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PubMed2004

Antifungal agents for preventing fungal infections in solid organ transplant recipients.

BACKGROUND: Invasive fungal infections (IFIs) are important causes of morbidity and mortality in solid organ transplant recipients. OBJECTIVES: This study aims to systematically identify and summarise the effects of antifungal prophylaxis in solid organ transplant recipients. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (Issue 3, 2003), MEDLINE (1966-June 2003), and EMBASE (1980-June 2003) were searched. Reference lists, abstracts of conference proceedings and scientific meetings (1998-2003) were handsearched. Authors of included studies and pharmaceutical manufacturers were contacted. SELECTION CRITERIA: Randomised controlled trials (RCTs) in all languages comparing the prophylactic use of any antifungal agent or regimen with placebo, no antifungal, or another antifungal agent or regimen. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied selection criteria, performed quality assessment, and extracted data using an intention-to-treat approach. Differences were resolved by discussion. Data were synthesised using the random effects model and expressed as relative risk (RR) with 95% confidence intervals (95% CI). MAIN RESULTS: Fourteen unique trials with 1497 randomised participants were included. Antifungal prophylaxis did not reduce mortality (RR 0.90, 95% CI 0.57 to 1.44). In liver transplant recipients, a significant reduction in IFIs was demonstrated for fluconazole (RR 0.28, 95% CI 0.13 to 0.57). Although less data were available for itraconazole and liposomal amphotericin B, indirect comparisons and one direct comparative trial suggested similar efficacy. Fluconazole prophylaxis did not significantly increase invasive infections or colonisation with fluconazole-resistant fungi. In renal and cardiac transplant recipients, neither ketoconazole nor clotrimazole significantly reduced invasive infections. Overall, the strength and precision of comparisons however were limited by a paucity of data. REVIEWERS' CONCLUSIONS: For liver transplant recipients, antifungal prophylaxis with fluconazole significantly reduces the incidence of IFIs with no definite mortality benefit. Given a 10% incidence of IFI, 14 liver transplant recipients would require fluconazole prophylaxis to prevent one infection. In transplant centres where the incidence of IFIs is high, or in situations where the individual risk is great, antifungal prophylaxis should be considered.

Antifungal Agents↗
PubMed2004

Treatment for avascular necrosis of bone in people with sickle cell disease.

BACKGROUND: Avascular necrosis of bone is a frequent and severe complication of sickle cell disease and its treatment is not standardised. It is therefore important to gather evidence about the safety and effectiveness of different interventions. OBJECTIVES: To determine the impact of surgery compared to non-surgical management on both the short- and the long-term outcomes (efficacy, safety, and adverse events) for people with sickle cell disease-related avascular necrosis. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register, which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Additional randomized controlled trials were sought from the reference lists of the trials found and reviews identified by the search strategy. Date of the most recent search: April 2004. SELECTION CRITERIA: All randomized or quasi-randomized controlled trials (published or unpublished). DATA COLLECTION AND ANALYSIS: One ongoing clinical trial has been identified but no data are available for inclusion in the review. MAIN RESULTS: Five trials were identified by the searches. Four trials were not eligible for inclusion and one is an ongoing clinical trial. REVIEWERS' CONCLUSIONS: We were unable to find any evidence from completed randomized controlled trials assessing treatments for avascular necrosis in people with sickle cell disease. We await the results of an ongoing clinical trial to assess the benefits and risks of a surgical approach compared to a non-surgical approach as a means of improving survival and quality of life for people with sickle cell disease-related avascular necrosis of bone.

Anemia, Sickle Cell↗
PubMed2005

Non-invasive positive pressure ventilation for treatment of respiratory failure due to severe acute exacerbations of asthma.

BACKGROUND: Non-invasive positive pressure ventilation (NPPV) has been shown to be effective in chronic obstructive pulmonary disease (COPD) patients with acute respiratory failure. However, its role in patients with severe acute asthma is uncertain. The pathophysiologic condition of acute respiratory failure in asthma is in many ways similar to that of acute respiratory failure in COPD. Therefore, there is reason to believe that NPPV could also be successful in patients with severe acute asthma. OBJECTIVES: To determine the efficacy of NPPV in adults with severe acute asthma, in comparison to usual medical care, with respect to mortality, tracheal intubation, changes in blood gases, and hospital length of stay. SEARCH STRATEGY: An initial search for studies was carried out using the Cochrane Controlled Trials Register (CENTRAL). Additional searches were carried out on MEDLINE, EMBASE, CINAHL, Science Citation and web based clinical trials databases. Key journals with web sites were also searched as well as respiratory conference proceedings. Following this, the bibliographies of each randomised controlled trial obtained (and any review articles) were searched for additional studies. The date of the most recent search for trials was May 2004. SELECTION CRITERIA: All data were analysed using RevMan. For continuous variables a weighted mean difference and 95% confidence interval (95% CI) was calculated for each study outcome. For dichotomous variables relative risk with 95% confidence interval was calculated. DATA COLLECTION AND ANALYSIS: All data was analysed using RevMan. For continuous variables, a weighted mean difference and 95% confidence interval (95%CI) was calculated for each study outcome. For dichotomous variables relative risk with 95% confidence interval was calculated. MAIN RESULTS: From an initial search of 696 abstracts, 11 trials were obtained in full text for closer examination. Ten trials were excluded and one included. The one included trial, on 30 patients, showed benefit with NPPV when compared to usual medical care alone, with significant improvements in hospitalisation rate, number of patients discharged from emergency department, percent predicted forced expiratory volume in one minute (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR) and respiratory rate. AUTHORS' CONCLUSIONS: The application of NPPV in patients suffering from status asthmaticus, despite some interesting and very promising preliminary results, still remains controversial. Large, prospective randomised controlled trials are therefore needed to determine the role of NPPV in status asthmaticus.

