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Results for “Randomized trial”

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At least 919 records · Page 51Linked to original sources

PubMed1992

Interim analysis of a randomized trial of radiation therapy of rectal cancer with/without WR-2721.

The objectives of this randomized trial are to define the maximum tolerated dose of radiation therapy, at curative dose levels, that can be delivered following WR-2721, and to observe the anti-tumor effects and normal tissue responses. One hundred patients with inoperable, unresectable, or recurrent rectal cancer were stratified and randomized to radiation only, or WR-2721 and radiation. The entire pelvis is treated with 4 portals 4 times a week to a total of 4500 cGy (first level dose) in 5 weeks. WR-2721, 340 mg/m2 was given 15 minutes before radiation to the combination group. Subsequently, both groups received a conedown of 720 cGy in 4 days to 144(2) cm portals APPA, and if originally inoperable or unresectable 720 cGy in four days to second conedown of 64(2) cm. Patients were observed from 3 to 18 months (median = 12 months). No significant hypotension or hematologic toxicity occurred in the WR-2721 treated group. Mild to moderate emesis occurred in 80% of the courses. (No antiemetics were used.) Moderate or severe acute toxicities to normal tissues were observed less frequently in the WR-2721 arm. No moderate or severe late toxicities to the skin, mucous membrane, urinary bladder or intestine was observed in the WR-2721 group, however, 5 patients treated with radiation alone experienced moderate or severe late toxicity to these organs. No evidence of tumor protection was observed.

Adenocarcinoma↗

PubMed2005

Randomized trial of a fixed combination (KanJang) of herbal extracts containing Adhatoda vasica, Echinacea purpurea and Eleutherococcus senticosus in patients with upper respiratory tract infections.

The clinical efficacy of KanJang oral solution, a fixed combination of standardised extracts of Echinacea purpurea, Adhatoda vasica and Eleutherococcus senticosus, was compared with the combined extracts of Echinacea purpurea and Eleutherococcus senticosus alone (Echinacea mixture) in a controlled, double blind, randomized trial, and with Bromhexine (a standard treatment) in a controlled, open, randomized clinical trial on patients with non-complicated acute respiratory tract infections. Many of the parameters evaluated, such as severity of coughing, frequency of coughing, efficacy of mucus discharge in the respiratory tract, nasal congestion and a general feeling of sickness, showed significantly greater improvement in patients treated with KanJang compared with those receiving the standard treatment. However, no significant differences in the improvement of these symptoms (except in a reduced frequency of coughing) were observed between patients treated with the Echinacea mixture and those receiving the standard treatment. The only explanation is that the lack of extract of A. vasica in the Echinacea mixture reduces its efficacy compared with the complete KanJang oral solution even though direct double-blind comparison yielded no significant differences between these two groups of patients. The recovery time of patients being treated with KanJang or Echinacea mixture was 2 days shorter than that of patients receiving the standard treatment. None of the patients completing the study reported adverse reactions to the medication taken. The significance of the results obtained in this study is discussed with respect to the efficacy of KanJang in the treatment of acute respiratory infection and to the concept that multi-drug therapy offers higher efficacy compared with mono-drug treatment of such infections.

Administration, Oral↗

PubMed2001

A randomized trial of the effectiveness of cognitive-behavioral therapy and supportive counseling for anxiety symptoms in older adults.

The authors used a randomized trial to compare cognitive-behavioral therapy (CBT) and supportive counseling (SC) in the treatment of anxiety symptoms in older adults who met Diagnostic and Statistical Manual of Mental Disorders (4th ed.: American Psychiatric Association, 1994) criteria for anxiety disorders. Both conditions had a 6-week baseline no-treatment phase. Treatment was delivered primarily in patients' own homes and in an individual format. Outcomes were assessed at posttreatment and at 3-, 6-, and 12-month follow-ups. There was no spontaneous improvement during the baseline phase. Both groups showed improvement on anxiety measures following treatment, with a better outcome for the CBT group on self-rating of anxiety and depression. Over the follow-up period, the CBT group maintained improvement and had significantly greater improvement than the SC group on anxiety and 1 depression measure. Treatment response for anxiety was also superior for the CBT group, although there was no difference between groups in endstate functioning.

Aged↗

PubMed2006

Assessing the effectiveness of antiretroviral adherence interventions. Using marginal structural models to replicate the findings of randomized controlled trials.

