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PubMed2005

Base administration or fluid bolus for preventing morbidity and mortality in preterm infants with metabolic acidosis.

BACKGROUND: Metabolic acidosis in the early newborn period is associated with adverse outcomes in preterm infants. The most commonly used strategies to correct metabolic acidosis are intravascular infusion of base, for example sodium bicarbonate, and intravascular infusion of a fluid bolus, usually a crystalloid or colloid solution. OBJECTIVES: To evaluate the available evidence from randomised controlled trials that either infusion of base, or of a fluid bolus, reduces mortality and adverse neurodevelopmental outcomes in preterm infants with metabolic acidosis. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005), MEDLINE (1966 - January 2005), EMBASE (1980 - January 2005), CINAHL (1982 - January 2005). SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that evaluated the following treatments for preterm infants with metabolic acidosis:1. Infusion of base versus no treatment.2. Infusion of fluid bolus versus no treatment.3. Infusion of base versus fluid bolus. DATA COLLECTION AND ANALYSIS: We extracted the data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two authors, and synthesis of data using relative risk and risk difference. MAIN RESULTS: We found two small randomised controlled trails that fulfilled the eligibility criteria (Corbet 1977; Dixon 1999). Corbet 1977 compared treating infants with sodium bicarbonate infusion (N = 30) versus no treatment (N = 32) and did not find evidence of an effect on mortality [Relative risk 1.39 (95% confidence interval 0.72 to 2.67), risk difference 0.12 (95% confidence interval -0.12 to 0.36)], or in the incidence of intra/peri-ventricular haemorrhage [Relative risk 1.24 (95% confidence interval 0.47 to 3.28), risk difference 0.05 (95% confidence interval -0.16 to 0.25)]. Dixon 1999 compared treatment with sodium bicarbonate (N = 16) versus fluid bolus (N = 20). The primary outcome assessed was arterial blood pH/base excess two hours after the intervention. Other clinical outcomes were not reported. Neither trial assessed longer term neurodevelopmental outcomes. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials to determine whether infusion of base or fluid bolus reduces morbidity and mortality in preterm infants with metabolic acidosis. Further large randomised trials are needed.

Acidosis↗
PubMed2002

Moving targets and ghosts of the past: outcome measurement in brain tumour therapy.

Evaluation of novel therapies for brain tumours should logically consider quality and quantity of patient survival as primary endpoints. The urgency of the problem, however, frequently leads investigators to use surrogate endpoints and historical controls in order to more rapidly evaluate outcome. To examine the impact of the use of surrogate endpoints and historical controls on the evaluation of innovative brain tumour therapy, selective literature review of three content areas (intraarterial chemotherapy for malignant glioma, interstitial brachytherapy for malignant glioma and stereotactic radiosurgery for cerebral metastasis and malignant glioma) was carried out. The impact of surrogate outcome measures and use of historical controls was assessed by comparing the results of trials using these methods and randomised clinical trials. In the evaluation of both intraarterial chemotherapy and interstitial brachytherapy, promising results in early phase trials were not confirmed in randomised clinical trials. This result can be explained by selection bias and predicted by the use of controls carefully selected from large treatment data bases. In the evaluation of stereotactic radiosurgery, early phase trials are promising, but randomised clinical trials have not yet been done. Prior experience suggests that the early promising results with stereotactic radiosurgery should be subjected to randomised clinical trial validation before being considered proven. Careful selection of controls for early phase trials is necessary if erroneous conclusions are to be avoided.

Brachytherapy↗
PubMed2004

Non-absorbable disaccharides for hepatic encephalopathy: systematic review of randomised trials.

