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Results for “Randomized trial”

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At least 1,207 records · Page 67Linked to original sources

PubMed1997

A comparative, randomized trial of UFT and 5-fluorouracil in combination with cyclophosphamide and doxorubicin in the treatment of advanced breast cancer patients at The Philippines General Hospital.

A comparative, randomized trial was conducted to determine the efficacy of oral UFT (Tegafur and Uracil) versus 5-fluorouracil (5-FU) in combination with cyclophosphamide and doxorubicin in patients with metastatic breast cancer. Of 62 evaluable patients, 31 received UFT (350 mg/m2/day orally x 14 days), doxorubicin (50 mg/m2 intravenously [I.V.] day 1) and cyclophosphamide (500 mg/m2 I.V. day 1). The other 31 patients received 5-FU (500 mg/m2 I.V. days 1 and 8), doxorubicin (50 mg/m2 I.V. day 1), and cyclophosphamide (500 mg/m2 I.V. day 1). Regimens were repeated for a total of six cycles. The two groups were comparable in terms of age, gender, performance status, menopausal status, and number and sites of metastases. No statistical difference in overall response rates was seen (UFT arm, 48.4% vs. 5-FU arm, 35 %; p = 0.30). Median response duration was 16 weeks (range, 4-30) for both arms. The toxicity profile (alopecia, anemia, leukopenia, thrombocytopenia, diarrhea) was similar in both groups and both regimens were well tolerated. Anemia and stomatitis were significantly more common in the 5-FU arm (p = 0.02). Thus, oral UFT has response rates and duration of response that are comparable to 5-FU in a combination regimen for advanced breast cancer.

Administration, Oral↗

PubMed2004

A randomized trial comparing the effects of self-help materials and proactive telephone counseling on teen smoking cessation.

We conducted a 2-arm randomized trial to test the efficacy of self-help materials with or without proactive telephone counseling to increase cessation among teen smokers. Teen smokers (N = 402) recruited from 11 shopping malls and 1 amusement park in the southeastern United States were randomized to 1 of 2 groups: written self-help material plus video; or written self-help material, video, and telephone counseling. Cessation rates based on 7-day point-prevalent abstinence for the self-help and counseling arms were 11% and 16%, respectively (p = .25), at 4 months postbaseline and 19% and 21%, respectively (p = .80), at 8 months postbaseline. Sustained abstinence, reflecting 7-day abstinence at both time points, in the self-help and counseling arms was 7% and 9% (p = .59). Results suggest that minimal self-help cessation approaches that target youth have comparable success to that shown among adult smokers. However, refinements in telephone-counseling approaches may be needed to achieve the success observed in adult populations.

Adolescent↗

PubMed2005

Breast milk HIV-1 suppression and decreased transmission: a randomized trial comparing HIVNET 012 nevirapine versus short-course zidovudine.

OBJECTIVE: To compare the effect of perinatal regimens of short-course nevirapine (HIVNET 012) and zidovudine [Thai-Centers for Disease Control and Prevention (CDC) regimen] on breast milk viral shedding and perinatal transmission during the first 6 weeks postpartum in a randomized clinical trial. DESIGN: Randomized clinical trial. METHODS: Pregnant HIV-1 seropositive women in Nairobi, Kenya who planned to breastfeed were randomized to HIVNET 012 or Thai-CDC regimens. Two to four breast milk samples were collected each week between delivery and 6 weeks postpartum. Breast milk HIV-1 RNA was quantified using the Gen-Probe TMA assay. Infants were tested for HIV-1 DNA at birth and 6 weeks. RESULTS: From March to October 2003, 76 women were enrolled and 795 breast milk samples were collected from 60 women who were randomized and followed after delivery. Between 3 and 21 days postpartum, nevirapine was associated with significantly greater suppression of breast milk log10 HIV-1 RNA: days 3 to 7 (1.98 versus 2.42, P = 0.1); days 8 to 14 (1.78 versus 2.48, P = 0.005); days 15 to 21 (1.90 versus 2.97, P = 0.003). At 6 weeks, the HIV-1 perinatal transmission rate was significantly lower among those who took nevirapine than zidovudine (6.8% versus 30.3%, P = 0.02). CONCLUSIONS: Compared to a peripartum zidovudine regimen, nevirapine was significantly more likely to decrease HIV-1 RNA in breast milk during the first week and through the third week postpartum following single-dose administration, and corresponded with decreased transmission risk at 6 weeks. Sustained breast milk HIV-1 suppression may contribute to the ability of nevirapine to decrease perinatal transmission of HIV-1.

