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PubMed2004

Herbal medicines for viral myocarditis.

BACKGROUND: Herbal medicines are being used for treating viral diseases including viral myocarditis, and many controlled trials have been done to investigate their efficacy. OBJECTIVES: To assess the effects of herbal medicines on clinical and indirect outcomes in patients with viral myocarditis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library 2003, Issue 3, MEDLINE (January 1966 to October 2003), EMBASE (January 1998 to October 2003), Chinese Biomedical Database (1979-2003), AMED (1985-2003), LILACS accessed in October 2003 and the trials register of the Cochrane Complementary Medicine Field. We handsearched Chinese journals and conference proceedings. No language or publication restrictions were used. SELECTION CRITERIA: Randomised controlled trials of herbal medicines (with a minimum of seven days treatment duration) compared with placebo, no intervention, or conventional interventions were included. Trials of herbal medicine plus conventional drug versus drug alone were also included. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and evaluated trial quality. Study authors were contacted for additional information. Adverse effects information was collected from the trials. MAIN RESULTS: Forty randomised trials, involving 3448 people were included. All trials were conducted and published in China, and the methodological quality was assessed as generally low. No trial had diagnosis of viral myocarditis confirmed histologically, and few trials attempted to establish viral aetiology for the myocarditis. Twenty-five different herbal medicines were tested in the included trials, which compared herbs with supportive therapy (17 trials), other controls (three trials), or treatment of herbs plus supportive therapy with supportive therapy alone (20 trials). The trials reported electrocardiogram, myocardial enzymes, cardiac function, symptoms, and adverse effects. Astragalus membranaceus (either as single herb or compound of herbs) showed significantly effects on improving arrhythmia, CPK levels, and cardiac function. Salviae miltiorrhizae injection showed significant effects on decreasing the arrhythmia and reducing LDH levels. Shenmai and Shengmai injection (Ginseng preparation) showed significantly effects on reducing myocardial enzymes and improving cardiac function. No serious adverse effect was reported. REVIEWERS' CONCLUSIONS: Some herbal medicines may have anti-arrhythmia effect in suspected viral myocarditis. However, interpretation of these findings should be careful due to the low methodological quality, small sample size, and limited number of trials on individual herbs. In the light of the findings, some herbal medicines deserve further examination in rigorous trials.

Drugs, Chinese Herbal↗
PubMed2003

Inhaled bronchodilators for acute chest syndrome in people with sickle cell disease.

BACKGROUND: Bronchodilators are used to treat bronchial hyper-responsiveness in asthma. Bronchial hyper-responsiveness may be a component of the acute chest syndrome in people with sickle cell disease. Therefore, bronchodilators may be useful in the treatment of acute chest syndrome. OBJECTIVES: To assess the benefits and risks associated with the use of bronchodilators in people with acute chest syndrome. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings. Additional searches were carried out on MEDLINE (1966 to 2002) and EMBASE (1981 to 2002).Date of the most recent search of the Group's haemoglobinopathies register: May 2002. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials. Trials using quasi-randomisation methods will be included in future updates of this review if there is sufficient evidence that the treatment and control groups are similar at baseline. DATA COLLECTION AND ANALYSIS: We found no trials investigating the use of bronchodilators for acute chest syndrome in people with sickle cell disease. MAIN RESULTS: We found no trials investigating the use of bronchodilators for acute chest syndrome in people with sickle cell disease. REVIEWER'S CONCLUSIONS: If bronchial hyper-responsiveness is an important component of some episodes of acute chest syndrome in people with sickle cell disease, the use of inhaled bronchodilators may be indicated. There is need for a well-designed, adequately powered randomised controlled trial to assess the benefits and risks of the addition of inhaled bronchodilators to established therapies for acute chest syndrome in people with sickle cell disease.

Acute Disease↗
PubMed2003

Erythromycin for the prevention of chronic lung disease in intubated preterm infants at risk for, or colonized or infected with Ureaplasma urealyticum.

BACKGROUND: Controversy exists over whether or not Ureaplasma urealyticum colonization or infection of the respiratory tract contributes to the severity of chronic lung disease (CLD), a major cause of morbidity and mortality in preterm infants. OBJECTIVES: To evaluate the efficacy and safety of prophylactic or therapeutic erythromycin in preventing chronic lung disease in intubated preterm infants with unknown U. urealyticum status or proven positivity. SEARCH STRATEGY: Searches were done of MEDLINE (1966-June 9, 2003), EMBASE (1980-May 5, 2003), The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2002), previous reviews including cross-references, and abstracts of conference proceedings (Pediatric Academic Societies 2000-2003, American Thoracic Society 2001-2003). There were no language restrictions. Expert informants were contacted. SELECTION CRITERIA: Randomized or quasi-randomized studies comparing either prophylactic or therapeutic administration of oral or intravenous erythromycin (regardless of dose and duration) versus no treatment or placebo among intubated preterm infants <37 weeks and <2500 grams with either unknown U. urealyticum status or proven positivity by culture or polymerase chain reaction. DATA COLLECTION AND ANALYSIS: Data were extracted by all of the authors independently and differences were resolved by consensus. Treatment effects for categorical outcomes were expressed as relative risk, with 95% confidence intervals. MAIN RESULTS: Two small controlled studies, both involving intubated babies <30 weeks gestation, were eligible for inclusion. Lyon 1998 tested prophylactic erythromycin in babies whose U. urealyticum status was unknown at the time of initiation of treatment. Jonsson 1998 tested erythromycin in babies known to be culture positive for U. urealyticum. Neither trial showed a statistically significant effect of erythromycin on CLD, death or the combined outcome CLD or death. Because the two studies differed importantly in their design, the results were not combined in meta-analyses. No adverse effects of a 7-10 day course of erythromycin were reported in either study. REVIEWER'S CONCLUSIONS: Current evidence does not demonstrate a reduction in CLD/death when intubated preterm infants are treated with erythromycin prophylactically before U. urealyticum culture/PCR results are known or when Ureaplasma colonized, intubated preterm infants are treated with erythromycin. However, a true benefit could easily have been missed with the small sample sizes in the two eligible studies. The studies were greatly underpowered to detect uncommon adverse effects such as pyloric stenosis. Additional controlled trials are required to determine whether antibiotic therapy of Ureaplasma reduces CLD and/or death in intubated preterm infants.

