Abstract:
BACKGROUND:Bifeprunox is a novel antipsychotic drug designed to treat schizophrenia. However, research into the drug was ceased in 2009 due to rejection of licence to go to market by the US Food and Drug Administration (FDA), who could not approve the drug for acute or long-term symptoms of schizophrenia because more research was required to demonstrate convincing effects "beyond those already achieved" with currently licenced drugs. There were also concerns expressed over one death of a person whilst on the drug. OBJECTIVES:To investigate the clinical and adverse effects of bifeprunox for people with schizophrenia. SEARCH METHODS:We searched the Cochrane Schizophrenia Group's Trials Register on 23 October 2015, which is based on regular searches of MEDLINE, EMBASE, CINAHL, BIOSIS, AMED, PubMed, PsycINFO, and clinical trials registries. There are no language, date, document type, or publication status limitations for inclusion of records in the register. SELECTION CRITERIA:All randomised clinical trials focusing on bifeprunox versus placebo for schizophrenia. DATA COLLECTION AND ANALYSIS:We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a random-effects model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. MAIN RESULTS:We included four randomised controlled trials (RCTs). We found evidence of missing data and poor reporting. When bifeprunox 20 mg was compared with placebo for schizophrenia, the drug resulted in a reduction of the Positive and Negative Syndrome Scale (PANSS) positive subscale score regarding positive symptoms (n = 549, 2 RCTs, MD -1.89, 95% CI -2.85 to -0.92, low-quality evidence) and the PANSS negative subscale regarding negative symptoms (n = 549, 2 RCTs, MD -1.53, 95% CI -2.37 to -0.69, low-quality evidence). There was a clear improvement regarding deterioration in the bifeprunox 20 mg group (n = 231, 1 RCT, RR 0.71 95% CI, 0.54 to 0.93, very low-quality evidence). The total number of participants with equal to or greater than 7% weight increase was similar between bifeprunox and placebo (n = 483, 1 RCT, RR 1.02 95% CI 0.31 to 3.33 moderate-quality evidence). There were no useable data for quality of life, economic outcomes, and service use. AUTHORS' CONCLUSIONS:Our results showed some positive effects and a favourable adverse effect profile for bifeprunox, although there were few data overall and none were of high quality. It would seem that these data alone would not have been enough for the FDA to decide to halt progress of the drug to market. We can only assume that we are missing important data. Both the FDA and the relevant pharmaceutical companies have not made all relevant data accessible. As some of these trials also involved an additional haloperidol, olanzapine, quetiapine, or risperidone arm, these data are not only relevant to evaluation of bifeprunox. In not making all data accessible, it is hard to see how the FDA and the drug companies have fulfilled their full obligations to people with schizophrenia or their clinicians.
journal_name
Cochrane Database Syst Revjournal_title
The Cochrane database of systematic reviewsauthors
Chattopadhyay A,Frey S,Green Gdoi
10.1002/14651858.CD012029.pub2subject
Has Abstractpub_date
2016-10-12 00:00:00pages
CD012029issn
1469-493Xjournal_volume
10pub_type
杂志文章,meta分析,评审abstract:BACKGROUND:Portal hypertension commonly accompanies advanced liver disease and often gives rise to life-threatening complications, including bleeding (haemorrhage) from oesophageal and gastrointestinal varices. Variceal bleeding commonly occurs in children with chronic liver disease or portal vein obstruction. Therefor...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析
doi:10.1002/14651858.CD011573.pub2
更新日期:2020-03-05 00:00:00
abstract:BACKGROUND:Many people with atopic eczema are reluctant to use the most commonly recommended treatments because they fear the long-term health effects. As a result, many turn to dietary supplements as a possible treatment approach, often with the belief that some essential ingredient is 'missing' in their diet. Various...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD005205.pub3
更新日期:2012-02-15 00:00:00
abstract:BACKGROUND:Lateral and posterior position of the baby's head (the back of the baby's head facing to the mother's side or back) may be associated with more painful, prolonged or obstructed labour and difficult delivery. It is possible that certain positions adopted by the mother may influence the baby's position. OBJEC...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD001063.pub3
更新日期:2007-10-17 00:00:00
abstract:BACKGROUND:The prevalence of chronic heart failure is increasing, and increases with increasing age. Major symptoms include breathlessness and restricted activities of daily living due to reduced functional capacity, which in turn affects quality of life. Exercise training has been shown to be effective in patients wit...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD003331.pub2
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND:The chronic hyperglycaemia of diabetes is associated with long-term damage, dysfunction, and failure of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels. The risk of developing type 2 diabetes increases with age, obesity, and lack of physical activity. Insulin resistance is a fu...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD005525.pub2
