Top PDF Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

The present study of the attitudes of patients with schizophrenia toward placebo-controlled clinical trials is the first such survey of an Asian population. In our survey, although more than half of the patients (62%) stated that they approve of clinical trials in principle, only 33% of the respondents reported that they would be willing to participate in placebo-controlled clinical tri- als. An expectation of disease improvement (Q3), a guarantee of hospital treatment continua- tion (Q8), and encouragement from family or friends (Q10) were associated with a willingness to participate, whereas a belief of additional time required for medical examinations (Q2) was associated with non-participation. A previous study conducted in Austria [15] reported that 44% of the respondents were willing to participate in a placebo-controlled clinical trial. The reasons most often given by the patients who were willing to participate in such a study were (1) the wish to support the development of new drugs, (2) the possibility of remaining unmedi- cated, and (3) the desire to receive more medical care. In another study [17], the attitudes of patients with schizophrenia toward four hypothetical research protocols were assessed. The patients perceived significantly greater harm in medication washout or placebo treatment, and they were less willing to enroll in protocols perceived as more harmful. Furthermore, the patients indicated that doctor recommendations, monetary incentives, and, to a lesser extent, family preferences had a mild influence on their participation decisions. Schäfer and colleagues [18] evaluated the attitudes toward psychiatric research among patients with schizophrenia or depression in 7 European countries. They showed that most patients (98%) approved of psy- chiatric research and the reasons to participate were mainly altruistic. In the same study, expec- tation to receive a feedback of the studies' results was significantly more expressed by patients with schizophrenia as compared to depressive patients. With respect to schizophrenia researchers’ attitudes toward placebo-controlled clinical trials in Europe [19], willingness to participate in such clinical trials involving acutely ill patients was expressed by 30%, and 34% said that they would perform such a study in maintenance treatment. In response to the ques- tion of whether they believed that their local ethics committee would permit a placebo-con- trolled clinical trial, 24% answered yes for acute studies and 29% for maintenance studies.
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Treatment of Non-neurogenic Overactive Bladder with OnabotulinumtoxinA: Systematic Review and Meta-analysis of Prospective, Randomized, Placebo-controlled Clinical Trials

Treatment of Non-neurogenic Overactive Bladder with OnabotulinumtoxinA: Systematic Review and Meta-analysis of Prospective, Randomized, Placebo-controlled Clinical Trials

In comparison with the placebo, onabotulinumtoxinA pro- motes significant improvement of urinary urgency, urinary frequency, nocturia, and incontinence symptoms. There is higher incidence of urinary retention and urinary tract infec- tion among patients in the toxin group in relation with the placebo group. It was not possible to evaluate the effects on quality of life. This systematic review is endorsed by the Urogynecology Committee of the Federação das Associações Brasileiras de Ginecologia e Obstetrícia (Brazilian Federation of the Societies of Gynecology and Obstetrics, [FEBRASGO, in the Portuguese acronym]) and suggests that the dose of 100 units of onabotulinumtoxinA is effective in the treatment of non- neurogenic refractory overactive bladder.
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Factors that influence parental attitudes toward enrollment in type 1 diabetes trials.

Factors that influence parental attitudes toward enrollment in type 1 diabetes trials.