OBJECTIVE: To assess the effects of non-absorbable disaccharides (lactulose and lactitol) in patients with hepatic encephalopathy. DATA SOURCES: Cochrane Hepato-Biliary Group controlled trials register, Cochrane Library, Medline, and Embase until March 2003; reference lists of relevant articles; authors and pharmaceutical companies. REVIEW METHODS: Randomised trials that compared non-absorbable disaccharides with placebo, no intervention, or antibiotics for hepatic encephalopathy were included. The primary outcome measures were no improvement of hepatic encephalopathy and all cause mortality. RESULTS: 22 trials were included. Compared with placebo or no intervention, non-absorbable disaccharides seemed to reduce the risk of no improvement in patients with hepatic encephalopathy (relative risk 0.62, 95% confidence interval 0.46 to 0.84, six trials). However, high quality trials found no significant effect (0.92, 0.42 to 2.04, two trials). Compared with placebo or no intervention, non-absorbable disaccharides had no significant effect on mortality (0.41, 0.02 to 8.68, four trials). Non-absorbable disaccharides were inferior to antibiotics in reducing the risk of no improvement (1.24, 1.02 to 1.50, 10 trials) and lowering blood ammonia concentration (weighted mean difference 2.35 micromol/l, 0.06 micromol/l to 13.45 micromol/l, 10 trials). There was no significant difference in mortality (0.90, 0.48 to 1.67, five trials). CONCLUSIONS: There is insufficient evidence to support or refute the use of non-absorbable disaccharides for hepatic encephalopathy. Antibiotics were superior to non-absorbable disaccharides in improving hepatic encephalopathy, but it is unclear whether this difference is clinically important. Non-absorbable disaccharides should not serve as comparator in randomised trials on hepatic encephalopathy.

Anti-Infective Agents↗
PubMed2004

Stereotactic radiosurgery for primary trigeminal neuralgia: state of the evidence and recommendations for future reports.

OBJECTIVE: To identify systematically all the studies reporting outcomes and complications of stereotactic radiosurgery for trigeminal neuralgia and to evaluate them against predefined quality criteria. METHODS: Inclusion criteria for outcome analysis included thorough demographic documentation, defined diagnostic and outcome criteria, a minimum of 30 patients treated with 12 months median/mean follow up, not more than 20% lost to follow up, Kaplan-Meier actuarial analysis, primary trigeminal neuralgia, not more than 10% of patients retreated for failure or early recurrence, and minimum dose of 70 Gy. RESULTS: Of 38 studies identified, four could be used to evaluate rates of pain relief on a yearly basis, and two for actuarial rates of complete pain relief; seven provided data on latencies and 18 were used to evaluate complications. Pain relief typically occurs within three months. Complete relief is initially achieved by three quarters of the patients, but half maintain this outcome at three years. One half or less can permanently stop drug treatments. Sensory disturbance, including anaesthesia dolorosa, is the most frequent complication of stereotactic radiosurgery. CONCLUSIONS: Outcomes after stereotactic radiosurgery appear in line with other ablative techniques. Results are better when it is used as primary treatment in patients with typical symptoms. Current data are largely observational and the quality is generally poor. This technique should be evaluated in a randomised, controlled trial with universal outcome measures, actuarial methodology, and validated measures of patient satisfaction and quality of life.

Follow-Up Studies↗
PubMed2004

The therapeutic potential of angiotensin II receptor blockers in the treatment of heart failure.

In clinical heart failure (HF) the renin-angiotensin-aldosterone system is an important component of neurohormonal activation. Angiotensin-converting enzyme inhibitors have been shown to be of great clinical benefit in reducing the production of angiotensin II. However, they do not fully suppress angiotensin II production in HF because there are other pathways through which angiotensin II can be produced. Theoretically, angiotensin II receptor blockers (ARBs) have great potential because of their ability to directly block angiotensin II produced through any pathway. A large body of literature has accumulated examining the effects of ARBs in HF. The earlier, smaller studies examined outcomes such as symptoms, neurohormonal concentrations and cardiac function. More recent, larger studies have examined the effects of ARBs on mortality and morbidity. This paper reviews the data defining the role of ARBs in the treatment of HF patients, focusing more on the large randomised clinical outcome trials.

