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Controlled Clinical Trials (controlled + clinical_trials)
Selected AbstractsRandomized Controlled Clinical TrialsJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 2 2003CH Cole No abstract is available for this article. [source] Introduction to Randomized Controlled Clinical Trials, 2nd Edition edited by Matthews, J. N. S.BIOMETRICS, Issue 1 2007Article first published online: 16 APR 200 No abstract is available for this article. [source] Secondary delusional parasitosis treated with paliperidoneCLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 3 2009R. W. Freudenmann Summary Second-generation antipsychotics (SGA) are increasingly used in primary and secondary delusional parasitosis (DP) because of their better overall tolerability compared with first-generation antipsychotics (FGA) such as pimozide. Controlled clinical trials with antipsychotics in DP are lacking, owing to difficulties in obtaining informed consent and in securing adherence to a study protocol by patients with DP. We present the case of an 88-year-old man with a 12-year history of DP secondary to leucoencephalopathy. After 9 days of an age-adapted dose of paliperidone, the patient no longer experienced the presence of vermin on his skin and stopped showering at night to get rid off of them. Paliperidone was well tolerated. At follow-up after 2 weeks, the DP was still remitted. Paliperidone appears to expand the therapeutic arsenal in treating DP with modern SGAs; however, this finding needs to be replicated. [source] Management of chronic hand eczemaCONTACT DERMATITIS, Issue 4 2007Thomas L. Diepgen Hand eczema (HE) is one of the most frequent skin diseases and has often a chronically relapsing course with a poor prognosis resulting in a high social and economic impact for the individual and the society. In this article, we highlight the results of an expert workshop on the ,management of severe chronic hand eczema' with the focus on the epidemiology, the burden of severe HE, its classification and diagnostic procedures, and the current status of treatment options according to an evidence-based approach (randomized controlled clinical trials, RCTs). We conclude that despite the abundance of topical and systemic treatment options, disease management in patients with severe chronic HE is frequently inadequate. There is a strong need for RCTs of existing and new treatment options based on clearly diagnosed subtypes of HE and its severity. [source] Efficacy of interpersonal therapy-group format adapted to post-traumatic stress disorder: an open-label add-on trialDEPRESSION AND ANXIETY, Issue 1 2010Rosaly F.B. Campanini MSc. Abstract Background: Post-traumatic stress disorder (PTSD) is a highly prevalent condition, yet available treatments demonstrate only modest efficacy. Exposure therapies, considered by many to be the "gold-standard" therapy for PTSD, are poorly tolerated by many patients and show high attrition. We evaluated interpersonal therapy, in a group format, adapted to PTSD (IPT-G PTSD), as an adjunctive treatment for patients who failed to respond to conventional psychopharmacological treatment. Methods: Research participants included 40 patients who sought treatment through a program on violence in the department of psychiatry of Federal University of São Paulo (UNIFESP). They had received conventional psychopharmacological treatment for at least 12 weeks and failed to have an adequate clinical response. After signing an informed consent, approved earlier by the UNIFESP Ethics Review Board, they received a semi-structured diagnostic interview (SCID-I), administered by a trained mental health worker, to confirm the presence of a PTSD diagnosis according to DSM-IV criteria. Other instruments were administered, and patients completed out self-report instruments at baseline, and endpoint to evaluate clinical outcomes. Results: Thirty-three patients completed the trial, but all had at least one second outcome evaluation. There were significant improvements on all measures, with large effect sizes. Conclusions: IPT-G PTSD was effective not only in decreasing symptoms of PTSD, but also in decreasing symptoms of anxiety and depression. It led to significant improvements in social adjustment and quality of life. It was well tolerated and there were few dropouts. Our results are very preliminary; they need further confirmation through randomized controlled clinical trials. Depression and Anxiety, 2010. © 2009 Wiley-Liss, Inc. [source] Vitamin D and innate immunityDERMATOLOGIC THERAPY, Issue 1 2010Jeremiah Miller ABSTRACT Vitamin D's role in bone health has been well established. Recently, studies have identified additional roles of vitamin D in the immune system, cardiovascular system, and cancer prevention. The effect of vitamin D on the immune system is particularly relevant to the dermatologist in that it has implications for atopic dermatitis, psoriasis, and skin cancer. However, there is much disagreement on a dose of vitamin D that is both safe and effective as both ultraviolet exposure and certain vitamin D-rich foods come with unwanted consequences. This review aims to update the dermatologist on the roles of vitamin D in the immune system, the safety and dose of different sources, and risk factors for vitamin D deficiency that may necessitate supplementation. Immune consequences of vitamin D status represent one additional aspect that illustrates how guidelines for supplementation are needed and will only be useful clinically if they are presented in context with validated controlled clinical trials. [source] The potential of cinnamon to reduce blood glucose levels in patients with type 2 diabetes and insulin resistanceDIABETES OBESITY & METABOLISM, Issue 12 2009S. Kirkham Aim: Cinnamon has a long history as an antidiabetic spice, but trials involving cinnamon supplementation have produced contrasting results. The aim of this review was to examine the results of randomized controlled clinical trials of cinnamon and evaluate the therapeutic potential amongst patients with diabetes and insulin-resistant patients, particularly the ability to reduce blood glucose levels and inhibit protein glycation. Methods: A systematic electronic literature search using the medical subject headings ,cinnamon' and ,blood glucose' was carried out to include randomized, placebo-controlled in vivo clinical