Randomized controlled trials of interventions to improve adherence to antiretroviral medications are not always feasible. Marginal structural models (MSM) are a statistical methodology that aims to replicate the findings of randomized controlled trials using observational data. Under the assumption of no unmeasured confounders, 3 MSM estimators are available to estimate the causal effect of an intervention. Two of these estimators, G-computation and inverse probability of treatment weighted (IPTW), can be implemented using standard software. G-computation relies on fitting a multivariable regression of adherence on the intervention and confounders. Thus, it is related to the standard multivariable regression approach to estimating causal effects. In contrast, IPTW relies on fitting a multivariable logistic regression of the intervention on confounders. This article reviews the implementation of these methods, the assumptions underlying them, and interpretation of results. Findings are illustrated with a theoretic data example in which MSM are used to estimate the effect of a behavioral intervention on adherence to antiretroviral therapy.

Anti-HIV Agents↗

PubMed1988

Clinical evaluation of pressure-controlled intermittent coronary sinus occlusion: randomized trial during coronary artery surgery.

Pressure-controlled intermittent coronary sinus occlusion (PICSO) was evaluated in a randomized trial in 30 patients undergoing bypass surgery. PICSO was applied for one hour during early reperfusion. Myocardial function was determined from short-axis cross-sectional views of intraoperative two-dimensional echocardiography. Changes of sectional and segmental wall motion during extracorporeal circulation were analyzed. Although sectional wall motion did not change significantly, hypokinetic segments were preserved better in PICSO-treated patients than in controls (-1.3 +/- 2.4 versus -9.1 +/- 2.6 delta% fractional area change; p less than 0.04). Although not significant, the same trend was found for normal and severely hypokinetic segments. Cumulative enzyme release was related to coronary sinus occluded pressure (r = 0.94; p less than 0.006), indicating washout of metabolites during PICSO. Three months after operation, functional classification was similarly favorable in both groups. Long-term effects of PICSO cannot be predicted because PICSO was applied only during early reperfusion. We conclude that PICSO is a safe procedure and that its short-term beneficial effects on myocardial function suggest a preservation of myocardial viability.

Catheterization↗

PubMed1994

A meta-analysis of randomized trials of calcium antagonists to reduce restenosis after coronary angioplasty.

The usefulness of calcium antagonists to reduce restenosis after coronary angioplasty remains uncertain despite 5 randomized trials involving 919 patients. Review and meta-analysis of these trials are performed to provide insight into whether calcium antagonists reduce angiographic restenosis. In aggregate, these trials suggest that patients treated with calcium antagonists had approximately a 30% reduction in the odds of angiographic restenosis (odds ratio = 0.68; 95% confidence interval of 0.49 to 0.94, p = 0.03) compared with control patients. Given the relatively low toxicity and cost of these agents, this reduction in angiographic restenosis may translate into a meaningful clinical benefit. A large, randomized clinical trial should be performed to confirm these findings before widespread adoption of this treatment strategy.

Adult↗

PubMedDate not supplied

[Ethical aspects of randomized clinical trials].

Randomized clinical trials represent the final, essential link between basic medical research and human health. However, their conduction presents very complex ethical problems, since the patient is the actual target of the experiment. Proper randomization, informed consent, and preliminary disclosure of results create deep ethical conflicts between the role of caretaker and that of impartial observer, both played by the same doctor. The dilemma reproduces the conflict between two different ethics. One is based on the inalienable individual rights stemming from the concept of man as an end in himself and not a means to an end. The other, derived from utilitarian philosophies, is based on the benefit for society as a whole. If we agree that randomized clinical trials represent the best method to test the validity of a new treatment, there is no easy solution. The dilemma could be solved by separating the role of the family doctor, committed to the best treatment possible for his patient, from the role of the scientist, committed to the progress of science and humanity. The former is involved in the treatment of individual patients, the latter in clinical and scientific experiments of a therapeutic nature. The patient may trade his rights to the best possible cure for the safety and the efficiency guaranteed by the scientific institution conducting the trial. Trials on relevant issues--expected to produce important results and impeccably designed scientifically--could be endowed with the ethics of science per se and this could be considered equivalent to the individual rights waived by the patient.

Ethics, Medical↗

PubMed1987

Abdominal wound drainage--a prospective, randomized trial.

Prophylactic drainage of abdominal wounds with a closed suction system has been carried out in a prospective, randomized trial. There was no significant difference in the incidence of haematomas or infection rates in the groups with or without drainage. We conclude that wound drainage should be reserved for selected cases and that routine prophylactic drainage should not be practiced.

