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PubMed2003

Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys.

BACKGROUND: Circumcision is a commonly performed surgical procedure in boys and caudal analgesia is frequently used to minimize discomfort of penile surgery postoperatively. For humanitarian and physiological reasons pain should be anticipated and effectively controlled while ensuring patient safety. Several non-caudal analgesic techniques can be used including: penile block, systemic opioids and topical local anaesthetic cream,emulsion or gel. OBJECTIVES: To compare the relative efficacy and side effects of caudal epidural analgesia with other forms of postoperative analgesia following circumcision in boys. SEARCH STRATEGY: CENTRAL, MEDLINE (from 1966), and EMBASE are searched using MeSH headings: Circumcision, Anesthesia-Caudal, Pediatric or Child, and the text words circumcision and caudal. Bibliographies of published trials and conference proceedings are also reviewed. Date of last search: December 2002. SELECTION CRITERIA: Published randomized and quasi-randomized controlled trials in which postoperative analgesia by caudal epidural block is compared with a non-caudal method of analgesia, in boys whose mean age is between 28 days and 16 years, having elective surgery for circumcision. DATA COLLECTION AND ANALYSIS: Trials identified from searching are assessed for inclusion and data extracted independently by two reviewers. Review Manager software is used for calculation of the treatment effect, represented by relative risks (RR), using a fixed effects model with 95% Confidence Intervals (CI). MAIN RESULTS: Seven trials of average quality involving 374 patients are included in this review. Only two comparisons of caudal analgesia have been investigated; parenteral analgesics in six trials, and penile block in one trial. Although some trial heterogeneity is evident this does not reach statistical significance. The need for rescue analgesia is reduced when caudal analgesia is compared with parenteral medications,((RR 0.32(0.16,0.63)). The incidence of nausea and vomiting is decreased in caudal patients compared with those receiving parenteral analgesics (RR 0.57 (0.35-0.93)) but not with those receiving penile block. REVIEWER'S CONCLUSIONS: Few studies compare caudal analgesia with other commonly available methods of analgesia in boys having circumcision surgery. Although the need for rescue analgesia is reduced in the early postoperative period when caudal is compared with parenteral analgesia,evidence from trials may no longer reflect current practice and is limited by small numbers and poor methodology. There is a need for properly designed trials to study the relative efficacy of caudal epidural with other methods such as penile block, morphine, simple analgesics and topical local anaesthetic cream,emulsions or gel.

Anesthesia, Caudal↗
PubMed2001

Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer.

BACKGROUND: Postoperative air leak is a frequent complication after pulmonary resection for lung cancer. It may cause serious complications, such as empyema, or prolong the need for chest tube and hospitalisation. Surgical sealants of different types have been developed to prevent or to reduce postoperative air leaks. A systematic review was therefore undertaken to evaluate the evidence on their effectiveness. OBJECTIVES: To evaluate the effectiveness of surgical sealants in preventing or in reducing postoperative air leaks after pulmonary resection for lung cancer. SEARCH STRATEGY: Electronic databases and, bibliographies were searched and, hand searching of conference proceedings was conducted to identify published and unpublished trials. SELECTION CRITERIA: Randomised controlled clinical trials were included in which standard closure techniques plus a sealant were compared with the same intervention with no use of any sealant in patients undergoing elective pulmonary resection provided that a large proportion of the patients studied had undergone pulmonary resection for lung cancer. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected the trials to be included in the review, assessed methodological quality of each trial and extracted data using a standardised form. Because of several limitations, narrative synthesis was used at this stage. MAIN RESULTS: Two hundred and thirty-two patients from 4 trials were included. In two trials no differences were found between treatment and control patients in terms of reduction of duration of air leaks, chest tube drainage, hospitalisation or complications attributable to prolonged intercostal drainage. In the other two trials, postoperative air leaks were significantly reduced in the treatment groups, but there were no differences in hospital stay, complications, fever, intraoperative and postoperative intubation times, chest tube drainage or cost. REVIEWER'S CONCLUSIONS: Systematic use of surgical sealants in clinical practice cannot be recommended at the moment. More randomised controlled clinical trials are needed.

Air↗
PubMed2005

Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer.

BACKGROUND: Postoperative air leak is a frequent complication after pulmonary resection for lung cancer. It may cause serious complications, such as empyema, or prolong the need for chest tube and hospitalisation. Surgical sealants of different types have been developed to prevent or to reduce postoperative air leaks. A systematic review was therefore undertaken to evaluate the evidence on their effectiveness. OBJECTIVES: To evaluate the effectiveness of surgical sealants in preventing or in reducing postoperative air leaks after pulmonary resection for lung cancer. SEARCH STRATEGY: The electronic databases MEDLINE (1966 to 2004), EMBASE (1974 to 2004), Cancerlit (1993 to 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3/2004) and listed references were searched, and handsearching of conference proceedings was conducted to identify published and unpublished trials. SELECTION CRITERIA: Randomised controlled clinical trials were included in which standard closure techniques plus a sealant were compared with the same intervention with no use of any sealant in patients undergoing elective pulmonary resection provided that a large proportion of the patients included in the studies had undergone pulmonary resection for lung cancer. DATA COLLECTION AND ANALYSIS: Three reviewers independently selected the trials to be included in the review, assessed methodological quality of each trial and extracted data using a standardised form. Because of several limitations, narrative synthesis was used at this stage. MAIN RESULTS: Twelve trials, with 1097 patients in total, were included. In eight trials there was a statistically significant difference between treatment and control patients in reducing postoperative air leaks. However this reduction only proved a significant reduction of hospital stay in one trial. Only in one trial reduction of time of chest drain removal and reduction of percentage of patient with persistent air leak were significantly smaller in the treatment group. AUTHORS' CONCLUSIONS: Although surgical sealants seem to reduce postoperative air leaks, length of hospitalisation is not affected and infectious complications may be increased. Therefore, systematic use of surgical sealants in clinical practice cannot be recommended at the moment. More randomised controlled clinical trials are needed.

