Beraprost sodium (beraprost) is a stable, orally active prostacyclin analogue with vasodilatory, antiplatelet and cytoprotective effects. Beraprost acts by binding to prostacyclin membrane receptors ultimately inhibiting the release of Ca2+ from intracellular storage sites. This reduction in the influx of Ca2+ has been postulated to cause relaxation of the smooth ...

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a randomized clinical outcome trial of antihypertensive and lipid-lowering therapy in a diverse population (including substantial numbers of women and minorities) of 42,419 high-risk hypertensives aged > or = 55 years with a planned mean follow-up of 6 ...

Complementary therapies are often used to treat patients with persisting conditions. In a typical randomized trial, patients are assessed for symptom severity at baseline, randomized to treatment or control and then reassessed after a suitable follow-up period. It can be shown that the number of patients required for such trials ...

The authors evaluated whether early enrollment affects the significance of the results and the time to completion and publication of randomized controlled trials. Seventy-seven efficacy randomized controlled trials (total enrollment, 28,992 patients) initiated by the Acquired Immunodeficiency Syndrome Clinical Trials Group between 1986 and 1996 were evaluated. After adjustment for ...

This paper argues for a standardized use of definitions and outcome measures in publications on West syndrome. Specific recommendations include the need for a validated definition of hypsarrhythmia, the use of the term non-symptomatic and abandoning the terms cryptogenic and idiopathic, talking about underlying disease association and not aetiology or ...

OBJECTIVE: To review the literature concerning intraventricular administration of fibrinolytic agents to treat patients with intraventricular hemorrhage (IVH). DATA SOURCES: An extensive literature search (MEDLINE, EMBASE, Conference Proceedings) was conducted to identify articles in English published between 1966 and May 2000 pertaining to the pathophysiology of IVH and its treatment ...

BACKGROUND: The authors evaluated the quality of clinical trials published in four anesthesia journals during the 20-yr period from 1981-2000. METHODS: Trials published in four major anesthesia journals during the periods 1981-1985, 1991-1995, and the first 6 months of 2000 were grouped according to journal and year. Using random number ...

PURPOSE: Although the randomized, controlled trial has gained preeminence as the criterion standard for evaluating pharmaceutical treatments, randomized controlled trials in surgery have been perceived as difficult to surmount. Furthermore, attitudes of surgeons toward randomized, controlled trials are not well understood. We determined the views of Australian surgeons about feasibility ...

BACKGROUND: We reviewed suicide rates in affective disorder and their variation with electroconvulsive therapy (ECT) and antidepressant availability. METHOD: Suicide rates were calculated from 75 follow-up studies, identified by systematic literature searches and analyzed for differences over time eras characterized by the availability of specific treatments. DATA SOURCES AND STUDY ...

OBJECTIVE: To systematically review the evidence examining the use of incentive spirometry (IS) for the prevention of postoperative pulmonary complications (PPCs). METHODS: We searched MEDLINE, CINAHL, HealthSTAR, and Current Contents databases from their inception until June 2000. Key terms included "incentive spirometry," "breathing exercises," "chest physical therapy," and "pulmonary complications." ...

Doctors, patients, and their relatives face a complex decision when there are multiple treatment options that differ in their profiles of risk and benefit over time. Doctors from a single specialist paediatric cardiac unit participated in a correlational study that used a novel tool (subjective multi-state survival graphs) to elicit ...

The safety profile of pioglitazone has been evaluated in trials including over 5,400 subjects, of whom over 3,500 received active treatment resulting in over 2,500 patient-years of exposure. Since its launch, over 1.4 million patients have been prescribed pioglitazone. This paper will examine the clinical trial tolerability and safety data ...

OBJECTIVE: This study was conducted to investigate whether the quality of antidepressant drug trials has improved during the last 40 years. METHOD: A sample of 314 randomized clinical trials published between 1962 and 1998 was analysed. RESULTS: From 1962 to 1970 the median number of patients per trial was 56 ...

OBJECTIVE: To perform a systematic review of the emergency medicine literature to assess the appropriateness of an intervention to identify, counsel, and refer emergency department (ED) patients >64 years old who are at high risk for falls. METHODS: The systematic review was facilitated through the use of a structured template, ...

Although unanswered questions remain, scores of observational studies and several small randomized clinical trials (RCTs) indicate that lung volume reduction surgery (LVRS) offers safe and effective palliation for a relatively well defined subset of patients with advanced emphysema. Nonetheless, Medicare and other insurers stopped reimbursement for the procedure. Subsequently, two ...

To compare reduced osmolarity oral rehydration solution with standard World Health Organization oral rehydration solution in children with acute diarrhoea. Systematic review of randomised controlled trials. 15 randomised controlled trials including 2397 randomised patients. The primary outcome was unscheduled intravenous infusion; secondary outcomes were stool output, vomiting, and hyponatraemia. In ...