Anti-Bacterial Agents↗
PubMed2003

Antibiotics for acute pyelonephritis in children.

BACKGROUND: Urinary tract infection (UTI) is one of the most common bacterial infection in infants. The most severe form of UTI is acute pyelonephritis, which results in significant acute morbidity and may cause permanent renal damage. Published guidelines recommend treatment of acute pyelonephritis initially with intravenous (IV) therapy followed by oral therapy for 7-14 days though there is no consensus on the duration of either IV or oral therapy. OBJECTIVES: To determine the benefits and harms of different antibiotic regimens for the treatment of acute pyelonephritis in children. SEARCH STRATEGY: We searched the Cochrane Register of Controlled Trials (Cochrane Library Issue 3, 2002), MEDLINE (1966 - September 2002), EMBASE (1988 -September 2002), reference lists of articles and abstracts from conference proceedings without language restriction. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing different antibiotic agents, routes, frequencies or durations of therapy in children aged 0-18 years with proven UTI and acute pyelonephritis were selected. 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 or weight mean difference (WMD) for continuous data with 95% confidence intervals (CI). MAIN RESULTS: Sixteen trials involving 1872 children were eligible for inclusion. No significant differences were found in persistent renal damage at six months (one trial, 306 infants: RR 1.45, 95% CI 0.69 to 3.03) or in duration of fever (WMD 0.80, 95% CI -4.41 to - 6.01) between oral cefixime therapy (14 days) and IV therapy (three days) followed by oral therapy (10 days). Similarly no significant differences in persistent renal damage (three trials, 315 children: RR 0.99, 95% CI 0.72 to 1.37) were found between IV therapy (3-4 days) followed by oral therapy and IV therapy for 7-14 days. In addition no significant differences in efficacy were found between daily and thrice daily administration of aminoglycosides (one trial, 179 children, persistent symptoms at three days: RR 1.98, 95% CI 0.37 to 10.53). REVIEWER'S CONCLUSIONS: These results suggest that children with acute pyelonephritis can be treated effectively with oral cefixime or with short courses (2-4 days) of IV therapy followed by oral therapy. If IV therapy is chosen, single daily dosing with aminoglycosides is safe and effective. Trials are required to determine the optimal total duration of therapy and if other oral antibiotics can be used in the initial treatment of acute pyelonephritis.

Adolescent↗
PubMed2005

Antibiotics for acute pyelonephritis in children.

BACKGROUND: Urinary tract infection (UTI) is one of the most common bacterial infection in infants. The most severe form of UTI is acute pyelonephritis, which results in significant acute morbidity and may cause permanent renal damage. Published guidelines recommend treatment of acute pyelonephritis initially with intravenous (IV) therapy followed by oral therapy for seven to 14 days though there is no consensus on the duration of either IV or oral therapy. OBJECTIVES: To determine the benefits and harms of different antibiotic regimens for the treatment of acute pyelonephritis in children. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, reference lists of articles and abstracts from conference proceedings without language restriction. Date of most recent search: June 2004. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing different antibiotic agents, routes, frequencies or durations of therapy in children aged 0 to 18 years with proven UTI and acute pyelonephritis were selected. 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 or weight mean difference (WMD) for continuous data with 95% confidence intervals (CI). MAIN RESULTS: Eighteen trials (2612 children) were eligible for inclusion. No significant differences were found in persistent renal damage at six months (one trial, 306 infants: RR 1.45, 95% CI 0.69 to 3.03) or in duration of fever (WMD 0.80, 95% CI -4.41 to - 6.01) between oral cefixime therapy (14 days) and IV therapy (three days) followed by oral therapy (10 days). Similarly no significant differences in persistent renal damage (three trials, 315 children: RR 0.99, 95% CI 0.72 to 1.37) were found between IV therapy (3-4 days) followed by oral therapy and IV therapy for 7-14 days. In addition no significant differences in efficacy were found between daily and thrice daily administration of aminoglycosides (one trial, 179 children, persistent symptoms at three days: RR 1.98, 95% CI 0.37 to 10.53). AUTHORS' CONCLUSIONS: These results suggest that children with acute pyelonephritis can be treated effectively with oral cefixime or with short courses (2-4 days) of IV therapy followed by oral therapy. If IV therapy is chosen, single daily dosing with aminoglycosides is safe and effective. Trials are required to determine the optimal total duration of therapy and if other oral antibiotics can be used in the initial treatment of acute pyelonephritis.