Air↗
PubMed2003

Area-wide traffic calming for preventing traffic related injuries.

BACKGROUND: It is estimated that by 2020 road traffic crashes will have moved from ninth to third in the world disease burden ranking, as measured in disability adjusted life years, and second in developing countries. The identification of effective strategies for the prevention of traffic related injuries is of global health importance. Area-wide traffic calming schemes that discourage through traffic on residential roads is one such strategy. OBJECTIVES: To evaluate the effectiveness of area-wide traffic calming in preventing traffic related crashes, injuries, and deaths. SEARCH STRATEGY: We searched the following electronic databases: Cochrane Injuries Group's Specialised Register, Cochrane Controlled Trials Register, MEDLINE, EMBASE and TRANSPORT (NTIS, TRIS, TRANSDOC). We searched the web sites of road safety organisations, handsearched conference proceedings, checked reference lists of relevant papers and contacted experts in the area. The search was not restricted by language or publication status. SELECTION CRITERIA: Randomised controlled trials, and controlled before-after studies of area-wide traffic calming schemes. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data on type of study, characteristics of intervention and control areas, and length of data collection periods. Before and after data were collected on the total number of road traffic crashes, all road user deaths and injuries, pedestrian-motor vehicle collisions and road user deaths. The statistical package STATA was used to calculate rate ratios for each study, which were then pooled to give an overall estimate using a random effects model. MAIN RESULTS: We found no randomised controlled trials, but 16 controlled before-after trials met our inclusion criteria. Seven studies were done in Germany, six in the UK, two in Australia and one in the Netherlands. There were no studies in low or middle income countries. Eight trials reported the number of road traffic crashes resulting in deaths. The pooled rate ratio was 0.63 (0.14, 2.59 95% CI). Sixteen studies reported the number of road traffic crashes resulting in injuries (fatal and non fatal). The pooled rate ratio was 0.89 (0.80, 1.00 95% CI). Nine studies reported the total number of road traffic crashes. The pooled rate ratio was 0.95 (0.81, 1.11 95% CI). Thirteen trials reported the number of pedestrian-motor vehicle collisions. The pooled rate ratio was 1.00 (0.84, 1.18). There was significant heterogeneity for the total number of crashes and deaths and injuries. REVIEWER'S CONCLUSIONS: The results from this review suggest that area-wide traffic calming in towns and cities may be a promising intervention for reducing the number of road traffic injuries, and deaths. However, further rigorous evaluations of this intervention are needed.

Accident Prevention↗
PubMed2005

Long-acting beta2-agonists versus anti-leukotrienes as add-on therapy to inhaled corticosteroids for chronic asthma.

BACKGROUND: Patients who continue to experience asthma symptoms despite taking regular inhaled corticosteroids (ICS) represent a management challenge. Leukotriene receptor antagonists (LTRA) and long-acting beta2-agonists (LABA) agents may both be considered as add-on therapy to inhaled corticosteroids (ICS). OBJECTIVES: We compare the efficacy and safety profile of adding either daily LABA or LTRA in asthmatic patients with asthma who remained symptomatic on ICS. SEARCH STRATEGY: MEDLINE, EMBASE, CINAHL databases were searched for randomised controlled trials up to and including January 2004. Reference lists of all included studies and reviews were screened to identify potentially relevant citations. Inquiries regarding other published or unpublished studies supported by the authors of the included studies or pharmaceutical companies who manufacture these agents were made. Conference proceedings of major respiratory meetings were also searched. SELECTION CRITERIA: Only randomised controlled trials conducted in adults or children with recurrent asthma where a LABA (for example, salmeterol or formoterol) or LTRA (for example, montelukast, pranlukast, zafirlukast) was added to ICS for a minimum of 28 days were considered for inclusion. Inhaled short-acting beta2-agonists and short courses of oral steroids were permitted as rescue medications. Other daily asthma treatments were permitted, providing the dose remained constant during the intervention period. Two reviewers independently reviewed the literature searches. DATA COLLECTION AND ANALYSIS: Data extraction and trial quality assessment were conducted independently by two reviewers. Whenever possible, primary study authors were requested to confirm methodology and data extraction and to provide additional information and clarification when needed. Where necessary, expansion of graphic reproductions and estimation from other data presented in the paper was performed. MAIN RESULTS: Twelve randomised controlled trials met the inclusion criteria; only eight trials including 5,895 patients, provided data in sufficient details to allow aggregation. All eight trials pertained to adults with moderate airway obstruction (% predicted FEV1 66-76%) at baseline. Montelukast (n=6) or Zafirlukast (n=2) was compared to Salmeterol (n=7) or Formoterol (n=1) as add-on therapy to 400-565 mcg of beclomethasone or equivalent. Risk of exacerbations requiring systemic corticosteroids was significantly lower with LABA+ICS when compared to LTRA+ICS (RR= 0.83, 95% Confidence Interval (95%CI): 0.71, 0.97): the number needed to treat with LABA compared to LTRA, to prevent one exacerbation over 48 weeks, was 38 (95% CI: 23 to 247). The following outcomes also improved significantly with the addition of LABA compared to LTRA to inhaled steroids (Weighted Mean Difference; 95%CI): morning PEFR (16 L/min; 13 to 18), evening PEFR (12 L/min; 9 to 15), FEV(1) (80 mL; 60 to 100), rescue-free days (9%; 4 to 14), symptom-free days (6%; 2 to 11), rescue beta2-agonists (-0.4 puffs/day; -0.2 to -0.5), quality of life (0.1; 0.05 to 0.2), symptom score (Standard Mean Difference -0.2; -0.1 to -0.3), night awakenings (-0.1/week; -0.06 to -0.2) and patient satisfaction (RR 1.12; 1.07 to 1.16). Risk of withdrawals due to any reason was significantly lower with LABA+ICS compared to LTRA+ICS (Relative Risk 0.84, 95% CI 0.74 to 0.96). Withdrawals due to adverse events or due to poor asthma control, hospitalisation, osteopenia, serious adverse events, overall adverse events, headache or cardiovascular events were not significantly different between the two study groups. AUTHORS' CONCLUSIONS: In asthmatic adults inadequately controlled on low doses of inhaled steroids, the addition of LABA is superior to LTRA for preventing exacerbations requiring systemic steroids, and for improving lung function, symptoms, and use of rescue beta2-agonists.

