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PubMed1999

Left ventricular hypertrophy regression: the LIVE trial.

Left ventricular hypertrophy (LVH) is a clinical condition associated with an increased risk of vascular events. Several trials have been done to evaluate the action of different antihypertensive treatments on the regression of LVH IN HYPERTENSIVE PATIENTS. The efficacy of diuretics in the reduction of LVH is controversial. The LIVE study (Left Ventricular Hypertrophy Regression: Indapamide Versus Enalapril) is a European, prospective, double-blind, randomised, controlled trial aimed to compare the efficacy of indapamide 1.5 mg daily with that of enalapril 20 mg daily in the reduction of LVH in hypertensive patients (systolic blood pressure > 160 and < 210 mmHg) with LVH (left ventricular mass index 120 g/m2 in men and > 100 g/m2 in women) after 1 year of treatment. The assessment of LVH was done by echocardiography. A blind randomised reading of the echo recordings was performed at the end of the study by an independent Core Echocardiography Committee with three readers. Preliminary data are available from this trial. These data confirm the antihypertensive efficacy of indapamide and its efficacy in the reduction of left ventricular mass through a progressive action over 1 year.

Antihypertensive Agents↗
PubMed2005

Volume-targeted versus pressure-limited ventilation in the neonate.

BACKGROUND: Inflammation caused by lung overdistension (volutrauma) is thought to be important in the pathogenesis of bronchopulmonary dysplasia (BPD). Preterm infants with variable lung compliance are particularly at risk. Volume-targeted neonatal ventilators have been developed as alternatives to traditional pressure-limited ventilators. They deliver consistent, appropriate tidal volumes with the aim of reducing lung damage. It is suggested that these would provide an effective, safer means of ventilating the newborn infant. OBJECTIVES: To determine whether volume-targeted ventilation compared with pressure-limited ventilation leads to reduced rates of death and BPD in newborn infants. Secondary objectives were to determine whether use of volume modes affected clinical outcomes such as incidence of airleak, growth, duration of ventilation or cranial ultrasound findings. SEARCH STRATEGY: The search strategy comprised searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2004), MEDLINE PubMed 1966 to November 2004, and hand searches of reference lists of relevant articles and conference proceedings. SELECTION CRITERIA: All randomised and quasi-randomised trials comparing the use of volume-targeted versus pressure-limited ventilation in neonates in the first 28 days of life. DATA COLLECTION AND ANALYSIS: Two authors assessed the methodological quality of eligible trials and extracted data independently. When appropriate, meta-analysis was conducted to provide a pooled estimate of effect. For categorical data the relative risk (RR) and risk difference (RD) were calculated with 95% confidence intervals. Number needed to treat was calculated when RD was statistically significant. Continuous data were analysed using weighted mean difference (WMD). MAIN RESULTS: Four randomised trials were identified that addressed the outcomes of this review, recruiting a total of 178 preterm infants. All were recruited during the first 72 hours of life. Caregivers and those evaluating the outcomes of trials were not masked. All trials report high rates of follow-up, although one trial with uneven patient distribution may have had some post-randomisation attrition. No significant difference was found for death by hospital discharge, and no trials reported the combined outcome of death or BPD. When secondary outcomes were examined, pooled analysis of the trials showed that volume-targeted ventilation resulted in significant reductions in duration of ventilation [WMD -2.93 days (-4.28, -1.57)] and rates of pneumothorax [typical RR 0.23 (0.07, 0.76), RD -0.11 (-0.20, -0.03), NNT 9]. There was also a significant difference in rates of severe (Grade 3 or 4) intraventricular haemorrhage favouring the volume-targeted group [typical RR 0.32 (0.11, 0.90), RD -0.16 (-0.29, -0.03), NNT 6]. There was a reduction in the incidence of BPD (supplemental oxygen at 36 weeks) amongst surviving infants, of borderline statistical significance [typical RR 0.34 (0.11, 1.05), RD -0.14 (-0.27, 0.00), NNT=7]. No significant differences were found for failure of mode of ventilation, use of neuromuscular paralysis, patent ductus arteriosus, airleak of any sort or pulmonary interstitial emphysema alone, cranial ultrasound abnormalities or periventricular leucomalacia. None of the trials addressed growth, death after discharge from hospital or neurodevelopmental outcome. AUTHORS' CONCLUSIONS: Although rates of death and BPD were not significantly different between the two ventilator strategies, statistically significant effects favouring volume targeting were shown for some clinically important outcomes. However, the numbers of trials and infants randomised are small and further studies are required to confirm the role of volume targeting in neonatal ventilation.