Acute Disease↗
PubMed2005

Non-invasive positive pressure ventilation for treatment of respiratory failure due to severe acute exacerbations of asthma.

BACKGROUND: Non-invasive positive pressure ventilation (NPPV) has been shown to be effective in chronic obstructive pulmonary disease patients with acute respiratory failure. However, its role in patients with severe acute asthma is uncertain. The pathophysiologic condition of acute respiratory failure in asthma is in many ways similar to that of acute respiratory failure in COPD. Therefore, there is reason to believe that NPPV could also be successful in patients with severe acute asthma. OBJECTIVES: To determine the efficacy of NPPV in adults with severe acute asthma in comparison to usual medical care with respect to mortality, tracheal intubation, changes in blood gases and hospital length of stay. SEARCH STRATEGY: An initial search for studies was carried out using CENTRAL. Additional searches were also carried out on MEDLINE, EMBASE, CINAHL, Science Citation, web based clinical trials databases and key journals with web sites were also searched as well as respiratory conference proceedings. Following this, the bibliographies of each randomised controlled trial obtained (and any review articles) was searched for additional studies. Date of most recent search for trials was conducted on May 2004. SELECTION CRITERIA: Only RCTs in adults patients with severe acute asthma were considered for inclusion. Studies including patients with features of COPD were excluded unless data was provided separately for patients with asthma in studies recruiting both COPD and asthma patients. DATA COLLECTION AND ANALYSIS: All data was analysed using RevMan. For continuous variables, a weighted mean difference and 95% confidence interval (95%CI) was calculated for each study outcome. For dichotomous variables relative risk with 95% confidence interval was calculated. MAIN RESULTS: From an initial search of 696 abstracts, 11 trials were obtained in full-text for closer examination. Ten trials were excluded and one included. The one included trial, on 30 patients, showed benefit with NPPV when compared to usual medical care alone with significant improvements in hospitalisation rate, number of patients discharged from emergency department, percent predicted FEV(1), FVC, PEFR and respiratory rate. AUTHORS' CONCLUSIONS: The application of NPPV in patients suffering from status asthmaticus, despite some interesting and very promising preliminary results, still remains controversial. Large, prospective, randomised controlled trials are therefore needed to determine the role of NPPV in status asthmaticus.

Acute Disease↗
PubMed2005

Intravenous immunoglobulin for presumed viral myocarditis in children and adults.

BACKGROUND: Case reports and case series have described dramatic responses to IVIG in adults and children with presumed viral myocarditis. Administration of IVIG has become commonplace in the management of this condition. OBJECTIVES: To compare the outcome of patients with presumed viral myocarditis treated with IVIG to patients who did not receive IVIG. SEARCH STRATEGY: We searched CENTRAL (Issue 2, 2003), MEDLINE/PubMed (1966-2003), EMBASE (1988-2003), CINAHL (1982-2003), Web of Science (1975-2003), trials registries and conference proceedings. We contacted authors of trials and checked reference lists of relevant papers. SELECTION CRITERIA: Studies were included if: (1) patients had a clinical diagnosis of acute myocarditis with either a left ventricular ejection fraction (LVEF) <= 0.45, LVEDD of >2 SDs above the norm, or a shortening fraction (SF) >2 SDs below the mean and the duration of cardiac symptoms was less than six months; (2) patients had no evidence of non-infectious or bacterial cardiac disease; and, (3) patients were randomised to receive at least 1 gm/kg of IVIG versus no IVIG or placebo. Studies were excluded if: (1) patients had received immunosuppression prior to outcome assessment; or, (2) onset of myocarditis was less than six months postpartum. DATA COLLECTION AND ANALYSIS: Searches were screened and inclusion criteria applied independently by two reviewers. Quality was assessed by two reviewers using the Jadad scale and allocation concealment. Data were extracted independently by two reviewers. Meta-analysis was not possible because only one relevant study was found. MAIN RESULTS: The relevant study involved 62 adults with acute myocarditis randomized to receive IVIG or an equivalent volume of 0.1% albumin in a blinded fashion. The incidence of death or requirement for cardiac transplant or placement of a left ventricular assist device was low in both groups (OR for event-free survival was 0.52 ,95% CI 0.12 to 2.30). Follow-up at six and 12 months showed equivalent improvement in LVEF (mean difference 0.00, 95% CI -0.07 to 0.07 at six months, mean difference 0.01, 95% CI -0.06 to 0.08 at 12 months). Functional capacity as assessed by peak oxygen consumption was equivalent in the two groups at 12 months (mean difference -0.80, 95% CI -4.57 to 2.97). Infusion-related side effects were more common in the treated group, but all appeared to be mild (OR 30.16, 95% CI 1.69 to 539.42). AUTHORS' CONCLUSIONS: Evidence from one trial does not support the use of IVIG for the management of adults with presumed viral myocarditis. There are no randomized paediatric trials. Further studies of the pathophysiology of this entity would lead to improved diagnostic criteria which would facilitate future research.

