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Randomized-controlled Trials (randomized-controlled + trials)
Selected AbstractsReview article: prebiotics in the gastrointestinal tractALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2006S. MACFARLANE Summary Background Prebiotics are short-chain carbohydrates that alter the composition, or metabolism, of the gut microbiota in a beneficial manner. It is therefore expected that prebiotics will improve health in a way similar to probiotics, whilst at the same time being cheaper, and carrying less risk and being easier to incorporate into the diet than probiotics. Aim To review published evidence for prebiotic effects on gut function and human health. Methods We searched the Science Citation Index with the terms prebiotic, microbiota, gut bacteria, large intestine, mucosa, bowel habit, constipation, diarrhoea, inflammatory bowel disease, Crohn's disease, ulcerative colitis, pouchitis, calcium and cancer, focussing principally on studies in humans and reports in the English language. Search of the Cochrane Library did not identify any clinical study or meta-analysis on this topic. Results Three prebiotics, oligofructose, galacto-oligosaccharides and lactulose, clearly alter the balance of the large bowel microbiota by increasing bifidobacteria and Lactobacillus numbers. These carbohydrates are fermented and give rise to short-chain fatty acid and intestinal gas; however, effects on bowel habit are relatively small. Randomized-controlled trials of their effect in a clinical context are few, although animal studies show anti-inflammatory effects in inflammatory bowel disease, while calcium absorption is increased. Conclusions It is still early days for prebiotics, but they offer the potential to modify the gut microbial balance in such a way as to bring direct health benefits cheaply and safely. [source] MARS®: a futile tool in centres without active liver transplant supportLIVER INTERNATIONAL, Issue 1 2007Chun-Tao Wai Abstract Background and aim: Studies on Molecular Adsorbent Recycling Systems (MARS®) showed inconclusive survival benefits. Patients and method: We evaluated the efficacy of MARS® for patients with either acute liver failure (ALF) or acute-on-chronic liver failure (AoCLF) at our centre, from February 2002 till April 2006 retrospectively. Results: Fifty ALF patients underwent median (range) three (1,10) sessions of MARS®. Acute exacerbations of chronic hepatitis B (n=26) and drug-induced liver injury (n=12) were the commonest causes. Living donors were available in 6, 2 paediatric patients underwent left lobe and four adults underwent right lobe living donor liver transplant. Among the 44 ALF patients without a suitable living donor, one underwent deceased donor liver transplant and survived, another 19-year-old male with acute exacerbations of chronic hepatitis B recovered without transplant, and the rest died. Twenty-six had AoCLF and underwent four (1,10) MARS® sessions. Sepsis (n=16) and upper gastrointestinal bleeding (n=4) were the commonest precipitating factors. None had a suitable living or deceased donor, suitable for transplantation during their hospitalization. Only one of 26 AoCLF patients survived the hospitalization, but the survivor died of sepsis 1 month later. Conclusion: In this non-randomized study, survival after MARS® was related to the availability of transplant, and in patients where living or deceased donor transplant was unavailable, MARS® was of little benefit. Randomized-controlled trials on MARS® are urgently needed to clarify its clinical utility. [source] Psychotherapy for depression among children and adolescents: a systematic reviewACTA PSYCHIATRICA SCANDINAVICA, Issue 2 2007N. Watanabe Objective:, To examine the clinical benefit, the harm and the cost-effectiveness of psychotherapies in comparison with no treatment, waiting-list controls, attention-placebos, and treatment as usual in depressed youths. Method:, Meta-analyses were undertaken by using data from all relevant randomized-controlled trials identified by a comprehensive literature search. The primary outcome was relative risk (RR) of response. Results:, We identified 27 studies containing 35 comparisons and 1744 participants. At post-treatment, psychotherapy was significantly superior (RR = 1.39, 95% CI 1.18,1.65, P = 0.0001, number-needed to treat 4.3). There was an evidence of the existence of small study effects, including a publication bias (P < 0.001). The superiority of psychotherapy was no longer statistically significant (1.18 [0.94,1.47], P = 0.15) at 6-month follow-up. None of the studies reported adverse effects or cost-effectiveness outcomes. Conclusion:, Although the findings were biased by some small positive trials, psychotherapies appear to help depressed youths for the short term, but are no longer