Search

Abstract Background At present, there is no conclusive evidence regarding the best treatment method for reducible unstable fractures of the distal radius. This study compared the effectiveness of two methods used in surgical treatment of such fractures: percutaneous pinning and external fixation. Methods We randomly allocated 100 patients into two groups treated surgically with modified De Palma percutaneous pinning and bridging external fixation. Independent but not blinded evaluators administered the DASH quality-of-life questionnaire at postoperative months 6 and 24, performed functional assessment of pain, range of motion, and palm grip strength, and radiographic examinations (volar and radial angle, and height of the radius) before the operation, immediately afterwards, and at 6 and 24 months postoperative. Modified De Palma percutaneous pinning patients used an above-elbow cast whereas external fixation group had unrestricted elbow motion after surgery. Patients who for any reason demonstrated treatment failure or required additional interventions were followed up and their results were included in the group into which these patients had initially been randomised according to the intention-to-treat principle. A significance level of 5% (alpha = 0.05). was used for all statistical tests, such that tests presenting a p-value less than 0.05 were considered statistically significant. Results Ninety one (58.8 mean age and 66 participants were female) were included in the final assessment at 24 months. The DASH questionnaire evaluation showed a statistically significant result favouring the De Palma group (mean difference = -7.1 p = 0.044) after six months, but this was not maintained at 24 months. There were no statistically differences between the groups with respect to palm grip strength. Analysis of the range-of-motion limitation index (uninjured side minus affected side motion of) showed a statistical difference (mean difference = 2.4 p = 0.043) favoring the external fixator group with regard to the supination movement 6 months after the operation; however, this was not maintained at 24 months. The final results of the radiographic evaluation were similar for the two groups. Overall, five patients developed complications: two with De Palma pinning and three with external fixation. Conclusion There was a small statistically significant difference favouring the De Palma method in early functional at 6 months according to the DASH questionnaire, and for supination movement favouring the fixator group. However, both were not clinical relevant. By 24 months the groups were similar for all outcomes Trial registration Current Controlled Trials ISRCTN04892785

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.

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.

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.

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.

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.

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., (© 2013 The American Laryngological, Rhinological and Otological Society, Inc.)

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.

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.

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.

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.

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.

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.

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.

Background: Injuries of the posterior cruciate ligament (PCL) of the knee frequently occur in automobile accidents and sports injuries, although they are less frequent overall than injuries of the anterior cruciate ligament (ACL). Some patients show significant symptoms and subsequent articular deterioration, while others are essentially asymptomatic, maintaining habitual function. Management of PCL injuries remains controversial and prognosis can vary widely. Interventions extend from non-operative (conservative) procedures to reconstruction of the PCL, in the hope that the surgical procedure may have a positive effect in the reduction/prevention of future osteoarthritic changes in the knee., Objectives: To determine the effectiveness and safety of surgical and conservative interventions for PCL injuries in adults., Search Methods: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (April 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE via PubMed (1966 to April 2004), EMBASE (1966 to April 2004), CINAHL (1982 to April 2004), LILACS (1982 to April 2004), SportsDiscus (1975 to April 2004), and reference lists of articles., Selection Criteria: Randomized or quasi-randomized clinical trials comparing various methods of operative and conservative interventions, and comparisons with each other for the treatment of PCL injuries., Data Collection and Analysis: References found with the search strategy were evaluated independently by two review authors., Main Results: No randomized or quasi-randomized controlled studies meeting the selection criteria were identified., Authors' Conclusions: Future research should include randomized controlled trials of acute isolated PCL injuries, or PCL injuries when combined with other ligament injuries of the knee, treated operatively and conservatively. Adequate numbers of patients and an objective methodology for patient evaluation must be used in future studies of these interventions to determine the long-term results.