Acute Disease↗
PubMed2005

Antibiotic prophylaxis for bacterial infections in afebrile neutropenic patients following chemotherapy.

BACKGROUND: Bacterial infections are a major cause of morbidity and mortality in neutropenic patients following chemotherapy for malignancy. Trials have shown the efficacy of antibiotic prophylaxis in decreasing the incidence of bacterial infections, but not in reducing mortality rates. OBJECTIVES: This review aimed to evaluate whether antibiotic prophylaxis in afebrile neutropenic patients reduced mortality when compared to placebo or no intervention. SEARCH STRATEGY: Electronic searches on The Cochrane Cancer Network Register of Trials (2004), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to 2004) and EMBASE (1980 to 2004) and abstracts of conference proceedings; references of identified studies; the first author of each included trial was contacted. SELECTION CRITERIA: RCTs or quasi-RCTs comparing different types of antibiotic prophylaxis with placebo or no intervention, or another antibiotic to prevent bacterial infections in afebrile neutropenic patients. DATA COLLECTION AND ANALYSIS: Two authors independently appraised the quality of each trial and extracted data from the included trials. Relative risks (RR) or average differences, with their 95% confidence intervals (CI) were estimated. MAIN RESULTS: One hundred trials (10,274 patients) performed between the years 1973 to 2004 met inclusion criteria. Antibiotic prophylaxis significantly decreased the risk for death when compared with placebo or no intervention (RR, 0.66 [95% CI 0.54 to 0.81]). The authors estimated the number needed to treat (NNT) in order to prevent 1 death from all causes as 60 (95% CI 34 to 268). Prophylaxis resulted in a significant decrease in the risk of infection-related death, RR 0.58 (95% CI 0.45 to 0.74) and in the occurrence of fever, RR 0.78 (95% CI 0.75 to 0.82). A reduction in mortality was also evident when the more recently conducted quinolone trials were analysed separately. Quinolone prophylaxis reduced the risk for all-cause mortality, RR 0.52 (95% CI, 0.37 to 0.84). AUTHORS' CONCLUSIONS: Our review demonstrated that prophylaxis significantly reduced all-cause mortality. The most significant reduction in mortality was observed in trials assessing prophylaxis with quinolones. The benefit demonstrated in our review outweighs harm, such as adverse effects, and development of resistance, since all-cause mortality is reduced. Since most trials in our review were of patients with haematologic cancer, prophylaxis, preferably with a quinolone, should be considered for these patients.

Anti-Bacterial Agents↗
PubMed2004

Chlorproguanil-dapsone for treating uncomplicated malaria.

BACKGROUND: In Africa, malaria is often resistant to chloroquine and sulfadoxine-pyrimethamine. Chlorproguanil-dapsone is a potential alternative. OBJECTIVES: To compare chlorproguanil-dapsone with other antimalarial drugs for treating uncomplicated falciparum malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (May 2004), CENTRAL (The Cochrane Library Issue 2, 2004), MEDLINE (1966 to May 2004), EMBASE (1988 to May 2004), LILACS (May 2004), Biosis Previews (1985 to May 2004), conference proceedings, and reference lists, and contacted researchers working in this field. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials comparing chlorproguanil-dapsone to other antimalarial drugs. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied the inclusion criteria, extracted data, and assessed methodological quality. We calculated the relative risk (RR) for dichotomous data and weighted mean difference for continuous data, and presented them with 95% confidence intervals (CI). MAIN RESULTS: Six trials (n = 3352) met the inclusion criteria. Chlorproguanil-dapsone (with 1.2 mg chlorproguanil) as a single dose had fewer treatment failures than chloroquine (1 trial), but more treatment failures and people with parasitaemia at day 28 than sulfadoxine-pyrimethamine (3 trials). Two trials compared the three-dose chlorproguanil-dapsone (with 2 mg chlorproguanil) regimen with sulfadoxine-pyrimethamine in new attendees. There were fewer treatment failures with chlorproguanil-dapsone by day 7 (RR 0.30, CI 0.19 to 0.49; n = 827, 1 trial) and day 14 (RR 0.36, CI 0.24 to 0.53; n = 1709, 1 trial). Neither trial reported total failures by day 28. A further trial was carried out in participants selected because they had previously failed sulfadoxine-pyrimethamine. Adverse event reporting was inconsistent between trials, but chlorproguanil-dapsone was associated with more adverse events leading to discontinuation of treatment compared with sulfadoxine-pyrimethamine (RR 4.54, CI 1.74 to 11.82; n = 829, 1 trial). It was also associated with more red blood cell disorders (RR 2.86, CI 1.33 to 6.13; n = 1850, 1 trial). REVIEWERS' CONCLUSIONS: There are insufficient data about the effects of the current standard chlorproguanil-dapsone regimen (three-dose, 2 mg chlorproguanil). Randomized controlled trials that follow up to day 28, record adverse events, and use an intention-to-treat analysis are required to inform any policy decisions.