A total of 166 questionnaires were collected, with an overall response rate of 36%. Of these, 21 questionnaires (12.7%) were completed during Vanderbilt Diabetes Family Day while the remainder was collected from clinic visits. Sociodemographic data of the sample is summarized in Table 1. The majority of parents who participated in our survey were White (90%) females (81%). Our overall clinic population (n = 1867) from which this sample was taken consists of 60% White, 10.4% Black or African American, 1.6% Hispanic, 0.5% Asian or Pacific Islander, and 27.4% pediatric patients with unknown ethnic background. To understand how our respondents related to actual clinical trial participants at our institution, we examined the demographics of the most recent enrollees at our Clinical Center in the Type 1 Diabetes TrialNet Pathways to Prevention, a longitudinal study of at-risk relatives of children with diabetes. When we examined demographics of the most recent 102 TrialNet enrollees younger than 18 years of age at our institution, a similar 89% were White and 5% were Black or African American. Most consent forms for these individuals were signed by mothers or female guardians (89%).76% of participants were aware that T1DCTs exist and 68% were aware of trials conducted locally. 66% recalled receiving information about clinical trials, which most often came from healthcare providers. The majority deemed the information received to be completely or a great deal easy to understand, although 38% reported at least some difficulty with comprehen- sion. Only 18% recalled having been asked specifically to enroll their child with diabetes or unaffected child into a trial. Of these, 62% and 60% agreed to enroll their child with diabetes and unaffected child, respectively, at least some of the time. Parents reported slightly higher willingness to enroll children with diabetes (WTEDC, 47%) compared to unaffected children (WTEnDC, 36%). Most parents (81%) considered their child’s participation in T1DCTs to be important. 67% disagreed that there is currently sufficient enrollment in T1DCTs.
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Metabolic effects of fluoxetine in adults with type 2 diabetes mellitus: a meta-analysis of randomized placebo-controlled trials.

Metabolic effects of fluoxetine in adults with type 2 diabetes mellitus: a meta-analysis of randomized placebo-controlled trials.

Type 2 diabetic patients under lifestyle intervention will lose, on average, 8% of initial body weight over 3–12 months [20]. However, most obese people regain their weight they have successfully lost from dietary and behavioral treatment in long- term outcome [21,22]. It seems difficult to achieve sustained weight control in general population [20,23]. For Type 2 diabetic patients, this issue is more complicated. Studies demonstrated that diabetic patients lost less weight and regained their weight more rapidly compared with the non-diabetic [24], which can be attributed to the physiologic derangement and insulin treatment of T2DM [25]. Hence, in the obese individuals for whom behavioral therapy has failed, medical interventions such as weight-manage- ment drugs are required in addition to the usual anti-diabetic treatment. In general, pharmacologic therapy of obesity consists of centrally acting appetite suppressants, drugs with a peripheral effect on appetite, drugs that affect nutrient partitioning, and drugs that increase thermogenesis. Several weight-loss medications have been proved to be effective, and some have been applied in clinical practice. However, only two drugs, orlistat and sibutramine, have been approved by the US Food and Drug Administration (FDA) to treat obesity long term, and both medications have undesirable side effects, leaving an enormous unmet need for efficacious and safe therapy for obesity.
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Attitudes of doctors and medical students toward patients with suicidal ideation

Attitudes of doctors and medical students toward patients with suicidal ideation

26. Malakouti SK, Nojomi M, Ahmadkhaniha HR, Hosseini M, Fallah MY, Khoshalani MM. Integration of suicide prevention program into primary health care network: a field clinical trial in Iran. Med J Islam Repub Iran [Internet]. 2015 [acesso 11 jul 2016];29:208. Disponível: https://bit.ly/2wsCl5N 27. Beurs DP, Groot MH, Bosmans JE, Keijser J, Mokkenstorm J, Verwey B et al. Reducing patients’ suicide ideation through training mental health teams in the application of the Dutch multidisciplinary practice guideline on assessment and treatment of suicidal behavior: study protocol of a randomized controlled trial. Trials [Internet]. 2013 [acesso 3 dez 2014];14:372. Disponível: https://bit.ly/39kUHTv
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Attitudes of doctors and medical students toward patients with suicidal ideation

Attitudes of doctors and medical students toward patients with suicidal ideation

26. Malakouti SK, Nojomi M, Ahmadkhaniha HR, Hosseini M, Fallah MY, Khoshalani MM. Integration of suicide prevention program into primary health care network: a field clinical trial in Iran. Med J Islam Repub Iran [Internet]. 2015 [acesso 11 jul 2016];29:208. Disponível: https://bit.ly/2wsCl5N 27. Beurs DP, Groot MH, Bosmans JE, Keijser J, Mokkenstorm J, Verwey B et al. Reducing patients’ suicide ideation through training mental health teams in the application of the Dutch multidisciplinary practice guideline on assessment and treatment of suicidal behavior: study protocol of a randomized controlled trial. Trials [Internet]. 2013 [acesso 3 dez 2014];14:372. Disponível: https://bit.ly/39kUHTv
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Attitudes of doctors and medical students toward patients with suicidal ideation

