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PubMed2000

Polyunsaturated fatty acid (fish or evening primrose oil) for schizophrenia.

BACKGROUND: Limited evidence gives support to an hypothesis suggesting that the symptoms of schizophrenia may result from altered neuronal membrane structure and metabolism. The latter are dependent on blood plasma levels of certain essential fatty acids (EFAs) and their metabolites. Several studies have shown those with schizophrenia often have low levels of the particular EFAs necessary for normal nerve cell membrane metabolism. OBJECTIVES: To review the effects of supplementing standard antipsychotic treatment with polyunsaturated fatty acids, whether essential (EFAs) or non-essential, for those with schizophrenia and, in recent updates to also evaluate the effects of EFA's as a sole antipsychotic treatment. To evaluate the relative efficacy of different types of fatty acid supplementation. SEARCH STRATEGY: Relevant randomised trials were identified by searching the following electronic databases: Biological Abstracts (1985-1998), CINAHL (1982-1998), Cochrane Library (Issue 4, 1999), Cochrane Schizophrenia Group's Register (February 2000), EMBASE (1980-1998), MEDLINE (1966-1998) and PsycLIT (1974-1998). In addition, reviewers searched references of included and excluded studies and contacted authors to identify further studies. SELECTION CRITERIA: All randomised clinical trials of polyunsaturated fatty acid supplementation to standard treatment or as primary intervention for schizophrenia (however defined) versus standard care. DATA COLLECTION AND ANALYSIS: Reviewers evaluated data independently and analysed on an intention-to-treat basis. They assumed that people who left the study early or were lost to follow-up had no improvement. Where possible and appropriate relative risk (RR) and their 95% confidence intervals (CI) were calculated. The number needed to treat (NNT) was estimated. For continuous data weighted mean differences (WMD) and their 95% confidence intervals were calculated. Data were inspected for heterogeneity and publication biases. MAIN RESULTS: Four relatively small trials (total n=204) showed low levels of loss to follow up and adverse effects for those taking essential fatty acids. Early results from a few trials suggest a positive effect of eicosapentaenoic acid (EPA) over placebo for scale-derived mental state outcomes. The data, however, is limited making these results difficult to analyse and interpret with confidence. A single small study (n=30) investigated the value of using EPA as sole treatment for people hospitalised for relapse. Results suggest that EPA may help one third of people avoid instigation of standard antipsychotic drugs for 12 weeks (RR 0.6, CI 0.4-0.91). There were no clear effects of primrose oil (omega-6) EFA supplementation. REVIEWER'S CONCLUSIONS: All data are preliminary, but results look encouraging for fish oil. EPA does not seem harmful, may be acceptable to people with schizophrenia and have moderately positive effect. A further trial is soon to be reported from the USA and more are underway or planned in the South Africa and Norway. Considering that EPA may be an acceptable intervention, large, long simple studies reporting clincially meaningful data should be anticipated.

Antipsychotic Agents↗
PubMed2000

Long acting beta-agonists versus theophylline for maintenance treatment of asthma.

BACKGROUND: Theophylline and long acting beta2-agonists are bronchodilators used for the management of persistent asthma symptoms, especially nocturnal asthma. They represent different classes of drug with differing side-effect profiles. OBJECTIVES: To assess the comparative efficacy, safety and side-effects of long-acting beta-agonists and theophylline in the maintenance treatment of asthma. SEARCH STRATEGY: Randomised, controlled trials (RCTs) were identified using the Cochrane Airways Group register. The register was searched using the following terms: asthma and theophylline and long acting beta-agonist or formoterol or foradile or eformoterol or salmeterol or bambuterol or bitolterol. Titles and abstracts were then screened to identify potentially relevant studies. The bibliography of each RCT was searched for additional RCTs. Authors of identified RCTs were contacted for other relevant published and unpublished studies. SELECTION CRITERIA: All included studies were RCTs involving adults and children with clinical evidence of asthma. These studies must have compared oral sustained release and/or dose adjusted theophylline with an inhaled long-acting beta-agonist. DATA COLLECTION AND ANALYSIS: Potentially relevant trials, identified by screening titles and/or abstracts, were obtained. Two reviewers independently assessed full text versions of these trials to decided whether the trial should be included in the review, and assessed its methodological quality. Where there was disagreement between reviewers, this was resolved by consensus, or reference to a third party. Data were extracted by two independent reviewers. Inter-rater reliability was assessed by simple agreement. Study authors were contacted to clarify randomisation methods, provide missing data, verify the data extracted and identify unpublished studies. Relevant pharmaceutical manufacturers were also contacted. MAIN RESULTS: Six trials met the inclusion criteria. Five used salmeterol and one, biltoterol. They were of varying quality. There was a trend for salmeterol to improve FEV1 more than theophylline in three studies and salmeterol use was associated with more symptom free nights. Bitolterol, used in only one study, was reported to be less effective than theophylline. Subjects taking salmeterol experienced fewer adverse events than those using theophylline (Relative Risk 0.38; 95%Confidence Intervals 0.25, 0.57). Significant reductions were reported for central nervous system adverse events (Relative Risk 0.51; 95%Confidence Intervals 0.30, 0.88) and gastrointestinal adverse events (Relative Risk 0.32; 95%Confidence Intervals 0.17, 0.59). REVIEWER'S CONCLUSIONS: Salmeterol may be more effective than theophylline in reducing asthma symptoms including night waking and improving lung function. More adverse events occurred in subjects using theophylline when compared to salmeterol.

Adrenergic beta-Agonists↗
PubMed2000

Inhaled short acting beta2-agonist use in asthma: regular vs as needed treatment.

