What is the evidence for the efficacy of cryoplasty?

Cryoplasty is a technique for treating vascular stenosis which combines balloon angioplasty with cold injury. The combination is proposed to reduce the incidence of restenosis by inhibition of neointimal hyperplasia. There have been several clinical studies which purport to show improved patency compared to conventional angioplasty. Unfortunately, these are not comparative or controlled studies and have not been performed, analyzed or reported in accordance with recognized reporting standards for peripheral vascular intervention. The studies on femoropopliteal disease have selected favourable patients. Of greatest concern is the use of surrogate endpoints in lieu of objective demonstration of vessel patency. Critical interpretation of the results fails to demonstrate any convincing superiority of cryoplasty compared to conventional balloon angioplasty. Where little difference in outcome exists between two techniques, a trial comparing them will require hundreds of patients to be sufficiently powered to demonstrate a benefit of one technique over the other. As cryoplasty is significantly more expensive than conventional angioplasty, the cost benefit ratio is unfavourable and such a trial is unlikely to occur.This article is a critical review of the technique of cryoplasty. The reader will be able to: describe expected outcomes from balloon angioplasty; describe the theoretical role for cold injury as a component of angioplasty; recognize the need to adhere to well defined standards when reporting the results of new techniques for treating vascular disease; critically review the results of cryoplasty; understand the limitations and relevance of the published clinical results of cryoplasty.     

Hypertension: a disorder of volume control? What is the evidence?

Hypertension is a common trait worldwide and is responsible for a major expenditure of health-care dollars in the United States. Although the etiological factors responsible for the expression of this phenotype are complex, several experimental and clinical observations point to a major role of the kidney as responsible. Genetic studies of uncommon diseases, which express monogenetic inheritance, all have in common a dysregulation of sodium balance and volume expansion. Furthermore, epidemiological data suggest an increased incidence of hypertension in communities with high excretory rates of sodium. Experimental data also suggest that low birth weight is associated with an increase in the frequency of hypertension later in life and raises the possibility that intrauterine imprinting may contribute to the expression of the phenotype. Indeed, data suggesting up-regulation of the Na(+)/K(+)/2Cl(-) and thiazide-sensitive transporters in low-birth-weight animals may provide the physiological basis for these observations. Finally, subtle gain of function mutations in one or more of these transporters may unmask defects in volume homeostasis with increasing salt intake.     

Use of Acticoat™ dressings in burns: What is the evidence?

The virtues of silver as an antimicrobial agent have been known for some time. Various silver containing dressings are currently used for the treatment of wounds. Introduced in the late 1990s, Acticoat™ is a nanocrystalline silver dressing developed to overcome some shortcomings of the older dressings by providing sustained release of silver up to 7 days. We aim to determine the level of evidence available in the literature in view of recent increased usage of Acticoat™.     

Use of Teriparatide to improve fracture healing: What is the evidence?

Teriparatide is a recombinant form of the biologically active component of Parathyroid hormone. It has been shown to increase bone mass and prevent fractures in osteoporotic bone. It is licensed by the Food and Drug Administration for the treatment of Osteoporosis. Over the last decade, a growing body of evidence has accumulated suggesting a role for Teriparatide in the management of fractures. Studies in both normal and delayed healing models have shown improvement in callus volume and mineralisation, bone mineral content, rate of successful union and strength at fracture sites. However most of these results have been derived from animal studies. The majority of this research on humans has comprised low level evidence, with few randomised controlled trials, many case reports and case series. Nevertheless, the results from these studies seem to support research from animal models. This has led to a growing number of clinicians using Teriparatide “off license” to treat fractures and non-unions in their patients. This review presents a critical appraisal of the current evidence supporting the use of Teriparatide for fracture healing, delayed unions and non unions and in the setting of osteoporotic fractures, the studies producing this evidence and their transferability to human beings.     