Attitudes of doctors and medical students toward patients with suicidal ideation

26. Malakouti SK, Nojomi M, Ahmadkhaniha HR, Hosseini M, Fallah MY, Khoshalani MM. Integration of suicide prevention program into primary health care network: a field clinical trial in Iran. Med J Islam Repub Iran [Internet]. 2015 [acesso 11 jul 2016];29:208. Disponível: https://bit.ly/2wsCl5N 27. Beurs DP, Groot MH, Bosmans JE, Keijser J, Mokkenstorm J, Verwey B et al. Reducing patients’ suicide ideation through training mental health teams in the application of the Dutch multidisciplinary practice guideline on assessment and treatment of suicidal behavior: study protocol of a randomized controlled trial. Trials [Internet]. 2013 [acesso 3 dez 2014];14:372. Disponível: https://bit.ly/39kUHTv
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Rev. Bras. Psiquiatr.  vol.27 número2

Rev. Bras. Psiquiatr. vol.27 número2

The selective serotonin reuptake inhibitors (SSRIs) entered the world wide market place in the late 1980s with the introduction of fluoxetine. Since then five others: sertraline, paroxetine, fluvoxamine, citalopram, and escitalopram have also become available in many countries around the world. These compounds are used to treat major depression, obsessive- compulsive disorder, generalized anxiety disorder, panic disorder and social anxiety disorder. Due to the perceived safety of these drugs and their convenience (e.g., single day dosing, no need for blood level monitoring), the SSRIs have dominated the market. Although a majority of the research to date has been in adult populations, there have been several large scale studies in pediatric populations. Thus, in many western countries, one or more of the SSRIs are approved for obsessive- compulsive disorder (OCD) or depression in children and adolescents. Recent warnings about suicidal thoughts and self- injurious behavior in youth treated with selective serotonin reuptake inhibitors raise fundamental questions about the risk- benefit ratio of this class of medications. This paper examines this controversy and provides essential clinical considerations. The recent controversy about the use of the SSRIs in children emerged about two years ago following a review by the British drug regulatory agency of paroxetine for depression. This agency expressed concern that the rate of suicidal ideation and behavior was greater for paroxetine-treated subjects than the rate in the placebo group. In addition, the agency concluded that the evidence for efficacy of the treatment of youth with depression was not convincing. This review was followed by a thorough examination of the evidence by the Food and Drug Administration (FDA) in the United States. Based on a meta- analysis of 24 placebo-controlled trials of the SSRIs (most of which were unpublished) involving over 4000 pediatric patients, the agency expressed concern about the possibility of worsening depression, the emergence of suicidal thoughts and behaviors, hyperactivity, irritability, and impulsiveness following the initiation of SSRI treatment. Thus, in October, 2004, the FDA issued a warning on the use of SSRIs in pediatric patients (see http://www.fda.gov/cder/drug/antidpressants/SSRIlabeling). Concern about the suicidal ideation and hyperactivity in young people treated with SSRIs is not new. The combination of hyperactivity, elevated mood and impulsiveness, of ten labeled behavioral activation, tends to occur early in the treatment and is not unique to the treatment of youth with depression. For example, in the placebo-controlled trial of sertraline in children with OCD, 13% of the subjects in the active treatment group became activated compared to 2% in the placebo group. 1 Similarly, 12.3% of children in the
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Efficacy, safety and tolerability of aripiprazole in bipolar disorder : an updated systematic review and metaanalysis of randomized controlled trials

Efficacy, safety and tolerability of aripiprazole in bipolar disorder : an updated systematic review and metaanalysis of randomized controlled trials

