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Results for “Randomized trial”

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PubMed1990

[A randomized trial of single and multifraction radiation therapy for bone metastasis: a preliminary report].

From April, 1989 through January, 1990, a randomized trial was conducted to investigate the efficacy of single fraction radiation treatment (8, 10, 12, 15Gy) compared to a multifraction dose schedule (5Gy x 4, 5Gy x 5, 5Gy x 6) as a therapy for a bone metastasis. Both subjective and objective pain scores were used to measure the therapeutic results. A total of 31 patients participated in the trial and, for analysis, 27 of these patients were follow-up for more than 8 weeks after the start of the radiation therapy. The following statistics resulted. Of the single fraction series, symptomatic pain relief was obtained in 86% of the patients (12/14 treatment areas), and of the multifraction series, 92% (12/13). Further, a complete response was achieved in 57% (8/14) of the single fraction patients and 31% (4/13) of the multifraction patients, respectively. Between the two treatment regimens, no difference was found in the incidence of pain relief, speed of onset, or acute morbidity. Finally, no severe morbidity was seen in either arm.

Adult↗

PubMed2002

Randomized trial of medical or endoscopic therapy to prevent recurrent ulcer hemorrhage in patients with adherent clots.

BACKGROUND & AIMS: Treatment of high-risk patients with nonbleeding adherent clots on ulcers is controversial. In a previous randomized trial, there was no benefit to endoscopic therapies compared with medical therapy for prevention of ulcer rebleeding. Our purpose was to test the hypothesis that patients treated with combination endoscopic therapy would have significantly lower rebleeding rates than those treated with medical therapy. METHODS: In this randomized, controlled trial, 32 high-risk patients with severe ulcer hemorrhage and nonbleeding adherent clots resistant to target irrigation were randomized to medical therapy or to combination endoscopic therapy (with epinephrine injection, shaving down the clot with cold guillotining, and bipolar coagulation on the underlying stigmata). Physicians blinded to the endoscopic therapy managed all patients. RESULTS: Patients were similar at study entry, except for older age in the medical group and lower platelet count in the endoscopic group. By hospital discharge, significantly more medically treated patients (6/17; 35.3%) than endoscopically treated patients (0/15; 0%) rebled (P = 0.011). There were no complications of endoscopic treatment. CONCLUSIONS: Combination endoscopic therapy of nonbleeding adherent clots significantly reduced early ulcer rebleeding rates in high-risk patients compared with medical therapy alone. This endoscopic treatment was safe.

Aged↗

PubMed2005

The efficacy of tailored print materials in promoting colorectal cancer screening: results from a randomized trial involving callers to the National Cancer Institute's Cancer Information Service.

In this large randomized trial among callers to the Cancer Information Service (CIS), tailored print materials were tested for efficacy in promoting colorectal cancer (CRC) screening (fecal occult blood test [FOBT], flexible sigmoidoscopy, or colonoscopy). All participants completed baseline interviews at the end of their usual service calls to the CIS, as well as short-term (6-month) and longer-term (14-month) telephone follow-up interviews. The study sample (n = 4,014) was restricted to English-speaking CIS callers 50 + years of age, who would be eligible for CRC screening at 14 months follow-up and did not call the CIS about CRC or CRC screening. Four experimental conditions were compared: a single untailored (SU) mailout of print material (the control condition); a single tailored (ST) mailout of print material; four (multiple) tailored (MT) mailouts of print materials spanning 12 months, all of which were tailored to information obtained at baseline; and four (multiple) retailored (MRT) mailouts also spanning 12 months, with retailoring of the print materials (mailouts 2, 3, and 4) based on updated information obtained from the 6-month follow-up interviews. Consistent with the main hypothesis of this trial, a significant linear trend across the SU, ST, MT, and MRT groups was found at 14 months (42%, 44%, 51%, and 48%, respectively, p = 0.05). Only for MT was there a significant difference compared with SU (p = 0.03) for the sample as a whole, while no differences were found for MT vs. MRT at 14 months. Significant moderator effects in the predicted direction were found among females, younger participants, and among those with a history of CRC screening, all of which involved the SU vs. MT MRT comparisons. Only among younger participants (ages 50-59) was there a difference between SU vs. ST at 14 months. Given these results, we conclude from this trial the following: (1) the MRT intervention failed to show added benefit beyond the MT intervention, (2) the significant intervention effects involving the MT and MRT conditions can be explained by tailoring and/or the longitudinal nature of both interventions, and (3) the most compelling evidence in support of tailoring was found for the ST condition among younger participants, where a significant need for interventions exists at the national level. Directions for future research are discussed in light of the results summarized above.

