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PubMed2004

Depot pipotiazine palmitate and undecylenate for schizophrenia.

BACKGROUND: Antipsychotic drugs are usually given orally but compliance may be problematic. The development of depot injections in the 1960s gave rise to their extensive use as a means of long-term maintenance treatment. Pipotiazine palmitate is a depot from the phenothiazine family of antipsychotic drugs. OBJECTIVES: To assess the clinical, social and economic effects of depot pipotiazine palmitate and undecylenate compared with placebo, oral antipsychotics and other depot antipsychotic preparations for people with schizophrenia. SEARCH STRATEGY: For this update we searched the Cochrane Schizophrenia Group's Register (June 2003). We also inspected references of all identified trials for more studies and contacted relevant industries. SELECTION CRITERIA: We included all randomised clinical trials comparing depot pipotiazine palmitate and undecylenate to oral antipsychotics or other depot preparations for people with schizophrenia. DATA COLLECTION AND ANALYSIS: We reliably selected, quality rated and independently extracted data from relevant studies. We calculated the random effects relative risk (RR), the 95% confidence intervals (CI) and, where possible the number needed to treat (NNT) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). We only presented scale data for those tools that had attained pre-specified levels of quality. MAIN RESULTS: When pipotiazine palmitate was compared with 'standard' oral antipsychotic no differences were found for outcomes of global impression (n=53, 1 RCT, RR 2.57, CI 0.8 to 8.6), relapse (n=124, 1 RCT, RR 1.55 CI 0.76 to 3.2), study attrition (n=219, 3 RCTs, RR 1.37 CI 0.8 to 2.4) and behaviour (n=124, 1 RCT, WMD 4.65, CI -1.1 to 10.4). There was also no reported difference in adverse effects such as tardive dyskinesia or the need for anticholinergic drugs. Sixteen studies compared pipotiazine palmitate with other depot preparations (n=1123). Pipotiazine palmitate was consistently equivalent to other depots in terms of a range of outcomes, including global impression (n=217, 4 RCTs, RR not improved 0.99 CI 0.91 to 1.07), relapse (n=239, 5 RCTs, RR relapse by 1 year 0.98 CI 0.55 to 1.75), and adverse effects (n=337, 5 RCTs, RR needing anticholinergic medication 0.98 CI 0.84 to 1.15). REVIEWERS' CONCLUSIONS: Although well-conducted and reported randomised trials are still needed to fully inform practice (no trial data exists reporting hospital and services outcomes, satisfaction with care and economics) pipotiazine palmitate is a viable choice for both clinician and recipient of care.

Administration, Oral↗
PubMed2000

Follow-up strategies for women treated for early breast cancer.

BACKGROUND: Follow-up examinations are commonly performed after primary treatment for women with breast cancer. They are used to detect recurrences at an early (asymptomatic) stage. OBJECTIVES: To assess the effectiveness of different policies of follow-up for distant metastases on mortality, morbidity and quality of life in women treated for early breast cancer. SEARCH STRATEGY: We searched the Breast Cancer Groups specialised register, the Cochrane Controlled Trials Register ( Cochrane Library Issue 4, 1999), MEDLINE (January 1975-September 1999) and EMBASE (1988-September 1999) using "Breast Neoplasms" and "follow-up". References from retrieved articles were also checked, as were the lists of presentations from recent breast cancer meetings. SELECTION CRITERIA: All randomised controlled trials (RCTs) assessing the effectiveness of different policies of follow-up after primary treatment were reviewed for inclusion. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and eligibility for inclusion in the review. Data were pooled in an individual patient data meta-analysis for the two RCTs testing the effectiveness of different follow-up schemes. Subgroup analyses by age, tumour size and lymph node status before primary treatment are also presented. MAIN RESULTS: Four RCTs involving 3204 women with early breast cancer (clinical stage I, II or III) have been included. Two RCTs involving 2563 women compared follow-up based on clinical visits and mammography with a more intensive scheme including radiological and laboratory tests. After pooling the data, no significant differences in overall survival (hazard ratio 0.96, 95% confidence interval 0.80 to 1.15) or disease-free survival (hazard ratio 0.84, 95% confidence interval 0.71 to 1.00) emerged. No differences in overall survival and disease-free survival emerged in subgroup analyses according to patient age, tumour size and lymph node status before primary treatment. One RCT (296 women) compared follow-up performed by a hospital-based specialist to follow-up performed by general practitioners. No significant differences in time to detection of recurrence and quality of life emerged. One RCT (196 women) compared regularly scheduled follow-up visits to less frequent visits restricted to the time of mammography. No significant differences emerged in interim use of telephone and frequency of GP's consultations. REVIEWER'S CONCLUSIONS: Follow-up programs based on regular physical examinations and yearly mammography alone appear to be as effective as more intensive approaches based on regular performance of laboratory and instrumental tests in terms of timeliness of recurrence detection, overall survival and quality of life. In one RCT, follow up care performed by general practitioners had comparable effectiveness to that delivered by hospital based specialists in terms of quality of life and time to detection of distant metastases.

Breast Neoplasms↗
PubMed2005

Follow-up strategies for women treated for early breast cancer.