Bronchopulmonary Dysplasia↗
PubMedDate not supplied

Radiotherapy of prostate cancer: established results and new developments.

Radical radiotherapy has been established as an effective modality for eradicating localised prostate cancer. No satisfactory comparisons have been made with patients treated by total prostatectomy, but in surgically staged patients with negative lymph nodes survival after radiotherapy exceeds that of an aged matched population, cancer deaths occurring in only 6-15% of patients and 85% remaining free of local recurrence after 10 years. Results are predictably less satisfactory in surgically unstaged cases and for more advanced localised presentations. Nevertheless, radical radiotherapy achieves local control of disease in the majority of patients. Improved local control may be obtained by increasing radiation dose but at the expense of increased radiation-induced side-effects. Conformal radiotherapy and combined modality treatment with the neoadjuvant or adjuvant androgen deprivation show considerable promise as novel methods to improve the therapeutic ratio, and prospective randomised studies are underway to test these approaches.

Algorithms↗
PubMed1997

Screening for prostate cancer.

Over the past few decades it has become clear that prostate cancer is a serious health problem in elderly men. The population of most Western countries is ageing and the number of deaths from prostate cancer patients is increasing. The most promising way to deal with this problem seems to be through early detection of the disease, which can be accomplished through case finding and screening of the male population at risk. The basic purpose of screening for a given disease is to separate from a large group of apparently healthy individuals those who have a high probability of having the disease under study. These individuals may be given a diagnostic workup, and if the diagnosis is established they can be brought to treatment. The concept of prostate cancer screening, however, is an extensively debated issue. The limited knowledge of the natural history, uncertainties about the effectiveness of treatment in reducing mortality and the adverse effects of treatment lead to fear of overdiagnosis and subsequent overtreatment. Routine application of screening for prostate cancer should not take place before the results of multicentre prospective randomised studies demonstrate a reduction in prostate cancer mortality through screening of the male population.

Adult↗
PubMed2004

Psychological treatment for bipolar disorders--a review of randomised controlled trials.

The increased acceptance of stress-vulnerability models of severe mental disorders and of brief evidence-based psychological treatments in their treatment has finally led to increased interest in the role of psychotherapies in bipolar disorders. This paper reviews the results from randomised controlled trials of psychological therapies as an adjunct to standard medications. The evidence suggests that the addition of a psychological therapy may significantly reduce symptoms, enhance social adjustment and functioning, and reduce relapses and hospitalisations in patients with bipolar disorder. However, the methodological problems in the published randomised controlled trials and the heterogeneity in the outcomes achieved (some therapies reduce manic but not depressive relapses, others have the opposite effect) suggests that further studies are required to fully establish the place of these approaches in day to day practice.

Bipolar Disorder↗
PubMed1998

The WHO antenatal care randomised controlled trial: rationale and study design.

