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PubMed2000

Premedication for anxiety in adult day surgery.

BACKGROUND: Surgery is increasingly performed on a day-case basis. Many patients are anxious pre-operatively and might benefit from pharmacological anxiolysis. Drugs are sometimes not used, however, for fear of delaying discharge from hospital. OBJECTIVES: To asses the effect of anxiolytic premedication on time to discharge in adult patients undergoing day case surgery under general anaesthesia. SEARCH STRATEGY: Trials were identified by computerised searches of the Cochrane Controlled Trials Register, MEDLINE, EMBASE, by checking the reference lists of trials and review articles, by hand-searching three main anaesthesia journals and by contacting five researchers active in the field and the Product Information departments of the manufacturers of five commonly used premedicants. SELECTION CRITERIA: All randomised controlled trials comparing an anxiolytic drug(s) with placebo before general anaesthesia in adult day case surgical patients. DATA COLLECTION AND ANALYSIS: We collected data on anaesthetic drugs used, results of tests of psychomotor function where these were used to assess residual effect of premedication, and on times from end of anaesthesia to ability to walk unaided or readiness for discharge from hospital. Formal statistical synthesis of individual trials was not performed in view of the variety of drugs studied. MAIN RESULTS: Searching identified twenty-nine reports; fourteen studies, with data from a total of 1263 patients, were considered eligible for analysis. Only two studies specifically addressed the discharge question; both found no delay in premedicated patients. Three other studies used clinical criteria to assess fitness for discharge, though times were not given. Again, there was no difference from placebo. Four studies used both clinical measures and tests of psychomotor function as tests of recovery from anaesthesia. In none of these studies did the premedication appear to delay discharge, although performance on tests of psychomotor function was sometimes still impaired. Of the four studies which used tests of psychomotor function to assess recovery, three showed impaired recovery (after midazolam 7.5mg, midazolam 15mg or diazepam 15mg) which might possibly interfere with discharge from hospital. REVIEWER'S CONCLUSIONS: We have found no evidence of a difference in time to discharge from hospital in patients who received anxiolytic premedication. However, in view of the age and variety of anaesthetic techniques used, inferences for current day-case practice should be made with caution.

Adult↗
PubMed2001

Digitalis for treatment of congestive heart failure in patients in sinus rhythm.

BACKGROUND: Digitalis glycosides have been in clinical use in the treatment of congestive heart failure for more than 200 years. In recent years several trials have been conducted to address concerns about efficacy and toxicity. Although a systematic review of the literature was recently published, an update is required to include more current trials. OBJECTIVES: To examine the effectiveness of digitalis glycosides in treating congestive heart failure in patients with normal sinus rhythm. To examine the effect of digitalis in patients taking diuretics, ACE inhibitors, and beta blockers; patients with varying severity and duration of disease; patients with prior exposure to digitalis vs. no prior exposure; and patients with diastolic vs. systolic dysfunction. SEARCH STRATEGY: Electronic databases were searched between 1966 and 2000. Dissertation Abstracts and annual meeting abstracts of the American Heart Association, American College of Cardiology, and European Society of Cardiology were searched from 1996-2000. In addition, reference lists provided by the pharmaceutical industry (Glaxo Wellcome Inc.) were searched. SELECTION CRITERIA: Included were randomized placebo-controlled trials of 20 or more adult patients of either sex with symptomatic congestive heart failure who were studied for seven weeks or more. Excluded were trials in which the prevalence of atrial fibrillation was 2% or greater, or in which any arrhythmia that might compromise cardiac function or any potentially reversible cause of heart failure such as acute ischemic heart disease or myocarditis was present. DATA COLLECTION AND ANALYSIS: Articles selected from the searches described above were reviewed by one of the coauthors, and validated by staff from the central office of the Heart Collaborative Review Group in Bristol, UK. MAIN RESULTS: Eleven articles meeting the defined criteria were identified, and major endpoints of mortality, hospitalization, and clinical status, based respectively upon on 8, 4, and 10 of these selected studies, were recorded and analyzed. The data show that there is no difference in mortality between treatment and control groups, whereas digitalis therapy is associated with a lower rate of hospitalization and of clinical deterioration. REVIEWER'S CONCLUSIONS: The literature indicates that digitalis has a useful role in the treatment of patients with congestive heart failure who are in normal sinus rhythm.

Cardiotonic Agents↗
PubMed2001

Haloperidol for agitation in dementia.

