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Results for “Randomized controlled trial”

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PubMed1995

Benefit of mammography screening in women ages 40 to 49 years. Current evidence from randomized controlled trials.

BACKGROUND: Eight randomized controlled trials (RCTs) of screening mammography were conducted involving women ages 40 to 49 years at entry. Current data gathered for periods ranging from 7 to 18 years of follow-up are available from these trials. METHODS: Meta-analyses were performed using a Mantel-Haenszel estimator method to combine current follow-up data from the eight RCTs of mammography that included women ages 40 to 49 years. RESULTS: Combining all current data on women ages 40 to 49 years at entry into the trials yielded a 16% [corrected] benefit from screening mammography, without statistical significance at the 95% confidence level. Combining all data on women ages 40 to 49 years at entry, excluding results from the Canadian National Breast Screening Study, yielded a 24% [corrected] benefit to women invited for screening, with statistical significance at the 95% confidence level. CONCLUSIONS: These results suggest that screening mammography in women ages 40 to 49 years at entry can reduce mortality from breast cancer when combined with adequate follow-up.

Adult↗
PubMedDate not supplied

Persistent effects of a message counter-marketing light cigarettes: results of a randomized controlled trial.

In a randomized, controlled trial, a national sample of smokers of Light cigarettes heard by telephone a "radio message" counter-marketing Light cigarettes. This message caused immediate changes in beliefs. Follow-up telephone interviews were done about 7 months later. The Message Group (N = 181) was more likely than the Control Group (N = 85) to report that (a) one Light equaled one Regular in tar yield to smokers, (b) Lights did not decrease health risks, and (c) they wanted to give up smoking (P<.05); they did not report greater quitting or intention to quit, or greater knowledge of filter ventilation. Systematic counter-marketing of Lights is recommended. A telephone-based exposure and follow-up procedure could be a good way to study message effects.

Adult↗
PubMed2004

Efficacy of heat and moisture exchangers in preventing ventilator-associated pneumonia: meta-analysis of randomized controlled trials.

OBJECTIVE: Several randomized controlled trials (RCT) have examined the effect of antibacterial humidification strategies, particularly the replacement of heated humidifiers (HH) by heat and moisture exchangers (HME), in preventing ventilator-associated pneumonia (VAP). The present meta-analysis reviews these RCTs. METHODS: RCTs were identified by searching the Medline and Cochrane Central Register of Controlled Trials databases from 1990 to 2003. We included RCTs using HMEs in the treatment group and HHs in the control group and reporting the incidence of pneumonia as a study outcome. Two investigators independently abstracted key data on design, population, intervention and outcome of the studies. RESULTS: Between 1990 and 2003 eight RCTs met the inclusion criteria of this analysis. Pooling the results from these studies revealed a reduction in the relative risk of VAP in the HME group (0.7), particularly in MV with a duration of at least 7 days (five RCTs, relative risk 0.57). CONCLUSIONS: This meta-analysis found a significant reduction in the incidence of VAP in patients humidified with HMEs during MV, particularly in patients ventilated for 7 days or longer. This finding is limited by the exclusion of patients at high risk for airway occlusion from some of the studies. Moreover, contraindications (tenacious secretions, airway obstructive disease, hypothermia) and technical issues of HMEs must be considered. Further RCTs are necessary to examine the wider applicability of HMEs and their extended use.

Air Conditioning↗
PubMed2003

Role of somatostatin in the prevention of pancreatic stump-related morbidity following elective pancreaticoduodenectomy in high-risk patients and elimination of surgeon-related factors: prospective, randomized, controlled trial.

A prospective, randomized, controlled trial was performed to determine the efficacy of somatostatin in the prevention of pancreatic stump-related complications with elimination of surgeon-related factors in high-risk patients undergoing pancreaticoduodenectomy. From August 1997 to December 2000, 54 patients, 28 men and 26 women, with age ranged from 32 to 89 years, were randomly assigned to somatostatin group ( n = 27) or placebo group ( n = 27). Ninety-four percent of the patients had pancreatic and periampullary lesions; 6% had secondary lesion involving the duodenum such as local recurrent colon carcinoma and renal cell carcinoma. These patients received either standard pancreaticoduodenectomy or pylorus-preserving pancreaticoduodenectomy. An experienced surgeon performed all operations in same fashion to minimize the surgical factor. A transanastomotic tube was inserted into the pancreatic duct for diversion of pancreatic juice in the pancreaticojejunostomy for a 3-weeks period postoperatively. Intravenous infusion of somatostatin was given at a dose of 250 microg/hr in the somastotatin group and normal saline was given to the control group for 7 days postoperatively. There was one perioperative death in each group, resulting in a 3.7% mortality rate. In the somastotatin group, as compared to the placebo group, the incidence of overall morbidity and pancreatic stump related complications were significantly lower with a mean decrease of 50% pancreatic juice output and a slightly shorter duration of hospital stays. In conclusion, after excluding surgeon related factor, prophylactic use of somatostatin reduces the incidence and severity of pancreatic stump related complications in high-risk patients having pancreaticoduodenectomy via decreased secretion of pancreatic exocrine.

