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PubMed2005

Inhaled magnesium sulfate in the treatment of acute asthma.

BACKGROUND: Asthma exacerbations can be frequent and range in severity from relatively mild to status asthmaticus. The use of magnesium sulfate (MgSO4) is one of numerous treatment options available during acute exacerbations. While the efficacy of intravenous MgSO4 has been demonstrated, little is known about inhaled MgSO4. OBJECTIVES: To examine the efficacy of inhaled MgSO4 in the treatment asthma exacerbations. SEARCH STRATEGY: Randomised controlled trials were identified from the Cochrane Airways Group "Asthma and Wheez*" register. These trials were supplemented with trials found in the reference list of published studies, studies found using extensive electronic search techniques, as well as a review of the gray literature and conference proceedings. SELECTION CRITERIA: Randomised (or pseudo-randomised) controlled trials were eligible for inclusion. Studies were included if patients were treated with nebulised MgSO4 alone or in combination with beta2-agonist and where compared to beta2-agonist alone or inactive control. DATA COLLECTION AND ANALYSIS: Trial selection, data extraction and methodological quality were assessed by two independent reviewers. Efforts were made to collect missing data from authors. Results from fixed effects models are presented as standardized mean differences (SMD) for pulmonary functions and relative risks (RR) for hospital admission; both are displayed with their 95% confidence intervals (95% CI). MAIN RESULTS: Six trials involving 296 patients were included. Four studies compared nebulised MgSO4 with beta2-agonist to beta2-agonist and two studies compared MgSO4 to beta2-agonist alone. Three studies enrolled only adults and 2 enrolled exclusively pediatric patients; three of the studies enrolled severe asthmatics. Overall, there was a significant difference in pulmonary function between patients whose treatments included nebulised MgSO4 in addition to beta2-agonist (SMD: 0.37; 95% CI: 0.1 to 0.63; 4 studies); however, hospitalizations were similar between the groups (RR: 0.64; 95% CI: 0.40 to 1.04; 3 studies). Subgroup analyses did not demonstrate significant differences in lung function improvement between adults and children, or between severe and mild to moderate asthmatics. Conclusions regarding treatment with nebulised MgSO4 alone are difficult to draw due to lack of studies in this area. AUTHORS' CONCLUSIONS: Nebulised inhaled magnesium sulfate in addition to beta2-agonist in the treatment of an acute asthma exacerbation, appears to have benefits with respect to improved pulmonary function and there is a trend towards benefit in hospital admission. Heterogeneity between trials included in this review precludes a more definitive conclusion.

Acute Disease↗
PubMed2005

Inhaled magnesium sulfate in the treatment of acute asthma.

BACKGROUND: Asthma exacerbations can be frequent and range in severity from relatively mild to status asthmaticus. The use of magnesium sulfate (MgSO4) is one of numerous treatment options available during acute exacerbations. While the efficacy of intravenous MgSO4 has been demonstrated, little is known about inhaled MgSO4. OBJECTIVES: To examine the efficacy of inhaled MgSO4 in the treatment asthma exacerbations. SEARCH STRATEGY: Randomised controlled trials were identified from the Cochrane Airways Group "Asthma and Wheez*" register. These trials were supplemented with trials found in the reference list of published studies, studies found using extensive electronic search techniques, as well as a review of the gray literature and conference proceedings. SELECTION CRITERIA: Randomised (or pseudo-randomised) controlled trials were eligible for inclusion. Studies were included if patients were treated with nebulised MgSO4 alone or in combination with beta(2)-agonist and where compared to beta2-agonist alone or inactive control. DATA COLLECTION AND ANALYSIS: Trial selection, data extraction and methodological quality were assessed by two independent reviewers. Efforts were made to collect missing data from authors. Results from fixed effects models are presented as standardized mean differences (SMD) for pulmonary functions and relative risks (RR) for hospital admission; both are displayed with their 95% confidence intervals (95% CI). MAIN RESULTS: Six trials involving 296 patients were included. Four studies compared nebulised MgSO4 with beta2-agonist to beta2-agonist and two studies compared MgSO4 to beta2-agonist alone. Three studies enrolled only adults and 2 enrolled exclusively pediatric patients; three of the studies enrolled severe asthmatics. Overall, there was a significant difference in pulmonary function between patients whose treatments included nebulised MgSO4 in addition to beta2-agonist (SMD: 0.30; 95% CI: 0.03 to 0.56; 4 studies); however, hospitalizations were similar between the groups (RR: 0.69; 95% CI: 0.42 to 1.12; 3 studies). Subgroup analyses did not demonstrate significant differences in lung function improvement between adults and children, but were significantly different between severe and mild to moderate asthmatics (SMD: 0.69; 95% CI 0.13 to 1.25). Conclusions regarding treatment with nebulised MgSO4 alone are difficult to draw due to lack of studies in this area. AUTHORS' CONCLUSIONS: Nebulised inhaled magnesium sulfate in addition to beta2-agonist in the treatment of an acute asthma exacerbation, appears to have benefits with respect to improved pulmonary function and there is a trend towards benefit in hospital admission. The benefit is significantly greater in more severe asthma exacerbations. Heterogeneity between trials included in this review precludes a more definitive conclusion.