Adult↗
PubMed2004

Intramuscular arteether for treating severe malaria.

BACKGROUND: Quinine and artemisinin drugs are used in severe malaria, but quinine resistance is increasing. Arteether is a recently developed artemisinin derivative that is oil soluble, has a long elimination half life, and is more stable than other derivatives. OBJECTIVES: To compare intramuscular arteether with other antimalarial drugs to treat severe malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (August 2004), CENTRAL (The Cochrane Library Issue 3, 2004), MEDLINE (1966 to August 2004), EMBASE (1980 to August 2004), U.S. National Library of Medicine (NLM) Gateway (1953 to 1965), Web Science Citation (1981 to August 2004), LILACS (August 2004), Google search engine (August 2004), conference proceedings, and reference lists. We also contacted researchers, organizations, and pharmaceutical companies to help identify trials. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials of intramuscular arteether in adults and children with severe malaria. DATA COLLECTION AND ANALYSIS: We independently assessed the methodological quality of the trials and extracted data, and analysed data using Review Manager 4.2. MAIN RESULTS: Two small trials (n = 194) met the inclusion criteria. Both trials compared arteether with quinine in children with cerebral malaria and reported on similar outcomes. There was no statistically significant difference in the number of deaths (relative risk 0.75, 95% confidence interval 0.43 to 1.30; n = 194, 2 trials), neurological complications (relative risk 1.18, 95% confidence interval 0.31 to 4.46; n = 58, 1 trial), or other outcomes including time to regain consciousness, parasite clearance time, and fever clearance time. The meta-analyses lack statistical power to detect important differences. REVIEWERS' CONCLUSIONS: More trials with a larger number of participants are needed before a firm conclusion about the efficacy and safety of arteether can be reached.

Adult↗
PubMed2003

Preoperative fasting for adults to prevent perioperative complications.

BACKGROUND: Fasting before general anaesthesia aims to reduce the volume and acidity of stomach contents during surgery, thus reducing the risk of regurgitation/aspiration. Recent guidelines have recommended a shift in fasting policy from the standard 'nil by mouth from midnight' approach to more relaxed policies which permit a period of restricted fluid intake up to a few hours before surgery. The evidence underpinning these guidelines however, was scattered across a range of journals, in a variety of languages, used a variety of outcome measures and methodologies to evaluate fasting regimens that differed in duration and the type and volume of intake permitted during a restricted fasting period. Practice has been slow to change. OBJECTIVES: To systematically review the effect of different preoperative fasting regimens (duration, type and volume of permitted intake) on perioperative complications and patient wellbeing (including aspiration, regurgitation and related morbidity, thirst, hunger, pain, nausea, vomiting, anxiety) in different adult populations. SEARCH STRATEGY: Electronic databases, conference proceedings and reference lists from relevant articles were searched for studies of preoperative fasting in August 2003 and experts in the area were consulted. SELECTION CRITERIA: Randomised controlled trials which compared the effect on postoperative complications of different preoperative fasting regimens on adults were included. DATA COLLECTION AND ANALYSIS: Details of the eligible studies were independently extracted by two reviewers and where relevant information was unavailable from the text attempts were made to contact the authors. MAIN RESULTS: Thirty eight randomised controlled comparisons (made within 22 trials) were identified. Most were based on 'healthy' adult participants who were not considered to be at increased risk of regurgitation or aspiration during anaesthesia. Few trials reported the incidence of aspiration/regurgitation or related morbidity but relied on indirect measures of patient safety i.e. intra-operative gastric volume and pH. There was no evidence that the volume or pH of participants' gastric contents differed significantly depending on whether the groups were permitted a shortened preoperative fluid fast or continued a standard fast. Fluids evaluated included water, coffee, fruit juice, clear fluids and other drinks (e.g. isotonic drink, carbohydrate drink). Participants given a drink of water preoperatively were found to have a significantly lower volume of gastric contents than the groups that followed a standard fasting regimen. This difference was modest and clinically insignificant. There was no indication that the volume of fluid permitted during the preoperative period (i.e. low or high) resulted in a difference in outcomes from those participants that followed a standard fast. Few trials specifically investigated the preoperative fasting regimen for patient populations considered to be at increased risk during anaesthesia of regurgitation/aspiration and related morbidity. REVIEWER'S CONCLUSIONS: There was no evidence to suggest a shortened fluid fast results in an increased risk of aspiration, regurgitation or related morbidity compared with the standard 'nil by mouth from midnight' fasting policy. Permitting patients to drink water preoperatively resulted in significantly lower gastric volumes. Clinicians should be encouraged to appraise this evidence for themselves and when necessary adjust any remaining standard fasting policies (nil-by-mouth from midnight) for patients that are not considered 'at-risk' during anaesthesia.

Adult↗
PubMed2004

Phytomedicines (medicines derived from plants) for sickle cell disease.