Acute Disease↗
PubMed2005

Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients.

BACKGROUND: The risk of cytomegalovirus (CMV) infection in solid organ transplant recipients has resulted in the frequent use of prophylaxis with the aim of preventing the clinical syndrome associated with CMV infection. OBJECTIVES: To determine the benefits and harms of antiviral medications to prevent CMV disease and all-cause mortality in solid organ transplant recipients. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, reference lists and abstracts from conference proceedings without language restriction. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing antiviral medications with placebo or no treatment, trials comparing different antiviral medications and trials comparing different regimens of the same antiviral medications in recipients of any solid organ transplant. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data from each trial. Statistical analyses were performed using the random effects model and results expressed as relative risk (RR) for dichotomous outcomes with 95% confidence intervals (CI). Subgroup analysis and univariate meta-regression were performed using restricted maximum-likelihood to estimate the between study variance. Multivariate meta-regression was performed to investigate whether the results were altered after allowing for differences in drugs used, organ transplanted and recipient CMV serostatus at the time of transplantation. MAIN RESULTS: Thirty two trials (3737 participants) were identified. Prophylaxis with aciclovir, ganciclovir or valaciclovir compared with placebo or no treatment significantly reduced the risk for CMV disease (19 trials; RR 0.42, 95% CI 0.34 to 0.52), CMV infection (17 trials; RR 0.61, 95% CI 0.48 to 0.77), and all-cause mortality (17 trials; RR 0.63, 95% CI 0.43 to 0.92) primarily due to reduced mortality from CMV disease (seven trials; RR 0.26, 95% CI 0.08 to 0.78). Prophylaxis reduced the risk of herpes simplex and herpes zoster disease, bacterial and protozoal infections but not fungal infection, acute rejection or graft loss. Meta-regression showed no significant difference in the risk of CMV disease or all-cause mortality by organ transplanted or CMV serostatus; no conclusions were possible for CMV negative recipients of negative organs. In direct comparison trials, ganciclovir was more effective than aciclovir in preventing CMV disease (seven trials; RR 0.37, 95% Cl 0.23 to 0.60). Valganciclovir and intravenous ganciclovir were as effective as oral ganciclovir. AUTHORS' CONCLUSIONS: Prophylaxis with antiviral medications reduces CMV disease and CMV-associated mortality in solid organ transplant recipients. They should be used routinely in CMV positive recipients and in CMV negative recipients of CMV positive organ transplants.

Acyclovir↗
PubMed2005

Argon plasma coagulation therapy for acute non-variceal upper gastrointestinal bleeding.

BACKGROUND: Endoscopic treatment is recommended for initial hemostasis in non-variceal upper gastrointestinal bleeding. Many endoscopic hemostatic devices are used. Argon Plasma Coagulation (APC) is an alternative. OBJECTIVES: This study reviews all available literature to access the efficacy of APC compared to other endoscopic therapies in the control of acute non-variceal upper GI hemorrhage. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4 2003), MEDLINE 1966 to December 2003, EMBASE 1980 to December 2003, Web of Science for SCISEARCH (1980 to December 2003), BIOSIS (1985 to December 2003), and the National Research Register Issue 4 2003. We also handsearched abstracts from conference proceedings of the United European Gastroenterology Week and Digestive Disease Week. SELECTION CRITERIA: Randomized, controlled trials of APC compared with other endoscopic hemostasis interventions in the treatment of non-variceal upper gastrointestinal bleeding. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and independently extracted data. MAIN RESULTS: Two trials involving 121 people were included. There was no common intervention to pool. One trial compared APC to heat probe, another trial compared APC to injection sclerotherapy. There was no significant difference between groups in either of these trials. AUTHORS' CONCLUSIONS: On the basis of the two randomised controlled trials identified in this review, there is no evidence to suggest that APC is superior to other endoscopic therapies. Further randomised controlled trials are needed.

Argon↗
PubMed2003

Lithium for schizophrenia.