Adrenal Cortex Hormones↗
PubMed2006

Long-acting beta2-agonists versus anti-leukotrienes as add-on therapy to inhaled corticosteroids for chronic asthma.

BACKGROUND: Patients who continue to experience asthma symptoms despite taking regular inhaled corticosteroids (ICS) represent a management challenge. Leukotriene receptor antagonists (LTRA) and long-acting beta(2)-agonists (LABA) agents may both be considered as add-on therapy to inhaled corticosteroids (ICS). OBJECTIVES: We compared the efficacy and safety profile of adding either daily LABA or LTRA in asthmatic patients who remained symptomatic on ICS. SEARCH STRATEGY: The Cochrane Airways Group Specialised Register was searched for randomised controlled trials up to and including March 2006. Reference lists of all included studies and reviews were screened to identify potentially relevant citations. Inquiries regarding other published or unpublished studies supported by the authors of the included studies or pharmaceutical companies who manufacture these agents were made. Conference proceedings of major respiratory meetings were also searched. SELECTION CRITERIA: Only randomised controlled trials conducted in adults or children with recurrent asthma where a LABA (for example, salmeterol or formoterol) or LTRA (for example, montelukast, pranlukast, zafirlukast) was added to ICS for a minimum of 28 days were considered for inclusion. Inhaled short-acting beta(2)-agonists and short courses of oral steroids were permitted as rescue medications. Other daily asthma treatments were permitted, providing the dose remained constant during the intervention period. Two reviewers independently reviewed the literature searches. DATA COLLECTION AND ANALYSIS: Data extraction and trial quality assessment were conducted independently by two reviewers. Whenever possible, primary study authors were requested to confirm methodology and data extraction and to provide additional information and clarification when needed. Where necessary, expansion of graphic reproductions and estimation from other data presented in the paper was performed. MAIN RESULTS: Fifteen randomised controlled trials met the inclusion criteria; eleven trials including 6,030 participants provided data in sufficient detail to permit aggregation. All eleven trials pertained to adults with moderate airway obstruction (% predicted FEV(1) 66-76%) at baseline. Montelukast (n=9) or Zafirlukast (n=2) was compared to Salmeterol (n=9) or Formoterol (n=2) as add-on therapy to 400-565 mcg of beclomethasone or equivalent. Risk of exacerbations requiring systemic corticosteroids was significantly lower with LABA+ICS when compared to LTRA+ICS (RR= 0.83, 95% Confidence Interval (95%CI): 0.71, 0.97): the number needed to treat with LABA compared to LTRA, to prevent one exacerbation over 48 weeks, was 38 (95% CI: 23 to 247). The following outcomes also improved significantly with the addition of LABA compared to LTRA to inhaled steroids (Weighted Mean Difference; 95%CI): morning PEFR (16 L/min; 13 to 18), evening PEFR (12 L/min; 9 to 15), FEV(1) (80 mL; 60 to 100), rescue-free days (9%; 5% to 13%), symptom-free days (6%; 2 to 11), rescue beta(2)-agonists (-0.5 puffs/day; -0.2 to -1), quality of life (0.1; 0.05 to 0.2), symptom score (Standard Mean Difference -0.2; -0.1 to -0.3), night awakenings (-0.1/week; -0.06 to -0.2) and patient satisfaction (RR 1.12; 1.07 to 1.16). Risk of withdrawals due to any reason was significantly lower with LABA+ICS compared to LTRA+ICS (Risk Ratio 0.83, 95% CI 0.73 to 0.95). Withdrawals due to adverse events or due to poor asthma control, hospitalisation, osteopenia, serious adverse events, overall adverse events, headache or cardiovascular events were not significantly different between the two study groups. AUTHORS' CONCLUSIONS: In asthmatic adults inadequately controlled on low doses of inhaled steroids, the addition of LABA is superior to LTRA for preventing exacerbations requiring systemic steroids, and for improving lung function, symptoms, and the use of rescue beta(2)-agonists.

Adrenal Cortex Hormones↗
PubMed2002

Blood transfusion for preventing stroke in people with sickle cell disease.