The World Health Organisation and collaborating institutions in developing countries are conducting a multicentre randomised controlled trial to evaluate a new antenatal care (ANC) programme, consisting of tests, clinical procedures and follow-up actions scientifically demonstrated to be effective in improving maternal and newborn outcomes. These activities are distributed, for practical reasons, over four visits during the course of pregnancy and are aimed at achieving predetermined goals. The study is taking place in four countries, Argentina, Cuba, Saudi Arabia and Thailand. Recruitment of study subjects started on 1 May 1996. All 53 ANC clinical units had been enrolled by December 1996. Clinics in each country were randomly allocated (cluster randomisation) to provide either the new programme or the traditional programme currently in use. Approximately 24,000 women presenting for ANC at these clinics over an average period of 18 months will have been recruited. As women attending the control clinics receive the 'best standard treatment' as currently offered in these clinics, individual informed consent is requested only from women attending the intervention clinics. Authorities of the corresponding health districts and all participating clinics have provided written institutional informed consent before randomisation. The primary outcome of the trial in relation to maternal conditions is the rate of a morbidity indicator index, defined as the presence of at least one of the following conditions for which ANC is relevant: (a) pre-eclampsia or eclampsia during pregnancy or within 24 h of delivery; (b) postpartum anaemia (haemoglobin < 90 g/L); or (c) severe urinary tract infection/pyelonephritis, defined as an episode requiring antibiotic treatment and/or hospitalisation. The primary fetal outcome is the rate of low birthweight (< 2500 g). Adverse maternal and fetal outcomes are expected for approximately 10% of the control group. Several maternal and perinatal secondary outcomes are also considered. A comprehensive cost-effectiveness analysis and women's and providers' satisfaction evaluation are performed concurrently with the trial. Health-care programmes should be rigorously evaluated by randomised controlled trials, which are feasible in developing countries and should be conducted before introducing new treatments or health interventions.

Argentina↗
PubMed2003

Oral protein-energy supplements for children with chronic disease: systematic review.

Growth failure and poor nutritional status are features of children with chronic disease. Oral protein-energy supplements are one of a number of interventions provided with the aim of improving nutritional status in these children. The present paper describes a Cochrane systematic review assessing the efficacy of these products in children with chronic disease. The objective was to examine the evidence that in children with chronic disease oral protein-energy supplements alter nutrient intake, nutritional indices, survival and quality of life. All randomised controlled trials of the use of oral protein-energy supplements in children with chronic disease were identified through searching electronic databases and hand searching the abstract books of nutrition conferences. Studies identified were independently assessed for eligibility and methodological quality, and data on outcomes of interest were combined in a meta-analysis where possible. Two trials were eligible for inclusion in the review, both of which were undertaken with children with cystic fibrosis. No statistical differences could be found between treatment and control groups when data from both studies were combined. Oral protein-energy supplements are widely used to improve the nutritional status of children with chronic disease. No conclusions can be drawn on the efficacy of these products based on the limited data available. Further randomised controlled trials are required to investigate the use of these products in children with chronic disease. Until further data are available, these products should be used with caution.

Adolescent↗
PubMed1981

Reversal of vasectomy: the effects of sperm antibodies on subsequent fertility.

Antisperm antibodies were measured in serum and seminal plasma in 130 males before and after vasectomy reversal and the occurrence of pregnancy was analysed in the partners of 77 who were followed for more than one year. Sperm-agglutinating antibodies were found in the serum of 79% of patients; seminal plasma antibodies were present in only 9.5% before reversal and this rose to 26% afterwards. Pregnancies occurred in the partners of 53% of those men who were trying to produce children. A pregnancy was significantly less likely when the pre-operative serum antisperm antibody titre was 512 or more, but no decrease in fertility was seen with titres below this. Several pregnancies were produced by patients with seminal plasma antibodies, but numbers and follow-up are too small to permit detailed analysis. A randomised controlled trial of per-operative steroids showed that they produced no benefit. The antisperm antibodies associated with vasectomy reversal appear to differ fundamentally from those occurring in naturally subfertile males.

Agglutination Tests↗
PubMed1997

Reduction of inappropriate use of blood products by prospective monitoring of transfusion request forms.