Aged↗

PubMed1988

Triazinate and platinum efficacy in combination with 5-fluorouracil and doxorubicin: results of a three-arm randomized trial in metastatic gastric cancer. Gastrointestinal Tumor Study Group.

The Gastrointestinal Tumor Study Group compared three regimens in a controlled prospectively randomized trial for the treatment of patients with advanced gastric cancer. All regimens contained 5-fluorouracil and doxorubicin (FA) but differed in the third drug: semustine (Me), triazinate (T), or cisplatin (P). FAT produced significantly superior overall survival (P less than .01) compared to FAMe. One-year survival rate for the FAT regimen was 30% compared to 15% for the FAMe regimen, and median survival times were 30 versus 24 weeks, respectively. The FAP regimen demonstrated a similar survival advantage compared to the FAMe regimen. The improved survival was observed despite decreased 5-fluorouracil and doxorubicin dosages for patients on the FAT and FAP arms. Severe toxicity rates were 42% for FAT, 69% for FAP, and 62% for FAMe. The FAT regimen produced significantly less hematologic toxicity than either FAP or FAMe, while mild neurotoxicity was the limiting toxicity of cisplatin in this study. Two classes of drugs, without known risks of potentially fatal long-term toxic effects, appear to be effective substitutes for long-acting alkylating agents such as Me or mitomycin in the treatment of advanced gastric cancer. These findings identify new approaches to therapy for this common disease.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1985

A report of a randomized trial of d(15)+Be neutrons compared with megavoltage X ray therapy of bladder cancer.

The results of a randomized trial of d(15)+Be neutrons compared with 4 or 6 MV photons for the treatment of transitional cell carcinoma of the bladder. Between December 1978 and December 1981, 113 patients were accrued, 53 allocated to be treated by neutrons and 60 by photons. Complete local tumor regression was observed in 64% of patients treated by neutrons and 62% treated by photons. Recurrent cancer was subsequently confirmed in 31% of patients, similar in both treatment groups. There was no significant difference in the control rates by T stage between the two treatment groups. Late morbidity was significantly worse in patients treated by neutrons. Following neutron therapy, 78% of patients had serious late morbidity in at least one tissue compared with 38% in the group treated by photons. Survival was significantly better in the photon treated group 45.3% (+/- 11%) at 5 years compared with 12% (+/- 6%) after neutron therapy.

Aged↗

PubMedDate not supplied

Elective cholecystectomy without drainage and without prophylactic antibiotics. A prospective randomized trial with clinical and bacteriological aspects.

A consecutive series of 50 patients undergoing elective cholecystectomy without prophylactic antibiotics entered a prospective randomized trial to compare the post-operative clinical course whether the subhepatic space was drained or not. 26 patients (mean age 58 yrs) were drained and 24 patients (mean age 59 yrs) were not. The incidence of positive gallbladder bile cultures were respectively 8 and 19% (N.S.) in the drained and undrained groups. The incidence of post-operative mortality, thrombo-phlebitis and intra-abdominal sepsis was zero in both groups. In the drained or undrained series, the incidence of wound infection was respectively 4% and 0% (N.S.), that of urinary infection was 8% and 13% (N.S.) and that of pulmonary atelectasis was 15 and 17% (N.S.). A further consecutive series of 100 undrained elective cholecystectomies (18% positive bile cultures) without prophylactic antibiotics was then performed with the same uneventful postoperative course. This study therefore indicates that even in the presence of bacterobilia elective cholecystectomy can be safely performed without subhepatic space drainage and without prophylactic antibiotics.

Adult↗

PubMed2005

A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women.

