Publications by authors named "Álvaro N Atallah"

48 Publications

Enzyme replacement therapy with galsulfase for mucopolysaccharidosis type VI.

Cochrane Database Syst Rev 2021 09 17;9:CD009806. Epub 2021 Sep 17.

Emergency Medicine and Evidence Based Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Mucopolysaccharidosis type VI (MPS VI) or Maroteaux-Lamy syndrome is a rare genetic disorder caused by the deficiency of arylsulphatase B. The resultant accumulation of dermatan sulphate causes lysosomal damage. The clinical symptoms are related to skeletal dysplasia (i.e. short stature and degenerative joint disease). Other manifestations include cardiac disease, impaired pulmonary function, ophthalmological complications, hepatosplenomegaly, sinusitis, otitis, hearing loss and sleep apnea. Intellectual impairment is generally absent. Clinical manifestation is typically by two or three years of age; however, slowly progressive cases may not present until adulthood. Enzyme replacement therapy (ERT) with galsulfase is considered a new approach for treating MPS VI.

Objectives: To evaluate the effectiveness and safety of treating MPS VI by ERT with galsulfase compared to other interventions, placebo or no intervention.

Search Methods: Eletronic searches were performed on the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register. Date of the latest search:  09 June 2021. Further searches of the following databases were also performed: CENTRAL, MEDLINE, LILACS, the Journal of Inherited Metabolic Disease, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov. Date of the latest search: 20 August 2021.

Selection Criteria: Randomized and quasi-randomized controlled clinical studies of ERT with galsulfase compared to other interventions or placebo.

Data Collection And Analysis: Two authors independently screened the studies, assessed the risk of bias, extracted data and assessed the certainty of the the evidence using the GRADE criteria.

Main Results: One study was included involving 39 participants who received either ERT with galsulfase (recombinant human arylsulphatase B) or placebo. This small study was considered overall to have an unclear risk of bias in relation to the design and implementation of the study, since the authors did not report how both the allocation generation and concealment were performed. Given the very low certainty of the evidence, we are uncertain whether at 24 weeks there was a difference between groups in relation to the 12-minute walk test, mean difference (MD) of 92.00 meters (95% confidence interval (CI) 11.00 to 172.00), or the three-minute stair climb, MD 5.70 (95% CI -0.10 to 11.50). In relation to respiratory tests, we are uncertain whether galsulfase makes any difference as compared to placebo in forced vital capacity in litres (FVC (L) (absolute change in baseline), given the very low certainty of the evidence. Cardiac function was not reported in the included study. We found that galsulfase, as compared to placebo, may decrease urinary glycosaminoglycan levels at 24 weeks, MD -227.00 (95% CI -264.00 to -190.00) (low-certainty evidence). We are uncertain whether there are differences between the galsulfase and placebo groups in relation to adverse events (very low-certainty evidence). In general, the dose of galsulfase was well tolerated and there were no differences between groups. These events include drug-related adverse events, serious and severe adverse events, those during infusion, drug-related adverse events during infusion, and deaths. More infusion-related reactions were observed in the galsulfase group and were managed with interruption or slowing of infusion rate or administration of antihistamines or corticosteroids drugs. No deaths occurred during the study.   AUTHORS' CONCLUSIONS: The results of this review are based only on one small study (a 24-week randomised phase of the study and prior to the open-label extension). We are uncertain whether galsulfase is more effective than placebo, for treating people with MPS VI, in relation to the 12-minute walk test or the three-minute stair climb, as the certainty of the evidence has been assessed as very low. We found that galsulfase may reduce urinary glycosaminoglycans levels. We are also uncertain whether there are any differences between treatment groups in relation to cardiac or pulmonary functions, liver or spleen volume, overnight apnea-hypopnea, height and weight, quality of life and adverse effects. Further studies are needed to obtain more information on the long-term effectiveness and safety of ERT with galsulfase.
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http://dx.doi.org/10.1002/14651858.CD009806.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447860PMC
September 2021

Prophylactic anticoagulants for people hospitalised with COVID-19.

Cochrane Database Syst Rev 2020 10 2;10:CD013739. Epub 2020 Oct 2.

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Coronavirus disease 2019 (COVID-19) is a serious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The primary manifestation is respiratory insufficiency that can also be related to diffuse pulmonary microthrombosis in people with COVID-19. This disease also causes thromboembolic events, such as pulmonary embolism, deep venous thrombosis, arterial thrombosis, catheter thrombosis, and disseminated intravascular coagulopathy. Recent studies have indicated a worse prognosis for people with COVID-19 who developed thromboembolism. Anticoagulants are medications used in the prevention and treatment of venous or arterial thromboembolic events. Several drugs are used in the prophylaxis and treatment of thromboembolic events, such as heparinoids (heparins or pentasaccharides), vitamin K antagonists and direct anticoagulants. Besides their anticoagulant properties, heparinoids have an additional anti-inflammatory potential, that may affect the clinical evolution of people with COVID-19. Some practical guidelines address the use of anticoagulants for thromboprophylaxis in people with COVID-19, however, the benefit of anticoagulants for people with COVID-19 is still under debate.

Objectives: To assess the effects of prophylactic anticoagulants versus active comparator, placebo or no intervention, on mortality and the need for respiratory support in people hospitalised with COVID-19.

Search Methods: We searched CENTRAL, MEDLINE, Embase, LILACS and IBECS databases, the Cochrane COVID-19 Study Register and medRxiv preprint database from their inception to 20 June 2020. We also checked reference lists of any relevant systematic reviews identified and contacted specialists in the field for additional references to trials.

Selection Criteria: Randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cohort studies that compared prophylactic anticoagulants (heparin, vitamin K antagonists, direct anticoagulants, and pentasaccharides) versus active comparator, placebo or no intervention for the management of people hospitalised with COVID-19. We excluded studies without a comparator group. Primary outcomes were all-cause mortality and need for additional respiratory support. Secondary outcomes were mortality related to COVID-19, deep vein thrombosis (DVT), pulmonary embolism, major bleeding, adverse events, length of hospital stay and quality of life.

Data Collection And Analysis: We used standard Cochrane methodological procedures. We used ROBINS-I to assess risk of bias for non-randomised studies (NRS) and GRADE to assess the certainty of evidence. We reported results narratively.

Main Results: We identified no RCTs or quasi-RCTs that met the inclusion criteria. We included seven retrospective NRS (5929 participants), three of which were available as preprints. Studies were conducted in China, Italy, Spain and the USA. All of the studies included people hospitalised with COVID-19, in either intensive care units, hospital wards or emergency departments. The mean age of participants (reported in 6 studies) ranged from 59 to 72 years. Only three included studies reported the follow-up period, which varied from 8 to 35 days. The studies did not report on most of our outcomes of interest: need for additional respiratory support, mortality related to COVID-19, DVT, pulmonary embolism, adverse events, and quality of life. Anticoagulants (all types) versus no treatment (6 retrospective NRS, 5685 participants) One study reported a reduction in all-cause mortality (adjusted odds ratio (OR) 0.42, 95% confidence interval (CI) 0.26 to 0.66; 2075 participants). One study reported a reduction in mortality only in a subgroup of 395 people who required mechanical ventilation (hazard ratio (HR) 0.86, 95% CI 0.82 to 0.89). Three studies reported no differences in mortality (adjusted OR 1.64, 95% CI 0.92 to 2.92; 449 participants; unadjusted OR 1.66, 95% CI 0.76 to 3.64; 154 participants and adjusted risk ratio (RR) 1.15, 95% CI 0.29 to 2.57; 192 participants). One study reported zero events in both intervention groups (42 participants). The overall risk of bias for all-cause mortality was critical and the certainty of the evidence was very low. One NRS reported bleeding events in 3% of the intervention group and 1.9% of the control group (OR 1.62, 95% CI 0.96 to 2.71; 2773 participants; low-certainty evidence). Therapeutic-dose anticoagulants versus prophylactic-dose anticoagulants (1 retrospective NRS, 244 participants) The study reported a reduction in all-cause mortality (adjusted HR 0.21, 95% CI 0.10 to 0.46) and a lower absolute rate of death in the therapeutic group (34.2% versus 53%). The overall risk of bias for all-cause mortality was serious and the certainty of the evidence was low. The study also reported bleeding events in 31.7% of the intervention group and 20.5% of the control group (OR 1.8, 95% CI 0.96 to 3.37; low-certainty evidence). Ongoing studies We found 22 ongoing studies in hospital settings (20 RCTs, 14,730 participants; 2 NRS, 997 participants) in 10 different countries (Australia (1), Brazil (1), Canada (2), China (3), France (2), Germany (1), Italy (4), Switzerland (1), UK (1) and USA (6)). Twelve ongoing studies plan to report mortality and six plan to report additional respiratory support. Thirteen studies are expected to be completed in December 2020 (6959 participants), eight in July 2021 (8512 participants), and one in December 2021 (256 participants). Four of the studies plan to include 1000 participants or more.

Authors' Conclusions: There is currently insufficient evidence to determine the risks and benefits of prophylactic anticoagulants for people hospitalised with COVID-19. Since there are 22 ongoing studies that plan to evaluate more than 15,000 participants in this setting, we will add more robust evidence to this review in future updates.
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http://dx.doi.org/10.1002/14651858.CD013739DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166900PMC
October 2020

Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems.

Cochrane Database Syst Rev 2018 10 1;10:CD001059. Epub 2018 Oct 1.

Walter Sisulu University, University of Fort Hare, University of the Witwatersrand, Eastern Cape Department of Health, East London, South Africa.

Background: Pre-eclampsia and eclampsia are common causes of serious morbidity and death. Calcium supplementation may reduce the risk of pre-eclampsia, and may help to prevent preterm birth. This is an update of a review last published in 2014.

Objectives: To assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child outcomes.

Search Methods: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (18 September 2017), and reference lists of retrieved studies.

Selection Criteria: We included randomised controlled trials (RCTs), including cluster-randomised trials, comparing high-dose calcium supplementation (at least 1 g daily of calcium) during pregnancy with placebo. For low-dose calcium we included quasi-randomised trials, trials without placebo, trials with cointerventions and dose comparison trials.

Data Collection And Analysis: Two researchers independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two researchers assessed the evidence using the GRADE approach.