Adult↗

PubMedDate not supplied

A prospective randomized trial of central venous catheter removal versus intravenous amphotericin B in febrile neutropenic patients.

Empiric amphotericin B therapy was compared to central venous catheter Githdrawal in a prospective randomized trial. Of 32 febrile, neutropenic patients with indwelling Broviac catheters and without documented infection, 14 had persistent fever while receiving broad spectrum antibacterial drugs. Six patients were randomized to catheter removal and eight patients received amphotericin B empirically. None of six patients responded to catheter removal and six of eight defervesced after receiving antifungal therapy (p less than 0.01). Of the six patients in whom catheters were removed, two later became afebrile while on subsequent therapy with amphotericin B. Culture and histologic evaluation of the removed catheters failed to implicate the prosthesis as an infectious source. Central venous catheters in a persistently febrile neutropenic host need not be removed, unless local difficulties or bacteremia with skin commensal organisms occur. Amphotericin B can be infused through a central venous catheter in febrile, neutropenic patients unresponsive to empiric antibacterial drugs, with many patients becoming afebrile as a result of this therapy.

Adult↗

PubMed1983

Ranitidine and placebo in the treatment of reflux oesophagitis. A double-blind randomized trial.

A study was carried out to assess the effectiveness of ranitidine in the short-term treatment of reflux oesophagitis. In a double-blind randomized trial of 37 outpatients with symptomatic, endoscopically proven, moderate or severe reflux oesophagitis, 18 patients received ranitidine (150 mg twice a day) and 19 patients received identical-looking placebo tablets for a period of six weeks. Clinical, laboratory, and endoscopic assessments were made initially, and at the end of six weeks. Two patients withdrew during the trial. Endoscopic evidence of improvement was found in 15 of 17 ranitidine-treated and in five of 18 placebo-treated patients. This difference was significant (P less than 0.01). Antacid consumption was significantly lower in the ranitidine-treated group (P less than 0.01). Improvement in histological findings, and the relief of retrosternal pain, regurgitation, dysphagia, and epigastric pain did not achieve levels of statistical significance. No adverse clinical or laboratory changes occurred in patients in either group. It is concluded that, as judged by endoscopic evidence, ranitidine is an effective drug for the short-term treatment of reflux oesophagitis.

Clinical Trials as Topic↗

PubMed1992

A randomized trial of high-dose ciprofloxacin versus azlocillin and netilmicin in the empirical therapy of febrile neutropenic patients.

A prospective, randomized trial comparing monotherapy with high-dose ciprofloxacin versus a standard combination regimen of azlocillin and netilmicin in the empirical treatment of febrile episodes in neutropenic patients was performed. One hundred and forty-six patient episodes were randomized, but ten (seven ciprofloxacin and three azlocillin/netilmicin) were considered unevaluable for efficacy, and three episodes were withdrawn due to incorrect randomization or non-neutropenia. Of the remaining 133 episodes, infections resolved without modification of therapy in 25/66 (38%) versus 28/67 (42%) of ciprofloxacin and azlocillin/netilmicin treated groups respectively (P = 0.72). Considering all randomized episodes, therapy was modified in 46/73 (63%) episodes with ciprofloxacin and 39/70 (56%) with azlocillin/netilmicin (P = 0.40). Of 73 patient episodes randomized to ciprofloxacin, 25 (34%) received oral follow-on therapy after a median of three days of intravenous therapy. Infections were microbiologically documented in 31/73 (42%) ciprofloxacin and 32/70 (46%) azlocillin/netilmicin, of which 8/27 (30%) and 14/31 (45%) of evaluable episodes resolved without modification of therapy respectively (P = 0.28). Gram-positive organisms accounted for 78% of all organisms cultured with 36% coagulase-negative staphylococci. Bacteriological eradication was recorded in 18/24 (75%) and 26/29 (90%) evaluable patient episodes treated with ciprofloxacin and azlocillin/netilmicin respectively (P = 0.27). Superinfections were seen in 14% of episodes in both groups, and subsequent infections in 12% ciprofloxacin and 14% azlocillin/netilmicin treated patients. Two patients (one ciprofloxacin and one azlocillin/netilmicin) died within 48 h of randomization, and a further 13 patients (four ciprofloxacin and nine azlocillin/netilmicin) died before resolution of neutropenia. Adverse events were recorded in 9% and 15% of ciprofloxacin and azlocillin/netilmicin treated patients respectively, with skin rash (five ciprofloxacin and four azlocillin/netilmicin), nephrotoxicity (two azlocillin/netilmicin), abnormal liver function tests (two azlocillin/netilmicin), ototoxicity (one azlocillin/netilmicin) and nausea (one ciprofloxacin) being the major events recorded. It was concluded that monotherapy with ciprofloxacin at this dosage is a safe alternative to combination therapy with azlocillin/netilmicin, and has the advantages of twice daily administration, iv and oral presentations, no cross allergy in beta-lactam-hypersensitive patients, and no nephro- or oto-toxicity.