Abdominal Muscles↗

PubMed2004

The Cannabis Youth Treatment (CYT) Study: main findings from two randomized trials.

This article presents the main outcome findings from two inter-related randomized trials conducted at four sites to evaluate the effectiveness and cost-effectiveness of five short-term outpatient interventions for adolescents with cannabis use disorders. Trial 1 compared five sessions of Motivational Enhancement Therapy plus Cognitive Behavioral Therapy (MET/CBT) with a 12-session regimen of MET and CBT (MET/CBT12) and another that included family education and therapy components (Family Support Network [FSN]). Trial II compared the five-session MET/CBT with the Adolescent Community Reinforcement Approach (ACRA) and Multidimensional Family Therapy (MDFT). The 600 cannabis users were predominately white males, aged 15-16. All five CYT interventions demonstrated significant pre-post treatment during the 12 months after random assignment to a treatment intervention in the two main outcomes: days of abstinence and the percent of adolescents in recovery (no use or abuse/dependence problems and living in the community). Overall, the clinical outcomes were very similar across sites and conditions; however, after controlling for initial severity, the most cost-effective interventions were MET/CBT5 and MET/CBT12 in Trial 1 and ACRA and MET/CBT5 in Trial 2. It is possible that the similar results occurred because outcomes were driven more by general factors beyond the treatment approaches tested in this study; or because of shared, general helping factors across therapies that help these teens attend to and decrease their connection to cannabis and alcohol.

Adolescent↗

PubMed2001

High-dose therapy and autologous stem-cell transplantation versus conventional-dose consolidation/maintenance therapy as postremission therapy for adult patients with lymphoblastic lymphoma: results of a randomized trial of the European Group for Blood and Marrow Transplantation and the United Kingdom Lymphoma Group.

PURPOSE: To determine whether a combination of high-dose therapy and autologous stem-cell transplantation (ASCT) is superior to conventional-dose consolidation and maintenance chemotherapy as postremission therapy in adults with lymphoblastic lymphoma. PATIENTS AND METHODS: One hundred nineteen patients were entered onto this prospective randomized trial from 37 centers. Patients received standard remission induction therapy, and responding patients were randomized either to continue with a conventional consolidation/maintenance protocol (CC) or to receive high-dose therapy and ASCT. In some centers, patients with HLA-identical sibling donors were registered on the trial but proceeded to allogeneic bone marrow transplantation (BMT) without randomization. RESULTS: Of the 119 patients entered, 111 were assessable for response to induction therapy. The overall response rate was 82% (56% complete response, 26% partial response). Of the 98 patients eligible for randomization, 65 were randomized, 31 to ASCT and 34 to CC. Reasons for failure to randomize included patient refusal (12 patients), early progression or death on induction therapy (eight patients), excessive toxicity of induction regimen (six patients), and elective allogeneic BMT (12 patients). With a median follow-up of 37 months, the actuarial 3-year relapse-free survival rate is 24% for the CC arm and 55% for the ASCT arm (hazards ratio = 0.55 in favor of the ASCT arm; 95% confidence interval [CI], 0.29 to 1.04; P =.065). The corresponding figures for overall survival are 45% and 56%, respectively (hazards ratio = 0.87 in favor of the ASCT arm; 95% CI, 0.42 to 1.81; P =.71). CONCLUSION: The use of ASCT in adults with lymphoblastic lymphoma in first remission produced a trend for improved relapse-free survival but did not improve overall survival compared with conventional-dose therapy in this small randomized trial.

Adolescent↗

PubMed1990

A randomized trial of amniotomy in active labor.

The role of amniotomy in active labor is controversial because of contradictory data and a paucity of randomized studies. A randomized trial was conducted on the role of amniotomy in spontaneous labor. Fifty-three women who were admitted to the Family Medicine Service in active labor were randomly assigned to receive amniotomy (n = 26) or no amniotomy (n = 27). Amniotomy shortened the time from randomization to delivery by 143 minutes (t = 2.3, P less than .05, 95% confidence interval [CI] = 19-265). After adjusting for possible confounders, the effect of amniotomy was to shorten labor by 155 minutes (CI = 9-301). The effect of amniotomy on labor was not found to be related to parity or cervical dilatation. Amniotomy had no apparent effect on Apgar scores or use of analgesia.

