Navegando por Palavras-chave "Randomized Controlled Trials as Topic"

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    Aerobic exercise training programmes for improving physical and psychosocial health in adults with Down syndrome
    (Wiley-Blackwell, 2010-01-01) Andriolo, Regis B. [UNIFESP]; El Dib, Regina P.; Ramos, Luis [UNIFESP]; Atallah, Alvaro N. [UNIFESP]; Silva, Edina M. K. da [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); McMaster Univ
    BackgroundAlthough physical fitness has been suggested to improve physical and psychosocial health for a variety of population profiles, there is a lack of information about the safety and effectiveness of aerobic exercise for adults with Down syndrome.ObjectivesTo evaluate the effectiveness and safety of aerobic exercise training programmes for physiological and psychosocial outcomes in adults with Down syndrome.Search strategyThe following electronic databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL) (2009, Issue 1); MEDLINE (1966 to August 2009); EMBASE (1980 to August 2009); CINAHL (1982 to August 2009); LILACS (1982 to August 2009); PsycINFO (1887 to August 2009); ERIC (1966 to August 2009); Current Controlled Trials (August 2009); and Campbell Collaboration's Social, Psychological, Educational and Criminological Register (C2-SPECTR) (to August 2009). Information about ongoing clinical trials was sought by searching ClinicalTrials.gov (http://clinicaltrials.gov) (accessed August 2009), and the National Research Register (NRR) (2009 Issue 1).Selection criteriaRandomised or quasi-randomised controlled trials using supervised aerobic exercise training programmes with behavioral components accepted as co-interventions.Data collection and analysisTwo reviewers selected relevant trials, assessed methodological quality and extracted data. Where appropriate, data were pooled using meta-analysis with a random-effects model. Positive values favour the intervention group, while negative values favour the control group.Main resultsThree studies included in this systematic review used different kinds of aerobic activity: walking/jogging and rowing training and included participants with a broad age range (17 to 65 years). They were conducted in the USA, Portugal and Israel. in the meta-analyses, only maximal treadmill grade was improved after aerobic exercise training programmes (4.26 grades (%) [ 95% CI 2.06, 6.45]). Other variables relative to work performance that could not be combined in a meta-analysis were also improved in the intervention group (maximal test time P=0.0003), total turns of fan wheel (P=0.02), resistance of ergometer (p=0.003), power knee extension and flexion (p<0.00001), and timed up and go test (p=0.008). Thirty other outcomes measured in this review including, oxidative stress and body composition variables, could not be combined in the meta-analysis. Apart from work performance, trials reported no statistically significant improvements.Authors' conclusionsThere is insufficient evidence to demonstrate that there is improvement in physical or psychosocial outcomes of aerobic exercise in adults with Down syndrome. Although evidence exists to support improvements in physiological and psychological aspects from strategies using mixed physical activity programmes, well-conducted research examining long-term physical outcomes, adverse effects, psychosocial outcomes and costs is required before informed practice decisions can be made.
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    Botulinum toxin for myofascial pain syndromes in adults
    (Wiley-Blackwell, 2014-01-01) Soares, Adriana [UNIFESP]; Andriolo, Regis B.; Atallah, Alvaro N.; Silva, Edina M. K. da [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Univ Estado Para; Brazilian Cochrane Ctr
    BackgroundThis 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.ObjectivesTo 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 methodsThis 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 criteriaWe 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 analysisTwo review authors independently screened identified studies, extracted data, assessed trial quality and analysed results using the Cochrane PaPaS Review Group criteria.Main resultsFour 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' conclusionsSince 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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    Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems
    (Wiley-Blackwell, 2010-01-01) Hofmeyr, G. Justus; Lawrie, Theresa A.; Atallah, Álvaro Nagib [UNIFESP]; Duley, Lelia; Torloni, Maria Regina [UNIFESP]; Univ Ft Hare; Universidade Federal de São Paulo (UNIFESP); Univ Leeds
    BackgroundPre-eclampsia and eclampsia are common causes of serious morbidity and death. Calcium supplementation may reduce the risk of preeclampsia through a number of mechanisms, and may help to prevent preterm birth.ObjectivesTo assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child outcomes.Search strategyWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2010) and contacted study authors.Selection criteriaRandomised trials comparing at least 1 g daily of calcium during pregnancy with placebo.Data collection and analysisWe assessed eligibility and trial quality, extracted and double-entered data.Main resultsWe included 13 studies of good quality (involving 15,730 women). the average risk of high blood pressure was reduced with calcium supplementation rather than placebo (12 trials, 15,470 women: risk ratio (RR) 0.65, 95% confidence interval (CI) 0.53 to 0.81). There was also a reduction in the average risk of pre-eclampsia associated with calcium supplementation (13 trials, 15,730 women: RR 0.45, 95% CI 0.31 to 0.65). the effect was greatest for high-risk women (five trials, 587 women: RR 0.22, 95% CI 0.12 to 0.42), and those with low baseline calcium intake (eight trials, 10,678 women: RR 0.36, 95% CI 0.20 to 0.65).The average risk of preterm birth was reduced in the calcium group overall (11 trials, 15,275 women: RR 0.76, 95% CI 0.60 to 0.97) and amongst women at high risk of developing pre-eclampsia recruited to four small trials (568 women: RR 0.45, 95% CI 0.24 to 0.83).There was no overall effect on the risk of stillbirth or death before discharge from hospital (11 trials 15,665 babies; RR 0.90, 95% CI 0.74 to 1.09). the composite outcome maternal death or serious morbidity was reduced (four trials, 9732 women; RR 0.80, 95% CI 0.65 to 0.97). Most of the women in these trials were low risk and had a low calcium diet. Maternal deaths were reported in only one trial. One death occurred in the calcium group and six in the placebo group, a difference which was not statistically significant (RR 0.17, 95% CI 0.02 to 1.39).Blood pressure in childhood has been assessed in two studies, only one of which is currently included: childhood systolic blood pressure greater than 95th percentile was reduced (514 children: RR 0.59, 95% CI 0.39 to 0.91).Authors' conclusionsCalcium supplementation appears to approximately halve the risk of pre-eclampsia, to reduce the risk of preterm birth and to reduce the rare occurrence of the composite outcome ' death or serious morbidity'. There were no other clear benefits, or harms.