Background: Congenital choanal atresia is a rare abnormality characterized by unilateral or bilateral lack of patency of the posterior end of the nasal cavity. With an incidence of 1:5000 to 1:8000 births, it is twice as prevalent in females as it is in males. Surgical procedures aim to provide adequate functional choanal patency and a low rate of restenosis, avoid harm to any structure in development, enable shorter surgery and hospitalization times, and minimize morbidity and mortality., Objectives: To evaluate the effectiveness and safety of the available surgical techniques for the treatment of congenital choanal atresia in patients with unilateral and bilateral atresia., Search Methods: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the search was 31 January 2011., Selection Criteria: We planned to include parallel randomized or quasi-randomized controlled trials testing surgical approaches for the treatment of congenital atresia (irrespective of gender and age) that evaluated normal/adequate respiratory function (self reported or preserved nasal airway) and restenosis as the main primary outcomes. We did not consider reoperation and non-congenital atresia (e.g. traumatic, iatrogenic atresias) for inclusion., Data Collection and Analysis: Three review authors independently assessed the titles and abstracts of the identified articles to determine potential relevance. For dichotomous and continuous variables, we planned to calculate risk ratios (relative risks; RR) and mean differences (MD) with 95% confidence intervals (CI), respectively. We planned to use the random-effects model since we were expecting substantial clinical and methodological heterogeneity., Main Results: No randomized controlled trials were identified. From the 120 reports retrieved using our search strategy, 46 primary studies had the potential to be included since they had tested surgical approaches for choanal atresia. However, we excluded all of them during the final selection process because their study designs did not meet our inclusion criteria., Authors' Conclusions: There is no definitive evidence, based on randomized controlled trials, to demonstrate the potential advantages and disadvantages of any specific surgical technique for patients with choanal atresia. Specialists should unify their efforts in multicenter randomized controlled trials that test the effectiveness and safety of different surgical techniques in patients with choanal atresia.

Background: Premature ejaculation (PE) is a very common sexual dysfunction among patients, and with varying prevalence estimates ranging from 3% to 20%. Although psychological issues are present in most patients with premature PE, as a cause or as a consequence, research on the effects of psychological approaches for PE has in general not been controlled or randomised and is lacking in long-term follow up., Objectives: To assess the efficacy of psychosocial interventions for PE.To investigate any differences in efficacy between different types of psychosocial treatments for PE.To compare psychosocial interventions with pharmacological treatment and pharmacological treatment in association with psychosocial treatment for PE., Search Strategy: Trials were searched in computerized general and specialized databases, such as: MEDLINE by PubMed (1966 to 2010); PsycINFO (1974 to 2010); EMBASE (1980 to 2010); LILACS (1982 to 2010); the Cochrane Central Register of Controlled Trials (Cochrane Library, 2010); and by checking bibliographies, and contacting manufacturers and researchers., Selection Criteria: Randomised or quasi-randomised controlled trials evaluating psychosocial interventions compared with different psychosocial interventions, pharmacological interventions, waiting list, or no treatment for PE., Data Collection and Analysis: Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The primary outcome measure for comparing the effects of psychosocial interventions to waiting list and standard medications was improvement in IELT (i.e., time from vaginal penetration to ejaculation). The secondary outcome was change in validated PE questionnaires., Main Results: In one study (De Carufel 2006) behavioral therapy (BT) was significantly better than waiting list for duration of intercourse (MD (mean difference) 407.90 seconds, 95% CI 302.42 to 513.38), and couples' sexual satisfaction (MD -26.10, CI -50.48 to -1.72). BT was also significantly better for a new functional-sexological treatment (FS) (MD 412.00 seconds, 95% CI 305.88 to 518.12), change over time in subjective perception of duration of intercourse (Women: MD 2.88, 95% CI 2.06 to 3.70; Men: MD 2.52, CI 1.65 to 3.39) and couples' sexual satisfaction (MD -25.10, 95% CI -47.95 to -2.25), versus waiting list.One study (Li 2006) showed that the combination of chlorpromazine and BT was superior than chlorpromazine alone for IELT (MD 1.11, 95% CI 0.82 to 1.40), SAS (Self-rating Anxiety Scale) (MD -8.72, 95% CI -11.09 to -6.35) and for some CIPE (Chinese Index Premature Ejaculation) questions ('anxiety in sexual activity', 'partner sexual satisfaction', 'patient sexual satisfaction', 'control ejaculatory reflex' and 'ejaculatory latency') ('Analysis 1.2').One study (Yuan 2008) showed that citalopram significantly improved IELT (RR (risk ratio) 0.52, 95% CI 0.34 to 0.78) and the number of couples satisfied with their sex life after treatment (RR 0.60, 95% CI 0.39 to 0.93), versus BT.In the last study (Abdel-Hamid 2001), 31 patients received 1 of 4 drugs administered on an as-needed basis 35 hours before anticipated coitus (clomipramine, sertraline, paroxetine, sildenafil), or were instructed to use the pause-squeeze technique. The study consisted of five four-week periods of treatment, separated by two-week washout periods. Anxiety score and ejaculation latency time were measured before treatment, after each treatment and during washout periods. Sexual satisfaction scores were measured after each treatment. However the available data from the article were not sufficient to be included, and the related database was not available anymore, according to the main author., Authors' Conclusions: Overall, there is weak and inconsistent evidence regarding the effectiveness of psychological interventions for the treatment of premature ejaculation. Three of the four included randomised controlled studies of psychotherapy for PE reported our primary outcome (Improvement in IELT), and the majority have a small sample size. The early success reports (97.8%) of Masters and Johnson could not be replicated. One study found a significant improvement from baseline in the duration of intercourse, sexual satisfaction and sexual function with a new functional-sexological treatment and behavior therapy compared to waiting list. One study showed that the combination of chlorpromazine and BT was superior to chlorpromazine alone. Randomised trials with larger group samples are still needed to further confirm or deny the current available evidence for psychological interventions for treating PE.