Main Results: We included 27 studies (18,064 women). We assessed the included studies as being at low risk of bias, although bias was frequently difficult to assess due to poor reporting and inadequate information on methods.High-dose calcium supplementation (≥ 1 g/day) versus placeboFourteen studies examined this comparison, however one study contributed no data. The 13 studies contributed data from 15,730 women to our meta-analyses. The average risk of high blood pressure (BP) was reduced with calcium supplementation compared with placebo (12 trials, 15,470 women: risk ratio (RR) 0.65, 95% confidence interval (CI) 0.53 to 0.81; I² = 74%). There was also a reduction in the risk of pre-eclampsia associated with calcium supplementation (13 trials, 15,730 women: average RR 0.45, 95% CI 0.31 to 0.65; I² = 70%; low-quality evidence). This effect was clear for women with low calcium diets (eight trials, 10,678 women: average RR 0.36, 95% CI 0.20 to 0.65; I² = 76%) but not those with adequate calcium diets. The effect appeared to be greater for women at higher risk of pre-eclampsia, though this may be due to small-study effects (five trials, 587 women: average RR 0.22, 95% CI 0.12 to 0.42). These data should be interpreted with caution because of the possibility of small-study effects or publication bias. In the largest trial, the reduction in pre-eclampsia was modest (8%) and the CI included the possibility of no effect.The composite outcome maternal death or serious morbidity was reduced with calcium supplementation (four trials, 9732 women; RR 0.80, 95% CI 0.66 to 0.98). Maternal deaths were no different (one trial of 8312 women: one death in the calcium group versus six in the placebo group). There was an anomalous increase in the risk of HELLP syndrome in the calcium group (two trials, 12,901 women: RR 2.67, 95% CI 1.05 to 6.82, high-quality evidence), however, the absolute number of events was low (16 versus six).The average risk of preterm birth was reduced in the calcium supplementation group (11 trials, 15,275 women: RR 0.76, 95% CI 0.60 to 0.97; I² = 60%; low-quality evidence); this reduction was greatest amongst women at higher risk of developing pre-eclampsia (four trials, 568 women: average RR 0.45, 95% CI 0.24 to 0.83; I² = 60%). Again, these data should be interpreted with caution because of the possibility of small-study effects or publication bias. There was no clear effect on admission to neonatal intensive care. There was also no clear effect on the risk of stillbirth or infant death before discharge from hospital (11 trials, 15,665 babies: RR 0.90, 95% CI 0.74 to 1.09).One study showed a reduction in childhood systolic BP greater than 95th percentile among children exposed to calcium supplementation in utero (514 children: RR 0.59, 95% CI 0.39 to 0.91). In a subset of these children, dental caries at 12 years old was also reduced (195 children, RR 0.73, 95% CI 0.62 to 0.87).Low-dose calcium supplementation (< 1 g/day) versus placebo or no treatmentTwelve trials (2334 women) evaluated low-dose (usually 500 mg daily) supplementation with calcium alone (four trials) or in association with vitamin D (five trials), linoleic acid (two trials), or antioxidants (one trial). Most studies recruited women at high risk for pre-eclampsia, and were at high risk of bias, thus the results should be interpreted with caution. Supplementation with low doses of calcium reduced the risk of pre-eclampsia (nine trials, 2234 women: RR 0.38, 95% CI 0.28 to 0.52). There was also a reduction in high BP (five trials, 665 women: RR 0.53, 95% CI 0.38 to 0.74), admission to neonatal intensive care unit (one trial, 422 women, RR 0.44, 95% CI 0.20 to 0.99), but not preterm birth (six trials, 1290 women, average RR 0.83, 95% CI 0.34 to 2.03), or stillbirth or death before discharge (five trials, 1025 babies, RR 0.48, 95% CI 0.14 to 1.67).High-dose (=/> 1 g) versus low-dose (< 1 g) calcium supplementationWe included one trial with 262 women, the results of which should be interpreted with caution due to unclear risk of bias. Risk of pre-eclampsia appeared to be reduced in the high-dose group (RR 0.42, 95% CI 0.18 to 0.96). No other differences were found (preterm birth: RR 0.31, 95% CI 0.09 to 1.08; eclampsia: RR 0.32, 95% CI 0.07 to 1.53; stillbirth: RR 0.48, 95% CI 0.13 to 1.83).

Authors' Conclusions: High-dose calcium supplementation (≥ 1 g/day) may reduce the risk of pre-eclampsia and preterm birth, particularly for women with low calcium diets (low-quality evidence). The treatment effect may be overestimated due to small-study effects or publication bias. It reduces the occurrence of the composite outcome 'maternal death or serious morbidity', but not stillbirth or neonatal high care admission. There was an increased risk of HELLP syndrome with calcium supplementation, which was small in absolute numbers.The limited evidence on low-dose calcium supplementation suggests a reduction in pre-eclampsia, hypertension and admission to neonatal high care, but needs to be confirmed by larger, high-quality trials.
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http://dx.doi.org/10.1002/14651858.CD001059.pub5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517256PMC
October 2018

Physical Activity Interventions in Faith-Based Organizations: A Systematic Review.

Am J Health Promot 2018 03 13;32(3):677-690. Epub 2017 Jan 13.

3 Postgraduate Program of Evidence-Based Health, Universidade Federal de São Paulo, São Paulo, Brazil.

Objective: To review and assess the effectiveness of physical activity interventions delivered in faith-based organizations.

Data Source: We searched the Cochrane Library, DoPHER, EMBASE, LILACS, MEDLINE, PsycINFO, WHO ICTRP, and Clinicaltrials.gov databases until January 2016, without restriction of language or publication date.

Study Inclusion And Exclusion Criteria: Randomized and nonrandomized controlled trials investigating physical activity interventions for adults delivered in faith-based organizations.

Data Extraction: Two independent reviewers extracted data and assessed study methodological quality.

Data Synthesis: We used relative risk and mean difference with 95% confidence interval to estimate the effect of the interventions on measures of physical activity, physical fitness, and health.

Results: The review included 18 studies. Study participants were predominantly female, and the majority of trials were conducted in the United States. Study heterogeneity did not allow us to conduct meta-analyses. Although interventions delivered in faith-based organizations increased physical activity and positively influenced measures of health and fitness in participants, the quality of the evidence was very low.

Conclusion: Faith-based organizations are promising settings to promote physical activity, consequently addressing health disparities. However, high-quality randomized clinical trials are needed to adequately assess the effectiveness of interventions delivered in faith-based organizations.
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http://dx.doi.org/10.1177/0890117116688107DOI Listing
March 2018

Is surgical debridement necessary in the diabetic foot treated with photodynamic therapy?

Diabet Foot Ankle 2017 19;8(1):1373552. Epub 2017 Sep 19.

Departamento de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.

: Diabetic patients are susceptible to developing foot ulcers with serious complications such as osteomyelitis and amputations. Treatment approaches are still empirical and the benefit of usual procedures such as surgical debridement has not been properly evaluated. Photodynamic Therapy (PDT) is a non-invasive and highly efficient method for the treatment of the diabetic foot, being able to eradicate the infection and to stimulate healing, decreasing considerably the amputation risk. In the day-to-day practice of our service, we have been faced with the question whether debridement is necessary before PDT. In here, we designed a study to answer that question. : Patients were divided in two groups: In one of the groups (n = 17), debridement was performed before PDT and in the other (n = 40) only PDT treatment was performed. PDT sessions were performed once a week in all patients until healing was achieved, as indicated by visual inspection as well as by radiographic and laboratory exams. At the start of the study, the two groups had no statistical differences concerning their clinical features: average age, gender, insulin use, diabetes mellitus onset time and previous amputations. : PDT was effective in the treatment of 100% of the patients showing no relapses after one year of follow up. The group submitted to PDT without previous debridement had a statistically significant (p = 0.036, Mann-Whitney) shorter cure time (29 days, ~27%). : Our data indicates that debridement is not necessary in the treatment of diabetic foot in patients that have enough peripheral arterial perfusion. In addition, we reproduced previous studies confirming that PDT is an efficient, safe, simple and affordable treatment method for the diabetic foot.
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http://dx.doi.org/10.1080/2000625X.2017.1373552DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5642141PMC
September 2017

Effectiveness and safety of procalcitonin evaluation for reducing mortality in adults with sepsis, severe sepsis or septic shock.

Cochrane Database Syst Rev 2017 01 18;1:CD010959. Epub 2017 Jan 18.

Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, Rua Borges Lagoa, 564 cj 63, São Paulo, São Paulo, Brazil, 04038-000.

Background: Serum procalcitonin (PCT) evaluation has been proposed for early diagnosis and accurate staging and to guide decisions regarding patients with sepsis, severe sepsis and septic shock, with possible reduction in mortality.

Objectives: To assess the effectiveness and safety of serum PCT evaluation for reducing mortality and duration of antimicrobial therapy in adults with sepsis, severe sepsis or septic shock.

Search Methods: We searched the Central Register of Controlled Trials (CENTRAL; 2015, Issue 7); MEDLINE (1950 to July 2015); Embase (Ovid SP, 1980 to July 2015); Latin American Caribbean Health Sciences Literature (LILACS via BIREME, 1982 to July 2015); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO host, 1982 to July 2015), and trial registers (ISRCTN registry, ClinicalTrials.gov and CenterWatch, to July 2015). We reran the search in October 2016. We added three studies of interest to a list of 'Studies awaiting classification' and will incorporate these into formal review findings during the review update.

Selection Criteria: We included only randomized controlled trials (RCTs) testing PCT-guided decisions in at least one of the comparison arms for adults (≥ 18 years old) with sepsis, severe sepsis or septic shock, according to international definitions and irrespective of the setting.

Data Collection And Analysis: Two review authors extracted study data and assessed the methodological quality of included studies. We conducted meta-analysis with random-effects models for the following primary outcomes: mortality and time spent receiving antimicrobial therapy in hospital and in the intensive care unit (ICU), as well as time spent on mechanical ventilation and change in antimicrobial regimen from a broad to a narrower spectrum.

Main Results: We included 10 trials with 1215 participants. Low-quality evidence showed no significant differences in mortality at longest follow-up (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.65 to 1.01; I = 10%; 10 trials; N = 1156), at 28 days (RR 0.89, 95% CI 0.61 to 1.31; I = 0%; four trials; N = 316), at ICU discharge (RR 1.03, 95% CI 0.50 to 2.11; I = 49%; three trials; N = 506) and at hospital discharge (RR 0.98, 95% CI 0.75 to 1.27; I = 0%; seven trials; N = 805; moderate-quality evidence). However, mean time receiving antimicrobial therapy in the intervention groups was -1.28 days (95% CI to -1.95 to -0.61; I = 86%; four trials; N = 313; very low-quality evidence). No primary study has analysed the change in antimicrobial regimen from a broad to a narrower spectrum.

Authors' Conclusions: Up-to-date evidence of very low to moderate quality, with insufficient sample power per outcome, does not clearly support the use of procalcitonin-guided antimicrobial therapy to minimize mortality, mechanical ventilation, clinical severity, reinfection or duration of antimicrobial therapy of patients with septic conditions.
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http://dx.doi.org/10.1002/14651858.CD010959.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6353122PMC
January 2017

Nipple- and areola-sparing mastectomy for the treatment of breast cancer.

Cochrane Database Syst Rev 2016 11 29;11:CD008932. Epub 2016 Nov 29.

Department of Obstetrics and Gynecology, Instituto do câncer de São Paulo (ICESP/FMUSP), Av. Dr Arnaldo 251, Sao Paulo, Sao Paulo, Brazil, 01246-000.

Background: The efficacy and safety of nipple-sparing mastectomy and areola-sparing mastectomy for the treatment of breast cancer are still questionable. It is estimated that the local recurrence rates following nipple-sparing mastectomy are very similar to breast-conserving surgery followed by radiotherapy.

Objectives: To assess the efficacy and safety of nipple-sparing mastectomy and areola-sparing mastectomy for the treatment of ductal carcinoma in situ and invasive breast cancer in women.

Search Methods: We searched the Cochrane Breast Cancer Group's Specialized Register, the Cochrane Center Register of Controlled Trials (CENTRAL), MEDLINE (via PubMed), Embase (via OVID) and LILACS (via Biblioteca Virtual em Saúde [BVS]) using the search terms "nipple sparing mastectomy" and "areola-sparing mastectomy". Also, we searched the World Health Organization's International Clinical Trials Registry Platform and ClinicalTrials.gov. All searches were conducted on 30th September 2014 and we did not apply any language restrictions.