Humidification is a time-honoured therapy for childhood croup (acute laryngotracheobronchitis). Despite a paucity of evidence supporting its use, many physicians, nurses and parents still apply this treatment. Our objective was to summarize available evidence and assess the rationale for the ongoing use of humidity to treat childhood croup. Searches of ...

The purpose of this study was to identify and quantify the endodontic literature available for clinical decision making. A search strategy based on Medical Subject Headings for endodontics was developed to examine MEDLINE. The identified articles were limited to human subjects and English. Sensitive and specific methodological search filters identified ...

Advances in medicine are closely linked to clinical research, but certain study procedures may be in conflict with the fundamental principles of ethics and codes of conduct in medicine. Following an analysis of two studies involving treatments for acute myocardial infarction (AMI), the admissibility of continuing a study was questioned ...

AIMS: Intention-to-treat (ITT) analyses are the gold standard in endpoint analyses of randomized clinical trials. Valuable information, however, may be lost in this approach as the actual time on trial medication is not accounted for in patients who withdraw early. Since compliance per se can be a prognostic factor and ...

A control chart system was developed in an earlier paper to identify the occurrence of actual risk changes or deviation from the expected levels of road crash fatalities during the course of a year. This paper discusses the development of a prediction method for estimating number of fatalities during a ...

OBJECTIVE: This study examined the effects of pain and stress associated with a dental procedure, root canal treatment (RCT), on natural killer cell cytotoxicity (NKCC) and the subsequent development of symptoms of upper respiratory illness during the following month. METHODS: Patients (N = 33) were recruited from those scheduled for ...

OBJECTIVE: To evaluate work status and its determinants among patients with ankylosing spondylitis (AS). METHODS: A systematic literature review of original studies published after 1980 in which work status in AS was an outcome. Medline was searched and references of retrieved reports were checked for additional studies. RESULTS: Sixteen full ...

BACKGROUND: Preclinical and clinical studies of gabapentin in patients with ALS led the authors to undertake a phase III randomized clinical trial. METHODS: Patients were randomly assigned, in a double-blinded fashion, to receive oral gabapentin 3,600 mg or placebo daily for 9 months. The primary outcome measure was the average ...

This paper discusses interim analysis of randomized clinical trials for which the primary endpoint is observed at a specific long-term follow-up time. For such trials subjects only yield direct information on the primary endpoint once they have been followed through to the long-term follow-up time, potentially eliminating a large proportion ...

The registration of adverse events is an important issue in the field of medicine. Even today adverse event screening and registration is not part of the routine in most medical areas. In 1994, the Department of Neurosurgery at the University of Heidelberg implemented a conference for screening and registering adverse ...

BACKGROUND: This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of oral prostaglandin E2 for third trimester induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register ...

BACKGROUND: Bronchiectasis is predominantly an acquired disease process representing the end stage of a variety of unrelated pulmonary insults. It is defined as a persistent irreversible dilatation and distortion of medium-sized bronchi. Patients diagnosed with bronchiectasis frequently have difficulty exporating the infected sputum. Mucolytic agents target hyper-secretion or changed physiochemical ...

Available evidence of thrombolysis in acute ischemic stroke comes from a series of recent trials conducted in patients with acute stroke, and from a meta-analysis published in the Cochrane Library. The objective of this paper is to review the literature on tolerability and efficacy of thrombolytic therapy in patients with ...

BACKGROUND: The timing of surgery to secure a ruptured aneurysm after a subarachnoid haemorrhage is an important issue. Early clipping of an aneurysm prevents rebleeding, a major cause of death after a subarachnoid haemorrhage. However, concerns about the possible deleterious effects of early surgery raise questions about the safety and ...

Present knowledge regarding the clinical efficacy and safety of sublingual immunotherapy (SLIT) for the treatment of respiratory allergy is reviewed. Allergen-specific immunotherapy is presently considered a 'biological response modifier' for the treatment of respiratory allergy, to be used in association with drug therapy and allergen avoidance. Its value in the ...

BACKGROUND: Appendicitis is the most common cause of acute abdominal pain requiring surgical intervention. The cause of appendicitis is unclear and the mechanism of pathogenesis continues to be debated. Despite improved asepsis and surgical techniques, postoperative complications, such as wound infection and intraabdominal abscess, still account for a significant morbidity. ...

Most patients with sciatica (often caused by disc herniations) are managed conservatively at first. The natural course seems to be favorable. The additional value of many conservative therapies remains controversial. Because a systematic review of the conservative treatment of sciatica is lacking, such a review was carried out. After a ...

The purpose of this study was to identify and quantify the availability of orthodontic literature for evidence-based clinical decision-making (ie, sound clinical studies of etiology, diagnosis, treatment, or prognosis meeting basic methodologic criteria for direct clinical use). This is a first step toward developing online decision analysis systems. A search ...