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, postprostatectomy incontinence may be caused by sphincter malfunction and/or bladder dysfunction. The majority of men with post-prostatectomy incontinence (60 to 100%) have stress urinary incontinence, which is the complaint of 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 either benign LUTS secondary to BPH (transurethral resection of prostate (TURP), photo vaporization of the prostate, laser enucleation of the prostate and open prostatectomy) or radical prostatectomy for prostate cancer (retropubic, perineal, laparoscopic, or robotic)., Search Strategy: We searched the Cochrane Incontinence Group Specialised Register (searched 28 June 2010), MEDLINE (January 1966 to January 2010), EMBASE (January 1988 to January 2010), LILACS (January 1982 to January 2010) and the reference lists of relevant articles, handsearched conference proceedings and 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 subgroups (minimal or total incontinence) and each group was randomized 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%) (OR 5.67, 95% 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 confidence intervals were wide. There were more severe complications in the group undergoing AUS, and the costs were higher., Authors' Conclusions: The evidence available at present is limited because only one small randomised clinical trial was identified. Although the result is 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.

Background: Mortality rates among patients with sepsis, severe sepsis or septic shock ranges from 27% to 54%. Empirical broad-spectrum antimicrobial treatment is aimed at achieving adequate antimicrobial therapy and 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 with a narrower antimicrobial therapy. This is done by either changing the pharmacological agent or discontinuing a pharmacological combination according to the patient's microbial culture results., 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 Strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 8); MEDLINE via PubMed (from inception to August 2010); EMBASE (from inception to August 2010); LILACS (from inception to August 2010); Current Controlled Trials and bibliographic references of relevant studies. We also contacted the main authors in the area. We applied no language restriction., Selection Criteria: We planned to include randomized controlled trials 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 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 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: We retrieved 436 references via the search strategy. No randomized controlled trials testing de-escalation antimicrobial treatment for adult patients diagnosed with sepsis, severe sepsis or septic shock could be included in this review., 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. Therefore, it is not possible to either recommend or not recommend the de-escalation of antimicrobial agents in clinical practice for septic patients. This uncertainty warrants further research via randomized controlled trials or cohort studies.

Background: Pre-eclampsia and eclampsia are common causes of serious morbidity and death. Calcium supplementation may reduce the risk of pre-eclampsia through a number of mechanisms, 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 Strategy: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2010) and contacted study authors., Selection Criteria: Randomised trials comparing at least 1 g daily of calcium during pregnancy with placebo., Data Collection and Analysis: We assessed eligibility and trial quality, extracted and double-entered data., Main Results: We 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' Conclusions: Calcium 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.