BACKGROUND: Follow-up examinations are commonly performed after primary treatment for women with breast cancer. They are used to detect recurrences at an early (asymptomatic) stage. OBJECTIVES: To assess the effectiveness of different policies of follow-up for distant metastases on mortality, morbidity and quality of life in women treated for stage I, II or III breast cancer. SEARCH STRATEGY: We searched, the Breast Cancer Group's specialized register (May 14, 2004), the Cochrane Controlled Trial Register (Cochrane Library Issue 1, 2004), Medline (January 1966 - May 2004) and EMBASE (1988 - May 2004). References from retrieved articles were also checked. SELECTION CRITERIA: All randomised controlled trials (RCTs) assessing the effectiveness of different policies of follow-up after primary treatment were reviewed for inclusion. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and eligibility for inclusion in the review. Data were pooled in an individual patient data meta-analysis for the two RCTs testing the effectiveness of different follow-up schemes. Subgroup analyses were conducted by age, tumour size and lymph node status. MAIN RESULTS: Four RCTs involving 3055 women with breast cancer (clinical stage I, II or III) were included. Two of these involving 2563 women compared follow-up based on clinical visits and mammography with a more intensive scheme including radiological and laboratory tests. After pooling the data, no significant differences in overall survival (hazard ratio 0.96, 95% confidence interval 0.80 to 1.15) or disease-free survival (hazard ratio 0.84, 95% confidence interval 0.71 to 1.00) emerged. No differences in overall survival and disease-free survival emerged in subgroup analyses according to patient age, tumour size and lymph node status before primary treatment. In 1999, 10-year follow-up data became available for Rosselli Del Turco and no significant differences in overall survival were found. One RCT (296 women) compared follow-up performed by a hospital-based specialist to follow-up performed by general practitioners. No significant differences in time to detection of recurrence and quality of life emerged. Patient satisfaction was greater among patients treated by general practitioners. One RCT (196 women) compared regularly scheduled follow-up visits to less frequent visits restricted to the time of mammography. No significant differences emerged in interim use of telephone and frequency of GP's consultations. AUTHORS' CONCLUSIONS: This updated review of RCTs conducted almost 20 years ago suggest that follow-up programs based on regular physical examinations and yearly mammography alone are as effective as more intensive approaches based on regular performance of laboratory and instrumental tests in terms of timeliness of recurrence detection, overall survival and quality of life. In one RCT, follow-up care performed by trained general practitioners working in an organized practice setting had comparable effectiveness to that delivered by hospital-based specialists in terms of quality of life and time to detection of distant metastases.

Breast Neoplasms↗
PubMed2000

Inhaled nitric oxide for acute hypoxemic respiratory failure in children and adults.

OBJECTIVES: To determine the effect of iNO, compared with inhaled placebo, on outcome in AHRF in children and/or adults. SEARCH STRATEGY: Randomised controlled trials (RCT's) were identified from electronic databases; MEDLINE, EMBASE, the Cochrane Library, and CINAHL, as well as from bibliographies of retrieved articles. Relevant journals and conference proceedings were hand searched and authors published in this field were contacted for knowledge of unpublished ongoing trials. SELECTION CRITERIA: RCT's comparing iNO with maximal conventional therapy and inhaled placebo, for AHRF in either children or adults. DATA COLLECTION AND ANALYSIS: Data were extracted and the analyses performed independently by two reviewers. All 5 authors were contacted for missing data. Qualitative assessment of each trial was made according to methodology described by Schulz (Schulz 1995), and analyses according to statistical methods in Review Manager MetaView 3.1. The fixed effect model was applied. Where possible, sub-group analyses were performed to assess the impact of iNO in varied doses. MAIN RESULTS: Five RCT's were evaluated, assessing 535 patients with AHRF. Inhaled nitric oxide made no impact on mortality in trials without cross-over (RR 0.98, 95%CI 0.66, 1.44), or with cross-over of treatment failures to open-label iNO (RR 1.22, 95%CI 0.65, 2.29). Published evidence from one study demonstrated that iNO resulted in a transient improvement in oxygenation in the first 24 hours of treatment: the oxygenation index (OI) showed a mean difference of -3 [95% CI -5.354, -0.646], and PaO2/FiO2 ratio, a mean difference of 35 [95% CI 20.236, 49.764]. Limited data demonstrated no difference in ventilator-free days between treatment and placebo groups, and no specific dose of iNO was significantly advantageous over another. Other clinical indicators of effectiveness, such as duration of hospital and intensive care stay, were inconsistently reported. There were no complications reported to be directly attributable to this treatment. REVIEWER'S CONCLUSIONS: From the data provided to date, iNO had no effect on mortality and only transiently improved oxygenation in AHRF in children and/or adults. There was a lack of data to assess other end points. The long term adverse effects of this drug are not known, as no long term follow-up of trial participants has been reported. If further trials comparing iNO with an inhaled placebo are to proceed, they should be stratified for primary disease and must specifically evaluate clinically relevant outcomes, before any benefit of iNO in AHRF can be excluded.

Acute Disease↗
PubMed2002

Nebulised morphine for severe interstitial lung disease.

BACKGROUND: The evidence to support the use of nebulized morphine to improve dyspnoea and exercise limitation in terminally ill patients with chronic lung disease is conflicting. OBJECTIVES: To assess the effectiveness of nebulized morphine in reducing dyspnoea in patients with end-stage interstitial lung disease SEARCH STRATEGY: RCTs and good quality CCTs were identified by searching Medline, Embase, Cinahl as well as the Cochrane controlled clinical trial register. The following search terms were used: (inhaled OR nebulised)/AND/morphine AND/Idiopathic pulmonary fibrosis/or/pulmonary fibrosis/or/idiopathic interstitial pneumonia/or/nonspecific interstitial pneumonia/or/non-specific interstitial pneumonia/or/usual interstitial pneumonia/or/desquamative interstitial pneumonia/or/cryptogenic fibrosing alveolitis/or/interstitial pneumonia/or/idiopathic interstitial lung disease/or/chronic interstitial pneumonia SELECTION CRITERIA: Any RCT and adequate quality CCT in adult patients with ILD that compared nebulized morphine with a control group. DATA COLLECTION AND ANALYSIS: Only one small RCT was identified. MAIN RESULTS: Compared to placebo (normal saline), administration of low-dose nebulized morphine (2.5 and 5.0 mg) to six patients with ILD did not improve maximal exercise performance, and did not reduce dyspnoea during exercise. REVIEWER'S CONCLUSIONS: The hypothesis that nebulized morphine may reduce dyspnoea in patients with interstitial lung disease has not been confirmed in the single small RCT identified.

Analgesics, Opioid↗
PubMed2001

Domiciliary oxygen for interstitial lung disease.