Acute Disease↗
PubMed2005

Inhaled magnesium sulfate in the treatment of acute asthma.

BACKGROUND: Asthma exacerbations can be frequent and range in severity from relatively mild to status asthmaticus. The use of magnesium sulfate (MgSO4) is one of numerous treatment options available during acute exacerbations. While the efficacy of intravenous MgSO4 has been demonstrated, little is known about inhaled MgSO4. OBJECTIVES: To examine the efficacy of inhaled MgSO4 in the treatment asthma exacerbations. SEARCH STRATEGY: Randomised controlled trials were identified from the Cochrane Airways Group "Asthma and Wheez*" register. These trials were supplemented with trials found in the reference list of published studies, studies found using extensive electronic search techniques, as well as a review of the gray literature and conference proceedings. SELECTION CRITERIA: Randomised (or pseudo-randomised) controlled trials were eligible for inclusion. Studies were included if patients were treated with nebulised MgSO4 alone or in combination with beta2-agonist and where compared to beta2-agonist alone or inactive control. DATA COLLECTION AND ANALYSIS: Trial selection, data extraction and methodological quality were assessed by two independent reviewers. Efforts were made to collect missing data from authors. Results from fixed effects models are presented as standardized mean differences (SMD) for pulmonary functions and relative risks (RR) for hospital admission; both are displayed with their 95% confidence intervals (95% CI). MAIN RESULTS: Six trials involving 296 patients were included. Four studies compared nebulised MgSO4 with beta2-agonist to beta2-agonist and two studies compared MgSO4 to beta2-agonist alone. Three studies enrolled only adults and 2 enrolled exclusively pediatric patients; three of the studies enrolled severe asthmatics. Overall, there was a non significant improvement in pulmonary function between patients whose treatments included nebulised MgSO4 in addition to beta2-agonist (SMD: 0.23; 95% CI: -0.03 to 0.50; 4 studies). Hospitalizations were similar between the groups (RR: 0.69; 95% CI: 0.42 to 1.12; 3 studies). Subgroup analyses did not demonstrate significant differences in lung function improvement between adults and children, but in severe asthmatics the lung function difference was significant (SMD: 0.55; 95% CI: 0.12 to 0.98). Conclusions regarding treatment with nebulised MgSO4 alone are difficult to draw due to lack of studies in this area. AUTHORS' CONCLUSIONS: Nebulised inhaled magnesium sulfate in addition to beta2-agonist in the treatment of an acute asthma exacerbation, appears to have benefits with respect to improved pulmonary function in patients with severe asthma and there is a trend towards benefit in hospital admission. Heterogeneity between trials included in this review precludes a more definitive conclusion.

Acute Disease↗
PubMed2005

Additional anti-Gram-positive antibiotic treatment for febrile neutropenic cancer patients.

BACKGROUND: The pattern of infections among neutropenic cancer patients has shifted in the last decades to a predominance of Gram-positive infections. Some of these Gram-positive bacteria are increasingly resistant to beta-lactams and necessitate specific antibiotic treatment. OBJECTIVES: To assess the effectiveness of empirical anti-Gram-positive (antiGP) antibiotic treatment for febrile neutropenic cancer patients in terms of mortality and treatment failure. To assess the rate of resistance development, further infections and adverse events associated with additional antiGP treatment. SEARCH STRATEGY: We searched The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to 2004), EMBASE (January 1980 to 2004), LILACS (1982 to 2004), conference proceedings, and all references of included studies. First authors of all included and potentially relevant trials were contacted. SELECTION CRITERIA: Randomised controlled trials comparing one antibiotic regimen to the same regimen with the addition of an antiGP antibiotic for the treatment of febrile neutropenic cancer patients. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial eligibility, methodological quality and extracted all data. Relative risks (RR) with 95% confidence intervals (CI) were calculated. A random effects model was used for all comparisons showing substantial heterogeneity (I(2 )> 50%). Outcomes were extracted by intention-to-treat and the analysis was patient-based whenever possible. MAIN RESULTS: Thirteen trials and 2392 patients or episodes were included. Empirical antiGP antibiotics were tested at the onset of treatment in eleven studies and for persistent fever in two studies. The antiGP treatment was a glycopeptide in nine trials. Seven studies were assessed in the overall mortality comparison and no significant difference between the comparator arms was seen, RR 0.82 (95% CI 0.56 to 1.20, 852 patients). Ten trials assessed failure including modifications as failures, while six assessed overall failure, disregarding treatment modifications. Failure with modifications was significantly reduced, RR 0.76 (95% CI 0.68 to 0.85, 1779 patients) while overall failure was equal, RR 1.00, 95% CI (0.79 to 1.27, 943 patients). Both mortality and failure did not differ significantly among patients with Gram-positive infections, but comparisons were small. Data regarding other patient subgroups likely to benefit from antiGP treatment were not available. Glycopeptides did not increase fungal superinfection rates, and were associated with a reduction in documented Gram-positive superinfections. Resistant colonisation was not documented in the studies. AUTHORS' CONCLUSIONS: Current evidence shows that the addition of antiGP treatment, namely glycopeptides, prior to documentation of a Gram-positive infection does not improve outcomes.

