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PubMed2002

Prophylactic antibiotics for preventing pneumococcal infection in children with sickle cell disease.

BACKGROUND: People with sickle cell disease are particularly susceptible to infection. Infants and very young children are especially vulnerable, and the Cooperative Study of Sickle Cell Disease observed an incidence rate of 10 per 100 patient years of pneumococcal septicaemia in children under the age of three. Vaccines, including customary pneumococcal vaccines, may be of limited use in this age group. Therefore, prophylactic penicillin regimes may be advisable for this population. OBJECTIVES: To assess the effects of prophylactic antibiotic regimes for preventing pneumococcal infection in children with sickle cell disease. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references identified from comprehensive electronic database searches, hand searching relevant journals and hand searching abstract books of conference proceedings. Date of the most recent search: December 2001. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing prophylactic antibiotics to prevent pneumococcal infection in children with sickle cell disease with placebo, no treatment or a comparator drug. DATA COLLECTION AND ANALYSIS: Both reviewers independently extracted data and assessed trial quality. MAIN RESULTS: Five trials were identified by the initial search, of which three trials met the inclusion criteria. All of the included trials showed a reduced risk of infection in children with sickle cell disease (SS or Sb0Thal) receiving prophylactic penicillin. For initiation of treatment the odds ratio was 0.37 (95% CI 0.16, 0.86), and for withdrawal OR= 0.49 (95% CI 0.09, 2.71). Adverse drug effects were rare and minor. Rates of pneumococcal infection were found to be relatively low in children over the age of five. REVIEWER'S CONCLUSIONS: Prophylactic penicillin significantly reduces risk of pneumococcal infection in children with homozygous sickle cell disease, and is associated with minimal adverse reactions. Further research may help to determine the ideal age to safely withdraw penicillin.

Adolescent↗
PubMed2005

Inhaled bronchodilators for cystic fibrosis.

BACKGROUND: Recurrent wheeze and breathlessness are common in people with cystic fibrosis, and bronchodilators are commonly prescribed. Despite their wide-scale and often long-term use, there is limited objective evidence about their efficacy in cystic fibrosis. OBJECTIVES: To evaluate the effectiveness of inhaled bronchodilators in children and adults with cystic fibrosis. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic databases searches, and handsearches of relevant journals and abstract books of conference proceedings. Latest search of the Group's Trials Register: August 2005 SELECTION CRITERIA: Randomised or quasi-randomised trials comparing inhaled bronchodilators to placebo or another inhaled bronchodilator in people with CF, diagnosed clinically and by sweat or genetic testing and at all stages and severity of lung disease. DATA COLLECTION AND ANALYSIS: The authors independently extracted data and assessed trial quality. If data were missing, the primary author was contacted where possible. The data were subgrouped into classes of bronchodilator and for each class into short-term effects (less than one week) and long-term effects (greater or equal to one week). MAIN RESULTS: The search identified 43 references. Fourteen trials, with a total of 257 participants, were suitable for inclusion. The trials were all cross-over in design; in this case a meta-analysis was not possible. There were varied conclusions from the different trials, reflecting their heterogeneity. Compared to placebo, short-acting beta-2 agonists increased forced expiratory volume at one second (FEV(1)) in the short term in three out of five trials, and in the long-term increased peak expiratory flow rate in individuals who had been shown to have bronchial hyperreactivity or bronchodilator responsiveness or both. Compared to placebo, long-acting beta-2 agonists increased FEV(1) and forced expiratory flow between 25% and 75% of expiratory flow (FEF 25-75%) in the short term in participants known to have bronchodilator responsiveness, but produced inconsistent results in long-term trials. Short acting-anticholinergics had no consistent effect on lung function tests in either the short or the long term. We found no published trials of fenoterol, formoterol or tiotropium and the use of these agents in cystic fibrosis cannot be supported. AUTHORS' CONCLUSIONS: It was not possible to determine fully the effectiveness of inhaled bronchodilators in cystic fibrosis as a meta-analysis was not possible. However, both short and long-acting beta-2 agonists can be beneficial both in the short and long term in individuals with demonstrable bronchodilator responsiveness or bronchial hyperrresponsiveness.

Adrenergic beta-Agonists↗
PubMed2002

'As required' medication regimens for seriously mentally ill people in hospital.