BACKGROUND: Sickle cell disease is a common inherited haemoglobin disorder. The abnormal haemoglobin causes distortion of red blood cells, anaemia, vaso-occlusion and dysfunction in virtually any organ system in the body. Stroke occurs in around 10% of children with sickle cell anaemia, and recurrences after a first stroke are likely. Chronic blood transfusion regimes are often used in an attempt to dilute the sickled red blood cells, thus reducing the risk of vaso-occlusion and stroke. However, the side-effects of such regimens can be severe. OBJECTIVES: To assess the relative risks and benefits of chronic blood transfusion regimes in patients with sickle cell disease to prevent a first stroke or further strokes. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. Date of the most recent search of the Group's specialised register: July 2001 SELECTION CRITERIA: All those randomised or quasi-randomised controlled trials in which blood transfusion as a preventative measure for stroke in patients with sickle cell disease are compared to an alternative treatment or to no treatment. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality and extracted data from the study included. MAIN RESULTS: One trial was identified by the initial search and this met the inclusion criteria for the review. The trial compared a chronic transfusion regime to maintain sickle haemoglobin at less than 30% with standard care in 130 children with sickle cell disease who were judged to be at high risk of a first stroke through transcranial doppler ultrasonography. Eleven children in the standard care group suffered a stroke during the trial, compared to only one in the transfusion group. Because of this 92% relative risk reduction, the trial was terminated 16 months early. It had been planned that all patients would be treated for 30 months, but median follow-up only 21.1 months. However, a high rate of complications such as iron overload, alloimmunisation and transfusion reactions were seen in the children who were receiving transfusions. No randomised controlled trials were identified which investigated use of transfusion for preventing recurrence of stroke. REVIEWER'S CONCLUSIONS: While the included study demonstrated a significantly reduced risk of stroke in patients receiving regular blood transfusions, the degree of risk must be balanced against the burden of a chronic transfusion regime. Further research is required to establish the use of transfusion in preventing secondary stroke, the age, or length of time after an event, at which transfusion can safely be stopped, and to further define risk factors for stroke in order to reduce the chance of unnecessarily putting children onto a chronic transfusion regime.

Anemia, Sickle Cell↗
PubMed2004

Positive expiratory pressure physiotherapy for airway clearance in people with cystic fibrosis.

BACKGROUND: Chest physiotherapy is widely prescribed to assist the clearance of airway secretions in people with cystic fibrosis (CF). Positive expiratory pressure (PEP) devices provide constant back pressure to the airways during expiration. This may improve clearance by building up gas behind mucus via collateral ventilation. Given the widespread use of PEP devices, there is a need to determine the evidence for their effect. OBJECTIVES: To determine the effectiveness and acceptability of PEP devices compared to other forms of physiotherapy as a means of improving mucus clearance and other outcomes in people with CF. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register comprising of references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. The electronic database CINAHL was also searched from 1982 to 2001. Most recent search of the Group's register: November 2003. SELECTION CRITERIA: Randomised controlled trials in which PEP was compared with any other form of physiotherapy in people with CF. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied the inclusion and exclusion criteria to publications and assessed the quality of the included studies. MAIN RESULTS: Thirty-three studies were identified and twenty studies involving 429 participants met review inclusion criteria. Most included studies had low scores on a scale of study quality. Sixteen of these studies involving 257 participants were cross-over in design. Data were not published in sufficient detail in these studies to perform meta-analysis.Forced expiratory volume in one second (FEV1) was the most frequently measured outcome. Single interventions or series of treatments continued for up to one month demonstrated no significant difference in effect between PEP and other methods of airway clearance on FEV1. Long-term studies had equivocal or conflicting results regarding the effect on FEV1. Patient preference was reported in nine studies. In all studies with an intervention period of at least one month, measures of patient preference were in favour of PEP. The results for the remaining outcome measures were not examined or reported in sufficient detail to provide any high level evidence. REVIEWER'S CONCLUSIONS: There was no clear evidence that PEP was a more or less effective intervention overall than other forms of physiotherapy. There was limited evidence that PEP was preferred by participants compared to other techniques but this finding is from studies of low quality.

Cystic Fibrosis↗
PubMed2006

Positive expiratory pressure physiotherapy for airway clearance in people with cystic fibrosis.

BACKGROUND: Chest physiotherapy is widely prescribed to assist the clearance of airway secretions in people with cystic fibrosis (CF). Positive expiratory pressure (PEP) devices provide constant back pressure to the airways during expiration. This may improve clearance by building up gas behind mucus via collateral ventilation. Given the widespread use of PEP devices, there is a need to determine the evidence for their effect. OBJECTIVES: To determine the effectiveness and acceptability of PEP devices compared to other forms of physiotherapy as a means of improving mucus clearance and other outcomes in people with CF. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. The electronic database CINAHL was also searched from 1982 to 2001. Most recent search of the Group's register: February 2006. SELECTION CRITERIA: Randomised controlled studies in which PEP was compared with any other form of physiotherapy in people with CF. DATA COLLECTION AND ANALYSIS: Two authors independently applied the inclusion and exclusion criteria to publications and assessed the quality of the included studies. MAIN RESULTS: Forty studies were identified and twenty-five studies involving 507 participants met the review inclusion criteria. Most included studies had low scores on a scale of study quality. Twenty of these studies involving 300 participants were cross-over in design. Data were not published in sufficient detail in most of these studies to perform meta-analysis.Forced expiratory volume in one second (FEV1) was the most frequently measured outcome. Single interventions or series of treatments continued for up to three months demonstrated no significant difference in effect between PEP and other methods of airway clearance on FEV1. Long-term studies had equivocal or conflicting results regarding the effect on FEV1. Participant preference was reported in nine studies. In all studies with an intervention period of at least one month, measures of participant preference were in favour of PEP. The results for the remaining outcome measures were not examined or reported in sufficient detail to provide any high level evidence. AUTHORS' CONCLUSIONS: There was no clear evidence that PEP was a more or less effective intervention overall than other forms of physiotherapy. There was limited evidence that PEP was preferred by participants compared to other techniques, but this finding is from studies of low quality.