Adult↗
PubMed2005

Three psychotherapies for anorexia nervosa: a randomized, controlled trial.

OBJECTIVE: Few randomized, controlled trials have examined the efficacy of treatments for anorexia nervosa. Cognitive behavior therapy and interpersonal psychotherapy are effective in a related disorder, bulimia nervosa. There are theoretical and treatment indications for these therapies in anorexia nervosa. METHOD: Fifty-six women with anorexia nervosa diagnosed by using strict and lenient weight criteria were randomly assigned to three treatments. Two were specialized psychotherapies (cognitive behavior therapy and interpersonal psychotherapy), and one was a control treatment combining clinical management and supportive psychotherapy (nonspecific supportive clinical management). Therapy consisted of 20 sessions over a minimum of 20 weeks. RESULTS: For the total study group (intent-to-treat group), there were significant differences among therapies in the primary global outcome measure. Nonspecific supportive clinical management was superior to interpersonal psychotherapy, while cognitive behavior therapy was intermediate, neither worse than nonspecific supportive clinical management nor better than interpersonal psychotherapy. For the women completing therapy, nonspecific supportive clinical management was superior to the two specialized therapies. CONCLUSIONS: The finding that nonspecific supportive clinical management was superior to more specialized psychotherapies was opposite to the primary hypothesis and challenges assumptions about the effective ingredients of successful treatments for anorexia nervosa.

Adolescent↗
PubMed1999

Design of the 'Stent or Surgery' trial (SoS): a randomized controlled trial to compare coronary artery bypass grafting with percutaneous transluminal coronary angioplasty and primary stent implantation in patients with multi-vessel coronary artery disease.

The 'Stent or Surgery' trial (SoS) is a randomized controlled trial to compare coronary artery bypass grafting with percutaneous transluminal coronary angioplasty and primary stent implantation in patients with multi-vessel coronary artery disease. This is a multicentre, multinational venture involving over 40 centres in 12 countries throughout Europe and Canada. Eligible and consenting patients will be randomly allocated, in equal proportions, to open revascularization by CABG or by PTCA with the primary implantation of intracoronary stents. The trial design is pragmatic and imposes few protocol restrictions in patient selection, surgical and intervention techniques or adjunctive medication schedules. The rationale and design of the trial are discussed, including important sub-studies, examining quality of life, neuropsychological outcome, cost and cost benefit.

Angioplasty, Balloon, Coronary↗
PubMed2005

Premedication with intravenous ketorolac trometamol (Toradol) in colonoscopy: a randomized controlled trial.

OBJECTIVE: We conducted a prospective double-blinded placebo-controlled randomized trial to investigate the effect of ketorolac trometamol (KT) administered intravenously as premedication in colonoscopy. METHODS: One hundred and forty patients undergoing colonoscopy were randomized to receive either 60 mg of KT (KT group (KTG), n=70) or placebo (normal saline group (NSG), n=70) intravenously as premedication 30 min prior to procedure. Patient-controlled sedation (PCS) was used as the mode of sedation. Outcome measures included patient self-assessed pain score in a 10-cm unscaled visual analog scale (VAS), endoscopist assessment of patient pain score in VAS, patient's willingness to repeat colonoscopy, administered and demanded doses of PCS, patient satisfaction score in VAS, and hemodynamic changes during and after the procedure. RESULTS: The mean patient self-assessed pain score (SD) during procedure was significantly lower in KTG than NSG: 5.08 (2.74) vs 6.62 (2.45); p=0.001. The mean endoscopist assessment of patient pain score (SD) was significantly lower in KTG than NSG as well: 3.99 (2.80) vs 5.28 (2.71); p=0.006. More patients in KTG were willing to repeat procedure as compared with NSG (80.0%vs 57.1%; p=0.004). No significant difference was found in the administered and demanded doses of PCS, mean satisfactory scores and hemodynamic changes in both groups. No serious complication related to intravenous (IV) KT was noted. CONCLUSIONS: Premedication with IV KT (Toradol) improves pain control during colonoscopy with no associated serious complications.