BACKGROUND: Agitation includes wandering, crying out, abusive vocalization, and assaultive behavior and occurs in up to 70% of patients with dementia. Although the neuroleptic haloperidol has been used for decades to control disruptive behavior in psychotic and demented patients, the effectiveness of this drug for agitated dementia remains in question. The first meta-analysis on the effectiveness of haloperidol for agitated dementia, published in 1990, was limited in scope and was unable to provide clear guidelines for the use of haloperidol for demented patients who are agitated. Meta-analyses in 1998 and 2000 examined haloperidol compared with other neuroleptics as well as with placebo and omitted a number of databases, including non-English language publications. To determine the effect of haloperidol, compared with placebo, in the control of agitated dementia and to make recommendations for future research in this area a more widely based, yet more highly focussed review was carried out. OBJECTIVES: The main objective was to determine whether evidence supports the use of haloperidol to treat agitation in demented patients. SEARCH STRATEGY: The CDCIG Specialized Register was searched to identify all available reports on haloperidol treatment of agitated dementia. SELECTION CRITERIA: We examined randomized, placebo-controlled trials, with concealed allocation, where subjects' dementia and agitation were assessed. Trials involving treatment of less than one week were not included. DATA COLLECTION AND ANALYSIS: 1. Two reviewers extracted data from included trials. 2. Data were pooled, where possible, and analysed using appropriate statistical methods. 3. Odds ratios or average differences were calculated. 4. Only 'intention to treat' data were included. Where a cross-over design was employed (Devanand, 1998), only the initial phase of the study was used to compare haloperidol versus placebo. 5. Sensitivity analysis was applied to heterogeneity of results and to gauge the effect of the included studies of small sample size. 6. In addition to the overall meta-analysis, individual analyses of the reports were carried out to examine the effect of degree of dementia, dose of haloperidol, and duration of therapy on agitated dementia. Analysis included the following groups: All patients treated with haloperidol compared with placebo. MAIN RESULTS: There were five included trials. All studies stated "intention to treat" analysis of their results. Three studies were from the United States, and two studies were from Europe. Two studies examined patients with various forms of dementia, and three studies included only patients with diagnosed Alzheimer's dementia. 1. Overall meta-analysis of the response of agitated patients to haloperidol, compared with controls, showed no improvement in agitation. There is some evidence that haloperidol helps to control aggression. Adverse reactions and dropouts were more frequent among haloperidol treated patients, compared with controls. This meta-analysis provided no information about the relationship between the degree of dementia, the kind of agitation manifested, or the dosage and duration of therapy with haloperidol and response to treatment of demented patients with agitation. 2. The results of this meta-analysis were too broad to permit specific recommendations for treatment of agitated dementia with haloperidol. 3. Higher dose haloperidol, or prolonged haloperidol (12 weeks compared with 3 - 6 weeks) was associated with increased side effects, largely related to Parkinsonian symptoms of rigidity and bradykinesia. REVIEWER'S CONCLUSIONS: 1. Haloperidol appeared to provide no improvement in agitation among demented patients compared with placebo, but side effects were frequent. 2. Dropout rates were higher for haloperidol compared with placebo treated patients, suggesting that side effects led to discontinuation of treatment in some patients. 3. Because of the wide focus of this meta-analysis, not enough information was provided to permit recommendations linking haloperidol treatment of agitated dementia to degree of dementia, manifestations of agitation, or dosage and duration of treatment of haloperidol. 4. Individual analysis of reports indicated that higher dose haloperidol (more than 2 mg per day) may have been more effective than lower dose haloperidol (less than 2 mg per day) in controlling aggression, but not other manifestations of agitation, among patients with mild to moderate dementia. 5. Similar analysis suggested that prolonged therapy with haloperidol (more than 3 - 6 wks) or higher dosage (more than 2 mg per day) was more likely to result in side effects than were short term therapy (3 weeks) or lower dose haloperidol (less than 2 mg per day). 6. The reports provided too little information to permit interpretation of the effect of degree or type of dementia on response to haloperidol. Except for a favorable response of aggression to haloperidol, no other manifestations of agitated dementia were found to have improved following therapy with haloperidol, compared with controls.

Aggression↗
PubMed2000

Postoperative radiotherapy for non-small cell lung cancer.