We also analyzed the CGI-S as an alternative measurement of effi- cacy of aripiprazole treatment. Comparing aripiprazole monotherapy and a placebo in the acute stage of BD, aripiprazole was associated with significant improvements in the CGI-S than a placebo across manic/ mixed and depressed states, and also with aripiprazole monotherapy and a placebo in the maintenance stage. These results are comparable to previous studies (Brown et al., 2013; Fountoulakis et al., 2011) which reported categories of CGI, however further clinical trials are necessary for subgroup analysis within different categories of mood state. In three trials (Keck et al., 2009; Vieta et al., 2005; Young et al., 2009), ar- ipiprazole was significantly better than other medications (haloperidol or lithium) in the CGI-S (effect size: −0.191, p = 0.003) with regards to treatment efficacy of BD during the acute phase. In addition, the efficacy of treatment for psychotic features is also important due to the effect on recovery in BD. Psychotic mania has been associated with longer periods of remission (Rosenthal et al., 1979), higher rates of relapse, worse social functioning, and occupational status (Tohen et al., 1990) compared to non-psychotic mania. Moreover, psychotic features are highly associated with suicide attempts in patients with BD (McGrady et al., 2017). Aripiprazole monotherapy tended to reduce PANSS scores compared to a placebo in the acute phase, indicating a beneficial effect in treating psychotic features. Another meta-analysis (Fountoulakis et al., 2009) also supports the usefulness of aripiprazole for psychotic symptoms during the acute manic and maintenance phases of BD, which is consistent with our results.
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Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.

Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.

Chronic idiopathic constipation (CIC), estimated to affect between 12% and 19% of North Americans,[1] is characterized by a variety of bowel symptoms including reduced bowel move- ment (BM) frequency, hard stools, straining during defecation, and a sense of incomplete evac- uation after defecation, as well as abdominal symptoms of bloating and discomfort.[2–4] Abdominal bloating refers to subjective sensations of excessive gas, a fullness or tightness in the abdomen, or a feeling of abdominal swelling.[5,6] Subjective sensations of abdominal bloat- ing may or may not be associated with distention, which can be defined as a visible change in abdominal girth.[6] Abdominal bloating is a common and particularly bothersome symptom of CIC.[4,6,7] The etiology of abdominal bloating is incompletely understood, may differ from patient to patient, and is likely multifactorial in nature.[8] Potential causes include visceral hypersensitivity, abnormal intestinal gas transit, impaired evacuation of rectal gas, excess fer- mentation of bowel contents, an abnormal abdomino-diaphragmatic reflex, and disorders related to the gut microbiota.[6,9] Few treatments have been shown to improve abdominal bloating in patients with CIC.[10,11] In fact, abdominal bloating may be exacerbated by some treatments aimed at improving constipation-related symptoms.[10,11]
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Rev. bras. ter. intensiva  vol.21 número1 en v21n1a13

Rev. bras. ter. intensiva vol.21 número1 en v21n1a13

Our objective is to review relevant studies on the oc- currence of PONV in adults and draw up an algorithm for prevention and treatment of the syndrome. A refer- ence survey was made in the database PubMed using the keywords “postoperative nausea and vomiting”, as Mesh terms, producing 1680 references. Survey limits were used to focus search on the more relevant articles: stud- ies in humans, English or Portuguese language, in adults (over 19 years of age) and clinical studies of any kind (case reports or series, stage I,II, III or IV studies, com- parative studies, controlled clinical studies with or with- out randomization). he search disclosed 741 articles (6 reviews) classiied as: etiology (203), physiopathology (12), epidemiology (178), diagnosis (13), therapy (487) prevention and control (405) and economy (13).
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Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

Patients were randomly allocated to either daily oral itracon- azole capsules or identical placebo capsules for a 24 week treatment period. Dosing of itraconazole was calculated to provide a daily dose of 5 mg/kg/d as per CF Consensus Guidelines [11]. Itraconazole, or identical placebo, was given once daily by mouth, unless the dose exceeded 200 mg/day, in which case it was given twice daily. Patients were advised to take study medication with orange juice or at least 8 oz of a cola beverage in order to maximize oral absorption. Patients were also instructed to take the study medication at least 4 hours before using medications which decrease stomach acidity, such as histamine-blockers or proton pump inhibitors. All study patients otherwise continued standard therapy for their CF as prescribed by their treating physician.
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Patients’ preferences for selection of endpoints in cardiovascular clinical trials