Academic Medical Centers↗
PubMed2002

Relief of chronic neck and shoulder pain by manual acupuncture to tender points--a sham-controlled randomized trial.

OBJECTIVES: To compare the effects of real acupuncture to tender points for neck and shoulder pain and stiffness (Japanese: katakori) with those of sham acupuncture. DESIGN: Randomized-controlled trial. METHODS: Thirty-four volunteers from an acupuncture school with complaints of chronic pain and stiffness, who had no arm symptoms and gave informed consent, were randomly allocated to acupuncture or sham groups. Acupuncture or sham acupuncture was applied to the tender points once a week for 3 weeks. In the acupuncture group the acupuncture needle was inserted to the muscle, then the sparrow pecking technique was applied five times. Sham acupuncture was done without insertion of the needle. Dull pain and stiffness were evaluated by visual analog scale (VAS) before, and every 2 days after the first needling for 1 month. Pressure pain threshold on the tender points was measured before and after each treatment. RESULTS: There was no statistical difference of VAS scores between acupuncture and sham groups 9 days after the last treatment. However, the acupuncture group showed significant reduction of VAS scores immediately after and/or 1 day after the real acupuncture treatments (P<0.01). The effect tended to be prolonged after repeated treatment. Pressure pain thresholds tended to increase after real acupuncture treatment but not after sham acupuncture. CONCLUSIONS: Acupuncture applied to tender points appears to have short-term effects on neck and shoulder pain and stiffness, but this study was unable to demonstrate any long-term superiority over sham acupuncture.

Acupuncture Analgesia↗
PubMed2000

Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 10(6)/L CD4 cell counts: A randomized controlled trial.

CONTEXT: Despite enormous improvements achieved through the use of antiretroviral therapies (ARTs), the risk for eventual human immunodeficiency virus (HIV) disease progression remains high. Agents that enhance the immunologic mechanism for viral recognition might reduce disease progression. OBJECTIVE: To determine whether the addition of HIV-1 Immunogen would confer added clinical efficacy to that achievable by ARTs. DESIGN AND SETTING: Multicenter, double-blind, placebo-controlled, randomized trial beginning March 1996 and ending May 1999 conducted at 77 centers in the United States providing primary care or referral care for persons infected with HIV. PATIENTS: Adults infected with HIV who have baseline CD4 cell counts between 300 x 10(6)/L and 549 x 10(6)/L without prior acquired immunodeficiency syndrome-defining conditions receiving stable ART (or no therapy) were screened and 2527 were randomized. INTERVENTIONS: Ten units of HIV-1 Immunogen, derived from a Zairian HIV isolate, inactivated and formulated with incomplete Freund adjuvant, was administered intramuscularly every 12 weeks. The placebo was incomplete Freund adjuvant. Changes in ARTs were allowed. MAIN OUTCOME MEASURES: HIV progression-free survival; secondary end points included overall survival, changes in HIV RNA, CD4 cell counts, CD4 percentage, body weight, and immunogenicity. RESULTS: The overall event rate was 1.8 per 100 person-years of follow-up. Fifty-three subjects developed clinical progression in each treatment group (relative risk [RR], 0.97; 95% confidence interval [CI], 0.66-1.42; P =.89). There were 19 and 23 deaths in the placebo and HIV-1 Immunogen groups, respectively (RR, 0.81; 95% CI, 0.44-1. 48; P =.49). There were no statistically significant differences between the groups with respect to changes in HIV RNA (P =.59), CD4 percentage (P =.63), or body weight (P =.89). Subjects in the HIV-1 Immunogen group had an increase in average CD4 cell count of approximately 10 x 10(6)/L greater than the placebo group (P =.02). CONCLUSION: HIV-1 Immunogen with unrestricted ART failed to demonstrate an increase in HIV progression-free survival. JAMA. 2000;284:2193-2202.

AIDS Vaccines↗
PubMed2004

Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial.