BACKGROUND: Sickle cell disease (SCD) is a common recessively inherited disorder of haemoglobin affecting peoples originating from sub-Saharan Africa, the Middle East and Mediterranean basin, the Indian subcontinent, the Caribbean and South America. The homozygous state (SS) is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass much of what the populations most affected would encounter in terms of plant-remedies from traditional healers. There has been little in the way of systematic appraisal of their benefits. OBJECTIVES: To assess the benefits and risks of phytomedicines in people with SCD of all types, of any age, in any setting. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders group specialised register of controlled trials of haemoglobinopathies, which comprises references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We performed an additional search of the bibliographic database of Allied and Complementary Medicine (AMED). Date of most recent search of the trials register: September 2003. SELECTION CRITERIA: All randomised or quasi-randomised trials with participants of all ages with SCD, in all settings, comparing the administration of phytomedicines, by any mode to placebo or standard treatment, including blood transfusion and hydroxyurea. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality and extracted data from the study. MAIN RESULTS: Reports of two trials were found, of which only one, including 82 participants, was eligible for inclusion in this review. This Phase IIB (pivotal) study suggests that a phytomedicine, NIPRISAN, was effective in reducing episodes of SCD crisis associated with severe pain over a six-month period. NIPRISAN did not appear to affect the risk of severe complications or the level of anaemia. No serious adverse effects were reported. REVIEWERS' CONCLUSIONS: While NIPRISAN, as a phytomedicine, appeared to be safe and effective, over a six-month follow-up period of this study, in reducing crises associated with severe pain, further studies are required to assess its role in the management of people with sickle cell disease. The results of Phase III, multicentre trials are awaited.

Anemia, Sickle Cell↗
PubMed2004

Recombinant Factor VIIa concentrate versus plasma derived concentrates for the treatment of acute bleeding episodes in people with Haemophilia A and inhibitors.

BACKGROUND: In some people with haemophilia, therapeutic clotting agents are recognised as a foreign protein and anti-FVIII antibodies, known as 'inhibitors', are produced. This review investigates which treatment most effectively arrests acute bleeding in people with haemophilia A and inhibitors. OBJECTIVES: To determine the clinical effectiveness of recombinant FVIIa concentrate in comparison to plasma-derived concentrates for the treatment of acute bleeding episodes in people with haemophilia A and inhibitors. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises of references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. Date of the most recent search of the Group's trials register: September 2003. SELECTION CRITERIA: Randomised (RCTs) and quasi-randomised controlled clinical trials comparing Recombinant FVIIa concentrate to human plasma-derived concentrates (high-dose human or recombinant FVIII concentrate; prothrombin complex concentrates (PCCs); activated prothrombin complex concentrate (aPCC)) in people with haemophilia A. Comparisons with animal derived products were excluded. DATA COLLECTION AND ANALYSIS: No studies were found that were eligible for inclusion in this review. MAIN RESULTS: A total of four studies were identified by the searches, however, none of these were eligible for inclusion in this review. REVIEWERS' CONCLUSIONS: No RCTs on the relative effectiveness of Recombinant FVIIa concentrate compared to human plasma-derived concentrates in people with haemophilia A and inhibitors were identified for inclusion in this review. The research evidence on which to base clinical decisions is therefore limited to case reports, and other less robust evidence. There is need for a well-designed, adequately-powered randomised controlled trial to assess the relative benefits and risks of using Recombinant FVIIa concentrate compared to human plasma-derived concentrates in people with haemophilia A and inhibitors.

Acute Disease↗
PubMed2003

Risedronate for the prevention and treatment of postmenopausal osteoporosis.

BACKGROUND: Postmenopausal osteoporosis results in an increased susceptibility to low-trauma fractures due to reduced bone volume and microarchitectural deterioration. Risedronate, a third generation bisphosphonate, has been shown in multiple clinical trials to reduce fracture risk and improve bone mineral density in postmenopausal women with osteoporosis. First and second generation bisphosphonates are known to have gastrointestinal side-effects and risedronate may be better tolerated. OBJECTIVES: To systematically review the efficacy of risedronate on bone density, and fracture reduction in postmenopausal women. SEARCH STRATEGY: The Cochrane Controlled Trials Registry Medline, and Current Contents were searched from 1990 - 2001. The electronic search was supplemented by handsearching four osteoporosis journals and their conference proceedings, as well as contacting content experts and industry sources for unpublished data. SELECTION CRITERIA: We included eight trials that randomised women to risedronate or an alternative (placebo or calcium and /or vitamin D) and measured bone mineral density for at least one year. DATA COLLECTION AND ANALYSIS: For each trial three independent reviewers assessed the methodological quality and abstracted data. Data was extracted for outcomes of fracture, bone mineral density and adverse events. The more conservative random effects model was used to pool data. The quality of trials was assessed according to the Jadad five-point scale. MAIN RESULTS: Both vertebral and non-vertebral fractures were statistically and clinically reduced with risedronate. Eleven out of one hundred women who received risedronate had a vertebral fracture compared to 17 out of one hundred of those who received an alternative treatment (pooled relative risk for vertebral fractures of 0.64 (95% CI 0.52 - 0.77). Three percent of participants who received risedronate had a non-vertebral fracture compared to 4.6% of those who received an alternative treatment (pooled relative risk for nonvertebral fractures of 0.73 (95% CI 0.61 - 0.87). The weighted mean difference for the percent change from baseline for bone mineral density with 5 mg daily for lumbar spine, femoral neck and trochanter was 4.54% (95%CI 4.12 - 4.97), p<0.01; 2.75% (95% CI 2.32 - 3.17), p<0.01; and 4.38% (95% CI 3.51 - 5.25), p<0.01 respectively. REVIEWER'S CONCLUSIONS: There is good evidence for the efficacy of risedronate in the reduction of both vertebral and non-vertebral fractures. In addition, there is evidence from randomized trials that risedronate is able to achieve this without increasing risk for overall withdrawals due to adverse effects.