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    Conservative interventions for treating middle third clavicle fractures in adolescents and adults
    (Wiley-Blackwell, 2014-01-01) Lenza, Mario [UNIFESP]; Belloti, Joao Carlos [UNIFESP]; Andriolo, Regis Bruni [UNIFESP]; Faloppa, Flávio [UNIFESP]; Hosp Israelita Albert Einstein; Universidade Federal de São Paulo (UNIFESP); Univ Estado Para
    BackgroundClavicle (collarbone) fractures account for around 4% of all fractures; treatment of these fractures is usually non-surgical (conservative). Commonly used treatments are arm slings, strapping, figure-of-eight bandages and splints.This is an update of a Cochrane review first published in 2009.ObjectivesTo evaluate the effects of different methods for conservative (non-operative) treatment for acute (treated soon after injury) middle third clavicle fractures in adolescents and adults.Search methodsWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (2013, Issue 12), MEDLINE (from 1966), EMBASE (from 1980), LILACS (from 1982), trial registers, orthopaedic proceedings and reference lists of articles. We applied no language or publication restrictions. the date of the last search was 29 January 2014.Selection criteriaRandomised and quasi-randomised controlled trials testing conservative interventions for treating adolescents and adults with acute middle third clavicle fractures. the primary outcomes were shoulder function or disability, pain and treatment failure.Data collection and analysisAt least two authors selected eligible trials, independently assessed risk of bias and cross-checked data extraction. We calculated risk ratios and 95% confidence intervals for dichotomous variables, and mean differences and 95% confidence intervals for continuous variables. There was no pooling of data.Main resultsWe included three trials in this review with 354 participants. No new trials were included in this update.Very low quality evidence was available from two trials (234 participants) that compared the figure-of-eight bandage with an arm sling for treating acute middle third clavicle fractures. Both trials were underpowered and compromised by poor methodology. One trial found slightly higher pain levels in the bandage group at 15 days (mean difference 0.80, 95% confidence interval 0.34 to 1.26; visual analogue scale: 0 (no pain) to 10 (worst pain)); and the other trial reported greater discomfort during bandage wear. There were no significant differences between the two interventions in functional or other outcomes reported for either trial.Moderate quality evidence was available from the third trial (120 participants), which evaluated therapeutic ultrasound. This trial was at low risk of any type of bias but was underpowered. the trial found no statistically significant difference between low-intensity pulsed ultrasound and placebo in the time to clinical fracture healing (mean difference -0.32 days, 95% CI -5.85 to 5.21 days), nor in any of the other reported outcomes.Authors' conclusionsThere is limited evidence available from randomised controlled trials to determine which methods of conservative treatment are the most appropriate for acute middle third clavicle fractures in adolescents and adults. Further research is warranted.
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    Depot versus daily administration of gonadotrophin-releasing hormone agonist protocols for pituitary down regulation in assisted reproduction cycles
    (Wiley-Blackwell, 2013-01-01) Albuquerque, Luiz Eduardo T.; Tso, Leopoldo O. [UNIFESP]; Saconato, Humberto; Albuquerque, Maria Cecilia R. M.; Macedo, Cristiane R. [UNIFESP]; Fertivitro Ctr Reprod Humana; Universidade Federal de São Paulo (UNIFESP); Santa Casa Campo Mourao; Ctr Reprod Humana Fertivitro; Ctr Estudos Med Baseada Evidencias & Avaliacao Te
    BackgroundGonadotrophin-releasing hormone agonist (GnRHa) is commonly used to switch off (down regulate) the pituitary gland and thus suppress ovarian activity in women undergoing in vitro fertilisation (IVF). Other fertility drugs (gonadotrophins) are then used to stimulate ovulation in a controlled manner. Among the various types of pituitary down regulation protocols in use, the long protocol achieves the best clinical pregnancy rate. the long protocol requires GnRHa administration until suppression of ovarian activity occurs, within approximately 14 days. GnRHa can be used either as daily low-dose injections or through a single injection containing higher doses of the drug (depot). It is unclear which of these two forms of administration is best, and whether single depot administration may require higher doses of gonadotrophins.ObjectivesTo compare the effectiveness and safety of a single depot dose of GHRHa versus daily GnRHa doses in women undergoing IVF.Search methodsWe searched the following databases: Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched July 2012), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7), MEDLINE (1966 to July 2012), EMBASE (1980 to July 2012) and LILACS (1982 to July 2012). We also screened the reference lists of articles.Selection criteriaWe included RCTs comparing depot and daily administration of GnRHa for long protocols in IVF treatment cycles in couples with any cause of infertility, using various methods of ovarian stimulation. the primary review outcomes were live birth or ongoing pregnancy, clinical pregnancy and ovarian hyperstimulation syndrome (OHSS). Other outcomes included number of oocytes retrieved, miscarriage, multiple pregnancy, number of gonadotrophin (FSH) units used for ovarian stimulation, duration of gonadotrophin treatment, cost and patient convenience.Data collection and analysisTwo review authors independently selected studies, extracted data and assessed study quality. for dichotomous outcomes, we calculated odds ratios (ORs) and 95% confidence intervals (CIs) per woman randomised. Where appropriate, we pooled studies.Main resultsSixteen studies were eligible for inclusion (n = 1811 participants), 12 (n = 1366 participants) of which were suitable for meta-analysis. No significant heterogeneity was detected.There were no significant differences between depot GnRHa and daily GnRHa in live birth/ongoing pregnancy rates (OR 0.95, 95% CI 0.70 to 1.31, seven studies, 873 women), but substantial differences could not be ruled out. Thus for a woman with a 24% chance of achieving a live birth or ongoing pregnancy using daily GnRHa injections, the corresponding chance using GnRHa depot would be between 18% and 29%.There was no significant difference between the groups in clinical pregnancy rate (OR 0.96, 95% CI 0.75 to 1.23, 11 studies, 1259 women). for a woman with a 30% chance of achieving clinical pregnancy using daily GnRHa injections, the corresponding chance using GnRHa depot would be between 25% and 35%.There was no significant difference between the groups in the rate of severe OHSS (OR 0.84, 95% CI 0.29 to 2.42, five studies, 570 women), but substantial differences could not be ruled out. for a woman with a 3% chance of severe OHSS using daily GnRHa injections, the corresponding risk using GnRHa depot would be between 1% and 6%.Compared to women using daily GnRHa, those on depot administration required significantly more gonadotrophin units for ovarian stimulation (standardised mean difference (SMD) 0.26, 95% CI 0.08 to 0.43, 11 studies, 1143 women) and a significantly longer duration of gonadotrophin use (mean difference (MD) 0.65, 95% CI 0.46 to 0.84, 10 studies, 1033 women).Study quality was unclear due to poor reporting. Only four studies reported live births as an outcome and only five described adequate methods for concealment of allocation.Authors' conclusionsWe found no evidence of a significant difference between depot and daily GnRHa use for pituitary down regulation in IVF cycles using the long protocol, but substantial differences could not be ruled out. Since depot GnRHa requires more gonadotrophins and a longer duration of use, it may increase the overall costs of IVF treatment.