BACKGROUND: The role of postoperative radiotherapy in the treatment of patients with completely resected non-small cell lung cancer was not clear. A systematic review and quantitative meta-analysis was therfore undertaken to evaluate the available evidence from randomised trials. OBJECTIVES: To evaluate the effect of post-operative radiotherapy (PORT) on survival and recurrence in patients with completely resected non-small cell lung cancer. To investigate whether or not pre-defined patient sub-groups benefit more or less from PORT. SEARCH STRATEGY: MEDLINE and CANCERLIT searches were supplemented by information from trial registers and by hand searching relevant meeting proceedings and by discussion with relevant trialists and organisations. SELECTION CRITERIA: Both published and unpublished trials were eligible for inclusion provided the patients had undergone a complete resection; had been randomised between radiotherapy and no immediate further treatment; that the method of randomisation precluded prior knowledge of the treatment to be assigned; and that recruitment was between 1965 and 1995. DATA COLLECTION AND ANALYSIS: A quantitative meta-analysis using updated information from individual patients from all available randomised trials was carried out. Data from all patients randomised in all eligible trials were sought directly from those responsible. Updated information on survival, recurrence and date of last follow up were obtained, as were details of treatment allocated, date of randomisation, age, sex, histological cell type, stage and performance status. To avoid potential bias, information was requested for all randomised patients including those who had been excluded from the investigators' original analyses. All analyses were done on intention to treat on the endpoints of survival and recurrence-free survival. Subgroup analyses by age, sex, histological cell type, tumour stage and performance status were also done. MAIN RESULTS: 2128 patients from 9 trials were included (median follow-up of 3.9 years). The results show a significant adverse effect of PORT on survival with a hazard ratio of 1.21 or 21% relative increase in the risk of death. This is equivalent to an absolute detriment of 7% at 2 years (95% confidence interval 3 to 11%) reducing overall survival from 55% to 48%. Exploratory subgroup analyses suggested that this detrimental effect was most pronounced for patients with stage I/II, N0-N1 disease, whereas for stage III, N2 patients there was no clear evidence of an adverse effect. REVIEWER'S CONCLUSIONS: PORT is detrimental to patients with early stage completely resected non-small cell lung cancer and should not be used in the routine treatment of such patients. The role of PORT in the treatment of N2 tumours is not clear and may justify further research.

Carcinoma, Non-Small-Cell Lung↗
PubMed2026

Endoscopic Ultrasound-Guided Versus Transjugular Portal Pressure Measurements: Systematic Review and Meta-Analysis.

PURPOSE: Published reviews of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) have emphasized feasibility and safety. We performed a systematic review and meta-analysis specifically to evaluate how closely EUS-based portal pressure measurements track invasive comparator measurements in prospective paired studies and to summarize agreement, technical success, and adverse events. METHODS: We searched major databases through January 2026 for prospective cohorts reporting same-patient EUS-based portal pressure measurement and invasive hemodynamic measurements. Correlations were pooled with random-effects models and analyzed separately for studies comparing EUS-PPG with hepatic venous pressure gradient (HVPG) and studies comparing EUS-based portal measurements with direct portal venous pressure. Agreement and threshold discordance were summarized descriptively. RESULTS: Six prospective cohorts (127 attempted procedures) were included. In studies using HVPG as the comparator, the pooled correlation was 0.82 (95% CI, 0.72-0.89; I2 = 0%). In studies comparing EUS-based portal measurements with direct portal venous pressure, the pooled correlation was 0.86 (95% CI, 0.72-0.93; I2 = 16.9%). Technical success was 95.3%. EUS-PPG-attributed adverse events occurred in 2.4% of procedures, with no procedure-related deaths. Agreement data were limited. Reported limits of agreement were wide (approximately - 6 to + 7 mmHg), and discrepancies of 5 mmHg or greater occurred in 4 of 30 paired measurements. CONCLUSIONS: EUS-based portal pressure measurement is feasible and shows a strong association with invasive hemodynamic comparators, but the evidence base remains small (six cohorts, 127 attempted procedures). Further study will be necessary to establish patient-level agreement, procedural reproducibility, EUS-specific clinically significant portal hypertension thresholds, and whether HVPG-based decision thresholds can be transferred to EUS-derived measurements.

Humans↗
PubMed2001

Dopamine agonists for cocaine dependence.

BACKGROUND: Cocaine is a major drug of abuse. Cocaine dependence is a common and serious condition, which has become nowadays a substantial public health problem. There is a wide and well documented range of consequences associated to chronic use of this drug, such as medical, psychological and social problems, including the spread of infectious diseases (e.g. AIDS, hepatitis and tuberculosis), crime, violence and neonatal drug exposure. Therapeutic management of the cocaine addicts includes an initial period of abstinence from the drug. During this phase the subjects may experience, besides the intense craving for cocaine, symptoms such as depression, fatigue, irritability, anorexia, and sleep disturbances. It was demonstrated that the acute use of cocaine may enhance dopamine transmission and chronically it decreases dopamine concentrations in the brain. Pharmacological treatment that affects dopamine could theoretically reduce these symptoms and contribute to a more successful therapeutic approach. OBJECTIVES: To evaluate the efficacy and acceptability of dopamine agonists for treating cocaine dependence. SEARCH STRATEGY: We searched: The Cochrane Controlled Trials Register (Cochrane Library, issue 4, 2000), MEDLINE (from 1966 - 2000), EMBASE (from 1980 - 2000), LILACS (from 1982 - 2000), PsycLIT (from 1974 - 2000), Biological Abstracts (1982 to 2000). Reference searching; personal communication; conference abstracts; unpublished trials from pharmaceutical industry; book chapters on treatment of cocaine dependence. SELECTION CRITERIA: The inclusion criteria for all randomised controlled trials were that they should focus on the use of dopamine agonists on the treatment of cocaine dependence. Trials including patients with additional diagnosis such as opiate dependence were also eligible. DATA COLLECTION AND ANALYSIS: The reviewers extracted the data independently and Relative Risks, weighted mean difference and number needed to treat were estimated. The reviewers assumed that people who died or dropped out had no improvement and tested the sensitivity of the final results to this assumption. MAIN RESULTS: Twelve studies were included, with 587 participants randomised. Amantadine and Bromocriptine were compared to placebo in most of trials. In two studies amantadine was directly compared to bromocriptine, while amantadine was compared to desipramine, an antidepressant in three. The main efficacy outcome presented was positive urine sample for cocaine metabolites, with no significant differences between interventions. When retention in treatment was assessed as an acceptability measure, it was found a similar rate of patients remaining in treatment in both placebo and active drugs. There were no significant differences in trials where participants had primary cocaine dependence or had additional diagnosis of opioid dependence and/or were in methadone maintenance treatment. REVIEWER'S CONCLUSIONS: Current evidence does not support the clinical use of dopamine agonists in the treatment of cocaine dependence. Given the high rate of dropouts in this population, clinicians may consider adding psychotherapeutic supportive measures aiming to keep patients in treatment.

