An Analysis of Medical Malpractice Litigation due to Intravenous Steroid Treatment for Acute Spinal Cord Injury.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To evaluate the incidence of litigation due to using or foregoing methylprednisolone (MP), naloxone, or tirilazad for treatment of acute spinal cord injury (ASCI) through querying the Westlaw and VerdictSearch databases. SUMMARY OF BACKGROUND DATA: There is historic controversy regarding the use of intravenous steroids for treatment of ASCI. Many highlight that MP continues to be used for ASCI treatment mainly as a defensive medicine tactic due to the fear of malpractice litigation. METHODS: Westlaw and VerdictSearch were queried for cases involving steroid treatment for ASCI between the years 1998 and 2021. Collected data for each case included year of case hearing, verdict ruling, location of filed claim, and the plaintiff's basis of litigation. Cases were reviewed and categorized by two independent reviewers based on the grievance(s) levied by the plaintiff. Inclusion criteria for topic relevance was defined as a plaintiff's basis of litigation resting on a claim of medical malpractice due to the use, or lack thereof, of MP, naloxone, or tirilazad for treatment of ASCI. RESULTS: Upon review of 238 cases, case claims were grouped into five categories based on reason for litigation: Social Security benefits (171), lawsuit due to vaccination (25), medical malpractice unrelated to steroid use (16), fungal infections due to MP injections (4), and other (22). Zero cases were found to be related to lawsuits filed due to steroid use or lack thereof for ASCI treatment. CONCLUSION: Our findings suggest there is limited risk of malpractice litigation due to steroid use or lack thereof in the treatment of ASCI. As such, steroid-related treatment decisions for ASCI should be informed by evidence-based approaches to care not influenced by medicolegal concerns.

The economic burden of topical corticosteroid use in dermatophytosis: a cost-of-illness analysis of steroid-modified vs. steroid-naive dermatophytosis.

Dermatophytosis is one of the leading causes of visits to the dermatology department, especially in India, where the hot and humid climate favours fungal acquisition and perpetuation. Usual modalities of treatment include the use of either oral or topical antifungals or a combination of both, depending on the severity and extent of infection as well as the type of causative organism. But recently, steroid-modified dermatophytosis, an iatrogenically perpetuated dermatophytosis caused by the indiscriminate use of topical corticosteroids has emerged as a troublesome epidemic. We planned a cost-of-illness analysis of superficial dermatophytosis comparing the direct healthcare costs in steroid-naive and steroid-modified dermatophytosis. In our study, the average total cost of treatment for steroid-naive and steroid-modified dermatophytosis was found to be rupees (Rs) 2172.42 and Rs 3770.61 respectively, meaning that the cost for patients who used topical steroids is an additional 40% on average for treatment, when compared with the cost for patients who are steroid naive. The need for more consultations, investigations (relating to atypical presentation) and extended duration of treatment with higher-grade antifungals were found to contribute to the increased financial burden in steroid-modified dermatophytosis.

Health service engagement, side effects and concerns among men with anabolic-androgenic steroid use: a cross-sectional Norwegian study.

BACKGROUND: Recreational use of anabolic-androgenic steroids (AAS) is a public health concern world-wide associated with a range of physical and psychological side effects. Still, people who use AAS tend to be reluctant to seek treatment. This study aims to explore use characteristics, treatment-seeking behaviour, side effects and associated health concerns among men with AAS use. METHODS: The study includes cross-sectional self-report data from 90 men with a current or previous use of AAS exceeding 12 months, where 41 (45.6%) had sought treatment at least once during their lifetime, and 49 (54.4%) had not. Health service engagement was examined with descriptive statistics on reasons for contacting health services, transparency about AAS use, satisfaction with health services and reasons for not seeking treatment. Furthermore, experienced side effects and health concerns were compared between the treatment seeking and the non-treatment seeking group, using two-sample t-tests and Chi2 or Fisher exact tests for numerical and categorical variables, respectively. RESULTS: All 90 AAS-using men reported side effects from AAS use. Treatment seekers were significantly younger, experienced more side effects including gynecomastia, excessive sweating, fatigue, depression and anxiety, and expressed more concern for testosterone deficiency. Preventive health check-up was the most common reason for seeking treatment (n = 22, 53.7%), and 38 men (93%) were transparent about AAS use during consultations with health professionals. The main reported reasons for not seeking healthcare services were that the experienced side effects were not considered to be of treatment demanding nature (n = 39, 79.6%) and the belief that healthcare providers had scarce knowledge about AAS use and its health impacts (n = 12, 24.5%). CONCLUSIONS: Reluctance to seek treatment among people who use AAS, despite having associated side effects and health concerns, may contribute to continued health risks. It is important to fill the knowledge gap on how to reach and treat this new patient group, and policy makers and treatment providers need to be educated on how to meet their treatment needs.

STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan.

BACKGROUND: Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks). METHODS: The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (control group), (2) intervention group 1 versus transforaminal epidural injection with levobupivacaine and saline solution added to oral pain medication (intervention group 2), and (3) intervention group 2 versus control group. Co-primary outcomes were physical functioning (Roland Morris Disability Questionnaire), pain intensity (10-point numerical rating scale), and global perceived recovery (7-point Likert scale, dichotomized into 'recovered' and 'not recovered'). For all three comparisons, we defined the following minimal clinically relevant between-group differences: two points for pain intensity (range 0-10), four points for physical functioning (range 0-24) and a 20% difference in recovery rate. Secondary outcomes are health-related quality of life (EQ-5D-5L) and patient satisfaction (7-point Likert scale) and surgery rate. We also collected resource use data to perform an economic evaluation. Analyses will be conducted by intention-to-treat with p < 0.05 (two-tailed) for all three comparisons. Effects will be estimated using mixed models by maximum likelihood. For each comparison, mean differences, or difference in proportions, between groups will be tested per time point and an overall mean difference, or difference in proportions, between groups during the complete duration of follow-up (6 months) will be estimated. In the economic evaluation, Multivariate Imputation by Chained Equations will be used to handle missing data. Cost and effect differences will be estimated using seemingly unrelated regression, and uncertainty will be estimated using bootstrapping techniques. DISCUSSION: This statistical analysis plan provides detailed information on the intended analysis of the STAR trial, which aims to deliver evidence about the (cost-)effectiveness of TESI during the acute phase of sciatica (< 8 weeks). TRIAL REGISTRATION: Dutch National trial register NTR4457 (6 March 2014).

Assessment of factors associated with mizoribine responsiveness in children with steroid-dependent nephrotic syndrome.

BACKGROUND: Several immunosuppressants have been used to treat children with steroid-dependent nephrotic syndrome (SDNS). Mizoribine (MZR) is an immunosuppressant used to maintain remission in children with SDNS, although its effectiveness for treating SDNS remains controversial. Therefore, in this study, we assessed the clinical factors associated with children having SDNS who were successfully treated with MZR. METHODS: A total of 47 children with SDNS who underwent MZR treatment were retrospectively evaluated. Clinical features including pharmacokinetics after MZR administration were compared between MZR responders and non-responders. RESULTS: The comparison of the two groups revealed no significant differences in age, body weight (BW), daily dose of MZR per BW, serum concentration 2 h after administration (C2), peak serum concentration (Cmax), and area under the concentration curve 0-4 h after administration (AUC0-4). C2/(single dose/BW), Cmax/(single dose/BW), and AUC0-4/(single dose/BW) were significantly higher in the MZR responders than in the non-responders (all p < 0.01). Receiver operating characteristic analysis revealed that the cutoff values of C2 (single dose/kg), Cmax/(single dose/BW), and AUC0-4/(single dose/BW) were 0.55, 0.58, and 1.37, respectively. CONCLUSIONS: MZR is a useful immunosuppressant for treating frequent-relapse NS in children who are susceptible to the drug. The efficacy of MZR may be associated with not only serum concentrations defined by the dosage or absorption efficiency through MZR transporters, but also the susceptibility defined by the expression level and performance of MZR transporters on the target cells.