OBJECTIVE: To determine the effect of prospective monitoring on appropriateness of transfusions of red cells, platelets and fresh frozen plasma (FFP). DESIGN: Prospective interventional study. SETTING: Royal Melbourne Hospital (a tertiary teaching hospital), Melbourne, Victoria, March-May 1996. INTERVENTION: The blood product request form was modified to incorporate indications for transfusion and clinical and laboratory data. Requests were monitored by blood bank laboratory staff for conformation with hospital transfusion guidelines; non-conforming requests were discussed with the requesting medical practitioner by the Haematology Registrar before blood products were issued. In case of disagreement, blood products were always issued. SUBJECTS: 200 consecutive transfusion episodes for each product (red cells, platelets and FFP). OUTCOME MEASURES: Appropriateness of transfusion, assessed by a Consultant Haematologist according to hospital guidelines. Rates of inappropriate transfusion episodes after intervention were compared with rates in a previous study. RESULTS: After intervention, rates of inappropriate transfusion episodes fell significantly (red cells, 16% to 3% [P = 0.004]; platelets, 13% to 2.5% [P = 0.02]; and FFP, 31% to 15% [P = 0.02]). Almost all inappropriate FFP transfusion episodes post-intervention were due to failure to demonstrate prolongation of prothrombin or activated partial thromboplastin times more than 1.5 times the control value. CONCLUSION: Prospective monitoring of request forms can reduce rates of inappropriate transfusions. High rates of inappropriate FFP transfusions possibly reflect uncertainty about appropriate laboratory criteria for FFP transfusion. While results of large prospective randomised controlled clinical trials of FFP transfusions are awaited, currently laboratory criteria can be retained, but should be applied with flexibility.

Blood Component Transfusion↗
PubMed2006

[Interactions between radiation and hormonal therapy in breast cancer: simultaneous or sequential treatment].

BACKGROUND: Combining radiation and hormone therapy (administration of selective estrogen receptor modulators) has become common clinical practice in recent years for receptor positive breast cancer. Little is known about a possible interaction of both treatment modalities if they are given simultaneously. Tamoxifen (antiestrogen molecule, triphenylethylene derivative) may theoretically render cancer cells less responsive to radiotherapy arresting hormone-receptor-positive cells in G0/G1 phase and increase the risk of breast and lung fibrosis stimulating the secretion of transforming growth factor beta in human fibroblasts. PURPOSE: This article reviews the published data to assess the impact of sequencing of hormonal and radiation therapy on outcomes in breast cancer. METHODS: Computerised searches for publications debating the sequencing of hormonal therapy relative to radiation therapy were done using MEDLINE data. RESULTS: Results of tamoxifen experiments with cell culture regarding radioprotection of tumour clonogens are conflicting. In contrast to in vitro results, in animal studies no protective effect of tamoxifen was observed. In one in vitro study, letrozole (non-steroid selective aromatase inhibitor) had a radiosensitizing effect on breast-cancer lines. No randomised clinical trials to date have studied sequencing of tamoxifen or other selective estrogen receptor modulators and radiotherapy. Results from retrospective clinical studies which included treatment arms with and without tamoxifen showed reduction in tumour recurrence with tamoxifen. Some of these studies have noted increased risk of lung and breast fibrosis with tamoxifen with radiotherapy. Results of three articles examined the effect of tamoxifen sequence showed no adverse effect on local control or survival in sequential versus concurrent tamoxifen and radiation patients. One of the three studies also assessed the risk of complications with respect to the timing of tamoxifen with radiotherapy. There was no difference in the rates of complications between the two groups. The association of radiation and selective aromatase inhibitors or aromatase inactivators has not been addressed in clinical studies. CONCLUSIONS: Combined application of tamoxifen and radiotherapy improves survival and local control in breast cancer. Available clinical studies do not indicate that the simultaneous application of tamoxifen and radiotherapy is disadvantageous, as was suggested by some of the in vitro studies. The risk of subcutaneous breast and lung fibrosis might be slightly increased if tamoxifen is given simultaneously with radiotherapy. Both treatment modalities should be started early after surgery. There is no sufficient evidence to withhold tamoxifen administration during irradiation of breast cancer. The issue of optimal sequencing of hormonal and radiotherapy should be addressed in randomised clinical trials.

Animals↗
PubMed2001

[Hormonal supplements for postmenopausal women: no evidence of protection against cardiovascular disease].