Selection Criteria: Randomised controlled trials (RCTs) however if there were no RCTs, we expanded our criteria to include non-randomised comparative studies (cohort and case-control studies). Studies evaluated nipple-sparing and areola-sparing mastectomy compared to modified radical mastectomy or skin-sparing mastectomy for the treatment of ductal carcinoma in situ or invasive breast cancer.

Data Collection And Analysis: Two review authors (BS and RR) performed data extraction and resolved disagreements. We performed descriptive analyses and meta-analyses of the data using Review Manager software. We used Cochrane's risk of bias tool to assess studies, and adapted it for non-randomised studies, and we evaluated the quality of the evidence using GRADE criteria.

Main Results: We included 11 cohort studies, evaluating a total of 6502 participants undergoing 7018 procedures: 2529 underwent a nipple-sparing mastectomy (NSM), 818 underwent skin-sparing mastectomy (SSM) and 3671 underwent traditional mastectomy, also known as modified radical mastectomy (MRM). No participants underwent areola-sparing mastectomy. There was a high risk of confounding for all reported outcomes. For overall survival, the hazard ratio (HR) for NSM compared to SSM was 0.70 (95% CI 0.28 to 1.73; 2 studies; 781 participants) and the HR for NSM compared to MRM was 0.72 (95% CI 0.46 to 1.13; 2 studies, 1202 participants). Local recurrence was evaluated in two studies, the HR for NSM compared to MRM was 0.28 (95% CI 0.12 to 0.68; 2 studies, 1303 participants). The overall risk of complications was different in NSM when compared to other types of mastectomy in general (RR 0.10, 95% CI 0.01 to 0.82, 2 studies, P = 0.03; 1067 participants). With respect to skin necrosis, there was no evidence of a difference with NSM compared to other types of mastectomy, but the confidence interval was wide (RR 4.22, 95% CI 0.59 to 30.03, P = 0.15; 4 studies, 1948 participants). We observed no difference among the three types of mastectomy with respect to the risk of local infection (RR 0.95, 95% CI 0.44 to 2.09, P = 0.91, 2 studies; 496 participants). Meta-analysis was not possible when assessing cosmetic outcomes and quality of life, but in general the NSM studies reported a favourable aesthetic result and a gain in quality of life compared with the other types of mastectomy. The quality of evidence was considered very low for all outcomes due to the high risk of selection bias and wide confidence intervals.

Authors' Conclusions: The findings from these observational studies of very low-quality evidence were inconclusive for all outcomes due to the high risk of selection bias.
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http://dx.doi.org/10.1002/14651858.CD008932.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5868722PMC
November 2016

Statins for aortic valve stenosis.

Cochrane Database Syst Rev 2016 Sep 5;9:CD009571. Epub 2016 Sep 5.

Department of Education in Health Sciences, Marilia Medical School, Marilia, Brazil.

Background: Aortic valve stenosis is the most common type of valvular heart disease in the USA and Europe. Aortic valve stenosis is considered similar to atherosclerotic disease. Some studies have evaluated statins for aortic valve stenosis.

Objectives: To evaluate the effectiveness and safety of statins in aortic valve stenosis.

Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS - IBECS, Web of Science and CINAHL Plus. These databases were searched from their inception to 24 November 2015. We also searched trials in registers for ongoing trials. We used no language restrictions.

Selection Criteria: Randomised controlled clinical trials (RCTs) comparing statins alone or in association with other systemic drugs to reduce cholesterol levels versus placebo or usual care.

Data Collection And Analysis: Primary outcomes were severity of aortic valve stenosis (evaluated by echocardiographic criteria: mean pressure gradient, valve area and aortic jet velocity), freedom from valve replacement and death from cardiovascular cause. Secondary outcomes were hospitalisation for any reason, overall mortality, adverse events and patient quality of life.Two review authors independently selected trials for inclusion, extracted data and assessed the risk of bias. The GRADE methodology was employed to assess the quality of result findings and the GRADE profiler (GRADEPRO) was used to import data from Review Manager 5.3 to create a 'Summary of findings' table.

Main Results: We included four RCTs with 2360 participants comparing statins (1185 participants) with placebo (1175 participants). We found low-quality evidence for our primary outcome of severity of aortic valve stenosis, evaluated by mean pressure gradient (mean difference (MD) -0.54, 95% confidence interval (CI) -1.88 to 0.80; participants = 1935; studies = 2), valve area (MD -0.07, 95% CI -0.28 to 0.14; participants = 127; studies = 2), and aortic jet velocity (MD -0.06, 95% CI -0.26 to 0.14; participants = 155; study = 1). Moderate-quality evidence showed no effect on freedom from valve replacement with statins (risk ratio (RR) 0.93, 95% CI 0.81 to 1.06; participants = 2360; studies = 4), and no effect on muscle pain as an adverse event (RR 0.91, 95% CI 0.75 to 1.09; participants = 2204; studies = 3; moderate-quality evidence). Low- and very low-quality evidence showed uncertainty around the effect of statins on death from cardiovascular cause (RR 0.80, 95% CI 0.56 to 1.15; participants = 2297; studies = 3; low-quality evidence) and hospitalisation for any reason (RR 0.84, 95% CI 0.39 to 1.84; participants = 155; study = 1; very low-quality evidence). None of the four included studies reported on overall mortality and patient quality of life.

Authors' Conclusions: Result findings showed uncertainty surrounding the effect of statins for aortic valve stenosis.The quality of evidence from the reported outcomes ranged from moderate to very low. These results give support to European and USA guidelines (2012 and 2014, respectively) that so far there is no clinical treatment option for aortic valve stenosis.
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http://dx.doi.org/10.1002/14651858.CD009571.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6457620PMC
September 2016

Enzyme replacement therapy with galsulfase for mucopolysaccharidosis type VI.

Cochrane Database Syst Rev 2016 Mar 4;3:CD009806. Epub 2016 Mar 4.

Universidade Federal de São Paulo, Dr Wladimir dos Santos Mello 122, São Paulo, São Paulo, Brazil, 04112-030.

Background: Mucopolysaccharidosis type VI or Maroteaux-Lamy syndrome is a rare genetic disorder caused by the deficiency of arylsulphatase B. The resultant accumulation of dermatan sulphate causes lysosomal damage.The clinical symptoms are related to skeletal dysplasia (i.e. short stature and degenerative joint disease). Other manifestations include cardiac disease, impaired pulmonary function, ophthalmological complications, hepatosplenomegaly, sinusitis, otitis, hearing loss and sleep apnea. Intellectual impairment is generally absent. Clinical manifestation is typically by two or three years of age; however, slowly progressive cases may not present until adulthood.Enzyme replacement therapy with galsulfase is considered a new approach for treating mucopolysaccharidosis type VI.

Objectives: To evaluate the effectiveness and safety of treating mucopolysaccharidosis VI by enzyme replacement therapy with galsulfase compared to other interventions, placebo or no intervention.

Search Methods: Eletronic searches were performed on the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register, in CENTRAL, MEDLINE, LILACS, the Journal of Inherited Metabolic Disease and ClinicalTrials.gov. Date of the last search of the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register: 05 February 2016.

Selection Criteria: Randomized and quasi-randomized controlled clinical studies of enzyme replacement therapy with galsulfase compared to other interventions or placebo.

Data Collection And Analysis: Two authors independently screened the studies, assessed the risk of bias and extracted data.

Main Results: One study was included involving 39 participants who received either enzyme replacement therapy with galsulfase (recombinant human arylsulphatase B) or placebo. This small study was considered to be of overall unclear quality, since the authors did not report how both the allocation generation and concealment were performed.The key finding at 24 weeks in the 12-minute walk test was a statistically significant mean difference of 92.00 meters between the two groups in favour of the galsulfase group (95% confidence interval 11.00 to 172.00). While week 24 results for the three-minute stair climb demonstrated some improvement in the treatment group as compared to the placebo group, this was not significant, mean difference 5.70 (95% confidence interval -0.10 to 11.50).A significant decrease in the urinary glycosaminoglycan levels was observed in favour of the galsulfase group at 24 weeks, mean difference -227.00 (95% confidence interval -264.00 to -190.00).In general, the dose of galsulfase was well tolerated and there were no significant differences in relation to adverse events. These events include drug-related adverse events, serious and severe adverse events, those during infusion, drug-related adverse events during infusion, and deaths. More infusion-related reactions were observed in the galsulfase group and were managed with interruption or slowing of infusion rate or administration of antihistamines or corticosteroids drugs. No deaths occurred during the study.

Authors' Conclusions: The results of one small study (based on 24-week randomised phase of the study and prior to the open-label extension) demonstrated that galsulfase is more effective than placebo in people with MPS VI, with significant improvements in the 12-minute walk test and a reduction in urinary glycosaminoglycans.There were no significant changes in cardiac or pulmonary functions, liver or spleen volume, overnight apnea-hypopnea, height and weight, quality of life and adverse effects.Further studies are needed to obtain more information on the long-term effectiveness and safety of enzyme replacement therapy with galsulfase.
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March 2016

Noninvasive positive pressure ventilation for acute respiratory failure following upper abdominal surgery.

Cochrane Database Syst Rev 2015 Oct 5(10):CD009134. Epub 2015 Oct 5.

Department of Emergency Medicine, Universidade Federal de São Paulo, Rua Pedro de Toledo, 598, Vila Clementino, São Paulo, São Paulo, Brazil, 04039-001.

Background: Each year, more than four million abdominal surgeries are performed in the US and over 250,000 in England. Acute respiratory failure, a common complication that can affect 30% to 50% of people after upper abdominal surgery, can lead to significant morbidity and mortality. Noninvasive ventilation has been associated with lower rates of tracheal intubation in adults with acute respiratory failure, thus reducing the incidence of complications and mortality. This review compared the effectiveness and safety of noninvasive positive pressure ventilation (NPPV) versus standard oxygen therapy in the treatment of acute respiratory failure after upper abdominal surgery.

Objectives: To assess the effectiveness and safety of noninvasive positive pressure ventilation (NPPV), that is, continuous positive airway pressure (CPAP) or bilevel NPPV, in reducing mortality and the rate of tracheal intubation in adults with acute respiratory failure after upper abdominal surgery, compared to standard therapy (oxygen therapy), and to assess changes in arterial blood gas levels, hospital and intensive care unit (ICU) length of stay, gastric insufflation, and anastomotic leakage.

Search Methods: The date of the last search was 12 May 2015. We searched the following databases: the Cochrane Handbook for Systematic Reviews of Interventions (CENTRAL) (2015, Issue 5), MEDLINE (Ovid SP, 1966 to May 2015), EMBASE (Ovid SP, 1974 to May 2015); the physiotherapy evidence database (PEDro) (1999 to May 2015); the Cumulative Index to Nursing and Allied Health Literature (CINAHL, EBSCOhost, 1982 to May 2015), and LILACS (BIREME, 1986 to May 2015). We reviewed reference lists of included studies and contacted experts. We also searched grey literature sources. We checked databases of ongoing trials such as www.controlled-trials.com/ and www.trialscentral.org/. We did not apply language restrictions.

Selection Criteria: We selected randomized or quasi-randomized controlled trials involving adults with acute respiratory failure after upper abdominal surgery who were treated with CPAP or bilevel NPPV with, or without, drug therapy as standard medical care, compared to adults treated with oxygen therapy with, or without, standard medical care.

