Carmen Bouza

Efficacy and safety of balloon kyphoplasty in the treatment of vertebral compression fractures: a systematic review

The aim of this study is to evaluate the efficacy and safety of balloon kyphoplasty (BK) in the management of vertebral compression fractures (VCFs). This study is based on a systematic review of the literature (until October 2004) and meta-analysis of clinical studies assessing the efficacy and safety of BK in the treatment of VCFs. Estimates of effect were based on a random effects model. Meta-regression analyses were carried out where required. A total of 26 studies met the inclusion criteria. Although studies displayed considerable methodological limitations, the results of the clinical series indicate significant improvements in pain intensity, vertebral height, sagittal alignment, functional capacity, and quality of life. Compared with conventional medical management, BK afforded significant improvement in pain intensity and mobility. Likewise, a significant reduction was observed in vertebral collapse, kyphotic deformity, the development of new vertebral fractures, and hospital stay. Compared with vertebroplasty, the technique reduced the loss of height and the degree of kyphotic deformity, and afforded a significantly lower leakage rate—with no differences in relation to other variables. Regarding adverse effects, leakage affected 7% of all levels treated, while complications were recorded in 2% of the patients, and new vertebral fractures in 16%. The available evidence suggests that BK can be effective and safe in application to VCFs. However, existing studies evince substantial methodological limitations and relatively short follow-up periods. Better clinical research is required to determine the capacity of BK to avoid the functional and physiological sequelae of VCFs and to define the true role of the technique among the existing therapeutic options.

Meta-analysis of percutaneous radiofrequency ablation versus ethanol injection in hepatocellular carcinoma

BackgroundPercutaneous radiofrequency ablation (RFA) has gained popularity in the treatment of hepatocellular carcinoma (HCC). However, its role versus other conventional minimally invasive therapies is still a matter of debate. The purpose of this work is to analyse the efficacy and safety of RFA versus that of ethanol injection (PEI), the percutaneous standard approach to treat nonsurgical HCC.MethodsSystematic review and meta-analysis of randomised or quasi-randomised controlled trials published up to August 2008 in PubMed, ISI Web of Science and The Cochrane Library. Overall survival, local recurrence rate and adverse effects were considered as primary outcomes. Studies were critically appraised and estimates of effect were calculated according to the random-effects model. Inconsistency across studies was evaluated using the I2 statistic. Sensitivity analyses were conducted to explore statistical heterogeneity.ResultsSix studies were eligible. The studies reported data on 396 patients treated by RFA and 391 treated by PEI. In general, subjects were in Child-Pugh class A (74%) and had unresectable HCC (mean size 2.5 cm). Mean follow-up was 25 ± 11 months. The survival rate showed a significant benefit for RFA over PEI at one, two, three and four years. The advantage in survival increased with time with Relative Risk values of: 1.28 (95%CI:1.12–1.45) and 1.24 (95%CI:1.05–1.48) for RFA versus PEI at 3- and 4-years respectively. Likewise, RFA achieved significantly lower rates of local recurrence (RR: 0.37, 95%CI: 0.23–0.59). The overall rate of adverse events was higher with RFA (RR:2.55, 95%CI: 1.8–3.6) yet no significant differences were found concerning major complications (RR:1.85, 95%CI: 0.68–5.01). There was not enough evidence supporting a better cost-effectiveness ratio for RFA compared to PEI.ConclusionAvailable evidence from adequate quality controlled studies support the superiority of RFA versus PEI, in terms of better survival and local control of the disease, for the treatment of patients with relatively preserved liver function and early-stage non-surgical HCC. However, the higher rate of adverse events displayed is something that will have to be tested with appropriate weighting of the possible benefits in each individual case. Overall cost-effectiveness of RFA needs further evaluation.

Systematic review and meta-analysis of Transurethral Needle Ablation in symptomatic Benign Prostatic Hyperplasia