BACKGROUND: Randomized trials have shown that low-dose aspirin decreases the risk of a first myocardial infarction in men, with little effect on the risk of ischemic stroke. There are few similar data in women. METHODS: We randomly assigned 39,876 initially healthy women 45 years of age or older to receive 100 mg of aspirin on alternate days or placebo and then monitored them for 10 years for a first major cardiovascular event (i.e., nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes). RESULTS: During follow-up, 477 major cardiovascular events were confirmed in the aspirin group, as compared with 522 in the placebo group, for a nonsignificant reduction in risk with aspirin of 9 percent (relative risk, 0.91; 95 percent confidence interval, 0.80 to 1.03; P=0.13). With regard to individual end points, there was a 17 percent reduction in the risk of stroke in the aspirin group, as compared with the placebo group (relative risk, 0.83; 95 percent confidence interval, 0.69 to 0.99; P=0.04), owing to a 24 percent reduction in the risk of ischemic stroke (relative risk, 0.76; 95 percent confidence interval, 0.63 to 0.93; P=0.009) and a nonsignificant increase in the risk of hemorrhagic stroke (relative risk, 1.24; 95 percent confidence interval, 0.82 to 1.87; P=0.31). As compared with placebo, aspirin had no significant effect on the risk of fatal or nonfatal myocardial infarction (relative risk, 1.02; 95 percent confidence interval, 0.84 to 1.25; P=0.83) or death from cardiovascular causes (relative risk, 0.95; 95 percent confidence interval, 0.74 to 1.22; P=0.68). Gastrointestinal bleeding requiring transfusion was more frequent in the aspirin group than in the placebo group (relative risk, 1.40; 95 percent confidence interval, 1.07 to 1.83; P=0.02). Subgroup analyses showed that aspirin significantly reduced the risk of major cardiovascular events, ischemic stroke, and myocardial infarction among women 65 years of age or older. CONCLUSIONS: In this large, primary-prevention trial among women, aspirin lowered the risk of stroke without affecting the risk of myocardial infarction or death from cardiovascular causes, leading to a nonsignificant finding with respect to the primary end point.

Age Factors↗

PubMed2005

Coronary heart disease mortality after 5 years of adjuvant tamoxifen therapy: results from a randomized trial.

From January 1, 1983, through December 31, 1992, a total of 4610 patients entered a randomized trial that compared mortality among patients receiving 2 years of adjuvant tamoxifen therapy with that in patients receiving 5 years of adjuvant tamoxifen therapy, 4175 of whom were recurrence free after 2 years of tamoxifen therapy. Among the 2046 patients randomly assigned to the 5-year group all-cause mortality, breast cancer-specific mortality, and the incidence of contralateral breast cancer were reduced, compared with those among 2129 patients randomized in the 2-year group, but the incidence of endometrial cancer was increased. In addition, mortality from coronary heart disease was statistically significantly reduced in the 5-year group, compared with that in the 2-year group (hazard ratio = 0.67, 95% confidence interval = 0.47 to 0.94; P = .022 [two-sided Wald test]). Ten years after surgery, 2.1% of the patients in the 5-year group and 3.5% of those in the 2-year group had died from coronary heart disease. No statistically significant increases in mortality from other heart diseases, cerebrovascular diseases, or other vascular diseases were observed.

Aged↗

PubMed2002

When small degrees of bias in randomized trials can mislead clinical decisions: an example of individualizing preventive treatment of upper gastrointestinal bleeding.

OBJECTIVE: Although randomized trials yield less biased estimates of treatment effects than other study designs, unconcealed randomization and lack of blinding can lead to overestimates of the treatment benefit on the order of 15% to 40% on average. In applying the results of clinical trials to patient care, clinicians need to be concerned about bias of this order when it would change patient management. The aim of this study is to assess under which circumstances clinicians need to be concerned about bias in clinical trials. DESIGN: Sensitivity analysis. SETTING: Recently published meta-analysis of RCTs on the benefit of H2-blockers on the prevention of gastrointestinal bleeding in critically ill patients. INTERVENTIONS: Assessment of the effect of different degrees of bias on clinical decision making in various clinical scenarios. RESULTS: Bias of even a modest degree (15% to 40% overestimation of effect) changed clinical decisions more frequently when treatment benefits were small and when the patients' risk to suffer an adverse outcome was low. When the benefit was large and the patients were at high risk, clinical decisions remained unchanged, despite bias in the estimation of effect. CONCLUSIONS: When treatments of moderate benefit are applied to patients of low to moderate risk, even small biases in the estimation of effects carry a high risk of erroneous decisions. When the treatment benefit is large and the patients are at high risk, clinicians need to be less concerned about bias in RCTs.

Bias↗

PubMed1999

Challenges in palliative care research; recruitment, attrition and compliance: experience from a randomized controlled trial.

Randomized controlled trials (RCTs) in palliative cancer care often experience methodological problems. In this paper we discuss issues of major concern, including recruitment, patient attrition and compliance, arising from an RCT that compared comprehensive palliative care to conventional care. The main criteria for trial entry were incurable malignant disease and a survival expectancy of between 2 and 9 months. Patients' health-related quality of life (HRQL), self-assessed by multi-item questionnaires, was a defined endpoint. The planned number of patients was successfully recruited, although the patients were referred late in the course of their disease so that follow-up tended to be short. Compliance in completing HRQL questionnaires was good up to 1 month before the patient's death; but in the final weeks it was found to drop substantially. Based on our experience, recommendations are given for those planning similar research. Procedures for improving patient recruitment are suggested, stressing the need for local data management, repeated information to referral sources, extensive screening for potentially eligible patients and simple referral routines. Precise inclusion criteria, including prognostic factors other than physicians' estimates of life expectancy, should be used to ensure a sufficient follow-up period. For HRQL assessment, multi-item questionnaires can achieve excellent compliance up to 1 month before patients' death, but in order to evaluate the very final weeks of life we recommend the use of simpler methods.