Cystic Fibrosis↗
PubMed2001

Preoperative blood transfusions for sickle cell disease.

BACKGROUND: Sickle cell disease is one of the most common inherited diseases in the world, and causes haemolytic anaemia, vaso-occlusive crises and dysfunction in virtually any organ system in the body. Surgical procedures are often required. Blood transfusion regimes can be used preoperatively in an attempt to increase transport of oxygen around the body and dilute the sickled red blood cells, thus reducing the risk of vaso-occlusion. OBJECTIVES: To assess the relative risks and benefits of preoperative blood transfusion regimes in patients with sickle cell disease undergoing surgery of any type in any setting. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. Date of the most recent search: January 2001 SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing preoperative blood transfusion regimes to different regimes or no transfusion in patients with sickle cell disease undergoing surgery. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality and extracted data from the study included. MAIN RESULTS: Only one trial met the inclusion criteria for the review. The trial compared an aggressive transfusion regime (decreasing sickle haemoglobin to less than 30%) to a conservative transfusion regime (increasing haemoglobin to 10 g/dl) in 604 elective operations in patients with sickle cell disease. The conservative regime was found to be as effective as the aggressive regime in preventing perioperative complications, and was associated with less transfusion related adverse events. No randomised controlled trials were found for transfusion compared to no transfusion. REVIEWER'S CONCLUSIONS: While in general conservative therapy appears to be as effective as aggressive in preparation for surgery in sickle cell patients, further research is needed to examine the optimal regime for different surgical types, and to address whether preoperative transfusion is needed in all surgical situations.

Anemia, Sickle Cell↗
PubMed2005

Chemotherapy, radiotherapy and combined modality for Hodgkin's disease, with emphasis on second cancer risk.

BACKGROUND: Second malignancies (SM) are a major late effect of treatment for Hodgkin's disease (HD). Reliable comparisons of SM risk between alternative treatment strategies are lacking. OBJECTIVES: Radiotherapy (RT), chemotherapy (CT) and combined chemo-radiotherapy (CRT) for newly-diagnosed Hodgkin's disease are compared with respect to SM risk, overall (OS) and progression-free (PFS) survival. Further, involved-field (IF-)RT is compared to extended-field (EF-)RT. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, PubMed, EMBASE, CancerLit, LILACS, relevant conference proceedings, trials lists and publications. SELECTION CRITERIA: RCTs accruing 30+ patients and completing accrual before/during 2000, comparing at least two treatment modalities for newly-diagnosed HD. DATA COLLECTION AND ANALYSIS: Individual patient data were collected and assessed for data quality. Trialists submitted additional information concerning methods and data quality. Peto Odds Ratios (OR) with 95% confidence intervals (CI) were calculated for OS, PFS and SM-free survival. Secondary acute leukemia (AL), non-Hodgkin's lymphoma (NHL) and solid tumours (ST) were also analysed separately. MAIN RESULTS: 37 trials (9312 patients) were analysed: 15 (3343) for RT vs. CRT, 16 (2861) for CT vs. CRT, 3 (415) for RT vs. CT and 10 (3221) for IF-RT vs. EF-RT.CRT was superior to RT in terms of OS (OR=0.76, CI=0.66 to 0.89, p=0.0004), PFS (OR=0.49, CI=0.43 to 0.56, p<0.0001) and SM (OR=0.78. CI=0.62 to 0.98, p=0.03). The superiority of CRT also applied to early and advanced stages (mainly IIIA) separately. Excess SM with RT is due mainly to ST and is apparently caused by greater need for salvage therapy after RT.CRT was superior to CT in terms of PFS (OR=77, CI 0.68 to 0.77, p<0.0001). OS was better with CRT for early stages only (OR=0.62, CI 0.44 to 0.88, p=0.006). SM risk was higher with CRT (OR=1.38, CI 1.00 to 1.89, p=0.05), although not significant for early stages alone. This effect, also seen in AL and ST separately, was due directly to first-line treatment. Data were insufficient to compare RT to CT.EF-RT was superior to IF-RT (each additional to CT in most trials) in terms of PFS (OR=81, CI 0.68 to 0.95, p=0.009) but not OS. No significant difference in SM was observed. AUTHORS' CONCLUSIONS: CRT seems to be optimal for most early stage (I-II) HD patients. For advanced stages (III-IV), CRT better prevents progression/relapse but CT alone seems to cause less SM. RT alone gives a higher overall SM risk than CRT due to increased need for salvage therapy. Reduced SM risk after IF-RT instead of EF-RT could not be demonstrated. Due to the large number of studies excluded because no IPD were received, to the inclusion of many outdated treatments and to the limited amount of long-term data, one must be cautious in applying these results to current therapies.

Antineoplastic Agents↗
PubMed2002

Granulopoiesis-stimulating factors in the prevention for adverse effects in the therapeutic treatment of malignant lymphoma.