BackgroundBenign prostatic hyperplasia (BPH) constitutes a major clinical problem. Minimally invasive therapies for the treatment of symptomatic BPH include Transurethral Needle Ablation (TUNA), but it is unclear what impact this technique has on the disease and its role among other currently available therapeutic options. The objective of this study is to ascertain the efficacy and safety of TUNA in the treatment of BPH.MethodsSystematic review of the literature until January 2005 and meta-analysis of clinical studies assessing TUNA in symptomatic BPH. Studies were critically appraised. Estimates of effect were calculated according to the random-effects model.Results35 studies (9 comparative, 26 non-comparative) were included. Although evidence was limited by methodological issues, the analysis of relevant outcomes indicates that while TUNA significantly improves BPH parameters with respect to baseline, it does not reach the same level of efficacy as TURP in respect to all subjective and objective variables. Further, its efficacy declines in the long-term with a rate of secondary-treatment significantly higher than of TURP [OR: 7.44 (2.47, 22.43)]. Conversely, TUNA seems to be a relatively safe technique and shows a lower rate of complications than TURP [OR:0.14 (0.05, 0.14)] with differences being particularly noteworthy in terms of postoperative bleeding and sexual disorders. Likewise, TUNA has fewer anesthetic requirements and generates a shorter hospital stay than TURP [WMD: -1.9 days (-2.75, -1.05)]. Scarce data and lack of replication of comparisons hinder the assessment of TUNA vs. other local therapies. No comparisons with medical treatment were found.ConclusionThe body of evidence on which TUNA has been introduced into clinical practice is of only moderate-low quality. Available evidence suggest that TUNA is a relatively effective and safe technique that may eventually prove to have a role in selected patients with symptomatic BPH. TUNA significantly improves BPH parameters with respect to baseline values, but it does not reach the same level of efficacy and long-lasting success as TURP. On the other hand, TUNA seems to be superior to TURP in terms of associated morbidity, anesthetic requirements and length of hospital stay. With respect to the role of TUNA vis-à-vis other minimally invasive therapies, the results of this review indicate that there are insufficient data to define this with any degree of accuracy. Overall cost-effectiveness and the role of TUNA versus medical treatment need further evaluation.

Efficacy of modern dressings in the treatment of leg ulcers: A systematic review

Healing of leg ulcers constitutes a major clinical problem. Local methods for accelerating the healing process include modern wound dressings, but it is unclear what impact these dressings have on ulcer healing. This study examines the collective evidence on the effectiveness of modern dressings in the treatment of leg ulcers. To this end, a meta‐analysis was conducted covering randomized clinical trials identified following a systematic review of the literature in different databases. Estimates of effect were calculated according to the fixed effects model. Thirty‐one studies met the inclusion criteria (26 on ulcers of venous etiology, 5 on ulcers of mixed or poorly differentiated etiology). We found no study that exclusively addressed arterial ulcers. Although studies displayed considerable methodological limitations, analysis showed no significant differences in terms of the proportion of healed ulcers or reduction in wound size for both modern and conventional dressings. Similarly, no significant differences were observed between the different modern dressings compared in the studies. Thus, the current medical literature is poor in supporting the use of modern dressings to improve the healing rate of leg ulcers. There is insufficient evidence to determine whether the choice of any specific dressing type affects the healing course of these ulcers. Well‐conducted trials are warranted to reliably address this question.

Balloon kyphoplasty in malignant spinal fractures: a systematic review and meta-analysis.

BackgroundSpinal fractures are a common source of morbidity in cancer patients. Balloon Kyphoplasty (BKP) is a minimally invasive procedure designed to stabilize fractures and correct vertebral deformities. We performed a meta-analysis to determine the efficacy and safety of BKP for spinal fractures in cancer patients.MethodsWe searched several electronic databases up to September 2008 and the reference lists of relevant publications for studies reporting on BKP in patients with spinal fractures secondary to osteolytic metastasis and multiple myeloma. Outcomes sought included pain relief, functional capacity, quality of life, vertebral height, kyphotic angle and adverse events. Studies were assessed for methodological bias, and estimates of effect were calculated using a random-effects model. Potential reasons for heterogeneity were explored.ResultsThe literature search revealed seven relevant studies published from 2003 to 2008, none of which were randomized trials. Analysis of those studies indicated that BKP resulted in less pain and better functional outcomes, and that these effects were maintained up to 2 years post-procedure. While BKP also improved early vertebral height loss and spinal deformity, these effects were not long-term. No serious procedure-related complications were described. Clinically asymptomatic cement leakage occurred in 6% of all treated levels, and new vertebral fractures in 10% of patients. While there is a lack of studies comparing BKP to other interventions, some data suggested that BKP provided similar pain relief as vertebroplasty and a lower cement leakage rate.ConclusionIt appears that there is level III evidence showing BKP is a well-tolerated, relatively safe and effective technique that provides early pain relief and improved functional outcomes in patients with painful neoplastic spinal fractures. BKP also provided long-term benefits in terms of pain and disability. However, the methodological quality of the original studies prevents definitive conclusions being drawn. Further investigation into the use of BKP for spinal fractures in cancer patients is warranted.