Adult↗

PubMed1979

Treatment of cirrhosis with colchicine. A double-blind randomized trial.

As part of a double-blind, randomized, controlled trial to evaluate the effect of colchicine on liver cirrhosis, 43 cirrhotic patients were assigned to either a placebo (20 patients) or a colchicine (23 patients) treatment group. Colchicine 1 mg and an indistinguishable placebo were administered orally on a daily dose 5 days a week. In the colchicine group, 12 were males and 11 females, while in the control group 13 were males and 7 females. The time elapsed between diagnosis and inclusion in the study was 14.1 mo for the controls and 14.5 mo for the patients on colchicine. Mortality related to the liver disease occurred in 4 patients on colchicine and 8 patients on placebo. Although the probability of surviving in the colchicine group was greater than that of the placebo, the difference did not reach statistically significant levels. Of the colchicine-treated patients, in three a remarkable decrease in liver fibrosis was observed in serial biopsies. In two other patients, carcinoma of the liver developed. Six of the survivors on colchicine have improved clinically, noticing disappearance of ascites and edema, as well as a decrease in the size of the spleen. All the survivors on placebo continue to show clinical deterioration. In contrast to the usual drop of serum albumin seen in the cirrhotic patients, those receiving colchicine increased and maintained their serum albumin levels throughout the study. Serum proline values were elevated only in the alcohol cirrhotic patients. Serum alkaline phosphatase increased only in those patients receiving colchicine. The results indicate that in some cases, liver fibrosis could be modified by treatment with antifibrotic drugs. The use of colchicine at present should remain within controlled studies.

Adult↗

PubMed1978

Prevention of deep vein thrombosis in neurosurgical patients: a controlled, randomized trial of external pneumatic compression boots.

A prospective, randomized clinical trial in 95 patients undergoing neurosurgical operative procedures was performed to investigate the efficacy of external pneumatic compression (EPC) of the calves as compared with results in a control group that received no specific form of prophylaxis for prevention of deep vein thrombosis (DVT). The diagnosis of DVT was established by the I125 fibrinogen scan and radiographic contrast phlebography. The data indicate that EPC provides significant protection against the development of DVT in comparison with results in the control group (p less than 0.005). There were no known pulmonary emboli in any of the EPC-treated patients. There were no complications of EPC.

Evaluation Studies as Topic↗

PubMed1992

A randomized trial of cyclosporine and prednisolone versus cyclosporine, azathioprine, and prednisolone in primary cadaveric renal transplantation.

A randomized trial was performed with the aim to compare two immunosuppressive treatment schedules in adult recipients of first cadaveric renal transplants. A total of 229 patients were randomized to double therapy with cyclosporine and prednisolone and 234 patients were randomized to triple therapy with cyclosporine, azathioprine, and prednisolone. Minimum follow-up was 4 years. The actuarial 5-year patient survival was 79.8% in the double therapy group and 82.3% in the triple therapy group (n.s.). The corresponding graft survival figures were 54.4% and 59.6% in the two groups, respectively (n.s.). There were no differences between the groups regarding cause of death or cause of graft loss. Renal function as determined by serum creatinine did not differ between the groups and was stable throughout the observation period. Azathioprine was instituted in a total of 51 patients randomized to double therapy. This subgroup of patients had a patient and graft survival not different from the remaining patients randomized to double therapy or from the patients randomized to triple therapy. There were no differences between the double and triple therapy groups regarding incidence and timing of acute rejection or infections. The incidence of other medical diseases and adverse events such as nephrotoxicity or malignancy did not differ between the groups. Azathioprine-induced leukopenia was uncommon (19 episodes in the triple therapy group). In a multivariate analysis of the whole series the only covariates that significantly influenced graft survival were age of recipient and occurrence of acute rejection, while among other factors treatment schedule did not. Thus this prospective study, in accordance with previous such studies, failed to find support for the use of triple therapy as first choice immunosuppression in first cadaveric renal transplantation. However, the study could not rule out the possibility that some patients at risk for the development of irreversible rejection or nephrotoxicity of CsA might benefit from the addition of azathioprine to the treatment schedule.

Adult↗

PubMed2002

Randomized trial of Lichtenstein versus Shouldice hernia repair in general surgical practice.

