95% CI: 0.03-0.20, p < .01) and social unacceptability of e-cigarette use (β=0.10, 95% CI: 0.03-0.18, p < .01), while decreasing intentions to vape (RRR = 0.59, 95% CI: 0.36-0.97, p < .05). Notably, these attitudinal shifts occurred even with relatively low ad exposure and over an extended intervention period, while controlling for the e-cigarette use status (never, former, or current) of participants. Discussion These findings support the effectiveness of digital media campaigns in influencing health-related behaviors and attitudes among young adults. Specifically, embedding anti e-cigarette content directly in the feed of young adults is shown to be effective in shifting attitudes in a space where these young adults are already engaged. Limitations include limited ad impressions and minimal change in ad awareness recall, suggesting future research should explore longer interventions and broader nicotine product messaging.

Humans↗

PubMed2026

Nurse-Led Home-Based Mobile Health Cardiac Rehabilitation Program for Patients With Chronic Heart Failure: A Randomized Controlled Trial.

This 12-week randomized controlled trial evaluated a nurse-led mHealth intervention for patients with chronic heart failure, conceptually informed by Riegel's middle-range theory of self-care of chronic illness. The program integrated wearable activity tracking with weekly nurse-led behavioral coaching, reflecting the core self-care processes of monitoring, maintenance, and management. Compared with usual care, the intervention significantly improved daily step count, 6-minute walk distance, metabolic equivalents, and left ventricular ejection fraction. Findings highlight the effectiveness of theory-informed, nurse-delivered mHealth strategies in enhancing physical activity and cardiopulmonary function, while underscoring the critical role of advanced practice nurses in home-based chronic disease management.

Aged↗

PubMed1986

Initial antihypertensive drug therapy: alpha blocker or diuretic. Interim report of a randomized, controlled trial.

A two-center, randomized, controlled trial designed to evaluate and compare an alpha blocker and a diuretic as initial antihypertensive drug treatment is currently in progress. Approximately 100 men and women, aged 30 to 69 years, are being randomly assigned to treatment with either of these two agents. If diastolic blood pressure is not reduced to its target level and is 85 mm Hg or higher, the alternate agent is added. The alternate agent is substituted if a patient does not tolerate the assigned agent. This preliminary report presents data concerning 62 patients who completed at least three of the planned 12 months of drug treatment. At that point, the alpha blocker prazosin and the diuretic hydrochlorothiazide were similar in their ability to lower the average diastolic blood pressure to normal levels. Serum total cholesterol and triglyceride levels declined in prazosin-treated patients but increased in hydrochlorothiazide-treated patients, a difference that was statistically significant. No significant weight change, a possible confounding variable, occurred in either group. More patients were unable to tolerate prazosin than were unable to tolerate hydrochlorothiazide (10 of 30 receiving prazosin, compared with three of 32 receiving hydrochlorothiazide). For those able to continue with prazosin, the favorable lipid response appears to be an asset in regard to reducing possible atherogenic effects of treatment.

Adrenergic alpha-Antagonists↗

PubMed1992

The effect of 17 alpha-hydroxyprogesterone caproate/oestradiol valerate on the development and outcome of early pregnancies following in vitro fertilization and embryo transfer: a prospective and randomized controlled trial.