Anti-Bacterial Agents↗
PubMed2005

Cardioprotective interventions for cancer patients receiving anthracyclines.

BACKGROUND: Anthracyclines are among the most effective chemotherapeutic agents in the treatment of numerous malignancies. Unfortunately, their use is limited by a dose-dependent cardiotoxicity. In an effort to prevent this cardiotoxicity, different cardioprotective agents have been studied. OBJECTIVES: The objective of this review was to assess the efficacy of different cardioprotective agents in preventing heart damage in cancer patients treated with anthracyclines. SEARCH STRATEGY: We searched the databases of CENTRAL (The Cochrane Library, Issue 3, 2002), MEDLINE (1966 to August 2002) and EMBASE (1980 to August 2002). In addition, we handsearched reference lists and conference proceedings of the International Society for Paediatric Oncology (SIOP) and the American Society of Clinical Oncology (ASCO) (1998 to 2002). SELECTION CRITERIA: Randomised controlled trials (RCTs) in which any cardioprotective agent was compared to no additional or placebo therapy in cancer patients (children and adults) receiving anthracyclines. DATA COLLECTION AND ANALYSIS: Two reviewers independently performed the study selection, quality assessment and data-extraction including adverse effects. MAIN RESULTS: We identified RCTs for 5 cardioprotective agents: N-acetylcysteine (1 study; 54 patients), phenetylamines (2 studies; 100 patients), coenzyme Q10 (1 study; 20 patients), combination of vitamin E, vitamin C and N-acetylcysteine (1 study; 14 patients) and dexrazoxane (6 studies; 1013 patients). All studies had methodological limitations. Due to the insufficient number of studies, for the first four mentioned cardioprotective agents pooling of the results was impossible. None of the individual studies showed a cardioprotective effect. The meta-analysis of the dexrazoxane-studies showed a statistically significant benefit in favour of dexrazoxane for the occurrence of heart failure (Relative Risk (RR) = 0.28, 95% Confidence Interval (CI) 0.18 to 0.42, P < 0.00001). No statistically significant difference in response rate between the dexrazoxane and control group was found (RR = 0.88, 95% CI 0.77 to 1.01, P = 0.06), but there was some suggestion that patients treated with dexrazoxane might have a lower anti-tumour response rate. Our meta-analysis of survival showed no significant difference between the dexrazoxane and control group. For adverse effects pooling was impossible. However, no important differences in the occurrence of side effects were found. The majority of the patients included in this meta-analysis were adults with advanced breast cancer. AUTHORS' CONCLUSIONS: For cardioprotective agents for which pooling was impossible no high quality evidence was available and therefore, no definitive conclusions can be made about their efficacy. Dexrazoxane prevents heart damage, however there was some suggestion that patients treated with dexrazoxane might have a lower anti-tumour response rate. There was no significant difference in survival between the dexrazoxane and control group. We conclude that if the risk of cardiac damage is expected to be high, it might be justified to use dexrazoxane in patients with cancer treated with anthracyclines. However, for each individual patient clinicians should weigh the cardioprotective effect of dexrazoxane against the possible risk of a lower response rate.

Anthracyclines↗
PubMed2004

Preoperative skin antiseptics for preventing surgical wound infections after clean surgery.

BACKGROUND: Approximately 15% of elective surgery patients and 30% of patients receiving contaminated or dirty surgery are estimated to develop post-operative wound infections. The costs of surgical wound infection can be considerable in financial as well as social terms. Preoperative skin antisepsis is performed to reduce the risk of post-operative wound infections by removing soil and transient organisms from the skin. Antiseptics are thought to be both toxic to bacteria and aid their mechanical removal. The effectiveness of preoperative skin preparation is thought to be dependent on both the antiseptic used and the method of application, however it is unclear whether preoperative skin antisepsis actually reduces post-operative wound infection and if so which antiseptic is most effective. OBJECTIVES: To determine whether preoperative skin antisepsis reduces post-operative surgical wound infection. SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Trials Register and the Cochrane Central Register of Controlled Trials in April 2004. In addition we handsearched journals, conference proceedings and bibliographies. SELECTION CRITERIA: Randomised controlled trials evaluating the use of preoperative skin antiseptics applied immediately prior to incision in clean surgery. There were no restrictions based on language, date or publication status. DATA COLLECTION AND ANALYSIS: Three reviewers independently undertook data extraction and assessment of study quality. Pooling was inappropriate and trials are discussed in a narrative review. MAIN RESULTS: We identified six eligible RCTs evaluating preoperative antiseptics. There was significant heterogeneity in the comparisons and the results could not be pooled. In one study, infection rates were significantly lower when skin was prepared using chlorhexidine compared with iodine. There was no evidence of a benefit in four trials associated with the use of iodophor impregnated drapes. REVIEWERS' CONCLUSIONS: There is insufficient research examining the effects of preoperative skin antiseptics to allow conclusions to be drawn regarding their effects on post-operative surgical wound infections. Further research is needed.

Anti-Infective Agents, Local↗
PubMed2004

Nasal versus oral route for placing feeding tubes in preterm or low birth weight infants.