Influence of disease duration and socioeconomic factors on the prevalence of infection and hospitalization in rheumatoid arthritis: KRAC study.

AIM: The use of healthcare resources by rheumatoid arthritis (RA) patients can be related to the presence of disease, comorbid conditions, use of steroids, and the combined use of immunosuppressants. This study evaluated the risk factors associated with infection and hospitalization in RA. METHODS: This multicenter, cross-sectional study enrolled 3247 RA subjects fulfilling the 2010 American College of Rheumatology/European League Against Rheumatism criteria to examine the prevalence of hospitalization and episodes of documentable non-tubercular infections as a part of the "Karnataka rheumatoid arthritis comorbidity" study (KRAC). The study included 2081 subjects and 1166 were excluded due to incomplete data. Demographic, clinical and treatment variables were collected, and the events related to infections and hospitalization were extracted from the medical records. Comparative analysis and multivariate logistic regression were performed. RESULTS: Around 22% of the subjects had hospitalizations and 2.9% had infections. Infections were pertaining to dental (1.3%), urinary tract (1.6%) and candidiasis (0.2%). Skin- and soft tissue-related infections were found in 1.8% and 0.3% of patients, respectively. Increased need of hospitalization in RA patients was associated with advanced age (≥60 years), lower education, family income, and longer duration of RA. Presence of comorbidity, usage of three or more disease-modifying anti-rheumatic drugs (DMARDs) and family income influenced the likelihood of infection. Dental infections were less likely in working subjects and more likely in patients with increased disease duration, higher family income, comorbidities and those between the age group 40-59 years. Urinary tract infection was associated with DMARD usage. CONCLUSION: Patient-specific risk factors should be considered to improve treatment strategies and to reduce the risk of infection and hospitalization in RA patients.

A checklist for clinical trials in rare disease: obstacles and anticipatory actions-lessons learned from the FOR-DMD trial.

BACKGROUND: Trials in rare diseases have many challenges, among which are the need to set up multiple sites in different countries to achieve recruitment targets and the divergent landscape of clinical trial regulations in those countries. Over the past years, there have been initiatives to facilitate the process of international study set-up, but the fruits of these deliberations require time to be operationally in place. FOR-DMD (Finding the Optimum Steroid Regimen for Duchenne Muscular Dystrophy) is an academic-led clinical trial which aims to find the optimum steroid regimen for Duchenne muscular dystrophy, funded by the National Institutes of Health (NIH) for 5 years (July 2010 to June 2015), anticipating that all sites (40 across the USA, Canada, the UK, Germany and Italy) would be open to recruitment from July 2011. However, study start-up was significantly delayed and recruitment did not start until January 2013. METHOD: The FOR-DMD study is used as an example to identify systematic problems in the set-up of international, multi-centre clinical trials. The full timeline of the FOR-DMD study, from funding approval to site activation, was collated and reviewed. Systematic issues were identified and grouped into (1) study set-up, e.g. drug procurement; (2) country set-up, e.g. competent authority applications; and (3) site set-up, e.g. contracts, to identify the main causes of delay and suggest areas where anticipatory action could overcome these obstacles in future studies. RESULTS: Time from the first contact to site activation across countries ranged from 6 to 24 months. Reasons of delay were universal (sponsor agreement, drug procurement, budgetary constraints), country specific (complexity and diversity of regulatory processes, indemnity requirements) and site specific (contracting and approvals). The main identified obstacles included (1) issues related to drug supply, (2) NIH requirements regarding contracting with non-US sites, (3) differing regulatory requirements in the five participating countries, (4) lack of national harmonisation with contracting and the requirement to negotiate terms and contract individually with each site and (5) diversity of languages needed for study materials. Additionally, as with many academic-led studies, the FOR-DMD study did not have access to the infrastructure and expertise that a contracted research organisation could provide, organisations often employed in pharmaceutical-sponsored studies. This delay impacted recruitment, challenged the clinical relevance of the study outcomes and potentially delayed the delivery of the best treatment to patients. CONCLUSION: Based on the FOR-DMD experience, and as an interim solution, we have devised a checklist of steps to not only anticipate and minimise delays in academic international trial initiation but also identify obstacles that will require a concerted effort on the part of many stakeholders to mitigate.