Data Collection And Analysis: Two authors independently selected and abstracted data from eligible studies using a standardized form. We evaluated study quality by assessing allocation concealment; random sequence generation; incomplete outcome data; blinding of participants, personnel, and outcome assessors; selective reporting; and adherence to the intention-to-treat (ITT) principle.

Main Results: We included two trials involving 269 participants. The participants were mostly men (67%); the mean age was 65 years. The trials were conducted in China and Italy (one was a multicentre trial). Both trials included adults with acute respiratory failure after upper abdominal surgery. We judged both trials at high risk of bias. Compared to oxygen therapy, CPAP or bilevel NPPV may reduce the rate of tracheal intubation (risk ratio (RR) 0.25; 95% confidence interval (CI) 0.08 to 0.83; low quality evidence) with a number needed to treat for an additional beneficial outcome of 11. There was very low quality evidence that the intervention may also reduce ICU length of stay (mean difference (MD) -1.84 days; 95% CI -3.53 to -0.15). We found no differences for mortality (low quality evidence) and hospital length of stay. There was insufficient evidence to be certain that CPAP or NPPV had an effect on anastomotic leakage, pneumonia-related complications, and sepsis or infections. Findings from one trial of 60 participants suggested that bilevel NPPV, compared to oxygen therapy, may improve blood gas levels and blood pH one hour after the intervention (partial pressure of arterial oxygen (PaO2): MD 22.5 mm Hg; 95% CI 17.19 to 27.81; pH: MD 0.06; 95% CI 0.01 to 0.11; partial pressure of arterial carbon dioxide (PCO2) levels (MD -9.8 mm Hg; 95% CI -14.07 to -5.53). The trials included in this systematic review did not present data on the following outcomes that we intended to assess: gastric insufflation, fistulae, pneumothorax, bleeding, skin breakdown, eye irritation, sinus congestion, oronasal drying, and patient-ventilator asynchrony.

Authors' Conclusions: The findings of this review indicate that CPAP or bilevel NPPV is an effective and safe intervention for the treatment of adults with acute respiratory failure after upper abdominal surgery. However, based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, the quality of the evidence was low or very low. More good quality studies are needed to confirm these findings.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8080101PMC
October 2015

FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study.

PeerJ 2015 25;3:e1015. Epub 2015 Jun 25.

Federal University of São Paulo (Unifesp) , São Paulo , Brazil.

The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.
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http://dx.doi.org/10.7717/peerj.1015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4485238PMC
July 2015

Early versus late tracheostomy for critically ill patients.

Cochrane Database Syst Rev 2015 Jan 12;1:CD007271. Epub 2015 Jan 12.

Brazilian Cochrane Centre, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, Rua Borges Lagoa, 564 cj 63, São Paulo, São Paulo, Brazil, 04038-000.

Background: Long-term mechanical ventilation is the most common situation for which tracheostomy is indicated for patients in intensive care units (ICUs). 'Early' and 'late' tracheostomies are two categories of the timing of tracheostomy. Evidence on the advantages attributed to early versus late tracheostomy is somewhat conflicting but includes shorter hospital stays and lower mortality rates.

Objectives: To evaluate the effectiveness and safety of early (≤ 10 days after tracheal intubation) versus late tracheostomy (> 10 days after tracheal intubation) in critically ill adults predicted to be on prolonged mechanical ventilation with different clinical conditions.

Search Methods: This is an update of a review last published in 2012 (Issue 3, The Cochrane Library) with previous searches run in December 2010. In this version, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 8); MEDLINE (via PubMed) (1966 to August 2013); EMBASE (via Ovid) (1974 to August 2013); LILACS (1986 to August 2013); PEDro (Physiotherapy Evidence Database) at www.pedro.fhs.usyd.edu.au (1999 to August 2013) and CINAHL (1982 to August 2013). We reran the search in October 2014 and will deal with any studies of interest when we update the review.

Selection Criteria: We included all randomized and quasi-randomized controlled trials (RCTs or QRCTs) comparing early tracheostomy (two to 10 days after intubation) against late tracheostomy (> 10 days after intubation) for critically ill adult patients expected to be on prolonged mechanical ventilation.

Data Collection And Analysis: Two review authors extracted data and conducted a quality assessment. Meta-analyses with random-effects models were conducted for mortality, time spent on mechanical ventilation and time spent in the ICU.

Main Results: We included eight RCTs (N = 1977 participants). At the longest follow-up time available in these studies, evidence of moderate quality from seven RCTs (n = 1903) showed lower mortality rates in the early as compared with the late tracheostomy group (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.70 to 0.98; P value 0.03; number needed to treat for an additional beneficial outcome (NNTB) ≅ 11). Divergent results were reported on the time spent on mechanical ventilation and no differences were noted for pneumonia, but the probability of discharge from the ICU was higher at day 28 in the early tracheostomy group (RR 1.29, 95% CI 1.08 to 1.55; P value 0.006; NNTB ≅ 8).

Authors' Conclusions: The whole findings of this systematic review are no more than suggestive of the superiority of early over late tracheostomy because no information of high quality is available for specific subgroups with particular characteristics.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517297PMC
January 2015

Metoclopramide for post-pyloric placement of naso-enteral feeding tubes.

Cochrane Database Syst Rev 2015 Jan 7;1:CD003353. Epub 2015 Jan 7.

Joaquim Calado 120, Federação, Salvador, Bahia, 40230093, Brazil.

Background: Enteral nutrition by feeding tube is a common and efficient method of providing nutritional support to prevent malnutrition in hospitalised patients who have adequate gastrointestinal function but who are unable to eat. Gastric feeding may be associated with higher rates of food aspiration and pneumonia than post-pyloric naso-enteral tubes. Thus, enteral feeding tubes are placed directly into the small intestine rather than the stomach, and the use of metoclopramide, a prokinetic agent, has been recommended to achieve post-pyloric placement, but its efficacy is controversial. Moreover, metoclopramide may include adverse reactions, which with high doses or prolonged use may be serious and irreversible.

Objectives: To determine the effect of intravenous metoclopramide on post-pyloric placement of the naso-enteral tube in adults.

Search Methods: Trials were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10) which includes the CUGPD group's specialised register of trials, MEDLINE (1996 to 21 October 2014), EMBASE (1988 to 21 October 2014), LILACS (2005 to 21 October 2014)   We did not confine our search to English language publications. Searches in all databases were updated originally in January 2005, then in November 2008 and again in October 2014. No new studies were found in 2008 or in 2014.

Selection Criteria: We selected randomised controlled trials of adults needing enteral nutrition, who received intravenous or intramuscular metoclopramide to aid placement of transpyloric naso-enteral feeding tubes, compared to placebo or no intervention.

Data Collection And Analysis: We used standard methodological procedures expected by The Cochrane Collaboration. All analyses were performed according to the intention-to-treat method. We present risk ratios (RR) with 95% confidence intervals (CI).

Main Results: Four studies, with a total of 204 participants were included and analysed. The trials compared metoclopramide with placebo (two trials) or with no intervention (two trials). Metoclopramide was investigated at doses of 10 mg (two trials) and 20 mg (two trials). There was no statistically significant difference between metoclopramide versus placebo or no intervention administered to promote tube placement (RR 0.82, 95% CI 0.61 to 1.10). Metoclopramide at doses of 10 mg (RR 0.82, 95% CI 0.60 to 1.11) and 20 mg (RR 0.62, 95% CI 0.15 to 2.62) were equally ineffective in facilitating post-pyloric intubation when compared with placebo or no intervention.

Authors' Conclusions: In this review, we found only four studies that fitted our inclusion criteria. These were small, underpowered studies, in which metoclopramide was given at doses of 10 mg and 20 mg. Our analysis showed that metoclopramide did not assist post-pyloric placement of naso-enteral feeding tubes.Ideally randomised clinical trials should be performed that have a significant sample size, administering metoclopramide against control, however, given the lack of efficacy revealed by this review it is unlikely that further studies will be performed.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7170214PMC
January 2015

Beta-blockers for preventing stroke recurrence.

Cochrane Database Syst Rev 2014 Oct 15(10):CD007890. Epub 2014 Oct 15.

Brazilian Cochrane Centre, Universidade Federal de São Paulo, Rua Pedro de Toledo 598, São Paulo, São Paulo, Brazil, 04039-001.

Background: Stroke affects 15 million people per year worldwide. Despite recent developments in acute stroke treatment, prevention remains very important. Stroke has a high rate of recurrence; therefore secondary prevention is also important. Many clinical approaches to control risk factors have been proposed. One of these approaches is the prescription of beta-blockers that have effects beyond the reduction of blood pressure, which can reduce the recurrence of stroke.

Objectives: To evaluate the efficacy of beta-blockers for preventing stroke recurrence and for reducing death and major vascular events in people with a previous stroke or transient ischaemic attack (TIA), and to determine their safety, particularly with regard to the development of diabetes mellitus.

Search Methods: We searched the Cochrane Stroke Group Trials Register (May 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Database of Systematic Reviews (CDSR) (The Cochrane Library 2014, Issue 5), the Database of Abstracts of Reviews of Effects (DARE) (May 2014), MEDLINE (1966 to May 2014), EMBASE (1980 to May 2014), and Latin American and Caribbean Health Sciences Literature (LILACS) (1982 to May 2014). We also searched ongoing trials registers and reference lists.

Selection Criteria: Randomised controlled trials (RCTs) that included participants with previous stroke or TIA due to arterial thrombosis or embolism. The intervention was any beta-blocker versus control, or beta-blocker plus other treatment versus other treatment.

Data Collection And Analysis: Two review authors independently screened the trials identified, appraised quality, and extracted data.

Main Results: We included two RCTs involving 2193 participants in the review. Both studies randomised participants to either beta-blocker (atenolol 5 mg) or placebo and were of a high methodological quality. We noted no statistical differences among the groups in risks of fatal and non-fatal stroke (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.76 to 1.18). For other outcomes analysed (major vascular events, death from all causes, death from cardiovascular causes) , we observed no significant differences between the groups. There were minor blood pressure reductions in the intervention group. Neither of the included studies reported the occurrence of diabetes among their outcomes or assessed quality of life. Adverse events were significantly more frequent in participants taking atenolol than in those given placebo, and were the most common reason given for discontinuing treatment (RR 1.85, 95% CI 1.45 to 2.35).

Authors' Conclusions: To date, no available evidence supports the routine use of beta-blockers for secondary prevention after stroke or TIA. More studies with larger samples are needed.
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October 2014

Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery.

Cochrane Database Syst Rev 2014 Sep 27(9):CD008306. Epub 2014 Sep 27.

Department of Urology, Universidade Federal de São Paulo, Rua Doutor Nicolau de Sousa Queiros, 629. Ap.130B, São Paulo, São Paulo, Brazil, 04105002.

Background: Incontinence after prostatectomy for benign or malignant disease is a well-known and often a feared outcome. Although small degrees of incidental incontinence may go virtually unnoticed, larger degrees of incontinence can have a major impact on a man's quality of life.Conceptually, post-prostatectomy incontinence may be caused by sphincter malfunction or bladder dysfunction, or both. Most men with post-prostatectomy incontinence (60% to 100%) have stress urinary incontinence, which is involuntary urinary leakage on effort or exertion, or on sneezing or coughing. This may be due to intrinsic sphincter deficiency and may be treated with surgery for optimal management of incontinence. Detrusor dysfunction is more common after surgery for benign prostatic disease.