BACKGROUND: Enteral feeding tubes for preterm or low birth weight infants may be placed via either the nose or mouth. Nasal placement may compromise respiration. However, orally placed tubes may be more prone to displacement, local irritation, and vagal stimulation. OBJECTIVES: To assess the available evidence from randomised controlled trials concerning the effects of nasally placed compared with orally placed feeding tubes on growth and development, and the incidence of adverse consequences in preterm or low birth weight infants. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group, including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2004), MEDLINE (1966 - April 2004), EMBASE (1988 - April 2004), and CINAHL (1982- April 2004), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that compared the use of the nasal versus oral route for placing feeding tubes in preterm or low birth weight infants. DATA COLLECTION AND ANALYSIS: We extracted data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by each author, and analysis of data using relative risk, risk difference and mean difference. MAIN RESULTS: We found only one eligible trial. Forty-two infants participated in the study. This primary aim of the trial was to assess the effect of oral versus nasal placement of feeding tubes on the incidence of apnea and periodic breathing in preterm infants. The trial did not report data on the pre-specified primary outcomes for this review (growth and development). REVIEWERS' CONCLUSIONS: There are insufficient data available to inform practice. A large randomised controlled trial is required to determine if the use of nasally placed feeding tubes compared with orally placed feeding tubes improves growth and development, without increasing adverse consequences in preterm or low birth weight infants.

Enteral Nutrition↗
PubMed2004

Systemic antifungal drugs for invasive fungal infection in preterm infants.

BACKGROUND: Invasive fungal infection is an increasingly common cause of mortality and morbidity in preterm infants. In addition to amphotericin B, a variety of newer antifungal drugs and drug preparations are available for treatment. There is a need to assess their relative merits. OBJECTIVES: In preterm infants with suspected or confirmed invasive fungal infection, does treatment with newer systemic antifungal drugs or drug preparations, versus conventional amphotericin B alone, reduce mortality and adverse neurodevelopmental outcomes? SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2003), MEDLINE (1966 - August 2003), EMBASE (1980 - August 2003), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised and quasi-randomised control trials comparing one antifungal agent or combination of agents with another in preterm infants with suspected or confirmed invasive fungal infection. DATA COLLECTION AND ANALYSIS: We extracted the data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by each author, and synthesis of data using relative risk and risk difference. The pre-specified outcomes were death prior to hospital discharge, longer term neurodevelopment, and adverse drug reactions resulting in discontinuation of therapy. MAIN RESULTS: We identified only one small trial. This study compared the use of fluconazole with amphotericin B (5-Fluorocytosine added if fungal meningitis present). Three of 11 infants who were treated with fluconazole died and four of 10 infants who were treated with amphotericin B died : Relative risk: 0.68 (95% confidence interval 0.20, 2.33), Risk Difference -0.13 (95% confidence interval -0.53, 0.27) There were not any data on longer term outcomes. REVIEWER'S CONCLUSIONS: From this one small study there are insufficient data to favour one antifungal agent or combination to reduce mortality and adverse neurodevelopmental outcomes in preterm infants with suspected or confirmed invasive fungal infection. A large randomised controlled trial is required to compare the newer antifungal preparations with conventional amphotericin B. Further research may also determine the relative convenience and cost effectiveness of the available drugs.

Amphotericin B↗
PubMed2004

Naloxone for preventing morbidity and mortality in newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia.

BACKGROUND: Studies in animal models have suggested that naloxone, a specific opiate antagonist, may improve outcomes for newborn infants with perinatal asphyxia. OBJECTIVES: In newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia: to assess the effects of naloxone versus placebo or no drug, and of single versus multiple doses of naloxone, on mortality, long term neurological problems, severity of hypoxic-ischaemic encephalopathy, and frequency of neonatal seizures. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2003), MEDLINE (1966 - August 2003), EMBASE (1980 - August 2003), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing naloxone versus placebo, or no drug, or another dose of naloxone, in newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia. DATA COLLECTION AND ANALYSIS: We extracted data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two authors. The pre-specified outcomes for this review were: death before hospital discharge, severe neurodevelopmental disability, severity of hypoxic-ischaemic encephalopathy, and seizures in the neonatal period. MAIN RESULTS: We identified only one eligible randomised controlled trial. This study compared the use of naloxone with placebo in newborn infants with an Apgar score of six or less at one minute after birth. There were not any data on the pre-specified outcomes for this review. REVIEWER'S CONCLUSIONS: There are insufficient data available to evaluate the safety and effectiveness of the routine use of naloxone for newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia. A further randomised controlled trial is needed to determine if naloxone benefits newborn infants with suspected perinatal asphyxia. Such a trial should assess clinically important outcomes such as mortality, and adverse short and long term neurological outcomes.

Asphyxia Neonatorum↗
PubMed2004

Adrenaline for prevention of morbidity and mortality in preterm infants with cardiovascular compromise.