BACKGROUND: Inhaled beta2-adrenergic agonists delivered by inhalation are very widely used in asthma. There has been much controversy of the use and possible consequences of the use of these agents for regular, as opposed as-needed use in asthma. OBJECTIVES: This review to assessed the clinical trial evidence to test whether using regular use of short-acting beta2-agonists reduced asthma control and pulmonary function; worsened symptoms, airway reactivity and quality of life; and increased the rate of exacerbations. SEARCH STRATEGY: A search was carried out of the Cochrane Airways Group "Asthma and Wheez* RCT" register using the terms: regular AND [beta agonist OR bronchodilator OR salbutamol OR albuterol Or terbutaline OR isoproterenol OR reproterol OR fenoterol]. Bibliographies of existing trials were searched and primary trial authors and pharmaceutical companies were approached for additional trials. SELECTION CRITERIA: Randomised controlled trials in which the short-acting beta2-agonist was given regularly in the experimental group, together with an inhaled bronchodilator for relief of symptoms ('rescue use'). The control group consisted of matching placebo inhaled regularly, with an inhaled bronchodilator for as-needed 'rescue use'. DATA COLLECTION AND ANALYSIS: Data were extracted and quality assessments were made by both reviewers. Parallel group and cross-over trials were analysed separately. Where possible data were pooled using a fixed effects model. MAIN RESULTS: Over 800 abstracts were identified, following a review, 60 papers were requested for full assessment by both reviewers. 34 trials from 30 papers met the entry criteria. Data from 31 outcomes were analyzable. There was little difference between the treatments for nearly all outcomes. In cross-over studies, evening peak flow was better with regular treatment, weighted mean difference (WMD) 13.1 l/min (95% confidence interval 24.3, 1.9). In contrast, the FEV1 was better with as-needed treatment (WMD 157 ml (95% CI: 123, 192). Bronchial hyper reactivity was slightly better in the as-needed group, standardised mean difference 0.23, 95% CI: 0.52, 1.12. REVIEWER'S CONCLUSIONS: These results support current guidelines. There is little advantage in using short-acting beta2-agonists regularly, and potentially some small clinical disadvantage.

Adrenergic beta-Agonists↗
PubMed2005

Olanzapine for schizophrenia.

BACKGROUND: Olanzapine is an atypical antipsychotic reported to be effective without producing disabling extrapyramidal adverse effects associated with older, typical antipsychotic drugs. OBJECTIVES: To determine the clinical effects and safety of olanzapine compared with placebo, typical and other atypical antipsychotic drugs for schizophrenia and schizophreniform psychoses. SEARCH STRATEGY: We updated the first search [Biological Abstracts (1980-1999), The Cochrane Library (Issue 2, 1999), EMBASE (1980-1999), MEDLINE (1966-1999), PsycLIT (1974-1999) and The Cochrane Schizophrenia Group's Register (October 2000)] in October 2004 using the Cochrane Schizophrenia's Group's register of trials. We also searched references of all included studies for further trials, and contacted relevant pharmaceutical companies and authors. SELECTION CRITERIA: We included all randomised clinical trials comparing olanzapine with placebo or any antipsychotic treatment for people with schizophrenia or schizophreniform psychoses. DATA COLLECTION AND ANALYSIS: We independently extracted data and, for homogeneous dichotomous data, calculated the random effects relative risk (RR), the 95% confidence intervals (CI) and the number needed to treat (NNT) on an intention-to-treat basis. For continuous data we calculated weighted mean differences. MAIN RESULTS: Fifty five trials are included (total n>10000 people with schizophrenia). Attrition from olanzapine versus placebo studies was >50% by six weeks, leaving interpretation of results problematic. Olanzapine appeared superior to placebo at six weeks for the outcome of 'no important clinical response' (any dose, 2 RCTs n=418, RR 0.88 CI 0.8 to 0.1, NNT 8 CI 5 to 27). Although dizziness and dry mouth were reported more frequently in the olanzapine-treated group, this did not reach statistical significance. The olanzapine group gained more weight. When compared with typical antipsychotic drugs, data from several small trials are incomplete. With high attrition in both groups (14 RCTs, n=3344, 38% attrition by six weeks, RR 0.81 CI 0.65 to 1.02) the assumptions included in all data are considerable. For the short term outcome of 'no important clinical response', olanzapine seems as effective as typical antipsychotics (4 RCTs, n=2778, RR 0.90 CI 0.76 to 1.06). People allocated olanzapine experienced fewer extrapyramidal adverse effects than those given typical antipsychotics. Weight change data for the short term are not statistically significant but results between three to 12 months suggest a clinically important average gain of four kilograms for people given olanzapine (4 RCTs, n=186, WMD 4.62, CI 0.6 to 8.64). Twenty three percent of people in trials of olanzapine and other atypical drugs left by eight weeks; 48% by three to12 months (11 RCTs, n=1847, RR 0.91 CI 0.82 to 1.00). There is little to choose between the atypicals, although olanzapine may cause fewer extrapyramidal adverse effects than other drugs in this category. Olanzapine produces more weight gain than other atypicals with some differences reaching conventional levels of statistical significance (1 RCT, n=980, RR gain at 2 years 1.73 CI 1.49 to 2.00, NNH 5 CI 4 to 7). There are very few data for people with first episode illness (1 RCT, duration 6 weeks, n=42). For people with treatment-resistant illness there were no clear differences between olanzapine and clozapine (4 RCTs, n=457). AUTHORS' CONCLUSIONS: The large proportion of participants leaving studies early in these trials makes it difficult to draw firm conclusions on olanzapine's clinical effects. For people with schizophrenia it may offer antipsychotic efficacy with fewer extrapyramidal adverse effects than typical drugs, but more weight gain. There is a need for further large, long-term randomised trials with more comprehensive data.