BACKGROUND: Drugs used to treat psychotic illnesses may take weeks to have an effect. Often, in the interim, additional, 'as required' doses of medication can be used to calm patients in psychiatric wards. 20 to 50% of people on acute psychiatric wards are written up for 'as required' doses of medication. In this situation, a doctor prescribes the frequency and upper limit of dose, and the drug is then given at the discretion of clinical staff. OBJECTIVES: To compare the effects of 'as required' medication regimens with regular regimens of medication for the treatment of psychotic symptoms or behavioural disturbance, thought to be secondary to psychotic illness. This is in addition to any regular psychotropic medication for the long-term treatment of schizophrenia or schizophrenia-like illnesses. SEARCH STRATEGY: The reviewers searched the Cochrane Schizophrenia Group's register of trials (November 2001). This register is compiled by methodical searches of BIOSIS, CINAHL, Dissertation abstracts, EMBASE, LILACS, MEDLINE, PSYNDEX, PsycINFO, RUSSMED, Sociofile and is supplemented with hand searching of relevant journals and numerous conference proceedings. SELECTION CRITERIA: Relevant randomised control trials, involving hospital inpatients with schizophrenia or schizophrenia-like illnesses, comparing any regimen of medication administered for the short term relief of behavioural disturbance, or psychotic symptoms, to be given at the discretion of ward staff ('as required', 'prn') with fixed non-discretionary patterns of drug administration of the same drug(s). This is in addition to regular psychotropic medication for the long-term treatment of schizophrenia or schizophrenia-like illnesses where prescribed. The primary outcomes of interest were levels of disturbance, severity of psychiatric symptoms, dose of medication, and adverse effects. DATA COLLECTION AND ANALYSIS: Studies were reliably selected, quality rated and data extracted. For dichotomous data, relative risks (RR) would have been estimated, with the 95% confidence intervals (CI). Where possible, the number needed to treat statistic (NNT) was to have been calculated. Analysis would have been by intention-to-treat. Normal continuous data were to have been summated using the weighted mean difference (WMD). Scale data were to have been presented for only those tools which had attained pre-specified levels of quality. Tests of heterogeneity and for publication bias were to have been undertaken. MAIN RESULTS: No randomised trials comparing 'as required' medication regimens to regular regimens of the same drug were identified. REVIEWER'S CONCLUSIONS: This common current practice has no support from randomised trials. Current practice is based on clinical experience and habit rather than high quality evidence. Current practice, therefore, outside of a well designed, conducted and reported randomised trial, is therefore difficult to justify.

Antipsychotic Agents↗
PubMed2002

Dopamine for prevention of morbidity and mortality in term newborn infants with suspected perinatal asphyxia.

BACKGROUND: Perinatal asphyxia remains an important condition with significant mortality and long-term morbidity. Multisystem involvement including hypotension and low cardiac output is common in infants with perinatal asphyxia. Dopamine is commonly used for infants with hypotension of any etiology, with the goal of improving cardiac output and preventing its detrimental consequences. OBJECTIVES: To determine if dopamine, compared to placebo, no treatment, volume or another inotrope reduces morbidity and mortality in term newborn infants with suspected perinatal asphyxia. SEARCH STRATEGY: The standard search strategy of the Neonatal Review Group was used. Searches were conducted of the Oxford Database of Perinatal Trials, Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002), MEDLINE (1966 to March 2002), previous reviews including cross references, abstracts and conference proceedings (Perinatal Society of Australia and New Zealand 1998-2002 and Pediatric Academic Societies meetings 1998-2001). SELECTION CRITERIA: Randomised controlled trials comparing dopamine with placebo, no treatment, other inotropic agents, or volume in infants greater than 36 weeks gestation. Perinatal asphyxia could be suspected on the basis of a cord blood pH < 7.0, cord blood base excess < -16 mEq/L or 5 minute Apgar score < 6. DATA COLLECTION AND ANALYSIS: Standard methods of the Cochrane Neonatal Review Group with use of relative risk (RR), risk difference (RD) and weighted mean difference (WMD). The fixed effects model using RevMan 4.1 was used for meta-analysis. Data from individual studies were only eligible for inclusion if at least 75% of participants were followed up. MAIN RESULTS: Only one study (DiSessa 1981) was eligible. This study compared low dose dopamine at 2.5 mcg/kg/min with placebo (dextrose in water). This study enrolled 14 term infants with a 5 minute Apgar <6 and a systolic BP >=50 mmHg at a mean of 10 hours age. Seven infants only were randomised to treatment with dopamine and seven to receive placebo. No significant differences between these two groups were found for mortality or long term neurodevelopmental outcome. Length of hospitalisation was not significantly different between the two groups. No study was found that examined the effect of dopamine in infants with evidence of cardiovascular compromise, nor were any studies identified in which dopamine was compared to other inotropic agents for term infants with suspected asphyxia. REVIEWER'S CONCLUSIONS: There is currently insufficient evidence from randomised controlled trials that the use of dopamine in term infants with suspected perinatal asphyxia improves mortality or long-term neurodevelopmental outcome. The question of whether dopamine improves outcome for term infants with suspected perinatal asphyxia has not been answered. Further research is required to determine whether or not the use of dopamine improves mortality and long-term morbidity for these infants and if so, issues such as which infants, at what dose and with what co-interventions should be addressed.

Asphyxia Neonatorum↗
PubMed2002

Pharmacological treatments for psychosis-related polydipsia.