更新日期:2007-01-24 00:00:00
abstract:BACKGROUND:Controversy exists as to whether adjuvant chemotherapy improves survival in patients with invasive bladder cancer, despite a number of randomised controlled trials. OBJECTIVES:To evaluate the effect of adjuvant chemotherapy in invasive bladder cancer. We conducted a systematic review and meta-analysis of up...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD006018
更新日期:2006-04-19 00:00:00
abstract:BACKGROUND:Traditionally, laparoscopic cholecystectomy is performed using two 10-mm ports and two 5-mm ports. Recently, a reduction in the number of ports has been suggested as a modification of the standard technique with a view to decreasing pain and improving cosmesis. The safety and effectiveness of using fewer-tha...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD007109.pub2
更新日期:2014-02-20 00:00:00
abstract:BACKGROUND:Diseases caused by Streptococcus pneumoniae (S. pneumoniae) continue to cause substantial morbidity and mortality globally. Whilst pneumococcal polysaccharide vaccines (PPVs) have the potential to prevent disease and death, the degree of protection afforded against various clinical endpoints and within diffe...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD000422.pub3
更新日期:2013-01-31 00:00:00
abstract:BACKGROUND:Long-term tunnelled central venous catheters (TCVC) are increasingly used in oncology patients. Despite guidelines on insertion, maintenance and use, infections remain an important complication. Most infections are caused by Gram-positive bacteria. Therefore antimicrobial prevention strategies aimed at these...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD003295
更新日期:2003-01-01 00:00:00
abstract::This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effectiveness of red blood transfusions and hydroxyurea alone or in combination and HSCT to reduce or prevent SCI in people with SCD. ...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章
doi:10.1002/14651858.CD012389
更新日期:2016-10-01 00:00:00
abstract:BACKGROUND:People with chronic plaque psoriasis often have lesions on the scalp. Hair makes the scalp difficult to treat and the adjacent facial skin is particularly sensitive to topical treatments. OBJECTIVES:To assess the efficacy and safety of topical treatments for scalp psoriasis. SEARCH METHODS:We searched the ...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD009687.pub2
更新日期:2016-02-26 00:00:00
abstract:BACKGROUND:In recent years there has been a rise in the participation rate of women in employment. Some may become pregnant while in employment and subsequently deliver their babies. Most may decide to return early to work after giving birth for various reasons. Unless these mothers get support from their employers and...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD006177.pub2
更新日期:2007-07-18 00:00:00
abstract:BACKGROUND:Surgical site infections (SSIs) are wound infections that occur after invasive (surgical) procedures. Preoperative bathing or showering with an antiseptic skin wash product is a well-accepted procedure for reducing skin bacteria (microflora). It is less clear whether reducing skin microflora leads to a lower...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD004985.pub4
更新日期:2012-09-12 00:00:00
abstract:BACKGROUND:Alzheimer's disease is the most common cause of dementia in older people. One of the aims of therapy is to inhibit the breakdown of a chemical neurotransmitter, acetylcholine, by blocking the relevant enzyme. This can be done by a group of chemicals known as cholinesterase inhibitors. OBJECTIVES:The objecti...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD001190.pub2
更新日期:2006-01-25 00:00:00
abstract:BACKGROUND:Around 5% of English speakers have a significant problem with learning to read words. Poor word readers are often trained to use letter-sound rules to improve their reading skills. This training is commonly called phonics. Well over 100 studies have administered some form of phonics training to poor word rea...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD009115.pub2
更新日期:2012-12-12 00:00:00
abstract:BACKGROUND:Diclofenac is a benzene-acetic acid derivative that acts, like other NSAIDs, by inhibiting cyclo-oxygenase isoforms that mediate the body's production of the prostaglandins implicated in pain and inflammation. Diclofenac is widely available as a sodium or potassium salt. Diclofenac potassium tablets are know...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD004768
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND:This is an update of the original review that was published in The Cochrane Database of Systematic Reviews, 2009, Issue 2. Gestational trophoblastic neoplasia (GTN) are malignant disorders of the placenta that include invasive hydatidiform mole, choriocarcinoma, placental-site trophoblastic tumour (PSTT) and...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD005196.pub4
更新日期:2013-01-31 00:00:00