Epidural steroid injections: update on efficacy, safety, and newer medications for injection.

The best evidence for epidural injection appears to be in the setting of radicular pain with epidural steroid and non-steroid injections more efficacious than non-epidural injections. Studies showed the efficacy of non-particulate steroid to approach the efficacy of particulate steroid and very limited comparisons demonstrated no significant difference between epidural steroid and epidural non-steroid (local anesthetic) injection. Preliminary studies evaluating epidural injection of disease modifying anti-rheumatic drugs such etanercept and tocilizumab showed conflicting results and had significant limitations. Randomized studies support better efficacy of transforaminal injection due to greater incidence of ventral epidural spread of injectate when compared to interlaminar injection. Thus, the transforaminal approach is recommended when unilateral radicular pain is limited to one nerve root. However, the transforaminal approach is associated with greater incidence of central nervous system injury, including paraplegia, attributed to embolization of the particulate steroid. Recent studies showed that non-particulate steroids potentially last as long as particulate steroids. Therefore non-particulate steroid should be used in initial transforaminal epidural injection. Future studies should look into the role of adjunct diagnostic aids, including digital subtraction angiography, in detecting intravascular injection and the ideal site of needle placement, whether it is the safe triangle or the triangle of Kambin. Finally, the role of epidural disease -modifying antirheumatic drugs in the management of back pain needs to be better elucidated.

The influence of age, gender and treatment with steroids on the incidence of osteonecrosis of the femoral head during the management of severe acute respiratory syndrome: a retrospective study.

Corticosteroid use has been implicated in the development of osteonecrosis of the femoral head (ONFH). The exact mechanism and predisposing factors such as age, gender, dosage, type and combination of steroid treatment remain controversial. Between March and July 2003, a total of 539 patients with severe acute respiratory syndrome (SARS) were treated with five different types of steroid. There were 129 men (24%) and 410 women (76%) with a mean age of 33.7 years (21 to 59). Routine screening was undertaken with radiographs, MRI and/or CT to determine the incidence of ONFH. Of the 129 male patients with SARS, 51 (39.5%) were diagnosed as suffering from ONFH, compared with only 79 of 410 female patients (19.3%). The incidence of ONFH in the patients aged between 20 and 49 years was much higher than that of the group aged between 50 and 59 years (25.9% (127 of 491) versus 6.3% (3 of 48); p = 0.018). The incidence of ONFH in patients receiving one type of steroid was 12.5% (21 of 168), which was much lower than patients receiving two different types (28.6%; 96 of 336) or three different types of steroid (37.1%; 13 of 35).

Noninvasive Keratograph assessment of tear film break-up time and location in patients with age-related cataracts and dry eye syndrome.

OBJECTIVE: To investigate tear-film break-up time and spatial distribution via noninvasive Keratograph 4 in patients with cataracts and dry eye syndrome (DES). METHODS: Noninvasive first break-up time (NIKf-BUT) and average break-up time (NIKav-BUT) were evaluated via Keratograph 4 in patients with age-related cataracts and DES. The location and size of tear break regions were recorded and the distribution of first break-up areas was summarized. Patients also underwent conventional break-up time assessments (TBUT test and Schirmer's test). RESULTS: A total of 43 left and 43 right eyes were examined. There was no significant difference between TBUT and NIKav-BUT. NIKf-BUT was significantly shorter than TBUT. Both NIKf-BUT and NIKav-BUT correlated positively with TBUT. In both the left and right eye, the most common first break-up areas were the peripheral domain of the inferior precorneal surface and the central domain of the superior portion. CONCLUSIONS: The Keratograph 4 appears to provide an effective noninvasive method for assessing tear film, enabling effective preoperative evaluation of tear film break-up regularity, informing the location of the incision and reducing the probability of postoperative DES.