Angiotensin II↗
PubMed1999

Women's role and satisfaction in the decision to have a caesarean section.

OBJECTIVE: To examine women's role in the decision to perform caesarean section (CS). DESIGN: Cross-sectional survey. Written questionnaires were completed seven weeks after giving birth by CS. SETTING: An obstetric tertiary referral hospital (Women's and Children's Hospital, Adelaide, South Australia), July to December 1996. PARTICIPANTS: A consecutive sample of women who underwent CS over a six-month period. To be eligible, women had to be at least 18 years old, able to complete a questionnaire in English and well enough to consent to study participation. MAIN OUTCOME MEASURES: Women's involvement in decision making, stated preference for CS, and satisfaction with obstetric care. RESULTS: 278 women (76.4%) returned questionnaires: 171 women (61.5%; 95% confidence interval [CI], 55.8%-67.2%) reported being involved in the decision to have a CS. Factors influencing their decision were physical duress and partner's reaction during labour (emergency CS), considerations about recovery, planning for the event and pain (elective CS), and information from the doctor (both groups). Half the women "strongly agreed" that they were satisfied with the decision to have a CS, but 40.9% only "agreed" and 4.7% were "not sure". About 20% reported they needed more information on other options, and only 28.8% "strongly agreed" that they had been given good information to prepare for the possibility of CS. 27.9% of women (95% CI, 22.5%-33.2%) "agreed" or "strongly agreed" that they had "insisted on a CS" and 21.3% (95% CI, 16.4%-26.2%) that they had told the staff they were "keen to have a CS". Given the option of a vaginal delivery, 37.8% of women (95% CI, 22.5%-55.2%) with a breech presentation, and 34% of women (95% CI, 21.2%-48.8%) who had had a previous CS, chose a CS. CONCLUSIONS: It is of concern that over a third of women felt they had not been involved in the decision to have a CS; others were very positive about CS, but an appreciable proportion may not have received sufficient information. A broad-based strategy of providing more information to women and their partners could be one way of ensuring appropriate CS rates and should be tested in a randomised controlled trial.

Adult↗
PubMed1984

[Methodology of controlled clinical studies on the primary treatment of operable breast cancer].

We discuss in this paper the thesis that the underlying questions in breast cancer clinical trials are complex in nature and that multivariate procedures are required for statistical analysis. The variety of statistics resulting from multiple significance testing may be insufficient and misleading. Analysis using multivariate methods centres around interactions between treatments and prognostic factors, time dependence of treatment effects, multi-state models of the disease process, and problems of quality of life. Interpretation of results is not an easy task, as can be shown by some recent examples in the field. In the Federal Republic of Germany full informed consent will have to be taken into account. Emphatically we reject the often held view that legal problems can be bypassed by using historical controls instead of controlled clinical trials. As an alternative we favour the concept of a comprehensive cohort study with a randomised trial being just a part of it.

Breast Neoplasms↗
PubMed1999

Use of different outcome measures in randomised studies of malignant glioma can significantly alter the interpretation of time to progression: reanalysis of the MRC BR2 study.

The Medical Research Council (MRC) BR2 study [1] is a randomised trial of two doses of cranial radiation for patients with malignant glioma. We reanalysed data to examine the effect of using change in ranked scales of neurological status (MRC Neurological Status Scale) and performance (World Health Organisation Scale: WHO) to determine progression rather than clinician's impression. Four hundred and seventy four patients were studied. Where clinicians recorded no progression, ranked scales frequently documented progression (MRC 13%; WHO 13%). Where clinicians recorded progression, ranked scales frequently did not alter (MRC 33%; WHO 30%) or occasionally improved (MRC 5%; WHO 3%). When analysing time to progression based on a variety of measures, the estimated difference between treatments was most extreme (hazard ratio 0.81, logrank p = 0.04) when change in WHO status was used, and least extreme when change in MRC neurological status was used (hazard ratio 0.99, p = 0.94). This study highlights how different outcome measures can significantly alter the interpretation of randomised studies.