CONTEXT: Ziconotide (formerly SNX-111) selectively blocks N-type voltage-sensitive calcium channels and may be effective in patients with pain that is refractory to opioid therapy or those with intolerable opioid-related adverse effects. OBJECTIVE: To assess the safety and efficacy of intrathecal ziconotide in patients with pain that is refractory to conventional treatment. DESIGN, SETTING, AND PATIENTS: Double-blind, placebo-controlled, randomized trial conducted from March 12, 1996, to July 11, 1998, at 32 study centers in the United States, Australia, and the Netherlands. Patients were 111 individuals ages 24 to 85 years with cancer or AIDS and a mean Visual Analog Scale of Pain Intensity (VASPI) score of 50 mm or greater. Patients were randomly assigned in a 2:1 ratio to receive ziconotide or placebo treatment. INTERVENTIONS: Intrathecal ziconotide was titrated over 5 to 6 days, followed by a 5-day maintenance phase for responders and crossover of nonresponders to the opposite treatment group. MAIN OUTCOME MEASURE: Mean percentage change in VASPI score from baseline to the end of the initial titration period. RESULTS: Of the evaluable population, 67 (98.5%) of 68 patients receiving ziconotide and 38 (95%) of 40 patients receiving placebo were taking opioids at baseline (median morphine equivalent dosage of 300 mg/d for the ziconotide group and 600 mg/d for the placebo group; P =.63, based on mean values), and 36 had used intrathecal morphine. Mean (SD) VASPI scores were 73.6 (1.8) mm in the ziconotide group and 77.9 (2.3) mm in the placebo group (P =.18). Mean VASPI scores improved 53.1% (95% confidence interval [CI], 44.0%-62.2%) in the ziconotide group and 18.1% (95% CI, 4.8%-31.4%) in the placebo group (P<.001), with no loss of efficacy of ziconotide in the maintenance phase. Pain relief was moderate to complete in 52.9% of patients in the ziconotide group compared with 17.5% in the placebo group (P<.001). Five patients receiving ziconotide achieved complete pain relief, and 50.0% of patients receiving ziconotide responded to therapy compared with 17.5% of those receiving placebo (P =.001). CONCLUSION: Intrathecal ziconotide provided clinically and statistically significant analgesia in patients with pain from cancer or AIDS.

Acquired Immunodeficiency Syndrome↗
PubMed2005

A randomized controlled trial of duloxetine alone, pelvic floor muscle training alone, combined treatment and no active treatment in women with stress urinary incontinence.

PURPOSE: We primarily compared the effectiveness of combined pelvic floor muscle training (PFMT) and duloxetine with imitation PFMT and placebo for 12 weeks in women with stress urinary incontinence (SUI). In addition, we compared the effectiveness of combined treatment with single treatments, single treatments with each other and single treatments with no treatment. MATERIALS AND METHODS: This blinded, doubly controlled, randomized trial enrolled 201 women 18 to 75 years old with SUI at 17 incontinence centers in the Netherlands, United Kingdom and United States. Women averaged 2 or more incontinence episodes daily and were randomized to 1 of 4 combinations of 80 mg duloxetine daily, placebo, PFMT and imitation PFMT, including combined treatment (in 52), no active treatment (in 47), PFMT only (in 50) and duloxetine only (in 52). The primary efficacy measure was incontinence episode frequency. Other efficacy variables included the number of continence pads used and the Incontinence Quality of Life questionnaire score. RESULTS: The intent to treat population incontinence episode frequency analysis demonstrated the superiority of duloxetine with or without PFMT compared with no treatment or with PFMT alone. However, pad and Incontinence Quality of Life analyses suggested greater improvement with combined treatment than single treatment. A completer population analysis demonstrated the efficacy of duloxetine with or without PFMT and suggested combined treatment was more effective than either treatment alone. CONCLUSIONS: The data support significant efficacy of combined PFMT and duloxetine in the treatment of women with SUI. We hypothesize that complementary modes of action of duloxetine and PFMT may result in an additive effect of combined treatment.

Adult↗
PubMed1992

Erythropoietin treatment in allogeneic BMT accelerates erythroid reconstitution: results of a prospective controlled randomized trial.

Twenty-eight allogeneic BMT patients (16 with acute leukemia, 12 with chronic myeloid leukemia) were included in a single center, prospective, randomized, controlled trial to assess the value of recombinant human erythropoietin (rh-Epo) in this setting. rh-Epo was administered through a central venous catheter as a single bolus injection (days 0-7: 100 U/kg/d; days 7-30: 150 U/kg/d). No secondary effects to rh-Epo treatment were detected. An earlier appearance of reticulocytes and a diminished need of red blood cells (RBCs) transfusions were observed in patients who were treated with rh-Epo (4 units vs 12 units; p < 0.05). The time to unsupported platelets above 25 x 10(9)/l was less in patients treated with rh-Epo than in control patients (19 days vs 31; p < 0.05), and they received significantly fewer platelet transfusions (36 units vs 138.5; p < 0.05). Our results show that rh-Epo treatment is capable of accelerating the erythroid reconstitution and decreasing the need for RBC transfusions. A beneficial effect on platelet reconstitution is also suggested, but further studies are necessary to confirm this point.

Adolescent↗
PubMed2002

A prospective, controlled, randomized trial comparing early active extension with passive extension using a dynamic splint in the rehabilitation of repaired extensor tendons.