Amantadine↗
PubMed2000

Pre-operative traction for fractures of the proximal femur.

BACKGROUND: Pre-operative traction following an acute hip fracture remains standard practice in some hospitals. OBJECTIVES: To evaluate the effects of traction applied to the injured limb prior to surgery for a fractured hip. Different methods of applying traction (skin or skeletal) were considered. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register, MEDLINE (1983 to August 1999), CINAHL (1982 to July 1999), EMBASE (1980 to September 1999), CENTRAL (Issue 4, 1999 of The Cochrane Library) and bibliographies of trial reports. Date of the most recent search: September 1999. SELECTION CRITERIA: All randomised or quasi-randomised trials comparing either skin or skeletal traction with no traction, or skin with skeletal traction for patients with an acute hip fracture prior to surgery. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality, using a nine item scale, and extracted data. Additional information was sought from all trialists. Wherever appropriate and possible, the data are presented graphically. MAIN RESULTS: Five randomised trials, mainly of moderate quality, involving a total of 635 predominantly elderly patients, were identified and included in the review. The review has been updated twice to include additional and new data from two of the studies. The availability of this additional data resulted in no important change in the results nor conclusions. The four trials which compared traction with no traction found no evidence of benefit from traction, either in the relief of pain, ease of fracture reduction or quality of fracture reduction at time of surgery. One of these trials included both skin and skeletal traction groups. This trial and one other which compared skeletal traction with skin traction found no important differences between these two methods, although the initial application of skeletal traction was noted as being more painful and most costly. REVIEWER'S CONCLUSIONS: From the evidence available, the routine use of traction (either skin or skeletal) prior to surgery for a hip fracture does not appear to have any benefit. Where a policy of general or selective application of traction exists, the choice of method must remain a decision based on evaluation of the individual patient. Further, high quality trials would be required to confirm or refute the absence of benefits of traction.

Femoral Fractures↗
PubMed2003

An example of the use of systematic reviews to answer an effectiveness question.

Systematic reviews assist nurses, other health care providers, decision makers, and consumers in managing the explosion of health care information by synthesizing valid data and reporting the effects of interventions. Nurses are increasingly using systematic reviews to guide their practice and develop policy. The purpose of the article is to outline the steps involved in conducting a systematic review with examples taken from a systematic review titled "Strategies to Manage the Behavioral Symptoms Associated With Alzheimer's Disease." The steps of a systematic review include: (a) formulating a well-defined question, (b) developing relevance and validity tools, (c) conducting a comprehensive search to retrieve published and unpublished reports, (d) assessing the reports using relevance and validity tools, (e) data extraction, (f) synthesis of the findings, and (g) report writing. Understanding the steps involved in a systematic review will assist nurses in critically appraising reviews and in conducting their own reviews.

Humans↗
PubMed2002

Prevention of oral mucositis and oral candidiasis for patients with cancer treated with chemotherapy: cochrane systematic review.

The objectives of this study were to determine whether oral prophylactic agents are superior to placebo or no treatment on the incidence of oral mucositis and oral candidiasis for patients with cancer. A Cochrane systematic review was conducted of randomized trials of oral (and topical) prophylactic agents for mucositis and oral candidiasis, anywhere in the world, among patients with cancer (excluding head and neck) who were receiving chemotherapy. Eleven studies were included in the meta-analysis for mucositis. Of the six prophylactic agents used for mucositis, only one--ice chips--was effective (relative risk 0.57, 95% CI 0.43 to 0.77). Fifteen studies were included in the meta-analysis for oral candidiasis. There is evidence that antifungal agents that are partially or fully absorbed from the gastrointestinal tract prevent oral candidiasis and that the partially absorbed agents may be more effective than the fully absorbed agents. The RR for partially absorbed agents was 0.13 (95% CI 0.06 to 0.27). In conclusion, there is weak and unreliable evidence that ice chips prevent mucositis. There is evidence that prophylactic use of antifungal agents, which are absorbed or partially absorbed from the gastrointestinal tract, reduce the clinical signs of oral candidiasis.