trials using Cinnamomum verum or Cinnamomum cassia conducted between January 2003 and July 2008. Results: Five type 2 diabetic and three non-diabetic studies (total N = 311) were eligible. Two of the diabetic studies illustrated significant fasting blood glucose (FBG) reductions of 18,29% and 10.3% (p < 0.05), supported by one non-diabetic trial reporting an 8.4% FBG reduction (p < 0.01) vs. placebo, and another illustrating significant reductions in glucose response using oral glucose tolerance tests (p < 0.05). Three diabetic studies reported no significant results. Conclusions: Whilst definitive conclusions cannot be drawn regarding the use of cinnamon as an antidiabetic therapy, it does possess antihyperglycaemic properties and potential to reduce postprandial blood glucose levels. Further research is required to confirm a possible correlation between baseline FBG and blood glucose reduction and to assess the potential to reduce pathogenic diabetic complications with cinnamon supplementation. [source] Effects of Qi therapy (external Qigong) on symptoms of advanced cancer: a single case studyEUROPEAN JOURNAL OF CANCER CARE, Issue 5 2005M.S. LEE phd The aim of this study was to examine the effectiveness of Qi therapy (external Qigong) in the management of symptoms of advanced cancer in a man. We used a single case study design to evaluate the effectiveness of Qi therapy (external Qigong) in a 35-year-old man with advanced cancer (Stage IV) involving metastases in the stomach, lung and bone (Karnofsky performance scale: KPS, 40: requires special care and assistance, disabled). Treatment involved six days of pre-assessment, eight treatment sessions on alternate days over 16 days, and a two-week follow-up phase. A visual analogue scale (VAS) was used to assess the patient's self-reported symptoms of cancer over the intervention and follow-up periods. Following treatment, VAS scores' analysis revealed beneficial effects on pain, vomiting, dyspnoea, fatigue, anorexia, insomnia, daily activity and psychological calmness. These improvements were maintained over the two-week follow-up phase. After the first Qi therapy session, the patient discontinued medication and could sit by himself; after the fourth session, the patient was able to walk and use the toilet without assistance (improvement in KPS: 70: care for self, unable to perform normal activity or to do active work). Although limited by the single case study approach, our results support previous studies on this topic and provide reasons to conduct controlled clinical trials. [source] Survival probability of zirconia-based fixed dental prostheses up to 5 yr: a systematic review of the literatureEUROPEAN JOURNAL OF ORAL SCIENCES, Issue 5 2010Jaana-Sophia Schley Schley J-S, Heussen N, Reich S, Fischer J, Haselhuhn K, Wolfart S. Survival probability of zirconia-based fixed dental prostheses up to 5 yr: a systematic review of the literature. Eur J Oral Sci 2010; 118: 443,450. © 2010 Eur J Oral Sci The purpose of this systematic review was to calculate the 5-yr survival rates of all-ceramic zirconia-based fixed dental prostheses (FDPs) and to analyze technical and biological complications. An electronic literature search of MEDLINE (PubMed) was conducted independently by three reviewers to identify clinical studies from 1999 to 2009 and was completed by a manual search. Keywords and inclusion and exclusion criteria were well-defined. The search revealed 399 titles and led to the final analysis of 18 full-text articles. Nine studies met the inclusion criteria. Extracted data were statistically calculated into 5-yr survival rates and 5-yr complication-free rates by using Poisson regression analysis. In total, 310, 3- to 4-unit FDPs and 20 FDPs with more than 4 units were included. The estimated 5-yr survival rate for all FDPs was 94.29% (95% CI: 58.98,99.32); 19 FDPs were lost as a result of catastrophic failures. The 5-yr complication-free rate regarding technical complications was 76.41% (95% CI: 42.42,91.60) with chipping being the most frequent complication. Regarding biological complications, the 5-yr complication-free rate was 91.72% (95% CI: 59.19,98.53). The survival rates of zirconia-based short-unit FDPs are promising. However, an important improvement of the veneering systems is required, and for FDPs with more units in function, further randomized, controlled clinical trials are necessary. [source] Nearly half of dental randomized controlled trials published in German are not included in MedlineEUROPEAN JOURNAL OF ORAL SCIENCES, Issue 6 2002Jens C. Türp Randomized controlled trials (RCTs) are considered the most reliable type of clinical intervention studies. However, not all reports of RCTs are accessible in Medline. This can impede the validity of the results of systematic reviews. Ten German-language dental journals were manually searched to locate reports of controlled clinical trials published between 1970 and 2000. The publication type was determined and compared with Medline. Of the 15 777 articles, 210 reports of RCTs and 410 articles of non-randomized controlled clinical trials (CCTs) were identified. Only 56% of the RCTs and 75% of the CCTs are available in Medline. Of the 118 reports of RCTs registered in Medline, 15 are indexed with the correct Publication Type term. Our data suggest that (a) hand-searching plays a valuable role in identifying reports of clinical dental trials, and (b) a literature search in Medline is likely to yield incomplete results. [source] An emerging role for interferon in haemophiliacs with chronic hepatitis C?HAEMOPHILIA, Issue 1 2001C. Aguilar The combination of interferon (IFN) and ribavirin is the current gold standard for treatment of chronic hepatitis C virus (HCV) infection with sustained remission rates of 35,40% being achieved in haemophilic patients. A similar beneficial effect of this combined therapy has been suggested even for patients with compensated liver cirrhosis and some authors have reported a possible role for IFN and ribavirin in the prevention or delay in the development of hepatocellular carcinoma (HCC), a well known complication of HCV infection in haemophiliacs. The absence, due to design difficulties, of definite randomized controlled clinical trials remains a handicap for the routine use of specific therapy of HCV infected patients with the aim of preventing HCC. A discussion of these important