BACKGROUND: Polydipsia is the intake of more than three litres of fluids per day. Primary polydipsia occurs when excessive drinking cannot be explained by an identified medical condition, and is not secondary to polyuria. The prevalence of this problem in psychiatric inpatients has been estimated at between 6 and 17%. It can hinder standard care and be a highly disabling, even life-threatening condition. OBJECTIVES: To review the effect of pharmacological interventions for the treatment of psychosis-related polydipsia. SEARCH STRATEGY: The reviewers searched the Cochrane Schizophrenia Group's Register (January 2002) which is compiled by up-to-date methodical searches of BIOSIS, The Cochrane Library, CINAHL, Dissertation abstracts, EMBASE, LILACS, MEDLINE, PSYNDEX, PsycINFO, RUSSMED and Sociofile and is supplemented with hand searching of relevant journals and numerous conference proceedings. References of all identified studies were also searched for further trials. SELECTION CRITERIA: All randomised controlled trials involving people with a psychotic illness and secondary polydipsia, which evaluated drug treatments, and measured clinically meaningful outcomes. DATA COLLECTION AND ANALYSIS: Reviewers, working independently, inspected citations, ordered papers, and then re-inspected and quality assessed the studies. They also worked independently to extract data. For homogeneous dichotomous data, the relative risk (RR), 95% confidence interval (CI), and, where appropriate, the number needed to treat (NNT) and the number needed to harm (NNH), were calculated on an intention-to-treat basis. Reviewers assumed that people who left the study early or were lost to follow-up had no improvement. Weighted mean differences (WMD) were calculated for continuous data. Data was excluded if loss to follow-up was greater than 50%. MAIN RESULTS: The reviewers identified two trials which fulfilled the inclusion criteria, (total n=17, duration 3-6 weeks). Few data were reported and, because of inappropriate use of crossover methodology, it could not all be used in this review. For the few chronically ill people in these trials, neither the 'active' tetracycline bacteriostatic agent, oral demeclocycline, nor the opiate antagonist naloxone, nor placebo, gave any suggestion of serious adverse effects for a period of up to six weeks. The two small studies did not report any useful data on measures of polydipsia, physical symptoms secondary to increased fluid intake, mental state, general functioning or economic outcomes. REVIEWER'S CONCLUSIONS: The trials offer little to the clinician hoping to treat psychosis-related polydipsia with drugs, except that further evaluative studies need to be conducted in this area. Treatment of any sort for psychosis related polydipsia might only be informative within a well designed, conducted and reported randomised study. The two pioneering studies suggest that larger trials, though difficult, would not be impossible with adequate support and co-ordination.

Drinking↗
PubMed2006

Pharmacological treatments for psychosis-related polydipsia.

BACKGROUND: Polydipsia is the intake of more than three litres of fluids per day. Primary polydipsia occurs when excessive drinking cannot be explained by an identified medical condition, and is not secondary to polyuria. The prevalence of this problem in psychiatric inpatients has been estimated at between 6 and 17%. It can hinder standard care and be a highly disabling, even life-threatening condition. OBJECTIVES: To review the effect of pharmacological interventions for the treatment of psychosis-related polydipsia. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's Register (January 2002 and February 2005) which is compiled by up-to-date methodical searches of BIOSIS, The Cochrane Library, CINAHL, Dissertation abstracts, EMBASE, LILACS, MEDLINE, PSYNDEX, PsycINFO, RUSSMED and Sociofile and is supplemented with hand searching of relevant journals and numerous conference proceedings. References of all identified studies were also searched for further trials. SELECTION CRITERIA: We included all randomised controlled trials involving people with a psychotic illness and secondary polydipsia, which evaluated drug treatments, and measured clinically meaningful outcomes. DATA COLLECTION AND ANALYSIS: Working independently, we inspected citations, ordered papers, and then re-inspected and quality assessed the studies and extracted data. For homogeneous dichotomous data, we calculated the relative risk (RR), 95% confidence interval (CI), and, where appropriate, the number needed to treat (NNT) and the number needed to harm (NNH), on an intention-to-treat basis. We assumed that people who left the study early or who were lost to follow-up had no improvement. We calculated weighted mean differences (WMD) for continuous data. We excluded data if loss to follow-up was greater than 50%. MAIN RESULTS: We identified two small trials (Alexander 1991 and Nishikawa 1996) which fulfilled the inclusion criteria, (total n=17, duration 3-6 weeks). Few data were reported and, because of inappropriate use of crossover methodology, we could not include all of the data in this review. For the few chronically ill people in these trials, neither the 'active' tetracycline bacteriostatic agent, oral demeclocycline, nor the opiate antagonist naloxone, nor placebo, gave any suggestion of serious adverse effects for a period of up to six weeks. The studies did not report any useful data on measures of polydipsia, physical symptoms secondary to increased fluid intake, mental state, general functioning or economic outcomes. AUTHORS' CONCLUSIONS: The trials offer little useful data to the clinician hoping to treat psychosis-related polydipsia with drugs, except that further evaluative studies need to be conducted in this area. Treatment of any sort for psychosis related polydipsia might only be informative within a well designed, conducted and reported randomised study. The two pioneering studies suggest that larger trials, though difficult, would not be impossible with adequate support and co-ordination.

Drinking↗
PubMed2004

Interventions for idiopathic steroid-resistant nephrotic syndrome in children.

