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PubMed1978

Results of a controlled randomized trial of proximal gastric vagotomy with and without pyloroplasty.

The 1--5 year results of a prospective randomized trial of proximal gastric vagotomy (PGV) with and without pyloroplasty in 64 men operated upon electively for chronic duodenal ulcer are reported. The effects of the operation on gastric secretion, as tested at 6 months with pentagastrin and isulin, were the same in both groups. There was no statistically significant difference in the clinical results between the two groups. The authors conclude that the addition of pyloroplasty makes little, if any, difference to the results of PGV. Pyloroplasty is thus better omitted as it adds nothing of value and may increase the risk of the procedure.

Adult↗
PubMed1978

Adjuvant chemotherapy in large-bowel cancer: demonstration of effectiveness of single agent chemotherapy in a prospectively controlled,, randomized trial.

In a prospectively randomized study, the effect of adjuvant chemotherapy with 5-FU on survival and recurrence rates was analyzed in 299 evaluable patients with colorectal carcinoma who either underwent a curative or a palliative resection. In the treatment group, chemotherapy consisted of the intravenous administration of 12 mg/kg daily of 5-FU for 4 consecutive days, then 6 mg/kg on alternate days, to the point of toxicity, or to a maximum of five doses, followed by 12mg/kg weekly for 1 year. Some degree of drug toxicity was seen in the majority of patients, was rarely severe, and there have been no drug-related deaths. Analysis of the survival curves and disease-free interval curves reveal definite evidence of drug benefit in two unfavorable subgroups, namely patients with Dukes C tumors and in patients whose tumor was located in the rectum. In the chemotherapy groups, patients who were treated to toxicity (WBC less than 4000 mm3), the disease-free interval was significantly longer than the nonleukopenic patients. We conclude that the addition of 5-FU to the surgical treatment of colorectal carcinoma provides a small, but significant benefit in patients with colorectal cancer in certain unfavorable subgroups, namely patients with Dukes C lesions and patients with rectal carcinoma.

Clinical Trials as Topic↗
PubMed1996

High-dose interferon-alpha 2b for re-treatment of nonresponders or relapsing patients with chronic hepatitis C. A controlled randomized trial.

Relatively few patients with chronic hepatitis C treated with standard doses of interferon-alpha 2b (3 million units per week for 24 weeks) have a sustained response. Our aim was to evaluate whether higher doses of interferon would improve this rate of response. Twenty-four patients with chronic hepatitis C who had failed to respond to (N = 21) or had relapsed after (N = 3) an initial course of standard interferon therapy were randomized to 15 million units (N = 13) or 22.5-30 million units per week (N = 11) for 24 weeks. Five of 13 subjects given 15 million units per week and 3/11 of subjects given 22.5-30 million units per week had complete normalization of serum alanine aminotransferase levels during therapy. Five patients (24% who had not responded to standard interferon had a complete response to high-dose interferon during therapy. Only one patient had a sustained response, with normal serum alanine aminotransferase 24 weeks after stopping interferon. Six patients were withdrawn before completing treatment, five in the 22.5-30 million unit per week group. We conclude that higher doses of interferon ameliorate the severity of hepatitis in patients who failed to respond to or relapsed after standard interferon therapy, but are unlikely to produce a sustained response. High-dose therapy is associated with an increase in side effects.

Alanine Transaminase↗
PubMed2001

Regular physical exercise and bone mineral density: a four-year controlled randomized trial in middle-aged men. The DNASCO study.

The aim of the study was to investigate the effects of regular aerobic exercise training on bone mineral density (BMD) in middle-aged men. A population based sample of 140 men (53-62 years) was randomly assigned into the exercise and reference groups. BMD and apparent volumetric BMD (BMDvol) of the proximal femur and lumbar spine (dual-energy X-ray absorptiometry, DXA) and anthropomorphic measurements were performed at the randomization and 2 and up to 4 years later. The participation rate was 97% and 94% at the second and third BMD measurements, respectively. As another indication of excellent adherence and compliance, the cardiorespiratory fitness (aerobic threshold) increased by 13% in the exercise group. The 2% decrease in the reference group is regarded as an age-related change in cardiorespiratory fitness. Regardless of the group, there was no association between the increase in aerobic threshold and change in BMD. In the entire group, age-related bone loss was seen in the femoral neck BMD and BMDvol (p < 0.01). BMD and BMDvol values increased with age in L2-L4 (p < 0.004). An increased rate of bone loss at the femoral neck was observed in men with a low energy-adjusted calcium intake (p = 0.003). Men who increased their alcohol intake during the intervention showed a decrease in the rate of bone loss at the femoral neck (p = 0.040). A decrease in body height associated with decreased total femoral BMD (r = 0.19, p = 0.04) and the change in body height was a predictor of bone loss in the femoral neck (beta = 0.201). Long-term regular aerobic physical activity in middle-aged men had no effect on the age-related loss of femoral BMD. On the other hand, possible structural alterations, which are also essential for the mechanical strength of bone, can not be detected by the DXA measurements used in this study. The increase seen in lumbar BMD reflects age-related changes in the spine, thus making it an unreliable site for BMD follow-up in men.