Predictors of medication non-adherence for vasculitis patients.

The primary purpose of this article is to document whether demographic, clinical, regimen-related, intrapersonal, and interpersonal factors predict medication non-adherence for vasculitis patients. A secondary purpose is to explore whether adherence varies by medication type and whether patients experienced drug-related side effects. Vasculitis patients (n = 228) completed online baseline and 3-month follow-up surveys. Demographic (age, gender, education, race, marital status, and insurance status), clinical (perceived vasculitis severity, disease duration, vasculitis type, and relapse/remission status), regimen-related (experience of side effects), intrapersonal (depressive symptoms), and interpersonal (adherence-related support from family and friends) factors were measured at baseline. Medication non-adherence was assessed at follow-up using the Vasculitis Self-Management Survey medication adherence subscale (α = 0.89). Variables that significantly correlated (p < 0.05) with non-adherence were included in a linear regression model to predict non-adherence. Younger age (r = -0.23, p < 0.001), female sex (r = 0.16, p < 0.05), experience of side effects (r = 0.15, p < 0.05), and more depressive symptoms (r = 0.22, p < 0.001) were associated with more medication non-adherence. In the regression model, younger age (ß = -0.01, p = 0.01) and more depressive symptoms (ß = 0.01 p = 0.02) predicted worse adherence. For six out of eight vasculitis medication types, patients who experienced side effects were less adherent than patients who did not experience side effects. Multiple factors are associated with medication non-adherence for vasculitis patients. Providers should discuss medication adherence and drug-related side effects with vasculitis patients. Providers may want to particularly target younger patients and patients with clinical signs of depression.

Steroid withdrawal in renal transplantation.

Over the last decade, steroid minimization became one of the major goals in pediatric renal transplantation. Different protocols have been used by individual centers and multicenter study groups, including early and late steroid withdrawal or even complete avoidance. The timing of steroid withdrawal determines if antibodies are used, as avoidance and early withdrawal require antibody induction, while late withdrawal typically does not. A monoclonal antibody was used in most protocols during an early steroid withdrawal together with tacrolimus and mycophenolate mofetil in low immunological risk patients. Polyclonal induction was reported as effective in high-risk patients. Cyclosporine A and mycophenolate mofetil were used in late steroid withdrawal with no induction. All described protocols were effective in terms of preventing acute rejection and preserving renal graft function. There was no superiority of any specific protocol in terms of clinical benefits of steroid withdrawal. Pre-puberty determined growth benefit while other clinical advantages, including better control of glycemia, lipids, and blood pressure, were age independent. It is not clear whether the steroid withdrawal increases the risk of recurrence of primary glomerular diseases post-transplant, however it cannot be excluded. There is no evidence to date for a higher risk of anti-HLA production in steroid-free children after renal transplantation. Key summary points--Current strategies to minimize the steroid-related adverse effects in pediatric renal graft recipients include steroid withdrawal, early or late after transplantation, or complete steroid avoidance--Early steroid withdrawal or avoidance is generally used following the induction therapy with mono- or polyclonal antibodies, while in late steroid withdrawal induction therapy was generally not used- Elimination of steroids (early or late) does not increase the risk of acute rejection and does not deteriorate long-term renal graft function- Early steroid withdrawal is possible in patients at high immunological risk using a combination of polyclonal antibody induction, tacrolimus, and mycophenolate mofetil- All protocols of steroid minimization showed relevant clinical benefits, however the growth-related benefit was limited to pre-pubertal patients in all but one of the studies- Adverse events of steroid withdrawal occurred in a higher incidence of post-transplant bone marrow suppression Key research points - There is no clear evidence of the impact of steroid withdrawal on the risk of recurrence of primary glomerulonephritis after renal transplantation in children, therefore further evaluation of this important issue should be performed in prospective trials- There is limited pediatric data on the risk of anti-HLA/donor-specific antibody production in steroid-free patients after renal transplantation. It is not clear whether the selection of the type of induction antibody (lymphocyte depleting versus short, two-dose administration of anti-IL2R inhibitor) is important in this term. The production of anti-HLA antibodies should then be monitored on a regular basis and analyzed in prospective trials.