Antipsychotic Agents↗
PubMed2001

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids are interventions designed to help people make specific and deliberative choices among options (including status quo) by providing (at a minimum) information on the options and outcomes relevant to a person's health status. A systematic review is needed to summarize what is known about their efficacy. OBJECTIVES: 1. To create an inventory of existing decision aids. 2. To conduct a systematic review of randomized controlled trials of decision aids aimed at improving people's decision making and outcomes. SEARCH STRATEGY: The following electronic databases were searched: MEDLINE, EMBASE, PsycINFO, CINAHL, Aidsline, Cancerlit, the Cochrane Controlled Trials Register. In addition, individuals known to be active in the field of decision support were contacted. SELECTION CRITERIA: We screened titles and abstracts for all interventions providing structured, detailed, and specific information on treatment or screening options and outcomes to aid decision making. Information about the decision aids was compiled in an inventory and those evaluated in a randomized controlled trial were reviewed in detail. DATA COLLECTION AND ANALYSIS: Using Cochrane review methods, two reviewers independently screened and extracted data on several evaluation criteria. Results of randomized trials were pooled using weighted mean differences and relative risks with all data analysed using a random effects model. MAIN RESULTS: Eighty-seven decision aids were identified. Twenty-three of them had been evaluated in 24 randomized controlled trials. Among the trials comparing decision aids to usual care interventions, decision aids performed better in terms of: a) greater knowledge of options in seven of seven studies (weighted mean difference (WMD = 19 out of 100, 95% confidence interval (CI): 13,25); b) more realistic expectations in two of three studies (RR=1.48 95%CI 1.02, 2.14); c) lower decisional conflict related to feeling informed in three of three studies (WMD = -9.0 of 100 95%CI: -15, -3); d) reducing the proportion of people who were passive in decision making in three of four studies (RR = 0.63, 95% CI: 0.5, 0.8). When simpler decision aids were compared to more detailed ones, the relative improvement was significant in: a) improved knowledge in two of seven studies (WMD = 4 out of 100, 95% CI: 2, 5); b) realistic expectations in two of two studies (relative risk (RR ranged from 1.5 95%CI: 1.3,1.8); and c) decisional conflict in one of two studies (WMD= -4 95% CI -8,-0.2). There was a consistent trend for decision aids to do no better than comparison interventions in affecting: satisfaction with the decision in five of six studies, satisfaction with the decision making process in four of five studies, and anxiety in four of five studies. Decision aids had a variable effect on which screening or treatment options were selected. Exposure to decision aids relative to controls resulted in a consistent non-significant trend toward reduced preference for major surgery over conservative options by 21 to 42 per cent in five of five studies; however, they had no impact on circumcision in two of two studies. For colon and prostate cancer screening choices, the results were inconsistent. Two studies have shown no impact on persistence with chosen option and few studies have shown significant benefits on general health outcomes (two of three studies), or disease-specific health outcomes (one of four studies). REVIEWER'S CONCLUSIONS: The number of decision aids is expanding, but there is considerable overlap in some areas leaving gaps in others. Trials of decision aids indicate that they are superior to usual care interventions in improving knowledge and realistic expectations of the benefits and harms of options; reducing passivity in decision making; and lowering decisional conflict stemming from feeling uninformed. When simpler versions of decision aids are compared to more detailed aids, the differences in knowledge are marginal but there are other benefits in terms of creating realistic expectations and in reducing decisional conflict. To date, decision aids have had little effect on anxiety or satisfaction with the decision making process or satisfaction with the decision. Their effects on choices vary with the decision. The effects on persistence with chosen therapies and health outcomes require further evaluation. The essential elements in decision aids for different groups and different types of decisions need to be established. Consensus needs to be reached regarding standards for developing and evaluating decision aids.

Decision Support Techniques↗
PubMed2001

Antibiotics versus placebo for prevention of postoperative infection after appendicectomy.

BACKGROUND: Appendicitis is the most common cause of acute abdominal pain requiring surgical intervention. The cause of appendicitis is unclear and the mechanism of pathogenesis continues to be debated. Despite improved asepsis and surgical techniques, postoperative complications, such as wound infection and intraabdominal abscess, still account for a significant morbidity. Several studies implicate that postoperative infections are reduced by administration of antimicrobial regimes. OBJECTIVES: The objective of this review is to compare the use of antibiotics with placebo or no treatment in patients undergoing appendectomy. Will these patients benefit from antimicrobial prophylaxis? The outcomes are described according to the nature of the appendix, as either simple appendicitis (including the non-infectious stage) and complicated appendicitis. This review do not attempt to compare the effect of different regimens, a clinical question that is addressed in another review undertaken by this Group (CCCG). SEARCH STRATEGY: We searched The Cochrane Controlled Trials Register (Cochrane Library 2000 issue 4), Medline (January 1966 to September 2000), Embase and the Cochrane Colorectal Cancer Group specialised register (September 2000). In addition we manually searched the reference lists of the primary identified trials. SELECTION CRITERIA: Randomised Controlled Trials (RCT) and Controlled Clinical Trials (CCT) in which any antibiotic regime were compared to placebo in patients suspected of having appendicitis undergoing appendectomy were evaluated. Both studies on children and adults were reviewed. The outcome measures of the studies were either wound infection, intraabdominal abscess, length of stay in hospital or mortality. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality were assessed, recorded and cross-checked by to reviewers. MAIN RESULTS: Forty-four studies including 9298 patients were included in this review. The overall result is that use of antibiotics is superior to placebo for the outcome wound infection and intraabdominal abscess, with no apparent difference in the nature of the removed appendix. Studies exclusively on children and studies examining topical application reported results in favour to the above although the results were not significant. REVIEWER'S CONCLUSIONS: Antibiotic prophylaxis is effective in the prevention of postoperative complications in appendectomised patients, whether the administration are given pre-, per- and post-operatively and could be considered for routine in emergency appendectomies.

Abdominal Abscess↗
PubMed2000

Elastic compression stockings for prevention of deep vein thrombosis.