BACKGROUND: Retrospective survival data have suggested poor effectiveness of oxygen therapy in patients with interstitial lung disease (ILD). OBJECTIVES: To determine the effect of domiciliary oxygen therapy on survival and quality of life in patients with a diagnosis of ILD and hypoxaemia. SEARCH STRATEGY: Randomized Controlled Trials (RCTs) were identified using the Cochrane Airways Group register and the search terms: (home OR domiciliary AND oxygen AND (Interstitial lung disease OR ILD OR pulmonary fibrosis OR IPF)). SELECTION CRITERIA: Any randomized controlled trial (RCT) in adult patients with hypoxaemia and ILD that compared long term domiciliary or home oxygen therapy with a control group. DATA COLLECTION AND ANALYSIS: Only one unpublished RCT was identified. MAIN RESULTS: Only one trial was identified. Mortality for both the oxygen treated and control groups was approximately 91% after 3 years (Peto odds ratio 0.99, 95% confidence intervals 0.16,6.26). The effect of oxygen therapy on quality of life and physiological parameters was not reported. REVIEWER'S CONCLUSIONS: The assumption that home oxygen therapy has a beneficial survival effect in patients with ILD has not been demonstrated in the single RCT identified.

Confidence Intervals↗
PubMed2002

Deep transverse friction massage for treating tendinitis.

BACKGROUND: Deep transverse friction massage (DTFM) is one of several physiotherapy interventions suggested for the management of pain due to iliotibial band friction syndrome (ITBFS). OBJECTIVES: To assess the effectiveness of DTFM for treating ITBFS observed in runners. SEARCH STRATEGY: We searched the Medline, Embase, Healthstar, Sports Discus, CINAHL, the Cochrane Controlled Trials Register, PEDro, the specialized registry of the Cochrane musculoskeletal group and the Cochrane field of Physical and Related Therapies up to the end of December 2000, using the sensitive search strategy developed by the Cochrane Collaboration. The search was complemented with bibliography searching of the reference list of the trials retrieved from the electronic search. Key experts in the area were contacted for further published and unpublished articles. SELECTION CRITERIA: All randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing therapeutic ultrasound against placebo or another active intervention in patients with patellofemoral pain syndrome were selected. DATA COLLECTION AND ANALYSIS: Two reviewers determined the studies to be included based on inclusion and exclusion criteria (LB, VR). Data were independently abstracted by two reviewers (VR, LB), and checked by a third reviewer (BS) using a pre-developed form of the Cochrane Musculoskeletal Group. The same two reviewers, using a validated scale, assessed the methodological quality of the RCTs and CCTs independently. Iliotibial band friction syndrome outcome measures were extracted from the publications. The pooled analysis was performed using weighted mean differences (WMDs) for pain relief as described as 1) daily pain; 2) pain while running and 3) percentage of maximum pain when running. A chi-square test was used to assess heterogeneity among trials. Fixed effects models were used throughout and random effects for outcomes showing heterogeneity. MAIN RESULTS: One RCT, including 17 patients with ITBFS was included. The experimental group (DTFM combined to rest, stretching exercises, cryotherapy and therapeutic ultrasound) (n=9) was compared to the control group (rest, stretching exercises, cryotherapy and therapeutic ultrasound only) (n=8). This trial showed no statistical difference in the three types of pain relief measured after four consecutive sessions of DTFM combined with other physiotherapy modalities for runners. Despite lack of statistical significance, there was a clinically important relative percentage difference in pain while running of 22%. REVIEWER'S CONCLUSIONS: DTFM combined with other physiotherapy modalities did not show consistent benefit over control of pain for runners experiencing ITBFS. These conclusions are limited by the low methodological quality of the one small sample size trial (n=17) included. No conclusions can be drawn about the use or non use of DTFM for the treatment of ITBFS. Future trials, utilizing appropriate methods and adequate sample sizes are needed before conclusions can be drawn regarding the effect of massage on iliotibial band friction syndrome.

Clinical Trials as Topic↗
PubMed2002

Patient education for adults with rheumatoid arthritis.

BACKGROUND: Because of the unpredictability people with arthritis face on a daily basis, patient education programmes have become an effective complement to traditional medical treatment giving people with arthritis the strategies and the tools necessary to make daily decisions to cope with the disease. OBJECTIVES: To assess the effectiveness of patient education interventions on health status in patients with rheumatoid arthritis. SEARCH STRATEGY: We searched MEDLINE, EMBASE and PsycINFO and the Cochrane Controlled Trials Register. A selection of review articles (see references) were examined to identify further relevant publications. There was no language restriction. SELECTION CRITERIA: Randomised controlled trials (RCT's) evaluating patient education interventions that included an instructional component and a non-intervention control group; pre- and post-test results available separately for RA, either in the publication or from the studies' authors; and study results presented in full, end-of-study report. MAIN RESULTS: Twenty-four studies with relevant data were included. We found significant effects of patient education at first follow-up for scores on disability, joint counts, patient global assessment and psychological status. Physician global assessment was not assessed in any of the included studies. The two separate dimensions of psychological status: anxiety and depression showed no significant effects, nor did the dimensions of pain and disease activity. At final follow up no significant effects of patient education were found. REVIEWER'S CONCLUSIONS: Patient education as provided in the studies reviewed here had moderate short-term effects on patient global assessment, and small short-term effects on disability, joint counts and psychological status. There were no long-term benefits.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2004

Non-surgical interventions for eosinophilic oesophagitis.

BACKGROUND: Patients with eosinophilic oesophagitis (EO) present with difficulty swallowing, vomiting, regurgitation, chest and/or abdominal pain. People with EO frequently fail to respond to treatment with gastric acid suppressants or anti-reflux surgery. OBJECTIVES: To evaluate the benefits and harms of medical interventions for eosinophilic oesophagitis. SEARCH STRATEGY: We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group trials register (The Cochrane Library Issue 1, 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to February 2004) and EMBASE (1980 to February 2004). SELECTION CRITERIA: Randomised controlled trials were included if they compared a medical or dietary intervention for eosinophilic oesophagitis with a placebo or one medical intervention with another medical intervention. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened the title of abstracts. MAIN RESULTS: No completed RCTs were found in the published literature. We found one abstract reporting preliminary data from an RCT (not completed) comparing oral prednisolone with topical (swallowed metered dose) fluticasone in children. In this study (50 children enrolled to date) healing rates of oesophagitis and symptom resolution with fluticasone were similar to those with prednisolone. For another ongoing RCT, comparing the efficacy of swallowed fluticasone with placebo for eosinophilic oesophagitis in males and females aged 3 to 21 years no results are available. REVIEWERS' CONCLUSIONS: The lack of completed RCT's makes it impossible to compare the relative benefits and harms of the wide range of medical interventions currently used for treating EO. Published case series suggest that an elemental diet, oral steroids and topical steroids all offer some benefits. However, lack of a comparison group in these studies makes it impossible to evaluate the effect of these interventions.

