Randomisation in the SYMPHONY trial.
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BACKGROUND: Based mainly on experimental data which indicates improvement to the cerebral microcirculation, Dan Shen, a form of herbal medicine, is widely used in the treatment of acute ischaemic stroke in China. We aimed to assess the evidence from randomised controlled trials of their effects. OBJECTIVES: To review the randomised or quasi-randomised controlled trials of Dan Shen agents for acute ischaemic stroke. The primary objective was to determine whether Dan Shen agents improve functional outcome without causing undue harm in patients with acute ischaemic stroke. Secondary objectives were to assess the effect of Dan Shen agents on impairment and on quality of life. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched September 2003), the register of the Cochrane Complementary Field (last searched September 2003) and the Chinese Stroke Trials Register (last searched September 2003). In addition we searched the following bibliographic databases: The Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2002), MEDLINE (1996 to December 2002), EMBASE (1980 to December 2002), CINAHL (1982 to December 2002), AMED (1985 to December 2002) and China Biological Medicine Database (CBM-disc 1979 to December 2002). We handsearched 10 Chinese journals, searched clinical trials and research databases, scanned reference lists and contacted the pharmaceutical company manufacturing Dan Shen. SELECTION CRITERIA: Randomised controlled trials or quasi-randomised controlled clinical trials comparing Dan Shen agents with placebo or open control (no placebo) in patients with acute ischaemic stroke. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed trial quality and extracted the data. MAIN RESULTS: Eight potentially eligible trials were identified, of which three trials (304 patients) were included. Two trials were excluded and three trials are awaiting assessment. Numbers of deaths and dependent patients at the end of follow-up of at least three months were not reported in the three included trials. Only one trial reported adverse events. Three trials measured the outcome "significant improvement in neurological deficit at the end of treatment". Compound Dan Shen agents were associated with a significant increase in the number of patients with the outcome (Peto Odds Ratio (OR) 2.72, 95% Confidence Interval (CI) 1.10 to 6.72). No deaths were reported within the first two weeks of treatment or during the whole follow-up period (21 to 28 days). The trials did not include any assessment of quality of life. REVIEWERS' CONCLUSIONS: There were too few patients and outcome events to draw reliable conclusions from the present data. The methodological qualities of all included studies were poor. Further high-quality randomised controlled trials should be performed.
It is claimed that regular practice of Transcendental Meditation (TM) improves cognitive function and increases intelligence. This systematic review assesses the evidence from randomised controlled trials for cumulative effects of TM on cognitive function. Searches were made of electronic databases and the collected papers and official websites of the TM organisation. Only randomised controlled trials with objective outcome measures of the cumulative effects of TM on cognitive function were included. Trials that measured only acute effects of TM, or used only neurophysiological outcome measures were excluded. 107 articles reporting the effects of TM on cognitive function were identified and 10 met the inclusion criteria. Most were excluded because they used no controls or did not randomize subjects between interventions. Of the 10 trials included, 4 reported large positive effects of TM on cognitive function, four were completely negative, and 2 were largely negative in outcome. All 4 positive trials recruited subjects from among people favourably predisposed towards TM, and used passive control procedures. The other 6 trials recruited subjects with no specific interest in TM, and 5 of them used structured control procedures. The association observed between positive outcome, subject selection procedure and control procedure suggests that the large positive effects reported in 4 trials result from an expectation effect. The claim that TM has a specific and cumulative effect on cognitive function is not supported by the evidence from randomised controlled trials.
Testicular germ-cell cancer is relatively rare, affecting less than 6 men per 100,000 in the UK, nevertheless, it is the most common cancer in men under 45 years. The two main types of tumours, seminomas and non-seminomas, respond to treatment differently. The standard treatment for stage I seminomas following orchidectomy is infradiaphragmatic lymph node irradiation with response rates approaching 100%, although surveillance is also a management option. The majority of early stage non-seminomas are cured by orchidedctomy alone. Bleomycin, etoposide and cisplatin, (BEP) is the most widely used chemotherapeutic regimen for metastatic germ cell tumours. In patients with 'good prognosis' the current focus is to reduce the drug-related toxicity but maintain the cure potential. Most attempts using dose reduction or alternative regimens have not proved superior to BEP. In patients with 'poor prognosis' the aim has been to increase the efficacy of treatment using high-dose chemotherapy and investigate new regimens. This article comprehensively reviews the treatment of testicular germ cell cancer with emphasis on high-grade evidence from randomised controlled trials.
This paper presents the development and pilot testing of an evidence-based decision-aid for pregnant women who have experienced previous caesarean section and who are considering options for birth in a subsequent pregnancy. The Ottawa Decision Support Framework (DSF) has been utilised and modified in the development of a tailored booklet entitled "Birth Choices: What is best for you...vaginal or caesarean birth?" Development included a review by women who had experienced previous caesarean birth as well as obstetric, midwifery and educational experts. The booklet was also reviewed for acceptability by 21 pregnant women who were facing this birth decision. Pre- and post-booklet preferences for birth were elicited and compared to actual birth outcomes. This decision-aid shows promise in facilitating informed decision-making in pregnancy. It is currently undergoing an evaluation in a multi-centre randomised controlled trial.
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