Antifungal Agents↗
PubMed2005

Reducing workload in systematic review preparation using automated citation classification.

OBJECTIVE: To determine whether automated classification of document citations can be useful in reducing the time spent by experts reviewing journal articles for inclusion in updating systematic reviews of drug class efficacy for treatment of disease. DESIGN: A test collection was built using the annotated reference files from 15 systematic drug class reviews. A voting perceptron-based automated citation classification system was constructed to classify each article as containing high-quality, drug class-specific evidence or not. Cross-validation experiments were performed to evaluate performance. MEASUREMENTS: Precision, recall, and F-measure were evaluated at a range of sample weightings. Work saved over sampling at 95% recall was used as the measure of value to the review process. RESULTS: A reduction in the number of articles needing manual review was found for 11 of the 15 drug review topics studied. For three of the topics, the reduction was 50% or greater. CONCLUSION: Automated document citation classification could be a useful tool in maintaining systematic reviews of the efficacy of drug therapy. Further work is needed to refine the classification system and determine the best manner to integrate the system into the production of systematic reviews.

Artificial Intelligence↗
PubMed2000

Co-ordinated multidisciplinary approaches for inpatient rehabilitation of older patients with proximal femoral fractures.

BACKGROUND: Hip fracture is a major cause of morbidity in older people and its impact, both on the individual and to society, is substantial. OBJECTIVES: To examine the effects of co-ordinated multidisciplinary inpatient rehabilitation, compared with usual orthopaedic care, for older patients with hip fracture. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register, Medline (up to April 1998), and reference lists of published papers and books. We also contacted colleagues and trialists. SELECTION CRITERIA: Randomised and quasi-randomised trials of postsurgical care using specialised rehabilitation of mainly older patients (aged 65 years or over) with hip fracture. DATA COLLECTION AND ANALYSIS: Trial assignment to included, excluded and awaiting assessment categories, was by consensus. Two reviewers independently assessed trial quality and extracted data. Limited additional information was sought from most trialists. As well as pooling of data from primary outcomes, supplementary analyses were performed to combine clinically relevant outcomes and investigate possible explanatory factors. MAIN RESULTS: In this minor update, one new trial is identified and has been placed in "studies awaiting assessment". Of another three trials previously pending assessment, one has now been excluded. The five included trials involved 1068 patients. The combined outcomes of death or requiring institutional care at final follow-up showed no significant difference between intervention and control groups (Peto odds ratio 0.92; 95% confidence interval 0.71 to 1.18). There was considerable heterogeneity in length of stay and cost data. Using death and deterioration in function as a further combined outcome variable yielded a Peto odds ratio of 0.83 (95% confidence interval 0.64 to 1. 07). This should be interpreted with caution due to heterogeneity. No quality of life measures were reported and the two trials investigating carer burden showed no detrimental effect from the intervention. The review update did not result in any new data for these outcomes. REVIEWER'S CONCLUSIONS: The trials reviewed had different aims, interventions and outcomes. As a consequence, results were heterogeneous and the question of effectiveness of different types of co-ordinated inpatient rehabilitation after hip fracture cannot be answered conclusively. There is a trend to effectiveness when combined outcome variables (death and institutional care, death and deterioration in function) are considered. Future trials of postsurgical care involving inpatient rehabilitation, or other models such as 'early supported discharge' and 'hospital at home' schemes, should aim to establish both effectiveness and cost effectiveness of multidisciplinary rehabilitation overall, rather than attempt to evaluate its components.

Aged↗
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↗
PubMed2001

Decongestants and antihistamines for acute otitis media in children.

BACKGROUND: Acute otitis media (AOM) is a common and important source of morbidity in children, although most cases resolve spontaneously. While frequently recommended, decongestant and antihistamine therapy is of unclear benefit. OBJECTIVES: To determine the efficacy of decongestant and antihistamine therapy in children with AOM on outcomes of AOM resolution, medication side effects, and complications of AOM. SEARCH STRATEGY: Comprehensive search of Cochrane's Controlled Trials Registry, Medline and Embase was conducted. Bibliographic review and requests for information from study authors and pharmaceutical companies supplemented this. SELECTION CRITERIA: Randomized controlled trials evaluating decongestant (DC) or antihistamine (AH) treatment for children with AOM were included. Patient-oriented outcomes were considered most relevant. There were no quality or language restrictions. DATA COLLECTION AND ANALYSIS: Investigators independently evaluated studies for inclusion, performed validity assessments, and completed data extraction. Dichotomous data were pooled to generate relative risks and numbers needed to treat, and homogeneity was assessed using approximate chi-square tests. MAIN RESULTS: For the combined control groups, healing rates at 2 weeks were high, with rates of persistent AOM <23%. No additional benefit was demonstrated from intervention subgroupings DC, AH, or any medication (DC and/or AH). Only the combined treatment (DC + AH) group demonstrated statistically lower rates of persistent AOM at the 2-week period (RR 0.76, 95% CI, NNT 10.5, 95% CI). No benefit was found for other outcomes including early or late cure rates, symptom resolution, prevention of surgery or other complications. There was an increased risk of medication side effects for those receiving an intervention, which reached statistical significance for the "any medication" and decongestant groupings (NNH 16.6, 14.3 respectively, 95% CI ). Validity subanalyses demonstrated that lower quality studies found benefit, but analysis of those studies with higher validity scores found no benefit to treatment. REVIEWER'S CONCLUSIONS: Given lack of benefit and increased risk of side effects, these data do not support the use of decongestant, antihistamine, or combined DC/AH treatment in children with AOM. The small statistical benefit found in the combination medication group is of small clinical significance and study design may be biasing the results.