Epidemiology and recent trends of severe sepsis in Spain: a nationwide population-based analysis (2006-2011)

BackgroundAlthough severe sepsis constitutes an important burden for healthcare systems, there is limited nationwide data on its epidemiology in European countries. Our objective was to examine the most recent epidemiological characteristics and trends of severe sepsis in Spain, from a population perspective.MethodsAnalysis of the 2006-2011 National Hospital Discharge Registry. Cases were identified by combining specific ICD-9CM codes. We estimated demographics, clinical characteristics and outcomes and calculated age- and sex- adjusted estimations of incidence and mortality rates. Trends were assessed in terms of annual percent change (APC) in rates using joinpoint regression analysis.ResultsOver the 6-year period we identified 240939 cases of severe sepsis nationwide representing 1.1% of all hospitalisations and 54% of hospitalisations with sepsis. Incidence was 87 cases per 100,000 population. Overall 58% of cases were men, 66% were over the age of 65 and about 67% had associated comorbidities. Bacteremia was coded in 16% of records. Almost 54% of cases had one organ dysfunction, 26% two and around 20% three or more dysfunctions. In-hospital case-fatality was 43% and associated with age, gender, comorbidities and organ dysfunctions, among others. We found significant demographic and clinical changes over time with an increase in the mean age of cases, comorbidities, number of organ dysfunctions and in the number of cases with gram-negative pathogens. Furthermore, even with gender disparities, standardised incidence and mortality rates increased with an overall APC of 8.6% (95% CI 5.1, 12.1) and 6% (95% CI 1.9, 10.3), respectively. Conversely, we detect a significant decrease in case-fatality rates with an overall APC of -3.24% (95% CI: -4.2, -2.2).ConclusionsThis nationwide population-based study shows that hospitalizations with severe sepsis are frequent and associated with substantial in-hospital mortality in Spain. Furthermore it indicates that the incidence and mortality rates of severe sepsis have notably increased in recent years, showing also a significant increase in the age and severity of the affected population. Despite this, there has been a significant decreasing trend in case-fatality rates over time. This information has significant implications for health-care system planning and may prove useful to estimate future care requirements.

Efficacy and Safety of Metformin for Treatment of Overweight and Obesity in Adolescents: An Updated Systematic Review and Meta-Analysis

Objective: To assess the efficacy and safety of using metformin in overweight and obese adolescents without related morbidity. Methods: We conducted a systematic review and meta-analysis of randomized clinical trials published until June 2011, comparing metformin to placebo or other interventions. Our primary variables were baseline BMI changes and development of adverse effects. Results: Nine studies (498 participants, mean age 14.2 years; mean BMI 36.4 kg/m2) met the inclusion criteria. In all but one study, metformin was combined with lifestyle modification and was compared to placebo combined with changes in lifestyle. Analysis showed that metformin reduced mean BMI by 1.42 kg/m2 (95% CI –2.18, 0.66), fasting insulin by 9.9 µU/ml (95% CI –13.8, –6.06) and the HOMA index by –1.78 (95% CI –3.32, –0.23). No changes in any other parameter were observed. No statistical differences were found in the rate of adverse events (33% metformin, 32% placebo).The withdrawal rates due to side effects in the metformin and placebo groups were 2.7% and 2.5%, respectively. Conclusions: The available evidence indicates that, in the short term, administration of metformin in addition to lifestyle modification is relatively effective for reducing BMI and hyperinsulinemia among obese adolescents without related morbidity, and displays an acceptable safety pattern. Nevertheless, its long-term impact is unknown.

Hospital admissions due to physical disease in people with schizophrenia: a national population-based study

OBJECTIVES To examine nonpsychiatric hospitalizations in people with schizophrenia and to describe the epidemiological features of these admissions. METHODS We analyzed the 2000-2004 Spanish National Hospital Discharge Registry, identified records coded for schizophrenia (295.xx), selected admissions due to non-psychiatric causes and characterized the physical diseases using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) system and the Deyo-Charlson Index. RESULTS From all 2000-2004 hospitalizations in subjects with schizophrenia, 21 484 records (34%) were eligible for analysis. The mean age was 53 years, 61% were men. The mean number of ICD-9-CM codes was 2.3. The main diagnoses at discharge were injury-poisoning (19%) and respiratory (15%), digestive (14%) and circulatory diseases (12%), but there were significant age and gender-related differences. Inhospital mortality was 6.9% and the mean age of death was 63 years. Circulatory, respiratory diseases and neoplasms accounted for 21%, 18% and 17% of deaths, respectively. Inhospital mortality significantly correlated with age, the Deyo-Charlson Index and some specific processes. CONCLUSIONS Hospitalizations due to physical disease are frequent among people with schizophrenia and associated with a substantial burden and in-hospital mortality in Spain. This information may prove useful for the design and application of preventive and therapeutic programs in the early and silent phases of the most prevalent physical diseases.