BACKGROUND: One of the settings in which deep vein thrombosis (DVT) in the lower limb and pelvic veins occurs is prolonged immobilisation in hospital for various surgical and medical illnesses. Use of graduated compression stockings (GCS) in these patients has been proposed to decrease the risk of DVT. OBJECTIVES: The objective of this review was to determine the magnitude of effectiveness of GCS in preventing DVT in various groups of hospitalised patients. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Disease Group trials register, MEDLINE, and EMBASE and hand searched Indexes Medicus. Various GCS manufacturing companies and the trialists in the ongoing trials were contacted. SELECTION CRITERIA: Randomised controlled trials (RCT's) involving:. Graduated compression stockings alone. Graduated compression stockings used on a background of any other DVT prophylactic method. DATA COLLECTION AND ANALYSIS: One reviewer extracted the data, assessed the quality of trials and analysed the results (SVA) this was cross-checked and authenticated by the other reviewer (TAL). MAIN RESULTS: A total of 16 RCTs were identified. GCS were applied on the day before surgery or on the day of surgery. GCS were worn up until discharge or until the patients were fully mobile. In the majority of the included studies, DVT was identified by radioactive I 125 uptake test. GCS alone. Nine RCTs were identified in this group. In the treatment group (GCS) of 624 patients, 81 developed DVT (13%) in comparison to the control group of 581 patients, where 154 (27%) had DVT, Peto's odds ratio 0.34 (95% confidence interval 0.25, 0.46) favouring treatment with GCS. GCS on a background of another prophylactic method. Seven RCTs were identified this group. In the treatment group (GCS + another method) of 501 patients, 10 (2%) developed DVT whereas in the control group of 505 patients, 74 (15%) developed DVT, Peto's odds ratio 0.24 (95% confidence interval 0.15, 0.37). REVIEWER'S CONCLUSIONS: Analysis of these RCT's confirm that GCS are effective in diminishing the risk of DVT in hospitalised patients. Data examination also suggests, that GCS on a background of another method of prophylaxis is even more effective than GCS alone.

Bandages↗
PubMed2004

Depot bromperidol decanoate for schizophrenia.

BACKGROUND: Antipsychotic drugs are the mainstay treatment for schizophrenia. Long-acting depot injections of drugs such as bromperidol decanoate are extensively used as a means of long-term maintenance treatment. OBJECTIVES: To assess the effects of depot bromperidol versus placebo, oral antipsychotics and other depot antipsychotic preparations for people with schizophrenia in terms of clinical, social and economic outcomes. SEARCH STRATEGY: Relevant trials were identified by searching Biological Abstracts (1982-1999), Cochrane Library (Issue 2, 1999), Cochrane Schizophrenia Group's Register (May 1999), EMBASE (1980-1999), MEDLINE (1966-1999) and PsycLIT (1974-1999). References of all identified trials were inspected and Janssen-Cilag was contacted in order to identify more trials. An update search was undertaken in October 2003. The Schizophrenia Groups trials register is based on regular searches of BIOSIS Inside; CENTRAL; CINAHL; EMBASE; MEDLINE and PsycINFO; the hand searching of relevant journals and conference proceedings, and searches of several key grey literature sources. A full description is given in the Group's module. SELECTION CRITERIA: All randomised trials focusing on people with schizophrenia where depot bromperidol, oral antipsychotics or other depot preparations were sought. Primary outcomes were death, clinically significant change in global function, mental state, relapse, hospital admission, adverse effects and acceptability of treatment. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers and cross-checked. Fixed effects relative risks (RR) and 95% confidence intervals (CI) were calculated for dichotomous data. Weighted or standardised means were calculated for continuous data. Where possible, the number needed to treat statistic (NNT) was calculated. Analysis was by intention-to-treat. MAIN RESULTS: Four controlled clinical trials were included (total n=117). We identified a single small study of six months duration comparing bromperidol decanoate with placebo injection. Similar numbers left the study before completion (n=20, 1 RCT, RR 0.4 CI 0.1 to 1.6) and there was no clear differences between bromperidol decanoate and placebo for a list of adverse effects (n=20, 1 RCT, RR akathisia 2.0 CI 0.21 to 18.69, RR increased weight 3.0 CI 0.14 to 65.9, RR tremor 0.33 CI 0.04 to 2.69). When bromperidol decanoate was compared with fluphenazine depot we found no important change on global outcome (n=30, RR no clinical important improvement 1.50 CI 0.29 to 7.73). People allocated to fluphenazine decanoate and haloperidol decanoate had less relapses than those given bromperidol decanoate (n=77, RR 3.92 Cl 1.05 to 14.60, NNH 6 CI 2 to 341). People allocated bromperidol decanoate required additional antipsychotic medication somewhat more frequently than those taking fluphenazine decanoate and haloperidol decanoate but the results did not reach conventional levels of statistical significance (n=77, 2 RCTs, RR 1.72 CI 0.7 to 4.2). The use of benzodiazepine drugs was very similar in both groups (n=77, 2 RCTs, RR 1.08 CI 0.68 to 1.70). People left the bromperidol decanoate group with the same frequency as those allocated other depots (n=97, 3 RCTs, RR 1.92 CI 0.8 to 4.6). Anticholinergic adverse effects were equally common between bromperidol and other depots (n=47, RR 3.13 CI 0.7 to 14.0) and additional anticholinergic medication was needed with equal frequency in both depot groups, although results did tend to favour the bromperidol decanoate group (n=97, 3 RCTs, RR 0.80 CI 0.64 to 1.01). The incidence of movement disorders was similar in both depot groups (n=77, 2 RCTs, RR 0.74 CI 0.47 to 1.17). REVIEWERS' CONCLUSIONS: Currently, minimal poorly reported trial data suggests that bromperidol decanoate may be better than placebo injection but less valuable than fluphenazine or haloperidol decanoate. If bromperidol decanoate is available it may be a viable choice, especially when there are reasons not to use fluphenazine or haloperidol decanoate. Well-conducted and reported randomised trials are needed to inform practice in Belgium, Germany, Italy and the Netherlands.