Atherothrombotic cardiovascular disease is a leading cause of death in women, especially in the postmenopause. It is controversial whether postmenopausal hormone replacement therapy is protective with regard to cardiovascular disease. On the one hand, observational studies consistently show that the risk of cardiovascular disease is 35 to 50% lower among users of hormonal replacement than among non-users. In addition, hormonal replacement is associated with an improvement of the lipid profile and several other potentially beneficial effects. On the other hand, two recent placebo-controlled randomised trials did not find evidence in favour of cardiovascular protection by hormonal replacement. This discrepancy may be explained by insufficient adjustment for lifestyle factors in observational studies and insufficient consideration of methodological flaws in experimental studies, both of which lead to an overestimation of the protective effect of hormonal replacement. Hormonal replacement may affect the pathophysiology of atherothrombosis in several ways, both positive and negative. Progress in this field requires the isolation of the positive effects.

Aged↗
PubMed2001

Field efficacy of a 10 per cent pyriproxyfen spot-on for the prevention of flea infestations on cats.

The clinical application of a new method for using the insect growth regulator, pyriproxyfen, for controlling flea populations in cat-owning homes is evaluated for the first time. In a multicentric, controlled and randomised trial, 107 flea-infested cats were treated with a minimum dose of 10 mg/kg bodyweight pyriproxyfen as a 10 per cent spot-on application on two occasions, with a three-month interval between doses. For comparison, 99 cats received lufenuron suspension orally, once a month, for six months. Flea counts decreased significantly over time in each group and were significantly lower in the pyriproxyfen group than in cats treated with the reference product. The percentage of 'zero-flea' cats increased from 49 per cent on day 30 to 88 per cent on day 180 in the pyriproxyfen group and from 30 to 71 per cent in the lufenuron group at the same time points (P<0.05). Appropriately timed topical applications of pyriproxyfen, therefore, offer a method of flea control in the domestic environment.

Administration, Cutaneous↗
PubMed2005

[Chemoradiotherapy and anal canal cancer].

Local control and sphincter preservation are the two challenges of anal canal cancer treatment. These tumors are radio- and chemo-sensitive and treatment moved from surgical approach, with abdominoperineal resection, to definitive radiation therapy with or without concurrent chemotherapy. Randomised trials proved the benefit of combined modality with chemoradiotherapy and of mitomycine C (MMC) compared with radiotherapy alone, with a toxic death rate of about 2%. Indications of chemoradiotherapy are locally advanced tumor T2 > or = 4 cm, T3-4 or N1-3 but the best modalities of combined treatment are still under debate. Standard chemotherapy is 5 flurouracile (5FU) + MMC, but cisplatinum (CDDP) is an effective and well tolerated substitute for MMC. Favourable results with CDDP-containing regimen in term of toxicity and carcinologic control have been reported in phase II and retrospective studies. Total radiation dose, overall duration of radiation therapy, duration of the gap and indications of additional boost are not clear, but it is demonstrated that overall duration of treatment should be as short as possible to improve the therapeutic radio. Phase II and III studies are ongoing, to evaluate the best chemotherapy regimen between 5FU+MMC and 5FU+CDDP, the benefit of neoadjuvant or maintenance chemotherapy and the interest of increased total dose. Next future could be the utilisation of oral 5FU. This article is a review of past randomised trials, phases II and retrospective study on radiochemotherapy of anal canal carcinoma.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2004

New strategies in anaemia management: ACORD (Anaemia CORrection in Diabetes) trial.

Anaemia is a key component of diabetic nephropathy, but its importance has only recently been recognised. Recombinant human erythropoietin (epoetin) is an established treatment for renal anaemia, and may help to reduce complications associated with diabetic nephropathy, such as cardiovascular disease. The limited experience with the use of epoetin in this patient group prompts the urgent need for clinical data on anaemia correction in early diabetic nephropathy, particularly with regard to benefits on cardiovascular risk reduction. The Anaemia CORrection in Diabetes (ACORD) study will investigate the effects of anaemia correction on cardiac structure and function in patients with early diabetic nephropathy. This 15-month multicentre study will recruit 160 adult patients with diabetes, mild or moderate chronic kidney disease (with creatinine clearance >or=30 ml/min at screening) and moderate anaemia (haemoglobin [Hb], 10.5-13.0 g/dl). Patients will be randomised to one of two groups: the early treatment group will receive subcutaneous epoetin beta (NeoRecormon) at study entry to maintain target Hb levels of 13-15 g/dl, while the control group will reflect current practice and will not receive epoetin therapy until Hb levels decline below 10.5 g/dl. The primary efficacy variable, change in left ventricular mass index, will be evaluated at 15 months following randomisation; secondary efficacy variables will include changes in cardiac structure and function over the study period. The ACORD study should provide valuable information on the benefits of anaemia correction in patients with early diabetic nephropathy. The study will also increase awareness of the importance of treating anaemia associated with diabetes.