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    Efeito de um antimicrobiano na microbiota duodenal; e na evolução clínica de lactentes hospitalizados por diarréia aguda e persistente: um ensaio clínico duplo-cego randomizado
    (Universidade Federal de São Paulo (UNIFESP), 2000) Tahan, Soraia [UNIFESP]; Morais, Mauro Batista de [UNIFESP]
    O objetivo do estudo foi avaliar o efeito da polimixina oral na microbiota duodenal e na evolução clínica de lactentes hospitalizados com quadros graves de diarréia aguda e persistente. Este estudo duplo-cego randomizado, incluiu 25 lactentes menores de um ano de idade, hospitalizados com diarréia aguda e persistente. Os pacientes foram randomizados para receber o tratamento com polimixina oral (10mg/kg/d) ou placebo por sete dias. Ambos os grupos receberam a mesma dieta (semi-elementar). Culturas de aspirado duodenal, incluindo pesquisa de aeróbios e anaeróbíos, e cultura de fezes, foram realizadas antes e após sete dias do tratamento. Cinco pacientes foram excluídos durante o decorrer do estudo. Os percentuais de pacientes que apresentaram proliferação bacteriana no intestino delgado (PBID) no grupo polimixina foram, respectivamente, 61,5 por cento (8113) antes do tratamento e 76,9 por cento (lOll3) após o tratamento. No grupo controle, estes valores foram, respectivamente, 71,4 por cento (5/7) e 57,1 por cento(4/7), antes e após o tratamento. No grupo polimixina, a Escherichia coli enteropatogênica clássica (EPEC) foi encontrada em 57,1 por cento (7113) dos pacientes antes do tratamento e em O,O por cento após tratamento. No grupo controle EPEC foi isolada em 57,1 por cento (4/7) dos pacientes antes do tratamento e em 14,3 por cento (2/7) após o tratamento. A duração, em dias, da diarréia após o início do estudo foi de 4,0 ñ 1,9 no grupo polimixina e em 3,8 ñ 2,3 no grupo controle (p=O,88). A média de ganho ponderar no final do ensaio foi 371 ñ 267g. no grupo polimixina e 276 ñ 244g. para o grupo controle (p=O,441). Cura clínica, no 4' dia, foi observada em 30,7 por cento (4113) no grupo polimixina e em 42,8 por cento (3/7) no grupo controle (p=O,651). Conclui-se que a polimixina por via oral não teve efeito em reduzir a proliferação bacteriana no intestino delgado e na evolução clínica de lactentes hospitalizados com diarréia aguda e persistente grave.
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    Enzyme replacement therapy with idursulfase for mucopolysaccharidosis type II (Hunter syndrome)
    (Wiley-Blackwell, 2014-01-01) Silva, Edina Mariko Koga da [UNIFESP]; Strufaldi, Maria Wany Louzada [UNIFESP]; Andriolo, Regis Bruni [UNIFESP]; Silva, Laercio Antonio da [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Univ Estado Para
    BackgroundMucopolysaccharidosis II, also known as Hunter syndrome, is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase, which catalyses a step in the catabolism of glycosaminoglycans. the glycosaminoglycans accumulate within tissues affecting multiple organs and physiologic systems. the clinical manifestations include neurologic involvement, severe airways obstruction, skeletal deformities and cardiomyopathy. the disease has a variable age of onset and variable rate of progression. in those with severe disease, death usually occurs in the second decade of life, whereas those patients with less severe disease may survive into adulthood. Enzyme replacement therapy with intravenous infusions of idursulfase has emerged as a new treatment for mucopolysaccharidosis type II.ObjectivesTo evaluate the effectiveness and safety of enzyme replacement therapy with idursulfase compared to other interventions, placebo or no intervention, for treating mucopolysaccharidosis type II.Search methodsWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register (date of last search 22 July 2013). We also searched EMBASE, PubMed and the Literature Latino-Americana e do Caribe em Ciencias da Saude (LILACS) (date of last search 09 July 2013).Selection criteriaRandomised and quasi-randomised controlled trials of enzyme replacement therapy with idursulfase compared to no intervention, placebo or other options (e. g. behavioral strategies, transplantation).Data collection and analysisTwo authors independently screened the trials identified, appraised quality of papers and extracted data.Main resultsOne study (96 patients) met the inclusion criteria, although the primary outcome of this review - z score for height and weight, was not assessed in the study. This trial was considered to be of overall good quality. Following 53 weeks of treatment, patients in the weekly idursulfase 0.5 mg/kg group demonstrated a significant improvement rate compared with placebo for the primary outcome: distance walked in six minutes on the basis of the sum of ranks of change from baseline, mean difference 37.00 (95% confidence interval 6.52 to 67.48). the every-other-week idursulfase 0.5 mg/kg group also showed an improvement, which was not significant compared with placebo, mean difference 23.00 (95% confidence interval -4.49 to 50.49). After 53 weeks, there was no statistical significance difference in per cent predicted forced vital capacity between the three groups and absolute forced vital capacity was significantly increased from baseline in the weekly dosing group compared to placebo, mean difference 0.16 (95% confidence interval CI 0.05 to 0.27). No difference was observed between the every-other-week idursulfase 0.5 mg/kg group and placebo.In addition, liver and spleen volumes and urine glycosaminoglycan excretion were significantly reduced from baseline by both idursulfase dosing regimens. Idursulfase was generally well tolerated, but infusion reactions did occur. Idursulfase antibodies were detected in 31.7% of patients at the end of the study and they were related to a smaller reduction in urine glycosaminoglycan levels.Authors' conclusionsThe current evidence is limited. While the randomised clinical trial identified was considered to be of good quality, it failed to describe important outcomes. It has been demonstrated that enzyme replacement therapy with idursulfase is effective in relation to functional capacity (distance walked in six minutes and forced vital capacity), liver and spleen volumes and urine glycosaminoglycan excretion in patients with mucopolysaccharidosis type II compared with placebo. There is no available evidence in the included study and in the literature on outcomes such as improvement in growth, sleep apnoea, cardiac function, quality of life and mortality. More studies are needed to obtain more information on the long-term effectiveness and safety of enzyme replacement therapy.