BACKGROUND: Inotropes are widely used in preterm infants to treat cardiovascular compromise, which may result from early adaptive problems of the transitional circulation, perinatal asphyxia or sepsis. Sustained hypotension and poor organ blood flow are associated with brain injury including peri/intraventricular haemorrhage and subsequent poor neurodevelopmental outcomes. Adrenaline (epinephrine) infusions are used in preterm infants with clinical cardiovascular compromise. OBJECTIVES: To determine the effectiveness and safety of adrenaline compared to no treatment or other inotropes in reducing mortality and morbidity in preterm infants with cardiovascular compromise. SEARCH STRATEGY: Randomised controlled trials were identified by searching MEDLINE (1966-August 2003), The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2003) and EMBASE (1980 - 2003), supplemented with searches of reference lists of published trials and abstracts of conference proceedings. SELECTION CRITERIA: Randomised controlled trials of preterm newborn infants that compared adrenaline to no treatment or other inotropic agents (including dopamine, dobutamine, noradrenaline or isoprenaline). DATA COLLECTION AND ANALYSIS: Data were extracted and analysed independently by two reviewers. Treatment effects on the following outcomes were to be determined: mortality in the newborn period, long term neurodevelopmental outcomes, radiological evidence of brain injury, short term haemodynamic changes, adverse drug effects and short term neonatal outcomes. Study authors were contacted for additional information. Studies were analysed for methodological quality using the criteria of the Cochrane Neonatal Review Group. MAIN RESULTS: One ongoing study (Pellicer 2003) was identified. One study comparing adrenaline with dopamine infusion was included but was published in abstract form only (Phillipos 1996). It enrolled hypotensive, predominantly preterm infants in the first 24 hours. Only infants >1750g are included in this review (report for infants <=1750g appears incomplete). The study was reported as being randomised and double blinded, but methods were not reported. Both adrenaline and dopamine significantly increased heart rate and mean BP, with no statistically significant effect on left or right ventricular outputs. No other clinical outcomes were reported. No studies were identified that compared adrenaline to other inotropes, placebo or no treatment. REVIEWER'S CONCLUSIONS: There are insufficient data on the use of adrenaline infusions in preterm infants with cardiovascular compromise to make recommendations for practice. There is a need for larger trials to determine whether adrenaline is effective in reducing morbidity and mortality in preterm infants with cardiovascular compromise.

Cardiotonic Agents↗
PubMed2005

Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients.

BACKGROUND: Kidney transplantation is the treatment of choice for most patients with end-stage renal disease (ESRD). Standard protocols in use typically involve three drug groups each directed to a site in the T-cell activation or proliferation cascade which are central to the rejection process: calcineurin inhibitors (e.g. cyclosporin, tacrolimus), anti-proliferative agents (e.g. azathioprine, mycophenolate mofetil) and steroids (prednisolone). It remains unclear whether new regimens are more specific or simply more potent immunosuppressants. OBJECTIVES: To compare the effects of tacrolimus with cyclosporin as primary therapy for kidney transplant recipients. SEARCH STRATEGY: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Renal Group's specialist register and conference proceedings were searched to identify relevant reports of randomised controlled trials (RCTs). Two reviewers assessed trials for eligibility, quality and extracted data independently. SELECTION CRITERIA: All RCTs where tacrolimus was compared with cyclosporin for the initial treatment of kidney transplant recipients DATA COLLECTION AND ANALYSIS: Data were synthesised (random effects model) and results expressed as relative risk (RR), values <1 favouring tacrolimus, with 95% confidence intervals (CI). Subgroup analysis and meta-regression were used to examine potential effect modification by differences in trial design and immunosuppressive co-interventions. MAIN RESULTS: 123 reports from 30 trials (4102 patients) were included. At six months graft loss was significantly reduced in tacrolimus-treated recipients (RR 0.56, 95% CI 0.36 to 0.86), and this effect was persistent up to three years. Meta-regression showed that this benefit diminished as higher trough levels of tacrolimus were targeted (P = 0.04), after allowing for differences in cyclosporin formulation (P = 0.97) and cyclosporin target trough level (P = 0.38). At one year, tacrolimus patients suffered less acute rejection (RR 0.69, 95% CI 0.60 to 0.79), and less steroid-resistant rejection (RR 0.49, 95% CI 0.37 to 0.64), but more insulin-requiring diabetes mellitus (RR 1.86, 1.11 to 3.09), tremor, headache, diarrhoea, dyspepsia and vomiting. Cyclosporin-treated recipients experienced significantly more constipation and cosmetic side-effects. We demonstrated no differences in infection or malignancy. AUTHORS' CONCLUSIONS: Tacrolimus is superior to cyclosporin in improving graft survival and preventing acute rejection after kidney transplantation, but increases post-transplant diabetes, neurological and gastrointestinal side effects. Treating 100 recipients with tacrolimus instead of cyclosporin would avoid 12 suffering acute rejection, two losing their graft but cause an extra five to become insulin-requiring diabetics.

Cyclosporine↗
PubMed2003

Continuous ambulatory peritoneal dialysis (CAPD) versus hospital or home haemodialysis for end-stage renal disease in adults.