Absorptiometry, Photon↗
PubMed2005

A placebo controlled randomized trial of the effects of phenylpropanolamine and nicotine gum on cessation rates and postcessation weight gain in women.

With smoking prevalence rates beginning to decline, studies designed to promote cessation in more challenging populations, like weight-concerned smokers, warrant attention. This study assessed the efficacy of two forms of pharmacotherapy [nicotine and phenylpropanolamine (PPA) gums] in addition to a 13-week cognitive behavioral smoking cessation program targeted for women. Participants were 439 females who met rigorous screening criteria and were randomized to one of the three treatment intervention groups (PPA gum, nicotine gum, or placebo gum). All participants attended a 13-week cognitive behavioral smoking cessation program and were given specific instructions on gum chewing. At posttest (13 weeks), and 6- and 12-month follow-ups, body weight and point prevalence abstinence were assessed. Analyses to determine potential differences between treatment groups on weight change and cessation rates were performed. Results indicated that neither change in body weight nor cessation rates significantly differed between groups. Attendance to sessions did appear to consistently increase the likelihood of quitting smoking at posttest and at each of the follow-ups. These results suggest that although the pharmacological interventions had no effect on cessation rates and postcessation weight gain, the behavioral component of the intervention was effective in increasing the odds of quitting smoking in weight-concerned women. Future efforts should focus on increasing adherence to behavioral program components, particularly session attendance.

Adult↗
PubMed1998

Corticosteroids and radiation mucositis in head and neck cancer. A double-blind placebo-controlled randomized trial.

Patients with head and neck cancer were randomized in a double-blind manner to receive 40 mg/day prednisone (n = 32) or placebo (n = 34). The prescribed daily tumour dose was 1.6 Gy twice daily with an interfraction interval of > or =6 h. Treatment interruptions were at the discretion of the radiation oncologists. The primary study end-point was the total duration of treatment. A mean 4.4 day reduction was observed in the total elapsed treatment duration for the prednisone arm, 34.3 versus 29.9 days (P = 0.013), which paralleled a significantly lower median total tumour and biologically effective dose (BED) Gy10 in this arm. A trend favouring shorter treatment interruptions in the prednisone arm was also found, but not a reduction in the intensity or duration of mucositis.

Adult↗
PubMed1986

Percutaneous transluminal coronary angioplasty after thrombolytic therapy: a prospective controlled randomized trial.

In 162 patients with acute transmural myocardial infarction, combined intravenous and intracoronary thrombolytic therapy with streptokinase was initiated. In vessels that remained occluded, mechanical recanalization was performed with a 3F recanalization catheter (group I, n = 79) or a 4F Grüntzig balloon catheter (group II, n = 83). After reperfusion, intracoronary streptokinase was administered superselectively. After termination of streptokinase infusion, angioplasty was performed only in patients in group II. There was no difference between the groups in relation to sex, age, infarct location, creatine kinase levels and time between onset of symptoms and start of treatment. Initial coronary angiography showed an open vessel in 27 (34%) of 79 patients in group I and 21 (25%) of 83 patients in group II. The final reperfusion rate was 90% (71 of 79) in group I and 86% (71 of 83) in group II. Angioplasty was attempted in 69 of the 71 patients in group II with a success rate of 65% and an occlusion rate of 3%. During the hospital stay, reocclusion occurred in 14 (20%) of 71 patients in group I. After thrombolytic therapy, coronary luminal narrowing in group I was 75 +/- 17% in patients without and 87 +/- 6% in patients with reocclusion (p less than 0.05). In group II, reocclusion was found in 10 (14%) of 71 patients. After angioplasty, the degree of coronary stenosis in group II was reduced from 82 +/- 12 to 51 +/- 30% (p less than 0.001). Reocclusion was found in 3 (7%) of the 45 patients with successful angioplasty and in 7 (32%) of the 22 patients with unsuccessful angioplasty (p less than 0.01). Improvement in regional left ventricular function was observed only in patients from group II with anterior myocardial infarction. In conclusion, by combined medical and mechanical recanalization, the rate of coronary reperfusion can be increased and infarct time shortened, providing the possibility of full revascularization by angioplasty, with improvement of regional wall motion and reduction of the rate of reocclusion.