Androstadienes↗
PubMed2004

Fetal pulse oximetry for fetal assessment in labour.

BACKGROUND: Fetal pulse oximetry (FPO) may contribute to the evaluation of fetal well-being during labour. OBJECTIVES: To compare the effectiveness and safety of FPO with conventional surveillance techniques, using the results of randomised controlled trials. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (31 July 2004) and conducted a systematic literature search of MEDLINE (1994 to July 2004), EMBASE (1994 to July 2004) and Current Contents (1994 to July 2004). SELECTION CRITERIA: All published and unpublished randomised controlled trials (RCTs) that compared maternal and fetal/neonatal/infant outcomes when FPO was used in labour, with or without concurrent use of conventional fetal surveillance, compared with using cardiotocography (CTG) alone. DATA COLLECTION AND ANALYSIS: Two independent reviewers performed data extraction. Analyses were performed on an intention-to-treat basis. We sought additional information from the investigators of the one reported trial. MAIN RESULTS: One published RCT (comparing FPO and CTG with CTG alone) was included; and two ongoing RCTs were identified. The single included RCT reported on 1010 cases. Unpublished pilot data were available for some outcomes to give a total of 1190 cases. There was no difference in the overall caesarean section rate between the two groups (relative risk (RR) 1.12, 95% confidence interval (CI) 0.91 to 1.37). There were less caesarean sections for nonreassuring fetal status in the FPO plus CTG group compared with the CTG only group (RR 0.45, 95% CI 0.28 to 0.72). The only reported neonatal seizure occurred in the CTG only group (RR 0.29 95% CI 0.01 to 7.08). Use of FPO with CTG decreased operative delivery (caesarean section, forceps, vacuum) for nonreassuring fetal status (RR 0.71, 95% CI 0.55 to 0.93) compared with CTG alone. No differences were seen for overall operative deliveries, endometritis, intrapartum or postpartum haemorrhage, uterine rupture, low Apgar scores, umbilical arterial pH or base excess, admission to the neonatal intensive care unit or fetal/neonatal death. REVIEWERS' CONCLUSIONS: The one published RCT reported that FPO decreased the caesarean section rate and operative delivery rates for nonreassuring fetal status, without adversely affecting maternal or fetal/neonatal outcomes. However, no difference was seen in the overall caesarean section (CS) or operative delivery rates because more CS were performed for dystocia in the FPO group. Further RCTs may address dystocia in labours monitored with FPO, maternal satisfaction with fetal monitoring and labour, long-term neurodevelopmental outcome of infants who exhibited nonreassuring fetal status in labour and costs of FPO.

Cardiotocography↗
PubMed2004

Alcohol ignition interlock programmes for reducing drink driving recidivism.

BACKGROUND: An ignition interlock device is part of a multi-dimensional programme aimed at reducing recidivism in convicted drink drivers. To operate a vehicle equipped with an ignition interlock device, the driver must first provide a breath specimen. If the breath alcohol concentration of the specimen exceeds the predetermined level, the vehicle will not start. As a measure to reduce circumvention of the device (i.e. someone else blows into the mouthpiece), random retests are required while the vehicle is running. Other components of the drink driving programme include information seminars for the driver and downloading data from the device's data logger, which logs all test attempts and records all passes, warnings and failures. OBJECTIVES: To systematically assess the effectiveness of ignition interlock programmes on recidivism rates of drink drivers, by examining rates of recidivism while the ignition interlock device was installed in the vehicle and after removal of the device. SEARCH STRATEGY: The Cochrane Controlled Trials Register was searched, in addition to relevant electronic databases and the Internet. SELECTION CRITERIA: Controlled trials in which offenders have been charged with drink driving and have either been sentenced to participate in an ignition interlock programme or the usual punishment (either licence suspension or some form of treatment programme). This study was not restricted by language or status of publication. DATA COLLECTION AND ANALYSIS: One randomised controlled trial (RCT) and ten controlled trials were identified, and also three ongoing trials. Data regarding recidivism while the interlock is installed in the vehicle; after the interlock has been removed from the vehicle and total recidivism during the study were extracted and entered into analyses using RevMan. MAIN RESULTS: The RCT showed that the interlock programme was effective while the device was installed in the vehicle; relative risk 0.36 (95% confidence interval 0.21 to 0.63). Controlled trials support this conclusion, with a general trend - in both first-time and repeat offenders - towards lower recidivism rates when the interlock device is installed. Neither the RCT nor the controlled trials provide evidence for any effectiveness of the programmes continuing once the device has been removed. REVIEWERS' CONCLUSIONS: In order to eliminate potential selection bias, more RCTs need to be conducted in this area so that effectiveness, as well as efficacy, can be ascertained. The interlock programme appears to be effective while the device is installed in the vehicle of the offender. Studies need to address ways of improving recidivism rates in the long term, as the major challenges are participation rates, compliance and durability.

Alcohol Drinking↗
PubMed2026

Magnesium sulphate for women at risk of preterm birth for neuroprotection of the fetus.