Central Nervous System Neoplasms↗
PubMed2003

Prolonged antibiotics for purulent bronchiectasis.

BACKGROUND: The vicious cycle hypothesis for bronchiectasis predicts that bacterial colonisation of the respiratory tract perpetuates inflammatory change. This damages the mucociliary escalator preventing bacterial clearance and allowing the persistence of pro-inflammatory mediators. Conventional treatment with physiotherapy and intermittent antibiotics are felt to improve the condition of bronchiectasis patients although there are no conclusive data showing that these interventions influence the natural history of the condition. Various strategies have been tried to interrupt this cycle of infection and inflammation and one of these is to prolong antibiotic treatment in the hope of allowing the airway mucosa to heal. OBJECTIVES: This systematic review brings together the evidence and where possible presents a meta-analysis of the data available to answer the question 'Does treatment with prolonged courses of antibiotics influence the outcome in purulent bronchiectasis?' SEARCH STRATEGY: The Cochrane Airways Group trials register and reference lists of identified articles were searched. SELECTION CRITERIA: Randomised trials looking at the use of prolonged antibiotic therapy in the treatment of bronchiectasis. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data extraction was carried out by the reviewers independently. Study authors were contacted for missing information. MAIN RESULTS: 447 abstracts were found and reviewed for suitability. Six trials were included and 302 patients were randomised amongst these trials. 40% of the patients were contributed by one trial. Antibiotics were given for between 4 weeks and one year. There were 40 withdrawals due to treatment failure and intolerable side effects. Only limited meta-analysis was possible due to the diversity of the trials. Response rates showed significant effects in favour of prolonged antibiotic treatment (Peto OR (95% CI), 3.37 (1.60 to 7.09)). Conversely for exacerbation rates there was no significant difference between prolonged antibiotics and placebo (Peto OR (95% CI), 0.96 (0.27 to 3.46)). For withdrawals there was no significant difference between treatment and placebo management (Peto OR (95% CI), 1.06 (0.42 to 2.65)). Data for lung function showed no significant benefit in favour of antibiotic treatment (% predicted FEV1, WMD (95% CI) -1.05 (-6.93 to 4.83)). REVIEWER'S CONCLUSIONS: The evidence available shows a small benefit for the use of prolonged antibiotics in the treatment of bronchiectasis. This review is limited by the diversity of the trials. Further randomised controlled trials with adequate power and standardised end points are required.

Adult↗
PubMed2001

Iron therapy for improving psychomotor development and cognitive function in children under the age of three with iron deficiency anaemia.