Adult↗
PubMed2000

Preseasonal local allergoid immunotherapy to grass pollen in children: a double-blind, placebo-controlled, randomized trial.

BACKGROUND: We assessed the efficacy of preseasonal local allergoid immunotherapy in a group of children with asthma and/or rhinitis and/or rhinoconjunctivitis due to grass pollen. METHODS: We randomly assigned 24 children allergic to grass pollen to receive local allergoid immunotherapy for 3 months before the pollen season and 24 such patients to receive identically appearing placebo. The immunotherapy consisted of tablets of monomeric allergoid grass pollen allergens held in the mouth until they dissolved and then swallowed. The study was double-blind. Symptoms and medications were scored on diary cards during the pollen season. Nasal eosinophil cationic protein levels were measured by the monoclonal antibodies EG1 and EG2 outside the pollen season and at low and at high pollen concentration during the pollen season. RESULTS: The active-treatment group had a statistically significant reduction of total symptoms (P<0.05), especially bronchial symptoms (P<0.05), in comparison with the placebo group. Immunotherapy was well tolerated and compliance was good. Nasal levels of EG2 and EG1 increased significantly during the pollen season, but there was no difference between groups. EG2/EG1 increased significantly only in the placebo group during natural allergen exposure (P<0.01). CONCLUSIONS: Our results suggest that this immunotherapy is effective for the treatment of asthma due to grass pollen in children.

Administration, Oral↗
PubMed2000

Administration of prostacyclin after liver transplantation: a placebo controlled randomized trial.

The shortage of suitable organs for liver grafts is responsible for the use of marginal donors for liver transplantation (OLT). If these liver grafts function poorly initially after OLT, a supportive therapy is necessary. The purpose of this study was to evaluate the effects of prostacyclin (PGI2) on postoperative liver graft function after OLT. A total of 30 adult recipients of primary OLT were randomized to either receive PGI2 (4 ng/kg per min body weight, n = 15) or a placebo for 6 d. To evaluate regional splanchnic oxygenation a fiberoptic pulmonary-artery catheter was inserted into a hepatic vein and the difference between mixed venous oxygen content and hepatic venous oxygen content was determined (deltaO2). Measurements were performed directly after transplantation and at 6, 12, 24 and 48 h postoperatively. A significant correlation between deltaO2 and the level of transaminases (ALT/AST) was observed 24 and 48 h after transplantation (p < 0.05). PGI2 treatment induced a significant decrease in deltaO2 after 24 and 48 h after reperfusion (p < 0.05). Peak AST levels tended to be lower in the PGI2 treatment group (418 +/- 99 vs. 638 +/- 156 U/L, p < 0.1). These results suggest that administration of PGI2 after OLT improves hepatic-splanchnic oxygenation and may thereby reduce reperfusion injury after OLT.

Adult↗
PubMed1975

Chemotherapy of advanced breast cancer: a controlled randomized trial of cyclophosphamide versus a four-drug combination.

Ninety-nine patients with advanced breast cancer were randomized to receive either cyclophosphamide continuously or a combination of cyclophosphamide, methotrexate, 5-fluorouracil and vinblastine given intermittently. The number and duration of objective responses were greater in patients receiving the combination but the differences between the two treatments did not achieve formal significance. The combination was logistically easier to manage and produced less toxicity.

Adult↗
PubMed1997

A placebo-controlled randomized trial of the terbutaline pump for prevention of preterm delivery.

To determine the efficacy of the terbutaline pump for the prevention of preterm delivery, patients in preterm labor defined by progressive cervical change underwent intravenous magnesium sulfate tocolysis (with or without oral indomethacin, as necessary), and once labor was arrested, were randomized to one of three treatment arms: terbutaline by pump, saline by pump (blinded), or oral terbutaline. If recurrent preterm labor occurred despite maximization of therapy, the treatment arm was determined and therapy was changed; saline pump and oral terbutaline were switched to terbutaline pump, terbutaline pump was switched to oral terbutaline. Patients who continued to labor were readmitted for aggressive intravenous therapy. Women randomized to the terbutaline pump (n = 15), saline pump (n = 12), and oral terbutaline (n = 15) groups were similar in terms of gravidity, parity, days of tocolysis before study entry, gestational age at entry, and cervical dilatation at entry. The mean gestational age at delivery was the same in all three groups (35 weeks), as were neonatal outcomes. Terbutaline by pump, saline by pump, and oral terbutaline appear equivalent for the prevention of preterm delivery. The terbutaline pump should remain experimental.