BACKGROUND: Magnesium sulphate is a common therapy in perinatal care. Its benefits when given to women at risk of preterm birth for fetal neuroprotection (prevention of cerebral palsy for children) were shown in a 2009 Cochrane review. Internationally, use of magnesium sulphate for preterm cerebral palsy prevention is now recommended practice. As new randomised controlled trials (RCTs) and longer-term follow-up of prior RCTs have since been conducted, this review updates the previously published version. OBJECTIVES: To assess the effectiveness and safety of magnesium sulphate as a fetal neuroprotective agent when given to women considered to be at risk of preterm birth. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 17 March 2023, as well as reference lists of retrieved studies. SELECTION CRITERIA: We included RCTs and cluster-RCTs of women at risk of preterm birth that assessed prenatal magnesium sulphate for fetal neuroprotection compared with placebo or no treatment. All methods of administration (intravenous, intramuscular, and oral) were eligible. We did not include studies where magnesium sulphate was used with the primary aim of preterm labour tocolysis, or the prevention and/or treatment of eclampsia. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed RCTs for inclusion, extracted data, and assessed risk of bias and trustworthiness. Dichotomous data were presented as summary risk ratios (RR) with 95% confidence intervals (CI), and continuous data were presented as mean differences with 95% CI. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included six RCTs (5917 women and their 6759 fetuses alive at randomisation). All RCTs were conducted in high-income countries. The RCTs compared magnesium sulphate with placebo in women at risk of preterm birth at less than 34 weeks' gestation; however, treatment regimens and inclusion/exclusion criteria varied. Though the RCTs were at an overall low risk of bias, the certainty of evidence ranged from high to very low, due to concerns regarding study limitations, imprecision, and inconsistency. Primary outcomes for infants/children: Up to two years' corrected age, magnesium sulphate compared with placebo reduced cerebral palsy (RR 0.71, 95% CI 0.57 to 0.89; 6 RCTs, 6107 children; number needed to treat for additional beneficial outcome (NNTB) 60, 95% CI 41 to 158) and death or cerebral palsy (RR 0.87, 95% CI 0.77 to 0.98; 6 RCTs, 6481 children; NNTB 56, 95% CI 32 to 363) (both high-certainty evidence). Magnesium sulphate probably resulted in little to no difference in death (fetal, neonatal, or later) (RR 0.96, 95% CI 0.82 to 1.13; 6 RCTs, 6759 children); major neurodevelopmental disability (RR 1.09, 95% CI 0.83 to 1.44; 1 RCT, 987 children); or death or major neurodevelopmental disability (RR 0.95, 95% CI 0.85 to 1.07; 3 RCTs, 4279 children) (all moderate-certainty evidence). At early school age, magnesium sulphate may have resulted in little to no difference in death (fetal, neonatal, or later) (RR 0.82, 95% CI 0.66 to 1.02; 2 RCTs, 1758 children); cerebral palsy (RR 0.99, 95% CI 0.69 to 1.41; 2 RCTs, 1038 children); death or cerebral palsy (RR 0.90, 95% CI 0.67 to 1.20; 1 RCT, 503 children); and death or major neurodevelopmental disability (RR 0.81, 95% CI 0.59 to 1.12; 1 RCT, 503 children) (all low-certainty evidence). Magnesium sulphate may also have resulted in little to no difference in major neurodevelopmental disability, but the evidence is very uncertain (average RR 0.92, 95% CI 0.53 to 1.62; 2 RCTs, 940 children; very low-certainty evidence). Secondary outcomes for infants/children: Magnesium sulphate probably resulted in little to no difference in severe intraventricular haemorrhage (grade 3 or 4) (RR 0.81, 95% CI 0.64 to 1.04; 6 RCTs, 6542 infants; moderate-certainty evidence) and may have resulted in little to no difference in chronic lung disease/bronchopulmonary dysplasia (average RR 0.92, 95% CI 0.77 to 1.10; 5 RCTs, 6689 infants; low-certainty evidence). Primary outcomes for women: Magnesium sulphate may have resulted in little or no difference in severe maternal outcomes potentially related to treatment (death, cardiac arrest, respiratory arrest) (RR 0.32, 95% CI 0.01 to 7.92; 4 RCTs, 5300 women; low-certainty evidence). However, magnesium sulphate probably increased maternal adverse effects severe enough to stop treatment (average RR 3.21, 95% CI 1.88 to 5.48; 3 RCTs, 4736 women; moderate-certainty evidence). Secondary outcomes for women: Magnesium sulphate probably resulted in little to no difference in caesarean section (RR 0.96, 95% CI 0.91 to 1.02; 5 RCTs, 5861 women) and postpartum haemorrhage (RR 0.94, 95% CI 0.80 to 1.09; 2 RCTs, 2495 women) (both moderate-certainty evidence). Breastfeeding at hospital discharge and women's views of treatment were not reported. AUTHORS' CONCLUSIONS: The currently available evidence indicates that magnesium sulphate for women at risk of preterm birth for neuroprotection of the fetus, compared with placebo, reduces cerebral palsy, and death or cerebral palsy, in children up to two years' corrected age. Magnesium sulphate may result in little to no difference in outcomes in children at school age. While magnesium sulphate may result in little to no difference in severe maternal outcomes (death, cardiac arrest, respiratory arrest), it probably increases maternal adverse effects severe enough to stop treatment. Further research is needed on the longer-term benefits and harms for children, into adolescence and adulthood. Additional studies to determine variation in effects by characteristics of women treated and magnesium sulphate regimens used, along with the generalisability of findings to low- and middle-income countries, should be considered.

Humans↗
PubMed2004

Early Intervention for psychosis.