BACKGROUND: A single preoperative high dose of methylprednisolone (15 to 30 mg/kg) has been advocated in surgery, because it may inhibit the surgical stress response and thereby improve postoperative outcome and convalescence. However, these potential clinical benefits must be weighed against possible adverse effects. OBJECTIVE: To conduct a risk-benefit analysis ...

BACKGROUND: Mannitol was reported to decrease cerebral edema associated with tissue damage and is used to treat acute stroke in many countries. SUMMARY OF REVIEW: We tested whether there is any evidence from unconfounded randomized clinical trials that treatment with mannitol reduces short- and long-term case fatality and dependency if ...

Little is known about the long-term effects of homeopathic treatment. Following a double-blind, placebo-controlled trial of classical homeopathy in chronic headaches, we conducted a complete follow-up study of all trial participants. All patients enrolled in the double-blind study were sent a 6-week headache diary, a follow-up questionnaire. Eighty-seven of the ...

A systematic review on the cost effectiveness of prophylactic treatments of non-steroidal anti-inflammatory drug (NSAID) induced gastropathy in patients with osteoarthritis or rheumatoid arthritis was conducted. Two reviewers conducted the literature search and the review. Both full and partial economic evaluations published in English, Dutch, or German were included. The ...

PURPOSE: To our knowledge a causal relationship between altered levels of androgens and erectile dysfunction has not yet been established. We reviewed the literature to assess the usefulness of androgen replacement for erectile dysfunction. MATERIALS AND METHODS: Meta-analysis was chosen as the method of evaluating the literature. Study inclusion criteria ...

Field experiments were conducted in southern Wisconsin from 1996 to 1998 to evaluate the effects of acetochlor applied preemergence (PRE) followed by nicosulfuron or sethoxydim applied postemergence (POST) and of cultivation on woolly cupgrass control, corn grain yield, and woolly cupgrass seed production. Sethoxydim treatments provided greater woolly cupgrass control ...

In this review the rationale for the possible beneficial effect of tetracycline derivatives for the treatment of rheumatoid arthritis is discussed. Early studies (Sanchez, Skinner et al. and Brown et al. ) and the two open trials of the 1980s are briefly discussed. The three double-blind studies conducted in the ...

The purpose of this study was to compare the baseline patient characteristics, treatments and outcomes of elderly patients with aggressive histology lymphoma who were entered or not entered onto a randomized phase II trial. We previously conducted a randomized phase II trial in patients > or = 65 years of ...

To-date, the therapeutic standards, defined by randomized studies for carcinoma of the exocrine pancreas are disappointing. Obviously, there is much interest in the improvement of these results based on the evidence of additional clinical trials. To identify some trends in the clinical research in this field, some characteristics of 31 ...

Changes in therapy, primarily intensification, for childhood leukemias have significantly improved cure rates during the past 30 years. The increasing number of survivors has led to a heightened appreciation of the late complications of treatment caused by both radiation and chemotherapy. Important late effects include decreased growth, poor school performance, ...

OBJECTIVES: To perform a meta-analysis of prospective, randomized controlled trials comparing the closed and open technique of diagnostic peritoneal lavage (DPL) in trauma patients to determine whether there are any difference in outcomes. METHODS: A search of MEDLINE database of English language articles published from 1977 to 1999 was conducted ...

This has been an unusual year for the accumulation of evidence regarding the clinical effects of inhibition of cyclooxygenase (COX)-1 and COX-2. This article reviews the available data regarding the clinical effects of the new COX-2-specific inhibitors, and speculates about the importance of the data as they relate to the ...

The aim of this study was to investigate the results of different treatment strategies for osteochondral defects (OCD) of the talus. Electronic databases from 1966 to July 1998 were systematically screened. Based on our inclusion criteria 32 studies describing the results of treatment strategies for OCD of the talus were ...

The diversity of strategies reflects as much the lack of ideal treatments as it does the imagination of the investigators. Many aspects such as manipulation of apoptosis and extracorporeal removal of autoantibodies have been omitted due to space restrictions. Although most successful treatment strategies have been based on proven basic ...

BACKGROUND: Nonarteritic ischemic optic neuropathy is characterized by sudden and painless loss of vision in one eye, accompanied by pallid swelling of the optic disc. Although various medical interventions, such as corticosteroids and phenytoin sodium, have been used to treat nonarteritic ischemic optic neuropathy, no therapy has been proven effective. ...

BACKGROUND: Removal of wisdom teeth is one of the most common surgical procedures performed in the UK. Little controversy surrounds the removal of impacted third molars when they are associated with pathological changes such as infection, non-restorable carious lesions, cysts, tumours, and destruction of adjacent teeth and bone. However, the ...