BACKGROUND: Granulopoiesis-stimulating factors (G-CSF and GM-CSF) are being used to prevent febrile neutropenia and infections in the treatment of patients with malignant lymphoma. The question whether G-CSF and GM-CSF improve dose-intensity, tumour response and overall survival in this patient population has not been answered yet. Since the results from single studies are inconclusive a systematic review was required. OBJECTIVES: To undertake a systematic review in patients with malignant lymphoma to determine the effectiveness of G-CSF and GM-CSF to prevent neutropenia, febrile neutropenia, infection, improve quality of life, adherence to the treatment protocol, tumour response, freedom from treatment failure (FFTF), overall survival (OS) and to assess adverse events of G-CSF and GM-CSF. SEARCH STRATEGY: Medline, Embase, CancerLit, the Cochrane Library and smaller databases, Internet-databases of ongoing trials, conference proceedings of the American Society of Clinical Oncology and the American Society of Hematology were searched. We included full-text and abstract publications as well as unpublished data. SELECTION CRITERIA: Randomised controlled trials comparing prophylaxis with G-CSF or GM-CSF versus placebo/no prophylaxis in adult patients with malignant lymphoma undergoing chemotherapy were included in this review. Both study arms had to receive identical chemotherapy and supportive care. DATA COLLECTION AND ANALYSIS: Eligibility and quality assessment, data extraction and analysis were done in duplicate. All authors were contacted to obtain missing data. MAIN RESULTS: We included 11 eligible studies with 1434 randomised patients. Compared with no prophylaxis, G-/GM-CSF significantly reduced the relative risk for severe neutropenia (RR 0.64 [95% CI 0.55-0.75]), febrile neutropenia (RR 0.74 [95% CI 0.62-0.89]) and infection (RR 0.74 [95% CI 0.64-0.85]). There was no evidence for G-/GM-CSF to decrease the number of patients who required iv antibiotics (RR 0.82 [95%CI 0.57-1.18]), to reduce infection related mortality (RR 2.07 [95% CI 0.81-5.34]), or to improve complete tumour response (RR 1.06 [95% CI 0.96-1.16]), FFTF (HR 1.22 [95% CI 0.83-1.80]) and OS (HR 0.98 [95% CI 0.81-1.18]). None of the studies evaluated quality of life parameters. REVIEWER'S CONCLUSIONS: G-CSF and GM-CSF, when given prophylactically in patients with malignant lymphoma undergoing conventional chemotherapy, reduce the risk of neutropenia, febrile neutropenia and infection. However, based on the currently available randomised trials in this clinical setting, there is no evidence for G-/GM-CSF to provide a significant advantage in terms of complete tumour response, FFTF and OS.

Antineoplastic Agents↗
PubMed2004

Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma.

BACKGROUND: Granulopoiesis-stimulating factors (G-CSF and GM-CSF) are being used to prevent febrile neutropenia and infections in the treatment of patients with malignant lymphoma. The question whether G-CSF and GM-CSF improve dose-intensity, tumour response and overall survival in this patient population has not been answered yet. Since the results from single studies are inconclusive a systematic review was required. OBJECTIVES: To undertake a systematic review in patients with malignant lymphoma to determine the effectiveness of G-CSF and GM-CSF to prevent neutropenia, febrile neutropenia, infection, improve quality of life, adherence to the treatment protocol, tumour response, freedom from treatment failure (FFTF), overall survival (OS) and to assess adverse events of G-CSF and GM-CSF. SEARCH STRATEGY: Medline, Embase, CancerLit, the Cochrane Library and smaller databases, Internet-databases of ongoing trials, conference proceedings of the American Society of Clinical Oncology and the American Society of Hematology were searched. We included full-text and abstract publications as well as unpublished data. SELECTION CRITERIA: Randomised controlled trials comparing prophylaxis with G-CSF or GM-CSF versus placebo/no prophylaxis in adult patients with malignant lymphoma undergoing chemotherapy were included in this review. Both study arms had to receive identical chemotherapy and supportive care. DATA COLLECTION AND ANALYSIS: Eligibility and quality assessment, data extraction and analysis were done in duplicate. Authors were contacted to obtain missing data. MAIN RESULTS: We included 12 eligible studies with 1.823 randomised patients. Compared with no prophylaxis, G-/GM-CSF significantly reduced the relative risk for severe neutropenia (RR 0.67 [95% CI 0.60-0.73]), febrile neutropenia (RR 0.74 [95% CI 0.62-0.89]) and infection (RR 0.74 [95% CI 0.64-0.85]). There was no evidence for G-/GM-CSF to decrease the number of patients who required iv antibiotics (RR 0.82 [95%CI 0.57-1.18]), to reduce infection related mortality (RR 1.37 [95% CI 0.66-2.82]), or to improve complete tumour response (RR 1.02 [95% CI 0.94-1.11]), FFTF (HR 1.11 [95% CI 0.91-1.35]) and OS (HR 1.00 [95% CI 0.86-1.16]). One study evaluated quality of life parameters and did not find differences between the groups. REVIEWER'S CONCLUSIONS: G-CSF and GM-CSF, when given prophylactically in patients with malignant lymphoma undergoing conventional chemotherapy, reduce the risk of neutropenia, febrile neutropenia and infection. However, based on the currently available randomised trials in this clinical setting, there is no evidence for G-/GM-CSF to provide a significant advantage in terms of complete tumour response, FFTF and OS.

Antineoplastic Agents↗
PubMed2004

Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma.