Acute Disease↗
PubMed2001

Antidepressants versus placebo for people with bulimia nervosa.

BACKGROUND: Bulimia Nervosa (BN) represents an important public health problem and is related to serious morbidity and even mortality. This review attempted to systematically evaluate the use of antidepressant medications compared with placebo for the treatment of bulimia nervosa. OBJECTIVES: The primary objective of this review was to determine whether using antidepressant medications was clinically effective for the treatment of bulimia nervosa. The secondary objectives were: (i) to examine whether there was a differential effect for the various classes/types of antidepressants with regard to effectiveness and tolerability (ii) to test the hypothesis that the effect of antidepressants on bulimic symptoms was independent of its effect on depressive symptoms SEARCH STRATEGY: (1) electronic searches of MEDLINE (1966 to December 2000), EMBASE (1980-December 2000), PsycLIT (to December 2000), LILACS & SCISEARCH (to 1997) (2) the Cochrane Register of Controlled Trials and the Cochrane Depression, Anxiety and Neurosis Group Register - ongoing (3) inspection of the references of all identified trials (4) contact with the pharmaceutical companies and the principal investigator of each included trial (5) inspection of the International Journal of Eating Disorders - ongoing SELECTION CRITERIA INCLUSION CRITERIA: every randomized, placebo-controlled trial in which antidepressant medications were compared to placebo to reduce the symptoms of bulimia nervosa in patients of any age or gender. Quality criteria: reports were considered adequate if they were classified as A or B according to the Cochrane Manual. The Jadad scale, with a cut off of 2 points, was applied to check the validity of the above referred criterion but was not used as an inclusion criterion. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers for each included trial. Dichotomous data were evaluated by the relative risk with 95% confidence intervals (CI) around this measure, based on the random effects model; continuous data were evaluated by the standardised mean difference with the 95% CI. NNT was calculated using the inverse of the absolute risk reduction. MAIN RESULTS: Currently the review includes 16 trials comparing antidepressants with placebo: 6 trials with TCAs (imipramine, desipramine and amitryptiline), 3 with SSRIs (fluoxetine), 4 with MAOIs (phenelzine, isocarboxazid and brofaromine) and 3 with other classes of drugs (mianserine, trazodone and bupropion). Similar results were obtained in terms of efficacy for these different groups of drugs. The pooled RR for remission of binge episodes was 0.88 (95% CI 0.83-0.93; p<0,001) favoring drugs. The NNT for a mean treatment duration of 8 weeks, taking the non-remission rate in the placebo controls of 92% as a measure of the baseline risk was 9 (95% CI 6 - 16). The RR for clinical improvement, defined as a reduction of 50% or more in binge episodes was 0.63 (95% CI 0.55-0.74) and the NNT for a mean treatment duration of 9 weeks was 4 (95% CI 3 - 6), with a non-improvement rate of 67% in the placebo group. Patients treated with antidepressants were more likely to interrupt prematurely the treatment due to adverse events. Patients treated with TCAs dropped-out due to any cause more frequently that patients treated with placebo. The opposite was found for those treated with fluoxetine, suggesting it may be a more acceptable treatment. Independence between antidepressant and antibulimic effects could not be evaluated due to incomplete published data. REVIEWER'S CONCLUSIONS: The use of a single antidepressant agent was clinically effective for the treatment of bulimia nervosa when compared to placebo, with an overall greater remission rate but a higher rate of dropouts. No differential effect regarding efficacy and tolerability among the various classes of antidepressants could be demonstrated.

Antidepressive Agents↗
PubMed2000

Oral beta-blockers for mild to moderate hypertension during pregnancy.