BACKGROUND: Proponents of early intervention have argued that outcome might be improved if more therapeutic effort were focused on the early stages of schizophrenia. Early intervention in schizophrenia has two elements that are distinct from standard care: early detection and phase-specific treatment. Both elements may be offered in addition to standard care, or may be provided by a specialised early intervention team. Early intervention is now well established as a therapeutic approach in America, Europe and Australasia, but it is unclear how far early detection, phase-specific treatments, and the use of early intervention teams are underpinned by evidence of effectiveness. OBJECTIVES: This review aims to evaluate the effects of: i. early detection and treatment of people with prodromal symptoms; ii. the use of early intervention teams for people in their first episode of psychosis; and iii. phase-specific treatments for people in their first episode of psychosis. SEARCH STRATEGY: We searched CINAHL (1982-2002), The Cochrane Controlled Trials Register (November 2001), The Cochrane Schizophrenia Group Register (July 2003), EMBASE (1980-2002), MEDLINE (1966-2002), PsycINFO (1967-2002), reference lists and contacted the European First Episode Network (2003). SELECTION CRITERIA: Randomised controlled trials designed to prevent progression to psychosis in people showing prodromal symptoms, or improve outcome for people with first episode psychosis. Eligible interventions, alone and in combination, included early detection, phase-specific treatments, and care from specialised early intervention teams. Non-randomised trials would only have been included if they had been studies of the effects of early detection strategies in reducing the duration of untreated psychosis (since this issue cannot be addressed by simple randomisation). DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers and cross-checked. Relative risks (RR) and 95% confidence intervals (CI) were calculated for dichotomous data. Weighted mean differences (WMD) were calculated for continuous data. MAIN RESULTS: In theory, seventeen different comparisons are possible, but the review only identified three studies that met inclusion criteria. One small trial (n=59) was concerned with a phase-specific intervention (low dose risperidone and cognitive behavioural therapy) for people with prodromal symptoms. This group were significantly less likely to develop psychosis at 6 month follow up than people who only received care from a specialised team which did not involve phase-specific treatment (n=59, 1 RCT, RR 0.27 CI 0.08 to 0.89, NNT 4 CI 2 to 20). This effect was not significant at 12 month follow up (n=59, 1 RCT, RR 0.54 CI 0.23 to 1.30). Another trial found that people in their first episode receiving a phase-specific intervention (family therapy) plus out patient care did have reduced admission rates care compared with those who received only outpatient care (n=83, 1 RCT, RR 0.28 CI 0.13 to 0.62, NNT 3 CI 2 to 6). The applicability of this finding was, however, questionable.Finally, one last study (n=76), comparing phase-specific intervention (family therapy) plus specialised team with specialised team for people in their first episode of schizophrenia found no difference between intervention and control groups at 12 months for the outcome of relapse but confidence intervals were wide (n=76, RR 1.06 CI 0.31 to 3.65). REVIEWERS' CONCLUSIONS: We identified insufficient trials to draw any definitive conclusions, although five ongoing trials should report shortly. The substantial international interest in early intervention offers an opportunity to make major positive changes in psychiatric practice, but this opportunity may be missed without a concerted international programme of research to address key unanswered questions.

Humans↗
PubMed2004

Psychological interventions for those who have sexually offended or are at risk of offending.

BACKGROUND: Sexual offending is both a social problem and a public health issue. To date, no positive treatment effects have been found in quasi-experimental institutional treatment programmes. OBJECTIVES: To evaluate effects of psychological interventions on target sexual acts, urges or thoughts for people who have been convicted, or cautioned, for sexual offences. SEARCH STRATEGY: 33 electronic databases including the Cochrane Controlled Trials Register (Issue 4, 2002) were searched. Relevant authors and organisations were contacted for additional data. SELECTION CRITERIA: Randomised controlled trials (RCTs) involving adults treated in institutional or community settings for sexual behaviours that have resulted in conviction or caution for sexual offences, or offences or violent behaviours with a sexual element. Behavioural, cognitive-behavioural, psychodynamic, and psychoanalytic therapies were compared with each other, drug treatment, or standard care. DATA COLLECTION AND ANALYSIS: Independent assessors selected and assessed studies and extracted data. Data were excluded where more than 50% of participants were lost to follow-up. For binary outcomes, standard estimations of risk ratio (RR) and their 95% confidence intervals (CI) were calculated. Where possible, number-needed-to-treat or harm statistics (NNT, NNH) and their 95% CIs were calculated. MAIN RESULTS: We included nine RCTs with over 500 male offenders, 231 of whom have been followed up for a decade. Cognitive behavioural therapy (CBT) in groups may reduce re-offence at one year for child molesters when compared with standard care (n=155, 1 RCT, RR any sexual/violent crime - 0.41 CI 0.2 to 0.82, NNT 6 CI 3 to 20). However, when CBT was compared with a trans-theoretical counselling group therapy the former may have increased poor attitudes to treatment (corrected n=38, 1 RCT, RR 2.8 CI 1.26 to 6.22, NNH 2 CI 1 to 5). The largest trial compared broadly psychodynamic group therapy with no treatment for 231 men guilty of paedophilia, exhibitionism or sexual assault. Re-arrest over ten years was greater for those allocated to group therapy (result not statistically significant [n=231, 1 RCT, RR 1.87 CI 0.78 to 4.47]). REVIEWERS' CONCLUSIONS: Limited data make recommendations difficult. One study suggests that a cognitive approach results in a decline in re-offending after one year. Another large study shows no benefit for group therapy and suggests the potential for harm at ten years. The ethics of providing this still-experimental treatment to a vulnerable and potentially dangerous group of people outside of a well-designed evaluative study are debatable. This review proves such studies are possible.

Humans↗
PubMed2004

Glucocorticoids for acute viral bronchiolitis in infants and young children.