Adolescent↗

PubMed1997

A prospective blinded randomized trial comparing oral sodium phosphate and polyethylene glycol solutions for bowel preparation prior to barium enema.

PURPOSE: A prospective blinded randomized trial to compare oral sodium phosphate (NaP) solution with polyethylene glycol (PEG) preparations as bowel preparation prior to barium enema examination. PATIENTS AND METHODS: One hundred and ten patients consented to take part and each patient was randomly assigned to receive either NaP (Oral Fleet Prep) or PEG (Lyteprep). The barium enemas were reviewed by two radiologists blinded to the type of bowel preparation the patient had received. The colon was divided into six segments and each segment was assessed for the amount of stool and water present, the adequacy of coating, the ability to exclude inflammatory bowel disease and the presence of polyps. A score of 0-3 (failure to good) was assigned per segment on each of these criteria. RESULTS: The average individual score for the NaP group was 89.2. The average individual score for the PEG group was 88.81. No significant difference was found in the quality of bowel cleansing between the two agents. In particular there was no significant difference in the scores for water retention (two-tailed P = 0.748) and the difference for the quality of coating was considered not quite significant (two-tailed P = 0.0818). CONCLUSION: Oral sodium phosphate cleans the colon as well as polyethylene glycol solutions. The use of NaP will result in significant cost savings and improved patient compliance.

Adolescent↗

PubMed1998

Percutaneous balloon versus surgical closed and open mitral commissurotomy: seven-year follow-up results of a randomized trial.

BACKGROUND: Percutaneous balloon mitral commissurotomy (BMC) has been proposed as an alternative to surgical closed mitral commissurotomy (CMC) and open mitral commissurotomy (OMC) for the management of rheumatic mitral valve stenosis (MS). METHODS AND RESULTS: We conducted a prospective, randomized trial comparing the results of the 3 procedures in 90 patients (30 patients in each group) with severe pliable MS. Cardiac catheterization was performed in all patients before and at 6 months after each procedure. All patients had clinical and echocardiographic evaluation initially and throughout the 7-year follow-up period. Gorlin mitral valve area (MVA) increased much more after BMC (from 0.9+/-0.16 to 2.2+/-0.4 cm2) and OMC (from 0.9+/-0.2 to 2.2+/-0.4 cm2) than after CMC (from 0.9+/-0.2 to 1.6+/-0.4 cm2). Residual MS (MVA <1.5 cm2) was 0% after BMC or OMC and 27% after CMC. There was no early or late mortality or thromboembolism among the three groups. At 7-year follow-up, echocardiographic MVA was similar and greater after BMC and OMC (1.8+/-0.4 cm2) than after CMC (1.3+/-0.3 cm2; P<.00l). Restenosis (MVA <1.5 cm2) rate was 6.6% after BMC or OMC versus 37% after CMC. Residual atrial septal defect was present in 2 patients and severe grade 3 mitral regurgitation was present in 1 patient in the BMC group. Eighty-seven percent of patients after BMC and 90% of patients after OMC were in New York Heart Association functional class I versus 33% (P<.0001) after CMC. Freedom from reintervention was 90% after BMC, 93% after OMC, and 50% after CMC. CONCLUSIONS: In contrast to surgical CMC, BMC and OMC produce excellent and comparable early hemodynamic improvement and are associated with a lower rate of residual stenosis and restenosis and need for reintervention. However, the good results, lower cost, and elimination of drawbacks of thoracotomy and cardiopulmonary bypass indicate that BMC should be the treatment of choice for patients with tight pliable rheumatic MS.