BACKGROUND: Renal replacement therapy (RRT) with dialysis and transplantation is the only means of sustaining life for patients with end-stage renal disease (ESRD). Although transplantation is the treatment of choice, the number of donor kidneys are limited and transplants may fail. Hence many patients require long-term or even life-long dialysis. Continuous ambulatory peritoneal dialysis (CAPD) is an alternative to hospital or home haemodialysis for patients with ESRD. OBJECTIVES: To assess the benefits and harms of CAPD versus hospital or home haemodialysis for adults with ESRD. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (Cochrane Library, Issue 2, 2002), the Cochrane Renal Group's Specialised Register (May 2002), MEDLINE (1966 - May 2002), EMBASE (1980 - May 2002), BIOSIS, CINHAL, SIGLE and NRR without language restriction. Reference lists of retrieved articles and conference proceedings were searched and known investigators and biomedical companies were contacted. SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs comparing CAPD to hospital or home haemodialysis for adults with ESRD were to be included. DATA COLLECTION AND ANALYSIS: Two reviewers were to independently assess the methodological quality of studies. Data was to be abstracted from included studies onto a standard form by one reviewer and checked by another. Statistical analyses were to be performed using the random effects model and the results to be expressed as relative risk (RR) with 95% confidence intervals (95% CI). MAIN RESULTS: Despite extensive searching, no RCTs or quasi-RCTs were identified. REVIEWER'S CONCLUSIONS: Data are not available to allow conclusions to be drawn about the relative effectiveness of CAPD compared with hospital or home haemodialysis for adults with ESRD. Efforts should be made to start and complete adequately powered RCTs, which compare the different dialysis modalities.

Adult↗
PubMed2004

Continuous ambulatory peritoneal dialysis (CAPD) versus hospital or home haemodialysis for end-stage renal disease in adults.

BACKGROUND: Renal replacement therapy (RRT) with dialysis and transplantation is the only means of sustaining life for patients with end-stage renal disease (ESRD). Although transplantation is the treatment of choice, the number of donor kidneys are limited and transplants may fail. Hence many patients require long-term or even life-long dialysis. Continuous ambulatory peritoneal dialysis (CAPD) is an alternative to hospital or home haemodialysis for patients with ESRD. OBJECTIVES: To assess the benefits and harms of CAPD versus hospital or home haemodialysis for adults with ESRD. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL in The Cochrane Library), the Cochrane Renal Group's specialised register, MEDLINE (1966 - May 2002), EMBASE (1980 - May 2002), BIOSIS, CINAHL, SIGLE and NRR without language restriction. Reference lists of retrieved articles and conference proceedings were searched and known investigators and biomedical companies were contacted. Date of most recent search January 2004. SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs comparing CAPD to hospital or home haemodialysis for adults with ESRD were to be included. DATA COLLECTION AND ANALYSIS: Two reviewers independently assess the methodological quality of studies. Data was abstracted from included studies onto a standard form by one reviewer and checked by another. Statistical analyses were performed using the random effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes with 95% confidence intervals (CI). MAIN RESULTS: One trial, reported in abstract form only, was located in the most recent search. There was no statistical difference in death or quality adjusted life years score at 2 years between peritoneal dialysis or haemodialysis patients. REVIEWERS' CONCLUSIONS: There is Insufficient data to allow conclusions to be drawn about the relative effectiveness of CAPD compared with hospital or home haemodialysis for adults with ESRD. Efforts should be made to start and complete adequately powered RCTs, which compare the different dialysis modalities.

Adult↗
PubMed2003

Immunosuppressive agents for treating IgA nephropathy.

BACKGROUND: IgA nephropathy (IgAN) is a world-wide disease and the cause of end-stage renal failure (ESRF) in 15 to 20% of patients within 10 years and in 30 to 40% of individuals within 20 years from the apparent onset of disease. No specific treatment has yet been established but many approaches have been investigated. OBJECTIVES: To assess the benefits and harms of immunosuppressive treatment for IgAN. SEARCH STRATEGY: We searched The Cochrane Renal Group's specialized register (May 2003), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 3, 2002) MEDLINE (1966 - September 2002), EMBASE (1988 - September 2002) and handsearched reference lists of retrieved articles and conference proceedings. SELECTION CRITERIA: Randomized controlled trials (RCTs) and quasi-RCTs comparing treatment of IgAN with immunosuppressive agents against placebo, no treatment, other immunosuppressive or non-immunosuppressive agents. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Statistical analyses were performed using the random effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes, with 95% confidence intervals (CI). MAIN RESULTS: Thirteen eligible RCTs involving 623 patients were identified. All identified RCTs had a placebo, no treatment or warfarin/dipyridamole control group. Seven trials used steroids, three used alkylating agents/cyclosporin and three used combinations of steroids and alkylating agents/cyclosporin. No trial directly compared steroids versus alkylating agents/cyclosporin. Quality was sub-optimal. Steroids were associated with a lower risk of progression to ESRF (RR 0.44, 95% CI 0.25 to 0.80) and lower urinary protein excretion (WMD -0.49 g/24h, 95% CI -0.72 to -0.12). Urinary protein excretion was lower for patients treated with alkylating agents/cyclosporin compared to placebo/no treatment (WMD -0.94 g/24h, 95% CI -1.43 to -0.46). There was no significant reduction of urinary protein excretion with combination treatment of steroids and alkylating agents compared with placebo/no treatment. REVIEWER'S CONCLUSIONS: The optimal management of IgAN remains uncertain. The RCTs identified were small, of sub-optimal methodological quality and tended to only report favorable and surrogate outcomes without a thorough reporting of treatment harms. All outcomes favor the use of immunosuppressive interventions, with steroids appearing to be the most promising. Further study, in the form of RCTs, is necessary to ascertain which patients would benefit from these interventions, whether they are the ones with early signs of renal dysfunction or those with more advanced renal impairment.