Objectives: To determine the effects of surgical treatment for urinary incontinence related to presumed sphincter deficiency after prostate surgery for:- men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) - transurethral resection of prostate (TURP), photo vaporisation of the prostate, laser enucleation of the prostate or open prostatectomy - and- men with prostate cancer - radical prostatectomy (retropubic, perineal, laparoscopic, or robotic).

Search Methods: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, and handsearching of journals and conference proceedings (searched 31 March 2014); MEDLINE (January 1966 to April 2014); EMBASE (January 1988 to April 2014); and LILACS (January 1982 to April 2014). We handsearched the reference lists of relevant articles and conference proceedings. We contacted investigators to locate studies.

Selection Criteria: Randomised or quasi-randomised trials that include surgical treatments of urinary incontinence after prostate surgery.

Data Collection And Analysis: Two authors independently screened the trials identified, appraised quality of papers, and extracted data.

Main Results: Only one study with 45 participants met the inclusion criteria. Men were divided in two sub-groups (minimal or total incontinence) and each group was randomised to artificial urethral sphincter (AUS) implantation or Macroplastique injection. Follow-up ranged from six to 120 months. In the trial as a whole, the men treated with AUS were more likely to be dry (18/20, 82%) than those who had the injectable treatment (11/23, 46%) (odds ratio (OR) 5.67, 95% confidence interval (CI) 1.28 to 25.10). However, this effect was only statistically significant for the men with more severe ('total') incontinence (OR 8.89, 95% CI 1.40 to 56.57) and the CIs were wide. There were more severe complications in the group undergoing AUS, and the costs were higher. AUS implantation was complicated in 5/22 (23%) men: the implant had to be removed from one man because of infection and in one man due to the erosion of the cuff, in one man the pump was changed due to mechanical failure, in one man there was migration to the intraperitoneal region, and one man experienced scrotal erosion. In the injectable group, 3/23 (13%) men had a complication: one man treated with Macroplastique injection had to be catheterised because of urinary retention and two men developed urinary tract infections.

Authors' Conclusions: The evidence available at present was of very low quality because we identified only one small randomised clinical trial. Although the result was favourable for the implantation of AUS in the group with severe incontinence, this result should be considered with caution due to the small sample size and uncertain methodological quality of the study found.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7105906PMC
September 2014

Botulinum toxin for myofascial pain syndromes in adults.

Cochrane Database Syst Rev 2014 Jul 25(7):CD007533. Epub 2014 Jul 25.

Department of Medicine, Universidade Federal de São Paulo, Rua Grão Pará, 570 apt.1101 Bairro Santa Efigênia, Belo Horizonte, Minais Gerais, Brazil, 30150-341.

Background: This is an updated version of the original Cochrane review published in Issue 4, 2012. Myofascial pain syndrome (MPS) is a regional muscular pain syndrome characterised by the presence of trigger points, which are painful points in one or more muscles. The pain can be felt at the site where the trigger point is located or it can be felt away from that place when the muscle is pressed (referred pain). Botulinum toxin is a protein produced by the bacterium Clostridium botulinum and is a potent neurotoxin that eventually inhibits muscle contractions. It is capable of selectively weakening painful muscles and interrupting the pain cycle.

Objectives: To assess the effectiveness and safety of botulinum toxin A (BTXA) in the treatment of myofascial pain syndrome (MPS), excluding MPS in neck and head muscles.

Search Methods: This is an updated version of the original Cochrane review published in Issue 4, 2012. The search strategy for the update was the same as in the original review and we searched CENTRAL in The Cochrane Library (2013, Issue 11 of 12), MEDLINE (Ovid) (2012 to 29 November 2013) and EMBASE (Ovid) (2012 to 27 November 2013). The search strategy was composed of terms for myofascial pain and botulinum toxin. For the original review, we also searched the Cochrane Pain, Palliative and Supportive Care (PaPaS) Review Group Specialised Register until December 2011, PubMed (from 1966 to 2011) and LILACS (from 1982 to 2011). There was no language restriction.

Selection Criteria: We included randomised controlled trials (RCTs) involving botulinum toxin for treating participants with MPS. We excluded studies with MPS of the neck and head from this review as they have already been assessed in existing systematic reviews. We considered a diagnosis of MPS to be based on the identification of trigger points in the taut band through palpation of sensitive nodules, local twitch response and specific patterns of referred pain associated with each trigger point.

Data Collection And Analysis: Two review authors independently screened identified studies, extracted data, assessed trial quality and analysed results using the Cochrane PaPaS Review Group criteria.

Main Results: Four studies with a total of 233 participants, comparing BTXA with placebo, met the inclusion criteria. In one study with 145 participants, significant improvement rates of pain intensity scores and duration of daily pain were demonstrated when comparing BTXA with placebo. The three other studies showed that there was no statistically significant difference between BTXA and placebo in pain intensity.

Authors' Conclusions: Since the first publication of this review, no new studies were found. There is inconclusive evidence to support the use of botulinum toxin in the treatment of MPS based on data from four studies with a total of 233 participants, which we considered were of sufficient quality to be included in this review. Meta-analyses were not possible due to the heterogeneity between studies. We suggest that in future studies the same methodology to assess pain, a standardised dose of treatment, follow-up of at least four months (to observe the maximum and minimum curve of the drug effect) and appropriate data presentation should be used. More high-quality RCTs of botulinum toxin for treating MPS need to be conducted before firm conclusions on its effectiveness and safety can be drawn.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202127PMC
July 2014

WITHDRAWN: Dipyrone for acute primary headaches.

Cochrane Database Syst Rev 2014 Jul 11(7):CD004842. Epub 2014 Jul 11.

Brazilian Cochrane Centre, Rua Pedro de Toledo, 598, São Paulo, SP, Brazil, 04039-001.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464613PMC
July 2014

Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems.

Cochrane Database Syst Rev 2014 Jun 24(6):CD001059. Epub 2014 Jun 24.

Department of Obstetrics and Gynaecology, East London Hospital Complex, University of the Witwatersrand, University of Fort Hare, Eastern Cape Department of Health, Frere and Cecilia Makiwane Hospitals, Private Bag X 9047, East London, Eastern Cape, South Africa, 5200.

Background: Pre-eclampsia and eclampsia are common causes of serious morbidity and death. Calcium supplementation may reduce the risk of pre-eclampsia, and may help to prevent preterm birth.

Objectives: To assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child outcomes.

Search Methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 March 2013) and contacted study authors for more data where possible. We updated the search in May 2014 and added the results to the 'Awaiting Classification' section of the review.

Selection Criteria: Randomised controlled trials (RCTs) comparing high-dose (at least 1 g daily of calcium) or low-dose calcium supplementation during pregnancy with placebo or no calcium.

Data Collection And Analysis: We assessed eligibility and trial quality, extracted and double-entered data.

Main Results: High-dose calcium supplementation (≥1 g/day)We included 14 studies in the review, however one study contributed no data. We included 13 high-quality studies in our meta-analyses (15,730 women). The average risk of high blood pressure (BP) was reduced with calcium supplementation compared with placebo (12 trials, 15,470 women: risk ratio (RR) 0.65, 95% confidence interval (CI) 0.53 to 0.81; I² = 74%). There was also a significant reduction in the risk of pre-eclampsia associated with calcium supplementation (13 trials, 15,730 women: RR 0.45, 95% CI 0.31 to 0.65; I² = 70%). The effect was greatest for women with low calcium diets (eight trials, 10,678 women: average RR 0.36, 95% CI 0.20 to 0.65; I² = 76%) and women at high risk of pre-eclampsia (five trials, 587 women: average RR 0.22, 95% CI 0.12 to 0.42; I² = 0%). These data should be interpreted with caution because of the possibility of small-study effect or publication bias.The composite outcome maternal death or serious morbidity was reduced (four trials, 9732 women; RR 0.80, 95% CI 0.65 to 0.97; I² = 0%). Maternal deaths were not significantly different (one trial of 8312 women: calcium group one death versus placebo group six deaths). There was an anomalous increase in the risk of HELLP (haemolysis, elevated liver enzymes and low platelets) syndrome (two trials, 12,901 women: RR 2.67, 95% CI 1.05 to 6.82; I² = 0%) in the calcium group, however, the absolute number of events was low (16 versus six).The average risk of preterm birth was reduced in the calcium group (11 trials, 15,275 women: RR 0.76, 95% CI 0.60 to 0.97; I² = 60%) and amongst women at high risk of developing pre-eclampsia (four trials, 568 women: average RR 0.45, 95% CI 0.24 to 0.83; I² = 60%), but no significant reduction in neonatal high care admission. There was no overall effect on the risk of stillbirth or infant death before discharge from hospital (11 trials 15,665 babies: RR 0.90, 95% CI 0.74 to 1.09; I² = 0%).One study showed a reduction in childhood systolic BP greater than 95th percentile among children exposed to calcium supplementation in utero (514 children: RR 0.59, 95% CI 0.39 to 0.91). In a subset of these children, dental caries at 12 years old was also reduced (195 children, RR 0.73, 95% CI 0.62 to 0.87). Low-dose calcium supplementation (< 1 g/day)We included 10 trials (2234 women) that evaluated low-dose supplementation with calcium alone (4) or in association with vitamin D (3), linoleic acid (2), or antioxidants (1). Most studies recruited women at high risk for pre-eclampsia, and were at high risk of bias, thus the results should be interpreted with caution. Supplementation with low doses of calcium significantly reduced the risk of pre-eclampsia (RR 0.38, 95% CI 0.28 to 0.52; I² = 0%). There was also a reduction in hypertension, low birthweight and neonatal intensive care unit admission.

Authors' Conclusions: Calcium supplementation (≥ 1 g/day) is associated with a significant reduction in the risk of pre-eclampsia, particularly for women with low calcium diets. The treatment effect may be overestimated due to small-study effects or publication bias. It also reduces preterm birth and the occurrence of the composite outcome 'maternal death or serious morbidity'. We considered these benefits to outweigh the increased risk of HELLP syndrome, which was small in absolute numbers. The World Health Organization recommends calcium 1.5 g to 2 g daily for pregnant women with low dietary calcium intake.The limited evidence on low-dose calcium supplementation suggests a reduction in pre-eclampsia, but needs to be confirmed by larger, high-quality trials. Pending such results, in settings of low dietary calcium where high-dose supplementation is not feasible, the option of lower-dose supplements (500 to 600 mg/day) might be considered in preference to no supplementation.
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June 2014

Pressure support versus T-tube for weaning from mechanical ventilation in adults.

Cochrane Database Syst Rev 2014 May 27(5):CD006056. Epub 2014 May 27.

Department of Internal and Therapeutic Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo, Rua Istambul, 20/casa 07. Trevo. 31370-470 Belo Horizonte - MG, Rua Pedro de Toledo, 598. Vila Clementino., São Paulo, São Paulo, Brazil, 04039-001.

Background: Mechanical ventilation is important in caring for patients with critical illness. Clinical complications, increased mortality, and high costs of health care are associated with prolonged ventilatory support or premature discontinuation of mechanical ventilation. Weaning refers to the process of gradually or abruptly withdrawing mechanical ventilation. The weaning process begins after partial or complete resolution of the underlying pathophysiology precipitating respiratory failure and ends with weaning success (successful extubation in intubated patients or permanent withdrawal of ventilatory support in tracheostomized patients).