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    Family intervention for schizophrenia
    (Wiley-Blackwell, 2010-01-01) Pharoah, Fiona; Mari, Jair de Jesus [UNIFESP]; Rathbone, John; Wong, Winson; Oxford & Buckinghamshire Mental Hlth NHS Fdn Trus; Universidade Federal de São Paulo (UNIFESP); Univ Sheffield; Yorkshire & Humber Postgrad Deanery
    BackgroundPeople with schizophrenia from families that express high levels of criticism, hostility, or over involvement, have more frequent relapses than people with similar problems from families that tend to be less expressive of emotions. Forms of psychosocial intervention, designed to reduce these levels of expressed emotions within families, are now widely used.ObjectivesTo estimate the effects of family psychosocial interventions in community settings for people with schizophrenia or schizophrenia-like conditions compared with standard care.Search strategyWe updated previous searches by searching the Cochrane Schizophrenia Group Trials Register (September 2008).Selection criteriaWe selected randomised or quasi-randomised studies focusing primarily on families of people with schizophrenia or schizoaffective disorder that compared community-orientated family-based psychosocial intervention with standard care.Data collection and analysisWe independently extracted data and calculated fixed-effect relative risk (RR), the 95% confidence intervals (CI) for binary data, and, where appropriate, the number needed to treat (NNT) on an intention-to-treat basis. for continuous data, we calculated mean differences (MD).Main resultsThis 2009-10 update adds 21 additional studies, with a total of 53 randomised controlled trials included. Family intervention may decrease the frequency of relapse (n = 2981, 32 RCTs, RR 0.55 CI 0.5 to 0.6, NNT 7 CI 6 to 8), although some small but negative studies might not have been identified by the search. Family intervention may also reduce hospital admission (n = 481, 8 RCTs, RR 0.78 CI 0.6 to 1.0, NNT 8 CI 6 to 13) and encourage compliance with medication (n = 695, 10 RCTs, RR 0.60 CI 0.5 to 0.7, NNT 6 CI 5 to 9) but it does not obviously affect the tendency of individuals/families to leave care (n = 733, 10 RCTs, RR 0.74 CI 0.5 to 1.0). Family intervention also seems to improve general social impairment and the levels of expressed emotion within the family. We did not find data to suggest that family intervention either prevents or promotes suicide.Authors' conclusionsFamily intervention may reduce the number of relapse events and hospitalisations and would therefore be of interest to people with schizophrenia, clinicians and policy makers. However, the treatment effects of these trials may be overestimated due to the poor methodological quality. Further data from trials that describe the methods of randomisation, test the blindness of the study evaluators, and implement the CONSORT guidelines would enable greater confidence in these findings.
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    Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft
    (Wiley-Blackwell, 2012-01-01) Freitas, Eliane R. F. S.; Soares, Bernardo G. O. [UNIFESP]; Cardoso, Jefferson R.; Atallah, Alvaro N. [UNIFESP]; UNOPAR Ctr Cochrane Brasil; Universidade Federal de São Paulo (UNIFESP); Universidade Estadual de Londrina (UEL)
    BackgroundIncentive 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.ObjectivesUpdate 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 methodsWe 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 criteriaRandomised controlled trials comparing IS with any type of prophylactic physiotherapy for prevention of postoperative pulmonary complications in adults undergoing CABG.Data collection and analysisTwo 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 resultsThis 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' conclusionsOur 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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    Interventions for vaginismus
    (Wiley-Blackwell, 2012-01-01) Melnik, Tamara [UNIFESP]; Hawton, Keith; McGuire, Hugh; Natl Collaborating Ctr Womens & Childrens Hlth; Universidade Federal de São Paulo (UNIFESP); Warneford Hosp
    BackgroundVaginismus is an involuntary contraction of the vaginal muscles which makes sexual intercourse difficult or impossible. It is one of the more common female psychosexual problems. Various therapeutic strategies for vaginismus, such as sex therapy and desensitisation, have been proposed, and uncontrolled case series appear promising.ObjectivesTo assess the effects of different interventions for vaginismus.Search methodsWe searched the Cochrane Depression, Anxiety and Neurosis Group's Specialised Register (CCDANCTR-Studies and CCDANCTR-References) to August 2012. This register contains relevant randomised controlled trials from: the Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO(1967 to date). We searched reference lists and conference abstracts. We contacted experts in the field regarding unpublished material.Selection criteriaControlled trials comparing treatments for vaginismus with another treatment, a placebo treatment, treatment as usual or waiting list control.Data collection and analysisThe review authors extracted data which we verified with the trial investigator where possible.Main resultsFive studies were included, of which four with a total of 282 participants provided data. No meta-analysis was possible due to heterogeneity of comparisons within included studies as well as inadequate reporting of data. All studies were considered to be at either moderate or high risk of bias. the results of this systematic review indicate that there is no clinical or statistical difference between systematic desensitisation and any of the control interventions (either waiting list control, systematic desensitisation combined with group therapy or in vitro (with women under instruction by the therapist) desensitisation) for the treatment of vaginismus. the dropout rates were higher in the waiting list groups.Authors' conclusionsA clinically relevant effect of systematic desensitisation when compared with any of the control interventions cannot be ruled out. None of the included trials compared other behaviour therapies ( e. g. cognitive behaviour therapy, sex therapy) to pharmacological interventions. the findings are limited by the evidence available and as such conclusions about the efficacy of interventions for the treatment of vaginismus should be drawn cautiously.