significantly favourable at 6-month follow-up. [source] Effects of implementation of psychiatric guidelines on provider performance and patient outcome: systematic reviewACTA PSYCHIATRICA SCANDINAVICA, Issue 6 2007S. Weinmann Objective:, To identify evidence from comparative studies on the effects of psychiatric guideline implementation on provider performance and patient outcome. Effects of different implementation strategies were reviewed. Method:, Articles published between 1966 and March 2006 were searched through electronic databases and hand search. A systematic review of comparative studies of structured implementation of specific psychiatric guidelines was performed. Rates of guideline adherence, provider performance data, illness detection and diagnostic accuracy rates were extracted in addition to patient relevant outcome data. Results:, Eighteen studies (nine randomized-controlled trials, six non-randomized-controlled studies and three quasiexperimental before-and-after studies) were identified. Effects on provider performance or patient outcome were moderate and temporary in most cases. Studies with positive outcomes used complex multifaceted interventions or specific psychological methods to implement guidelines. Conclusion:, There is insufficient high-quality evidence to draw firm conclusions on the effects of implementation of specific psychiatric guidelines. [source] Atypical antipsychotics and anorexia nervosa: A reviewEUROPEAN EATING DISORDERS REVIEW, Issue 1 2010Rebecca F. McKnight Abstract Background There is currently mixed opinion regarding the value of using atypical antipsychotics to treat anorexia nervosa (AN). Aims To evaluate the literature on the use of atypical antipsychotics in AN. Method A review of all studies and clinical guidelines published before September 2009 involving use of an atypical antipsychotic in patients with AN. Analysis is by narrative synthesis. Results Forty-three publications or study protocols were found, including four randomized-controlled trials, five open-label trials and 26 case reports. The most studied drugs were olanzapine, quetiapine and risperidone. Atypical antipsychotics appear safe and there is some evidence of positive effects on depression, anxiety and core eating disordered psychopathology in patients with anorexia nervosa. Currently there is insufficient evidence to confirm atypical antipsychotics enhance weight gain in this setting. Conclusions Further high quality evidence is needed in this area in order to provide practical guidance to clinicians. However, the main challenge is to persuade adequate numbers of AN patients to participate in research trials. Copyright © 2010 John Wiley & Sons, Ltd and Eating Disorders Association. [source] Treatments for Patients With Dual Diagnosis: A ReviewALCOHOLISM, Issue 4 2007Quyen Q. Tiet Background: Comorbid substance use and mental illness is prevalent and often results in serious consequences. However, little is known about the efficacy of treatments for patients with dual diagnosis. Methods: This paper reviews both the psychosocial and medication treatments for those diagnosed with a substance-related disorder and one of the following disorders: (a) depression, (b) anxiety disorder, (c) schizophrenia, (d) bipolar disorder, (e) severe mental illness, and (f) nonspecific mental illness. We made no restriction of study design to include all published studies, due to the dearth of studies on treatments of patients with dual diagnosis. Results: Fifty-nine studies were identified (36 randomized-controlled trials; RCT). Limited number of studies, especially RCTs, have been conducted within each comorbid category. This review did not find treatments that had been replicated and consistently showed clear advantages over comparison condition for both substance-related and other psychiatric outcomes. Conclusions: Although no treatment was identified as efficacious for both psychiatric disorders and substance-related disorder, this review finds: (1) existing efficacious treatments for reducing psychiatric symptoms also tend to work in dual-diagnosis patients, (2) existing efficacious treatments for reducing substance use also decrease substance use in dually diagnosed patients, and (3) the efficacy of integrated treatment is still unclear. This review provides a critique of the current state of the literature, identifies the directions for future research on treatment of dual-diagnosis individuals, and calls for urgent attention by researchers and funding agencies to conduct more and more methodologically rigorous research in this area. [source] Comparison of Oral Prednisone and Prednisone Combined with Metronidazole for Induction Therapy of Canine Inflammatory Bowel Disease: A Randomized-Controlled TrialJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 2 2010A.E. Jergens Background: Although prednisone and metronidazole are commonly used to treat canine inflammatory bowel disease (IBD), no randomized-controlled trials have been performed. Hypothesis: Combination drug therapy with prednisone and metronidazole will be more effective than prednisone alone for treatment of canine IBD. Reduction in disease severity will be accompanied by decreased canine IBD activity index (CIBDAI) scores and serum C-reactive protein (CRP) concentrations. Animals: Fifty-four pet dogs diagnosed with IBD of varying severity. Methods: Dogs were randomized to receive oral prednisone (1 mg/kg; n = 25) or prednisone and metronidazole (10 mg/kg; n = 29) twice daily for 21 days. Clinical (CIBDAI) scores and serum CRP were determined at diagnosis and after 21 days of drug therapy. The primary efficacy measure was remission at 21 days, defined as a 75% or greater reduction in baseline CIBDAI score. Results: Differences between treatments in the rate of remission (both exceeding 80%) or the magnitude of its change over time were not observed. CRP concentrations in prednisone-treated dogs were increased because of many dogs having active disease. Both treatments reduced CRP in comparison with pretreatment concentrations. An interaction between CIBDAI and CRP was identified in 42 of 54 dogs (78%), whereas 8 of 54 dogs (15%) showed disagreement between these indices. Conclusions and Clinical Importance: Prednisone is as effective as combined treatment with prednisone and metronidazole for induction therapy of canine IBD. CRP may be normal or increased in dogs with IBD and may be useful in assessing the response of individual dogs to treatment along with changes in the CIBDAI. [source] Molecular adsorbent recirculating system treatment for patients with liver failure: the Hong Kong experienceLIVER INTERNATIONAL, Issue 6 2006Alexander Chiu Abstract: Background: The molecular adsorbent recirculating system (MARS) is an extracorporeal liver dialysis system that allows selective removal of bilirubin and other albumin-bound toxins. We reported here our experience with the use of this technique for management of liver failure at Queen Mary Hospital, Hong Kong. Methods: From December 2002 to 2004, a total of 74 MARS sessions were performed on 22 patients. The cause of liver failure included acute liver failure (n=2), acute on chronic liver failure (n=12), posthepatectomy liver failure (n=4), and posttransplantation allograft failure (n=4). Results: MARS treatment showed significant reduction in total bilirubin level, serum ammonia level and blood urea, and nitrogen (P<0.001 for all three parameters). Five patients (22.7%) were able to bridge to transplantation and one patient (4.5%) made a spontaneous recovery. The 30-day mortality rate was 72.7%. Conclusions: Our results indicated that MARS can effectively improve serum biochemistry and is suitable for temporarily supporting patients with liver failure where transplantation is not immediately available. There is, however, no clear evidence showing that MARS can increase survival, improve the chance of transplantation or assist liver regeneration. Future studies in the form of randomized-controlled trials are crucial to characterize the true potential of this treatment. [source] Biomarker as a classifier in pharmacogenomics clinical trials: a tribute to 30th anniversary of PSI,,PHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 4 2007Sue-Jane Wang Abstract Pharmacogenetics is one of many evolving sciences that have come to the fore since the formation of the Statisticians in the Pharmaceutical Industry (PSI) 30 years ago. Following the completion of the human genome project and the HapMap in the early 21st century, pharmacogenetics has gradually focused on studies of whole-genome single-nucleotide-polymorphisms screening associating disease pathophysiology with potential therapeutic interventions. Around this time, transcription profiling aiming at similar objectives has also been actively pursued, known as pharmacogenomics. It has become increasingly apparent that treatment effects between different genomic patient subsets can be dissimilar, and the value and need for genomic biomarkers to help predict effects, particularly in cancer clinical studies, have become issues of paramount importance. Pharmacogenomics/pharmaogenetics has thus become intensely focused on the search for genomic biomarkers for use as classifiers to select patients in randomized-controlled trials. We highlight that the predictive utility of a genomic classifier has tremendous clinical appeal and that there will be growing examples in which use of a companion diagnostic will need to be considered and may become an integral part in the utilization of drugs in medical practice. The credible mechanism to test the clinical utility of a genomic classifier is to employ the study