BACKGROUND: The majority of children, who present with their first episode of nephrotic syndrome, achieve remission with corticosteroid therapy. Children who fail to respond to corticosteroids may be treated with immunosuppressive agents such as cyclophosphamide, chlorambucil or cyclosporin or with non-immunosuppressive agents such as ACE inhibitors. Optimal combinations of these agents with least toxicity remain to be determined. The aims of this systematic review are to assess the benefits and harms of interventions used to treat idiopathic steroid resistant nephrotic syndrome (SRNS) in children. OBJECTIVES: We aimed to evaluate the benefits and harms of all interventions for children with SRNS. SEARCH STRATEGY: Published and unpublished randomised controlled trials (RCTs) were identified from the Cochrane Controlled Trials Register, MEDLINE, EMBASE, reference lists of articles and abstracts from conference proceedings. SELECTION CRITERIA: RCTs and quasi-RCTs were included if they compared different immunosuppressive agents or non-immunosuppressive agents with placebo, prednisone or other agent given orally or parenterally in children aged 3 months to 18 years with SRNS. DATA COLLECTION AND ANALYSIS: Two reviewers independently searched the literature, determined trial eligibility, assessed quality, extracted data and entered it in RevMan. For dichotomous outcomes, results were expressed as relative risk (RR) and 95% confidence intervals (CI). Data were pooled using the random effects model. MAIN RESULTS: Nine RCTs involving 225 children were included. Cyclosporin when compared with placebo or no treatment significantly increased the number of children who achieved complete remission (three trials, 49 children: RR for persistent nephrotic syndrome 0.64, 95% CI, 0.47 to 0.88). There was no significant difference in the number of children who achieved complete remission between oral cyclophosphamide with prednisone and prednisone alone (two trials, 91 children: RR 1.01, 95% CI 0.74 to 1.36), between intravenous cyclophosphamide and oral cyclophosphamide (one study, 11 children: RR 0.09, 95% CI 0.01 to 1.39) and between azathioprine with prednisone and prednisone alone (one trial 31 children: RR 1.01, 95% CI 0.77 to 1.32). No RCTs were identified comparing combination regimens comprising high dose steroids, alkylating agents or cyclosporin with single agents, placebo or no treatment. REVIEWERS' CONCLUSIONS: Further adequately powered and well designed RCTs are needed to confirm the efficacy of cyclosporin and to evaluate other regimens for idiopathic SRNS including high dose steroids with alkylating agents or cyclosporin.

Azathioprine↗
PubMed2006

Interventions for idiopathic steroid-resistant nephrotic syndrome in children.

BACKGROUND: The majority of children who present with their first episode of nephrotic syndrome, achieve remission with corticosteroid therapy. Children who fail to respond may be treated with immunosuppressive agents such as cyclophosphamide, chlorambucil or cyclosporin, or with non-immunosuppressive agents such as ACE inhibitors. Optimal combinations of these agents with the least toxicity remain to be determined. OBJECTIVES: To evaluate the benefits and harms of interventions used to treat idiopathic steroid resistant nephrotic syndrome (SRNS) in children. SEARCH STRATEGY: Randomised controlled trials (RCTs) were identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, reference lists of articles and abstracts from conference proceedings. Date of most recent search: June 2005 SELECTION CRITERIA: RCTs and quasi-RCTs were included if they compared different immunosuppressive agents or non-immunosuppressive agents with placebo, prednisone or other agent given orally or parenterally in children aged three months to 18 years with SRNS. DATA COLLECTION AND ANALYSIS: Two reviewers independently searched the literature, determined trial eligibility, assessed quality, extracted data and entered it in RevMan. For dichotomous outcomes, results were expressed as relative risk (RR) and 95% confidence intervals (CI). Data were pooled using the random effects model. MAIN RESULTS: Eleven RCTs (312 children) were included. Cyclosporin when compared with placebo or no treatment significantly increased the number of children who achieved complete remission (three trials, 49 children: RR for persistent nephrotic syndrome 0.64, 95% CI, 0.47 to 0.88). There was no significant difference in the number of children who achieved complete remission between oral cyclophosphamide with prednisone and prednisone alone (two trials, 91 children: RR 1.01, 95% CI 0.74 to 1.36), between intravenous cyclophosphamide and oral cyclophosphamide (one study, 11 children: RR 0.09, 95% CI 0.01 to 1.39) and between azathioprine with prednisone and prednisone alone (one trial 31 children: RR 1.01, 95% CI 0.77 to 1.32). ACE inhibitors significantly reduced proteinuria (two trials, 70 children). After 12 weeks of treatment fosinopril reduced proteinuria by 0.95 g/24 h (95% CI -1.21 to -0.69). No RCTs were identified comparing combination regimens comprising high dose steroids, alkylating agents or cyclosporin with single agents, placebo or no treatment. AUTHORS' CONCLUSIONS: Further adequately powered and well designed RCTs are needed to confirm the efficacy of cyclosporin and to evaluate other regimens for idiopathic SRNS including high dose steroids with alkylating agents or cyclosporin.

Adolescent↗
PubMed2006

Quinolones for uncomplicated acute cystitis in women.

