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Results for “Randomized controlled trial”

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PubMed1996

Three-year controlled, randomized trial of the effect of dose-specified loading and strengthening exercises on bone mineral density of spine and femur in nonathletic, physically active women.

The objectives of this study were to evaluate (1) the effect of spinal muscle strengthening by loading exercises on the bone mineral density (BMD) of the spine, and (2) the effect of upper extremity loading exercises on the BMD of the midradius and femur in healthy, premenopausal women. The study design was a randomized, controlled trial of 3 years' duration. Ninety-six healthy, premenopausal, white women aged 30-40 years participated; 67 completed the study. All subjects were in good health (normal menses) and were active, but not athletic (that is, not involved in a regular sport activity). Subjects were randomized to an exercise or control group. The exercise group performed a supervised, non-strenuous, weight-lifting exercise program. Exercise performance was supervised once a week at the medical facility. In addition, the subjects performed the exercises twice a week on their own. Dietary calcium intake was to be maintained at 1,500 mg/day in both groups. Bone density was measured at the lumbar spine and hip with dual-energy X-ray absorptiometry at 0, 1, and 3 years. BMD of the midradius was measured with single photon absorptiometry. Measurements of muscle strength were obtained at baseline and every 3 months for 3 years. Maximal oxygen uptake was measured, and the level of physical activity was recorded. Compliance with the exercise program was excellent during the first year of the study, but decreased thereafter. At the end of 3 years, subject withdrawal was about 34% from the exercise group and about 22% from the control group (total subject withdrawal was about 30%). Muscle strength in the exercise group increased significantly at all involved skeletal sites (p values all < 0.001). There was a modest positive correlation between the BMD of Ward's triangle with spinal flexor strength (r = 0.32, p = 0.008) and with grip strength (r = 0.38, p = 0.001). Comparing study groups, we found no significant effect of the loading and nonstrenuous strengthening exercises in the exercise group or free physical activity group (our control group) on BMD at the spine, hip, or midradius measurement sites. In active, but not athletic premenopausal women, additional moderate weight-lifting exercises showed no significant effect on BMD.

Adult↗

PubMed2000

The effect of selenium supplementation on outcome in very low birth weight infants: a randomized controlled trial. The New Zealand Neonatal Study Group.

BACKGROUND: Low selenium (SE) status has been documented in preterm infants and has been suggested to be a risk factor for chronic lung disease. METHODS: A total of 534 infants with birth weight <1500 g were enrolled in 8 New Zealand centers in a double-blind placebo-controlled randomized trial of SE supplementation from week 1 of life until 36 weeks' postmenstrual age or discharge home. Supplemented infants received 7 microg/kg/d of SE when fed parenterally and 5 microg/kg/d when fed orally. Plasma SE and glutathione peroxidase concentrations were measured in mothers after delivery and in infants before randomization and at 28 days and 36 weeks' postmenstrual age. Primary outcome measures were oxygen dependency at 28 days and total days oxygen dependency. RESULTS: No significant differences were seen between the groups with respect to primary or secondary outcome measures, with the exception that fewer supplemented infants had an episode of sepsis after the first week of life (P <.038). Mean plasma SE concentrations were 0.33 micromol/L before randomization in both groups and at 28 days had risen in the supplemented group (0.56 micromol/L) but fallen in the control group (0.29 micromol/L) (P <.0001). There was no association between outcome measures and SE concentrations at 28 days or 36 weeks' postmenstrual age. However, lower maternal and infant prerandomization SE concentrations were associated with increased respiratory morbidity. CONCLUSIONS: Postnatal SE supplementation in very low birth weight infants did not improve neonatal outcome. Further investigation of SE supplementation of mothers from the second half of pregnancy is warranted.

Double-Blind Method↗

PubMed1993

Aerosolized pentamidine for primary prophylaxis of Pneumocystis carinii pneumonia: a controlled, randomized trial.