This prospective, randomized, controlled trial compared two methods of rehabilitating extensor tendon repairs in zones IV-VIII. Group A patients followed an early active mobilization regimen and Group B patients followed a dynamic splintage regimen. Data on 19 patients in Group A and 17 patients in Group B were collected at 4 weeks and at final follow-up (3 months median follow-up for both groups). Extension lag, flexion deficit and total active motion (TAM) were measured. At 4 weeks, patients in Group B had a better TAM (median 87%, range 56-102%) compared to patients in Group A (median 77%, range 52-97%). At final follow-up, there were no significant differences in the results of the two groups. There were no ruptures in either group.

Adult↗
PubMed2006

The effects of topical ketorolac and indomethacin on measles conjunctivitis: randomized controlled trial.

PURPOSE: To compare the effect of topical ketorolac and indomethacin on measles conjunctivitis. DESIGN: Prospective double-masked placebo-controlled randomized trial. METHODS: Sixty-two patients with severe measles conjunctivitis were included in this study. All patients were hospitalized and randomly assigned to receive ketorolac 0.5% or indomethacin 0.1% in the right eye and artificial tears in the left eye. Conjunctival hyperemia, burning sensations, foreign-body sensations, and photophobia scores were conducted at baseline and at days seven and 14. A satisfaction score was evaluated at the end of the study. RESULTS: The conjunctival injection score of the control eyes was significantly higher than those of the ketorolac- and indomethacin-treated eyes at day seven (P < .05). The conjunctival injection score of the ketorolac-treated eyes was lower than that of the indomethacin-treated eyes at days seven and 14, but this did not reach statistical significance. There was no significant difference in the burning and foreign-body sensations and in the photophobia scores among the study eyes at baseline, day seven, and day 14 (P > .05). There was no significant difference in the satisfaction score among the study eyes at the end of the study (P > .05). CONCLUSIONS: In patients with measles during the first two weeks of infection, ketorolac and indomethacin were more effective than artificial tears in decreasing conjunctival hyperemia, but burning sensations, foreign-body sensations, and photophobia were unaffected.

Administration, Topical↗
PubMed2004

Critical appraisal skills training for health care professionals: a randomized controlled trial [ISRCTN46272378].

INTRODUCTION: Critical appraisal skills are believed to play a central role in an evidence-based approach to health practice. The aim of this study was to evaluate the effectiveness and costs of a critical appraisal skills educational intervention aimed at health care professionals. METHODS: This prospective controlled trial randomized 145 self-selected general practitioners, hospital physicians, professions allied to medicine, and healthcare managers/administrators from the South West of England to a half-day critical appraisal skills training workshop (based on the model of problem-based small group learning) or waiting list control. The following outcomes were assessed at 6-months follow up: knowledge of the principles necessary for appraising evidence; attitudes towards the use of evidence about healthcare; evidence seeking behaviour; perceived confidence in appraising evidence; and ability to critically appraise a systematic review article. RESULTS: At follow up overall knowledge score [mean difference: 2.6 (95% CI: 0.6 to 4.6)] and ability to appraise the results of a systematic review [mean difference: 1.2 (95% CI: 0.01 to 2.4)] were higher in the critical skills training group compared to control. No statistical significant differences in overall attitude towards evidence, evidence seeking behaviour, perceived confidence, and other areas of critical appraisal skills ability (methodology or generalizability) were observed between groups. Taking into account the workshop provision costs and costs of participants time and expenses of participants, the average cost of providing the critical appraisal workshops was approximately pound 250 per person. CONCLUSIONS: The findings of this study challenge the policy of funding 'one-off' educational interventions aimed at enhancing the evidence-based practice of health care professionals. Future evaluations of evidence-based practice interventions need to take in account this trial's negative findings and methodological difficulties.

Attitude of Health Personnel↗
PubMed1996

The German Glomerulonephritis Therapy Study: 10 years of controlled randomized trials for the treatment of idiopathic glomerulonephritis.

The German Collaborative Glomerulonephritis Therapy Study, which celebrated its 10th anniversary in 1996, has collected data on more than 1,000 patients with biopsy-proven glomerulonephritis. 929 patients could be evaluated and 500 were treated according to at least one of various protocols developed for a randomized controlled trial. Current results show that prednisolone is effective in minimal-change nephropathy, and in combination with other immunosuppressants it can reduce proteinuria in individual cases of focal and segmental glomerulosclerosis, membranous glomerulonephritis and nephrotic IgA nephropathy. The majority of tested treatment protocols did not prove to be superior to symptomatic therapy for long-term outcome.

Adolescent↗