BACKGROUND: Uncomplicated acute cystitis is one of the most common bacterial infections in adults. The percentage of women who have at least one episode of acute cystitis is estimated to be between 40% to 50%. Quinolones are recommended for acute cystitis in regions where the level of resistance to other antimicrobials namely co-trimoxazole is high. However the efficacy, safety and tolerance of quinolones needs investigation. OBJECTIVES: To compare the efficacy, safety and tolerance of different quinolones in women with uncomplicated acute cystitis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library Issue 3, 2003), MEDLINE (1966 - September 2003), EMBASE (1988 - September 2003), reference lists of articles and abstracts from conference proceedings without language restriction. Reference lists of urology, infectious diseases and nephrology textbooks, review articles and relevant studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing two or more different quinolones in women (>/= 16 years) with uncomplicated acute cystitis 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 with 95% confidence intervals (CI). MAIN RESULTS: We identified 11 studies enrolling 7535 women. There were no significant differences in clinical or microbiological efficacy between quinolones. Photosensitivity reactions were more frequently observed for sparfloxacin when compared to ofloxacin. Any adverse event, adverse events causing withdrawal, skin adverse events, photosensitivity reactions were more common for lomefloxacin when compared to norfloxacin. Any adverse event, adverse drug reactions, CNS adverse events were more common for ofloxacin when compared to ciprofloxacin. CNS adverse events and insomnia were more often reported for rufloxacin when compared to pefloxacin. Adverse drug reactions occurred frequently for ofloxacin than levofloxacin. Insomnia was reported more frequently for enoxacin than ciprofloxacin. AUTHORS' CONCLUSIONS: We found no significant differences in clinical or microbiological efficacy between quinolones but some differences in occurrence and spectrum of quinolone safety.

Acute Disease↗
PubMed2003

Modification of the home environment for the reduction of injuries.

BACKGROUND: Injury in the home is extremely common, accounting for around a third of all injuries. The majority of injuries of children under five and people aged 75 and over occur at home. Multi-factorial injury prevention interventions have been shown to reduce injuries in the home. However, few studies have focussed specifically on the impact of physical adaptations to the home environment and the effectiveness of such intervention needs to be ascertained. OBJECTIVES: To review the evidence for the effect on injuries of modification of the home environment with a primary focus on interventions to reduce physical hazards. SEARCH STRATEGY: We searched the following databases: APId, ASSIA, British Nursing Index, CINAHL, Cochrane Library databases, Dissertation Abstracts, EMBASE, HealthSTAR, ICONDA, ISI Science (and Social Science) Citation Index, MEDLINE, National Research Register, PREMEDLINE, SIGLE and Urbadisk. Conference proceedings and reference lists were scanned. Experts in the field and trialists were contacted. Searches were not restricted to English language. Handsearching of relevant journals was not conducted. SELECTION CRITERIA: Randomised controlled trials, non-randomised controlled trials, controlled before-and-after studies and interrupted time series studies. DATA COLLECTION AND ANALYSIS: All abstracts were screened by two reviewers for relevance, outcome and design. Two reviewers independently evaluated methodological quality and extracted data from each eligible study. MAIN RESULTS: We found 28 published trials and one unpublished study. Trials were not sufficiently similar to allow for the combination of data by statistical analyses, so this review takes a narrative form. Studies were divided into three groups based on the primary population sample: children, older people and the general population. None of the 11 childhood studies demonstrated a reduction in injuries that might have been due to environmental adaptation in the home. One study reported a reduction in injuries and in hazards but the two could not be linked. The majority of studies used hazard reduction as the outcome. Of the 15 studies in older people, none demonstrated a reduction in injuries due to hazard reduction, although two demonstrated a reduction in falls that could be due to hazard reduction. In the mixed age group there were two trials; neither demonstrated an effect on injuries. REVIEWER'S CONCLUSIONS: There is insufficient evidence to determine the effects of interventions to modify environmental home hazards. Further interventions to reduce hazards in the home should be evaluated by adequately designed randomised controlled trials measuring injury outcomes. Recruitment of large study samples to measure effect may be a major consideration for future trials.

Accidents, Home↗
PubMed2006

Modification of the home environment for the reduction of injuries.

BACKGROUND: Injury in the home is extremely common, accounting for around a third of all injuries. The majority of injuries of children under five and people aged 75 and over, occur at home. Multifactorial injury prevention interventions have been shown to reduce injuries in the home. However, few studies have focused specifically on the impact of physical adaptations to the home environment and the effectiveness of such interventions needs to be ascertained. OBJECTIVES: To review the evidence for the effect on injuries of modification of the home environment with a primary focus on interventions to reduce physical hazards. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, EMBASE, National Research Register and other specialised databases. We also scanned conference proceedings and reference lists. In addition, we contacted experts and trialists in the field. The searches were not restricted by language or publication status. The searches were last updated in December 2004. SELECTION CRITERIA: Randomised controlled trials. DATA COLLECTION AND ANALYSIS: All abstracts were screened by two authors for relevance, outcome and design. Two authors independently assessed methodological quality and extracted data from each eligible study. MAIN RESULTS: We found 18 published and one unpublished trials. Trials were not sufficiently similar to allow pooling of data by statistical analyses, so this review takes a narrative form. Studies were divided into three groups based on the primary population sample; children (five studies), older people (14 studies) and the general population/mixed age group (no studies). None of the studies focusing on children demonstrated a reduction in injuries that might have been due to environmental adaptation in the home; one study reported a reduction in injuries and in hazards but the two could not be linked. Of the 14 included studies in older people, none demonstrated a reduction in injuries due to hazard reduction, although two demonstrated a reduction in falls that could be due to hazard reduction. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the effects of interventions to modify environmental home hazards. Further interventions to reduce hazards in the home should be evaluated by adequately designed randomised controlled trials measuring injury outcomes. Recruitment of large study samples to measure effect must be a major consideration for future trials.