Antipsychotic Agents↗
PubMed2000

Domicilary oxygen for chronic obstructive pulmonary disease.

BACKGROUND: Long-term domiciliary oxygen therapy has become one of the major forms of treatment for hypoxaemic chronic obstructive pulmonary disease (COPD) patients. OBJECTIVES: To determine the effect of domiciliary oxygen therapy on survival and quality of life in patients with COPD. SEARCH STRATEGY: Randomised controlled trials (RCTs) were identified using the Cochrane Airways Group COPD register using the search terms: (home OR domiciliary) AND oxygen. SELECTION CRITERIA: Any RCT in patients with hypoxaemia and COPD that compared long term domiciliary or home oxygen therapy with a control treatment. DATA COLLECTION AND ANALYSIS: Data extraction was performed independently by two reviewers. MAIN RESULTS: Four randomised controlled trials were identified. Data from none of these trials could be aggregated because of differences in trial design and patient selection. NOTT 1980, continuous oxygen therapy versus nocturnal oxygen therapy: there was a significant improvement in mortality after 24 months (Peto odds ratio 0.45, 95% confidence interval 0.25 to 0.81). MRC 1981, domiciliary oxygen therapy versus no oxygen therapy: there was a significant improvement over five years in mortality in the group receiving oxygen therapy (Peto odds ratio 0.42, 95% confidence interval 0.18 to 0.98). Fletcher 1992, nocturnal oxygen versus no oxygen in patients with COPD and arterial desaturation at night: there was no difference in mortality at 36 months. Gorecka 1997, long term oxygen versus no oxygen in moderate hypoxaemia: there was no effect on survival for up to three years of follow up. REVIEWER'S CONCLUSIONS: Long term oxygen therapy improved survival in a selected group of COPD patients with severe hypoxaemia (arterial PO2 less than 8.0 kPa). Long term oxygen did not appear to improve survival in patients with moderate hypoxaemia or in those with only arterial desaturation at night.

Home Care Services↗
PubMed2001

Orthotic devices for tennis elbow.

BACKGROUND: Lateral epicondylitis (tennis elbow) is a frequently reported condition. A wide variety of treatment strategies has been described. As of yet, no optimal strategy has been identified. OBJECTIVES: The objective of this review was to assess the effectiveness of orthotic devices for treatment of tennis elbow. SEARCH STRATEGY: An electronic database search was conducted using Medline, Embase, Cinahl, the Cochrane Controlled Trial Register, Current Contents and reference lists from all retrieved articles. Experts on the subjects were approached for additional trials. SELECTION CRITERIA: All randomised clinical trials (RCT) describing individuals with diagnosed lateral epicondylitis and comparing the use of an orthotic device as a treatment strategy were evaluated for inclusion. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the validity of the included trials and extracted data on relevant outcome measures. Dichotomous outcomes were expressed as Relative Risks (RRs) and continuous outcomes as Standardised Mean Differences (SMD), both with corresponding 95% confidence intervals (95% CI). Statistical pooling and subgroup analyses were intended MAIN RESULTS: Five small-size RCTs (N per group 7-49) were included. Validity score ranged from 3-9 positive items out of 11. Subgroup analyses were not performed due to the small number of trials. The limited number of included trials present few outcome measures and limited long-term results. Pooling was not possible due to large heterogeneity amongst trials. REVIEWER'S CONCLUSIONS: No definitive conclusions can be drawn concerning effectiveness of orthotic devices for lateral epicondylitis. More well-designed and well-conducted RCTs of sufficient power are warranted.

Humans↗
PubMed2004

Central action beta-blockers versus placebo for neuroleptic-induced acute akathisia.

BACKGROUND: Neuroleptic-induced akathisia is a common, distressing early-onset adverse effect of neuroleptic drugs. It has been associated with poor treatment compliance and an increased risk of relapse. OBJECTIVES: To determine the effects of central action beta-blockers compared with placebo for people with neuroleptic-induced acute akathisia. SEARCH STRATEGY: We updated previous searches of the Cochrane Schizophrenia Group Register (May 1999), Biological Abstracts (January 1982-March 1999), The Cochrane Library (issue 3 1999), EMBASE (January 1980-March 1999), LILACS (January 1982-March 1999), MEDLINE (January 1964-March 1999), PsycLIT (January 1974-March 1999), and SCISEARCH by searching the Cochrane Schizophrenia Group Register (November 2003). We sought further references from published trials and their authors. SELECTION CRITERIA: We included all randomised controlled clinical trials of central action beta-blockers versus placebo for people with neuroleptic-induced acute akathisia. DATA COLLECTION AND ANALYSIS: Working independently, we selected and critically appraised studies, extracted data and analysed on an intention-to-treat basis. Where possible and appropriate we calculated risk ratios (RR) and their 95% confidence intervals (CI) with the number needed to treat (NNT). For continuous data we calculated Weighted Mean Differences (WMD). MAIN RESULTS: We identified three randomised controlled trials (total n=51, maximum duration 72 hours). We were not able to draw any firm conclusions from such a small data set. In the two 48 hour studies no-one experienced full remission of akathisia, and only one person in each group experienced a 50% remission (n=11, 1 RCT, RR 1.04 CI 0.59 -1.83). One trial stated that no adverse effects occurred in the two groups (n=20, 1 RCT, RR not estimable). The 72 hour study did not show any statistical difference between the central acting beta-blocker (ICI 118,551) and placebo for the outcome 'no change/worse' (n=10, RR 0.22 CI 0.0 to 1.5). REVIEWERS' CONCLUSIONS: There are insufficient data to recommend beta-blocking drugs for akathisia. These drugs are experimental for this problem, and this review highlights the need for more evaluative studies.