The objective was to assess the efficacy of a biweekly dose of 60 mg aerosolized pentamidine (AP) for primary prophylaxis (PP) of Pneumocystis carinii pneumonia (PCP) and the impact of prophylaxis on survival in HIV-infected patients. Participants were AIDS patients with no history of PCP, patients with a CD4 count < or = 0.200 x 10(9)/L, or patients belonging to the CDC group IVC2, irrespective of CD4 count. It was an open, randomized, controlled trial. Patients were assigned to receive AP, 60 mg biweekly via a System 22 nebulizer, or to a control group not receiving any prophylaxis. Incidence curves for PCP and survival were generated using the Kaplan-Meier method, stratified by treatment group, and compared using the log-rank test. Data were analyzed according to intention to treat. There were 15 cases of PCP among 105 patients in the AP group and 32 cases among 104 patients in the control group. The cumulative incidence of PCP by 18 months was 13% (95% CI 5-21%) in the AP group and 30% (95% CI 18-41%) in the control group, (p = 0.002). During the study period 19 patients (18%) in the AP group died and 24 patients (23%) in the control group (NS; p = 0.28). We conclude that a biweekly dose of 60 mg AP is efficient as primary PCP prophylaxis when a System 22 nebulizer is used. There was, however, no difference in survival between the groups, suggesting that AP has an impact on morbidity only.

AIDS-Related Opportunistic Infections↗

PubMed1975

A controlled, randomized trial of highly selective vagotomy versus selective vagotomy and pyloroplasty in the treatment of duodenal ulcer.

The results of highly selective vagotomy without drainage and selective vagotomy with pyloroplasty for duodenal ulcer were compared in a randomized, controlled trial of a series of 100 patients. The frequency of dumping, diarrhoea, and epigastric fullness was significantly lower after highly selective (6, 6, and 8 percent) than after selective vagotomy (30, 20, and 28 percent) one year after the operations. Recurrent and persisting duodenal ulcers appearing from one to four years after the operations were significantly more frequent after highly selective (22 percent) than after selective vagotomy (8 percent). No significant relationships were found between recurrent ulceration and gastric acid secretion measurements after the two operations. The Hollander response was early positive in 28 percent and late positive in 30 percent of the patients subjected to highly selective vagotomy, while the corresponding figures after selective vagotomy were 26 and 32 percent. The overall clinical results of the two operations were not different according to the classification of Visick. Excluding the patients with recurrence resulted in significantly better clinical results after highly selective vagotomy.

Adult↗

PubMed2005

Regular physical exercise, heart rate variability and turbulence in a 6-year randomized controlled trial in middle-aged men: the DNASCO study.

HRV and HRT are independent predictors of cardiovascular mortality. Aging reduces HRV, but results from the physical exercise trials are controversial. The primary aim was to study changes in heart rate variability (HRV) and heart rate turbulence (HRT) in a six-year controlled randomized trial at regular low to moderate intensity physical exercise. One hundred forty men aged 53--63 years were randomized in to an exercise or a control groups. The participants underwent a maximal bicycle ergometer exercise test with respiratory gas analyses annually for six years. At baseline and after intervention, 24-h ambulatory ECG registrations were performed to assess HRV (n=100). HRT was determined among subjects with single ventricular premature complexes (VPC) (n=73). In the exercise group, ventilatory aerobic threshold (VAT) increased by 16% indicating enhanced submaximal cardiorespiratory fitness. No significant differences were found in any of the HRV or HRT parameters between the groups. However, the observed increase in VAT correlated significantly with the improvement in HRV parameters. The change in turbulence slope (TS) correlated with the changes in most HRV variables and the change in turbulence onset (TO) correlated with the changes in three frequency domain parameters. Our results suggest that in addition to improvement in submaximal cardiorespiratory fitness, regular low to moderate intensity physical exercise seems to have beneficial effects also on cardiac autonomic nervous function, a clinically relevant predictor of cardiovascular morbidity and mortality.

Anaerobic Threshold↗

PubMed1989

Efficacy of an attachable subcutaneous cuff for the prevention of intravascular catheter-related infection. A randomized, controlled trial.