issues has been performed in this paper. [source] Mirtazapine naturalistic depression study (in Sweden),MINDS(S): clinical efficacy and safetyHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 3 2006Jan Wålinder Abstract Objective To study how implementation of a naturalistic trial design for mirtazapine treatment in major depressive disorder for six (up to 12) months could be used and evaluated by means of clinical efficacy and safety. Method An open-labelled, prospective, multicenter, non-comparative trial was conducted during a 2-year period in patients with major depression according to DSM-IV treated in psychiatric departments and primary care in Sweden. Minimal inclusion and exclusion criteria were used in order to diminish the potential patient selection bias. Maximum flexibility of the dosage of mirtazapine was allowed, and clinical assessments included MADRS, CGI, vital signs and spontaneous reporting of adverse events. Results 192 patients were found eligible and enrolled in the study. A significant improvement in depressive symptoms according to MADRS and CGI was observed including particularly marked sleep improvement early in the treatment. Slight increases in body weight and BMI were observed. The investigational drug was well tolerated overall. Conclusion The clinical efficacy and safety of mirtazapine found in this naturalistic setting is in line with previously reported data on mirtazapine in traditional controlled clinical trials. The results confirm that the naturalistic study design facilitated conduct of the trial. The authors suggest that this type of study design should also be applied to other antidepressant drugs that are frequently prescribed in the general population. Copyright © 2006 John Wiley & Sons, Ltd. [source] Prebiotics in chronic intestinal inflammationINFLAMMATORY BOWEL DISEASES, Issue 3 2009Mirjam A.C. Looijer, Van Langen MD Abstract Prebiotics are nondigestible fermentable fibers that are reported to have health benefits for the host. Older as well as more recent studies show beneficial effects in experimental colitis and lately also in human inflammatory bowel diseases (IBD), such as Crohn's disease, ulcerative colitis, and chronic pouchitis. In this review we give an overview of the benefits of prebiotics in rodent IBD models and in IBD patients and discuss their possible protective mechanisms. Commensal intestinal bacteria induce and perpetuate chronic intestinal inflammation, whereas others are protective. However, most of the current medications are directed against the exaggerated proinflammatory immune response of the host, some of them toxic and costly. Feeding prebiotics changes the composition of the intestinal microflora toward more protective intestinal bacteria and alters systemic and mucosal immune responses of the host. Therapy for IBD targeting intestinal bacteria and their function is just emerging. Prebiotics have the promise to be relatively safe, inexpensive, and easy to administer. Unraveling their protective mechanisms will help to develop rational applications of prebiotics. However, the initial promising results with dietary prebiotics in preclinical trials as well as small studies in human IBD will need to be confirmed in large randomized controlled clinical trials. (Inflamm Bowel Dis 2008) [source] Probiotics and the management of inflammatory bowel diseaseINFLAMMATORY BOWEL DISEASES, Issue 3 2004FRCPC, Richard N. Fedorak MD Abstract The demonstration that immune and epithelial cells can discriminate between different microbial species has extended our understanding of the actions of probiotics beyond simple barrier and antimicrobial concepts. Several probiotic mechanisms of action, relative to inflammatory bowel disease, have been elucidated: (1) competitive exclusion, whereby probiotics compete with microbial pathogens for a limited number of receptors present on the surface epithelium; (2) immunomodulation and/or stimulation of an immune response of gut-associated lymphoid and epithelial cells; (3) antimicrobial activity and suppression of pathogen growth; (4) enhancement of barrier function; and (5) induction of T cell apoptosis in the mucosal immune compartment. The unraveling of these mechanisms of action has led to new support for the use of probiotics in the management of clinical inflammatory bowel disease. Though level 1 evidence now supports the therapeutic use of probiotics in the treatment of postoperative pouchitis, only levels 2 and 3 evidence is currently available in support of the use of probiotics in the treatment of ulcerative colitis and Crohn's disease. Nevertheless, one significant and consistent finding has emerged during the course of research in the past year: not all probiotic bacteria have similar therapeutic effects. Rigorously designed, controlled clinical trials are vital to investigate the unresolved issues related to efficacy, dose, duration of use, single or multi-strain formulation, and the concomitant use of prebiotics, synbiotics, or antibiotics. [source] Recent trends in the treatment of testosterone deficiency syndromeINTERNATIONAL JOURNAL OF UROLOGY, Issue 11 2007Bum Sik Hong Abstract: Testosterone deficiency syndrome (TDS) is defined as a clinical and biochemical syndrome associated with advancing age and is characterized by typical symptoms and deficiency in serum testosterone levels. TDS is a result of the interaction of hypothalamo-pituitary and testicular factors. Now, treatment of TDS with testosterone is still controversial due to a lack of large, controlled clinical trials on efficacy. The risks of treatment with testosterone appear to be minimal, although long-term studies on the safety of testosterone therapy are lacking. The aim of the therapy is to establish a physiological concentration of serum testosterone in order to correct the androgen deficiency, relieve its symptoms and prevent long-term sequelae. All of the available products, despite their varying pharmacodynamic and pharmacokinetic profiles, are able to reach this goal. Newer testosterone patches seem not to cause severe skin irritation. Testosterone gels minimize the skin irritation while providing flexibility in dosing and a low discontinuation rate. Oral testosterone undecanoate (TU) is free of liver toxicity. Recent formulation of oral TU markedly increased shelf-live, a major drawback in the older preparation. Producing swings in testosterone