BACKGROUND: Many people with schizophrenia do not achieve a satisfactory treatment response with ordinary antipsychotic drug treatment. In these cases, various add-on medications are used, among them lithium. OBJECTIVES: To review the effects of lithium for the treatment of schizophrenia and schizophrenia-like psychoses. SEARCH STRATEGY: The reviewers searched the Cochrane Schizophrenia Group's register (March 2002). This register is compiled by methodical searches of BIOSIS, CINAHL, Dissertation abstracts, EMBASE, LILACS, MEDLINE, PSYNDEX, PsycINFO, RUSSMED, Sociofile, supplemented with hand searching of relevant journals and numerous conference proceedings. We also contacted pharmaceutical companies and authors of relevant studies to identify further trials and to obtain original patient data. SELECTION CRITERIA: All randomised controlled trials comparing lithium to antipsychotics or to placebo (or no intervention), whether as sole treatment or as an adjunct to antipsychotic medication for the treatment of schizophrenia and/or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: Citations and, where possible, abstracts were independently inspected by reviewers, papers ordered, re-inspected and quality assessed. Data were extracted independently by at least two reviewers. Dichotomous data were analysed using relative risks (RR) and the 95% confidence interval (CI) estimated. Where possible the number needed to treat (NNT) or number needed to harm statistics were calculated. Continuous data were analysed using weighted mean differences (WMD). MAIN RESULTS: The review currently includes 20 studies with a total of 611 participants. Most studies were small, of short duration and incompletely reported, but a number of authors were willing to share their data with us. Three studies comparing lithium with placebo as the sole treatment showed no difference in any of the outcomes we analysed. In eight studies comparing lithium with antipsychotic drugs as the sole treatment more participants in the lithium group left the studies early (n=270, RR 1.8, CI 1.2 to 2.9, NNT 9, CI 5 to 33). Several of the outcomes relating to these studies suggested that lithium is less effective than antipsychotic drugs, but it was difficult to summarise the data, because a variety of rating scales were used in the studies. Eleven studies examined whether the augmentation of antipsychotic drugs with lithium salts is more effective than antipsychotic drugs alone. More participants who received lithium augmentation had a clinically significant response (n=244, RR 0.8, CI 0.7 to 0.96, NNT 8, CI 4 to 33). However, statistical significance became borderline when participants with schizoaffective disorders were excluded in a sensitivity analysis (n=120, RR 0.8, CI 0.6 to 1.0, p=0.07). Furthermore, more participants in the lithium augmentation groups left the studies early (n=320, RR 2.0 CI 1.3 to 3.1, NNT 7, CI 4 to 14), suggesting a lower acceptability of lithium augmentation compared to those on antipsychotics alone. No superior efficacy of lithium augmentation in any specific aspect of the mental state was found. While based on very little data, there were no differences between groups for adverse events. REVIEWER'S CONCLUSIONS: There is no randomised trial based evidence that lithium on its own is an effective treatment for people with schizophrenia. The evidence available on augmentation of antipsychotics with lithium is inconclusive, but it justifies further, large, simple and well-designed trials. These should concentrate on two target groups: 1) people with no affective symptoms, so that trialists can determine whether lithium has an effect on the core symptoms of schizophrenia, 2) people with schizoaffective disorders for whom lithium is widely used in clinical practice, although there is no evidence to support this use.

Antipsychotic Agents↗
PubMed2006

Eradication therapy for peptic ulcer disease in Helicobacter pylori positive patients.

BACKGROUND: Peptic ulcer disease is the cause for dyspepsia in about 10% of patients. 95% of duodenal and 70% of gastric ulcers are associated with Helicobacter pylori. Eradication of H pylori reduces the relapse rate of ulcers but the magnitude of this effect is uncertain. OBJECTIVES: The primary outcomes were the proportion of peptic ulcers healed initially and proportion of patients free from relapse following successful healing. Eradication therapy was compared to placebo or pharmacological therapies in H. pylori positive patients. Secondary aims included symptom relief and adverse effects. SEARCH STRATEGY: Searches were conducted on the Cochrane Central register of Controlled Trials - CENTRAL (which includes the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register) on The Cochrane Library (Issue 3 2002) MEDLINE (1966 to July 2002) and EMBASE (1980 to July 2002). Reference lists from trials selected by electronic searching were handsearched to identify further relevant trials. Published abstracts from conference proceedings from the United European Gastroenterology Week (published in Gut) and Digestive Disease Week (published in Gastroenterology) were handsearched. The search was updated in September 2003, November 2004 and November 2005. Members of the Cochrane UGPD Group, and experts in the field were contacted and asked to provide details of outstanding clinical trials and any relevant unpublished materials SELECTION CRITERIA: Randomised controlled trials of short and long-term treatment of peptic ulcer disease in H. pylori positive adults were analysed. Patients received at least one week of H pylori eradication compared with ulcer healing drug, placebo or not treatment. Trials were included if they reported assessment from 2 weeks onwards. DATA COLLECTION AND ANALYSIS: Data were collected on ulcer healing, recurrence, relief of symptoms and adverse effects. MAIN RESULTS: 63 trials were eligible. Data extraction was not possible in 7 trials, and 56 trials were included. In duodenal ulcer healing, eradication therapy was superior to ulcer healing drug (UHD) (34 trials, 3910 patients, relative risk [RR] of ulcer persisting = 0.66; 95% confidence interval [CI] = 0.58, 0.76) and no treatment (2 trials, 207 patients, RR = 0.37; 95% CI 0.26, 0.53). In gastric ulcer healing, no significant differences were detected between eradication therapy and UHD (14 trials, 1572 patients, RR = 1.25; 95% CI = 0.88, 1.76). In preventing duodenal ulcer recurrence no significant differences were detected between eradication therapy and maintenance therapy with UHD (4 trials, 319 patients, relative risk [RR] of ulcer recurring = 0.73; 95% CI = 0.42, 1.25), but eradication therapy was superior to no treatment (27 trials 2509 patients, RR = 0.20; 95% CI = 0.15, 0.26). In preventing gastric ulcer recurrence, eradication therapy was superior to no treatment (11 trials, 1104 patients, RR = 0.29; 95% CI 0.20, 0.42). AUTHORS' CONCLUSIONS: A 1 to 2 weeks course of H. pylori eradication therapy is an effective treatment for H. pylori positive peptic ulcer disease.

Adult↗
PubMed2003

Ventilation with lower tidal volumes versus traditional tidal volumes in adults for acute lung injury and acute respiratory distress syndrome.