We performed a randomized controlled trial of an attachable subcutaneous cuff for the prevention of central vascular catheter-related infection among patients receiving intensive care. Catheters were placed percutaneously into new sites with or without a cuff and were dressed with polyantibiotic ointment containing polymyxin, neomycin, and bacitracin. Microbial colonization developed in 34.5% of 29 control and 7.7% of 26 cuffed catheters. Catheter-related bloodstream infection occurred with 13.8% of control vs 0% of cuffed catheters. The cuff was not associated with adverse effects. An unexpectedly large proportion (75%) of catheter infections were due to Candida albicans. This may have been due, in part, to the use of polyantibiotic ointment, as suggested by a pooled analysis of previous trials that demonstrated increased Candida colonization of catheters with the ointment, which is not fungicidal. These data suggest that the cuff can reduce the incidence of catheter-related infection among high-risk patients receiving catheter site care with an antibacterial ointment.

Adult↗

PubMed1997

Prospective placebo-controlled randomized trial of lexipafant in predicted severe acute pancreatitis.

BACKGROUND: Many patients with severe acute pancreatitis develop organ system failure during the first few days of illness, and this accounts for the majority of early deaths. No specific therapy is available and treatment remains supportive. METHODS: In a randomized controlled trial conducted in 11 hospitals in the West of Scotland, 50 patients with predicted severe acute pancreatitis were selected from 188 screened over a 14-month period. Patients received placebo or lexipafant, a potent platelet-activating factor antagonist, by continuous intravenous infusion at a dose of 100 mg/day for up to 7 days. Early systemic complications were assessed by the measurement of organ failure scores. RESULTS: There was a significantly greater fall in organ failure score in the treatment group during the 7 days of study (mean and median changes in organ failure score were 0.17 and 0 in the placebo group versus -1.42 and -1 in the treatment group; P = 0.003, Wilcoxon rank sum test), associated with trends towards a reduction in mortality and a reduced incidence of systemic complications. CONCLUSION: These results suggest that lexipafant may be a useful adjunct to full supportive care in the early management of patients with severe acute pancreatitis.

Acute Disease↗

PubMed1994

Omeprazole versus ranitidine plus somatostatin in the treatment of severe gastroduodenal bleeding: a prospective, randomized, controlled trial.

In a randomized, controlled clinical trial omeprazole was compared with ranitidine plus somatostatin in the treatment of severe acute gastrointestinal bleeding due to peptic pathology. Intravenous infusion of the drugs was administered until clinical stabilization or surgical operation. The two regimens were equally effective in controlling bleeding. The need for blood transfusion and surgical operation together with the mortality rate did not differ significantly between groups. No toxic effects were observed as a result of the infusion of omeprazole. In this study the infusion of omeprazole alone showed an efficacy comparable to the association of ranitidine and somatostatin in the treatment of severe acute peptic bleeding.

Acute Disease↗

PubMed2004

The efficacy of a treatment program focusing on specific stabilizing exercises for pelvic girdle pain after pregnancy: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial with stratified block design. OBJECTIVES: To evaluate a treatment program focusing on whether specific stabilizing exercises for patients with pelvic girdle pain after pregnancy reduce pain, improve functional status, and improve quality of life. SUMMARY OF BACKGROUND DATA. : The evidence of effectiveness of treatment for pelvic girdle pain is weak. Recent research has focused on the importance of activation of muscles for motor control and stability of the lumbopelvic region. To the authors' knowledge, the efficacy of applying these principles for pelvic girdle pain has not previously been evaluated in a randomized controlled trial. METHODS: Eighty-one women with pelvic girdle pain were assigned randomly to two treatment groups for 20 weeks. One group received physical therapy with a focus on specific stabilizing exercises. The other group received individualized physical therapy without specific stabilizing exercises. Assessments were administered by a blinded assessor, at baseline, after intervention and 1 year post partum. Main outcome measures were pain, functional status and quality of life. RESULTS: There were no dropouts. After intervention and at 1 year post partum, the specific stabilizing exercise group showed statistically and clinically significant lower pain intensity, lower disability, and higher quality of life compared with the control group. Group difference in median values for evening pain after treatment was 30 mm on the Visual Analog Scale. Disability was reduced by more than 50% for the exercise group; changes were negligible in the control group. Significant differences were also observed for physical tests, in favor of the specific exercise group. CONCLUSION: An individualized treatment approach with specific stabilizing exercises appears to be more effective than physical therapy without specific stabilizing exercises for women with pelvic girdle pain after pregnancy.