Administration, Oral↗
PubMed2000

Day 5 versus day 3 embryo transfer: a controlled randomized trial.

Blastocyst transfer has been suggested to improve implantation rate without affecting pregnancy rate. The aim of this study was to compare the pregnancy and implantation rates of day 3 and 5 transfers in a prospective randomized manner. Patients with four or more zygotes were randomly allocated on day 1 to either day 3 or 5 transfers. Fertilization was achieved through regular IVF or intracytoplasmic sperm injection. Zygotes were kept in Medicult IVF medium for day 3 transfers and transferred into G1.2 and G2.2 on day 1 and 3 respectively for day 5 transfers. The morphologically best two or three embryos or blastocysts were chosen for transfer in both groups. Overall pregnancy rates per embryo transfer were the same (39%) in day 3 and 5 transfers. Implantation rates were 21 and 24% for day 3 and 5 transfers respectively. The pregnancy and implantation rates for day 5 transfers were significantly affected by the availability of at least one blastocyst to transfer and the number of zygotes. The number of good quality embryos on day 3 also significantly affected pregnancy and implantation rates on day 5 transfers. Multiple gestation rate, number of abortions and ongoing pregnancies were similar in both groups. In conclusion, day 3 and 5 transfer had similar pregnancy, implantation and twinning rates. Currently, day 5 transfers have no advantages over day 3 transfers.

Adult↗
PubMed1987

Psychological group counseling for the prevention of ulcer relapses. A controlled randomized trial in duodenal and prepyloric ulcer disease.

The effect of psychological counseling on 1-year ulcer relapse rate of recurrent duodenal and prepyloric ulcer disease was evaluated in 148 patients randomly allocated into three treatment groups; psychological counseling group, maintenance cimetidine (400 mg at bedtime), and placebo cimetidine at bedtime. Ulcer relapses were monitored by endoscopy at 6 and 12 months after inclusion and at symptomatic recurrence. The estimated proportion of relapse-free patients after 12 months follow-up in the psychological counseling group (0.43 +/- 0.08) did not differ significantly from the placebo group (0.47 +/- 0.07), whereas the corresponding value for the cimetidine group (0.70 +/- 0.07) was significantly higher (p less than 0.01). The effect of cimetidine on ulcer recurrence, however, was confined to smokers; relapse risk among nonsmokers did not differ significantly between the treatment groups. The negative outcome of psychological counseling raises doubts as to whether duodenal or prepyloric ulcer recurrences can be prevented by such a therapeutic approach.

Adolescent↗
PubMed2026

Assessment of blinding in pharmacotherapy and noninvasive neuromodulation randomized controlled trials for neuropathic pain in adults.

In randomized controlled trials (RCTs), study participants and research personnel are often blinded to minimize biases related to knowing treatment allocation. To determine if blinding was effective, participants may be asked which treatment they believe they received ("treatment guess"). This descriptive review characterized blinding assessment (BA) reporting in pharmacotherapy and neuromodulation neuropathic pain RCTs. Of 288 papers, 36 (12.5%) reported a BA. One paper reported the results of 2 studies, so in total 37 studies with a BA were assessed. Of these, 19 were crossover, 17 parallel, and 1 partial crossover in design. All 37 studies assessed participant blinding, and 10 also assessed investigator blinding. Approximately 27% included an "unsure" answer option for treatment guess, and 38% asked the reason for the guess. There were no clear patterns in BA reporting across time nor based on treatment type. Seventeen trials provided sufficient data to calculate Bang Blinding Index (BI) to determine blinding success. Participants remained blinded (BI = 0 &#xb1; 0.2) in 10/17 placebo and 10/17 treatment arms, 6 placebo and 5 treatment arms had a BI > 0.2 suggesting possible unblinding, whereas 1 placebo and 2 treatment arms had a BI < -0.2 suggesting misinformed guessing. Overall, we found that BAs are done in a minority of published neuropathic pain trials and with variable methodology. Given the importance of minimizing risk of bias because of treatment unblinding, future studies should consider including BAs, and further consensus building is necessary to determine if and how BAs should be conducted and interpreted in analgesic clinical trials.

Bias↗
PubMed2003

Home delivery of an injury prevention kit for children in four French cities: a controlled randomized trial.