BACKGROUND: Granulopoiesis-stimulating factors, such as granulocyte-colony-stimulating factor (G-CSF) and granulocyte-macrophage-colony-stimulating factor (GM-CSF), are being used to prevent febrile neutropenia and infection in patients undergoing treatment for malignant lymphoma. The question of whether G-CSF and GM-CSF improve dose intensity, tumour response, and overall survival in this patient population has not been answered yet. Since the results from single studies are inconclusive, a systematic review was undertaken. OBJECTIVES: To determine the effectiveness of G-CSF and GM-CSF in patients with malignant lymphoma with respect to preventing neutropenia, febrile neutropenia and infection; improving quality of life, adherence to treatment protocol, tumour response, freedom from treatment failure (FFTF) and overall survival (OS); and adverse effects. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, EMBASE, CancerLit, and other relevant literature databases; internet databases of ongoing trials; and conference proceedings of the American Society of Clinical Oncology and the American Society of Hematology (1980 - 2003). We included full-text and abstract publications as well as unpublished data. SELECTION CRITERIA: Randomised controlled trials comparing prophylaxis with G-CSF or GM-CSF versus placebo/no prophylaxis in adult patients with malignant lymphoma undergoing chemotherapy were included for review. Both study arms had to receive identical chemotherapy and supportive care. DATA COLLECTION AND ANALYSIS: Trial eligibility and quality assessment, data extraction and analysis were done in duplicate. Authors were contacted to obtain missing data. MAIN RESULTS: We included 12 eligible randomised controlled trials with 1823 patients. Compared with no prophylaxis, both G-CSF and GM-CSF significantly reduced the relative risk (RR) for severe neutropenia (RR 0.67; 95% confidence interval (CI) 0.60 to 0.73), febrile neutropenia (RR 0.74; 95% CI 0.62 to 0.89) and infection (RR 0.74; 95% CI 0.64 to 0.85). There was no evidence that either G-CSF or GM-CSF reduced the number of patients requiring intravenous antibiotics (RR 0.82; 95%CI 0.57 to 1.18); lowered infection related mortality (RR 1.37; 95% CI 0.66 to 2.82); or improved complete tumour response (RR 1.02; 95% CI 0.94 to 1.11), FFTF (hazard ratio 1.11; 95% CI 0.91 to 1.35) and OS (hazard ratio 1.00; 95% CI 0.86 to 1.16). One study evaluated quality of life parameters and found no differences between the treatment groups. REVIEWERS' CONCLUSIONS: G-CSF and GM-CSF, when used as a prophylaxis in patients with malignant lymphoma undergoing conventional chemotherapy, reduce the risk of neutropenia, febrile neutropenia and infection. However, based on the randomised trials currently available, there is no evidence that either G-CSF or GM-CSF provide a significant advantage in terms of complete tumour response, FFTF or OS.

Antineoplastic Agents↗
PubMed2001

Surgical interventions for treating distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. OBJECTIVES: To determine when, and if so what type of, surgical intervention is the most appropriate treatment for fractures of the distal radius in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group's specialised register, Cochrane Controlled Trials Register (The Cochrane Library Issue 4, 2000), MEDLINE, EMBASE, CINAHL, the National Research Register (Issues 2 to 4, 2000) and bibliographies of trial reports. The full search was concluded in December 2000. SELECTION CRITERIA: Randomised or quasi-randomised clinical trials involving skeletally mature patients with a fracture of the distal radius, which compared surgical treatment with conservative treatment, different types of surgical intervention or the duration of immobilisation after surgery. The main categories of surgical intervention were external fixation, percutaneous pinning, open reduction and internal fixation, and the insertion of bone scaffolding materials. DATA COLLECTION AND ANALYSIS: All trials, meeting the selection criteria, were independently assessed by both reviewers for methodological quality. Data were extracted for anatomical, functional and clinical outcomes (including complications). The trials were grouped into categories relating to the main comparisons and types of surgical intervention. Despite clear heterogeneity in the characteristics of comparable trials, pooling of data was undertaken where possible and appropriate. MAIN RESULTS: Forty four trials, examining 23 treatment comparisons, met the inclusion criteria of this review. These involved a total of 3193 mainly female and older patients with generally displaced, often comminuted and potentially or evidently unstable fractures. Half of the trials compared surgery with plaster cast immobilisation. Summarising the outcomes was hampered by the variation between the studies in participant characteristics, interventions, quality of trial methodology and reporting, and methods of outcome measurement. Surgical methods were usually associated with better anatomical appearance after fracture healing, but there was inadequate evidence to confirm that these had resulted in better functional and clinical outcomes for the patients. REVIEWER'S CONCLUSIONS: The 44 randomised trials do not provide robust evidence for most of the decisions necessary in the management of these fractures. Although, in particular, there is some evidence to support the use of external fixation or percutaneous pinning, their precise role and methods are not established. It is also unclear whether surgical intervention of most fracture types will produce consistently better long-term outcomes. There is a need for good quality evidence for the surgical management of these fractures.

Adult↗
PubMed2003

Nutritional interventions for preventing and treating pressure ulcers.

BACKGROUND: Pressure ulcers affect 10% of people in hospitals and older people are at highest risk. The correlation between nutritional intake and the development of pressure ulcers is suggested by several studies, but the results are inconsistent. OBJECTIVES: To evaluate the effectiveness of enteral and parenteral nutrition on the prevention and treatment of pressure ulcers. SEARCH STRATEGY: The Cochrane Wounds Group Specialised Trials Register and the Cochrane Central register of Controlled Trials were searched in September 2002. An additional search of PubMed and Cinahl and hand search of conference proceedings and journals was performed, bibliographies of relevant articles were examined and experts in the field as well as manufacturers were contacted in order to find additional literature that may be relevant. SELECTION CRITERIA: Randomised controlled trials evaluating the effectiveness of enteral or parenteral nutrition on the prevention and treatment of pressure ulcers by measuring the incidence of new ulcers, ulcer healing or changes in pressure ulcer severity. There were no restrictions on patients, setting, date, publication status or language. DATA COLLECTION AND ANALYSIS: Abstracts were independently inspected and full articles were obtained of potentially relevant studies. In case of disagreement advice was sought from a third person (AK). Data extraction and assessment of quality were undertaken by the three reviewers independently. MAIN RESULTS: Only 8 randomised controlled trials out of 16 potentially relevant articles were included. However, most of the 8 trials included are small and of poor methodological quality. PREVENTION: Four studies compared a combination of nutritional supplements, consisting of a minimum of energy and protein in different dosages, for the prevention of pressure ulcers. The largest study found that nutritional supplements reduced the number of new pressure ulcers (Bourdel-M 2000). The three smaller studies lacked power. TREATMENT: Four studies evaluated the effects of nutritional supplements for the treatment of existing pressure ulcers: one trial examined mixed nutritional supplements, one trial examined zinc, another the effect of proteins, and two studies compared ascorbic acid. The trials included are heterogeneous with regard to participants, interventions and outcomes; therefore it was considered inappropriate to perform a meta-analysis. REVIEWER'S CONCLUSIONS: It was not possible to draw any firm conclusions on the effect of enteral and parenteral nutrition on the prevention and treatment of pressure ulcers. Further trials of high methodological quality are necessary.