Background: Patients with rheumatoid arthritis may have an increased risk of falls due to impairments in lower-extremity joints, which may result in either mobility, or postural stability problems. There is evidence in the literature suggesting that balance, agility and coordination training techniques can induce changes in lower-extremity muscle activity patterns that result in improvement in dynamic joint stability.The mechanoreceptors present in and around the joints are responsible for maintaining postural control and joint position sense. These receptors are integrated to compose the somatosensorial system. In combination with visual and auditory inputs, which improve our spatial perception even further, the systems are able to maintain a stable body posture.However, there is a lack of information on the efficacy of balance training alone in patients with rheumatoid arthritis., Objectives: To assess the effectiveness and safety of balance training (proprioceptive training) to improve functional capacity in patients with rheumatoid arthritis., Search Strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 4), MEDLINE via PubMed (January 1966 to December 2008), EMBASE (January 1980 to December 2008), LILACS (January 1982 to December 2008), CINAHL (January 1982 to December 2008), PEDro and Scirus (inception to 2008). We also handsearched conference abstracts., Selection Criteria: All eligible randomised controlled trials (RCT) or controlled clinical trials (CCT) comparing balance training (proprioceptive training) with any other intervention or with no intervention., Data Collection and Analysis: Two review authors independently assessed titles or abstracts, or both, for inclusion criteria., Main Results: The electronic search identified 864 studies. From this search, 17 studies described general exercises in rheumatoid arthritis patients as the main topic. After analysing them, we observed that the main interventions were exercises to improve muscle strength, endurance, and dynamic exercises (swimming, walking, etc). As we did not find any studies investigating the effects of balance training alone or in combination with other therapies in patients with rheumatoid arthritis, it was not possible to include any data regarding the chosen topic in this systematic review., Authors' Conclusions: There is no research available examining the efficacy of balance training alone in patients with rheumatoid arthritis. The effectiveness and safety of balance training to improve functional capacity of these patients remains unclear. We suggest that future research should give more importance to balance training by either increasing the number and duration of sessions or investigating its efficacy alone.

Background: Although 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., Objectives: To evaluate the effectiveness and safety of aerobic exercise training programmes for physiological and psychosocial outcomes in adults with Down syndrome., Search Strategy: The 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 Criteria: Randomised or quasi-randomised controlled trials using supervised aerobic exercise training programmes with behavioral components accepted as co-interventions., Data Collection and Analysis: Two 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 Results: Three 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' Conclusions: There 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.

Background: Genital warts are common and usually are harmless but can be painful and psychologically burdensome. Several local treatments can be used, including topical 5-Fluorouracil (5-FU)., Objectives: To determine the effectiveness and safety of 5-FU topical treatment for genital warts in nonimmunocompromised individuals., Search Strategy: Databases searched were Cochrane Central Register of Controlled Trials (The Cochrane Library 2009 Issue 3), MEDLINE (1966 to August 2009), EMBASE (until August 2009), LILACS (1982 to August 2009). The search had no language or publication restrictions., Selection Criteria: The review included randomised controlled trials (RCTs) among women, men, or both sexes, aged 18 years and older, comparing: 5-FU versus placebo or no treatment; 5-FU in any dose versus other isolated treatment, topical or systemic; 5-FU in any dose associated with other treatment versus placebo; 5-FU in any dose associated with other treatment versus other isolated treatment, topical or systemic; 5-FU in any dose associated with other treatment versus other associated treatment, topical or systemic., Data Collection and Analysis: Two authors independently assessed trial quality and extracted data from the original publications., Main Results: Six trials involving 988 patients (645 women and 343 men) and reporting eight comparisons were found. Two studies reported withdrawals and dropouts, but none mentioned analysis by intention to treat (ITT). 5-FU presented better results for cure than placebo or no treatment (relative risk (RR) 0.39, 95% confidence interval (CI) 0.23 to 0.67), meta-cresol-sulfonic acid (MCSA) (RR 2.11, 95% CI 0.83 to 5.37), Podophylin 2%, 4% or 25% (RR 1.26, 95% CI 0.86 to 1.82). There were no statistical differences for treatment failure for 5-FU versus CO2 Laser (RR 0.69, 95% CI 0.43 to 1.11) versus 5-FU + INFalpha-2a (low dose) (RR 1.02, 95% CI 0.87 to 1.119). Worse results were found for 5-FU versus 5-FU + INFalpha-2a (high dose) (RR 10.78, 95% CI 1.50 to 77.36), and 5-FU + CO2 Laser INFalpha-2a (high dose) (RR 7.97, 95% CI 2.87 to 22.13)., Authors' Conclusions: The reviewed trials were highly variable in methods and quality, and the evidence provided by these studies was weak. Cure rates with several treatments were variable, and although 5-FU presents therapeutic results that are inferior to those seen with 5-FU + Inf alpha-2a (high dose) and 5-FU + CO2 Laser + Inf alpha-2a (high dose), the treatment should not be abandoned. Topical treatment with 5-FU has a therapeutic effect; however, the benefits and risks have not been determined clearly and further studies are needed.