results from a prospective trial that recruits all patients. Such investigations, if well designed, will allow analysis of all relevant performance factors in the drug and diagnostic combination including the sensitivity, specificity, positive and negative predictive values of the diagnostic test and the efficacy of the drug. Published in 2007 by John Wiley & Sons, Ltd. [source] Controversies in the treatment of high-risk prostate cancer,what is the optimal combination of hormonal therapy and radiotherapy: a review of literature,THE PROSTATE, Issue 7 2010Abrahim Al-Mamgani Abstract BACKGROUND In high-risk prostate carcinoma, there is controversy whether these patients should be treated with escalated-dose (,74 Gy) or conventional-dose radiotherapy (<74 Gy) combined with hormonal therapy. Furthermore, the issue of the optimal duration and timing of hormonal therapy are not well crystallized. PATIENTS AND METHODS A search for evidence from randomized- and large non-randomized studies in order to address these issues, was therefore initiated. For this purpose, MedLine, EMbase, and PubMed and the data base of the Dutch randomized dose-escalation trial, were consulted. RESULTS AND CONCLUSIONS From this search it was concluded that the benefit of hormonal therapy in combination with conventional-dose radiotherapy (<74 Gy) in high-risk prostate cancer is evident (Level 2 evidence); Levels 2 and 3 evidence were provided by several studies supporting the use of escalated-dose radiotherapy in high-risk prostate cancer. For the combination of hormonal therapy with escalated-dose radiotherapy in these patients, there is Level 2 evidence for moderately escalated dose (74 Gy) and high escalated dose (,78 Gy). The optimal duration and timing of hormonal therapy are not well defined. More randomized-controlled trials and meta-analyses are therefore needed to clearly determine the independent role of dose-escalation in high-risk patients treated with hormonal therapy and the optimal duration and timing of hormonal therapy. Prostate 70: 701,709, 2010. © 2009 Wiley-Liss, Inc. [source] Targeting Allograft Injury and Inflammation in the Management of Post-Lung Transplant Bronchiolitis Obliterans SyndromeAMERICAN JOURNAL OF TRANSPLANTATION, Issue 6 2009A. G. N. Robertson Chronic allograft dysfunction, manifesting as bronchiolitis obliterans syndrome (BOS), is the major cause of morbidity and mortality in human lung transplant recipients. While alloimmunity has a definite role, there is increasing interest in overall allograft injury and subsequent inflammation and remodeling. This review deals with nonalloimmune factors that may potentiate alloimmune injury. We discuss infection and reflux/aspiration as examples of allograft injury, which may lead to chronic loss of graft function and BOS. Surgical and nonsurgical treatments aimed at preventing these insults and improving survival are considered. The need for further evidence, including randomized-controlled trials, to evaluate the role of medical and surgical therapies is emphasized by the current literature. [source] The role of paracetamol in the pathogenesis of asthmaCLINICAL & EXPERIMENTAL ALLERGY, Issue 1 2010H. Farquhar Summary Paracetamol use represents a putative risk factor for the development of asthma. There is convincing epidemiological evidence that the risk of asthma may be increased with exposure to paracetamol in the intrauterine environment, infancy, later childhood and adult life. A dose-dependent association has also been observed in these different age groups in different populations world-wide. An association has also been shown between paracetamol use in both rhinoconjunctivitis and eczema. There is biological plausibility with paracetamol use leading to decreased glutathione levels resulting in increased oxidant-induced inflammation and potentially enhanced T-helper type 2 responses. At the population level, patterns of paracetamol use might explain, to some extent, the world-wide variation in the prevalence of asthma and related disorders, particularly the high rates in English-speaking countries, which have high per capita prescription and over-the-counter use of paracetamol. A temporal association also exists between the international trends of increasing paracetamol use and increasing prevalence of asthma over recent decades. Further research is urgently required, in particular randomized-controlled trials (RCTs) into the long-term effects of frequent paracetamol use in childhood, to determine the magnitude and characteristics of any such risk. Importantly, RCTs will also enable evidence-based guidelines for the recommended use of paracetamol to be developed. Cite this as: H. Farquhar, A. Stewart, E. Mitchell, J. Crane, S. Eyers, M. Weatherall and R. Beasley, Clinical & Experimental Allergy, 2010 (40) 32,41. [source] | ||||||||||