BACKGROUND: The aim of the present randomized trial was to compare the Shouldice procedure and the Lichtenstein hernia repair with respect to recurrence rate, technical difficulty, convalescence and chronic pain. A further aim was to determine to what extent general surgeons in routine surgical practice were able to reproduce the excellent results reported from specialist hernia centres. METHODS: Three hundred patients with primary inguinal hernia were randomized to either a Shouldice repair or to a tension-free Lichtenstein repair. In a pretrial training programme the five participating general surgeons were taught to perform the two techniques in a standard manner. Follow-up was performed after 8 weeks, 1 year and 3 years. The last examination was performed by an independent blinded assessor. RESULTS: There was a significant difference in operating time in favour of the Lichtenstein technique. After a follow-up of 36-77 months seven recurrences were found in the Shouldice group (95 per cent confidence interval (c.i.) 1.3 to 8.1) and one in the mesh group (95 per cent c.i. 0.0 to 2.0). Chronic groin pain was reported by 4.2 and 5.6 per cent in the Shouldice and Lichtenstein groups respectively. It was characterized as mild or moderate in all except two patients who had the Shouldice operation. CONCLUSION: Lichtenstein hernia repair was easier to learn, took less time and resulted in fewer recurrences. It was possible to achieve excellent results with this technique in a general surgical unit.

Adult↗

PubMed1990

Randomized trials in the study of antihypertensive drugs.

Heterogeneity in response to antihypertensive drugs can be addressed by randomized trials in individual subjects. In such a trial a patient receives pairs of treatment periods (one period of each pair active drug, one matched placebo, in random order); patient and clinician are blinded to allocation, and treatment targets are monitored. These trials can optimize antihypertensive therapy in clinical practice and facilitate the investigation of new drugs and the study of pathophysiology. Such trials also have potential in helping decide whether common, nonspecific symptoms reported by patients are really drug related.

Antihypertensive Agents↗

PubMed1991

Short-term prednisolone followed by recombinant human alpha-interferon alone or combined with adenine-arabinoside in chronic hepatitis B. A prospective and randomized trial.

Twenty-nine patients with chronic hepatitis B, presenting both hepatitis B surface antigen and hepatitis B virus deoxyribonucleic acid in serum, were studied in a randomized trial treatment consisting of oral prednisolone for 28 days followed 14 days after steroid withdrawal, by either a 55 s.c. injection course of 5 M unit recombinant human alpha-interferon (group 1, 14 patients) or by adenine-arabinoside (for 21 days) combined from the fourteenth day on with the same 55 s.c. injection schedule of interferon (IFN) (group 2, 15 cases). The two groups were well matched with respect to demographic, biochemical, virological and histologic features. Significant side-effects leading to premature discontinuation of interferon were observed in only four cases in group 2 and were always reversible. Efficacy was judged on a mean follow-up period of 17 months. For the whole population, 17 patients (59%) exhibited a sustained serum hepatitis B virus deoxyribonucleic acid disappearance which corresponded to a marked improvement in liver function as demonstrated by a quasi-normalization of their serum transaminase values (ALT with n less than 22 UI/l: 23 +/- 24 vs. 139 +/- 115 before treatment; P less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1988

Spectacle-use, bifocals and prevention of myopic progression. The two-years results of a randomized trial among schoolchildren.

This paper gives the two-year follow-up results of a randomized trial of three different types of corrective lenses: 1) minus lenses with full correction for continuous use (the Reference group); 2) minus lenses with full correction to be used for distant vision only; and 3) bifocal lenses. A total of 240 9-11-years old mildly myopic schoolchildren were randomly allocated to the three different treatment groups to be followed up for 3 years. After 2-years follow-up the change in the spherical equivalent was greatest in the distant use group. There were no significant positive correlations between changes in refraction and accommodation or refraction and convergence.

Accommodation, Ocular↗

PubMed1999

A randomized trial of cognitive therapy and imaginal exposure in the treatment of chronic posttraumatic stress disorder.

A randomized trial was performed in which imaginal exposure (IE) and cognitive therapy (CT) were compared in the treatment of chronic posttraumatic stress disorder (PTSD). Patients who continued to meet PTSD caseness at the end of a 4-week symptom-monitoring baseline period (n = 72) were randomly allocated to either IE or CT. There was a significant improvement in all measures over treatment and at follow-up, although there were no significant differences between the 2 treatments at any assessment. A significantly greater number of patients who showed worsening over treatment received IE, although this effect was not found at follow-up. Patients who worsened showed a greater tendency to miss treatment sessions, rated therapy as less credible, and were rated as less motivated by the therapist. It was concluded that either exposure or a challenge to cognition can result in symptom reduction, although neither resulted in complete improvement.

Adult↗