BACKGROUND: Patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) require mechanical ventilatory support. ALI/ARDS is further complicated by ventilator-induced lung injury. Lung-protective ventilation strategies may lead to improved survival. OBJECTIVES: To assess the effects of ventilation with lower tidal volume (Vt) on morbidity and mortality in adults patients affected by ALI/ARDS. A secondary objective was to determine whether the comparison between low and conventional Vt is different if a plateau airway pressure of greater than 30 to 35 cm H20 was used. SEARCH STRATEGY: We searched The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library issue 3, 2002; MEDLINE (1966 to June 2002); EMBASE and CINAHL (1982 to June 2002); intensive care journals and conference proceedings; databases of ongoing research, reference lists and 'grey literature'. SELECTION CRITERIA: Randomized trials comparing ventilation using lower Vt and/or low airway driving pressure (plateau pressure 30 cm H2O or less), resulting in Vt of 7 ml/kg or less versus ventilation that uses Vt in the range of 10 to 15 ml/kg, in adults (16 year-old or greater). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Wherever appropriate, results were pooled. Fixed and random effects models were applied. MAIN RESULTS: Five trials, involving 1202 patients, were eligible. The test for heterogeneity gave a P-value of 0.12. Ventilation with lower Vt was associated with a decreased mortality at the end of the follow up period for each trial: 216/605 (35.7%) versus 249/597 (41.7%), relative risk (RR) 0.85 (CI 0.74 to 0.98). The effect of the intervention was not statistically significant when a random effects model was used: RR 0.91 (CI 0.72 to 1.14). Mortality at day 28 was significantly reduced by lung-protective ventilation: RR 0.74 (CI 0.61 to 0.88). The comparison between low and conventional Vt was not significantly different if a plateau pressure less than or equal to 31 cm H2O in control group was used: RR 1.13 (CI 0.88 to 1.45). There was insufficient evidence about morbidity and long term outcomes. REVIEWER'S CONCLUSIONS: Clinical heterogeneity, such as different lengths of follow up and higher plateau pressure in control arms in two trials make the interpretation of the combined results difficult. Mortality is significantly reduced at day 28 and the effects on long term mortality are uncertain, although the possibility of a clinically relevant benefit cannot be excluded. There is no evidence that low Vt ventilation is beneficial in patients where hypercapnia is potentially harmful.

Adult↗
PubMed2004

Ventilation with lower tidal volumes versus traditional tidal volumes in adults for acute lung injury and acute respiratory distress syndrome.

BACKGROUND: Patients with acute respiratory distress syndrome and acute lung injury require mechanical ventilatory support. Acute respiratory distress syndrome and acute lung injury are further complicated by ventilator-induced lung injury. Lung-protective ventilation strategies may lead to improved survival. OBJECTIVES: To assess the effects of ventilation with lower tidal volume on morbidity and mortality in patients aged 16 years or older affected by acute respiratory distress syndrome and acute lung injury. A secondary objective was to determine whether the comparison between low and conventional tidal volume was different if a plateau airway pressure of greater than 30 to 35 cm H20 was used. SEARCH STRATEGY: We searched The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library issue 4, 2003; MEDLINE (1966 to October 2003); EMBASE and CINAHL (1982 to October 2003); intensive care journals and conference proceedings; databases of ongoing research, reference lists and 'grey literature'. SELECTION CRITERIA: Randomized trials comparing ventilation using either lower tidal volume or low airway driving pressure (plateau pressure 30 cm H(2)O or less), resulting in tidal volume of 7 ml/kg or less versus ventilation that uses Vt in the range of 10 to 15 ml/kg, in adults (aged 16 years or older). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Wherever appropriate, results were pooled. Fixed and random effects models were applied. MAIN RESULTS: Five trials, involving 1202 patients, were eligible. Mortality at day 28 was significantly reduced by lung-protective ventilation: relative risk 0.74 (confidence interval 0.61 to 0.88), whereas beneficial effect on long-term mortality was uncertain: relative risk 0.84 (confidence interval 0.68 to 1.05). The comparison between low and conventional tidal volume was not significantly different if a plateau pressure less than or equal to 31 cm H2O in control group was used: relative risk 1.13 (confidence interval 0.88 to 1.45). There was insufficient evidence about morbidity and long term outcomes. REVIEWERS' CONCLUSIONS: Clinical heterogeneity, such as different lengths of follow up and higher plateau pressure in control arms in two trials make the interpretation of the combined results difficult. Mortality is significantly reduced at day 28 and the effects on long term mortality are uncertain, although the possibility of a clinically relevant benefit cannot be excluded.

Adult↗
PubMed2003

Prophylactic intravenous antifungal agents to prevent mortality and morbidity in very low birth weight infants.