Bone Density↗
PubMed2005

Fluoroquinolones for treating typhoid and paratyphoid fever (enteric fever).

BACKGROUND: Fluoroquinolones are recommended as first-line therapy for typhoid and paratyphoid fever, but how they compare with other cheaper antibiotics and different fluoroquinolones is unclear. OBJECTIVES: To evaluate fluoroquinolone antibiotics for treating enteric fever in children and adults compared with other antibiotics, different fluoroquinolones, and different treatment durations of the same fluoroquinolone. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (August 2004), CENTRAL (The Cochrane Library Issue 3, 2004), MEDLINE (1966 to August 2004), EMBASE (1974 to August 2004), LILACS (1982 to August 2004), conference proceedings, reference lists, and contacted researchers. SELECTION CRITERIA: Randomized controlled trials of fluoroquinolones in people with blood or bone marrow culture-confirmed enteric fever. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the methodological quality of trials and extracted data. We calculated the odds ratio (OR) for dichotomous data with 95% confidence intervals. We analysed norfloxacin separately. MAIN RESULTS: Thirty-three trials met the inclusion criteria; 22 had unclear allocation concealment, and 29 were not blinded. Three trials exclusively included children, and two studied outpatients. The main analysis examined clinical failure, microbiological failure, and relapse. Compared with chloramphenicol, fluoroquinolones were not statistically significantly different for clinical (544 participants) or microbiological failure (378 participants) in adults; they reduced clinically diagnosed relapse in adults (OR 0.14, 0.04 to 0.50; 467 participants, 6 trials), but this was not statistically significant in participants with blood culture-confirmed relapse (121 participants, 2 trials). Compared with co-trimoxazole, we detected no statistically significant difference (82 participants, 2 trials). Among adults, fluoroquinolones reduced clinical failure compared with ceftriaxone (OR 0.08, 0.01 to 0.45; 120 participants, 3 trials), but showed no difference for microbiological failure or relapse. We detected no statistically significant difference between fluoroquinolones and cefixime (80 participants, 1 trial) or azithromycin (152 participants, 2 trials). In trials of hospitalized children, fluoroquinolones were not statistically significantly different from ceftriaxone (60 participants, 1 trial, involving norfloxacin) or cefixime (82 participants, 1 trial). Norfloxacin had more clinical failures than other fluoroquinolones (417 participants, 5 trials). Trials comparing different durations of fluoroquinolone treatment showed no statistically significant differences (693 participants, 8 trials). AUTHORS' CONCLUSIONS: Many trials were small, and methodological quality varied widely. Although enteric fever most commonly affects children, trials in this group were particularly sparse. Insufficient data in all comparisons preclude any firm conclusions to be made regarding superiority of fluoroquinolones over first-line antibiotics in children and adults.

Adult↗
PubMed2005

Artesunate plus mefloquine versus mefloquine for treating uncomplicated malaria.

BACKGROUND: Multiple-drug-resistant malaria is widespread, and in South-East Asia resistance is high against nearly all single therapy antimalarial drugs. Here, and in other areas with low malaria transmission, the combination of artesunate and mefloquine may provide an effective alternative. OBJECTIVES: To compare artesunate plus mefloquine with mefloquine alone for treating uncomplicated Plasmodium falciparum malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (May 2005), CENTRAL (The Cochrane Library Issue 2, 2005), MEDLINE (1966 to May 2005), EMBASE (1988 to May 2005), LILACS (May 2005), BIOSIS (1985 to June 2005), conference proceedings, and reference lists. We also contacted researchers, organizations, and pharmaceutical companies. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials comparing artesunate plus mefloquine with mefloquine alone for treating uncomplicated malaria. DATA COLLECTION AND ANALYSIS: Two authors independently applied the inclusion criteria, extracted data, and assessed methodological quality. The primary outcome was treatment failure by day 28, defined as evidence of parasitaemia with or without clinical failure between days zero (start of treatment) and 28. For dichotomous data we calculated relative risks (RR) and 95% confidence intervals (CI). MAIN RESULTS: Eight trials involving 1996 participants met the inclusion criteria. All were conducted in areas with low malaria transmission, seven in South-East Asia and one in the Peruvian Amazon. The doses and dosing regimens of artesunate and mefloquine varied across trials. The trials using a total dose of 25 mg/kg mefloquine and 10 mg artesunate reported fewer treatment failures with the combination at all time points: day 28 (RR 0.17, 95% CI 0.06 to 0.47; 824 participants, 4 trials), day 42 (RR 0.23, 95% CI 0.14 to 0.39; 298 participants, 1 trial), and day 63 (RR 0.26, 95% CI 0.09 to 0.77; 501 participants, 2 trials). The results for parasitaemia showed a similar trend. Trials using a lower dose of artesunate tended to favour the artesunate plus mefloquine combination. Overall, adverse events were similar across treatment arms. AUTHORS' CONCLUSIONS: Artesunate plus mefloquine performs better than mefloquine alone for treating uncomplicated falciparum malaria in areas with low malaria transmission. A total dose of 25 mg/kg mefloquine and at least 10 mg artesunate leads to higher cure rates. Better reporting of methods and standardisation of outcomes would help the interpretation of future trials.