Adrenergic beta-Antagonists↗
PubMed2002

Curative surgery for obstruction from primary left colorectal carcinoma: primary or staged resection?

BACKGROUND: In 8 to 29% of patients with colorectal carcinoma, obstruction is the main symptom at diagnosis, and 85% of patients undergoing emergency colorectal surgery have obstruction from colorectal carcinoma. The prognosis of patients who undergo emergency surgery for obstruction is often poor. So far, two types of surgical approach have been used for this condition: primary resection (primary anastomosis or Hartmann's procedure) with simultaneous treatment of carcinoma and obstruction or staged resection (treatment of the obstruction prior to resection). However, neither strategy has been found to have any advantages over the other. OBJECTIVES: To ascertain whether primary resection in patients with obstruction from left colorectal carcinoma has advantages over staged resection in terms of morbidity and mortality. SEARCH STRATEGY: Electronic database searches of Cochrane Controlled Trials Register, Medline, Cancerlit, Embase. Hand searching of the most important journals in the fields of oncology and surgery from the year 2000 until the time of writing. SELECTION CRITERIA: Randomised Clinical Trials (RCT) and Controlled Clinical Trials (CCT), in which a group of patients who undergo primary resection for intestinal obstruction from left primary colorectal carcinoma is compared with a group of patients who undergo staged resection for the same condition. Since only one study of this type was available, we considered all other studies, except for case-controls, on the basis of the best possible available evidence. Studies written in English, French, German and Italian and, where necessary, other languages, were considered. DATA COLLECTION AND ANALYSIS: Two reviewers (GLDS, CG) examined all the citations and abstracts derived from the electronic search strategy. Reports of potentially relevant trials were retrieved in full. Both reviewers independently applied the selection criteria to trials reports. Reviewers were not blind to the names of institutions, journals or authors of trials. A third opinion (SP, ML) was obtained to resolve disagreements. MAIN RESULTS: The electronic database searches yielded a total of 1412 citations: Medline 1026, Embase 386. From these, one study for potential inclusion was identified, but was then excluded. REVIEWER'S CONCLUSIONS: The limited number of identified trials together with their methodological weaknesses do not allow a reliable assessment of the role of either therapeutic strategy in the treatment of patients with bowel obstruction from colorectal carcinoma. It would appear advisable to conduct high quality large scale RCT to establish which treatment is more effective. However, it is doubtful whether they could be carried out in a timely and satisfactory way in this particular surgical context.

Colorectal Neoplasms↗
PubMed2004

Curative surgery for obstruction from primary left colorectal carcinoma: primary or staged resection?

BACKGROUND: In 8 to 29% of patients with colorectal carcinoma, obstruction is the main symptom at diagnosis, and 85% of patients undergoing emergency colorectal surgery have obstruction from colorectal carcinoma. The prognosis of patients who undergo emergency surgery for obstruction is often poor. So far, two types of surgical approach have been used for this condition: primary resection (primary anastomosis or Hartmann's procedure) with simultaneous treatment of carcinoma and obstruction, or staged resection (treatment of the obstruction prior to resection).However, neither strategy has been found to have any advantages over the other. OBJECTIVES: To ascertain whether primary resection in patients with obstruction from left colorectal carcinoma has advantages over staged resection in terms of morbidity and mortality. SEARCH STRATEGY: Electronic database searches of Cochrane Controlled Trials Register, Medline, Cancerlit, Embase. Hand searching of the most important journals in the fields of oncology and surgery from 2003 and onward until the time of writing. SELECTION CRITERIA: Randomised Clinical Trials (RCT) and Controlled Clinical Trials (CCT), in which a group of patients who undergo primary resection for intestinal obstruction from left primary colorectal carcinoma is compared with a group of patients who undergo staged resection for the same condition. Since only one study of this type was available, we considered all other studies, except for case-controls, on the basis of the best possible available evidence. Studies were considered without language restrictions. DATA COLLECTION AND ANALYSIS: Two reviewers (GLDS, CG) examined all the citations and abstracts derived from the electronic search strategy. Reports of potentially relevant trials were retrieved in full. Both reviewers independently applied the selection criteria to trials reports. Reviewers were not blind to the names of institutions, journals or authors of trials. A third opinion (SP, ML) was obtained to resolve disagreements. MAIN RESULTS: We identified 2043 citations: Medline 1205, Embase 635, Cancerlit 203. One study for potential inclusion was identified, but was then excluded (Kronborg 1995). REVIEWERS' CONCLUSIONS: The limited number of identified trials together with their methodological weaknesses do not allow a reliable assessment of the role of either therapeutic strategy in the treatment of patients with bowel obstruction from colorectal carcinoma. It would appear advisable to conduct high quality large scale RCT to establish which treatment is more effective. However, it is doubtful whether they could be carried out in a timely and satisfactory way in this particular surgical context.

Colorectal Neoplasms↗
PubMed2001

Hypothermia to reduce neurological damage following coronary artery bypass surgery.