BACKGROUND: Invasive fungal infection is an increasingly common cause of mortality and morbidity in very low birth weight infants. As the diagnosis is often difficult, and treatment is often delayed, there is a need to assess whether antifungal prophylaxis is beneficial. OBJECTIVES: To assess whether prophylactic intravenous antifungal therapy reduces mortality and adverse neurodevelopmental outcomes in very low birth weight infants. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2002), MEDLINE (1966 - September 2002), EMBASE (1980 - September 2002), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised controlled trials that compared the effect of prophylactic intravenous antifungal therapy versus placebo, or no drug, or another antifungal agent, in very low birth weight infants. 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, incidence of invasive fungal infection, emergence of antifungal resistance, and adverse drug reactions. MAIN RESULTS: We identified two eligible trials enrolling a total of 203 infants. Both trials compared the effect of prophylactic intravenous fluconazole versus placebo. 29 of the infants recruited to the two studies died. Meta-analysis revealed a statistically significantly reduced risk of death prior to hospital discharge for the infants who received fluconazole prophylaxis: typical relative risk: 0.44 (95% confidence interval 0.21, 0.91); typical risk difference: -0.11 (95% confidence interval -0.21, -0.02); number needed to treat: 9 (95% confidence interval 5, 50). There were not any data on longer term outcomes. REVIEWER'S CONCLUSIONS: We have found some evidence that prophylactic intravenous fluconazole reduces mortality prior to hospital discharge in very low birth weight infants. The meta-analysis suggests that there will be one fewer death in every nine infants treated with this intervention, but the 95% confidence interval around this estimate of effect is wide. The longer term neurodevelopmental consequences for infants exposed to this intervention remain to be determined. It will be important to identify any subgroups of very low birth weight infants that receive the most benefit from this intervention. There is also a need for further data on the effect of the intervention on the emergence of organisms with stable antifungal resistance.

Antifungal Agents↗
PubMed2004

Prophylactic intravenous antifungal agents to prevent mortality and morbidity in very low birth weight infants.

BACKGROUND: Invasive fungal infection is an increasingly common cause of mortality and morbidity in very low birth weight infants. As the diagnosis is often difficult, and treatment is often delayed, there is a need to assess whether antifungal prophylaxis is beneficial. OBJECTIVES: To assess whether prophylactic intravenous antifungal therapy reduces mortality and adverse neurodevelopmental outcomes in very low birth weight infants. 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 4, 2003), MEDLINE (1966 - October 2003), EMBASE (1980 - October 2003), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised controlled trials that compared the effect of prophylactic intravenous antifungal therapy versus placebo, or no drug, or another antifungal agent, in very low birth weight infants. 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, incidence of invasive fungal infection, emergence of antifungal resistance, and adverse drug reactions. MAIN RESULTS: We identified three eligible trials enrolling a total of 214 infants. Each of the trials compared the effect of prophylactic intravenous fluconazole versus placebo. Two of the trials reported death prior to hospital discharge as an outcome. 29 of the 203 infants recruited to these studies died. Meta-analysis revealed a statistically significantly reduced risk of death prior to hospital discharge for the infants who received fluconazole prophylaxis: typical relative risk: 0.44 (95% confidence interval 0.21, 0.91); typical risk difference: -0.11 (95% confidence interval -0.21, -0.02); number needed to treat: 9 (95% confidence interval 5, 50). None of the trials reported data on longer term outcomes. REVIEWER'S CONCLUSIONS: We have found some evidence that prophylactic intravenous fluconazole reduces mortality prior to hospital discharge in very low birth weight infants. The meta-analysis suggests that there will be one fewer death in every nine infants treated with this intervention, but the 95% confidence interval around this estimate of effect is wide. The longer term neurodevelopmental consequences for infants exposed to this intervention remain to be determined. It will be important to identify any subgroups of very low birth weight infants that receive the most benefit from this intervention. There is also a need for further data on the effect of the intervention on the emergence of organisms with stable antifungal resistance.

Antifungal Agents↗
PubMed2005

Supportive devices for preventing and treating subluxation of the shoulder after stroke.

BACKGROUND: Supportive devices such as slings, wheelchair attachments and orthoses have been used to treat subluxation of the shoulder after stroke. OBJECTIVES: To investigate the effect of supportive devices in preventing subluxation, re-positioning the head of humerus in the glenoid fossa, decreasing pain, increasing function and adversely increasing contracture in the shoulder after stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched on 22 March 2004). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2004), MEDLINE (1966 to March 2004), CINAHL (1982 to March 2004), EMBASE (1974 to March 2004), AMED (1985 to March 2004) and the Physiotherapy Evidence Database (PEDro, March 2004). We also handsearched conference proceedings and contacted authors for additional information. SELECTION CRITERIA: Studies were included if they were: randomised, quasi-randomised or controlled trials; participants had a stroke; intervention was supportive devices; and subluxation, pain, function or contracture were measured. DATA COLLECTION AND ANALYSIS: Two independent reviewers examined the identified studies which were assessed for methodological quality and analysed as (1) supportive devices versus no supportive devices or (2) two supportive devices. MAIN RESULTS: Four trials (one on slings, three on strapping - 142 participants) met the inclusion criteria. One trial testing a hemisling versus no device reported that no participants had subluxation greater than 10 mm, the same number had lost more than 30 degrees of shoulder external rotation (Peto odds ratio (OR) = 1.00, 95% confidence interval (CI) 0.1 to 9.3), and more participants in the hemisling group had pain (Peto OR = 8.7, 95% CI 1.1 to 67.1). The other three showed that strapping was effective in delaying the onset of pain (weighted mean difference (WMD) = 14 days, 95% CI 9.7 to 17.8), but was ineffective in reducing pain severity (WMD = -0.7 cm on a visual analogue scale, 95% CI -2.0 to 0.7), increasing upper limb function (WMD = 0.8, 95% CI -1.5 to 3.1) or affecting the degree of contracture (WMD = -1.4 degrees, 95% CI -10.9 to 8.1) at the shoulder. AUTHORS' CONCLUSIONS: There is insufficient evidence to conclude whether slings and wheelchair attachments prevent subluxation, decrease pain, increase function or adversely increase contracture in the shoulder after stroke. There is some evidence that strapping the shoulder delays the onset of pain but does not decrease it, nor does it increase function or adversely increase contracture.