A prospective and randomized study was performed to investigate the effect of supportive hormones on the development and outcome of early pregnancies following in vitro fertilization and embryo transfer. Immediately after pregnancies were confirmed endocrinologically on day 15 after oocyte collection, 17 alpha-hydroxyprogesterone caproate and oestradiol valerate (PC/EV) was administered to half of the patients in a randomly controlled trial. One group received supportive treatment until the twelfth week of gestation, whereas the other group received no treatment at all. Both groups were followed up by measurements of serum levels of human chorionic gonadotrophin (HCG), oestradiol and progesterone every three days until day 35, when a first ultrasound examination was carried out to confirm fetal vitality. Subsequently, pregnancies were monitored sonographically at regular intervals. In cases of miscarriage, dilatation and curettage was performed and histology analysed. A total of 120 pregnant patients entered the study: 55 of them received hormone treatment and 65 patients were controls. Within the treatment group 48 (89%) clinically ongoing pregnancies were observed, five (9%) miscarriages occurred after the seventh week of gestation and one preclinical pregnancy was noted. In the control group, 38 (59%) ongoing pregnancies were observed, nine (14%) miscarriages occurred and 17 (27%) preclinical pregnancies were recorded. Two ectopic pregnancies, one in each group, were excluded from evaluation. A significantly higher percentage of pregnancies were intact at 7 weeks of gestation after treatment with PC/EV (p less than or equal to 0.01).

17 alpha-Hydroxyprogesterone Caproate↗

PubMed1992

Economic analysis in randomized control trials.

In medical technology assessment, randomized control trials (RCTs) play an important role in determining the relative efficacy of compared treatments. As scarce resources necessitate choosing among options for care, comparing costs of alternative tests, treatments, or programs also becomes important. This study assessed the prevalence and completeness of economic analyses in RCTs published from January 1966 through June 1988. It was found that only 121 of over 50,000 published randomized trials (0.2%) included economic analyses. For a random sample of 51 of these 121 studies, results revealed a mean quality of research score of 0.32 (SD of measurement = 0.14) and a mean economic analysis completeness score of 0.52 (SD = 0.13) on scales of 0 to 1. It was also found that higher economic completeness scores were positively correlated with later dates of publication (r = 0.28, P = 0.046) and with the presence of a statement of study perspective (r = 0.38, P = 0.006). A near-zero correlation between the economic completeness and the quality of research scores was revealed. Also noted were several deficiencies among the economic analyses, including improper allocation of overhead costs, absence of sensitivity analyses, and the fact that only 28% of the 51 studies included some form of aggregation of treatment costs and consequences. Progress in health care depends on accurate assessments of both relative efficacy and costs. The quality of both needs improvement.

Cost-Benefit Analysis↗

PubMed1988

Prospective controlled randomized trial of prophylactic antiarrhythmic therapy in postmyocardial infarction patients with asymptomatic ventricular arrhythmias--study design and initial results.

In order to assess the effect of prophylactic antiarrhythmic therapy in asymptomatic patients with persistent complex ventricular ectopic activity after myocardial infarction, a prospective controlled trial was started in 1981 and is still ongoing. Until August 1986, 965 consecutive patients less than or equal to 70 hospitalized for acute myocardial infarction were screened without antiarrhythmic drugs by 24-h ECG before discharge from the hospital. In this group, 238 patients (28%) had ventricular arrhythmias Lown class III-IVb during at least 2 of 24 hours; they were randomly assigned to three treatment groups: (1) individualized antiarrhythmic therapy based on efficacy in multiple 24-h ECGs and drug level determinations (starting with mexiletine or quinidine; n = 79), (2) treatment with low-dose amiodarone (200-400 mg/day after a loading phase; n = 73), and (3) no antiarrhythmic therapy (n = 86). The three groups were comparable regarding age, gender, previous infarction, Q-wave infarction, ejection fraction, as well as incidence and severity of ventricular ectopic activity. Follow-up, including 24-h ECGs, was performed after 3, 6, and 12 months. Based on the results of this study which will be completed by the end of June 1988, it should be possible to estimate the benefit--or harm--of antiarrhythmic drug therapy as well as its cost in postmyocardial infarction patients with asymptomatic ventricular ectopic activity and to decide whether such treatment may improve survival.

Aged↗

PubMed1991

A comparison of sucralfate with placebo in the treatment of esophageal ulcers following therapeutic endoscopic sclerotherapy of esophageal varices--a prospective controlled randomized trial.