Accidents, Home↗
PubMed2004

Endoscopic retrograde cholangiopancreatography in gallstone-associated acute pancreatitis.

BACKGROUND: Early endoscopic retrograde cholangio-pancreatography with or without endoscopic sphincterotomy (ERCP+/-ES) has been advocated to reduce complications in patients presenting with a severe attack of gallstone-associated acute pancreatitis (GAP). However, a recent trial has reported contradictory results. Importantly, patients with acute cholangitis were excluded suggesting it may be a major confounding factor affecting previous studies. OBJECTIVES: To assess the effectiveness of early ERCP+/-ES compared to conservative management stratified according to severity of disease, concealment of randomisation, acute cholangitis and bilirubin level in the reduction of mortality, morbidity, length of hospitalisation and cost in adults suspected of having GAP. SEARCH STRATEGY: We searched - Cochrane Library (Issue 4 2003), Medline (1966-2004), EMBASE (1980-2004) and LILACS. 'Grey literature' was sought by looking at cited references and hand searched to identify further relevant trials. Conference proceedings of United European Gastroenterology Week (published in Gut) and Digestive Disease Week (published in Gastroenterology) were also hand searched. SELECTION CRITERIA: Randomized controlled trials (RCT) of adult patients, from 15 years old or greater, presenting with gallstone-associated acute pancreatitis (GAP) comparing ERCP +/- ES versus Conservative management within 72 hours of admission. DATA COLLECTION AND ANALYSIS: Data were assessed for quality independently by two reviewers. Wherever appropriate, results were pooled together and sub-grouped by predicted severity of disease. Fixed and random effects models were applied. Sensitivity analysis was performed to test the fragility of results. MAIN RESULTS: Three trials, involving 511 patients, met inclusion criteria. The test for heterogeneity yielded statistically non-significant results (p-value 0.1 to 0.63) suggesting all comparisons were above the established threshold for combinability (p<0.1). Fixed effect and random effect meta-analyses gave identical results. Early ERCP +/- ES was associated with non-significant effect on reduction of mortality in predicted mild (OR = 0.62, 95% CI = 0.27 to 1.41) and severe GAP (OR = 0.62, 95% CI = 0.27 to 1.41). Reduction in complications was non-significant in predicted mild (OR = 0.89, 95% CI = 0.53 to 1.49), but significant in severe GAP (OR = 0.27, 95% CI = 0.14 to 0.53). There was insufficient evidence to draw any conclusions about hospital stay and cost. REVIEWERS' CONCLUSIONS: Odds of having complications are reduced in predicted severe disease by early ERCP +/- ES. This effect was however, non-significant in predicted mild disease and for reduction of mortality in either predicted mild or severe disease. These results are controlled for confounding due to associated acute cholangitis and are robust for clinical and statistical heterogeneity.

Acute Disease↗
PubMed2005

Chinese medicinal herbs for acute pancreatitis.

BACKGROUND: Acute pancreatitis is a relatively common acute abdominal emergency but there is no specific therapy for it. Traditional Chinese medicinal herbs have been used widely for many years in China to treat acute pancreatitis, and several controlled trials have been carried out to investigate their efficacy. OBJECTIVES: To assess the efficacy and safety of traditional Chinese medicinal herbs for acute pancreatitis. SEARCH STRATEGY: The following electronic databases were searched, in September 2002: the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library Issue 3, 2002, MEDLINE, EMBASE, AHMED (Allied and Complementary Medicine Database) and SIGLE (System for Information on Grey Literature). Four Chinese journals and conference proceedings were handsearched. No language restriction was used. The searches were updated in October 2003 (The Cochrane Library Issue 3, 2003). SELECTION CRITERIA: All randomized controlled trials involving traditional Chinese medicinal herbs in the treatment of acute pancreatitis and published in any language, regardless of whether they were single-blinded, double-blinded, or not blinded. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers. The methodological quality of trials was evaluated using the Jadad scale plus allocation concealment. MAIN RESULTS: Eleven randomized clinical trials (including a total of 658 participants) were identified in which Chinese medicinal herbs or Chinese medicinal herbs plus routine treatment were compared with routine treatment. All of these trials were published in Chinese and all included inpatients. None of the articles described the method of randomisation. The large heterogeneity of the intervention prevented us from doing a meaningful subgroup analysis. There appeared to be some benefit from Chinese medicinal herbs over control for mortality rates, length of hospital stay and operative intervention but the trials were of low quality and this benefit did not reach statistical significance. AUTHORS' CONCLUSIONS: Some Chinese medicinal herbs may work in acute pancreatitis. However, the evidence is too weak to recommend any single herb. Rigorously designed, randomized, double-blind, placebo-controlled trials are required.