Background: Leptospirosis is a parasitic disease transmitted by animals. Severe leptospirosis may result in hospitalisation and about five per cent of the patients die. In clinical practice, penicillin is widely used for treating leptospirosis., Objectives: To evaluate the effectiveness and safety of antibiotics versus placebo or other antibiotic regimens in treating leptospirosis. We addressed the following clinical questions: a) Are treatment regimens with antibiotics more efficient than placebo for leptospirosis? b) Are treatment regimens with antibiotics safe when compared to placebo for leptospirosis? c) Which antibiotic regimen is the most efficient and safest in treating leptospirosis?, Search Strategy: Electronic searches and searches of the identified articles were combined., Studies: Randomised clinical trials in which antibiotics were used as treatment for leptospirosis. Language, date, or other restrictions were not applied., Participants: Patients with clinical manifestations of leptospirosis., Interventions: Any antibiotic regimen compared with a control group (placebo or another antibiotic regimen)., Data Collection and Analysis: Data and methodological quality of each trial were independently extracted and assessed by two reviewers. The random effects model was used irrespective of significant statistical heterogeneity., Main Results: Three trials met inclusion criteria. Allocation concealment and double blind methods were not clearly described in two. Of the patients enrolled, 75 were treated with placebo and 75 with antibiotics: 61 (81.3%) penicillin and 14 (18.6%) doxycycline. The patients assigned to antibiotics compared to placebo showed: a) Mortality: 1% (1/75) versus 4% (3/75); risk difference -2%, 95% confidence interval -8% to 4%. b) Duration of hospital stay (days): weighted mean difference 0.30, 95% confidence interval -1.26 to 1.86. c) Prolonged hospital stay (> seven days): 30% (7/23) versus 74% (14/19); risk difference -43%, 95% confidence interval -70% to -16%. Number needed-to-treat 3, 95% confidence interval 2 to 7. d) Period of disappearance of fever (days): weighted mean difference -4.04, 95% confidence interval -8.65 to 0.58. e) Leptospiruria: 5% (4/75) versus 40% (30/75); risk difference -46%, 95% confidence interval -88% to -3%. Number needed-to-treat 2, 95% confidence interval 1 to 33., Authors' Conclusions: Antibiotic regimens for treatment of leptospirosis is a form of care for which the evidence is insufficient to provide clear guidelines for practice. The randomised trials suggest that antibiotics could be a useful treatment for leptospirosis. Because of the questionable quality of two of the three trials, the indication for general use of antibiotics is uncertain. However, the evidence suggest that penicillin may cause more good than harm.

Background: Leptospirosis is an infectious disease transmitted by animals. Death occurs in about five per cent of the patients. In clinical practice, doxycycline is widely used for prevention., Objectives: To evaluate the effectiveness and safety of any antibiotic regimen versus placebo or other antibiotic regimens in the prophylaxis of leptospirosis., Search Strategy: The sources used were: EMBASE, LILACS, MEDLINE, SCISEARCH, The Cochrane Controlled Trials Register, The Cochrane Hepato-Biliary Group Controlled Trials Register, bibliographies of published papers, and personal communication with authors. There were no language or date restrictions in any of the searches., Studies: All randomised clinical trials in which antibiotics were used as prophylactic regimen for leptospirosis., Participants: People potentially exposed to leptospirosis, such as people in endemic areas during the rainy season, health professionals and other professionals with high risk of infection., Intervention: Any antibiotic regimen compared with a control group (placebo or another antibiotic regimen)., Outcomes: Infection (primary outcome) and adverse events (secondary outcome)., Data Collection and Analysis: Data were independently extracted and methodological quality of each trial was assessed by two reviewers as well as cross-checked. Details of the randomisation (generation and concealment), blinding, and the number of patients lost to follow-up were recorded. The results of each trial were summarised on an intention-to-treat basis in 2 x 2 tables for each outcome., Main Results: Two trials comparing doxycycline with placebo met the inclusion criteria. We did not find trials comparing doxycycline versus other antibiotics, or other antibiotics versus placebo. One of the trials had excellent methodological quality. In the other trial, the allocation concealment process, generation of allocation sequence, and blinding methods were not described.Of the 1022 participants enrolled, 509 were treated with doxycycline and 513 with placebo. Of these, 940 participants were soldiers included in one trial. The patients assigned to the antibiotics group compared with the ones assigned to the placebo group showed: Symptomatic, verified leptospirosis: 0.6% (3/509) versus 4.9% (25/ 513); risk difference (random effects model) -4.1%, 95% confidence interval -5.9% to -2.3%. Number needed-to-treat 24 (95% confidence interval 17 to 43). Adverse effects: 3% (13/469 participants) versus 0.2% (1/471 participants); random effects model 2.6%, 95% confidence interval 1.0% to 4.1%. Number needed-to-harm 39 (95% confidence interval 25 to 100)., Authors' Conclusions: Prophylaxis of leptospirosis may be achieved by administration of doxycycline to soldiers training in endemic areas with a high risk of exposure to leptospirosis. Whether these findings apply to other scenarios or not remains to be proven.