BACKGROUND: Coronary artery bypass surgery (CABG) may be life saving, but known side effects include neurological damage and cognitive impairment. The temperature used during cardiopulmonary bypass (CPB) may be important with regard to these adverse outcomes, where hypothermia is used as a means of neuroprotection. OBJECTIVES: To assess the effectiveness of hypothermia during CABG in reducing neurological damage and subsequent cognitive deficits. SEARCH STRATEGY: The Cochrane Controlled Trials Register was searched for randomised controlled trials (RCT) and this was updated by searching MEDLINE and EMBASE to December 1999 using database specific RCT filters. Reference lists of retrieved articles were searched and experts in the field were contacted. SELECTION CRITERIA: Only RCTs were considered. All patients undergoing CABG, either first time or revisions, elective or emergency procedures, were included. Any hypothermia protocol was considered. Only trials reporting neurological outcomes were included. DATA COLLECTION AND ANALYSIS: Studies were selected independently and data were extracted from the source papers independently by two reviewers. Authors were contacted for further information. Studies were combined with meta-analysis where appropriate, and meta-regression was used to explore heterogeneity. MAIN RESULTS: There was a trend towards a reduction in the incidence of non fatal strokes in the hypothermic group (OR 0.68 (0.43, 1.05)). Conversely, there was a trend for the number of non stroke related perioperative deaths to be higher in the hypothermic group (OR 1.46 (0.9, 2.37)). Hypothermia had no effect on the incidence of non fatal myocardial infarction (OR 1.05 (0.81, 1.37)), but the incidence of another marker of myocardial damage, low output syndrome, was higher in the hypothermic group (OR 1.21 (0.99, 1.48). When pooling all "bad" outcomes (stroke, perioperative death, myocardial infarction, low output syndrome, intra aortic balloon pump use) there was no significant advantage of either hypothermia or normothermia (OR 1.07 (0.92, 1.24)). Only 4 of 17 trials reported neuropsychological function as an outcome. REVIEWER'S CONCLUSIONS: This review could find no definite advantage of hypothermia over normothermia in the incidence of clinical events. Hypothermia was associated with a reduced stroke rate, but this is off set by a trend towards an increase in non stroke related perioperative mortality and myocardial damage. There is insufficient data to date to draw any conclusions about the use of mild hypothermia. Similarly, there is insufficient data to date to comment on the effect of temperature during CPB on subtle neurological deficits, and further trials are needed in these areas.

Cardiac Output, Low↗
PubMed2004

Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence.

BACKGROUND: Buprenorphine has recently been reported to be an alternative to methadone and LAAM for maintenance treatment of opioid dependent individuals, differing results are reported concerning its relative effectiveness indicating the need for an integrative review. OBJECTIVES: To evaluate the effects of buprenorphine maintenance against placebo and methadone maintenance in retaining patients in treatment and in suppressing illicit drug use. SEARCH STRATEGY: We searched the following databases up to 2001, inclusive: Cochrane Drugs and Alcohol Review Group Register, the Cochrane Controlled Trials Register, MEDLINE, EMBASE, Current Contents, Psychlit, CORK [www. state.vt.su/adap/cork], Alcohol and Drug Council of Australia (ADCA) [www.adca.org.au], Australian Drug Foundation (ADF -VIC) [www.adf.org.au], Centre for Education and Information on Drugs and Alcohol (CEIDA) [www.ceida.net.au], Australian Bibliographic Network (ABN), and Library of Congress databases, available NIDA monographs and the College on Problems of Drug Dependence Inc. proceedings, the reference lists of all identified studies and published reviews and authors of identified RCT's were asked about any other published or unpublished relevant RCT. SELECTION CRITERIA: Randomised clinical trials of buprenorphine maintenance compared with either placebo or methadone maintenance for opioid dependence. DATA COLLECTION AND ANALYSIS: Reviewers evaluated the papers separately and independently, rating methodological quality of concealment of allocation; data were extracted independently for meta-analysis and double-entered. MAIN RESULTS: Thirteen studies met the inclusion criteria, all were randomised clinical trials, all but one were double-blind. The method of concealment of allocation was not clearly described in 11 of the studies, otherwise methodological quality was good. Buprenorphine given in flexible doses appeared statistically significantly less effective than methadone in retaining patient in treatment (RR= 0.82; 95% CI: 0.69-0.96). Low dose buprenorphine is not superior to low dose methadone. High dose buprenorphine does not retain more patients than low dose methadone, but may suppress heroin use better. There was no advantage for high dose buprenorphine over high dose methadone in retention (RR=0.79; 95% CI:0.62-1.01), and high dose buprenorphine was inferior in suppression of heroin use. Buprenorphine was statistically significantly superior to placebo medication in retention of patients in treatment at low doses (RR=1.24; 95% CI: 1.06-1.45), high doses (RR=1.21; 95% CI: 1.02-1.44), and very high doses (RR=1.52; 95% CI: 1.23-1.88). However, only high and very high dose buprenorphine suppressed heroin use significantly above placebo. REVIEWERS' CONCLUSIONS: Buprenorphine is an effective intervention for use in the maintenance treatment of heroin dependence, but it is not more effective than methadone at adequate dosages.

Buprenorphine↗
PubMed2000

Intra-pleural fibrinolytic therapy vs. conservative management in the treatment of parapneumonic effusions and empyema.

BACKGROUND: Effusions and empyema may complicate lower respiratory tract infections. Loculation of fluid is a major problem with this condition so treatments have included surgical drainage and the use of intra-pulmonary fibrinolysis to break down fibrin bands that may cause loculation. OBJECTIVES: To conduct a systematic review of the benefit of adding intrapleural fibrinolytic therapy to intercostal tube drainage in the treatment of complicated parapneumonic effusions and empyema. SEARCH STRATEGY: The Cochrane Controlled Trials Register was initially searched for relevant RCT's. The search terms were Streptokinase OR Urokinase AND Pleural Effusion OR Intrapleural OR Pleur* OR Parapneumonic Or Empyema. Bibliographies and review articles identified herein were searched for further citations and RCT's. MEDLINE, EMBASE were searched and, where relevant, Index Medicus was hand searched. Trial authors were contacted for further information and details regarding the possibility of unpublished trials was requested. SELECTION CRITERIA: Types of Studies All studies in the review were Randomised Controlled Trials in adult patients empyema or complicated parapneumonic effusions who had not had prior surgical intervention or trauma. The intervention was an intrapleural fibrinolytic agent (streptokinase or urokinase) vs control or a comparison of the two. DATA COLLECTION AND ANALYSIS: All identified studies were reviewed independently by two reviewer and all data collected. Reviews were scored according to the Cochrane assessment of allocation concealment and the Jadad scale of methodological quality. Disagreements between reviewers were referred to a third reviewer. Where further information was required, authors of trial papers were contacted for further details. MAIN RESULTS: Three studies were identified, one which directly compared the fibrinolytics streptokinase and urokinase. Two small RCTs (total 58 patients) compared streptokinase or urokinase vs normal saline control. The pooled data showed small benefits in terms of hospital stay, time to defervescence, improvement in chest radiograph, requirement for surgery, but the results were not always consistent across studies. Complications attributable to therapy were not seen. REVIEWER'S CONCLUSIONS: There is currently insufficient evidence to support routine use of intrapleural fibrinolytic therapy in the treatment of parapneumonic effusion and empyema. The results of a large multi-centre study, currently underway, are awaited.