BACKGROUND: Hypertension is a common complication of pregnancy. Antihypertensive drugs are widely used in the belief these will improve outcome for both the woman (such as decreasing the risk of stroke or eclampsia) and her baby (such as decreasing the risk of preterm birth and its complications). Beta-blockers are a popular choice of antihypertensive agent during pregnancy; other choices include methyldopa and calcium channel blockers. OBJECTIVES: The aim of this review is to assess whether oral beta-blockers are overall better than placebo, or no beta-blocker, for women with mild-moderate hypertension during pregnancy, and to assess whether oral beta-blockers have any advantages over other antihypertensive agents for women with mild-moderate hypertension during pregnancy. Both maternal outcomes (e.g., the incidence of severe hypertension) and perinatal outcomes (e.g., mortality) were of interest. SEARCH STRATEGY: Register of trials maintained by the Cochrane Pregnancy and Childbirth Group, MEDLINE 1966-97, bibliographies of retrieved papers, personal files. Date of last search: June 2000. SELECTION CRITERIA: Trials comparing beta-blockers with (i) placebo or no therapy, or (ii) other antihypertensive agents, for women with mild-moderate pregnancy hypertension (i.e., blood pressure under 170 mm Hg systolic, or 110 mm Hg diastolic). DATA COLLECTION AND ANALYSIS: All data were extracted independently by two investigators, who were not blinded to outcome or other trial characteristics. Whenever possible, missing data were obtained by personal communication with authors. Discrepancies were resolved by discussion. The overview was divided into two comparisons: (i) beta-blockers versus placebo or no therapy, and (ii) beta-blockers versus other antihypertensives. MAIN RESULTS: Twenty-seven trials, involving just under 2400 women, are included in this review. Fourteen trials (1516 women) compared beta-blockers with placebo/no beta blocker. Oral beta-blockers decrease the risk of severe hypertension (relative risk (RR) 0.37, 95% confidence interval (CI) 0.26-0.53) and the need for additional antihypertensive drugs (RR 0.44, 95% CI 0.31-0.62). There are insufficient data for any conclusions about the effect on perinatal mortality or preterm delivery. Beta-blockers seem to be associated with an increase in small for gestational age infants (RR 1.34, 95% CI 1.01-1.79). Maternal hospital admission may be decreased, neonatal bradycardia increased and respiratory distress syndrome decreased, but these outcomes are only reported in a very small proportion of trials. Eleven trials (787 women) compared beta-blockers with methyldopa. Beta-blockers appear to be no more effective and probably equally as safe (from maternal and perinatal perspectives) as methyldopa. Single small trials have compared beta-blockers with hydralazine and with nicardipine. It is unusual for women to change drugs due to side effects. REVIEWER'S CONCLUSIONS: The improvement in control of maternal blood pressure with use of beta-blockers would be worthwhile only if it were reflected in other more substantive benefits for the mother and/or baby, and none have yet been clearly demonstrated. The effect of beta-blockers on perinatal outcome is uncertain, given that the worrying trend to an increase in small for gestational age infants is partly dependent on one small outlying trial. Large, randomised controlled trials are needed to determine whether antihypertensive therapy in general (rather than beta-blocker therapy specifically) results in benefits that outweigh the risks for treatment of mild-moderate pregnancy hypertension. If so, then it would be appropriate to look at which antihypertensive is best. Beta-blockers would remain a candidate class of agents.

Administration, Oral↗
PubMed2000

Eradication of helicobacter pylori for non-ulcer dyspepsia.

BACKGROUND: Helicobacter pylori (H pylori) is the main cause of peptic ulcer disease. The role of H pylori in non-ulcer dyspepsia is less clear. OBJECTIVES: To determine the effect of H pylori eradication on dyspepsia symptoms and quality of life scores in patients with non-ulcer dyspepsia. SEARCH STRATEGY: Trials were identified through electronic searches of the Cochrane Controlled Trials Register (CCTR), MEDLINE, EMBASE, CINAHL and SIGLE, using appropriate subject headings and keywords, searching bibliographies of retrieved articles, and through contacts with experts in the fields of dyspepsia and with pharmaceutical companies. SELECTION CRITERIA: All parallel group randomised controlled trials (RCTs) comparing drugs to eradicate H pylori with placebo or other drugs known not to eradicate H pylori for patients with non-ulcer dyspepsia. DATA COLLECTION AND ANALYSIS: Data were collected on individual and global dyspeptic symptom scores, quality of life measures and adverse effects. Dyspepsia outcomes were dichotomised into minimal/resolved versus same/worse symptoms. MAIN RESULTS: Seven randomised controlled trials were included in the systematic review. Five trials compared proton pump inhibitor dual or triple therapy with a proton pump inhibitor + placebo antibiotics, and evaluated dyspepsia at 6-12 months in 1,385 patients. H pylori eradication was significantly superior to placebo in treating non ulcer dyspepsia (relative risk reduction = 7%; 95% CI = 1% to 12%; p=0.02) and there was no significant heterogeneity between the studies. The number needed to treat to cure one case of dyspepsia = 19 (95% CI = 11 to 132). A further two trials compared Bismuth based H pylori eradication with an alternative pharmacological agent. These trials were smaller and had a shorter follow-up but suggested H pylori eradication was more effective than either H2 receptor antagonists or sucralfate in treating non-ulcer dyspepsia. REVIEWER'S CONCLUSIONS: H pylori eradication may be an effective therapy for H pylori positive non-ulcer dyspepsia. This result is not robust and further evidence on the efficacy of H pylori eradication in non ulcer dyspepsia would be helpful. The effect is modest and economic models would help establish whether this approach is cost-effective. This review will be updated as results from other ongoing trials (Malfertheiner 2000) are made available.