Adult↗

PubMedDate not supplied

[Endovascular management of abdominal aortic aneurysm: a critical analysis on the DREAM, EVAR 1 and EVAR 2 randomized controlled trials].

Fourteen years after its introduction in clinical practice and being subject to a large and widespread utilization, the endovascular management of the abdominal aortic aneurysm was evaluated through controlled randomized trials, to assess its efficacy facing the conventional open surgery. The results of these trials, recently published in the international literature, are the subject of a critical analysis by the author, who concludes that they are so significantly important that will probably influence the future, the indications and the range of utilization of the endovascular management of the abdominal aortic aneurysm.

Aortic Aneurysm, Abdominal↗

PubMed2005

Treatment of severe meconium aspiration syndrome with porcine surfactant: a multicentre, randomized, controlled trial.

AIM: A randomized, controlled clinical trial was performed in 19 Chinese neonatal intensive care units to evaluate the safety and efficacy of exogenous surfactant replacement therapy for severe meconium aspiration syndrome (MAS) in term and near-term neonates. METHODS: Sixty-one term infants with severe MAS were randomly assigned to either a surfactant or a control group within 36 h after birth. The infants in the surfactant group (n=31) received an initial dose of porcine lung-derived surfactant (Curosurf) at 200 mg/kg, and repeated doses of 200, 100 and 100 mg/kg were given at 6-12 h intervals to a maximum of four doses if oxygenation index (OI) deteriorated by >2 from baseline. The primary outcomes were a reduction of OI to less than 10 and an increase of the pre-treatment a/A PO(2) ratio of 100% over baseline 24 h after surfactant treatment. The secondary outcomes were duration of mechanical ventilation, incidence of complications and survival to discharge from hospital. RESULTS: The general demographic characteristics of the study subjects were similar. There was a trend for surfactant-treated infants to have an improvement in arterial oxygenation compared to the control group. In comparison with the control group at 24 h, the surfactant group had a lower mean OI (8.1 vs 10.9), more infants with a 100% increase of a/A PO(2) (83% vs 48%, p<0.01) over baseline, and a larger area under the curve for PaO(2)/FiO(2) over baseline (3762+/-1877 vs 2715+/-1644 mmHg(.)h, p<0.05). Repeated measures of these parameters were also in favour of the surfactant group during 24 h to 3 and 7 d compared to the baseline (p<0.05). No differences were found in mean duration of mechanical ventilation, incidence of major complications and number of survivors between the two groups. CONCLUSION: Surfactant replacement therapy improved oxygenation in the study subjects, suggesting that surfactant may have a role in the treatment of severe MAS in term and near-term infants.

Biological Products↗

PubMed2006

The treatment of disc-herniation-induced sciatica with infliximab: one-year follow-up results of FIRST II, a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To evaluate the long-term efficacy of infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF-alpha), in patients with acute/subacute sciatica secondary to herniated disc. SUMMARY OF BACKGROUND DATA: The results of experimental studies and our open-label trial support the use of infliximab in sciatica. Here we report the 1-year results of a randomized controlled trial (FIRST II, Finnish Infliximab Related STudy) evaluating the efficacy and safety of a single infusion of infliximab for sciatic pain. METHODS: Inclusion criteria were unilateral sciatic pain with a disc herniation concordant with the symptoms and signs of radicular pain. Patients had to be candidates for discectomy. Criteria for discectomy included (in addition to a symptomatic disc herniation on MRI) neural entrapment (straight leg raising [SLR] < or =60 degrees ) with either a short-term (2-4 weeks) severe or long-term (4-12 weeks) moderate leg pain. Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo. Differences in the clinical examination parameters (straight leg raise [SLR], muscle strength, sensory defects, tendon reflexes), patient-reported symptoms (leg and back pain using a visual analog scale [VAS], Oswestry disability, quality-of-life [RAND-36]), sick leaves, number of discectomies, and adverse effects between the two treatment groups over the 1-year follow-up were compared using Mann-Whitney U test or Student's t test, repeated-measures analysis, or Cox proportional hazards model. Logistic regression was used to assess the predictors of good response. RESULTS: Sixty-seven percent of patients in the infliximab group reported no pain at 52 weeks compared with 63% in the control group (P = 0.72). Similar efficacy was observed between treatment groups for other outcomes. Eight patients in each group required surgery. Three nonserious adverse reactions were encountered in the infliximab group. The response (irrespective of the treatment) was significantly better with shorter symptom duration and less SLR restriction at baseline. Patients in the infliximab group appeared to especially benefit in cases of a L4-L5 (or L3-L4) herniation and if a Modic change was colocalized at the symptomatic level. CONCLUSIONS: Although the long-term results of this randomized trial do not support the use of infliximab compared with placebo for lumbar radicular pain in patients with disc herniation-induced sciatica, further study in a subgroup of patients with L4-L5 or L3-L4 herniations, especially in the presence of Modic changes, appears to be warranted.