Braces↗
PubMed2005

Oxygen therapy for cystic fibrosis.

BACKGROUND: The most serious complications of cystic fibrosis (CF) relate to respiratory insufficiency. Oxygen supplementation therapy has been a standard of care for individuals with chronic lung diseases associated with hypoxemia for decades. It is common for physicians to prescribe oxygen therapy for people with CF when hypoxemia occurs. However, it is unclear if empiric evidence is available to provide indications for this therapy with its financial costs and often profound impact on lifestyle. OBJECTIVES: To assess whether oxygen therapy improves the longevity or quality of life of individuals with CF. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Most recent search of Group's Trials Register: April 2005. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials comparing oxygen, administered at any concentration, by any route, in people with documented CF for any time period. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality and extracted data. MAIN RESULTS: Nine published studies (149 participants) are included in this review, of which only one examined long-term oxygen therapy (28 participants). There was no statistically significant improvement in survival, lung, or cardiac health. Four studies examined the effect of oxygen supplementation during sleep by polysomnography. Although oxygenation improved, there were no demonstrable improvements in qualitative sleep parameters and modest hypoventilation was noted. In three studies, oxygen supplementation was evaluated during exercise. Hypoxemia was prevented, but mild hypercapnia resulted. Work performance was not improved, as measured in one study, but was improved in a second study. Furthermore, in two studies, exercise duration was enhanced by oxygen supplementation. In the study examining the impact of oxygen supplementation after exercise, recovery time was enhanced. AUTHORS' CONCLUSIONS: There are no published data to guide the prescription of chronic oxygen supplementation to people with advanced lung disease due to CF. Short-term oxygen therapy during sleep and exercise improves oxygenation but is associated with modest and probably clinically inconsequential hypercapnia. During exercise, there are improvements in exercise duration and peak performance. There is a need for larger, well-designed clinical trials to assess the benefits of long-term oxygen therapy in people with CF administered continuously or during exercise or sleep or both.

Cystic Fibrosis↗
PubMed2004

Pneumococcal vaccines for sickle cell disease.

BACKGROUND: People with sickle cell disease are particularly susceptible to pneumococcal infection, which may be fatal. Infants (children aged up to 23 months) are at particularly high risk, but conventional polysaccharide pneumococcal vaccines may be ineffective in this age group. New conjugate pneumococcal vaccines are now available, which may help to reduce the incidence of infection in people with sickle cell disease. OBJECTIVES: To determine the efficacy of pneumococcal vaccines for reducing morbidity and mortality in people with sickle cell disease. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register, comprising of references identified from comprehensive electronic database searches and hand searching relevant journals and abstract books of conference proceedings. In addition, we contacted relevant pharmaceutical companies and experts in the field.Date of most recent search of Group's trials register: November 2003. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials comparing a polysaccharide or conjugate pneumococcal vaccine regimen with a different regimen or no vaccination in people with sickle cell disease. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected studies for inclusion, extracted data and assessed trial quality. MAIN RESULTS: Nine trials were identified in the searches and five trials, with a total of 547 participants, met the inclusion criteria. Only one trial reported incidence of pneumococcal infection, and this demonstrated that the polysaccharide pneumococcal vaccine used (PPV14) failed to significantly reduce the risk of infection in children under three years of age, but was associated with only minor adverse events. Three trials of conjugate pneumococcal vaccines found that immune response was increased compared to control groups, including in infants, although clinical outcomes were not measured in these trials. REVIEWER'S CONCLUSIONS: Previous trials have shown that conjugate pneumococcal vaccines are safe and effective in normal healthy patients, even those under the age of two years. The controlled trials included in this review have demonstrated immunogenicity (the body's response, without which there is no protection) of these vaccines, and observational studies in people with sickle cell disease support these findings. We therefore recommend that conjugate pneumococcal vaccines are used in people with sickle cell disease. Randomised trials in patients with sickle cell disease will be needed to determine the optimal vaccination regimen when further, potentially more effective vaccines become available. Such trials should measure clinical outcomes of effectiveness.

Anemia, Sickle Cell↗
PubMed2002

Frequency of administration of recombinant human erythropoietin for anaemia of end-stage renal disease in dialysis patients.