BACKGROUND: Iron deficiency and iron deficiency anaemia (IDA) are common in young children. It has been suggested that the lack of iron may have important effects on children's psychomotor development and cognitive function. OBJECTIVES: To determine the effects of iron therapy on psychomotor development and cognitive function in iron deficient children less than 3 years of age. SEARCH STRATEGY: The following databases were searched: COCHRANE LIBRARY (2000 ISSUE 4) MEDLINE (1966-August 2000) EMBASE (1980-August 2000) Latin American Database (LILACS) PsycLIT Journal articles (1974-August 2000) PsycLIT Chapters and Books (1987-August 2000) The references of identified trials and of important review articles were scrutinised. Citation searches on trials from the primary search were performed within the Science Citation Index. Key authors were contacted. SELECTION CRITERIA: Studies were included if children less than 3 years of age with evidence of iron deficiency anaemia were randomly allocated to iron or iron and vitamin C versus a placebo or vitamin C alone and assessment of developmental status or cognitive function was carried out using standardised tests by observers blind to treatment allocation. DATA COLLECTION AND ANALYSIS: Abstracts and titles of studies identified on searches of electronic databases were read to determine whether they might meet the inclusion criteria. Full copies of those possibly meeting these criteria from electronic or other searches were assessed by two independent reviewers. Differences of opinion about suitability for inclusion were resolved by discussion. Data were analysed separately depending on whether participants had iron assessments were performed within one month of beginning iron therapy or later. MAIN RESULTS: Five trials, including 180 children with IDA, examined the effects of iron therapy on measures of psychomotor development between 5 and 11 days of commencement of therapy. Data from four trials could be pooled. The pooled difference in pre to post treatment change in Bayley Scale PDI between iron treated and placebo groups was -3.2 (95%CI -7.24, 0.85) and in Bayley Scale MDI, 0.55 (95% CI -2.84, 1.75). Two studies, including 160 randomised children with IDA, examined the effects of iron therapy on measures of psychomotor development more than 30 days after commencement of therapy. Aukett et al reported the mean number of skills gained after two months of iron therapy, using the Denver test. The intervention group gained 0.8 (95% CI -0.18, 1.78) more skills on average than the control group. Idjrandinata et al reported that the difference in pre to post treatment change in Bayley Scale PDI between iron treated and placebo groups after 4 months was 18.40 (95%CI 10.16, 26.64) and in Bayley Scale MDI, 18.80 (95% CI 10.19, 27.41). REVIEWER'S CONCLUSIONS: There is no convincing evidence that iron treatment of young children with IDA has an effect on psychomotor development discernable within 5-11 days. The effect of longer term treatment remains unclear but the data would be compatible with clinically significant benefit. There is urgent need for further randomised controlled trials with long term follow up.

Anemia, Iron-Deficiency↗
PubMed2003

Drug therapies for reducing gastric acidity in people with cystic fibrosis.

BACKGROUND: Malabsorption of fat and protein contributes to the poor nutritional status in people with cystic fibrosis. Impaired pancreatic function may also result in increased gastric acidity leading in turn to heartburn, peptic ulcers and the impairment of oral pancreatic replacement therapy. The administration of gastric reducing agents has been used as an adjunct to pancreatic enzyme therapy to improve nutritional status, fat malabsorption and gastro-intestinal symptoms in people with cystic fibrosis. It is thus important to establish the current level of evidence regarding potential benefits of drug therapies that reduce gastric acidity in people with cystic fibrosis. OBJECTIVES: To assess the effect of drug therapies for reducing gastric acidity: in improving nutritional status; on symptoms associated with increased gastric acidity; fat absorption; lung function; quality of life and survival; and to determine if any adverse effects are associated with their use. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books and conference proceedings. Most recent search of the Group's register: April 2002. SELECTION CRITERIA: All randomised and quasi-randomised trials involving agents that reduce gastric acidity compared to placebo or a comparator treatment. DATA COLLECTION AND ANALYSIS: Both reviewers independently selected trials and assessed trial quality. MAIN RESULTS: Thirty-six trials were identified from the initial search. Eleven trials with 172 participants were suitable for inclusion. Five trials were limited to children and three trials enrolled only adults. One trial found that drug therapies which reduce gastric acidity improve gastro-intestinal symptoms such as abdominal pain. Five trials reported significant improvement in measures of fat malabsorption. Two trials reported no significant improvement in nutritional status. Only one trial reported measures of respiratory function and one trial reported an adverse effect with prostaglandin E2 analogue misoprostol. No trials have been identified which assess the effectiveness of agents that reduce gastric acidity in improving quality of life, the complications of increased gastric acidity, or survival. REVIEWER'S CONCLUSIONS: Trials have shown limited evidence that the agents which reduce gastric acidity in people with cystic fibrosis are associated with improvement in gastro-intestinal symptoms and fat absorption. Currently, there is insufficient evidence to indicate whether there is an improvement in nutritional status, lung function, quality of life, or survival. We therefore recommend large, multicentre, randomised controlled clinical trials are undertaken to evaluate these interventions.