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    Metformin treatment before and during IVF or ICSI in women with polycystic ovary syndrome
    (Wiley-Blackwell, 2014-01-01) Tso, Leopoldo O. [UNIFESP]; Costello, Michael F.; Albuquerque, Luiz Eduardo T.; Andriolo, Regis B.; Macedo, Cristiane R. [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Royal Hosp Women & IVF Australia; Fertivitro Ctr Reprod Humana; Univ Estado Para; Ctr Estudos Saude Baseada Evidencias & Avaliacao
    BackgroundThe use of insulin-sensitising agents, such as metformin, in women with polycystic ovary syndrome (PCOS) who are undergoing ovulation induction or in vitro fertilisation (IVF) cycles has been widely studied. Metformin reduces hyperinsulinaemia and suppresses the excessive ovarian production of androgens. As a consequence, it is suggested that metformin could improve assisted reproductive techniques (ART) outcomes, such as ovarian hyperstimulation syndrome (OHSS), pregnancy and live birth rates.ObjectivesTo determine the effectiveness and safety of metformin as a co-treatment during IVF or intracytoplasmic sperm injection (ICSI) in achieving pregnancy or live birth in women with PCOS.Search methodsWe searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, LILACS, the metaRegister of Controlled Trials and reference lists of articles (up to 15 October 2014).Selection criteriaTypes of studies: randomised controlled trials (RCTs) comparing metformin treatment with placebo or no treatment in women with PCOS who underwent IVF or ICSI treatment.Types of participants: women of reproductive age with anovulation due to PCOS with or without co-existing infertility factors.Types of interventions: metformin administered before and during IVF or ICSI treatment.Types of outcome measures: live birth rate, clinical pregnancy rate, miscarriage rate, incidence of ovarian hyperstimulation syndrome, incidence of participant-reported side effects, serum oestradiol level on the day of trigger, serum androgen level, and fasting insulin and glucose levels.Data collection and analysisTwo review authors independently selected the studies, extracted the data according to the protocol and assessed study quality. the overall quality of the evidence was assessed using GRADE methods.Main resultsWe included nine randomised controlled trials involving a total of 816 women with PCOS. When metformin was compared with placebo there was no clear evidence of a difference between the groups in live birth rates (OR 1.39, 95% CI 0.81 to 2.40, five RCTs, 551 women, I-2 = 52%, low-quality evidence). Our findings suggest that for a woman with a 32 % chance of achieving a live birth using placebo or other treatment, the corresponding chance using metformin treatment would be between 28% and 53%.When metformin was compared with placebo or no treatment, clinical pregnancy rates were higher in the metformin group (OR 1.52; 95% CI 1.07 to 2.15; eight RCTs, 775 women, I-2 = 18%, moderate-quality evidence). This suggests that for a woman with a 31% chance of achieving a clinical pregnancy using placebo or no treatment, the corresponding chance using metformin treatment would be between 32% and 49%.The risk of ovarian hyperstimulation syndrome was lower in the metformin group (OR 0.29; 95% CI 0.18 to 0.49, eight RCTs, 798 women, I-2 = 11%, moderate-quality evidence). This suggests that for a woman with a 27% risk of having OHSS without metformin the corresponding chance using metformin treatment would be between 6% and 15%.Side effects (mostly gastrointestinal) were more common in the metformin group (OR 4.49, 95% CI 1.88 to 10.72, for RCTs, 431 women, I-2= 57%, low quality evidence)The overall quality of the evidence was moderate for the outcomes of clinical pregnancy, OHSS and miscarriage, and low for other outcomes. the main limitations in the evidence were imprecision and inconsistency.Authors' conclusionsThis review found no conclusive evidence that metformin treatment before or during ART cycles improved live birth rates in women with PCOS. However, the use of this insulin-sensitising agent increased clinical pregnancy rates and decreased the risk of OHSS.