Aged↗
PubMed2005

Cellulose, modified cellulose and synthetic membranes in the haemodialysis of patients with end-stage renal disease.

BACKGROUND: When the kidney fails the blood-borne metabolites of protein breakdown and water cannot be excreted. The principle of haemodialysis is that such substances can be removed when blood is passed over a semipermeable membrane. Natural membrane materials include cellulose or modified cellulose, more recently various synthetic membranes have been developed. Synthetic membranes are regarded as being more "biocompatible" in that they incite less of an immune response than cellulose-based membranes. OBJECTIVES: To assess the effects of different haemodialysis membrane material in patients with end-stage renal disease (ESRD). SEARCH STRATEGY: We searched MEDLINE, EMBASE, PreMEDLINE, HealthStar CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL), Biosis, SIGLE, CRIB, UK National Research Register and reference lists of relevant articles. We contacted biomedical companies, known investigators and handsearched selected journals and conference proceedings. Date of most recent search: June 2004. SELECTION CRITERIA: All randomised controlled trials (RCTs) or quasi-RCTs comparing different haemodialysis membrane material in patients with ESRD. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the methodological quality of studies. Data was abstracted onto a standard form by one reviewer and checked by another. Relative Risk (RR) and weighted mean difference (WMD) with 95% confidence intervals (CI)) MAIN RESULTS: Thirty two studies were identified. Pre-dialysis ss(2) microglobulin concentrations were not significantly lower in patients treated with synthetic membranes (WMD -14.67, 95% CI -33.10 to 4.05). When analysed for change in ss(2) microglobulin, a fall was only noted with high-flux membranes. The incidence of amyloid was less in patients who were dialysed for six years with high-flux synthetic membranes (one study, RR 0.03, 95% CI 0.00 to 0.54). There was a significant difference in favour of the synthetic (high-flux) membrane in comparison to cellulose membranes for triglycerides (WMD -0.66; 95% CI -1.18 to -0.14) but not for modified cellulose membranes. Dialysis adequacy measured by Kt/V was marginally higher when cellulose membranes were used (WMD -0.10; 95% CI -0.16 to 0.04), whereas synthetic membranes achieved significantly higher Kt/V values when compared with modified cellulose membranes (WMD 0.20, 95% 0.11 to 0.29) . There were no data on quality of life measures. AUTHORS' CONCLUSIONS: We found no evidence of benefit when synthetic membranes were compared with cellulose/modified cellulose membranes in terms of reduced mortality no reduction in dialysis-related adverse symptoms. Despite the relatively large number of RCTs undertaken in this area none of the included studies reported any measures of quality of life.

Cellulose↗
PubMed2006

Interventions for vitiligo.

BACKGROUND: Around 1% of the world's population has vitiligo, which causes a loss of skin colour in patches. The methods currently available to treat vitiligo are largely unsatisfactory and vary widely between cultures and within health systems. OBJECTIVES: To assess the effects of interventions used to manage vitiligo. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, AMED and other databases (last searched September 2004). Reference lists of articles and conference proceedings were searched. Authors of reviews were contacted. SELECTION CRITERIA: Randomised controlled trials (RCTs). DATA COLLECTION AND ANALYSIS: At least two reviewers independently assessed study eligibility and methodological quality and carried out data extraction. The included studies compared different interventions and used different outcome measures so we considered it inappropriate to combine their results. MAIN RESULTS: Nineteen trials with a total of 1350 participants were included. The RCTs generally had low numbers of participants and only RCTs of repigmentation and not other methods of managing vitiligo were able to be included. In one study, potent topical steroids resulted in better repigmentation than placebo and they were also better than oral psoralens plus sunlight in another study (RR 4.70 95% CI 1.14 to 19.39) although their long-term use is limited by adverse effects. Two studies suggested that topical calcipotriol enhanced repigmentation rates from PUVAsol and PUVA when compared with placebo. Another two studies showed higher repigmentation rates with oral PUVAsol versus placebo plus sunlight (RR 19.20 95% CI 1.21 to 304.50 in 79 adults and RR 2.29 95% CI 1.14 to 4.58 in a study of 50 children). The safety of these interventions was poorly described and none of the studies was able to demonstrate long term benefits. Very few studies were carried out on children or included segmental vitiligo. No trials evaluating micropigmentation, melanocyte transplantation, depigmentation or cosmetic camouflage could be found. Despite the fact that the main impact of vitiligo is psychosocial only one study on psychological therapy was found and it is awaiting assessment. AUTHORS' CONCLUSIONS: This review has found some evidence to support existing therapies for vitiligo, but the different designs and outcome measurements, lack of quality of life measures and adverse effect reporting in the studies limit the usefulness of their findings. There is a pressing need for high quality randomised trials using standardised measures of repigmentation and which address relevant clinical outcomes including quality of life.

Humans↗