Adolescent↗

PubMed1992

Causes of death during the first 5 years of a randomized trial of mass screening for colorectal cancer with fecal occult blood test.

The main purpose of population screening for colorectal cancer is to reduce mortality from the disease. The criteria of death from colorectal cancer are defined in the present randomized trial of 61,938 persons between 45 and 74 years old, and the need for an impartial death review committee was demonstrated. Causes of death within the first 5 years are described within subgroups of the test group and compared with those in the control group. Death rates were higher among non-responders to screening than among controls and among those in whom Hemoccult-II had been performed at least once. Persons with negative Hemoccult-II had a lower death rate than controls. The overall autopsy rate was 32%. Lethal complications from treatment of colorectal neoplasia were evaluated per se. Death from colorectal cancer occurred in 74 persons in the total screening group and in 91 among controls. Sources of bias are discussed. A method of evaluating possible benefit to those being screened is suggested. Final results cannot be expected before 1996.

Aged↗

PubMed1993

Five-year follow-up of a prospective randomized trial of hepatitis B recombinant DNA yeast vaccine vs. plasma-derived vaccine in children: immunogenicity and anamnestic responses.

In a prospective randomized trial, 318 children aged between 3 mo and 11 yr who were negative for all hepatitis B markers were randomized to receive two 5-micrograms doses of hepatitis B recombinant DNA yeast vaccine at 0 and 1 mo (group 1), three 5-micrograms doses of hepatitis B recombinant DNA yeast vaccine at 0, 1 and 6 mo (group 2) or three 10-micrograms doses of plasma-derived hepatitis B vaccine (group 3). The HBs antibody response rate at 8 mo was between 93% and 99%; it was still 75% to 87% at 5 yr in all three groups. Geometric mean titers at 1 yr were 83, 1,085 and 858 mIU/ml in groups 1, 2 and 3, respectively. These values had decreased after 5 yr to 47, 131 and 250 mIU/ml. Subjects in group 1 showed a significantly less proportional drop in geometric mean titer at the fifth year than did subjects in group 2 (p = 0.05) or group 3 (p = 0.015). None of the children developed HBc antibody, even after 5 yr of follow-up. We noted 42 episodes of significantly increased HBs antibody titers, probably due to anamnestic response, even when the titers had dropped to low levels. The mean age at which anamnestic response occurred was 8.7 yr.(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors↗

PubMed1999

Final results of the STent versus directional coronary Atherectomy Randomized Trial (START)

OBJECTIVES: This study was designed to compare primary stenting with optimal directional coronary atherectomy (DCA). BACKGROUND: No previous prospective randomized trial comparing stenting and DCA has been performed. METHODS: One hundred and twenty-two lesions suitable for both Palmaz-Schatz stenting and DCA were randomly assigned to stent (62 lesions) or DCA (60 lesions) arm. Single or multiple stents were implanted with high-pressure dilation in the stent arm. Aggressive debulking using intravascular ultrasound (IVUS) was performed in the DCA arm. Serial quantitative angiography and IVUS were performed preprocedure, postprocedure and at six months. The primary end point was restenosis, defined as > or =50% diameter stenosis at six months. Clinical event rates at one year were also assessed. RESULTS: Baseline characteristics were similar. Procedural success was achieved in all lesions. Although the postprocedural lumen diameter was similar (2.79 vs. 2.90 mm, stent vs. DCA), the follow-up lumen diameter was significantly smaller (1.89 vs. 2.18 mm; p = 0.023) in the stent arm. The IVUS revealed that intimal proliferation was significantly larger in the stent arm than in the DCA arm (3.1 vs. 1.1 mm ; p < 0.0001), which accounted for the significantly smaller follow-up lumen area of the stent arm (5.3 vs. 7.0 mm2; p = 0.030). Restenosis was significantly lower (32.8% vs. 15.8%; p = 0.032), and target vessel failure at one year tended to be lower in the DCA arm (33.9% vs. 18.3%; p = 0.056). CONCLUSIONS: These results suggest that aggressive DCA may provide superior angiographic and clinical outcomes to primary stenting.