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    Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema
    (Wiley-Blackwell, 2013-01-01) Vital, FMR; Ladeira, Magdaline Trindade [UNIFESP]; Atallah, Álvaro Nagib [UNIFESP]; Muriae Canc Hosp; Universidade Federal de São Paulo (UNIFESP); Ctr Estudos Med Baseada Evidencias & Avaliacao Te
    BackgroundThis 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.ObjectivesTo determine the effectiveness and safety of NPPV in the treatment of adult patients with cardiogenic pulmonary oedema in its acute stage.Search methodsWe 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 criteriaWe 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 analysisTwo 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 resultsWe 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' conclusionsNPPV 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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    Orthodontic and orthopaedic treatment for anterior open bite in children
    (Wiley-Blackwell, 2014-01-01) Lentini-Oliveira, Debora Aparecida [UNIFESP]; Carvalho, Fernando Rodrigues de [UNIFESP]; Rodrigues, Clarissa Garcia; Ye, Qingsong; Prado, Lucila B. F. [UNIFESP]; Prado, Gilmar Fernandes do [UNIFESP]; Hu, Rongdang; Universidade Federal de São Paulo (UNIFESP); Fundacao Univ Cardiol IC FUC; James Cook Univ; Wenzhou Med Univ
    BackgroundAnterior open bite occurs when there is a lack of vertical overlap of the upper and lower incisors. the aetiology is multifactorial including: oral habits, unfavourable growth patterns, enlarged lymphatic tissue with mouth breathing. Several treatments have been proposed to correct this malocclusion, but interventions are not supported by strong scientific evidence.ObjectivesThe aim of this systematic review was to evaluate orthodontic and orthopaedic treatments to correct anterior open bite in children.Search methodsThe following databases were searched: the Cochrane Oral Health Group's Trials Register (to 14 February 2014); the Cochrane Central Register of Controlled Trials (CENTRAL)(The Cochrane Library 2014, Issue 1); MEDLINE via OVID (1946 to 14 February 2014); EMBASE via OVID (1980 to 14 February 2014); LILACS via BIREME Virtual Health Library (1982 to 14 February 2014); BBO via BIREME Virtual Health Library (1980 to 14 February 2014); and SciELO (1997 to 14 February 2014). We searched for ongoing trials via ClinicalTrials.gov (to 14 February 2014). Chinese journals were handsearched and the bibliographies of papers were retrieved.Selection criteriaAll randomised or quasi-randomised controlled trials of orthodontic or orthopaedic treatments or both to correct anterior open bite in children.Data collection and analysisTwo review authors independently assessed the eligibility of all reports identified.Risk ratios (RRs) and corresponding 95% confidence intervals (CIs) were calculated for dichotomous data. the continuous data were expressed as described by the author.Main resultsThree randomised controlled trials were included comparing: effects of Frankel's function regulator-4 (FR-4) with lip-seal training versus no treatment; repelling-magnet splints versus bite-blocks; and palatal crib associated with high-pull chincup versus no treatment.The study comparing repelling-magnet splints versus bite-blocks could not be analysed because the authors interrupted the treatment earlier than planned due to side effects in four of ten patients.FR-4 associated with lip-seal training (RR = 0.02 (95% CI 0.00 to 0.38)) and removable palatal crib associated with high-pull chincup (RR = 0.23 (95% CI 0.11 to 0.48)) were able to correct anterior open bite.No study described: randomisation process, sample size calculation, there was not blinding in the cephalometric analysis and the two studies evaluated two interventions at the same time. These results should be therefore viewed with caution.Authors' conclusionsThere is weak evidence that the interventions FR-4 with lip-seal training and palatal crib associated with high-pull chincup are able to correct anterior open bite. Given that the trials included have potential bias, these results must be viewed with caution. Recommendations for clinical practice cannot be made based only on the results of these trials. More randomised controlled trials are needed to elucidate the interventions for treating anterior open bite.
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    Physical therapy for Bell's palsy (idiopathic facial paralysis)
    (Wiley-Blackwell, 2011-01-01) Teixeira, Lazaro J. [UNIFESP]; Valbuza, Juliana S. [UNIFESP]; Prado, Gilmar F. [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    BackgroundBell's palsy (idiopathic facial paralysis) is commonly treated by various physical therapy strategies and devices, but there are many questions about their efficacy.ObjectivesTo evaluate physical therapies for Bell's palsy (idiopathic facial palsy).Search methodsWe searched the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2011), MEDLINE (January 1966 to February 2011), EMBASE (January 1946 to February 2011), LILACS (January 1982 to February 2011), PEDro (from 1929 to February 2011), and CINAHL (January 1982 to February 2011). We included searches in clinical trials register databases until February 2011.Selection criteriaWe selected randomised or quasi-randomised controlled trials involving any physical therapy. We included participants of any age with a diagnosis of Bell's palsy and all degrees of severity. the outcome measures were: incomplete recovery six months after randomisation, motor synkinesis, crocodile tears or facial spasm six months after onset, incomplete recovery after one year and adverse effects attributable to the intervention.Data collection and analysisTwo authors independently scrutinised titles and abstracts identified from the search results. Two authors independently carried out risk of bias assessments, which, took into account secure methods of randomisation, allocation concealment, observer blinding, patient blinding, incomplete outcome data, selective outcome reporting and other bias. Two authors independently extracted data using a specially constructed data extraction form. We undertook separate subgroup analyses of participants with more and less severe disability.Main resultsFor this update to the original review, the search identified 65 potentially relevant articles. Twelve studies met the inclusion criteria (872 participants). Four trials studied the efficacy of electrical stimulation (313 participants), three trials studied exercises (199 participants), and five studies compared or combined some form of physical therapy with acupuncture (360 participants).For most outcomes we were unable to perform meta-analysis because the interventions and outcomes were not comparable. for the primary outcome of incomplete recovery after six months, electrostimulation produced no benefit over placebo (moderate quality evidence from one study with 86 participants). Low quality comparisons of electrostimulation with prednisolone (an active treatment)(149 participants), or the addition of electrostimulation to hot packs, massage and facial exercises (22 participants), reported no significant differences. Similarly a meta-analysis from two studies, one of three months and the other of six months duration, (142 participants) found no statistically significant difference in synkinesis, a complication of Bell's palsy, between participants receiving electrostimulation and controls. A single low quality study (56 participants), which reported at three months, found worse functional recovery with electrostimulation (mean difference (MD) 12.00 points (scale of 0 to 100) 95% confidence interval (CI) 1.26 to 22.74).Two trials of facial exercises, both at high risk of bias, found no difference in incomplete recovery at six months when exercises were compared to waiting list controls or conventional therapy. There is evidence from a single small study (34 participants) of moderate quality that exercises are beneficial on measures of facial disability to people with chronic facial palsy when compared with controls (MD 20.40 points (scale of 0 to 100), 95% CI 8.76 to 32.04) and from another single low quality study with 145 people with acute cases treated for three months where significantly fewer participants developed facial motor synkinesis after exercise (risk ratio 0.24, 95% CI 0.08 to 0.69). the same study showed statistically significant reduction in time for complete recovery, mainly in more severe cases (47 participants, MD -2.10 weeks, 95% CI -3.15 to -1.05) but this was not a prespecified outcome in this meta analysis.Acupuncture studies did not provide useful data as all were short and at high risk of bias. None of the studies included adverse events as an outcome.Authors' conclusionsThere is no high quality evidence to support significant benefit or harm from any physical therapy for idiopathic facial paralysis. There is low quality evidence that tailored facial exercises can help to improve facial function, mainly for people with moderate paralysis and chronic cases. There is low quality evidence that facial exercise reduces sequelae in acute cases. the suggested effects of tailored facial exercises need to be confirmed with good quality randomised controlled trials.