Study protocol- Lumbar Epidural steroid injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults.

BACKGROUND: Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis. METHODS: We will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection. DISCUSSION: This study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults. TRIAL REGISTRATION: Clinicaltrials.gov NCT01238536.

Steroid avoidance reduce the cost of morbidities after live-donor renal allotransplants: a prospective, randomized, controlled study.

OBJECTIVES: Steroids have had the main role in renal transplant for more than 4 decades. However, chronic use of steroids is associated with many comorbidities, owing to a lack of assessing cost-benefit of steroid avoidance in live-donor renal allotransplants. In this prospective, randomized, controlled study, we aimed to assess the cost-benefit of a steroid-free immunosuppression regimen among Egyptian live-donor renal transplants. MATERIALS AND METHODS: One hundred patients were randomly allocated to receive tacrolimus, mycophenolate mofetil, and steroids for only 3 days (n=50 patients; study group) or tacrolimus, mycophenolate mofetil, and steroids on a maintenance basis (n=50 patients; control group). All patients received basiliximab (Simulect) induction, with median follow-up of 12 months. RESULTS: Both groups showed comparable graft and patient survivals, rejection episodes, and graft functioning. Posttransplant comorbidities were significantly more prevalent in the steroid-maintenance group. Hypertension was detected in 4% of steroid-free group versus 24% in the steroid-maintenance group (P = .0009). Posttransplant diabetes mellitus, serious infections, and hyperlipidemia were significantly more prevalent in the steroid-maintenance group (P < .05). Associated hospitalization costs were 2.2-fold higher in the steroid-maintenance group than they were in the steroid-free group. One year after transplant, the cost of managing posttransplant comorbidities was significantly higher in steroid-maintenance group, despite comparable costs of immunosuppression. CONCLUSIONS: In low, immunologic risk recipients of live-donor renal transplants, using basiliximab induction and maintenance with tacrolimus, mycophenolate mofetil, steroid avoidance was associated with lower first annual total costs despite comparable immunosuppression costs, which was attributed to lower costs of associated morbidities.

ONJ in two dental practice-based research network regions.

The incidence of osteonecrosis of the jaw (ONJ) in the population is low, but specifics are unknown. Potential risk factors include bisphosphonate treatment, steroid treatment, osteoporosis, and head/neck radiation. This Dental Practice-Based Research Network study estimated ONJ incidence and odds ratios from bisphosphonate exposure and other risk factors using a key word search and manual chart reviews of electronic records for adults aged ≥ 35 yrs enrolled during 1995-2006 in two large health-care organizations. We found 16 ONJ cases among 572,606 cohort members; seven additional cases were identified through dental plan resources. Among 23 cases (0.63 per 100,000 patient years), 20 (87%) had at least one risk factor, and six (26%) had received oral bisphosphonates. Patients with oral bisphosphonates were 15.5 (CI, 6.0-38.7) more likely to have ONJ than non-exposed patients; however, the sparse number of ONJ cases limits firm conclusions and suggests that the absolute risks for ONJ from oral bisphosphonates is low.