levels rising rapidly to the supraphysiological range is not the case with the new injectable long-acting preparation of TU. To be able to rapidly react and stop treatment in cases where side-effects and contraindications are detected, the short-acting transdermal and oral delivery modes have certain advantages. However, there is no evidence that the use of an injectable long-acting TU in men with TDS has limitations in clinical application for this reason. The use of dehydroepiandrosterone is still controversial because of a lack of well designed long-term trials, although some recent studies suggest positive effects on various body systems. Only a few studies have been carried out to investigate the effect of hCG (human chorionic gonadotropin) in TDS with some positive results on various body systems. [source] A systematic review of the efficacy of non-pharmacological treatments for depression on glycaemic control in type 2 diabeticsJOURNAL OF CLINICAL NURSING, Issue 19 2008Mei-Yeh Wang Aims and objectives., This paper reported a systematic review of three randomised controlled clinical trials evaluating the efficacy of non-pharmacological treatment of depression on glycaemic control in individuals with type 2 diabetes. Background., Depression is associated with poor adherence to self-care regimen in individuals with diabetes. A significant relationship between depression and poor glycaemic control has also been suggested. Hence, the management of depression becomes an important aspect of diabetes care. Design., Systematic review. Methods., Cochrane library, Pubmed, MEDLINE, EBM review, ProQuest Medical Bundle and SCOPUS databases were searched using the following medical subject headings or key words , depression, mood disorder, depressive symptoms, diabetes mellitus, glycaemic control, glycated haemoglobin, glucose, psychological therapy, psychotherapy, non-pharmacological therapy and cognitive behaviour therapy. The publication date was limited from 1996,2007. Studies were selected if they used a randomised controlled trial design, were written in English, used non-pharmacological treatments for treating depression, included individuals with type 2 diabetes mellitus as participants and included depressive symptoms and glycaemic control (determined by haemoglobin A1C) as outcomes. Results., Non-pharmacological treatments of depression reduce depressive symptoms in diabetic patients. However, cognitive behaviour therapy did not improve glycaemic control. The treatment effect sizes for glycaemic control in the two collaborative-care programmes were also small. Conclusions., The available evidence indicated that non-pharmacological treatment of depression had limited effect on glycaemic control in individuals with type 2 diabetes. Relevance to clinical practice., The depression-focused interventions might not achieve optimal diabetes-related outcomes. The beneficial effect of psychological treatment for glycaemic control may be strengthened by employing treatments tailored to each individual's diabetes self-care needs in addition to depression management. [source] Feasibility of individualized treatment for hepatitis C patients in the real worldJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 1 2010Tsung-Ming Chen Abstract Background and Aim:, Individualized treatment with a combination of peg-interferon and ribavirin for patients with hepatitis C virus (HCV) infection has been validated in randomized controlled clinical trials, but its usefulness in the real world is unknown. The aim of the present study was to assess the feasibility of individualized treatment for HCV patients compared with standard therapy in a real-life clinical setting. Methods:, A total of 253 naïve patients with HCV infection who received peg-interferon and ribavirin combination treatment were analyzed and grouped into one of three clinical settings: (i) infection with genotype non-1 (HCV non-1) and treatment for standard 24 weeks (n = 105; none received an abbreviated therapy); (ii) genotype 1 (HCV-1) and standard therapy for either 24 weeks (n = 71) or 48 weeks (n = 21); and (iii) HCV-1 and individualized treatment (n = 56). The individualized therapy used was an abbreviated 24-week treatment for HCV-1 patients who achieved a rapid virological response, otherwise patients received a 48-week course of treatment. Early termination of treatment at week 16 was recommended for non-responders. Results:, A sustained virological response (SVR) was achieved in 83.8% of patients with HCV non-1 infection. Among the HCV-1-infected patients, 53.5% of patients who underwent standard 24-week treatment, 66.7% of patients who underwent standard 48-week treatment, and 64.3% of patients treated by individualized therapy achieved SVR. Patients infected with HCV-1 and treated by individualized therapy had a similar efficacy response compared with the standard 48-week therapy (adjusted odds ratio [OR] 0.765, 95% confidence interval [CI], 0.220,2.659, P = 0.673). Both individualized therapy (adjusted OR 2.855, 95% CI 1.189,6.855, P = 0.019) or standard 48-week treatment (adjusted OR 3.733, 95% CI 1.073,12.986, P = 0.038) had significantly higher odds of SVR compared with HCV-1 patients treated by standard 24-week course. Conclusion:, Individualized therapy is feasible in the real world, especially for patients with HCV-1 infection. [source] Acupuncture , a critical analysisJOURNAL OF INTERNAL MEDICINE, Issue 2 2006E. ERNST Abstract. Even though widely used in today's clinical practice, acupuncture has remained a controversial subject. Many reviews are currently available but most lack a critical stance and some are overtly promotional. The aim of this overview is to provide a balanced, critical analysis of the existing evidence. Some of the original concepts of traditional acupuncture are not supported by good scientific evidence. Several plausible theories attempt to explain how acupuncture works but none are proved beyond doubt. The clinical effectiveness of acupuncture continues to attract controversy. Many controlled clinical trials and numerous systematic reviews of these studies have been published. Considerable problems are encountered when interpreting these data. Heterogeneity is a significant drawback of both clinical trials and systematic reviews. Some of the controversies may be resolved through the use of the new ,placebo needles' which enable