Management of knee dislocation prior to ligament reconstruction: What is the current evidence? Update of a universal treatment algorithm

Traumatic knee dislocation is a rare but potentially limb-threatening injury. Thus proper initial diagnosis and treatment up to final ligament reconstruction are extremely important and a precondition to successful outcomes. Reports suggest that evidence-based systematic approaches lead to better results. Because of the complexity of this injury and the inhomogeneity of related literature, there are still various controversies and knowledge gaps regarding decision-making and step-sequencing in the treatment of acute multi-ligament knee injuries and knee dislocations. The use of ankle-brachial index, routine or selective angiography, braces, joint-spanning or dynamic external fixation, and the necessity of initial ligament re-fixation during acute surgery constitutes current topics of a scholarly debate. The aim of this article was to provide a comprehensive literature review bringing light into some important aspects about the initial treatment of knee dislocation (vascular injury, neural injury, immobilization techniques) and finally develop an accurate data-based universal algorithm, enabling attending physicians to become more acquainted with the management of acute knee dislocation.     

Hip hemi-arthroplasty for neck of femur fracture: What is the current evidence?

This editorial reviews and summarises the current evidence(meta-analyses and Cochrane reviews) relating to the use of hip hemi-arthroplasty for neck of femur fractures. Regarding the optimal surgical approach,two recent meta-analyses have found that posterior approaches are associated with: higher rates of dislocation compared to lateral and anterior approaches; and higher rates of re-operation compared to lateral approaches. Posterior approaches should therefore be avoided when performing hip hemi-arthroplasty procedures. Assessing the optimal prosthesis head component,three recent meta-analyses and one Cochrane review have found that while unipolar hemiarthroplasty can be associated with increased rates of acetabular erosion at short-term follow-up(up to 1 year),there is no significant difference between the unipolar hemi-arthroplasty and bipolar hemi-arthroplasty for surgical outcome,complication profile,functional outcome and acetabular erosion rates at longer-term follow-up(2 to 4 years). With bipolar hemi-arthroplasty being the more expensive prosthesis,unipolar hemi-arthroplasty is the recommended option. With regards to the optimal femoral stem insertion technique,three recent metaanalyses and one Cochrane Review have found that,while cemented hip hemi-arthroplasties are associated with a longer operative time compared to uncemented Hip Hemi-arthroplasties,cemented prostheses have lower rates of implant-related complications(particularly peri-prosthetic femoral fracture) and improved postoperative outcome regarding residual thigh pain and mobility. With no significant difference found between the two techniques for medical complications and mortality,cemented hip hemi-arthroplasty would appear to be the superior technique. On the topic of wound closure,one recent meta-analysis has found that,while staples can result in a quicker closure time,there is no significant difference in post-operative infections rates or wound healing outcomes when comparing staples to sutures. Therefore,either suture or staple wound closure techniques appear equally appropriate for hip hemiarthroplasty procedures.     

What is the evidence that microalbuminuria is a predictor of cardiovascular disease events?

PURPOSE OF REVIEW: This review describes recently published studies evaluating the association between microalbuminuria and the development of cardiovascular disease events either in the presence of diabetes or hypertension, or in the population as a whole. RECENT FINDINGS: Prospective studies confirm that microalbuminuria is predictive, independently of classical risk factors, of cardiovascular disease events and all-cause mortality within groups of patients with diabetes or hypertension and in the general population. However, these studies suggest that levels of albuminuria below the conventional cutoff point definition of microalbuminuria are significantly associated with cardiovascular morbidity and mortality. The pathophysiological mechanism underyling this association is still uncertain. Data from recent intervention studies suggest that treatment with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, as well as intensive multi-factorial intervention including behaviour modification and targeted pharmacotherapy in patients with microalbuminuria, offers significant reduction in cardiovascular and renal morbidity in people with albuminuria. SUMMARY: Future absolute risk prediction scores for primary cardiovascular events could include microalbuminuria as a modifiable risk factor. The association between levels of albuminuria and cardiovascular outcomes in individuals within the normoalbuminuric range questions the current categorical definition of microalbuminuria. Intensive multifactorial interventions, including the use of agents that affect the renin-angiotensin pathway, are effective in reducing cardiovascular risk in patients with microalbuminuria and diabetes or hypertension.     

Gastroparesis: What is the Current State-of-the-Art for Evaluation and Medical Management? What are the Results?