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    Prescrição de terapias baseadas em evidências para pacientes de alto risco cardiovascular: estudo REACT
    (Sociedade Brasileira de Cardiologia - SBC, 2013-03-01) Berwanger, Otávio [UNIFESP]; Mattos, Luiz Alberto Piva e; Martin, José Fernando Vilela; Lopes, Renato Delascio [UNIFESP]; Figueiredo, Estevão Lanna; Magnoni, Daniel; Precoma, Dalton Bertolim; Machado, Carlos Alberto; Guimarães, Jorge Ilha; Andrade, Jadelson Pinheiro de; Hospital do Coração; Sociedade Brasileira de Cardiologia; Instituto Dante Pazzanese de Cardiologia; Rede D'Or Unidades de Hemodinâmica e Intervenção Cardiovascular; Hospital de Base; Universidade Federal de São Paulo (UNIFESP); Hospital Lifecenter; Sociedade Hospitalar Angelina Caron; Ambulatório Médico de Especialidades Maria Zélia; Hospital da Bahia
    BACKGROUND: Data on outpatient care provided to patients at high cardiovascular risk in Brazil are insufficient. OBJECTIVE: To describe the profile and document the clinical practice of outpatient care in patients at high cardiovascular risk in Brazil, regarding the prescription of evidence-based therapies. METHODS: Prospective registry that documented the ambulatory clinical practice in individuals at high cardiovascular risk, which was defined as the presence of the following factors: coronary artery disease, cerebrovascular and peripheral vascular diseases, diabetes, or those with at least three of the following factors: hypertension, smoking, dyslipidemia, age > 70 years, family history of coronary artery disease, chronic kidney disease or asymptomatic carotid artery disease. Basal characteristics were assessed and the rate of prescription of pharmacological and non-pharmacological interventions was analyzed. RESULTS: A total of 2364 consecutive patients were included, of which 52.2% were males, with a mean age of 66.0 years (± 10.1). Of these, 78.3% used antiplatelet agents, 77.0% used statins and of patients with a history of myocardial infarction, 58.0% received beta-blockers. Concomitant use of these three classes of drugs was 34%; 50.9% of hypertensive, 67% of diabetic and 25.7% of dyslipidemic patients did not achieve the goals recommended by guidelines. The main predictors of prescription therapies with proven benefit were centers with a cardiologist and history of coronary artery disease. CONCLUSION: This national and representative registry identified important gaps in the incorporation of therapies with proven benefit, offering a realistic outlook of patients at high cardiovascular risk.
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    Psychological treatments for bulimia nervosa and binging
    (Wiley-Blackwell, 2009-01-01) Hay, Phillipa P. J.; Bacaltchuk, Josué [UNIFESP]; Stefano, Sergio [UNIFESP]; Kashyap, Priyanka; Univ Western Sydney; Universidade Federal de São Paulo (UNIFESP); Univ Mumbai
    BackgroundA specific manual-based form of cognitive behavioural therapy (CBT) has been developed for the treatment of bulimia nervosa (CBT-BN) and other common related syndromes such as binge eating disorder. Other psychotherapies and modifications of CBT are also used.ObjectivesTo evaluate the efficacy of CBT, CBT-BN and other psychotherapies in the treatment of adults with bulimia nervosa or related syndromes of recurrent binge eating.Search strategyHand search of the International Journal of Eating Disorders since first issue; database searches of MEDLINE, EXTRAMED, EMBASE, PsycInfo, CURRENT CONTENTS, LILACS, SCISEARCH, CENTRAL and the The Cochrane Collaboration Depression, Anxiety & Neurosis Controlled Trials Register; citation list searching and personal approaches to authors were used. Search date June 2007.Selection criteriaRandomised controlled trials of psychotherapy for adults with bulimia nervosa, binge eating disorder and/or eating disorder not otherwise specified (EDNOS) of a bulimic type which applied a standardised outcome methodology and had less than 50% drop-out rate.Data collection and analysisData were analysed using the Review Manager software program. Relative risks were calculated for binary outcome data. Standardised mean differences were calculated for continuous variable outcome data. A random effects model was applied.Main results48 studies (n = 3054 participants) were included. the review supported the efficacy of CBT and particularly CBT-BN in the treatment of people with bulimia nervosa and also (but less strongly due to the small number of trials) related eating disorder syndromes.Other psychotherapies were also efficacious, particularly interpersonal psychotherapy in the longer-term. Self-help approaches that used highly structured CBT treatment manuals were promising. Exposure and Response Prevention did not enhance the efficacy of CBT.Psychotherapy alone is unlikely to reduce or change body weight in people with bulimia nervosa or similar eating disorders.Authors' conclusionsThere is a small body of evidence for the efficacy of CBT in bulimia nervosa and similar syndromes, but the quality of trials is very variable and sample sizes are often small. More and larger trials are needed, particularly for binge eating disorder and other EDNOS syndromes. There is a need to develop more efficacious therapies for those with both a weight and an eating disorder.