researchers to adequately control for placebo effects of acupuncture. The majority of studies using such devices fails to show effects beyond a placebo response. Acupuncture has been associated with serious adverse events but most large-scale studies suggest that these are probably rare. Nonserious adverse effects occur in 7,11% of all patients. In conclusion, acupuncture remains steeped in controversy. Some findings are encouraging but others suggest that its clinical effects mainly depend on a placebo response. [source] Therapy with antioxidants in human diabetic neuropathyJOURNAL OF NEUROCHEMISTRY, Issue 2003D. Ziegler Increased oxidative stress has been implicated in the pathogenesis of diabetic polyneuropathy (DPN). Antioxidant treatment with alpha-lipoic acid (ALA) has been shown to prevent or ameliorate experimental diabetic neuropathy, providing the rationale for treatment in humans. A recent meta-analysis including four controlled clinical trials provided evidence that treatment with ALA (600 mg/day i.v.) over 3 weeks is safe and significantly improves both neuropathic symptoms and deficits to a clinically meaningful degree in patients with symptomatic DPN. Moreover, oral treatment for 4,7 months tends to ameliorate neuropathic deficits and cardiac autonomic neuropathy. Clinical and postmarketing surveillance studies have revealed a highly favorable safety profile of this drug. Based on these findings, a pivotal long-term multicenter trial of oral treatment with ALA (NATHAN 1 Study) is under way aimed at slowing the progression of DPN. [source] Statins and osteoporosis: new role for old drugsJOURNAL OF PHARMACY AND PHARMACOLOGY: AN INTERNATI ONAL JOURNAL OF PHARMACEUTICAL SCIENCE, Issue 1 2006Satyawan B. Jadhav Osteoporosis is the most common bone disease, affecting millions of people worldwide and leading to significant morbidity and high expenditure. Most of the current therapies available for its treatment are limited to the prevention or slowing down of bone loss rather than enhancing bone formation. Recent discovery of statins (HMG-CoA reductase inhibitors) as bone anabolic agents has spurred a great deal of interest among both basic and clinical bone researchers. In-vitro and some animal studies suggest that statins increase the bone mass by enhancing bone morphogenetic protein-2 (BMP-2)-mediated osteoblast expression. Although a limited number of case,control studies suggest that statins may have the potential to reduce the risk of fractures by increasing bone formation, other studies have failed to show a benefit in fracture reduction. Randomized, controlled clinical trials are needed to resolve this conflict. One possible reason for the discrepancy in the results of preclinical, as well as clinical, studies is the liver-specific nature of statins. Considering their high liver specificity and low oral bioavailability, distribution of statins to the bone microenvironment in optimum concentration is questionable. To unravel their exact mechanism and confirm beneficial action on bone, statins should reach the bone microenvironment in optimum concentration. Dose optimization and use of novel controlled drug delivery systems may help in increasing the bioavailability and distribution of statins to the bone microenvironment. Discovery of bone-specific statins or their bone-targeted delivery offers great potential in the treatment of osteoporosis. In this review, we have summarized various preclinical and clinical studies of statins and their action on bone. We have also discussed the possible mechanism of action of statins on bone. Finally, the role of drug delivery systems in confirming and assessing the actual potential of statins as anti-osteoporotic agents is highlighted. [source] A Systematic Review of Dowel (Post) and Core Materials and SystemsJOURNAL OF PROSTHODONTICS, Issue 6 2009Joanna N. Theodosopoulou DDS Abstract Purpose: The aim of this systematic review was to determine which dowel (post) and core system is the most successful when used in vivo to restore endodontically treated teeth. Materials and Methods: A MEDLINE, a Cochrane, and an EMBASE search (three specified searches) were conducted to identify randomized (RCT) and nonrandomized controlled clinical trials (CCT), cohort (CS), and case control studies (CCS) until January 2008, conducted on humans, and published in English, German, and French, relating to dowel and core systems for restoring endodontically treated teeth. Also, a hand search was conducted, along with contact with the authors when needed. Results: The MEDLINE, Cochrane, and EMBASE searches identified 997, 141, and 25 published articles, respectively. Ten articles from the MEDLINE and seven articles from the Cochrane search (that were also identified in the MEDLINE search) met the inclusion and validity assessment criteria. Six out of the ten studies were RCTs, two were CCTs, and two CSs. The RCT studies suggest that carbon fiber in resin matrix dowels are significantly better than precious alloy cast dowels (number needed to treat, NNT = 8.30). Tapered gold alloy cast dowels are better than ParaPost® gold alloy cast dowels (NNT = 13.15). ParaPost® prefabricated dowels are slightly better than ParaPost® cast dowels (NNT = 175.4). Glass fiber dowels are significantly better than metal screw dowels (NNT = 5.46), but worse than titanium (NNT =,21.73) (moderately). Carbon fiber dowels are worse than gold alloy cast dowels (significantly) (NNT =,5.81) and than amalgam dowels (NNT =,125) (slightly). The CCT studies suggest that metal dowels are better (NNT = 21.73) but also worse than cast dowels (NNT =,33.33) depending on the remaining amount of coronal hard tissue. Quartz fiber dowels show success rates similar to and worse than glass fiber-reinforced dowels (NNT =,37.03). The results from the CS studies suggest that carbon fiber in resin matrix dowels are better (moderately) than carbon fiber + quartz and quartz fiber dowels. Titanium dowels with a composite build-up are better (moderately) than gold alloy cast dowels. Conclusions: According to the studies of the highest levels of evidence, carbon fiber in resin matrix dowels are significantly better than precious alloy cast dowels (RCT). Glass fiber dowels are significantly better than metal screw dowels (RCT) and moderately better than quartz fiber dowels (CCT). Carbon fiber dowels are significantly worse than metal dowels (of