Antimalarials↗
PubMed2006

Routine surgery in addition to chemotherapy for treating spinal tuberculosis.

BACKGROUND: Tuberculosis is generally curable with chemotherapy, but there is controversy in the literature about the need for surgical intervention in the one to two per cent of people with tuberculosis of the spine. OBJECTIVES: To compare chemotherapy plus surgery with chemotherapy alone for treating people diagnosed with active tuberculosis of the spine. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (October 2005), CENTRAL (The Cochrane Library 2005, Issue 4), MEDLINE (1966 to October 2005), EMBASE (1974 to October 2005), LILACS (1982 to October 2005), conference proceedings, and reference lists. SELECTION CRITERIA: Randomized controlled trials with at least one year follow up that compared chemotherapy plus surgery with chemotherapy alone for treating active tuberculosis of the thoracic and/or lumbar spine. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial eligibility, methodological quality, and extracted data. We analysed data using odds ratio with 95% confidence intervals. MAIN RESULTS: Two randomized controlled trials (331 participants) met the inclusion criteria. They were conducted in the 1970s and 1980s with follow-up reports available after 18 months, three years, and five years; one trial also reported 10 years follow up. Completeness of follow up varied at the different time points, with less than 80% of participants available for analysis at several time points. There was no statistically significant difference for any of the outcome measures: kyphosis angle, neurological deficit (none went on to develop this), bony fusion, absence of spinal tuberculosis, death from any cause, activity level regained, change of allocated treatment, or bone loss. Neither trial reported on pain. Of the 130 participants allocated to chemotherapy only, 12 had a neurological deficit and five needed a decompression operation. One trial suggested that an initial kyphosis angle greater than 30 degrees is likely to deteriorate, especially in children. AUTHORS' CONCLUSIONS: The two included trials had too few participants to be able to say whether routine surgery might help. Although current medication and operative techniques are now far more advanced, these results indicate that routine surgery cannot be recommended unless within the context of a large, well-conducted randomized controlled trial. Clinicians may judge that surgery may be clinically indicated in some groups of patients. Future studies need to address these topics as well as the patient's view of their disease and treatment.

Aminosalicylic Acid↗
PubMed2004

Interventions for treating mallet finger injuries.

BACKGROUND: Mallet finger, also called drop or baseball finger, is where the end of a finger cannot be actively straightened out due to injury of the extensor tendon mechanism. Treatment commonly involves splintage of the finger for six or more weeks. Less frequently, surgical fixation is used to correct the deformity. OBJECTIVES: To examine the evidence for the relative effectiveness of different methods of treating mallet finger injuries. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register (November 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to February week 2 2004), EMBASE (1988 to 2004 week 8), other databases, reference lists of articles and various conference proceedings. SELECTION CRITERIA: Randomised or quasi-randomised clinical trials evaluating different interventions, including no intervention, for treating mallet finger injuries. DATA COLLECTION AND ANALYSIS: Two reviewers independently performed study selection, quality assessment and data extraction. Study authors were contacted for additional information. MAIN RESULTS: Four trials were included. These involved a total of 278, mainly adult, participants with 283 mallet finger injuries. All four trials were methodologically flawed, including inadequate outcome assessment. Three trials compared different types of finger splints versus a standard Stack splint. One trial found a lower incidence of treatment failure in participants treated with a perforated custom-made splint. One trial found there were fewer complications in participants treated with a padded aluminium-alloy malleable finger splint; however, the incidence of treatment failure was similar in the two treatment groups. One trial evaluating the Abouna splint found a similar incidence of treatment failure in the two groups. However, the Abouna splint often needed replacing due to disintegration of its rubber cover and rusting of the exposed wires and was also less popular with participants. The fourth trial found no statistically significant differences between participants whose mallet finger was treated with Kirschner wire fixation and those with a Pryor and Howard splint. Similar numbers had complications in the two groups. REVIEWERS' CONCLUSIONS: There was insufficient evidence from comparisons tested within randomised trials to establish the relative effectiveness of different, either custom-made or off-the-shelf, finger splints used for treating mallet finger injury. There was a useful reminder that splints used for prolonged immobilisation should be robust enough for everyday use, and of the central importance of patient adherence to instructions for splint use. There was insufficient evidence to determine when surgery is indicated.

Adult↗
PubMed2006

Speed enforcement detection devices for preventing road traffic injuries.