Physical disease in schizophrenia: a population-based analysis in Spain

BackgroundPhysical disease remains a challenge in patients with schizophrenia. Our objective was to determine the epidemiological characteristics and burden of physical disease in hospitalized patients with schizophrenia.MethodsWe analyzed the 2004 Spanish National Hospital Discharge Registry, identified records coded for schizophrenia (295.xx) and characterized the physical diseases using the ICD-9 system and the Charlson Index. We also calculated standardized mortality ratios (SMRs) versus the general population adjusted by age and calendar time.ResultsA total of 16, 776 cases (mean age: 43 years, 65% males) were considered for analysis. Overall, 61% of cases had at least one ICD-9 physical code and 32% had more than one ICD-9 code. The Charlson index indicated that 20% of cases had a physical disease of known clinical impact and prognostic significance. Physical disease appeared early in life (50% of cases were 15-31 years of age) and increased rapidly in incidence with age. Thus, for patients aged 53 years or more, 84% had at least one physical ICD-9 code. Apart from substance abuse and addiction, the most prevalent diseases were endocrine (16%), circulatory (15%), respiratory (15%), injury-poisoning (11%), and digestive (10%). There were gender-related differences in disease burden and type of disease. In-hospital mortality significantly correlated with age, the Charlson Index and several ICD-9 groups of physical disease. Physical disease was associated with an overall 3.6-fold increase in SMRs compared with the general population.ConclusionsThis study provides the first nationally representative estimate of the prevalence and characteristics of physical disease in hospitalized patients with schizophrenia in Spain. Our results indicate that schizophrenia is associated with a substantial burden of physical comorbidities; that these comorbidities appear early in life; and that they have a substantial impact on mortality. This information raises concerns about the consequences and causes of physical disorders in patients with schizophrenia. Additionally, it will help to guide the design and implementation of preventive and therapeutic programs from the viewpoint of clinical care and in terms of health-care service planning.

Outcomes of new quality standards of follitropin alfa on ovarian stimulation: meta-analysis of previous studies.

BackgroundHuman follicle-stimulating hormone (hFSH; follitropin alfa) can be employed therapeutically to induce ovarian follicular development in assisted reproduction treatments. Current recombinant hFSH (r-hFSH) preparations available for clinical use are labeled either in terms of the bioactivity expressed in international units (IU) or in mass (μg). Several clinical trials have tried to assess the clinical implications of the physicochemical improvements in the dosing of follitropin alfa filled by mass (FbM). The aim of this study was to perform a meta-analysis of previous studies in order to assess the efficacy and safety of ovarian stimulation using follitropin alfa FbM compared with follitropin alfa filled by international units (FbIU).MethodsA literature search was carried out in scientific databases to find published articles and abstracts comparing both hormone preparations. A fixed effects model meta-analysis was performed. The variables studied include the average dose (IU), days of treatment, estradiol peak, follicles >14 mm, number of extracted oocytes, number of embryos obtained, number of cases of ovarian hyperstimulation syndrome (OHSS), and clinical pregnancies.ResultsA total of six studies met the stated criteria and were included in the meta-analysis. In these studies, the average r-hFSH dose per patient was 230.29 IU less with administration of follitropin alfa FbM compared with FbIU, and the number of days of treatment was reduced by 0.48. In addition, a significantly greater number of oocytes (0.84) were extracted, more embryos (0.88) were obtained, and a higher peak level of estradiol (613.08 pmol/L) was achieved in the patients undergoing ovarian stimulation with follitropin alfa FbM. However, no statistically significant differences were observed in the number of follicles >14 mm, clinical pregnancies, or OHSS cases.ConclusionFollitropin alfa FbM, a technologically modified formulation of r-hFSH, is as safe as follitropin alfa FbIU but requires a smaller dose over a shorter period to produce more oocytes and final embryos.