Adult↗

PubMed1996

Effect of early, short-term supplementation on weight and linear growth of 4-7-mo-old infants in developing countries: a four-country randomized trial.

The effect of supplementation on growth was tested by means of four similar controlled randomized trials in the Congo (n = 120), Senegal (n = 110), Bolivia (n = 127), and New Caledonia (n = 90). Four-month-old infants were randomly allocated to supplement or control groups. A cereal-based precooked porridge was offered twice daily for 3 mo and consumption was monitored. Both groups were free to eat local food. At 7 mo of age, all infants were still breast-fed in the Congo, Senegal, and Bolivia compared with 47% in New Caledonia. Mean daily consumption of the supplement varied among countries (558-790 kJ/d). Mean length at 4 mo was lowest in Bolivia, higher in Senegal and the Congo, and near the National Center for Health Statistics reference in New Caledonia. The mean 4-7 mo length increment was 0.48 cm higher for supplemented than for control infants in Senegal (P < 0.05), whereas weight increments did not differ. No significant effect was found in the other countries.

Body Height↗

PubMed1995

Cessation of long-term nicotine gum use--a prospective, randomized trial.

Nicotine gum is an important adjunct for smoking cessation for many smokers, and long-term use of nicotine gum will occur in a small percentage of patients. To date, no method of cessation in long-term users has been studied in a randomized trial. We enrolled 26 subjects at the Mayo Clinic site of the Lung Health Study who had used nicotine gum for more than 6 months to participate in a trial where subjects were randomly assigned to: (1) abrupt cessation, (2) taper with placebo gum, or (3) taper with active gum. At the end of the 6-week trial, the percentage of subjects abstinent from gum use and not smoking was not different among the three groups: 66.7% for the abrupt cessation group, 71.4% for the taper with placebo gum group and 60% for the taper with active gum group. One subject in the taper with placebo gum group relapsed to smoking during the trial but was abstinent from smoking again at long-term follow-up. Long-term follow-up (median 284 days) showed 65% of subjects were abstinent from all nicotine products. Motivated subjects can stop long-term nicotine gum use without relapse to gum use or smoking by either abrupt cessation or brief tapering.

Adult↗

PubMed2004

Is low-dose haloperidol a useful antiemetic?: A meta-analysis of published and unpublished randomized trials.

The antiemetic efficacy of haloperidol was studied using data from 15 published (1962-1988) and 8 unpublished randomized trials; 1,397 adults received haloperidol, and 1,071 were controls. Settings were postoperative nausea or vomiting (1,994 patients), gastroenterology (261), chemotherapy (189), and radiation therapy (24). The relative benefit to prevent postoperative nausea or vomiting during 24 h with 0.5-4 mg haloperidol compared with placebo was 1.26-1.51 (number needed to treat, 3.2-5.1), without evidence of dose responsiveness; 0.25 mg was not antiemetic. With 1 mg haloperidol, the relative benefit to stop postoperative nausea or vomiting during 2-4 h compared with placebo was 1.53 (95% confidence interval, 1.17-2.00; number needed to treat, 6); with 2 mg, the relative benefit was 1.73 (1.11-2.68; number needed to treat, 4). In gastroenterology, 2 mg haloperidol was more effective than 1 mg. For chemotherapy and radiation therapy, no conclusions could be drawn. With 4 mg, one patient had extrapyramidal symptoms. With 5 mg, sedation was increased, with a relative risk of 2.09 (95% confidence interval, 1.73-2.52; number needed to treat, 4.4). There were no reports on cardiac toxicity. Postoperatively and in gastroenterology, haloperidol is antiemetic, with minimal toxicity. For other clinical settings and for children, valid data are unavailable.

Antiemetics↗

PubMed1992

A randomized trial of psychiatric consultation with distressed high utilizers.

This study reports the results of a randomized trial of a psychiatric consultation intervention with distressed, high utilizing patients of 18 physicians in two primary care clinics. Psychiatric consultation was associated with a significant increase in the use of antidepressants in intervention patients compared with controls in the first 6 months after intervention. Intervention patients were also significantly more likely to continue antidepressant treatment than control patients. The primary care physicians receiving psychiatric consultations increased the rate of prescribing antidepressant medications in their practice from 32 prescriptions filled per 1,000 visits before their participation in four consultations to 44 new prescriptions per 1,000 visits in the 12-month period after. There were no significant differences between intervention patients and controls at 6 and 12 months after randomization in psychiatric distress, functional disability, or utilization of health care (ambulatory visits, radiographic and laboratory testing services, admissions to inpatient medical care).