Objectives: To evaluate the effectiveness and safety of two strategies, a T-tube and pressure support ventilation, for weaning adult patients with respiratory failure that required invasive mechanical ventilation for at least 24 hours, measuring weaning success and other clinically important outcomes.

Search Methods: We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 6); MEDLINE (via PubMed) (1966 to June 2012); EMBASE (January 1980 to June 2012); LILACS (1986 to June 2012); CINAHL (1982 to June 2012); SciELO (from 1997 to August 2012); thesis repository of CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior) (http://capesdw.capes.gov.br/capesdw/) (August 2012); and Current Controlled Trials (August 2012).We reran the search in December 2013. We will deal with any studies of interest when we update the review.

Selection Criteria: We included randomized controlled trials (RCTs) that compared a T-tube with pressure support (PS) for the conduct of spontaneous breathing trials and as methods of gradual weaning of adult patients with respiratory failure of various aetiologies who received invasive mechanical ventilation for at least 24 hours.

Data Collection And Analysis: Two authors extracted data and assessed the methodological quality of the included studies. Meta-analyses using the random-effects model were conducted for nine outcomes. Relative risk (RR) and mean difference (MD) or standardized mean difference (SMD) were used to estimate the treatment effect, with 95% confidence intervals (CI).

Main Results: We included nine RCTs with 1208 patients; 622 patients were randomized to a PS spontaneous breathing trial (SBT) and 586 to a T-tube SBT. The studies were classified into three categories of weaning: simple, difficult, and prolonged. Four studies placed patients in two categories of weaning. Pressure support ventilation (PSV) and a T-tube were used directly as SBTs in four studies (844 patients, 69.9% of the sample). In 186 patients (15.4%) both interventions were used along with gradual weaning from mechanical ventilation; the PS was gradually decreased, twice a day, until it was minimal and periods with a T-tube were gradually increased to two and eight hours for patients with difficult and prolonged weaning. In two studies (14.7% of patients) the PS was lowered to 2 to 4 cm H2O and 3 to 5 cm H2O based on ventilatory parameters until the minimal PS levels were reached. PS was then compared to the trial with the T-tube (TT).We identified 33 different reported outcomes in the included studies; we took 14 of them into consideration and performed meta-analyses on nine. With regard to the sequence of allocation generation, allocation concealment, selective reporting and attrition bias, no study presented a high risk of bias. We found no clear evidence of a difference between PS and TT for weaning success (RR 1.07, 95% CI 0.97 to 1.17, 9 studies, low quality of evidence), intensive care unit (ICU) mortality (RR 0.81, 95% CI 0.53 to 1.23, 5 studies, low quality of evidence), reintubation (RR 0.92, 95% CI 0.66 to 1.26, 7 studies, low quality evidence), ICU and long-term weaning unit (LWU) length of stay (MD -7.08 days, 95% CI -16.26 to 2.1, 2 studies, low quality of evidence) and pneumonia (RR 0.67, 95% CI 0.08 to 5.85, 2 studies, low quality of evidence). PS was significantly superior to the TT for successful SBTs (RR 1.09, 95% CI 1.02 to 1.17, 4 studies, moderate quality of evidence). Four studies reported on weaning duration, however we were unable to combined the study data because of differences in how the studies presented their data. One study was at high risk of other bias and four studies were at high risk for detection bias. Three studies reported that the weaning duration was shorter with PS, and in one study the duration was shorter in patients with a TT.

Authors' Conclusions: To date, we have found evidence of generally low quality from studies comparing pressure support ventilation (PSV) and with a T-tube. The effects on weaning success, ICU mortality, reintubation, ICU and LWU length of stay, and pneumonia were imprecise. However, PSV was more effective than a T-tube for successful spontaneous breathing trials (SBTs) among patients with simple weaning. Based on the findings of single trials, three studies presented a shorter weaning duration in the group undergoing PS SBT, however a fourth study found a shorter weaning duration with a T-tube.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6492521PMC
May 2014

Intravenous versus inhalational anaesthesia for paediatric outpatient surgery.

Cochrane Database Syst Rev 2014 Feb 7(2):CD009015. Epub 2014 Feb 7.

Department of Surgery/ Discipline of Anesthesiology, Universidade Federal de São Paulo, Rua Napoleão de Barros 715 - 5th floor, São Paulo, São Paulo, Brazil, 04024002.

Background: Ambulatory or outpatient anaesthesia is performed in patients who are discharged on the same day as their surgery. Perioperative complications such as postoperative nausea and vomiting (PONV), postoperative behavioural disturbances and cardiorespiratory complications should be minimized in ambulatory anaesthesia. The choice of anaesthetic agents and techniques can influence the occurrence of these complications and thus delay in discharge.

Objectives: The objective of this review was to evaluate the risk of complications (the risk of postoperative nausea and vomiting (PONV), admission or readmission to hospital, postoperative behavioural disturbances and perioperative respiratory and cardiovascular complications) and recovery times (time to discharge from recovery ward and time to discharge from hospital) comparing the use of intravenous to inhalational anaesthesia for paediatric outpatient surgery.

Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2013, Issue 8); MEDLINE (1948 to 1 October 2013); EMBASE (1974 to 1 October 2013); Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) (1982 to 1 October 2013). We also handsearched relevant journals and searched the reference lists of the articles identified.

Selection Criteria: We included randomized controlled trials comparing paediatric outpatient surgery using intravenous versus inhalational anaesthesia.

Data Collection And Analysis: Two review authors independently assessed trial quality and extracted the data. When necessary, we requested additional information and clarification of published data from the authors of individual trials.

Main Results: We included 16 trials that involved 900 children in this review. Half of all the studies did not describe the generation of randomized sequence and most studies did not describe adequate allocation sequence concealment. The included studies showed variability in the types and combinations of drugs and the duration of anaesthesia, limiting the meta-analysis and interpretation of the results.For the induction and maintenance of anaesthesia there was a significant difference favouring intravenous anaesthesia with propofol; the incidence of PONV was 32.6% for sevoflurane and 16.1% for propofol (odds ratio (OR) 2.96; 95% confidence interval (CI) 1.35 to 6.49, four studies, 176 children, low quality evidence). The risk of postoperative behavioural disturbances also favoured intravenous anaesthesiaas the incidence was 24.7% for sevoflurane and 11.5% for propofol (OR 2.67; 95% CI 1.14 to 6.23, four studies, 176 children, very low quality evidence). There were no differences between groups in the risk of intraoperative and postoperative respiratory and cardiovascular complications (OR 0.75; 95% CI 0.27 to 2.13, three studies,130 children, very low quality evidence) and there was no difference in the time to recovery from anaesthesia and discharge from hospital. These results should be interpreted with caution due to heterogeneity between studies in the type and duration of operations, types of reported complications and the high risk of bias in almost all studies. Two studies (105 participants) compared halothane to propofol and showed heterogeneity in duration of anaesthesia and in the type of ambulatory procedure. For the risk of PONV the results of the studies were conflicting, and for the risks of intraoperative and postoperative complications there were no significant differences between the groups.For the maintenance of anaesthesia there was a significant difference favouring anaesthesia with propofol, with or without nitrous oxide (N2O), when compared to thiopentone and halothane + N2O (OR 3.23; 95% CI 1.49 to 7.02, four studies, 176 children, low quality evidence; and OR 7.44; 95% CI 2.60 to 21.26, two studies, 87 children, low quality evidence), respectively. For the time to discharge from the recovery room, there were no significant differences between groups. The studies were performed with different ambulatory surgeries and a high risk of bias.Four studies (250 participants) compared the induction of anaesthesia by the inhalational or intravenous route, with inhalational anaesthesia for maintenance, and found no significant differences between groups in all outcomes (the risk of PONV, behavioural disturbances, respiratory and cardiovascular complications and time to discharge from recovery room). Meta-analysis was not done in this comparison because of significant clinical heterogeneity.Readmission to hospital was not reported in any of the included studies. No other adverse effects were reported.

Authors' Conclusions: There is insufficient evidence to determine whether intravenous anaesthesia with propofol for induction and maintenance of anaesthesia in paediatric outpatients undergoing surgery reduces the risk of postoperative nausea and vomiting and the risk of behavioural disturbances compared with inhaled anaesthesia. This evidence is of poor quality. More high-quality studies are needed to compare the different types of anaesthesia in different subsets of children undergoing ambulatory surgery.
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February 2014

Conservative interventions for treating exercise-related musculotendinous, ligamentous and osseous groin pain.

Cochrane Database Syst Rev 2013 Jun 6(6):CD009565. Epub 2013 Jun 6.

Brazilian Cochrane Centre, Centro de Estudos de Medicina Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo,Brazil.

Background: Musculoskeletal, ligamentous and osseous groin injuries are common in athletes and may result in a delay of several months to resume sports. Even then, this may not be at the former level of sport activity. The treatment of exercise-related groin pain is mainly conservative (non-surgical), using interventions such as exercises, electrotherapy, manual therapy and steroid injections.

Objectives: To assess the effects (benefits and harms) of conservative interventions for treating exercise-related musculotendinous, ligamentous and osseous groin pain.

Search Methods: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2011); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4); MEDLINE (1948 to November week 3 2011); EMBASE (1980 to Week 49 2011); CINAHL (1982 to December 2011); LILACS (1982 to December 2011); PEDro (1929 to December 2011), SPORTDiscus (1985 to December 2011), OTseeker (to December 2011), reference lists of papers and conference proceedings (2000 to 2011).

Selection Criteria: Randomized controlled trials and quasi-randomized controlled trials evaluating conservative interventions for treating exercise-related musculotendinous, ligamentous and osseous groin pain were included. Studies comparing conservative with surgical treatments were excluded.

Data Collection And Analysis: Two review authors independently extracted data and conducted risk of bias assessments. There was no pooling of data.

Main Results: Two studies, involving a total of 122 participants who had experienced adductor-related groin pain for at least two months, were included in this review. All but one of the participants were male athletes aged between 18 and 50 years old. Both studies were assessed as 'high risk of bias' for at least one source of bias domain. The 'successful treatment' outcome reported in both studies was based primarily on pain measures.One study, based on an intention-to-treat analysis, found a significant difference favouring exercise therapy (strengthening with an emphasis on the adductor and abdominal muscles and training muscular co-ordination) compared with 'conventional' physiotherapy (stretching exercises, electrotherapy and transverse friction massage) in successful treatment at 16-week follow-up (25/34 (74%) versus 10/34 (29%); risk ratio (RR) 2.50, 95% CI 1.43 to 4.37, P = 0.001). Similarly, of those followed-up significantly more athletes treated by exercise therapy returned to sport at the same level (23/29 (79%) versus 4/30 (13%); RR 5.95, 95% CI 2.34 to 15.09, P = 0.0002). Although still favouring the exercise group, the differences between the two groups in patients' subjective global assessment at 16 weeks and successful treatment at 8 to 12 years follow-up were not statistically significant.The second study (54 participants) found no significant differences at 16-week follow-up between a multi-modal treatment (heat, manual therapy and stretching) and exercise therapy (the same intervention as in the above study) for the outcomes of successful treatment (14/26 (54%) versus 12/22 (55%); RR 0.99, 95% CI 0.59 to 1.66, P = 0.96) and return to full sports participation (13/26 (50%) versus 12/22 (55%); RR 0.92, 95% CI 0.53 to 1.58, P = 0.75). Those returning to full sports participation returned on average 4.5 weeks earlier after receiving multi-modal therapy (mean difference -4.50 weeks, 95% CI -8.60 to -0.40, P = 0.03) than those in the exercise therapy group. This study reported that there were no complications or side effects found in either intervention group.