Background: Myofascial pain (MP) is a painful condition characterized by pain transmitted from trigger points (TP) within myofascial structures (in the muscles), local or distant from the pain. TPs can produce a characteristic pattern of irradiated pain or autonomic symptoms when stimulated. Cyclobenzaprine, a muscle relaxant that suppresses muscle spasm without interfering with muscle function, is used in clinical management of MP to improve quality of sleep and reduce pain., Objectives: To assess efficacy and safety of cyclobenzaprine in treating MP., Search Strategy: The Pain Palliative and Supportive Care Review Group's Specialised Register, CENTRAL, PubMed, EMBASE, LILACS and Scielo were searched in February 2009., Selection Criteria: All RCTs and quasi-RCTs reporting use of cyclobenzaprine for treating MP with pain assessment as a primary or secondary outcome., Data Collection and Analysis: Two review authors independently screened studies identified, extracted data, assessed trial quality and analyzed results., Main Results: We identified two studies with a total of 79 participants. One study, with 41 participants, compared cyclobenzaprine with clonazepam and with placebo. Participants taking cyclobenzaprine had some improvement of pain intensity compared to those on clonazepam, mean difference (MD) -0.25 (95% CI, -0.41 to -0.09; P value 0.002) and placebo, MD -0.25 (95% CI, 0.41 to -0.09; P value 0.002). The other study, with 38 participants, compared cyclobenzaprine with lidocaine infiltration. Thirty days after treatment there were statistically non-significant differences between comparison groups, favoring lidocaine infiltration, for the mean for global pain, MD 0.90 (95% CI -0.35 to 2.15, P value 0.16), and for the mean for pain at digital compression, MD 0.60 (95% CI -0.55 to 1.75, P value 0.30). There were no life-threatening adverse events associated with the medications., Authors' Conclusions: There was insufficient evidence to support the use of cyclobenzaprine in the treatment of MP. We identified only two small studies in which a total of 35 participants were given cyclobenzaprine, and it was not possible to estimate risks for benefits or harms. Further high quality RCTs of cyclobenzaprine for treating MP need to be conducted before firm conclusions on its effectiveness and safety can be made. Experts in this area should elect cut-off points for participants to identify whether a patient has achieved a clinically relevant reduction of pain (primary outcome), so that their results can be combined easily into future versions of this review.