BACKGROUND: Systemic glucocorticoids have been widely prescribed for use in infants and young children with acute viral bronchiolitis but the actual benefit of this intervention requires clarification. OBJECTIVES: To systematically review the evidence on the effectiveness of systemic glucocorticoids for the treatment of infants and young children with acute viral bronchiolitis. SEARCH STRATEGY: Multiple strategies were incorporated to maximize identification of suitable studies. The following databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2003); MEDLINE (January 1966 to September 2003); Current Contents (1998 to 2000); EMBASE (January 1990 to September 2003); and Sci Search. Handsearches through cited references and contacts with experts were also used. SELECTION CRITERIA: Only randomised controlled trials (RCT) were eligible for inclusion. Studies were included if participants were diagnosed with acute viral bronchiolitis and treated with systemic (oral, intramuscular or intravenous) corticosteroids. Three reviewers independently selected potentially relevant articles. Four reviewers evaluated these studies, determined eligibility and assessed the methodological quality of each RCT. DATA COLLECTION AND ANALYSIS: The primary outcome of interest was length of hospital stay (LOS). Secondary outcomes were: respiratory rate, haemoglobin oxygen saturation, and hospital admission and revisit rates. Data were extracted independently by the four reviewers and the results compiled and compared. Two reviewers reassessed studies to clarify points of discrepancy in the data extraction and database entry processes. Missing data were requested from the authors or calculated from other data presented in the study report. MAIN RESULTS: There was complete agreement on the inclusion of 13 trials and the exclusion of five studies. Two main study recruitment groups were identified: a) infants and young children within the first 48 hours of hospitalisation (10 trials), and b) outpatient infants and young children who were randomised from the emergency department and who may nor may not have required hospital admission (three trials).A total of 1,198 children aged 0 to 30 months were treated with the equivalent of 0.5 to 10 mg/kg of systemic prednisone for two to seven days. Outcomes of interest were not measured in each RCT. In the pooled analysis of seven trials, there was a decrease in LOS in treated children of 0.38 days (95% confidence interval (CI) -0.81 to 0.05), indicating no significant difference between treatment groups. In the pooled analysis of eight trials, the day three clinical score measured: a standard mean difference (SMD) of -0.20 (95% CI -0.73 to 0.32), indicating no difference between treatment groups. Subgroup analyses for base LOS and clinical score outcomes were performed on infants who were a) less than 12 months of age, b) all respiratory syncytial virus (RSV) positive, c) treated with less than 6 mg/kg of prednisone equivalent throughout the illness and d) first-time wheezers. These were limited by the small number of studies in each subgroup. Hospital admission rates were examined in three trials and no difference was seen between treatment groups (odds ratio (OR) 1.05 (95% CI 0.23 to 4.87). Readmission rates were reported in six studies; with no significant differences between treatment groups. Hospital revisit rates were reported in three studies, with a significant difference between treatment groups reported in one study only. The respiratory rate and haemoglobin oxygen saturation were reported descriptively in six RCTs; no differences were found between groups. Co-interventions (oxygen, supportive fluids and bronchodilators) were used similarly between treatment groups in all RCTs. REVIEWERS' CONCLUSIONS: No benefits were found in either LOS or clinical score in infants and young children treated with systemic glucocorticoids as compared to placebo. There were no differences in these outcomes between treatment groups; either in the pooled groups; either in the pooled analysis or in any of the sub analyses. Among the three studies evaluating hospital admission rates following the initial hospital visit there was no difference between treatment groups. There were no differences found in respiratory rate, haemoglobin oxygen saturation, hospital revisit or readmission rates. Subgroup analyses were significantly limited by the low number of studies in each comparison. Marked study heterogeneity and occasionally conflicting direction of benefit between trials suggests that these results should be interpreted with caution. Specific data on the harm of corticosteroid therapy in this patient population are lacking. Available evidence suggests that corticosteroid therapy is not of benefit in this patient group.

Acute Disease↗
PubMed2005

Zuclopenthixol dihydrochloride for schizophrenia.

BACKGROUND: Zuclopenthixol dihydrochloride, given orally, is commonly used for managing the signs and symptoms of schizophrenia. OBJECTIVES: To determine the effects of zuclopenthixol dhydrochloride for treatment of schizophrenia. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's register (December 2004). This register is compiled of methodical searches of BIOSIS, CINAHL, Dissertation abstracts, EMBASE, LILACS, MEDLINE, PSYNDEX, PsycINFO, RUSSMED, Sociofile, supplemented with hand searching of relevant journals and numerous conference proceedings. To identify further trials we also contacted a pharmaceutical company and authors of relevant studies. SELECTION CRITERIA: We included all randomised controlled trials comparing zuclopenthixol dihydrocodine with antipsychotics or with placebo (or no intervention) for treatment of schizophrenia and/or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: We independently inspected citations and abstracts, ordered papers, re-inspected and quality assessed articles and extracted data. For dichotomous data we calculated relative risks (RR) and the 95% confidence intervals (CI) and the number needed to treat (NNT) or number needed to harm statistics. For continuous data we calculated weighted mean differences with 95% CIs for non-skewed data. MAIN RESULTS: We included eighteen trials involving 1578 people. Two trials compared zuclopenthixol with placebo and neither reported global or mental state outcomes. People allocated zuclopenthixol did have increased risk of experiencing extraparamydal symptoms compared with placebo (n=64, RR 5.37, CI 1.12 to 29.34 NNH 2 CI 2 to 31). Ten short trials (total n=478) compared zuclopenthixol with other typical antipsychotics. Risk of being unchanged or worse was decreased by allocation to zuclopenthixol (n=357, 7 RCTs, RR 0.72 CI 0.53 to 0.98, NNT 10 CI 6 to 131). No findings suggest any clear difference between zuclopenthixol and other typical antipsycotics across a whole range of adverse effects, including movement disorders (n=280, 6 RCTs, RR needing additional antiparkinsonian medication 1.07 CI 0.86 to 1.33) and general agitation (n=162, 3 RCTs, RR needing treatment with hypnotic/sedative drugs 1.09 CI 0.76 to 1.56). Fewer people allocated zuclopenthixol left in the short term compared with those given other typical antipsychotics (n=424, 22% vs 30%, 8 RCTs, RR 0.70 CI 0.51 to 0.95, NNT 12 CI 7 to 67). Three short trials (total n=233) compared zuclopenthixol with atypical antipsychotics. Zuclopenthixol was associated with no greater risk of being unchanged or worse compared with risperidone (n=98, 1 RCT, RR 1.30 CI 0.80 to 2.11). People allocated zuclopenthixol were prescribed antiparkinsonian medication more frequently compared to those treated with risperidone (n=98, 1 RCT, RR 1.92 CI 1.12 to 3.28, NNH 3 CI 3 to 17). Weight gain was equal for people allocated zuclopenthixol and those given sulpiride (n=61, 1 RCT, WMD 1.60 CI 8.35 to 5.15). Many people left these short studies early (45% zuclopenthixol vs 30% risperidone, n=159, 2 RCTs, RR 1.48 CI 0.98 to 2.22). The two isomers of zuclopenthixol, when compared in four short studies (total n=140), did not result in clearly different outcomes. AUTHORS' CONCLUSIONS: There is an indication that zuclopenthixol causes movement disorders, perhaps more so than the newer generation of drugs, though no more frequently than the older generation of antipsychotics. There is some suggestion from this review that oral zuclopenthixol may have some clinical advantage, at least in the short term, over other older drugs in terms of global state. If an older drug is going to be prescribed, zuclopenthixol dihydrochloride is a viable option but may be best taken with additional medication to offset movement disorders that occur in about half the people taking this drug. There is no information on service, functional, behavioural outcomes and important outcomes such as relapse, for such a widely used drug this would indicate the need for further studies. We feel that it should remain a choice in the treatment of those for whom older generation drugs are indicated.