Cystic Fibrosis↗
PubMed2003

Therapies for depression in Parkinson's disease.

BACKGROUND: Depression is one of the most common neuropsychiatric disturbances in Parkinson's disease. 40% of observed variation in quality of life is due to depression. However, there is little hard evidence of the efficacy and safety of antidepressant therapies in Parkinson's disease. OBJECTIVES: To assess the efficacy and safety of antidepressant therapies in idiopathic Parkinson's disease. Safety refers to both the direct side-effects of the therapy and also the therapy's interactions with the symptoms of Parkinson's disease and with the antiparkinsonian medications. SEARCH STRATEGY: Relevant clinical trials were identified by electronic searches the Cochrane Controlled Trials Register (the Cochrane Library Issue 3, 2001), MEDLINE(1996-2001), EMBASE (1974-2001), PsychLit (1800's-2001), CINAHL (1982-2001) databases. The reference list of all trial reports and reviews were examined. Queries were sent out to all manufacturers and distributors of antidepressants within the UK requesting information on any relevant clinical trials. SELECTION CRITERIA: Randomised controlled trials (RCT) examining licensed oral antidepressants, electroconvulsive therapy (ECT) or behavioural therapy in the treatment of depression in idiopathic Parkinson's disease. DATA COLLECTION AND ANALYSIS: Data was extracted and assessed independently by three of the authors. Disagreements were resolved by discussion. MAIN RESULTS: Three randomised controlled trials were found examining oral antidepressant medications in Parkinson's disease in a total of 106 patients. No eligible trials of ECT or behavioural therapy were found. In the first arm of the crossover trial by Andersen 1980 (n=22) patients in the nortriptyline group showed a larger improvement than placebo group in median depression score in a self-made 31-item depression rating scale after 16 weeks of treatment but statistical significance was not calculated. A parallel group trial by Wermuth 1998 (n=37) did not show any statistically significant difference between the citalopram and placebo groups in the Hamilton Depression Scale after 52 weeks of treatment. The third study by Rabey 1996 (n=47) was a randomised open-label trial to compare fluvoxamine versus amitriptyline. Similar numbers of patients in amitriptyline and fluvoxamine groups (60% vs 55%) had a 50% reduction of Hamilton score after 16 months of treatment. However, further assessment of this trial was not possible because only summary results were available from an abstract and attempts to contact the authors failed. Visual hallucinations or confusion had been reported in patients with fluvoxamine and amitriptyline. Otherwise, no other major side effects were found in the other two trials. REVIEWER'S CONCLUSIONS: Insufficient data on the effectiveness and safety of any antidepressants therapies in Parkinson's disease are available on which to make recommendations for their use. Further large scale randomised controlled trials are urgently required in this area.

Antidepressive Agents↗
PubMed2006

Aripiprazole for schizophrenia.