Acute Disease↗

PubMed2004

Octreotide in the prevention of intra-abdominal complications following elective pancreatic resection: a prospective, multicenter randomized controlled trial.

HYPOTHESIS: Prophylactic administration of octreotide acetate decreases the rate of postoperative intra-abdominal complications (IACs) after elective pancreatic resection. DESIGN: Single-blind, controlled, randomized trial. SETTING: Multicenter (N = 20) trial in France. PATIENTS: Of 230 randomized patients undergoing pancreatoduodenectomy and pancreatic enteric anastomosis or distal pancreatectomy for either malignant or benign tumor or chronic pancreatitis, 122 were allotted intraoperatively to receive octreotide; 108 served as controls. RESULTS: All 230 patients were analyzed. Both groups were comparable except that significantly more patients in the octreotide group had biological glue injected into the main pancreatic duct alone (P<.001) or reinforcing the pancreatic enteric anastomosis (68% [83/122] vs 39% [42/108]; P =.002). Fewer patients (P =.08) in the octreotide group sustained 1 or more IACs (22% vs 32%). In subgroup analysis, octreotide significantly reduced the rate of patients sustaining 1 or more IACs when the main pancreatic duct diameter was less than 3 mm (P<.02), when pancreatojejunostomy was performed (P<.02), or both (P<.02). No significant differences were found regarding IAC severity. Twenty-three patients (10%) died postoperatively, 16 (70% of deaths) of whom had 1 or more IACs. The only independent risk factor for IACs found on multivariate analysis was pancreatoduodenectomy compared with distal pancreatectomy (P<.01) (odds ratio, 3.54 [95% confidence interval, 1.44-8.65]). CONCLUSIONS: Our results suggest that octreotide is not necessary for all patients undergoing pancreatic resection; it could be useful when the main pancreatic duct is less than 3 mm in diameter and when pancreatoduodenectomy is completed by pancreatojejunostomy.

Adolescent↗

PubMed2005

[Treatment of severe meconium aspiration syndrome with porcine lung-derived surfactant: a multicenter, randomized, controlled trial].

OBJECTIVE: A randomized controlled clinical trial was performed in nineteen Chinese neonatal intensive care units to evaluate the safety and efficacy of exogenous surfactant replacement therapy for severe meconium aspiration syndrome (MAS) in term and near-term neonates. METHODS: During the period from March 22, 2001 to April 4, 2003, 61 term infants with severe MAS were randomly assigned to either a surfactant or a control group within 36 h after birth. The infants in the surfactant group (n = 31) received an initial dose of porcine lung-derived surfactant (Curosurf) at 200 mg/kg, and repeated doses of 200, 100 and 100 mg/kg were given at 6 - 12 h intervals to a maximum of four doses if oxygenation index (OI) deteriorated by > 2 from baseline. The primary outcomes were a reduction of OI to less than 10 and an increase of the pre-treatment a/A PO2 ratio of 100% over baseline 24 h after surfactant treatment. The secondary outcomes were duration of mechanical ventilation, occurrence of complications and survival to discharge from hospital. RESULTS: The general demographic characteristics of the study subjects between the 2 groups were similar. There was a trend for surfactant-treated infants to have an improvement in arterial oxygenation compared to the control group. In comparison with the control group at 24 h, the surfactant group had a lower mean OI (8.1 vs. 10.9), more infants with a 100% increase of a/A PO2 (83% vs. 48%, P < 0.01) over baseline, and a larger area under the curve for PaO2/FiO2 over baseline [(3762 +/- 1877) vs. (2715 +/- 1644) mm Hg x h (P < 0.05, 1 mm Hg = 0.133 kPa)]. Repeated measures of these parameters were also in favor of surfactant group during 24 h to 3 and 7 days compared to the baseline (P < 0.05). No significant differences were found in mean duration of mechanical ventilation (105 +/- 81 vs. 80 +/- 40), occurrence of major complications and survival rate (96.8% vs. 90.0%) between the surfactant and the control groups. CONCLUSION: Surfactant replacement therapy improved oxygenation but did not increase complications in the study subjects, suggesting that surfactant may be effective and safe for treatment of severe MAS in term and near-term infants.