BACKGROUND: It is estimated that by 2020, road traffic crashes will have moved from ninth to third in the world ranking of burden of disease, as measured in disability adjusted life years. The identification of effective strategies for the prevention of road traffic injuries is of global public health importance. Measures aimed at reducing traffic speed are considered essential to preventing road injuries; the use of speed enforcement detection devices (including speed cameras and radar and laser devices) is one such measure. OBJECTIVES: To assess whether the use of speed enforcement detection devices (SEDs) reduces the incidence of speeding, road traffic crashes, injuries and deaths. SEARCH STRATEGY: We searched the Cochrane Injuries Group's Specialised Register, CENTRAL, MEDLINE, EMBASE, Science (and Social Science) Citation Index, TRANSPORT, PsycINFO, CINAHL, EconLit. We searched the websites of road safety and motoring associations, as well as general internet searches. We handsearched selected journals and conference proceedings, and contacted experts in the field. The searches were conducted during May to November 2004. SELECTION CRITERIA: Randomised controlled trials and controlled before-after studies that assessed the impact of speed enforcement detection devices on speeding, road crashes, injuries and deaths were eligible for inclusion. For studies involving co-interventions, SEDs had to be the major intervention focus of the study to be eligible. DATA COLLECTION AND ANALYSIS: We independently screened search results, assessed studies for inclusion, extracted data and assessed methodological quality. Due to variability between and within included studies, a pooled analysis was not appropriate. MAIN RESULTS: No randomised controlled trials were identified. Twenty-six studies met the inclusion criteria, of which 22 were controlled before-after trials incorporating a distinct control or comparison group(s) and four were interrupted time series designs with a comparison group(s). Fourteen studies reported speed and crash outcomes, seven reported crash outcomes only and five reported speed outcomes only. All but one study reported an absolute reduction in pre/post average speeds. A pre/post reduction in the proportion of speeding vehicles ranged across studies from 5% to 70% depending on the speed threshold set. Pre/post reductions of 50% to 65% were reported in the proportion of speeding vehicles travelling >15 km/h over the speed limit. Compared with controls, the relative improvement was from 1% to 15% for average speed and from 14% to 65% for percent speeding. All studies reporting crash outcomes reported an absolute pre/post reduction in all crashes and injury related crashes. In the vicinity of camera sites these pre/post reductions ranged from 14% to 72% for all crashes, 8% to 46% for injury crashes, and 40% to 45% for crashes resulting in fatalities or serious injuries. More generalised effects over wider areas showed an absolute pre/post crash reduction ranging from 9% to 35%, 7% to 30% for all injury crashes and 13% to 58% for crashes resulting in fatalities alone, or in combination with serious injuries. The studies of longer duration showed that these positive trends were either maintained or improved with time. Compared with controls, the relative improvement in pre/post crash numbers resulting in any type of injury ranged from 5% to 36%. AUTHORS' CONCLUSIONS: Despite the methodological limitations of the studies reviewed, the consistency of reported positive reductions in speed and crash outcomes across all studies suggest that SEDs are a promising intervention for reducing the number of road traffic injuries and deaths. More studies of a scientifically rigorous nature are necessary to provide a stronger evidence base that these interventions are worthwhile. There is a need for international harmonisation of data collection methods, including standards on how best to measure speeds and collect crash data, over lengthy intervention and follow-up periods, as well as some consensus as to the expression of outcomes in studies, so that studies can be compared.

Accident Prevention↗
PubMed2005

Unit-dose packaged drugs for treating malaria.

BACKGROUND: Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly. OBJECTIVES: To summarize the effects of unit-dose packaged treatment on cure and treatment adherence in people with uncomplicated malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (November 2004), CENTRAL (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to November 2004), EMBASE (1980 to November 2004), LILACS (November 2004), conference proceedings, and reference lists of articles. We also contacted pharmaceutical companies, organizations, and researchers in the field. SELECTION CRITERIA: Randomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs, and controlled before-and-after studies of unit-dose packaged drugs for treating uncomplicated malaria. DATA COLLECTION AND ANALYSIS: We independently assessed study eligibility and methodological quality, and extracted data for an intention to treat analysis, where possible. We combined binary data using relative risk (RR) and the fixed-effect model, and presented them with 95% confidence intervals (CI). We attempted to contact study authors for additional information. MAIN RESULTS: Three quasi-RCTs (895 participants) and one cluster-RCT (6 health facilities) met the inclusion criteria. Trials were of poor methodological quality, and none adequately assessed treatment failure. Unit-dose packaged drugs (in conjunction with prescriber training and patient information) appeared to be associated with higher participant-reported treatment adherence in all trials.A meta-analysis of two trials (596 participants) showed that participant-reported treatment adherence was higher with blister-packed tablets compared with tablets in paper envelopes (RR 1.18, 1.12 to 1.25). Two trials using tablets in sectioned polythene bags as the intervention also noted an increase in participant-reported treatment adherence: the cluster-RCT (6 clusters) compared it with tablets in paper envelopes, and the other trial compared it with syrup in bottles (RR 2.15, 1.76 to 2.61; 299 participants). AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the effect of unit-dose packaged antimalarial drugs on treatment failure. Unit-dose packaging supported by prescriber training and patient information appears to improve participant-reported treatment adherence, but these data come from trials with methodological limitations.

Antimalarials↗