BACKGROUND: Treatment of people with schizophrenia using older typical antipsychotic drugs such as haloperidol can be problematic. Many fail to respond to these older antipsychotics and more people experience disabling adverse effects. Aripiprazole is said to be one of a new generation of atypical antipsychotics with good antipsychotic properties and minimal adverse effects. OBJECTIVES: To evaluate the effects of aripiprazole for people with schizophrenia and schizophrenia-like psychoses. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's Register (September 2005) which is based on regular searches of BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. We inspected references of all identified studies for further trials. We contacted relevant pharmaceutical companies, the FDA and authors of trials for additional information. SELECTION CRITERIA: All clinical randomised trials comparing aripiprazole with placebo, typical or atypical antipsychotic drugs for schizophrenia and schizophrenia-like psychoses. 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: Despite the fact that 7110 people participated in fifteen randomised aripiprazole studies, we were unable to extract any usable data on death, service outcomes, general functioning, behaviour, engagement with services, satisfaction with treatment; economic outcomes or cognitive functioning. Study attrition was very large and data reporting poor. Compared with placebo, aripiprazole significantly decreased relapse in both the short and medium term (n=300, 1 RCT, RR 0.66 CI 0.5 to 0.8, NNT 5 CI 4 to 8). It also produced better compliance with study protocol (n=2271, 8 RCTs, RR 0.72 CI 0.5 to 0.97, NNT 26 CI 16 to 239). Aripiprazole may decrease prolactin levels below that expected from placebo (n=305, 1 RCT, RR 0.32 CI 0.1 to 0.8, NNT 14 CI 11 to 50). Compared with typical antipsychotics there were no significant benefits for aripiprazole with regards to global state, mental state, quality of life or leaving the study early. Both groups reported similar rates of adverse effects, with the exception of akathisia (n= 955 RR 0.31 CI 0.2 to 0.6, NNT 20 CI 17 to 32) and the need for antiparkinson medication (n=1854, 4 RCTs, RR 0.45 CI 0.3 to 0.6, NNT 4 CI 3 to 5) which were lower in those receiving aripiprazole. When compared with olanzapine and risperidone, aripiprazole was no better or worse on outcomes of global state and leaving the study early. The rates of adverse effects were also similar, with the exception of less elevation of prolactin (n=301, 1 RCT, RR 0.04 CI 0.02 to 0.1, NNT 2 CI 1 to 2.5) and less prolongation of the average QTc (30 mg/day) (n=200, 1 RCT, WMD -10.0, CI -16.99 to -3.0) compared with risperidone. When compared with standard care (mixed group receiving typical and atypical antipsychotics) one aripiprazole study did have significantly less people not responding to treatment (n=1599, RR 0.70 CI 0.7 to 0.8, NNT 5 CI 4 to 6 ), not satisfied with care (n=1599, RR 0.62 CI 0.6 to 0.7, NNT 4 CI 4 to 5) and less people leaving the study early (n=1599, 1 RCT, RR 0.81 CI 0.7 to 0.9, NNT 13 CI 8 to 39). Results from the five new papers identified from the updated review search, did not significantly alter the main results or conclusions of the original review. AUTHORS' CONCLUSIONS: Aripiprazole may be effective for the treatment of schizophrenia, but it does not differ greatly from typical and atypical antipsychotics with respect to treatment response, efficacy or tolerability. In comparison with typical antipsychotics, aripiprazole may have a lower risk of akathisia, and in comparison to atypical antipsychotics, less risk of raised prolactin and prolongation of the QTc interval. Clearly reported pragmatic short, medium and long term randomised controlled trials should be undertaken to determine its position in everyday clinical practice.

Antipsychotic Agents↗
PubMed2002

[Screening for bronchial carcinoma].

Bronchial carcinoma is the principal cause of cancer death. Unlike cancers of the breast and colon that are already the subject of screening programmes, proof has not yet been provided that screening for bronchial carcinoma is of value in terms of reduction in mortality. Technological improvements and the advent of low dose spiral CT scanning has lead to a recent renewal of interest in this subject. The first preliminary studies seem to indicate that 2/3 of bronchial carcinomas discovered by CT scanning are detected at an early stage. Other data suggest a possible improvement in survival of tumours discovered by screening. Nevertheless it is necessary to demonstrate that screening improves the survival of patients with bronchial carcinoma. The present consensus does not advocate mass screening by CT scanning but that high risk subjects should voluntarily participate in randomised controlled trials which alone will confirm or refute the validity of this approach.

Bias↗
PubMed2002

Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ.

OBJECTIVE: To assess the association between competing interests and authors' conclusions in randomised clinical trials. DESIGN: Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political. STUDIES: 159 trials from 12 medical specialties. MAIN OUTCOME MEASURES: Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention. RESULTS: Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors' conclusions. The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty. CONCLUSIONS: Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors' conclusions.

Analysis of Variance↗