Acute Disease↗
PubMed2004

Cerebrospinal fluid drainage for thoracic and thoracoabdominal aortic aneurysm surgery.

BACKGROUND: During aortic aneurysm surgery, cross-clamping can lead to inadequate blood supply to the spinal cord resulting in neurological deficit. Cerebrospinal fluid drainage (CSFD) may increase the perfusion pressure to the spinal cord and hence reduce the risk of ischaemic spinal cord injury. OBJECTIVES: To determine the effect of CSFD during thoracic and thoracoabdominal aortic aneurysm (TAAA) surgery on the risk of developing spinal cord injury. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group Specialised Trials Register (last searched October 2003), the Cochrane Central Register of Controlled Trials (CENTRAL) database (last searched Issue 4, 2003), MEDLINE and EMBASE, and reference lists of relevant articles. Recent conference proceedings were scanned. SELECTION CRITERIA: Randomised trials involving CSFD during thoracic and TAAA surgery. DATA COLLECTION AND ANALYSIS: Both reviewers assessed the quality of trials independently. One reviewer (SNK) extracted data and the other reviewer (GS) verified the data. MAIN RESULTS: Three trials, with a total of 287 participants operated on for type I or II TAAA, were included. In the first trial of 98 patients, neurological deficits in the lower extremities occurred in 14 (30%) CSFD and 17 (33%) controls. The deficit was observed within 24 hours of the operation in 21 (68%), and from 3 to 22 days in 10 (32%). CSFD did not have a significant benefit in preventing ischaemic injury to the spinal cord. The second trial of 33 patients used a combination of CSFD and intrathecal papaverine. It showed a statistically significant reduction in the rate of postoperative neurological deficit (p = 0.039), compared to controls. Analysis was undertaken after only one third of the estimated sample size had entered the trial. In the third trial TAAA repair was performed on 145 patients. CSFD was initiated during the operation and continued for 48 hours after surgery. Paraplegia or paraparesis occurred in 9 of 74 patients (12.2%) in the control group versus 2 of 82 patients (2.7%) with CSFD (p = 0.03). Overall, CSFD resulted in an 80% reduction in the relative risk of postoperative deficits. Meta-analysis showed an odds ratio (OR) of 0.48 (0.25 to 0.92; confidence interval (CI) 95%). For CSFD trials only OR was 0.57 (0.28 to 1.17) and for intention-to-treat in CSFD only studies OR remained unchanged. REVIEWER'S CONCLUSIONS: There are limited data supporting the role of CSFD in thoracic and thoracoabdominal aneurysm surgery for prevention of neurological injury. Further clinical and experimental studies are indicated.

Aortic Aneurysm, Abdominal↗
PubMed2004

Chinese herbal medicines for type 2 diabetes mellitus.

BACKGROUND: Traditional Chinese herbal medicines have been used for a long time to treat diabetes, and many controlled trials have been done to investigate their efficacy. OBJECTIVES: To assess the effects of Chinese herbal medicines in patients with type 2 diabetes mellitus. SEARCH STRATEGY: We searched the following electronic databases: The Cochrane Library (CENTRAL), the Chinese BioMedical Database, MEDLINE, EMBASE, and LILACS, combined with hand searches on Chinese journals and conference proceedings. Date of last search was April 2004. No language restriction was used. SELECTION CRITERIA: Randomised trials of herbal medicines (with at least two months treatment duration) compared with placebo, pharmacological or non-pharmacological interventions were included. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers. The methodological quality of trials was evaluated using the parameters of randomisation, allocation concealment, double blinding, and drop-out rates. Meta-analyses were performed where data were available. MAIN RESULTS: Sixty-six randomised trials, involving 8302 participants, met the inclusion criteria. Methodological quality was generally low. Sixty-nine different herbal medicines were tested in the included trials, which compared herbal medicines with placebo, hypoglycaemic drugs, or herbal medicines plus hypoglycaemic drugs. Compared with placebo, Holy basil leaves, Xianzhen Pian, Qidan Tongmai, traditional Chinese formulae (TCT), Huoxue Jiangtang Pingzhi, and Inolter showed significantly hypoglycaemic response. Compared with hypoglycaemic drugs including glibenclamide, tolbutamide, or gliclazide, seven herbal medicines demonstrated a significant better metabolic control, including Bushen Jiangtang Tang, Composite Trichosanthis, Jiangtang Kang, Ketang Ling, Shenqi Jiangtang Yin, Xiaoke Tang, and Yishen Huoxue Tiaogan. In 29 trials that evaluated herbal medicines combined with hypoglycaemic drugs, 15 different herbal preparations showed additional better effects than hypoglycaemic drugs monotherapy. Two herbal therapies combined with diet and behaviour change showed better hypoglycaemic effects than diet and behaviour change alone. No serious adverse effects from the herbal medicines were reported. REVIEWERS' CONCLUSIONS: Some herbal medicines show hypoglycaemic effects in type 2 diabetes. However, these findings should be carefully interpreted due to the low methodological quality, small sample size, and limited number of trials. In the light of some positive findings, some herbal medicines deserve further examination in high-quality trials.