precious alloy) (RCT). Prefabricated metal dowels are slightly better than cast dowels (RCT), but moderately worse when no collar of the dentin above the gingiva could be achieved (CCT). [source] Issues in designing and interpreting clinical trials of treatments for chronic hepatitis CJOURNAL OF VIRAL HEPATITIS, Issue 2006C. O'Brien Summary., Many of the major advances in treating patients for chronic hepatitis C have been made based on the results of randomized, double-blind, controlled clinical trials. However, given the large number of hepatitis C medications in development, physicians need to understand the unique elements and types of clinical trials in order to make accurate comparisons of differing drug efficacy claims. Clinicians also need to be aware of the various factors that can influence the outcomes and interpretations of these trials, irrespective of the intervention under study. For example, similar trials conducted in the United States and Europe may have different outcomes simply because the study populations differ. Thus, both trial design and patient population are important considerations in the design and analysis of clinical trials for patients with chronic hepatitis C. [source] Herbal medicines for treatment of fungal infections: a systematic review of controlled clinical trialsMYCOSES, Issue 3-4 2004Karen W. Martin Antimykotische Chemotherapie; Phytomedizin Summary Traditional medicine has made use of many different plant extracts for treatment of fungal infections and some of these have been tested for in vitro antifungal activity. This systematic review evaluates antifungal herbal preparations that have been tested in controlled clinical trials. Four electronic databases were searched for controlled clinical trials of antifungal herbal medicines. Data were extracted in a standardized manner by two independent reviewers and are reviewed narratively. Seven clinical trials met our inclusion criteria. Tea tree oil preparations were tested in four randomized clinical trials and some positive outcomes were attributed to the intervention in all trials. Solanum species (two trials) and oil of bitter orange preparations (one trial) were compared with conventional treatments. In all cases encouraging results were reported. There are few controlled clinical trials of herbal antifungal medicines. The most thoroughly clinically tested is tea tree oil, which holds some promise. All herbal remedies require further investigation in rigorous clinical trials. Zusammenfassung Die traditionelle Medizin nutzt eine Vielzahl unterschiedlicher Pflanzenextrakte zur Behandlung von Pilzinfektionen, die teilweise auf antimyzetische Wirksamkeit in vitro untersucht wurden. Dieser Überblick bewertet diejenigen antimyzetischen Zubereitungen pflanzlichen Ursprungs, die in kontrollierten klinischen Studien geprüft worden sind. Zu diesem Zweck wurden vier elektronische Datenbanken gesichtet. Die Daten wurden mit einer standardisierten Methode von zwei unabhängigen Gutachtern erhoben und werden im Folgenden bewertend dargestellt. Sieben klinische Studien erfüllten unsere Einschlusskriterien. Teebaumöl-Zubereitungen wurden in vier randomisierten klinischen Studien getestet, und einige positive Ergebnisse wurden in allen Studien auf den Wirkstoff zurückgeführt. Zubereitungen von Solanum -Arten (zwei Studien) und Orangenbitteröl wurden mit konventionellen Behandlungsmethoden verglichen. In allen Studien wurden ermutigende Resultate erzielt. Diese wenigen kontrollierten klinischen Studien mit antimyzetischen Zubereitungen pflanzlichen Ursprungs ergaben, dass Teebaumöl am vielversprechendsten ist. Alle pflanzlichen Zubereitungen erfordern jedoch weitere Studien unter kritischen klinischen Versuchbedingungen. [source] FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease,,§AMERICAN JOURNAL OF HEMATOLOGY, Issue 5 2010Min Lu On June 30, 2009, the United States Food and Drug Administration (FDA) approved ferumoxytol (FerahemeÔ injection, AMAG Pharmaceuticals), an iron-containing product for intravenous (IV) administration, for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). The safety and efficacy of ferumoxytol were assessed in three randomized, open-label, controlled clinical trials. Two trials evaluated patients with nondialysis dependent CKD and a third trial assessed patients undergoing hemodialysis. Randomization was either to ferumoxytol or oral iron. Ferumoxytol was administered as two 510 mg IV injections, separated by 3,8 days. Oral iron, Ferro-Sequels®, was administered at a dose of 100 mg twice daily for 21 days. In all three clinical trials, ferumoxytol administration increased the mean blood hemoglobin (Hgb) concentrations by ,1.0 g/dL over the 35 day period, a mean increase that was greater than what was observed in patients receiving oral iron. Patients receiving ferumoxytol also had increases in blood transferrin saturation (TSAT) and ferritin values. For the proposed ferumoxytol dosing regimen, 4.9% of patients had serum ferritin ,800 ng/mL and TSAT ,50% post-treatment. The most important ferumoxytol safety concerns were hypersensitivity reactions and/or hypotension. Anaphylaxis or anaphylactoid reactions were reported in 0.2% of subjects, and other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria, or wheezing) were reported in 3.7%. Hypotension was observed in 1.9%, including three patients with serious hypotensive reactions. Ferumoxytol administration may transiently affect the diagnostic ability of magnetic resonance imaging and the drug label provides further information regarding this effect. Am. J. Hematol. 