abstract:BACKGROUND:Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), as well as vasectomy with vas irrigation or wi...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD003991.pub4
更新日期:2014-03-30 00:00:00
abstract:BACKGROUND:Bronchodilators are commonly used for acute bronchiolitis, despite uncertain effectiveness. OBJECTIVES:To examine the efficacy and safety of epinephrine in children less than two with acute viral bronchiolitis. SEARCH STRATEGY:We searched CENTRAL (2010, Issue 3) which contains the Acute Respiratory Infecti...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD003123.pub3
更新日期:2011-06-15 00:00:00
abstract:BACKGROUND:Following coronary artery bypass graft (CABG), the main causes of postoperative morbidity and mortality are postoperative pulmonary complications, respiratory dysfunction and arterial hypoxemia. Incentive spirometry is a treatment technique that uses a mechanical device (an incentive spirometer) to reduce su...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD004466.pub2
更新日期:2007-07-18 00:00:00
abstract:BACKGROUND:There is uncertainty as to whether and what extent occupational safety and health regulation and legislation enforcement activities, such as inspections, are effective and efficient to improve workers' health and safety. We use the term regulation to refer both to regulation and legislation. OBJECTIVES:To a...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD010183.pub2
更新日期:2013-08-30 00:00:00
abstract:BACKGROUND:Effective oral hygiene is a crucial factor in maintaining good oral health, which is associated with overall health and health-related quality of life. Dental floss has been used for many years in conjunction with toothbrushing for removing dental plaque in between teeth, however, interdental brushes have be...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD009857.pub3
更新日期:2019-04-24 00:00:00
abstract:BACKGROUND:Globally, harmful use of alcohol results in approximately 2.5 million deaths each year. About 9% of these deaths are young people between the ages of 15 and 29 years (WHO 2011), mainly resulting from motor vehicle accidents, homicides, suicides and drownings. Hazardous drinking levels for men (consuming over...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD007025.pub2
更新日期:2014-08-21 00:00:00
abstract:BACKGROUND:Hemorrhoidectomy is a frequently performed surgical procedure and associated with postprocedural pain. The use of the Ligasure could result in a decreased incidence of pain as coagulation with high frequency currency and active feedback control over the power output has minimal thermal spread and limited tis...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD006761.pub2
更新日期:2009-01-21 00:00:00
abstract:BACKGROUND:Breathlessness is one of the most common symptoms experienced in the advanced stages of malignant and non-malignant disease. Benzodiazepines are widely used for the relief of breathlessness in advanced diseases and are regularly recommended in the literature. However, the evidence for their use for this symp...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD007354.pub2
更新日期:2010-01-20 00:00:00
abstract:BACKGROUND:Treatment of cerebral sinus thrombosis with thrombolytics has been reported in cases with a deteriorating clinical course despite anticoagulant therapy. The rationale of this treatment is to promote rapid recanalisation of the occluded sinus. OBJECTIVES:To review the available evidence on the efficacy and s...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD003693.pub2
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND:Adequate nutrients early in life promote cognitive development and are critical for proper growth and functioning. The effect of individual nutrients consumed through food is often not the same as consuming the same nutrients in supplementary form due to 'food synergy', the biological and chemical interrelat...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD012818.pub2
更新日期:2019-02-19 00:00:00
abstract:BACKGROUND:Genital infections caused by Chlamydia trachomatis are the most prevalent bacterial sexually transmitted infection worldwide. Screening of sexually active young adults to detect and treat asymptomatic infections might reduce chlamydia transmission and prevent reproductive tract morbidity, particularly pelvic...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,评审
doi:10.1002/14651858.CD010866.pub2
更新日期:2016-09-13 00:00:00
abstract:BACKGROUND:This review is an update of a review published in 2011, itself a major update of previous reviews published in 2005 and 2000, investigating the effects of gabapentin in chronic neuropathic pain (pain due to nerve damage). Antiepileptic drugs are used to manage chronic neuropathic pain and fibromyalgia. OBJE...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD007938.pub3
更新日期:2014-04-27 00:00:00
abstract:BACKGROUND:Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective as indomethacin with fewer side effects. OBJECTIVES:To determine the efficacy and safety of ibupro...
journal_title:The Cochrane database of systematic reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1002/14651858.CD003481.pub5
更新日期:2013-04-30 00:00:00