Patients’ preferences for selection of endpoints in cardiovascular clinical trials

Because of these potential benefits, use of composite outcomes as a study design methodology has become commonplace in landmark, practice-changing clinical trials, as randomized controlled trials have become the new standard. In a review of 1,231 cardiovascular clinical trials conducted from 2000 to 2007, 37% used composite endpoints (3). Ideally, component outcomes should each be clinically meaningful, share the same biological effect or mechanism of action, contribute equally to the com- posite, and viewed with a similar degree of importance by patients (3). Unfortunately, those standards are not closely followed. In a review of 84 cardiovascular trials that used composite endpoints, 54% used endpoints with a wide range of importance to patients (4). The authors note that this practice may yield misleading impressions of the overall impact of the novel treatment, since higher event rates and larger treatment effects are associated with less important endpoints, such as hospitalization for chest pain, whereas more important endpoints, such as death due to myocardial infarction, were generally associated with lower event rates. Another author found inconsistent use of the composite endpoint approach across clinical trials, with flaws existing in both the methodology as well as the reporting of results (5), while another lamented, ‘The use of composite outcomes in trials is problematic. Components are often unreasonably combined, inconsistently defined, and inadequately re- ported. These problems will leave many readers confused, often with an exaggerated perception of how well in- terventions work’ (5).
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Int. braz j urol.  vol.37 número3

Int. braz j urol. vol.37 número3

biases in outcome interpretation. On the irst con- sultation, boys were evaluated and phimosis type was assessed according to the Kayaba classiica- tion (9) as shown in Table-2. Patients with phimo- sis type 4 were included because even if this is a lesser degree of the disease, however it is an abnor- mal condition and needs treatment. The assigned ointment was provided by a research assistant and parents were instructed to use a small amount twice a day for 60 days applying subtle traction on the foreskin (retracting maneuvers). The formula- tions were speciically designed for the study by the same pharmacy. Follow-up consultations were scheduled at 30 and 60 days. Patients whose treat- ments were successful were also scheduled to a follow-up consultation 180 days after the irst con- sultation. Compliance with the treatment, adverse effects, complications, and type of phimosis were then assessed. Data collection was performed by a third person based on patients’ iles.
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Use of Kampo diagnosis in randomized controlled trials of Kampo products in Japan: a systematic review.

Use of Kampo diagnosis in randomized controlled trials of Kampo products in Japan: a systematic review.

As for the limitations of the SR, firstly, there was possible publication bias. Clinical trial registration (the tool to prevent publication bias) was developed in 2005 in Japan [23]. The number of articles about the RCTs in this study is as follows: 1986- 89: 11 (2.9%), 1990s: 180 (47.6%), 2000s: 157 (41.5%), 2010- 11s:30 (7.9%). There were 261 RCT articles from 1986 to 2004, and 117 RCT articles from 2005 to 2011. Thus, 69.0% of RCTs were published before the problem of publication bias was addressed. Secondly, the motivations for conducting RCTs were not clearly stated; some were of purely academic interest, and some were of industrial interest. The CONSORT statements of 1996, 2001, and 2010 have been translated into Japanese but were ignored by those interested in Kampo medicine. And only the statement of 2010 addresses the role of the funding agency in the conduct of the study. Kampo industry may have more interest in RCTs that involve the use of Western medicine diagnosis because reporting them increases sales. PRISMA guidelines [24] should be used when preparing systematic reviews of RCTs with low risk of biased information.
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Estudos de medicamentos biosimilares