2010. Published 2010 Wiley-Liss, Inc. [source] Phototherapy in the management of atopic dermatitis: a systematic reviewPHOTODERMATOLOGY, PHOTOIMMUNOLOGY & PHOTOMEDICINE, Issue 4 2007N. Bhavani Meduri Background/purpose: Atopic dermatitis (AD) is a common and extremely burdensome skin disorder with limited therapeutic options. Ultraviolet (UV) phototherapy is a well tolerated, efficacious treatment for AD, but its use is limited by a lack of guidelines in the optimal choice of modality and dosing. Given this deficit, we aim to develop suggestions for the treatment of AD with phototherapy by systematically reviewing the current medical literature. Methods: Data sources: All data sources were identified through searches of MEDLINE via the Ovid interface, the Cochrane Central Register of Controlled Trials, and a complementary manual literature search. Study selection: Studies selected for review met these inclusion criteria, as applied by multiple reviewers: controlled clinical trials of UV phototherapy in the management of AD in human subjects as reported in the English-language literature. Studies limited to hand dermatitis and studies in which subjects were allowed unmonitored use of topical corticosteroids or immunomodulators were excluded. Data extraction: Included studies were assessed by multiple independent observers who extracted and compiled the following data: number of patients, duration of treatment, cumulative doses of UV radiation, adverse effects, and study results. Data quality was assessed by comparing data sets and rechecking source materials if a discrepancy occurred. Results: Nine trials that met the inclusion criteria were identified. Three studies demonstrated that UVA1 is both faster and more efficacious than combined UVAB for treating acute AD. Two trials disclosed the advantages of medium dose (50 J/cm2) UVA1 for treating acute AD. Two trials revealed the superiority of combined UVAB in the management of chronic AD. Two additional studies demonstrated that narrow-band UVB is more effective than either broad-band UVA or UVA1 for managing chronic AD. Conclusion: On the basis of available evidence, the following suggestions can be made: phototherapy with medium-dose (50 J/cm2) UVA1, if available, should be used to control acute flares of AD while UVB modalities, specifically narrow-band UVB, should be used for the management of chronic AD. [source] Replacement versus repair of defective restorations in adults: resin compositeAUSTRALIAN DENTAL JOURNAL, Issue 3 2010MO Sharif Background:, Composite filling materials have been increasingly used for the restoration of posterior teeth in recent years as a tooth coloured alternative to amalgam. As with any filling material composites have a finite life-span. Traditionally, replacement was the ideal approach to treat defective composite restorations, however, repairing composites offers an alternative more conservative approach where restorations are partly still serviceable. Repairing the restoration has the potential of taking less time and may sometimes be performed without the use of local anaesthesia hence it may be less distressing for a patient when compared with replacement. Objectives:, To evaluate the effectiveness of replacement (with resin composite) versus repair (with resin composite) in the management of defective resin composite dental restorations in permanent molar and premolar teeth. Search strategy:, For the identification of studies relevant to this review we searched the Cochrane Oral Health Group Trials Register (to 23rd September 2009); CENTRAL (The Cochrane Library 2009, Issue 4); MEDLINE (1950 to 23rd September 2009); EMBASE (1980 to 23rd September 2009); ISI Web of Science (SCIE, SSCI) (1981 to 22nd December 2009); ISI Web of Science Conference Proceedings (1990 to 22nd December 2009); BIOSIS (1985 to 22nd December 2009); and OpenSIGLE (1980 to 2005). Researchers, experts and organizations known to be involved in this field were contacted in order to trace unpublished or ongoing studies. There were no language limitations. Selection criteria:, Trials were selected if they met the following criteria: randomized or quasi-randomized controlled trial, involving replacement and repair of resin composite restorations. Data collection and analysis:, Two review authors independently assessed titles and abstracts for each article identified by the searches in order to decide whether the article was likely to be relevant. Full papers were obtained for relevant articles and both review authors studied these. The Cochrane Collaboration statistical guidelines were to be followed for data synthesis. Main results:, The search strategy retrieved 279 potentially eligible studies, after de-duplication and examination of the titles and abstracts all but four studies were deemed irrelevant. After further analysis of the full texts of the four studies identified, none of the retrieved studies met the inclusion criteria and all were excluded from this review. Authors' conclusions:, There are no published randomised controlled clinical trials relevant to this review question. There is therefore a need for methodologically sound randomised controlled clinical trials that are reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consort-statement.org/). Further research also needs to explore qualitatively the views of patients on repairing versus replacement and investigate themes around pain, anxiety and distress, time and costs. [source] The impact of prognosis without treatment on doctors' and patients' resource allocation decisions and its relevance to new drug recommendation processesBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 2 2008D. Ross Camidge What is already known about this subject ,,The dominant health economic units upon which new treatment funding decisions are made are the incremental cost per life year gained (LYG) or the cost per quality-adjusted life year (QALY) gained. ,,Neither of these units modifies the amount of health gained, by the amount of health patients would have had if they had not been given the treatment under consideration, which may unfairly undervalue the treatments for poor prognosis conditions. ,,How certain patients make decisions about their own treatment has previously been explored, but not how they, or doctors, would allocate hypothetical resource within a healthcare system given information on disease-treatment scenarios' prognoses with and without treatment. What this study adds ,,Information on prognosis without treatment is used within the resource allocation strategies of many doctors and most patients. ,,Individuals use this information in a variety of different ways and a single dominant strategy for quantitative modification of health units is not apparent. ,,Information on prognosis without treatment, or prognosis with standard treatment, is available from the control arm of randomized controlled clinical trials and should be used qualitatively to facilitate decision-making around the second inflexion point on cost per QALY/LYG acceptability curves. Aims Health economic assessments increasingly contribute to funding decisions on new treatments. Treatments for many poor prognosis