Aged↗

PubMed2003

A randomized trial of aprotinin (Trasylol) on blood loss, blood product requirement, and myocardial injury in total arterial grafting.

BACKGROUND: Total arterial grafting is increasingly preferred in coronary artery bypass grafting, but it increases blood loss. Aprotinin (Trasylol; Bayer Corp, Leverkusen, Germany) reduces blood loss in cardiac surgery but has not been subjected to a randomized trial in total arterial grafting. METHODS: A single-center, randomized, double blind, placebo-controlled trial of aprotinin administration in total arterial grafting was performed. The primary outcome variable was postoperative blood loss, and the secondary outcome variable was the number of units of donor blood or coagulant products transfused. The incidence of myocardial injury was determined from serial measurements of cardiac troponin T and creatine kinase-MB and renal injury from serum creatinine. RESULTS: The placebo group (n = 34) and aprotinin group (n = 36) were similar with respect to all preoperative and intraoperative comparisons. One patient in each group underwent reexploration for bleeding. Open-label aprotinin was administered to 9 patients in the placebo group (26%) and to 2 patients in the aprotinin group (6%). There was a highly significant reduction in the median (interquartile range) blood loss in the aprotinin group compared with the placebo group (785 mL [590-1025 mL] vs 1525 mL [1175-1920 mL], respectively). Similarly, the aprotinin group demonstrated a marked reduction in the need for blood transfusion (77% vs 39%; P =.0001), the mean number of transfused blood units (2.6 vs 0.8, P <.001), and the number of patients requiring coagulant products (24% vs 3%; P <.001). There was no difference in myocardial injury in the 2 groups. Four patients in the aprotinin group had persistently elevated creatinine levels in the postoperative period (3 of whom had elevated preoperative creatinine levels and perioperative complications). CONCLUSIONS: Aprotinin significantly reduces blood loss and the need for blood component transfusion in patients undergoing total arterial grafting without increasing the risk of myocardial injury. Aprotinin should be considered routinely in patients undergoing total arterial grafting but cautiously in patients with an elevated preoperative creatinine level.

Aprotinin↗

PubMed2004

Transmyocardial revascularization using an XeCl excimer laser: results of a randomized trial.

BACKGROUND: CO2 and holmium:yttrium aluminum garnet (YAG) transmyocardial laser revascularization (TMLR) are used to treat patients with refractory angina. A randomized trial to investigate the efficacy and safety of XeCl excimer TMLR was performed. METHODS: Thirty patients with refractory angina were randomized in pairs to excimer TMLR or maximal medication. We assessed angina, quality of life (QOL), exercise time, myocardial perfusion, and ventricular wall motion at base line and at 3, 6, and 12 months after TMLR. RESULTS: TMLR patients manifested a significantly better outcome with respect to angina class and quality of life. One TMLR patient died perioperatively versus none in the control group. After TMLR angina decreased from class 3.8 +/- 0.4 at base line to 1.9 +/- 0.9 at 12 months versus 3.9 +/- 0.3 to 3.7 +/- 0.6 in the control group, respectively (p = 0.000001). At 12 months a decrease of greater than or equal to two angina classes was indicated in 11 out of 14 TMLR patients versus none in the control group (p = 0.00001). Improved myocardial perfusion or exercise time was not indicated despite a small decrease in reversible wall motion abnormality score. CONCLUSIONS: Excimer TMLR significantly relieves angina and improves QOL without evidence of improved cardiac perfusion or function.

Adrenergic beta-Antagonists↗

PubMed1993

Long-term results of a prospective randomized trial of adjuvant brachytherapy in the management of completely resected soft tissue sarcomas of the extremity and superficial trunk.