In 1984 Roark published the first report of a sucralfate treatment of esophageal ulcers after sclerotherapy. Because this was an uncontrolled trial we planned a prospective double-blind placebo-controlled study with 60 patients. After therapeutic paravariceal injection-sclerotherapy of esophageal varices, patients were randomly treated with sucralfate suspension or placebo. Time of treatment was limited to a maximum of 3 weeks and the dosage of sucralfate was 1 g q.i.d. (Ulcogant-Suspension). Healing was assessed by endoscopy at weekly intervals. Fifty-three patients (25 sucralfate, 28 placebo) were evaluable according to the protocol. No patient left the study because of side effects. At the start of the trial, the patients in the sucralfate group showed a larger ulcer area than the placebo group. There was a tendency to faster healing in the sucralfate group, especially in patients with deeper ulcerations. However, there was no significant difference in global healing between both treatment groups after 3 weeks. Sucralfate suspension may be of value in accelerating the healing process in esophageal ulcers after sclerotherapy, especially in patients with deep ulcers. These results should be confirmed in further trials, in which patients should be stratified with respect to their ulcer volume and severity of liver disease.

Aged↗

PubMed1990

Captopril improves hemodynamic response to static exercise in patients with congestive heart failure: a double-blind, placebo-controlled, randomized trial.

Systemic and peripheral hemodynamic response to isometric exercise by handgrip test at 30% maximal voluntary contraction (MVC) for 3 minutes was assessed in 16 patients with congestive heart failure (CHF) after short-term treatment with either captopril or placebo given according to a double-blind, randomized, cross-over sequence. During placebo, isometric exercise increased blood pressure (BP) and total peripheral vascular resistance (TPVR) and decreased cardiac index (CI). Captopril reduced the pressor response to exercise (mean +/- SD) (% systolic: from 14.7 +/- 6 to 11.7 +/- 3; p less than .05/% diastolic: from 12.4 +/- 4 to 8 +/- 3; p less than .005) and increased CI (from 2.3 +/- .6 to 2.6 +/- .9 liters/min/m2; p less than .01) whereas TPVR remained virtually unchanged (from 1479 +/- 597 to 1594 +/- 692 U; NS). The changes in mean BP after exercise were inversely related to the early increase in forearm blood flow (FBF) in exercising forearm during both placebo (r = .67) and captopril (r = .71). The extent of reduction in mean BP response after captopril was inversely related to the extra increase in exercising FBF determined by the drug when compared to placebo (r = .73). We conclude that captopril is able to improve the hemodynamic response to static exercise in patients with CHF, probably by increasing the blood supply to exercising muscles during contraction, thus blunting the extent of reflex pressor response.

Blood Pressure↗

PubMed1988

Cyclosporin-induced remission of IDDM after early intervention. Association of 1 yr of cyclosporin treatment with enhanced insulin secretion. The Canadian-European Randomized Control Trial Group.

A randomized double-blind placebo-controlled trial was undertaken to determine whether cyclosporin enhances remission of insulin-dependent diabetes mellitus (IDDM) through the 1st yr after diagnosis. Dosage with insulin was minimized with target control of blood glucose levels less than or equal to 7.8 mM (140 mg/dl) before meals. Metabolic control was evaluated by serial determinations of glycosylated hemoglobin levels, and endogenous secretion of insulin was evaluated by determination of the levels of glucagon-stimulated insulin-connecting peptide (CP) in the plasma at 3-mo intervals. A compound definition of remission required a glucagon-stimulated CP level in plasma greater than or equal to 0.6 nM or a non-insulin-receiving state (NIR) in which target control of glycemia was maintained without administration of insulin. A clinical definition of remission required only the NIR state as defined. One hundred eighty-eight patients aged 10-35 yr entered the study within 6 wk of initiation of insulin therapy and within 14 wk of onset of symptoms and were studied for 1 yr. There were no significant differences in metabolic control between the two treatment groups during the study. The anticipated adverse effects of cyclosporin were not more frequent or severe than in other experience with the drug, but histological changes attributable to cyclosporin were present in some kidney biopsies obtained from selected patients after 1 yr. At 1 yr, by the compound definition, 33% of the cyclosporin-group and 21% of the placebo-group patients were in remission, when the corresponding rates for NIR remissions were 24 and 10%.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1989

Prospective, controlled, randomized trial of naloxone infusion in early hyperdynamic septic shock.