Avaliação descritiva sobre o uso de esteroides anabolizantes e seu efeito sobre as variáveis bioquímicas e neuroendócrinas em indivíduos que praticam exercício resistido / Descriptive assessment on the use of anabolic steroids and their effect on the biochemical and neuroendocrine variables in practitioners of resisted exercise

O uso dos esteroides anabolizantes vem se tornando um problema de saúde pública ao longo dos últimos anos. No bojo do uso abusivo, muitos efeitos deletérios são observados, na sua totalidade por disfunções dos vários sistemas fisiológicos. Sendo assim, o objetivo do estudo foi o de avaliar o eixo hipófise-gonadal, a função hormonal, as transaminases hepáticas e o perfil de hemograma de 61 voluntários distribuídos em três grupos: 20 usuários de esteroides anabolizantes praticantes de exercício físico resistido, 21 praticantes de exercício resistido sem uso de esteroides anabolizantes e 20 sedentários. Foi observada elevação do nível de creatina quinase nos dois grupos de indivíduos que se exercitavam de maneira resistida, em relação ao grupo de sedentários (p < 0,001). Redução das gonadotrofinas LH e FSH do grupo de usuários de esteroides anabolizantes e elevação do nível de estradiol, em comparação ao grupo sedentário e treinado que não usa esteroides anabolizantes (p < 0,001). Ainda, foi observada redução da fração HDL do colesterol, em relação aos dois grupos estudados (p < 0,001). Desta maneira, o uso dos esteroides anabolizantes causa alterações bioquímicas que podem levar a instalação de efeitos colaterais.

The use of anabolic asteroids has become a public health problem over the last years. Concerning their abusive use, many deleterious effects caused in their totality by dysfunction of the various physiological systems can be observed. Therefore, the aim of the present study was to assess the hypophyseal-gonadal axis, hormone function, hepatic transaminases and hemogram profile of 61 volunteers distributed in three groups: 20 anabolic steroid users, practitioners of resisted physical exercise; 21 practitioners of resisted physical exercise with no use of anabolic steroids and 20 sedentary subjects. Increase of the creatine kinase level was observed in the two exercised groups in comparison to the sedentary group (p < 0.001). Reduction of the LH and FSH gonadotrpins of the steroid users group and increase in the estradiol level were observed in comparison to the sedentary and with no steroid use groups (p < 0.001). Moreover, reduction of the HDL cholesterol fraction was observed in comparison to the two studied groups (p < 0.001). Thus, the use of anabolic steroids causes biochemical alterations which can lead to the installation of collateral effects.

Trauma, systemic inflammatory response syndrome, dietary supplements, illicit steroid use and a questionable malignant hyperthermia reaction.

BACKGROUND: Malignant hyperthermia (MH) is a pharmacogenetic disorder of skeletal muscle calcium regulation associated primarily, but not exclusively, with mutations in the skeletal muscle ryanodine receptor. Associated environmental factors, however, may also be important for expression of the syndrome. METHODS AND RESULTS: A 24-yr-old trauma patient developed a fulminant MH crisis after a 3 minute exposure to sevoflurane. A thorough evaluation of underlying co-morbidities revealed a number of environmental factors that could have altered skeletal muscle calcium regulation, and may have potentially influenced the effects of volatile inhaled anesthetics. Since MH is a syndrome characterized by abnormal skeletal muscle calcium regulation, other factors that alter calcium homeostasis may exacerbate the impact of inhaled MH-triggering drugs. CONCLUSIONS: While a thorough history of MH episodes in a proband and family is emphasized as part of a complete preanesthetic evaluation, obtaining a history of other environmental entities that may alter calcium regulation may be equally important to knowing the family history.

Osteoporosis risk factor assessment increases the appropriate use of dual energy X-ray absorptiometry in men and reduces ethnic disparity.