Ambulatory Care↗

PubMed1994

Prospective randomized trial of emergency portacaval shunt and emergency medical therapy in unselected cirrhotic patients with bleeding varices.

A prospective randomized trial was conducted in unselected, consecutive patients with bleeding esophageal varices resulting from cirrhosis comparing (1) emergency portacaval shunt performed within 8 hr of initial contact (21 patients) with (2) emergency medical therapy (intravenous vasopressin and esophageal balloon tamponade) followed in 9 to 30 days by elective portacaval shunt in survivors (22 patients). All patients underwent the same diagnostic workup within 3 to 6 hr of initial contact, and received identical supportive therapy initially. All patients were followed up for at least 10 yr. The protocol contained no escape or cross-over provisions. There were no statistically significant differences between the two treatment groups in the incidence of any of the clinical variables, results of laboratory tests or degree of portal hypertension. Child's risk classes in the shunt group were A-2 patients, B-8 patients and C-11 patients, whereas in the medical group they were A-10 patients, B-5 patients, and C-7 patients, a significant difference (p < 0.01) that might have favored emergency medical treatment. Bleeding was controlled initially and permanently by emergency shunt in every patient, but by medical therapy in only 45% (p < 0.001). Mean requirement for blood transfusion was 7.1 +/- 2.6 units in the shunt group and 21.4 +/- 2.6 units in the medical group (p < 0.001). Eighty-one percent of the patients in the shunt group were discharged alive compared with 45% in the medical group (p = 0.027). Five- and 10-yr observed survival rates were 67% and 57%, respectively, after emergency shunt compared with 18% and 18%, respectively, after the combination of emergency medical therapy and elective shunt (p < 0.01). These survival rates produced by emergency shunt performed within 8 hr of initial contact confirm the effectiveness of this procedure observed in our previous unrandomized studies.

Adult↗

PubMedDate not supplied

Prospective, randomized trial comparing sodium phosphate solution with polyethylene glycol-electrolyte lavage for colonoscopy preparation.

We performed a prospective randomized trial in a predominantly outpatient colonoscopy population to see how preparation with oral sodium phosphate solution compares with polyethylene glycol-electrolyte lavage in terms of the quality of colon cleansing, ease of preparation, and gastrointestinal intolerance. Before colonoscopy, a nurse administered a questionnaire to the patient to assess how well the preparation was tolerated (scale from 1 to 5:1 = easy, to 5 = unable to finish) and about the presence of four symptoms: abdominal pain, nausea, vomiting, and dizziness. The quality of colon cleansing was graded by the attending gastroenterologist, who was unaware of how the patient was prepared or tolerated the preparation (1 = excellent, 2 = good, 3 = fair, 4 = poor). The overall quality of bowel preparation with polyethylene glycol lavage was slightly better than with sodium phosphate (mean score, 1.93 vs 2.07); however, the difference was not statistically different. No statistical difference was seen in the frequency of patients with poor preparations (14.2% for sodium phosphate, 9.6% for polyethylene glycol lavage). Patients found preparation with sodium phosphate to be somewhat easier than polyethylene glycol lavage (mean score, 2.07 vs 2.41; p = 0.05). No difference was seen in the incidence of abdominal pain, nausea, or vomiting. Dizziness was more common with sodium phosphate but was mild and not believed to be clinically important. We conclude that the quality of colon cleansing is similar with polyethylene glycol lavage and oral sodium phosphate solution, with satisfactory preparation seen in 85% to 90% of patients. Patients found preparation with sodium phosphate to be slightly easier to tolerate.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗

PubMed2000

A randomized trial of emotion-focused therapy for couples in a training clinic.

Forty married couples participated in a randomized trial comparing 8 weekly sessions of emotion-focused therapy (EFT) for couples to a group of couples who were placed on an 8-week waiting list. A composite marital satisfaction score was created from scores on the Dyadic Adjustment Scale, Positive Feelings Questionnaire, and Personal Assessment of Intimacy in Relationships scale. Controlling for pretest scores, participants in the treatment group had significantly higher levels of marital satisfaction after 8 weeks than wait-list participants. Supplementary analyses identified variables associated with gains in therapy and with dropping out of the study.

Adaptation, Psychological↗