Background: Although 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., Objectives: To evaluate the effectiveness and safety of aerobic exercise training programmes for physiological and psychosocial outcomes in adults with Down syndrome., Search Strategy: Search terms and synonyms for "aerobic exercise" and "Down syndrome" were used within the following databases: CENTRAL (2007, Issue 1); MEDLINE via PUBMED (1966 to March 2007); EMBASE (2005 to April 2007); CINAHL (1982 to March 2007); LILACS (1982 to March 2007); PsycINFO (1887 to March 2007); ERIC (1966 to March 2007); CCT (March 2007); Academic Search Elite (to March 2007), C2- SPECTR (to March 2007 ), NRR (2007 Issue 1), ClinicalTrials.gov (accessed March 2007) and within supplements of Medicine and Science in Sports and Exercise., Selection Criteria: Randomised or quasi-randomised controlled trials using supervised aerobic exercise training programmes with behavioral components accepted as co-interventions., Data Collection and Analysis: Two reviewers selected relevant trials, assessed methodological quality and extracted data. Where appropriate, data was pooled using meta-analysis with a random effects model, Main Results: The two studies included in this trial used different kinds of aerobic activity: walking/jogging and rowing training. One included study was conducted in the USA, the other in Portugal. In the meta-analyses, only maximal treadmill grade, a work performance variable, was improved in the intervention group after aerobic exercise training programmes (-4.26 [95% CI -6.45, -2.06]) grade. The other outcomes in the meta-analysis showed no significant differences between intervention and control groups, as expressed by weighted mean difference: VO(2) peak -0.30 (95% CI -377, 3.17) mL.Kg.min(-1); peak heart rate, -2.84 (95% CI -10.73, 5.05) bpm; respiratory exchange ratio, 0.01 (95% CI -0.04, 0.06); pulmonary ventilation, -5.86 (95% CI -16.06, 4.34) L.min(-1). 30 other measures including work performance, oxidative stress and body composition variables could not be combined in the meta-analysis. Apart from work performance, trials reported no significant improvements in these measures., Authors' Conclusions: There is insufficient evidence to support improvement in physical or psychosocial outcomes of aerobic exercise in adults with Down syndrome. Although evidence exists which supports improvements in physiological and psychological aspects from strategies using mixed physical activity programmes, well-conducted research which examines long-term physical outcomes, adverse effects, psychosocial outcomes and costs are required before informed practice decisions can be made.

Background: Non-invasive positive pressure ventilation (NPPV) has been widely used to alleviate signs and symptoms of respiratory distress due to cardiogenic pulmonary edema. 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 edema., Search Strategy: We undertook a comprehensive search of the following databases in April 2005: CENTRAL, MEDLINE, EMBASE, CINAHL, DARE and LILACS. We also reviewed reference lists of included studies and contacted experts, equipment manufacturers, and the Cochrane Heart Group. We did not apply language restrictions., Selection Criteria: We selected blinded or unblinded randomized or quasi-randomized clinical trials, reporting on adult patients with acute or acute-on-chronic cardiogenic pulmonary edema and where NPPV (continuous positive airway pressure (CPAP)) and/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 standardized data collection form. We evaluated study quality with emphasis on allocation concealment, adherence to the intention-to-treat principle and losses to follow-up., Main Results: We included 21 studies involving 1,071 participants. Compared to standard medical care, NPPV significantly reduced hospital mortality (RR 0.6, 95% CI 0.45 to 0.84) and endotracheal intubation (RR 0.53, 95% CI 0.34 to 0.83) with numbers needed to treat of 13 and 8, respectively. We found no difference in hospital length of stay with NPPV, however, intensive care unit stay was reduced by 1 day (WMD -1.07 days, 95% CI -1.60 to -0.53). Compared to standard medical care, we did not observe significant increases in the incidence of acute myocardial infarction with NPPV during (RR 1.24, 95% CI 0.79 to 1.95) or after (RR 0.82, 95% CI 0.09 to 7.54) its application., Authors' Conclusions: NPPV, especially CPAP, in addition to standard medical care is an effective and safe intervention for the treatment of adult patients with acute cardiogenic pulmonary edema.

Rationale and Aim: Over the past 12 years, thousands of authors working with the Cochrane Collaboration around the world have produced systematic reviews to reduce uncertainty in health care decision making. We evaluated the conclusions from Cochrane systematic reviews of randomized controlled trials in terms of their recommendations for clinical practice and research., Methods: In our cross-sectional study of systematic reviews published in the Cochrane Library, we randomly selected and analysed completed systematic reviews published across all 50 Cochrane Collaborative Review Groups., Results: We analysed 1016 completed systematic reviews. Of these, 44% concluded that the interventions studied were likely to be beneficial, of which 1% recommended no further research and 43% recommended additional research. Also, 7% of the reviews concluded that the interventions were likely to be harmful, of which 2% did not recommend further studies and 5% recommended additional studies. In total, 49% of the reviews reported that the evidence did not support either benefit or harm, of which 1% did not recommend further studies and 48% recommended additional studies. Overall, 96% of the reviews recommended further research., Conclusions: Cochrane systematic reviews were about evenly split between those in which the authors concluded that at least one of the interventions was beneficial and those in which the evidence neither supported nor refuted the intervention tested. The Cochrane Collaboration needs to include clinical trial protocol summaries with a study design optimized to answer the relevant research questions.