BACKGROUND: Although the benefits of recombinant human erythropoietin (rHu EPO) administration in dialysis patients have been demonstrated the optimal frequency regimen has not as yet been established. Treatment with rHu EPO is expensive, there is therefore a need for optimising the efficiency of its administration. OBJECTIVES: The objectives of this review were to assess the effects of different frequency regimens of rHu EPO administration in dialysis patients in terms of i) effectiveness (correction of anaemia, quality of life and freedom from adverse events) ii) efficiency (optimal resource use) of different rHu EPO dose regimen policies. SEARCH STRATEGY: We searched MEDLINE (1980 to May Week 3 2001), EMBASE (1984 to Week 24 2001), BIOSIS (1985 to January 1997), CINAHL (1982 to October 1997), The Cochrane Library (Issue 1, 1997), CHEMABS (1984 to November 1996), SIGLE (1980 to June 1996), CRIB (10th edition, 1995), UK NRR (14th consolidation, September 1996), RSC ( 1980 to February 1997), HealthSTAR (1995 to October 1997), IBSS (1984 to July 1997), NEED (July 1997) and reference lists of relevant articles. We contacted biomedical companies and investigators in the field and we hand searched Kidney International (including all supplements but excluding all conference proceedings except for 1994) July 1983 to May 1997 inclusive. The Internet was also searched on: August 1997. We had also identified some studies from a previous broad search for all randomised controlled trials (RCTs) relevant to the management of end-stage renal disease. Date of the most recent search: June 2001. SELECTION CRITERIA: All randomised or quasi randomised controlled trials comparing different frequencies of rHu EPO administration in dialysis patients. Subgroup analyses were performed comparing haemodialysis and CAPD patients and also subcutaneous and intravenous administration. DATA COLLECTION AND ANALYSIS: Only published data were used. Data were abstracted by a single investigator on to a standard form. The data abstracted were relevant to the predetermined outcome measures: measures of correction of anaemia, rHu EPO dose, quality of life measures, adverse events, number of withdrawals from study, mortality. Where appropriate, a summary relative risk (RR) was calculated for dichotomous data and a weighted mean difference (WMD) or standardised mean difference (SMD) for continuous data. MAIN RESULTS: Eight studies met our inclusion criteria. When once a week administration was compared with twice weekly there was no significant difference in the ability to maintain the target haemoglobin (RR 1.00, 95% CI 0.42 to 2.40). Mean haemoglobin after twelve weeks of therapy was not different between the two groups (WMD -0.21g/dl, 95% CI -0.98 to 0.56). No difference was found in mean haemoglobin or haematocrit at the end of any studies which compared once with thrice weekly administration of rHu EPO (SMD -0.31, 95% CI -0.67 to 0.06). A single study which compared once with more that thrice weekly administration showed no significant difference in mean haemoglobin at the end of the maintenance phase (mean difference -0.2g/dl, 95% CI -0.65 to 0.25). The dosage of erythropoietin required by those on haemodialysis receiving rHu EPO once weekly was just significantly more (WMD 12.0 U/kg, 95% CI 0.24 to 23.76) than those receiving it twice weekly but the confidence interval is wide. No such difference was found for CAPD patients nor when the results were combined (WMD 5.15 U/kg, 95% CI -3.74 to 14.05). The result was not significant when comparing once weekly with thrice weekly administration (WMD 10.00 U/kg, 95% CI -80.87 to 100.87). There was no difference in the frequency of adverse events between any of the groups studies. REVIEWER'S CONCLUSIONS: There is no significant difference between once weekly versus thrice weekly subcutaneous administration of rHu EPO. Once weekly administration of rHu EPO would require an additional 12U/kg/week for patients on haemodialysis, however this is based on one very small study. The cost of this additional hRu EPO nee, however this is based on one very small study. The cost of this additional hRu EPO needs to assessed, in particular with regard to patient preference and compliance.

Anemia↗
PubMed2004

Interleukin 2 receptor antagonists for kidney transplant recipients.

BACKGROUND: Interleukin 2 receptor antagonists (IL2Ra) are used as induction therapy for prophylaxis against acute rejection in kidney transplant recipients. Use of IL2Ra has increased steadily, with 38% of new kidney transplant recipients in the United States, and 23% in Australasia receiving IL2Ra in 2002. OBJECTIVES: This study aims to systematically identify and summarise the effects of using an IL2Ra, as an addition to standard therapy, or as an alternative to other antibody therapy. SEARCH STRATEGY: The Cochrane Renal Group's specialised register (June 2003), the Cochrane Controlled Trials Register (in The Cochrane Library issue 3, 2002), MEDLINE (1966-November 2002) and EMBASE (1980-November 2002). Reference lists and abstracts of conference proceedings and scientific meetings were hand-searched from 1998-2003. Trial groups, authors of included reports and drug manufacturers were contacted. SELECTION CRITERIA: Randomised controlled trials (RCTs) in all languages comparing IL2Ra to placebo, no treatment, other IL2Ra or other antibody therapy. DATA COLLECTION AND ANALYSIS: Data was extracted and quality assessed independently by two reviewers, with differences resolved by discussion. Dichotomous outcomes are reported as relative risk (RR) with 95% confidence intervals (CI). MAIN RESULTS: One hundred and seventeen reports from 38 trials involving 4893 participants were included. Where IL2Ra were compared with placebo (17 trials; 2786 patients), graft loss was not significantly different at one (RR 0.83, 95% CI 0.66 to 1.04) or three years (RR 0.88, 95% CI 0.64 to 1.22). Acute rejection (AR) was significantly reduced at six months (RR 0.66, 95% CI 0.59 to 0.74) and at one year (RR 0.67, 95% CI 0.60 to 0.75). At one year, cytomegalovirus (CMV) infection (RR 0.82, 95% CI 0.65 to 1.03) and malignancy (RR 0.67, 95% CI 0.33 to 1.36) were not significantly different. Where IL2Ra were compared with other antibody therapy no significant differences in treatment effects were demonstrated, but adverse effects strongly favoured IL2Ra. REVIEWER'S CONCLUSIONS: Given a 40% risk of rejection, seven patients would need treatment with IL2Ra to prevent one patient having rejection, with no definite improvement in graft or patient survival. There is no apparent difference between basiliximab and daclizumab. IL2Ra are as effective as other antibody therapies and with significantly fewer side effects

Graft Rejection↗