To determine whether naloxone infusion is efficacious in severe hyperdynamic septic shock, we conducted a prospective study of 22 patients randomly assigned to a naloxone or placebo group. Patients were treated 12 +/- 2 h (SEM) after the onset of shock, with a mean arterial pressure (MAP) of 63 +/- 3 mm Hg. All patients had clinical evidence of an infectious process and required dopamine 20 +/- 2 micrograms/kg.min. Five (46%) of 11 patients in the naloxone group and one (9%) of the other 11 patients in the placebo group responded clinically. The MAP among the five responders increased from 62 +/- 5 to 89 +/- 4 mm Hg within 20 min of naloxone treatment (p less than .01). This favorable hemodynamic response was sustained throughout the patients' clinical course. In contrast, the MAP did not change significantly in the nonresponders who received naloxone, nor did it change in the placebo group. More patients in the naloxone group than in the placebo group received steroids concurrently. Survival rate was 100% in those who responded to naloxone clinically. However, overall survival rate in each group was essentially the same. No adverse effects were observed, except for mild agitation in some of the patients receiving naloxone. We conclude that naloxone infusion is clinically efficacious in improving the hemodynamic profile of a subgroup of patients with severe early hyperdynamic septic shock, but does not appear to improve the overall survival rate.

Aged↗

PubMed1979

Cimetidine for anastomotic ulcers after partial gastrectomy. A randomized controlled trial.

In a randomized double-blind multicenter trial, 15 outpatients with endoscopically proved anastomotic ulceration after Billroth I or Billroth II partial gastrectomy received cimetidine, 1 g daily over eight weeks, or a placebo. All patients also received antiacid. The ulcer healed completely in all seven cimetidine-treated patients and in one of the eight placebo-treated patients (P less than 0.01). Ulcers not healed during the double-blind phase of the trial were all subsequently healed on open cimetidine treatment. There was a trend toward improvement of daytime symptoms in favor of cimetidine (P = 0.06), and nighttime symptoms were significantly relieved during the initial four weeks of cimetidine treatment P = 0.02). We conclude that cimetidine, 1 g daily, promotes healing of anastomotic ulcers after partial gastrectomy.

Adult↗

PubMed1990

Intravenous recombinant tissue-type plasminogen activator in patients with unstable angina pectoris. Results of a placebo-controlled, randomized trial.

Because thrombus formation may contribute to coronary obstruction in patients with unstable angina pectoris, we performed a pilot investigation to determine whether thrombolytic therapy can relieve coronary narrowing in this acute ischemic syndrome. Sixty-seven patients with rest angina and angiographic evidence of coronary stenosis were randomly assigned to receive either low-dose intravenous recombinant tissue-type plasminogen activator (rt-PA) (0.75 mg/kg over 1 hour), high-dose intravenous rt-PA (0.75 mg/kg over 1 hour; total dose, 100 mg over 6 hours), or intravenous placebo followed by repeat coronary angiography at 24-48 hours to assess change in the severity of coronary narrowing. Each patient also received oral aspirin and intravenous heparin. Mean values of coronary stenosis severity (percent of diameter reduction) declined to a similar extent in each group: placebo, 75 +/- 14% to 72 +/- 14% (p = 0.07); low-dose rt-PA, 75 +/- 16% to 71 +/- 18% (p = 0.03), and high-dose rt-PA, 82 +/- 11% to 77 +/- 17% (p = 0.18), with only the low-dose rt-PA group achieving statistical significance. Resolution of intracoronary filling defects, increase in antegrade flow grade, or both also occurred equally among the three groups. There was considerable variation in individual patient response. Between 29% and 50% of patients within each group demonstrated a decrease in stenosis severity, whereas 50% to 57% noted either improvement in antegrade flow or resolution of intracoronary thrombus. There was no difference in incidence of major bleeding events among the three groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

PubMed1989

Quality assessment of randomized controlled trials of contrast media.