OBJECTIVES: Home delivery of counselling and safety devices to prevent child injuries could help parents to adopt safe behaviour. The aim of this study was to test a safety kit designed and used in Quebec (Canada). DESIGN AND SUBJECTS: One hundred families from four towns in the Paris suburbs were visited at home by nurses or doctors when their child reached 6-9 months. Selection criteria were: primipara, medical problem, psychological, and/or socioeconomic difficulties. INTERVENTIONS: During the first visit, 50 families (group 1) received counselling and a kit including preventive devices and pamphlets about indoor injuries and ways to avoid them. The other 50 families (group 2) received counselling but not the kit. A second home visit was made 6-8 weeks later. MAIN OUTCOME MEASURES: The number of safety improvements was calculated 6-8 weeks after a first home visit. Perceived usefulness of the kit was collected from families and from interviewers. RESULTS: Between the first and the second visits, safety improvement was significantly higher in the group with the kit. This was mainly related to the risk of fall (p<0.02), fire and burns (p<0.001), poisoning (p<0.01), and suffocation (p<0.001). For improvement related to devices provided in the kit, the difference between the groups was significant: 64.4% improvement in group 1 versus 41.2% in group 2 (p<0.01). The relative risk (RR) of safety improvement between groups was 1.56 (95% confidence interval (CI) 1.35 to 1.80). Even for improvements not related to the kit the difference remained significant: 31.2% in group 1 versus 20.2% in group 2 (p<0.05); RR = 1.54 (95% CI 1.22 to 1.93). CONCLUSION: Routine home visits by social services offer a good opportunity to tackle child injury prevention. Free delivery of prevention kits and counselling allow families to modify their behaviour and homes so as to reduce risks.

Accidents, Home↗
PubMed1993

Treatment of acute cortical infarct with intravenous glycerol. A double-blind, placebo-controlled randomized trial.

BACKGROUND AND PURPOSE: This clinical trial investigates the effectiveness of intravenous glycerol therapy in patients with acute cortical infarction in whom intracerebral hemorrhage was rigorously excluded. METHODS: Within 48 hours of symptoms from their first ischemic stroke, 113 hospital inpatients were randomized into the trial, provided that hemorrhage was excluded by computed tomography and informed consent was obtained. Patients were stratified into alert, semicoma, and coma groups using the Glasgow Coma Scale. Treatment was allocated according to a double-blind, randomized protocol; 56 patients received 500 mL of 10% glycerol in saline over 4 hours on 6 consecutive days, and 57 patients received corresponding placebo treatment with saline. Using a variety of objective scoring systems, patient follow-up was up to 6 months. RESULTS: Corresponding measures of outcome in the glycerol and placebo groups were similar. At 6 months, respective mortality rates were 17 of 56 and 16 of 57, and mean +/- SD improvements in scores were 9.98 +/- 14.40 vs 10.51 +/- 12.68 (long-term), 1.12 +/- 7.20 vs 1.57 +/- 6.30 (prognostic), -1.94 +/- 5.53 vs -2.06 +/- 5.34 (Glasgow Coma Scale), and 21.72 +/- 23.40 vs 11.94 +/- 18.10 (Barthel Index rating in survivors). Hemolysis (generally subclinical) was the only adverse effect. CONCLUSIONS: There was no clinically or statistically significant difference in outcome between the groups; a trend toward greater functional recovery among survivors was evident after treatment with glycerol.

Acute Disease↗
PubMed2002

HR (Paroven, Venoruton; 0-(beta-hydroxyethyl)-rutosides) in venous hypertensive microangiopathy: a prospective, placebo-controlled, randomized trial.

UNLABELLED: The aim of this study was to demonstrate whether HR (Paroven-Venoruton; 0-(beta-hydroxyethyl)-rutosides), was effective in improving the microcirculation in venous hypertension and microangiopathy. Sixty patients with severe venous hypertension due to chronic venous insufficiency, ankle swelling, and lipodermatosclerosis were included. After informed consent, patients were randomized into a treatment group and a placebo group. Patients in the treatment group received oral HR (2 g/day for 8 weeks); those in the placebo group received a comparable placebo. RESULTS: The two groups were comparable for age and sex distribution. The mean age was 45 years (SD 9) in the treatment group (31 patients) and 45.5 (SD 10) in the placebo group (29 patients). There were no differences between the placebo and treatment groups at inclusion. There was no change between inclusion and measurements at 8 weeks in the placebo group. A significant decrease (P < 0.05) in flux at rest and rate of ankle swelling was observed in the treatment group. The decrease in capillary filtration was associated with improvement in signs and symptoms (P < 0.05). The difference in flux, sign and symptoms, and filtration was clinically important at 8 weeks in the treatment group when compared with the placebo group. No adverse effects were observed. CONCLUSION: Venous microangiopathy was improved by HR treatment.

Adult↗