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    Stapled versus handsewn methods for colorectal anastomosis surgery
    (Wiley-Blackwell, 2012-01-01) Neutzling, Cristiane B. [UNIFESP]; Lustosa, Suzana A. S.; Proenca, Igor M. [UNIFESP]; Silva, Edina M. K. da [UNIFESP]; Matos, Delcio [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); UEPE
    BackgroundPrevious systematic reviews comparing stapled and handsewn colorectal anastomosis that are available in the medical literature have not shown either technique to be superior. An update of this systematic review was performed to find out if there are any data that properly answer this question.ObjectivesTo compare the safety and effectiveness of stapled and handsewn colorectal anastomosis surgery. the following primary hypothesis was tested: the stapled technique is more effective because it decreases the level of complications.Search methodsA computerized search was performed in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE according to the strategies of the Colorectal Cancer Group of the Cochrane Collaboration. There were no limits upon language, date or other criteria. A revised search strategy was performed for this updated version of the review May 2011.Selection criteriaAll randomised controlled trials (RCTs) in which stapled and handsewn colorectal anastomosis techniques were compared. Participants were adult patients undergoing elective colorectal anastomosis surgery. the interventions were endoluminal circular stapler and handsewn colorectal anastomosis surgery. Outcomes considered were a) mortality; b) overall anastomotic dehiscence; c) clinical anastomotic dehiscence; d) radiological anastomotic dehiscence; e) stricture; f) anastomotic haemorrhage; g) reoperation; h) wound infection; i) anastomosis duration; and j) hospital stay.Data collection and analysisData were independently analysed by the two review authors (CBN, SASL) and cross-checked. the methodological quality of each trial was assessed by the same two authors. After searching the literature for this update, no study was added to those in the previous version of this review. Details of randomizations (generation and concealment), blinding, whether an intention-to-treat analysis was done or not, and the number of patients lost to follow-up were recorded. the analysis of the risk of bias was updated according to the software Review Manager 5.1. the results of each RCT were summarized on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity was defined by the characteristics of the participants, interventions and the outcomes. the RCTs were stratified according to the level of colorectal anastomosis. the risk difference (RD) method (random-effects model) and number needed to treat (NNT) for dichotomous outcome measures and weighted mean differences (WMD) for continuous outcomes measures, with the corresponding 95% confidence intervals (CI), were presented in this review. Statistical heterogeneity was evaluated using a funnel plot and the Chi(2) test.Main resultsOf the 1233 patients enrolled in nine identified trials, 622 were treated with staples and 611 with manual suture. the following main results were obtained.a) Mortality, result based on 901 patients: RD -0.6%, 95% CI -2.8% to +1.6%.b) Overall dehiscence, result based on 1233 patients: RD 0.2%, 95% CI -5.0% to +5.3%.c) Clinical anastomotic dehiscence, result based on 1233 patients: RD -1.4%, 95% CI -5.2 to +2.3%.d) Radiological anastomotic dehiscence, result based on 825 patients: RD 1.2%, 95% CI -4.8% to +7.3%.e) Stricture, result based on 1042 patients: RD 4.6%, 95% CI 1.2% to 8.1%; NNT 17, 95% CI 12 to 31.f) Anastomotic haemorrhage, result based on 662 patients: RD 2.7%, 95% CI -0.1% to +5.5%.g) Reoperation, result based on 544 patients: RD 3.9%, 95% CI 0.3% to 7.4%.h) Wound infection, result based on 567 patients: RD 1.0%, 95% CI -2.2% to +4.3%.i) Anastomosis duration, result based on one study (159 patients): WMD -7.6 minutes, 95% CI -12.9 to -2.2 minutes.j) Hospital stay, result based on one study (159 patients): WMD 2.0 days, 95% CI -3.27 to +7.2 days.Authors' conclusionsThe evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis surgery, regardless of the level of anastomosis. There were no randomised clinical trials comparing these two types of anastomosis in elective conditions in the last decade. the relevance of this research question has possibly lost its strength where elective surgery is concerned. However, in risk situations, such as emergency surgery, trauma and inflammatory bowel disease, new clinical trials are needed.
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    Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery
    (Wiley-Blackwell, 2014-01-01) Silva, Laercio A. [UNIFESP]; Andriolo, Regis B.; Atallah, Alvaro N.; Silva, Edina M. K. da [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Univ Estado Para; Brazilian Cochrane Ctr
    BackgroundIncontinence 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.ObjectivesTo 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 methodsWe 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 criteriaRandomised or quasi-randomised trials that include surgical treatments of urinary incontinence after prostate surgery.Data collection and analysisTwo authors independently screened the trials identified, appraised quality of papers, and extracted data.Main resultsOnly 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' conclusionsThe 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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    Traditional suburethral sling operations for urinary incontinence in women
    (Wiley-Blackwell, 2011-01-01) Rehman, Haroon; Bezerra, Carlos C. B.; Bruschini, Homero [UNIFESP]; Cody, June D.; Univ Aberdeen; Foudat ABC; Universidade Federal de São Paulo (UNIFESP)
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    Urinary catheter policies for long-term bladder drainage
    (Wiley-Blackwell, 2012-01-01) Niel-Weise, Barbara S.; van den Broek, Peterhans J.; Silva, Edina Mariko Koga da [UNIFESP]; Silva, Laercio Antonio da [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Leiden Univ
    BackgroundPeople requiring long-term bladder draining commonly experience catheter-associated urinary tract infection and other problems.ObjectivesTo determine if certain catheter policies are better than others in terms of effectiveness, complications, quality of life and cost-effectiveness in long-term catheterised adults and children.Search methodsWe searched the Cochrane Incontinence Group Specialised Trials Register (searched 28 September 2011). Additionally, we examined all reference lists of identified trials.Selection criteriaAll randomised and quasi-randomised trials comparing catheter policies (route of insertion and use of antibiotics) for long-term (more than 14 days) catheterisation in adults and children.Data collection and analysisData were extracted by two reviewers independently and compared. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. If the data in trials had not been fully reported, clarification was sought from the authors. When necessary, the incidence-density rates (IDR) and/or the incidence-density differences (IDD) within a certain time period were calculated.Main resultsEight trials met the inclusion criteria involving 504 patients in four cross-over and four parallel-group randomised controlled trials. Only two of the pre-stated six comparisons were addressed in these trials.Four trials compared antibiotic prophylaxis with antibiotics when clinically indicated. for patients using intermittent catheterisation, there were inconsistent findings about the effect of antibiotic prophylaxis on symptomatic urinary tract infection (UTI). Only one study found a significant difference in the frequency of UTI favouring prophylaxis. for patients using indwelling urethral catheterisation, one small trial reported fewer episodes of symptomatic UTI in the prophylaxis group. Four trials compared antibiotic prophylaxis with giving antibiotics when microbiologically indicated. for patients using intermittent catheterisation, there was limited evidence that receiving antibiotics reduced the rate of bacteriuria (asymptomatic and symptomatic). There was weak evidence that prophylactic antibiotics were better in terms of fewer symptomatic bacteriuria.Authors' conclusionsNo eligible trials were identified that compared alternative routes of catheter insertion. the data from eight trials comparing different antibiotic policies were sparse, particularly when intermittent catheterisation was considered separately from indwelling catheterisation. Possible benefits of antibiotic prophylaxis must be balanced against possible adverse effects, such as development of antibiotic resistant bacteria. These cannot be reliably estimated from currently available trials.