Estudos de medicamentos biosimilares

No Brasil, o registro de novos medicamentos é feito apenas quando a agência reguladora – Agência Nacional de Vigilância Sanitária (Anvisa) – se satisfaz plenamente com as evidências de sua qualidade, eficácia e segurança, apresentadas por uma indústria farmacêutica que pleiteie esse registro. Com o vencimento de patentes, empresas farmacêuticas se sentem atraídas pela produção medicamentos biológicos chamados de biosimilares ou biogenéricos ou simplesmente genéricos, cuja aprovação pode resultar em redução de custos de tratamento. Mas é preciso que o biosimilar seja, pelo menos, igualmente eficaz e seguro e sem contaminantes em relação ao original. Consensos recentes apontam diretrizes para estabelecer critérios de eficácia e segurança desses medicamentos. Estudos pré-clínicos in vitro e in vivo, procedência da matéria-prima e estudos clínicos fase I, II e III são preconizados para registro do produto biosimilar no mercado internacional. As heparinas de baixo peso molecular encontram-se nessa situação. Nesta revisão, abordamos especificamente esse tipo de medicamento, o que pode servir de parâmetro para outros biosimilares.
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Video-Assisted Thoracoscopic Sympathectomy for Palmar Hyperhidrosis: A Meta-Analysis of Randomized Controlled Trials.

Video-Assisted Thoracoscopic Sympathectomy for Palmar Hyperhidrosis: A Meta-Analysis of Randomized Controlled Trials.

We evaluated three aspects of the operation: (1) resolution of symptoms; (2) patient satisfac- tion; (3) postoperative complications. In the meta-analysis, we found no significant difference in “resolution of symptoms” and “patient satisfaction” between different segments (p > 0.05). The data suggest that VTS of all segments could improve the symptom of hyperhidrosis, with a satisfaction close to 100% in all segments. CH was the most common complication reported and, when severe, could significantly affect quality of life. In the present study, we took postop- erative degree of CH as the main index to evaluate the success of the operation.
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Trends Psychiatry Psychother.  vol.38 número3

Trends Psychiatry Psychother. vol.38 número3

One participant in the study missed a session due to transportation problems. All patients were under adequate pharmacological therapy. Moreover, all of them were using atypical antipsychotic medication. Six patients were on olanzapine (up to 20 mg/day), two patients were on risperidone (up to 6 mg/day), and one patient was on aripiprazole (30 mg/day). Patients also reported irregular use of benzodiazepines (clonazepam up to 2 mg/day) due to sporadic insomnia. No other psychiatric drug was reported. Sixty-six percent (n = 6) of the patients were female, and mean age was 35.6±8.2 years. Patients presented no other clinical or psychiatric comorbidity.
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Rev. Bras. Psiquiatr.  vol.39 número1

Rev. Bras. Psiquiatr. vol.39 número1

1 Kahn JP, Meyers JR. Treatment of comorbid panic disorder and schizo- phrenia: evidence for a panic psychosis. Psychiatr Ann. 2000;30:29-33. 2 Veras AB, Nardi AE, Kahn JP. Attachment and self-consciousness: a dynamic connection between schizophrenia and panic. Med Hypo- theses. 2013;81:792-6.

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J. bras. pneumol.  vol.34 número1 en v34n1a07

J. bras. pneumol. vol.34 número1 en v34n1a07

Objective: To analyze the available evidence regarding the effect that corticosteroids have on the prevention of fat embolism syndrome after long bone fracture of the lower limbs or pelvic fracture. Methods: In March of 2007, we performed a search of various electronic databases, including Medline, the Excerpta Medica database, the Cochrane Library, the Latin American and Caribbean Health Sciences Literature database and the Scientific Electronic Library Online. We selected randomized controlled trials that compared the effect of corticosteroids with that of placebo (or standard care) on the prevention of fat embolism syndrome after long bone fracture of the lower limbs or pelvic fracture. References from the studies included were also reviewed. Results: Six studies were included. The pooled relative risk for developing fat embolism syndrome was 0.16 (95% CI: 0.08-0.35) in the corticosteroid group as compared with the control group. The pooled relative risk for developing hypoxemia was 0.34 (95% CI: 0.19-0.59) in the corticosteroid group as compared with the control group. Conclusion: The analysis of evidence showed that corticosteroids decrease the risk of developing fat embolism syndrome and hypoxemia after long bone fracture of the lower limbs.
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