Animals↗

PubMed2003

Ambulatory phlebectomy versus compression sclerotherapy: results of a randomized controlled trial.

BACKGROUND: Although no randomized controlled trial has assessed the effects of either compression sclerotherapy or ambulatory phlebectomy, both techniques are used to treat varicose veins worldwide. We performed a randomized controlled trial to compare recurrence rates of varicose veins and complications after compression sclerotherapy and ambulatory phlebectomy. METHODS: From September 1996 to October 1998, we randomly allocated 49 legs to compression sclerotherapy and 49 legs to ambulatory phlebectomy. Our primary outcome parameters were as follows: recurrence rates at 1 and 2 years and complications related to therapy. Eighty-two patients were included, of whom 16 were included with both of their legs. The number of treated legs was therefore 98, but two patients were lost to follow-up. RESULTS: One year recurrence amounted to 1 out of 48 for phlebectomy and 12 out of 48 for compression sclerotherapy (P<0.001); at 2 years, six additional recurrences were found, but then solely for compression sclerotherapy (P<0.001). Significant differences in complications occurring more in phlebectomy than in compression sclerotherapy therapy were blisters, teleangiectatic matting, scar formation, and bruising from bandaging. CONCLUSION: Our results show that ambulatory phlebectomy is an effective therapy for varicose veins of the leg. Recurrence rates are significantly lower than for compression sclerotherapy therapy. If varicose veins persist 4 weeks after compression sclerotherapy, it can be argued that to reduce the risk of future recurrence ambulatory phlebectomy should be considered as the better treatment option.

Ambulatory Surgical Procedures↗

PubMed2003

Case management in a heterogeneous congestive heart failure population: a randomized controlled trial.

BACKGROUND: Both randomized and nonrandomized controlled studies have linked congestive heart failure (CHF) case management (CM) to decreased readmissions and improved outcomes in mostly homogeneous settings. The objective of this randomized controlled trial was to test the effect of CHF CM on the 90-day readmission rate in a more heterogeneous setting. METHODS: A total of 287 patients admitted to the hospital with the primary or secondary diagnosis of CHF, left ventricular dysfunction of less than 40%, or radiologic evidence of pulmonary edema for which they underwent diuresis were randomized. The intervention consisted of 4 major components: early discharge planning, patient and family CHF education, 12 weeks of telephone follow-up, and promotion of optimal CHF medications. RESULTS: The 90-day readmission rates were equal for the CM and usual care groups (37%). Total inpatient and outpatient median costs and readmission median cost were reduced 14% and 26%, respectively, for the intervention group. Patients in the CM group were more likely to be taking CHF medication at target doses, but dosages did not increase significantly throughout 12 weeks. Although both groups took their medications as prescribed equally well, the rest of the adherence to treatment plan was significantly better in the CM group. Subgroup analysis of patients who lived locally and saw a cardiologist showed a significant decrease in CHF readmissions for the intervention group (P =.03). CONCLUSIONS: These results suggest several limitations to the generalizability of the CHF CM-improved outcome link in a heterogeneous setting. One explanation is that the lack of coordinated system supports and varied accessibility to care in an extended, nonnetworked physician setting limits the effectiveness of the CM.