PURPOSE: A prospective randomized trial evaluating adjuvant brachytherapy for soft tissue sarcomas was conducted between July 1982 and July 1987. METHODS AND MATERIALS: One hundred twenty-six patients with soft tissue sarcoma of the extremity or superficial trunk (STS) underwent grossly complete resection with limb-sparing surgery. Intra-operatively, patients were randomized to receive either adjuvant brachytherapy (BRT) or no further therapy (no BRT). BRT consisted of an Iridium-192 implant which delivered 4200-4500 cGy over 4-6 days. Total hospital stay for combined surgery and BRT was 10-14 days. Patients in each group were well matched with respect to age, sex, site, tumor size, depth, histologic type, and grade. Median follow-up is 66.5 months for all living patients. RESULTS: At 5 years, local control was 82% in the BRT group vs. 67% in the no BRT group (p = .049). When analyzed by histologic grade, high grade tumors had local control of 90% with BRT vs. 65% with no BRT (p = .013). There was no difference in local control in the low grade patients in either arm. At 5 years, the proportion free of distant metastases was approximately 76% in both arms, with no difference between BRT and no BRT. When analyzed by grade, high grade patients had a similar proportion free of distant metastasis in the BRT vs. no BRT arms despite improved local control in those receiving BRT. Similarly, the disease-specific survival for all patients at 5 years was 81% for BRT vs. 80% for no BRT (p = NS). When analyzed by grade, and treatment (BRT vs. no BRT), 5-year disease-specific survival for high grade was the same in both groups. CONCLUSIONS: Adjuvant BRT significantly improves local control in completely resected STS. This improvement is confined to patients with high grade histology. BRT provides excellent local control in this group, and significantly shortens the treatment time when compared to adjuvant external beam radiation. However, the improved local control does not translate into either decreased distant metastasis or increased disease-specific survival.

Age Factors↗

PubMed2001

Benefits of lifestyle modification in the pharmacologic treatment of obesity: a randomized trial.

BACKGROUND: Weight loss medications are recommended as an adjunct to diet and exercise modification but seem to be prescribed as a monotherapy by many physicians. This practice is likely to be associated with suboptimal weight loss. METHODS: This 1-year, randomized trial compared the effects of sibutramine hydrochloride used alone (ie, the drug-alone group) to sibutramine plus group lifestyle modification, prescribed with either a 5021- to 6276-kJ/d diet (1200-1500-kcal/d diet) (ie, the drug-plus-lifestyle group) or, for the first 4 months, a 4184-kJ/d diet (1000-kcal/d diet (ie, drug-plus-lifestyle with a portion-controlled diet [the combined treatment] group). Participants were 53 women with a mean (+/-SD) age of 47.2 +/- 9.8 years and weight of 101.3 +/- 9.7 kg. At baseline, they reported the number of pounds they expected to lose at the end of treatment. RESULTS: At month 12, patients treated with the drug alone lost (mean +/- SD) 4.1% +/- 6.3% of their initial body weight compared with significantly (P<.05) larger losses in the drug-plus-lifestyle group of 10.8% +/- 10.3% and the combined treatment group of 16.5% +/- 8.0%. Women in the 2 lifestyle groups achieved a significantly (P<.05) greater percentage of their expected weight loss than those in the drug-alone group and were significantly more satisfied with the medication and with changes in weight, health, appearance, and self-esteem (P<.05 for all). Significant reductions were observed at 12 months in triglyceride and low-density lipoprotein cholesterol levels but systolic and diastolic blood pressure both increased significantly (P<.05 for all). CONCLUSION: The addition of group lifestyle modification to the pharmacologic management of obesity significantly improved weight loss and patients' satisfaction with treatment outcome.

Adult↗

PubMed1984

VP-16-213 in combination chemotherapy with chest irradiation for small-cell lung cancer: a randomized trial of the Piedmont Oncology Association.