Antipsychotic Agents↗
PubMed2006

Lamotrigine for schizophrenia.

BACKGROUND: Treating the 20-30% of people with schizophrenia whose symptoms are resistant to treatment can be problematic. Adding lamotrigine to ongoing antipsychotic treatment has shown to be of benefit in preliminary studies. OBJECTIVES: To evaluate the effects of adjuvant lamotrigine for people with schizophrenia and schizophrenia-like psychoses. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's Register (February 2006) and inspected references of all identified studies for further trials. We contacted relevant authors of trials for additional information. SELECTION CRITERIA: We included all clinical randomised trials comparing lamotrigine with placebo or other antipsychotic augmentation strategies. DATA COLLECTION AND ANALYSIS: We extracted data independently. For homogenous dichotomous data we calculated random effects relative risk (RR), 95% confidence intervals (CI) and, where appropriate, numbers needed to treat (NNT) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). MAIN RESULTS: We found five relevant trials (total n=537), but no usable data on service outcomes, general functioning, behaviour, engagement with services, satisfaction with treatment or economic outcomes. Overall, reporting of data was poor. Those data we were able to use suggested that equal proportions of people allocated lamotrigine or placebo had no global response (n=208, 1 RCT, RR 1.06 CI 0.73 to 1.54). There was no significant difference between groups in the proportions of people whose mental state did not improve (n=297, 3 RCT, RR 1.26 CI 0.81 to 1.97). There was, however, a significant reduction in the PANSS total scores (n=67, 2 RCT, WMD -16.88 CI -8.57 to -25.18, p=0.0001), positive symptom sub-scale scores (n=65, 2 RCTs, WMD -5.10 CI -8.86 to -1.34) and negative symptom sub-scale scores (n=67, 2 RCTs, WMD -5.25, CI -7.07 to -3.43). Most cognitive measures showed no differences (n=329, 2 RCTs, RR not attaining BACS composite score of 0.5 1.10 CI 0.59 to 2.04). The proportion of participants leaving studies was about 25% at 12 weeks (n=537, 5 RCTs, RR 0.96 CI 0.71 to 1.29). The lamotrigine group did experience the outcome of any adverse effects significantly more frequent than people allocated placebo (n=429, 2 RCTs, RR 1.19 CI 1.02 to 1.38, NNH 10 CI 5 to 90). Among the many effects listed, only nausea was found to be significantly more (9%) in the lamotrigine group compared with placebo (n=465, 3 RCTs, RR 2.26 CI 1.05 to 4.88). AUTHORS' CONCLUSIONS: Evidence for use of lamotrigine as an adjuvant for people with schizophrenia is not robust and large well-designed, conducted and reported real-world randomised trials are needed to determine its place in everyday clinical practice.

Antipsychotic Agents↗
PubMed2006

Interventions for replacing missing teeth: dental implants in fresh extraction sockets (immediate, immediate-delayed and delayed implants).

BACKGROUND: Dental implants can be placed in fresh sockets just after tooth extraction. These are called 'immediate' implants. 'Immediate-delayed' implants are those implants inserted after weeks up to about a couple of months to allow for soft tissue healing. 'Delayed' implants are those placed thereafter in partially or completely healed bone. The advantages of immediate implants are that treatment time can be shortened and that bone height might be maintained thus possibly improving the aesthetic results. The potential disadvantages are an increased risk of infection and failures of the immediately placed implants. OBJECTIVES: To evaluate success, function, complications and patient satisfaction between 'immediate', 'immediate-delayed' and 'delayed' implants. SEARCH STRATEGY: The Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE were searched. Several dental journals were handsearched. The bibliographies of review articles were checked, and personal references were searched. More than 55 implant manufacturing companies were also contacted. Last electronic search was conducted on 7 August 2006. SELECTION CRITERIA: Randomised controlled trials (RCTs) and preference RCT evaluating immediate, immediate-delayed, and delayed implants, reporting the outcome of the interventions to at least 1 year after functional loading. DATA COLLECTION AND ANALYSIS: Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted independently and in duplicate. Authors were contacted for any missing information. Results were expressed as random-effects models using mean differences for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals (CIs). The statistical unit of the analysis was the patient. MAIN RESULTS: Two RCTs were included. One RCT compared immediate implants placed in periapical infected sites versus delayed implants in 50 patients and after 1 year found no statistically significant differences. The second RCT compared immediate-delayed versus immediate implants in 46 patients. After 1 year and a half there were no statistically significant differences for prosthesis and implant failures, complications, aesthetics assessed by the patient and the papilla height assessed by the dentist. However, patients in the delayed group perceiving the period between tooth extraction and insertion of the crown significantly longer than patients in the immediate-delayed group, mean difference of VAS -20.30 (95% CI -33.36 to -7.24). There was also statistically significantly higher patient satisfaction in the immediate-delayed group, mean difference (VAS) -6.51 (95% CI -12.63 to -0.39). An independent blinded assessor judged the level of the perimplant marginal mucosa in relation to that of the adjacent teeth as more appropriate in the immediate-delayed group, with risk ratio (RR) 1.68 (95% CI 1.04 to 2.72). AUTHORS' CONCLUSIONS: Despite that the evidence is derived from only two RCTs with a limited number of patients, it is possible to suggest that immediate implants and immediate-delayed implants may offer some advantages over conventional implants in healed sites in terms of patient satisfaction and aesthetics possibly by preserving alveolar bone. Immediate implants can work and are able to shorten treatment periods, however properly designed RCTs are still needed to fully evaluate the potential advantages and risks of this treatment modality since more complications and failures may occur.

Dental Implantation, Endosseous↗