Numerous randomized controlled trials (RCTs) have been conducted to define the relative benefits of low-osmolality contrast media (LOM) and high-osmolality contrast media (HOM). Because of the clinical and economic significance of the conclusions drawn from these RCTs, the authors used a standardized instrument to evaluate the quality of study design and data analysis of 100 RCTs published between 1982 and 1987 that compared LOM and HOM. The mean quality score (+/- standard deviation) was 39 +/- 12 (maximum possible score, 100). The largest number of patients studied in any RCT was 435; the smallest was five. A majority of the RCTs received high scores on three attributes of quality, intermediate scores on seven, and low scores on nine. These results underscore the difficulty of designing, performing, analyzing, and reporting high-quality RCTs. Nevertheless, limitations in study design and data analysis need to be considered when interpreting results of these RCTs. Future RCTs comparing LOM and HOM should be performed with greater attention to basic elements of good study design and data analysis.

Clinical Trials as Topic↗

PubMed1992

Dexamethasone and bacterial meningitis. A meta-analysis of randomized controlled trials.

A meta-analysis of 5 randomized, controlled trials using dexamethasone as adjunctive therapy in the treatment of bacterial meningitis in children was done to assess the efficacy in reducing sequelae. A 6th study including both children and adults was analyzed separately. Results of the 5 pediatric studies indicated no significant difference in case-fatality rate between the placebo and dexamethasone groups. Significantly more neurologic sequelae were found in the placebo group during the period from discharge from hospital to 6 weeks after discharge (relative risk [RR] = 1.99, 95% confidence interval [CI] 1.13 to 3.53) and during the period beginning 6 months after discharge (RR = 3.90, 95% CI 1.72 to 8.85). The incidence of neurologic sequelae from 6 weeks to 6 months after discharge, though less with dexamethasone administration, did not reach statistical significance. The frequency of bilateral hearing loss was significantly greater in the placebo group (RR = 4.12, 95% CI 1.74 to 9.79), but unilateral loss was not statistically different in the two groups. Dexamethasone administration in addition to antimicrobial therapy appears to be effective in reducing neurologic sequelae and bilateral hearing loss associated with bacterial meningitis in children.

Adult↗

PubMed1990

Intravenous streptokinase in the management of a subset of patients with unstable angina: a randomized controlled trial.

We report the results of a randomized controlled trial of intravenous streptokinase in a subset of patients with unstable angina. Seventy-six patients were admitted with prolonged (more than 20 minutes) angina at rest of less than 3 weeks onset. Fifty-two patients continued to have more than 3 episodes of prolonged angina in 48 hours on medical therapy with metoprolol, isosorbide dinitrate, nifedipine and intravenous nitroglycerin. Forty-eight patients consented to enter the study and were randomized into two groups. The first group, of 24 patients, received 1.5 million units of streptokinase infusion and the second group, also of 24 patients, received a placebo. Pain relief within 48 hours was achieved in 19/24 (79.1%) patients after streptokinase infusion as compared to 9/24 (37.5%) of the controls (P less than 0.05). Approximately 90% (17/19) of patients responding to streptokinase therapy were relieved of chest pain within the first six hours as against none in the controls. The incidence of acute myocardial infarction within six months was 12.5% (3/24) in those receiving streptokinase and 25% (6/24) in the controls. Mortality at six months stood at 8.33% (2/24) in the treated patients and 16.6% (4/24) in the controls. Intravenous streptokinase thus appears to be of benefit in patients with angina at rest of recent onset which does not respond to conventional medical therapy.

Angina Pectoris↗