The role of etoposide epipodophyllotoxin (VP-16-213) in a combined modality treatment program incorporating local chest irradiation and combination chemotherapy with cyclophosphamide, Adriamycin (Adria Laboratories, Columbus, Ohio), and vincristine has been evaluated in a randomized trial of 165 patients with small-cell lung cancer. The overall response rate (complete response [CR] plus partial response [PR]) was significantly greater in the VP-16-213 arm (85% v 64%, P = .005) primarily as a consequence of improved response in patients with extensive disease (85% v 38%, P = .002 and 30% v 8% for CR only, P = .045). No differences in the response rates were observed in limited disease. The duration of response (months) was greater in the VP-16-213 arm (8.6 v 7.0 overall and 14.4 v 11.5 for CR) but not significantly so. Median survival times (months) were consistently greater in the group receiving VP-16-213 when analyzed according to extent of disease and response (10.6 v 9.5 overall; 15.0 v 13.6 for limited disease; 9.0 v 6.7 for extensive disease; 18.5 v 16.2 for CR overall; and 18.6 v 16.1 for CR in limited disease); the results were not statistically significant. The median survival of extensive disease patients attaining a CR was 15.3 months (range 3.2 to 34.3 + months) in the VP-16-213 arm and 7.4+ and 8.1+ months for the two patients with CR in the other group. Anemia and leukopenia occurred to a greater degree in the four-drug regimen, but no unusual or significant compounding toxicity (ie, neurotoxicity) was observed otherwise. Further investigation of this agent in combination chemotherapy programs for small-cell lung cancer appears to be warranted.

Adult↗

PubMed1999

The influence of randomized trials on the use of anticoagulants for atrial fibrillation.

INTRODUCTION: Anticoagulants and anti-platelet drugs have been shown in randomized trials to reduce the risk of stroke in patients with atrial fibrillation (AF). We therefore investigated their use in patients known to be in AF before a stroke, transient ischaemic attack (either cerebral or ocular) or retinal artery occlusion to assess the influence of trials on clinical practice. METHODS: Inpatients and outpatients with acute stroke, transient ischaemic attack or retinal artery occlusion were prospectively identified by a stroke physician from 1990 to 1997. The presence or absence of AF before the vascular event, and prior use of anticoagulant and anti-platelet drugs were recorded at the time of the assessment and verified using information from general practitioner and hospital case notes. RESULTS: Of 1934 patients with stroke or retinal artery occlusion, 191 (10%) were in AF before their ischaemic event. Anticoagulants had been used in 40 (21%) of these, but only in 32 (2%) of the 1743 patients in sinus rhythm [odds ratio (OR) 14.2, 95% confidence interval (CI) 8.6-23.2]. Anti-platelet drugs had been used in 62 (32%) of those with AF compared with 500 (30%) of those in sinus rhythm (OR 1.2, 95% CI 0.9-1.64). Of the 161 patients in AF without contraindications to anticoagulants, only 36 (22%) were taking them. Although there was a statistically significant increase in anticoagulant use from 8% in 1990 to 23% in 1996, this could be explained solely by a fall in the age of the patients referred to our hospital. CONCLUSION: Anticoagulation is probably under-used in AF. We found no conclusive evidence that anticoagulation trials have influenced clinical practice. This raises issues about the dissemination and implementation of trial results.

Aged↗

PubMed1989

A prospective randomized trial of angelchik prosthesis versus Nissen fundoplication.

A total of 61 patients with gastro-oesophageal reflux; resistant to medical therapy, were entered into a prospective randomized trial comparing the Angelchik antireflux prosthesis with Nissen's fundoplication. Both groups had a similar age and sex distribution and their reflux profiles were comparable. An Angelchik prosthesis was inserted in 30 patients and 31 underwent fundoplication. The mean duration of postoperative follow-up was 38 months. At clinical assessment 23 (77 per cent) of the Angelchik group were graded Visick grade I or II, compared with 29 (94 per cent) of the Nissen group. Assessment by 24 h pH monitoring and manometry between 3 and 6 months after operation showed that both procedures were equally effective in reducing reflux and increasing lower oesophageal sphincter pressure. However, long-term endoscopic follow-up revealed grade III oesophagitis in seven patients in the Angelchik group. No patient in the fundoplication group had grade III oesophagitis. Three of eight patients with strictures in the Angelchik group reported persistent dysphagia. All seven patients with strictures in the Nissen group were relieved of their dysphagia. Migration or erosion of the prosthesis did not occur. Three prostheses (10 per cent) were removed, two for dysphagia and one because of sepsis.

Clinical Trials as Topic↗