Gastroparesis is a chronic motility disorder that leads to delayed gastric emptying and negatively impacts morbidity, mortality, and quality of life. This paper provides an overview of the pathophysiology leading to symptoms in gastroparesis, discusses tests for diagnosis, and examines the evidence behind different treatment options for gastroparesis. Although delayed gastric emptying is the cardinal finding in gastroparesis, other physiologic abnormalities may contribute to the pathogenesis of symptoms. Gastric emptying scintigraphy is considered the gold standard for the diagnosis of gastroparesis but novel tests are currently available. Although metoclopramide is the only FDA approved medication to treat gastroparesis, alternative therapeutic options are available and should be tailored according to symptoms as well as physiologic abnormalities.     

Local sacroiliac injections in the treatment of spondyloarthritis. What is the evidence?

Local sacroiliac injections represent an available treatment option in spondyloarthritis (SpA). There is no synthetic data about efficacy of this procedure in SpA. The aim of this review is to analyze the available data of the literature of local sacroiliac injections in SpA.MethodsA Pubmed search of papers published after 1990 was performed.ResultsPubmed search retained 15 publications in spondyloarthritis, 12 with corticosteroids (total of 468 injections in 268 patients), including 2 small-sized controlled studies, and 3 with TNF blockers (24 patients in open studies). With steroids, the two controlled studies (with a total number of 30 patients only) demonstrated significant results over placebo. In open studies, good response was reported in more than 80% of the cases, with a mean duration of improvement over 8 months. Reduction of sacroiliac inflammation on MRI was also found in several studies after injection. There is no consensus about the technique of injection or the type of steroid injected. No particular safety concern was reported. Many limitations have to be considered in the interpretation of these results.ConclusionThis kind of procedure should be kept in the therapeutic armament in the current setting of costly targeted systemic treatments of spondyloarthritis. However, definition of a clear position in the treatment strategy needs further well-conducted studies.     

Alpha-linolenic acid and the risk of prostate cancer. What is the evidence?

PURPOSE: Several studies have examined the association between polyunsaturated fatty acids and prostate cancer risk. We evaluated the evidence on the association between the essential polyunsaturated fatty acid, known as alpha-linolenic acid, and the risk of prostate cancer in humans. MATERIALS AND METHODS: We comprehensively reviewed published studies on the association between alpha-linolenic acid and the risk of prostate cancer using MEDLINE. RESULTS: A number of studies have shown a positive association between dietary, plasma or red blood cell levels of alpha-linolenic acid and prostate cancer. Other studies have demonstrated either no association or a negative association. The limitations of these studies include the assumption that dietary or plasma alpha-linolenic acid levels are positively associated with prostate tissue alpha-linolenic acid levels, and measurement errors of dietary, plasma and red blood cell alpha-linolenic acid levels. CONCLUSIONS: More research is needed in this area before it can be concluded that there is an association between alpha-linolenic acid and prostate cancer.     

Treatment of lateral epicondylitis: where is the evidence?

Lateral epicondylitis is the most commonly diagnosed elbow condition and affects about 1-3% of the population at large. It produces a heavy burden of workdays lost and residual impairments. Although many treatment modalities are used, few of them rest on scientific evidence and none has been proven more effective than the others. This paucity of evidence on treatments for lateral epicondylitis may stem from several sources, including the possible self-limiting nature of the condition, the lack of pathophysiological data, the methodological shortcomings of available studies, and the existence of numerous factors influencing the outcome.     

Pharmacogenetics of Osteoporosis: What is the Evidence?

The early genetic prediction of personal drug therapy outcome, both in terms of identification of poor responders or nonresponders, as well as of subjects at risk of developing adverse reactions, and its translation into the clinical practice are the main challenges of personalized medicine. The application of pharmacogenetic predictive tests will be very useful mostly in cases of chronic disorders, as in metabolic bone diseases, that require long-term treatments and for whom exist effective differently acting drugs to be alternatively chosen. Pharmacogenetic tests, prior to drug administration, would hypothetically grant the optimization of drug therapy, based on patient's genotype, to ensure maximum efficacy with minimal adverse effects. This review aims to offer an overview on the principal findings in the field of pharmacogenetics of osteoporosis, and it will discuss future perspectives and possible clinical applications of pharmacogenetic tests for antiresorptive drugs.