Diabetes Mellitus, Type 2↗
PubMed2005

Micronutrient supplementation in children and adults with HIV infection.

BACKGROUND: The scale and impact of the HIV/AIDS pandemic has made the search for simple, affordable, safe, and effective public health interventions all the more urgent. Micronutrient supplements hold the promise of meeting these criteria, but their widespread use needs to be based on sound scientific evidence of effectiveness and safety. OBJECTIVES: To assess whether micronutrient supplements are effective in reducing morbidity and mortality in adults and children with HIV infection. SEARCH STRATEGY: The Cochrane Library (CENTRAL), EMBASE, MEDLINE, AIDSearch, CINAHL, and conference proceedings were searched, and pharmaceutical manufacturers and researchers in the field were contacted to locate any ongoing or unpublished trials. SELECTION CRITERIA: Randomised controlled trials comparing the effects of micronutrient supplements (vitamins, trace elements, and combinations of these) with placebo or no treatment on mortality and morbidity in HIV-infected individuals. DATA COLLECTION AND ANALYSIS: Two reviewers independently appraised trial quality and extracted data. Study authors were contacted for additional data where necessary. A meta-analysis was not deemed appropriate due to significant heterogeneity between trials. MAIN RESULTS: Fifteen trials were included. Six trials comparing vitamin A/beta-carotene with placebo in adults failed to show any effects on mortality, morbidity, CD4 and CD8 counts, or on viral load. Four trials of other micronutrients in adults did not affect overall mortality, although there was a reduction in mortality in a low CD4 subgroup. In a large Tanzanian trial in pregnant and lactating women, daily multivitamin supplementation was associated with a number of benefits to both mothers and children: a reduction in maternal mortality from AIDS-related causes; a reduced risk of progression to stage four disease; fewer adverse pregnancy outcomes; less diarrhoeal morbidity; and a reduction in early-child mortality among immunologically- and nutritionally-compromised women. Vitamin A alone reduced all-cause mortality and improved growth in a small sub-group of HIV-infected children in one hospital-based trial, and reduced diarrhoea-associated morbidity in a small HIV-infected sub-group of infants in another trial. AUTHORS' CONCLUSIONS: There is no conclusive evidence at present to show that micronutrient supplementation effectively reduces morbidity and mortality among HIV-infected adults. It is reasonable to support the current WHO recommendations to promote and support adequate dietary intake of micronutrients at RDA levels wherever possible. There is evidence of benefit of vitamin A supplementation in children. The long-term clinical benefits, adverse effects, and optimal formulation of micronutrient supplements require further investigation.

Adult↗
PubMed2005

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

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

Bronchopulmonary Dysplasia↗
PubMed2004

Partial liquid ventilation for preventing death and morbidity in adults with acute lung injury and acute respiratory distress syndrome.

BACKGROUND: Acute lung injury (ALI), and acute respiratory distress syndrome (ARDS), are syndromes of severe respiratory failure. Adults with ALI or ARDS have high mortality and significant morbidity. Partial liquid ventilation (PLV) may be better (i.e., cause less lung damage) for these patients than other forms of respiratory support. Uncontrolled studies in adults have shown improvement in gas exchange and lung compliance with partial liquid ventilation. OBJECTIVES: To assess whether partial liquid ventilation reduces morbidity and mortality in adults with ALI or ARDS. SEARCH STRATEGY: We searched The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library Issue 2, 2004; MEDLINE (1966 to May 2004); and CINAHL (1982 to May 2004); intensive care journals and conference proceedings; reference lists and unpublished literature. SELECTION CRITERIA: Randomized controlled trials which compared partial liquid ventilation with other forms of ventilation, in adults (16 years old or greater) with ALI or ARDS, reporting one or more of the following: mortality; duration of mechanical ventilation, respiratory support, oxygen therapy, stay in the intensive care unit, or stay in hospital; infection; long term cognitive impairment or health related quality of life; long term lung function; or cost. DATA COLLECTION AND ANALYSIS: Two reviewers independently evaluated the quality of the relevant studies and extracted the data from the included studies. MAIN RESULTS: Problems with the inadequacy of the primary report of the one included study do not allow us to report any quantitative results for patients with ALI or ARDS. The only outcome we considered to be of clinical significance and reported for all enrolled patients (i.e., patients with ALI and ARDS and less severe respiratory insufficiency) was 28 day mortality. There was no statistically significant difference between groups for this outcome with a relative risk for 28 day mortality in the PLV group of 1.15 (95% confidence intervals of 0.64 to 2.10). REVIEWERS' CONCLUSIONS: There is no evidence from randomized controlled trials to support or refute the use of partial liquid ventilation in adults with ALI or ARDS; adequately powered, high quality randomized controlled trials are still needed to assess its efficacy. Clinically relevant outcome measures should be assessed (especially mortality at discharge and later, duration of respiratory support and hospital stay, and long term cognitive and quality of life outcomes) and the studies should be published in full.

Adult↗