Authors' Conclusions: The available evidence from the randomized trials is insufficient to advise on any specific conservative modality for treating exercise-related groin pain. While still low quality, the best evidence is from one trial which found that exercise therapy (strengthening of hip and abdominal muscles) in athletes improves short-term outcomes (based primarily on pain measures) and return to sports compared with physiotherapy consisting of passive modalities. Given the low quality of the available evidence from both included trials, further randomized trials are necessary to reinforce their findings.
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June 2013

Beta-blockers for preventing stroke recurrence.

Cochrane Database Syst Rev 2013 May 31(5):CD007890. Epub 2013 May 31.

Brazilian Cochrane Centre, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Stroke affects 15 million people per year worldwide. Despite recent developments in acute stroke treatment, prevention remains very important. Stroke has a high rate of recurrence; therefore secondary prevention is also important. Many clinical approaches to control risk factors have been proposed. One of these approaches is the prescription of beta-blockers that have effects beyond the reduction of blood pressure, which can reduce the recurrence of stroke.

Objectives: To evaluate the efficacy of beta-blockers for preventing stroke recurrence and for reducing death and major vascular events in people with a previous stroke or transient ischaemic attack (TIA), and to determine their safety, particularly with regard to the development of diabetes mellitus.

Search Methods: We searched the Cochrane Stroke Group Trials Register (December 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Database of Systematic Reviews (CDSR) (The Cochrane Library 2011, Issue 12), the Database of Abstracts of Reviews of Effects (DARE) (December 2011), MEDLINE (1966 to December 2011), EMBASE (1980 to December 2011), and Latin American and Caribbean Health Sciences Literature (LILACS) (1982 to December 2011). We also searched ongoing trials registers and reference lists.

Selection Criteria: Randomised controlled trials (RCTs) that included participants with previous stroke or TIA due to arterial thrombosis or embolism.The intervention was any beta-blocker versus control, or beta-blocker plus other treatment versus other treatment.

Data Collection And Analysis: Two review authors independently screened the trials identified, appraised quality, and extracted data.

Main Results: We included two RCTs involving 2193 participants in the review. Both studies randomised participants to either beta-blocker (atenolol 5 mg) or placebo. No statistical differences were noted among the groups in risks of fatal and non-fatal stroke (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.75 to 1.17). For all other outcomes analysed (death from all causes, cardiac death, non-fatal myocardial infarction, major vascular events), we observed no significant differences between the groups.

Authors' Conclusions: To date, no available evidence supports the routine use of beta-blockers for secondary prevention after stroke or TIA. More studies with larger samples are needed.
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May 2013

Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema.

Cochrane Database Syst Rev 2013 May 31(5):CD005351. Epub 2013 May 31.

Department of Physiotherapy, Muriaé Cancer Hospital, Muriaé, Brazil.

Background: This is an update of a systematic review previously published in 2008 about non-invasive positive pressure ventilation (NPPV). NPPV has been widely used to alleviate signs and symptoms of respiratory distress due to cardiogenic pulmonary oedema. NPPV prevents alveolar collapse and helps redistribute intra-alveolar fluid, improving pulmonary compliance and reducing the pressure of breathing.

Objectives: To determine the effectiveness and safety of NPPV in the treatment of adult patients with cardiogenic pulmonary oedema in its acute stage.

Search Methods: We searched the following databases on 20 April 2011: CENTRAL and DARE, (The Cochrane Library, Issue 2 of 4, 2011); MEDLINE (Ovid, 1950 to April 2011); EMBASE (Ovid, 1980 to April 2011); CINAHL (1982 to April 2011); and LILACS (1982 to April 2011). We also reviewed reference lists of included studies and contacted experts and equipment manufacturers. We did not apply language restrictions.

Selection Criteria: We selected blinded or unblinded randomised or quasi-randomised clinical trials, reporting on adult patients with acute or acute-on-chronic cardiogenic pulmonary oedema and where NPPV (continuous positive airway pressure (CPAP) or bilevel NPPV) plus standard medical care was compared with standard medical care alone.

Data Collection And Analysis: Two authors independently selected articles and abstracted data using a standardised data collection form. We evaluated study quality with emphasis on allocation concealment, sequence generation allocation, losses to follow-up, outcome assessors, selective outcome reporting and adherence to the intention-to-treat principle.

Main Results: We included 32 studies (2916 participants), of generally low or uncertain risk of bias. Compared with standard medical care, NPPV significantly reduced hospital mortality (RR 0.66, 95% CI 0.48 to 0.89) and endotracheal intubation (RR 0.52, 95% CI 0.36 to 0.75). We found no difference in hospital length of stay with NPPV; however, intensive care unit stay was reduced by 1 day (WMD -0.89 days, 95% CI -1.33 to -0.45). Compared with standard medical care, we did not observe significant increases in the incidence of acute myocardial infarction with NPPV during its application (RR 1.24, 95% CI 0.79 to 1.95) or after (RR 0.70, 95% CI 0.11 to 4.26). We identified fewer adverse events with NPPV use (in particular progressive respiratory distress and neurological failure (coma)) when compared with standard medical care.

Authors' Conclusions: NPPV in addition to standard medical care is an effective and safe intervention for the treatment of adult patients with acute cardiogenic pulmonary oedema. The evidence to date on the potential benefit of NPPV in reducing mortality is entirely derived from small-trials and further large-scale trials are needed.
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May 2013

Surgical treatment of sleep apnea: association between surgeon/hospital volume with outcomes.

Laryngoscope 2014 Jan 1;124(1):320-8. Epub 2013 Jul 1.

Department of Surgery, Duke University, Durham, North Carolina, U.S.A; Member of Research on Research Group, Department of Surgery , Duke University, Durham, North Carolina, U.S.A; Department of Emergency Medicine and Evidence-Based Medicine, Escola Paulista de Medicina da Universidade, Federal de Săo Paulo; CAPES Foundation , Ministry of Education of Brazil, Brasília, Brazil.

Objectives/hypothesis: To identify the association between surgeon/hospital volume with outcomes in surgical treatment for obstructive sleep apnea (OSA) in a nationally representative sample. We hypothesized that surgeons/hospitals with lower patient volumes would have: higher mortality rates, longer hospital length of stay (LOS), and higher postoperative complication rates and hospitalization charges.

Study Design: Secondary data analysis of the 2007 Nationwide Inpatient Sample database.

Methods: We selected 24,298 adults undergoing OSA surgery. The data analysis included trend test, regression, and multivariate models that were adjusted by demographic and clinical variables.

Results: The patients were mostly White (76.43%), male (78.26%), with a mean age of 46 years. Patients treated by surgeons with low volume of procedures (1 procedure/year) had significantly higher mortality rate (odds ratio [OR] 3.05; confidence interval [CI], 1.96-4.77), longer average LOS (increased until 8.16 hours), and higher hospitalization charges (increased up to $1701.75) versus medium- and high-volume surgeons (2-4 procedures/year; greater than/or equal to 5 procedures/year, respectively). Patients treated at hospitals with low volume of procedures (0-5/year) had significantly higher occurrence of oxygen desaturation (OR, 2.12; CI, 1.50-2.99), longer LOS (increased until almost 2 hours) and higher hospitalization charges (at least $951.50 more expensive) versus patients treated at high-volume hospitals (greater than/or equal to 18 procedures/year).

Conclusion: Our investigation validates the hypothesis that lower volume standards (surgeon/hospital) are associated with increase of LOS following surgery to treat OSA, as well as lower surgeon volume associated with increase of mortality and hospitalization charges and lower hospital volume with occurrence of oxygen desaturation as postoperative complication.
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January 2014

De-escalation of antimicrobial treatment for adults with sepsis, severe sepsis or septic shock.

Cochrane Database Syst Rev 2013 Mar 28(3):CD007934. Epub 2013 Mar 28.

Brazilian Cochrane Centre, Centro de Estudos de Medicina Baseada em Evidências e Avaliação Tecnológica de Saúde, São Paulo,Brazil.

Background: Mortality rates among patients with sepsis, severe sepsis or septic shock are highly variable throughout different regions or services and can be upwards of 50%. Empirical broad-spectrum antimicrobial treatment is aimed at achieving adequate antimicrobial therapy, thus reducing mortality; however, there is a risk that empirical broad-spectrum antimicrobial treatment can expose patients to overuse of antimicrobials. De-escalation has been proposed as a strategy to replace empirical broad-spectrum antimicrobial treatment by using a narrower antimicrobial therapy. This is done by reviewing the patient's microbial culture results and then making changes to the pharmacological agent or discontinuing a pharmacological combination.

Objectives: To evaluate the effectiveness and safety of de-escalation antimicrobial treatment for adult patients diagnosed with sepsis, severe sepsis or septic shock caused by any micro-organism.

Search Methods: In this updated version, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 10); MEDLINE via PubMed (from inception to October 2012); EMBASE (from inception to October 2012); LILACS (from inception to October 2012); Current Controlled Trials; bibliographic references of relevant studies; and specialists in the area. We applied no language restriction. We had previously searched the databases to August 2010.

Selection Criteria: We planned to include randomized controlled trials (RCTs) comparing de-escalation (based on culture results) versus standard therapy for adults with sepsis, severe sepsis or septic shock. The primary outcome was mortality (at 28 days, hospital discharge or at the end of the follow-up period). Studies including patients initially treated with an empirical but not adequate antimicrobial therapy were not considered for inclusion.

Data Collection And Analysis: Two authors planned to independently select and extract data and to evaluate methodological quality of all studies. We planned to use relative risk (risk ratio) for dichotomous data and mean difference (MD) for continuous data, with 95% confidence intervals. We planned to use the random-effects statistical model when the estimate effects of two or more studies could be combined in a meta-analysis.

Main Results: Our search strategy retrieved 493 studies. No published RCTs testing de-escalation of antimicrobial treatment for adult patients diagnosed with sepsis, severe sepsis or septic were included in this review. We found one ongoing RCT.

Authors' Conclusions: There is no adequate, direct evidence as to whether de-escalation of antimicrobial agents is effective and safe for adults with sepsis, severe sepsis or septic shock. This uncertainty warrants further research via RCTs and the authors are awaiting the results of an ongoing RCT testing the de-escalation of empirical antimicrobial therapy for severe sepsis.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517189PMC
March 2013

Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus.

Cochrane Database Syst Rev 2013 Feb 28(2):CD002265. Epub 2013 Feb 28.

Rheumatology/Internal Medicine and Therapeutics, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Neuropsychiatric involvement in systemic lupus erythematosus (SLE) is complex and it is an important cause of morbidity and mortality. Management of nervous system manifestations of SLE remains unsatisfactory. This is an update of a Cochrane review first published in 2000 and previously updated in 2006.

Objectives: To assess the benefits and harms of cyclophosphamide and methylprednisolone in the treatment of neuropsychiatric manifestations of SLE.

Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, SCOPUS and WHO up to and including June 2012. We sought additional articles through handsearching in relevant journals as well as contact with experts. There were no language restrictions.

Selection Criteria: We included all randomised controlled trials that compared cyclophosphamide to methylprednisolone in patients with SLE of any age and gender and presenting with any kind of neuropsychiatric manifestations.

Data Collection And Analysis: Two review authors independently extracted, assessed and cross-checked data. We produced a 'Summary of findings' table. We presented dichotomous data as risk ratios (RRs) with 95% confidence intervals (CIs).

Main Results: We did not include any new trials in this update. One randomised controlled trial of 32 patients is included. Concerning risk of bias, generation of the allocation sequence was at low risk; however, allocation concealment, blinding and selective reporting were at high risk. Treatment response, defined as 20% improvement from basal conditions by clinical, serological and specific neurological measures, was found in 94.7% (18/19) of patients using cyclophosphamide compared with 46.2% (6/13) in the methylprednisolone group at 24 months (RR 2.05, 95% CI 1.13 to 3.73). This was statistically significant and the number needed to treat for an additional beneficial outcome (NNTB) of treatment response is three. We found no statistically significant differences between the groups in damage index measurements (Systemic Lupus International Collaborating Clinics (SLICC)). The median SLE Disease Activity Index (SLEDAI) rating favoured the cyclophosphamide group. Cyclophosphamide use was associated with a reduction in prednisone requirements. All the patients in the cyclophosphamide group had electroencephalographic improvement but there was no statistically significant difference in decrease between groups in the number of monthly seizures. No statistically significant differences in adverse effects, including mortality, were reported between the groups.

Authors' Conclusions: This systematic review found one randomised controlled trial with a small number of patients in the different clinical subgroups of neurological manifestation. There is very low-quality evidence that cyclophosphamide is more effective in reducing symptoms of neuropsychiatric involvement in SLE compared with methylprednisolone. However, properly designed randomised controlled trials that involve large numbers of individuals, with explicit clinical and laboratory diagnostic criteria, sufficient duration of follow-up and description of all relevant outcome measures, are necessary to guide practice. As we did not find any new trials to include in this review at update, the conclusions of the review did not change.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6823222PMC
February 2013

Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft.

Cochrane Database Syst Rev 2012 Sep 12(9):CD004466. Epub 2012 Sep 12.

Physical Therapy Department, UNOPAR / Centro Cochrane do Brasil, Londrina, Brazil.

Background: Incentive spirometry (IS) is a treatment technique that uses a mechanical device to reduce pulmonary complications during postoperative care. This is an update of a Cochrane review first published in 2007.

Objectives: Update the previously published systematic review to compare the effects of IS for preventing postoperative pulmonary complications in adults undergoing coronary artery bypass graft (CABG).

Search Methods: We searched CENTRAL and DARE on The Cochrane Library (Issue 2 of 4 2011), MEDLINE OVID (1948 to May 2011), EMBASE (1980 to Week 20 2011), LILACS (1982 to July 2011) , the Physiotherapy Evidence Database (PEDro) (1980 to July 2011), Allied & Complementary Medicine (AMED) (1985 to May 2011), CINAHL (1982 to May 2011).

Selection Criteria: Randomised controlled trials comparing IS with any type of prophylactic physiotherapy for prevention of postoperative pulmonary complications in adults undergoing CABG.

Data Collection And Analysis: Two reviewers independently evaluated trial quality using the guidelines of the Cochrane Handbook for Systematic Reviews and extracted data from included trials. For continuous outcomes, we used the generic inverse variance method for meta-analysis and for dichotomous data we used the Peto Odds Ratio.

Main Results: This update included 592 participants from seven studies (two new and one that had been excluded in the previous review in 2007. There was no evidence of a difference between groups in the incidence of any pulmonary complications and functional capacity between treatment with IS and treatment with physical therapy, positive pressure breathing techniques (including continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP) and intermittent positive pressure breathing (IPPB), active cycle of breathing techniques (ACBT) or preoperative patient education. Patients treated with IS had worse pulmonary function and arterial oxygenation compared with positive pressure breathing. Based on these studies there was no improvement in the muscle strength between groups who received IS demonstrated by maximal inspiratory pressure and maximal expiratory pressure .

Authors' Conclusions: Our update review suggests there is no evidence of benefit from IS in reducing pulmonary complications and in decreasing the negative effects on pulmonary function in patients undergoing CABG. In view of the modest number of patients studied, methodological shortcomings and poor reporting of the included trials, these results should still be interpreted cautiously. An appropriately powered trial of high methodological rigour is needed to determine if there are patients who may derive benefit from IS following CABG.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094624PMC
September 2012

Effectiveness of aerobic physical training for treatment of chronic asymptomatic bacteriuria in subjects with spinal cord injury: a randomized controlled trial.

Clin Rehabil 2013 Feb 26;27(2):142-9. Epub 2012 Jul 26.

Physiotherapy Department, Laboratory of Biomechanics and Clinical Epidemiology at Universidade Estadual de Londrina, Londrina, Brazil.

Objective: To evaluate the effectiveness and safety of aerobic physical training for treatment of chronic asymptomatic bacteriuria in subjects with spinal cord injury.

Design: Randomized controlled trial.

Setting: University hospital.

Subjects: Forty-two participants with spinal cord injury between C8 and T12 segments were randomly assigned to intervention or control groups.

Intervention: In the intervention group, subjects received a risk evaluation, stress test and urinary culture before the start of the study and after 16 weeks. The study consisted of aerobic physical conditioning with moderate intensity for the intervention group while the control group was asked to maintain their daily life activities.

Main Measures: Increase of estimated peak oxygen consumption and also if there was a decrease in the proportions of positive urinary culture.

Results: The intervention group showed an increase of estimated peak oxygen consumption of between 939 (714-1215) and 1154 (1005-1351) mL/min (P = 0.009) and a reduction of chronic asymptomatic bacteria of between 52.3% (29.8-74.3%) and 14.2% (3-36.3%) (P < 0.001). No adverse effects related to physical activity were recorded during the period of training.

Conclusion: The regular practice of physical activity of moderate intensity applied to patients with spinal cord injury may be an effective and safe method for the treatment of chronic asymptomatic bacteriuria.
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February 2013

Botulinum toxin for myofascial pain syndromes in adults.

Cochrane Database Syst Rev 2012 Apr 18(4):CD007533. Epub 2012 Apr 18.

Department of Medicine, Universidade Federal de São Paulo, Belo Horizonte, Brazil.

Background: Myofascial pain syndrome (MPS) is a regional muscular pain syndrome characterised by the presence of trigger points, which are painful points in one or more muscles. The pain can be felt at the site where the trigger point is located or it can be felt away from that place when the muscle is pressed (referred pain). Botulinum toxin is a protein produced by the bacterium Clostridium botulinum and is a potent neurotoxin that eventually inhibits muscle contractions. It is capable of selectively weakening painful muscles and interrupting the pain cycle.

Objectives: To assess the effectiveness and safety of botulinum toxin in treating MPS, excluding MPS in neck and head muscles.

Search Methods: The search strategy was composed of terms for myofascial pain and botulinum toxin. We searched the Cochrane Pain, Palliative and Supportive Care (PaPaS) Review Group's Specialised Register until December 2011, CENTRAL (Cochrane Database of Systematic Reviews 2011, Issue 4), PUBMED (from 1966 to 2011), EMBASE (from 1980 to 2011) and LILACS (from 1982 to 2011). There was no language restriction.

Selection Criteria: We included randomised controlled trials (RCTs) involving botulinum toxin for treating participants with MPS. We excluded studies with MPS of the neck and head from this review, as they have already been assessed in existing systematic reviews. We considered a diagnosis of MPS to be based on the identification of trigger points in the taut band through palpation of sensitive nodules, local twitch response and specific patterns of referred pain associated with each trigger point.

Data Collection And Analysis: Two review authors independently screened identified studies, extracted data, assessed trial quality and analysed results using the Cochrane PaPaS Review Group criteria.

Main Results: Four studies with a total of 233 participants, comparing botulinum toxin A (BTXA) with placebo, met the inclusion criteria. In one study with 145 participants, a significant improvement rate of pain intensity scores, as shown by the mean difference (MD) of -0.23 (95% confidence interval (CI) -0.26 to -0.20; P value < 0.00001) and duration of daily pain (MD -1.11; 95% CI -1.37 to -0.85; P value < 0.00001), was demonstrated when comparing BTXA with placebo. The three other studies showed that there was no statistically significant difference between BTXA and placebo in pain intensity.

Authors' Conclusions: There is inconclusive evidence to support the use of botulinum toxin in the treatment of MPS based on data from four studies with a total of 233 participants, which we considered adequate to be included in this review. Meta-analyses were not possible due to the heterogeneity between studies. We suggest that in future studies the same methodology to assess pain, a standardised dose of treatment, follow-up of at least four months (to observe the maximum/minimum curve of the drug effect) and appropriate data presentation should be used. More high-quality RCTs of botulinum toxin for treating MPS need to be conducted before firm conclusions on its effectiveness and safety can be drawn.
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April 2012

Early versus late tracheostomy for critically ill patients.

Cochrane Database Syst Rev 2012 Mar 14(3):CD007271. Epub 2012 Mar 14.

Brazilian Cochrane Centre, Universidade Federal de São Paulo, São Paulo,

Background: Long-term mechanical ventilation is the most common situation where tracheostomy is indicated for patients in intensive care units (ICU). 'Early' and 'late' tracheostomies are two categories of the timing of tracheostomy. The evidence on the advantages attributed to early over late tracheostomy is somewhat conflicting but includes shorter hospital stays and lower mortality rates.

Objectives: To evaluate the effectiveness and safety of early (≤ 10 days after intubation) versus late tracheostomy (> 10 days after intubation) in critically ill adult patients predicted to be on prolonged mechanical ventilation and with different clinical conditions.

Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 12); MEDLINE (via PubMed) (1966 to December 2010); EMBASE (via Ovid) (from 1974 to December 2010); LILACS (1986 to December 2010); PEDro (Physiotherapy Evidence Database) at www.pedro.fhs.usyd.edu.au (1999 to December 2010) and CINAHL (1982 to December 2010).

Selection Criteria: We included all randomized or quasi-randomized controlled trials which compared early tracheostomy (two to10 days after intubation) against late tracheostomy (> 10 days after intubation) for critically ill adult patients expected to be on prolonged mechanical ventilation. There was no language restriction.

Data Collection And Analysis: Two authors extracted data and conducted a quality assessment. Meta-analyses using the random-effects model were conducted for mortality and pneumonia.

Main Results: We included four studies, with a high risk of bias, in which a total of 673 patients were randomized to either early or late tracheostomy. We could not pool data in a meta-analysis because of clinical, methodological and statistical heterogeneity between the included studies. There is no strong evidence for real differences between early and late tracheostomy in the primary outcome of mortality. In one study a statistically significant result favouring early tracheostomy was observed in the outcome measuring time spent on ventilatory support (mean difference (MD) -9.80 days, 95% CI -11.48 to -8.12, P < 0.001).

Authors' Conclusions: Updated evidence is of low quality, and potential differences between early and late tracheostomy need to be better investigated by means of randomized controlled trials. At present there is no specific information about any subgroup or individual characteristics potentially associated with better outcomes with either early or late tracheostomy.
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March 2012
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