BACKGROUND: Male patients are frequently not tested for osteoporosis even in the presence of recognized risk factors for that disease. OBJECTIVES: To evaluate if the assessment of risk factors for osteoporosis increases the utility of dual energy X-ray absorptiometry (DXA) in men over the age of 50 attending a rheumatology clinic. METHODS: Men over 50 attending a rheumatology clinic completed a checklist of 10 risk factors for osteoporosis before seeing the physician. The physician reviewed the checklist and made a management decision. The checklists and medical records were reviewed for medical history and DXA results. Comparisons were made with DXA requests before the use of the checklist. RESULTS: Medical records of 183 men were reviewed, including 111 African Americans (AA) and 67 whites. Twenty-three percent of patients had rheumatoid arthritis (14% of AA, 37% of whites) and 27% of patients were on glucococorticoids. Before the use of the checklist, 14% of men had a DXA (6% of AA and 29% of whites) compared with 29% of patients (21% for AA and 42% for whites) after the checklist was instituted in the clinic. Sixty-three percent of AA with rheumatoid arthritis had DXA compared with 65% of whites. Thirteen patients had osteoporosis whereas 16 had osteopenia. CONCLUSIONS: The use of a check list of risk factors for osteoporosis may increase the appropriate use of DXA in male patients over the age of 50 at risk for osteoporosis.

Seasonal allergic rhinitis: limited effectiveness of treatments.

(1) Seasonal allergic rhinitis, otherwise known as hayfever, is a harmless condition, although it can cause major discomfort and interfere with activities of daily living. We conducted a review of the literature, based on our in-house methodology, to determine the risk-benefits of treatments used in this setting. (2) Placebo-controlled trials show that sodium cromoglicate relieves symptoms, especially if it is used before symptoms appear. Adverse effects are rare with sodium cromoglicate nasal solutions and eye drops. (3) Nasal steroids have well-documented efficacy. Beclometasone is the best choice. Adverse effects include epistaxis, nasal irritation and, occasionally, systemic disorders. (4) Oral antihistamines are less effective than nasal steroids. They also provoke adverse effects, especially drowsiness. Nasal azelastine seems to have a similar efficacy as oral antihistamines. (5) The adverse effects of systemic steroids must not be overlooked, especially with long-term use. Oral administration is an alternative for severe symptoms that do not respond to other treatments, although this is rarely the case. Long-acting intramuscular steroids carry an increased risk of adverse effects. (6) Despite evaluation in several randomised controlled trials, there is no firm evidence that homeopathic preparations have any specific efficacy in allergic rhinitis. (7) Vasoconstrictors, ipratropium and montelukast, have negative risk-benefit balances in hay fever. (8) When a single allergen is responsible (grasses, ragweed, birch), clinical trials suggest that specific desensitisation can provide a modest improvement. However, this treatment carries a risk of local adverse effects, as well as a risk of rare but severe anaphylactic reactions, especially in patients who also have unstable severe asthma. (9) Sublingual desensitisation seems to be even less effective than subcutaneous desensitisation in adults. Follow-up is too short to know whether there is a risk of severe anaphylactic reactions. The results of paediatric studies are even less convincing. (10) In practice, when drug therapy is needed to relieve symptoms of seasonal allergic rhinitis, sodium cromoglicate is the first-line treatment. If a nasal steroid solution is chosen, it should be used for the shortest possible period.

Neonatal hearing assessment in very low birth weight infants exposed to antenatal steroids.

OBJECTIVE: We sought to evaluate neonatal hearing assessment by the otoacoustic emission (OAE) test in very low birth weight (VLBW) infants exposed to antenatal steroids. STUDY DESIGN: This is a retrospective cohort study of infants <1500 g delivered between July 1998 and July 2004 who completed hearing screens on discharge. All screens were performed by the OAE. Only infants who failed or passed the exam were included in the analysis. Infants with a partial or an inadequate exam were excluded. Neonates exposed to antenatal steroids were then compared to unexposed infants for the results of their OAE. RESULT: A total of 68,000 deliveries were performed during the study period. There were 703 VLBW infants who had hearing exams, of which 548 (78%) passed the screen, 95 (14%) failed and 59 (8%) were indeterminate. Gestational age, birth weight, score for neonatal acute physiology and severe intraventricular hemorrhage were associated with a failed screen (P<0.01). Antenatal steroid exposure was not associated with a failed screen (odds ratio: 0.83 (95% confidence interval 0.5-1.4), P=0.43). CONCLUSION: In our population, antenatal steroids were not associated with a positive or negative effect on hearing assessment of VLBW infants.