Anemia↗
PubMed2004

[Calcaneal fractures--the most frequent tarsal fractures].

Operative treatment of intra-articular calcaneal fractures with anatomical reduction and early mobilisation has lead to a considerable improvement of the functional results of these severe injuries over the recent two decades. New tendencies like modified approaches tailored according to the vascular anatomy, arthroscopic control of joint reduction in conjunction with open or percutaneous procedures, early flap coverage for severe open fractures or closed fractures with full thickness skin necrosis, the use of interlocking plates that further minimises the need of bone grafting and subtalar arthrolysis at the time of hardware removal for fibrous overgrowth have the potential for further improvement of the outcome. The observation from several comparative studies that operative treatment leads to superior results in displaced intra-articular calcaneal fractures has been qualified in a recent prospective, randomised multicentre trial. This paper presents and the authors' experience with the demanding operative treatment of these fractures together with new developments aiming at improving the clinical results.

Arthroscopy↗
PubMed1994

Treatment of Langerhans cell histiocytosis--evolution and current approaches.

Optimal treatment of Langerhans cell histiocytosis remains problematic. The absence of controlled studies and the lack of standard diagnostic and evaluation criteria have impeded therapeutic progress even though knowledge of basic aspects of LCH have advanced. Historical analysis of outcome suggests little improvement until very recently, but marked differences in outcome according to extent of disease. Consequently, major and now successful efforts have been made to stratify LCH patients into different 'risk groups'. Recent findings suggest that combination chemotherapy for multisystem disease is beneficial and that VP-16 is a useful new agent for treating LCH, despite controversies regarding its side effects. The first randomised international treatment study, LCH-1, being conducted by the Histiocyte Society, should resolve some of these controversies. Other experimental therapies may be considered for children with severe, unresponsive LCH.

Biological Factors↗
PubMed2005

Prognostic and predictive relevance of microsatellite instability in colorectal cancer.

Microsatellite instability (MSI) is the phenotypic hallmark of a deficient DNA mismatch-repair system, observed in 10-20% of sporadic colorectal cancers (CRC). Since the prognostic and predictive value of this genetic alteration has been assessed mainly in non-randomised, uncontrolled studies, we investigated the potential of MSI to predict patient survival and response to adjuvant chemotherapy in tumour specimens from a randomised trial of the Swiss Group for Clinical Cancer Research (SAKK) that tested the value of 5-fluorouracil/mitomycin adjuvant chemotherapy. MSI status was determined in matched normal and tumour tissue samples from 160 patients using a panel of 9 microsatellite markers. There was no correlation between high frequency MSI (MSI-H) and overall (OS) or disease-free survival (DFS) in the untreated control group of patients (HR=1.13, p=0.80; and HR=0.89, p=0.81, respectively). Furthermore, MSI-H phenotype did not predict for a larger benefit of adjuvant chemotherapy on OS or DFS (HR=0.49, p=0.41; HR=0.49, p=0.41, respectively), making a potential value of this molecular marker as a predictive factor in CRC unlikely. Our data do not confirm the prognostic relevance of MSI-H status in colorectal cancer patients found in some other studies. In addition, microsatellite instability did not correlate with the extent of chemotherapy benefit, although we observed a statistically non-significant favourable impact of 5-FU-based treatment in the MSI-H group compared to MSI-L/MSS patients. Larger prospective randomised trials are required to conclusively establish a potential clinical significance of MSI in colorectal cancer.

Antineoplastic Combined Chemotherapy Protocols↗