Glomerulonephritis, IGA↗
PubMed2006

Decompressive craniectomy for the treatment of refractory high intracranial pressure in traumatic brain injury.

BACKGROUND: High intracranial pressure (ICP) is the most frequent cause of death and disability after severe traumatic brain injury (TBI). High ICP is treated by general maneuvers (normothermia, sedation etc) and a set of first line therapeutic measures (moderate hypocapnia, mannitol etc). When these measures fail to control high ICP, second line therapies are started. Among these, second line therapies such as barbiturates, hyperventilation, moderate hypothermia or removal of a variable amount of skull bone (known as decompressive craniectomy) are used. OBJECTIVES: To assess the effects of secondary decompressive craniectomy (DC) on outcome and quality of life in patients with severe TBI in whom conventional medical therapeutic measures have failed to control raised ICP. SEARCH STRATEGY: We searched the Cochrane Injuries Group's Trial Register, CENTRAL, MEDLINE, EMBASE, Best Evidence, Clinical Practice Guidelines, PubMed, CINAHL, the National Research Register and Google Scholar. We also handsearched relevant conference proceedings and contacted experts in the field and the authors of included studies. SELECTION CRITERIA: Randomized or quasi-randomized studies assessing patients over the age of 12 months with a severe TBI who underwent DC to control ICP refractory to conventional medical treatments. DATA COLLECTION AND ANALYSIS: Two authors independently examined the electronic search results for reports of possibly relevant trials and for retrieval in full. One author applied the selection criteria, performed the data extraction and assessed methodological quality. Study authors were contacted for additional information. MAIN RESULTS: We found one trial with 27 participants conducted in the pediatric population (>18 years). DC was associated with a risk ratio (RR) for death of 0.54 (95% CI 0.17 to 1.72), and RR of 0.54 for death, vegetative status or severe disability 6 to 12 months after injury (95% CI 0.29 to 1.07). AUTHORS' CONCLUSIONS: There is no evidence to support the routine use of secondary DC to reduce unfavourable outcome in adults with severe TBI and refractory high ICP. In the pediatric population DC reduces the risk of death and unfavourable outcome. Despite the wide confidence intervals for death and the small sample size of the only study identified, this treatment maybe justified in patients below the age of 18 when maximal medical treatment has failed to control ICP. To date, there are no results from randomised trials to confirm or refute the effectiveness of DC in adults. However, the results of non-randomized trials and controlled trials with historical controls involving adults, suggest that DC may be a useful option when maximal medical treatment has failed to control ICP. There are two ongoing randomized controlled trials of DC (Rescue ICP and DECRAN) that may allow further conclusions on the efficacy of this procedure in adults.

Brain Injuries↗
PubMed2005

Intrarectal quinine for treating Plasmodium falciparum malaria.

BACKGROUND: In children with falciparum malaria, quinine administered rectally may be easier to use and less painful than intramuscular or intravenous administration. However, it may be less effective. OBJECTIVES: To compare intrarectal quinine with intravenous or intramuscular quinine for treating malaria caused by Plasmodium falciparum. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (July 2004), CENTRAL (The Cochrane Library Issue 3, 2004), MEDLINE (1966 to July 2004), EMBASE (1974 to July 2004), LILACS (1982 to July 2004), and CINAHL (1982 to July 2004). We also searched conference proceedings, contacted individual researchers and a pharmaceutical company, and checked reference lists. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials comparing intrarectal quinine with intramuscular and intravenous quinine for treating people with uncomplicated and severe falciparum malaria. DATA COLLECTION AND ANALYSIS: We independently assessed trial quality and extracted data, including adverse event data. We analysed dichotomous data using odds ratios and weighted mean difference for continuous data. MAIN RESULTS: Eight randomized controlled trials (involving 1247 children) fulfilled the inclusion criteria. The same principal investigator led seven of the trials. Five trials compared intrarectal with intravenous quinine, and six trials compared it with intramuscular treatment. We detected no statistically significant difference between intrarectal and intravenous or intramuscular routes for death, parasite clearance by 48 hours and 7 days, parasite clearance time, fever clearance time, coma recovery time, duration of hospitalization, and time to drinking. The trials reporting on these outcomes were small, which resulted in large confidence intervals for all outcomes apart from duration of hospitalization. One large trial (898 children) reported that intrarectal was less painful than intramuscular administration. AUTHORS' CONCLUSIONS: We detected no difference in the effect on parasites and clinical illness for intrarectal quinine, but most trials were small. Pain may be less with intrarectal quinine. Further larger trials, in patients with severe malaria and in adults, are required before the intrarectal route can be recommended.

Administration, Rectal↗
PubMed2005

Policies for the removal of short-term indwelling urethral catheters.