Adult↗
PubMed2004

Intra-pleural fibrinolytic therapy versus conservative management in the treatment of parapneumonic effusions and empyema.

BACKGROUND: Effusions and empyema may complicate lower respiratory tract infections. Loculation of fluid is a major problem with this condition and treatments have included surgical drainage and the use of intra-pleural fibrinolysis to break down fibrin bands that may cause loculation. OBJECTIVES: To conduct a systematic review of the benefit of adding intrapleural fibrinolytic therapy to intercostal tube drainage in the treatment of complicated para pneumonic effusions and empyema. SEARCH STRATEGY: The Cochrane Controlled Trials Register was initially searched for relevant RCT's. Trial authors were contacted for further information and details regarding the possibility of unpublished trials was requested. The most recent search was conducted in July 2003. SELECTION CRITERIA: All studies in the review were Randomised Controlled Trials in adult patients with empyema or complicated para pneumonic effusions who had not had prior surgical intervention or trauma. The intervention was an intrapleural fibrinolytic agent (streptokinase or urokinase) versus control or a comparison of the two. DATA COLLECTION AND ANALYSIS: All identified studies were reviewed independently by two reviewer and all data collected. Reviews were scored according to the Cochrane assessment of allocation concealment and the Jadad scale of methodological quality. Disagreements between reviewers were referred to a third reviewer. Where further information was required, authors of trial papers were contacted for further details. MAIN RESULTS: Four studies were included, one which directly compared the fibrinolytics streptokinase and urokinase. Three small RCTs (total 104 patients) compared streptokinase or urokinase versus normal saline control. The pooled data showed significant benefits in terms of hospital stay, time to defervescence, improvement in chest radiograph, requirement for surgery, but the results were not always consistent across studies. Complications attributable to therapy were not observed. REVIEWERS' CONCLUSIONS: The numbers of patients in the controlled trials are small. In meta-analysis of these trials, intrapleural fibrinolytic therapy confers significant benefit when compared with normal saline control. Although lesser levels of evidence suggest that intrapleural fibrinolysis can be considered as an important adjunctive therapy to intercostal tube drainage in these conditions, on the basis of RCT evidence alone, we cannot recommend the routine use of fibrinolysis in their management as the trial numbers are too small. Both streptokinase and urokinase are equally efficacious but streptokinase has a slightly higher non-fatal complication rate. Life-threatening complications are rare and were not seen in the RCTs.

Adult↗
PubMed2006

Techniques for surgical retrieval of sperm prior to ICSI for azoospermia.

BACKGROUND: Azoospermia, the absence of sperm in ejaculated semen, is the most severe form of male factor infertility and is present in approximately 5% of all investigated infertile couples. The advent of intra-cytoplasmic sperm injection (ICSI), however, has transformed treatment of this type of severe male factor infertility. Sperm can be retrieved for ICSI from either the epididymis or the testis depending on the type of azoospermia. OBJECTIVES: To evaluate the efficacy of the various surgical retrieval techniques for men with obstructive or non obstructive azoospermia prior to ICSI. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched 12 Jan 2005), Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to Nov 2004), EMBASE (1980 to Dec 2004), and Biological Abstracts (1980 to Nov 2004) and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing the effectiveness of sperm retrieval techniques in men with azoospermia prior to ICSI. Due to the lack of RCTs, non-randomised trials that used the participants as their own control, were also considered in the review but not included in the meta-analysis. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: Two trials involving 98 men were included. The first small RCT had 59 participants and compared two epididymal techniques. The trial gave limited evidence that microsurgical epididymal sperm aspiration (MESA) achieved significantly lower pregnancy (One pregnancy in 29 procedures compared with seven pregnancies in 30 procedures, OR 0.19, 95% CI 0.04 to 0.83) and fertilisation rates (OR 0.16, 95% CI 0.05 to 0.48) than the micropuncture with perivascular nerve stimulation technique. The other RCT comparing two testicular techniques in 39 participants gave no statistically significant evidence about the superiority of the ultrasound guided aspiration technique compared to the aspiration technique without ultrasound guidance. TSA with ultrasound resulted in pregnancy in 3 out of 16 participants and TSA without ultrasound in four pregnancies with 23 participants (OR 1.10, 95% CI 0.21 to 5.74) AUTHORS' CONCLUSIONS: There is insufficient evidence to recommend any specific sperm retrieval technique for azoospermic men undergoing ICSI. In the absence of evidence to support more invasive or more technically difficult methods the reviewers recommend the least invasive and simplest technique available. Further randomised trials are warranted, preferably multi-centred trials. The classification of azoospermia as obstructive and non-obstructive appears to be relevant to a successful clinical outcome so a distinction according to the cause azoospermia is important for future clinical trials.

Epididymis↗