conditions perform badly in such assessments because of high costs and modest effects on survival. We aimed to determine whether underlying shortness of prognosis should also be considered as a modifier in such assessments. Methods Two hundred and eighty-three doctors and 201 oncology patients were asked to allocate treatment resource between hypothetical patients with unspecified life-shortening diseases. The prognoses with and without treatment were varied such that consistent use of one of four potential allocation strategies could be deduced: life years gained (LYGs) , which did not incorporate prognosis without treatment information; percentage increase in life years (PILY); life expectancy with treatment (LEWT) or immediate risk of death (IRD). Results Random choices were rare; 47% and 64% of doctors and patients, respectively, used prognosis without treatment in their strategies; while 50% and 32%, respectively, used pure LYG-based strategies. Ranking orders were LYG > PILY > IRD > LEWT (doctors) and LEWT > LYG > IRD > PILY (patients). When LYG information alone could not be used, 76% of doctors prioritized shorter prognoses, compared with 45% of patients. Conclusions Information on prognosis without treatment is used within the resource allocation strategies of many doctors and most patients, and should be considered as a qualitative modifier during the health economic assessments of new treatments for life-shortening diseases. A single dominant strategy incorporating this information for any quantitative modification of health units is not apparent. [source] Remission induction therapy containing rituximab markedly improved the outcome of untreated mature B cell lymphomaBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2008Hirokazu Nagai Summary Many controlled clinical trials have proven that rituximab improves the clinical outcome of patients with mature B cell lymphoma. This study was conducted to assess the contribution of rituximab in the actual clinical practice. Patients with newly diagnosed mature B cell lymphoma treated at 20 National Hospital Organization hospitals from January 2000 to December 2004 were consecutively registered. Rituximab was approved in September 2002 for indolent B cell lymphoma and in September 2003 for aggressive B cell lymphoma in Japan. The patients were divided into two groups depending on whether they received induction therapy containing rituximab. The endpoint was to evaluate the rituximab benefit based on 2-year progression-free survival (PFS) and 2-year overall survival (OS). A total 1126 patients received chemotherapies. Of these, 762 were diagnosed as diffuse large B cell lymphoma (DLBCL) and 215 as follicular lymphoma (FL). PFS and OS were markedly improved in the rituximab group compared with the non-rituximab group in patients with DLBCL (both P < 0·001) and in patients with FL (P < 0·001 and P = 0·003 respectively). Rituximab, when used for remission induction therapy, significantly improved the clinical outcome of the mature B cell lymphoma patient in actual clinical practice. [source] EVER Lecture: Can uveal melanoma be conquered?ACTA OPHTHALMOLOGICA, Issue 2007T KIVELÄ The deadly natural history of uveal melanoma was fully described, unknowingly, in a well known English artist in 1792 and soon thereafter in an unknown Scottish woman around 1808. It became a well recognised entity much later, by 1868. Today, with the exception of being able to save the eye of their patient, ocular oncologists managing patients with uveal melanoma find themselves in essentially the same situation than their forebears: mortality rates have not noticeably decreased and metastatic melanoma continues to be the "hideous picture of disease" that it was 150 years ago. Metastatic melanoma is the single overwhelming cause of death in patients with uveal melanoma, and no consistently effective treatment is known for disseminated disease. One reason for this unhappy state of affairs is that patients formerly were dismissed after enucleation until they presented with advanced metastasis to an oncologist who did not recognise uveal melanoma as a disease very different from cutaneous melanoma. The advent of ocular oncology has led to rational early detection programs for subclinical metastasis, validated staging of metastatic disease, and first controlled clinical trials of managing metastases with therapies specifically aimed against this cancer. Basic research highlights uveal melanoma as a typically slowly growing, early metastasising cancer, and staging, grading and typing of primary tumours is leading to rational assignment of patients to follow-up and adjuvant treatment trials, which hopefully will improve their survival rate. The current understanding is that, by the time the eye becomes symptomatic, uveal melanomas prone to metastasis already have seeded micrometastases, which need to be kept under control if we are to eventually conquer this disease. [source] The effect of ascorbate on minor recurrent aphthous stomatitisACTA PAEDIATRICA, Issue 3 2010K Yasui Abstract Aim:, Minor recurrent aphthous stomatitis (MRAS) is a common, painful and inflammatory ailment of the oral cavity with juvenile onset and unknown aetiology. The purpose of this study was to evaluate the potential of ascorbate (vitamin C) to reduce the frequency of MRAS and severity of pain. Patients and methods:, Sixteen MRAS patients (9 boys and 7 girls: mean age, 12.0 ± 2.4 years old) were assigned to take an oral dosage of 2000 mg/m2/day ascorbate. Subjects:, Their baseline frequency of outbreaks and the level of pains were compared during the treatment; in addition, a crossover clinical trial was performed. Polymorphonuclear leucocytes play a role in the pathogenesis, and then superoxide anion production was evaluated in prior to ascorbate treatment. Results:, The data indicated a statistically significant 50% reduction in oral ulcer outbreaks and a decline of pain level. Neutrophils were primed for superoxide anion production in the patients with MRAS. Conclusion:, Ascorbate may modulate the generation of reactive oxygen species and augment neutrophil apoptosis, which could prevent neutrophil-mediated inflammation. Ascorbate seems to be effective, but the findings of our study were preliminary and it should be re-evaluated with a larger randomized controlled clinical trials. [source] | |||||||||||||||||||||||||||||||