BACKGROUND: Approximately 15% to 25% of all hospitalised patients have indwelling urethral catheters, mainly to assist clinicians to accurately monitor urine output during acute illness or following surgery, to treat urinary retention, and for investigative purposes. OBJECTIVES: The objective of this review was to determine the best strategies for the removal of catheters from patients with a short-term indwelling urethral catheter. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised register (searched 16 December 2002), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2004), MEDLINE (January 1966 to 12 October 2004), EMBASE (January 1980 to 12 October 2004), CINAHL (January 1982 to 12 October 2004), Nursing Collection (January 1995 to January 2002) and reference lists of relevant articles and conference proceedings were searched. We also contacted manufacturers and researchers in the field. No language or other restrictions were applied. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials (RCTs) that compared the effects of alternative strategies for removal of short-term indwelling urethral catheters on patient outcomes were considered for inclusion in the review. DATA COLLECTION AND ANALYSIS: Eligibility of the trials for inclusion in the review, details of eligible trials and the methodological quality of the trials were assessed independently by two reviewers. Relative risks (RR) for dichotomous data and a weighted mean difference (WMD) for continuous data were calculated with 95% confidence intervals (CI). Where synthesis was inappropriate, trials were considered separately. MAIN RESULTS: Eighteen trials involving a total of 1964 participants were included in the review. One trial included three treatment groups. In eight RCTs amongst 1020 people, removal at midnight was associated with large volumes of urine at first void, longer times to first void, and shorter lengths of hospitalisation. There was no significant difference in need for recatheterisation, although recatheterisation after removal at night was more likely to be during working hours. In eight trials amongst 822 participants early rather than delayed catheter removal was associated with shorter hospitalisation, but the estimates of other differences were all imprecise. In three trials involving 234 participants the data were too few to assess differential effects of catheter clamping compared with free drainage prior to withdrawal. No eligible trials compared flexible with fixed duration of catheterisation, or assessed prophylactic alpha sympathetic blocker drugs prior to catheter removal. AUTHORS' CONCLUSIONS: There is suggestive but inconclusive evidence of a benefit from midnight removal of the indwelling urethral catheter. There are resource implications but the magnitude of these is not clear from the trials. The evidence also suggests shorter hospital stay after early rather than delayed catheter removal but the effects on other outcomes are unclear. There is little evidence on which to judge other aspects of management, such as catheter clamping.

Adult↗
PubMed2001

Splints/orthoses in the treatment of rheumatoid arthritis.

BACKGROUND: Splints/orthoses are often recommended to patients with rheumatoid arthritis (RA) to decrease pain, decrease swelling and/or prevent deformity. These orthoses include resting hand splints, wrist supports, finger splints and special shoes and shoe inserts. OBJECTIVES: To assess the effectiveness of splints/orthoses in relieving pain, decreasing swelling and/or preventing deformity and determine the impact of splints/orthoses on strength, mobility and function in people with RA. SEARCH STRATEGY: We searched MEDLINE, EMBASE, the PEDro data base and Current Contents up to January 2002, and the Cochrane Controlled Trials Register to Issue 4, 2001 using the search strategy developed by the Cochrane Collaboration. Unpublished studies were sought by hand searching conference proceeding and contacting key experts. SELECTION CRITERIA: All randomized control trials (RCTs) and controlled clinical trials (CCTs), case-control and cohort studies comparing the use of specific orthoses against placebo, another active intervention (including another type of orthoses) or regular treatment were selected, according to an a priori protocol. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected the studies and abstracted data. The methodological quality of the RCTs and CCTs was assessed using a validated scale. MAIN RESULTS: Twelve papers reporting on 10 studies met the inclusion criteria. These studies dealt with the following: working wrist splints (5), resting hand and wrist splints (2), special shoes and insoles (3). There is evidence that wearing working wrist splints statistically significantly decreases grip strength and does not affect pain, morning stiffness, pinch grip, quality of life after up to 6 months of regular wear. We found no evidence that resting wrist and hand splints change pain, grip strength, Ritchie Index or number of swollen joints. However, patients who wore these splints for 2 months reported that they preferred use to non-use and padded resting splints to unpadded ones. The one study of special shoes provided evidence of significant benefits of wearing extra-depth shoes for 2 months including less pain on walking and stair climbing and more minutes pain free walking time. Extra-depth shoes with semi-rigid insoles provided better pain relief than extra-depth shoes alone when worn over 12 weeks. Posted insoles prevented progression of hallux valgus angle but did not affect pain or function. REVIEWER'S CONCLUSIONS: There is insufficient evidence to make firm conclusions about the effectiveness of working wrist splints in decreasing pain or increasing function for people with RA. Potential adverse effects such as decreased range of motion do not seem to be an issue, although some of these splints decrease grip strength and dexterity. Similarly, preliminary evidence suggests that resting hand and wrist splints do not seem to affect range of motion or pain, although patients preferred wearing a resting splint to not wearing one. There is evidence that extra-depth shoes and molded insoles decreases pain on weight-bearing activities such as standing, walking and stair-climbing. Posted insoles may be effective in preventing progression of hallux abductus angle but do not appear to have an impact on pain.

Arthritis, Rheumatoid↗