Adrenergic beta-Antagonists↗

PubMed2002

Westeinde sciatica trial: randomized controlled study of bed rest and physiotherapy for acute sciatica.

OBJECT: The authors conducted a study to compare the efficacies of three nonsurgical treatment strategies in patients with sciatica. Their hypothesis was that bed rest, physiotherapy, and continuation of activities of daily living (ADLs) (control treatment) are each of equivalent efficacy. METHODS: This randomized controlled trial was designed for comparison of bed rest, physiotherapy, and continuation of ADLs. The setting was an outpatient clinic. General practitioners were asked to refer patients for treatment as soon as possible. The authors enrolled 250 patients (< 60 years of age) with sciatica of less than 1-month's duration and who had not yet been treated with bed rest or physiotherapy. Primary outcome measures were radicular pain (based on a visual analog pain scale [VAPS]) and hampered ADLs (Quebec Disability Scale [QDS]). Secondary outcome measures were the rates of treatment-related failure and surgical treatment. Measures were assessed at baseline and during follow up at 1, 2, and 6 months. Mean differences in VAPS and QDS scores between bed rest and control treatment were 2.5 (95% confidence interval [CI] -6.4 to 11.4) and -4.8 (95% CI -10.6 to 0.9) at 1 month and 0.9 (95% CI -8.7 to 10.4) and -2.7 (95% CI -9.9 to 4.4) at 2 months, respectively. The respective differences between physiotherapy and control treatment were 0.8 (95% CI -8.2 to 9.8) and -0.5 (95% CI -6.3 to 5.3) at 1 month and -0.3 (95% CI -9.4 to 10) and 0.0 (95% CI -7.2 to 7.3) at 2 months. The respective odds ratios for treatment failure and surgical treatment of bed rest compared with control treatment were 1.6 (95% CI 0.8-3.5) and 1.5 (95% CI 0.7-3.6) at 6 months. When physiotherapy was compared with control treatment, these ratios were 1.5 (95% CI 0.7-3.2) and 1.2 (95% CI 0.5-2.9) at 6 months, respectively. CONCLUSIONS: Bed rest and physiotherapy are not more effective in acute sciatica than continuation of ADLs.

Activities of Daily Living↗

PubMed2005

Safety and efficacy of ximelagatran: meta-analysis of the controlled randomized trials for the prophylaxis or treatment of venous thromboembolism.

BACKGROUND: Ximelagatran has been approved in Europe for VTE prophylaxis in orthopedic surgery at fixed doses and without laboratory monitoring. Aim of the study was to evaluate safety and efficacy of ximelagatran in a meta-analysis of prophylaxis and/or treatment randomized controlled trials. METHODS: Absolute risk of events for ximelagatran and OR for its comparison with LMWH and coumarins were calculated. Subgroup analysis was performed for ximelagatran regimen, comparator agent, type of surgery, starting time of prophylaxis. RESULTS: Twelve studies and 16,992 patients were meta-analysed. Ximelagatran showed an absolute risk of major VTE of 4.04% and 1.69% and of major bleedings of 1.68% and 1.03% in prophylaxis and treatment trials, respectively. In prophylaxis trials, a significant excess mortality (OR: 2.5; 95% CI: 1.02 - 6.13) and an excess in major bleedings (OR: 1.41; 95% CI: 0.93 - 2.14) was found in the whole ximelagatran group. No evidence of treatment effect for major VTE was seen in the comparison with LMWH (OR: 1.01; 95% CI: 0.52 - 1.97). The cohort of patients treated with 24 mg b.i.d. showed similar results. An increase in the absolute risk of bleeding (from 1.04% to 3.03%) was found between post and preoperative administration of ximelagatran. Major VTE risk was increased when ximelagatran was compared to b.i.d. LMWH. CONCLUSIONS: Ximelagatran can be considered for its potential advantages for prevention and treatment of VTE. Future efforts are needed by researchers to prospectively investigate the best postoperatively starting time and by clinicians to monitor overall mortality in prophylactic use.

Anticoagulants↗