Anti-Bacterial Agents↗
PubMed2000

Exercise-based rehabilitation for coronary heart disease.

BACKGROUND: The burden of cardiovascular disease world-wide is one of great concern to patients and health care agencies alike. Circulatory diseases, including myocardial infarction (MI) and stroke, kill more people than any other disease. Cardiac rehabilitation aims to restore patients who have suffered myocardial infarction to optimal health through exercise only based rehabilitation or comprehensive cardiac rehabilitation (eg. smoking cessation advice, diet and counselling as well as exercise). Data from two published and widely cited meta-analyses (Oldridge 1988, O'Connor 1989) of over 4,000 patients each have demonstrated that patients randomised to exercise-based cardiac rehabilitation after MI have a statistically significant reduction in all-cause and cardiac mortality of about 20 to 25% compared to patients receiving conventional care. However, the trials included were small and often of poor methodological quality. Incomplete literature review methods may have resulted in publication bias thereby resulting in an over-estimate of the benefit of cardiac rehabilitation. The randomised controlled trials used in the reviews have focused almost exclusively on low-risk, middle-aged males post MI, thereby excluding women and the elderly. OBJECTIVES: To determine the effectiveness of exercise only rehabilitation and exercise in addition to other rehabilitation interventions (termed comprehensive cardiac rehabilitation) compared with usual care on the mortality, morbidity, health-related quality of life (HRQoL) and modifiable cardiac risk factors of patients with coronary heart disease. SEARCH STRATEGY: Electronic databases were searched for randomised controlled trials, using standardised trial filters, from the earliest date available to December 31st 1998. SELECTION CRITERIA: Men and women of all ages, in both hospital-based and community-based settings, who have had myocardial infarction, coronary artery bypass graft or percutaneous transluminal coronary angioplasty, or who have angina pectoris or coronary artery disease defined by angiography have been included. Studies involving participants following heart transplant, heart valve surgery or heart failure have been excluded. Follow up periods of less than 6 months were excluded. DATA COLLECTION AND ANALYSIS: Studies were selected independently by two reviewers, and data extracted independently. Authors were contacted where possible to obtain missing information. MAIN RESULTS: The current systematic review has allowed analysis of an increased number of patients from approximately 4500 in the earlier meta-analyses to 7683 (2582 in exercise only and 5101 in the comprehensive cardiac rehabilitation group). The quality of reporting overall was poor, with generally high losses to follow up. The pooled effect estimate for total mortality for the exercise only intervention shows a 27% reduction in all cause mortality (random effects model OR 0.73 (0.54, 0.98)). Similarly, comprehensive cardiac rehabilitation reduced all cause mortality compared to usual care, but to a lesser degree (OR 0.87 (0.71, 1.05)). Total cardiac mortality was reduced by 31% (random effects model OR 0.69 (0.51, 0.94)) and 26% (random effects model OR 0.74 (0.57, 0.96)) in the exercise only and comprehensive cardiac rehabilitation intervention groups respectively when compared to usual care. Neither intervention had any effect on the ocurrence of non-fatal myocardial infarction. There was a significant net reduction in total cholesterol in the comprehensive cardiac rehabilitation group (pooled WMD random effects model -0.57 mmol/l (-0.83, -0.31)), but not the exercise only rehabilitation group. Similarly, LDL was significantly reduced in the comprehensive cardiac rehabilitation group (pooled WMD random effects model -0.51 mmol/l (-0.82, -0.19). The effect of exercise only rehabilitation or comprehensive cardiac rehabilitation interventions on revascularisation rates, blood pressure or smoking behaviour could not be determined by this meta-analysis due to the small number of trials reporting these outcomes and heterogeneity between trials. It was not possible to combine the data from studies reporting HRQoL as an outcome. Eighteen different instruments were used to assess HRQoL in the 11 studies reporting it as an outcome. The data are presented qualitatively, only one trial reporting significant improvements with the intervention. REVIEWER'S CONCLUSIONS: Exercise-based cardiac rehabilitation appears to be effective in reducing cardiac deaths but the evidence base is weakened by poor quality trials. It is not clear from this review whether exercise only or a comprehensive cardiac rehabilitation intervention is more beneficial. The population studied in this review is still predominately male, middle aged and low risk. Identification of the ethnic origin of the participants was seldom reported. (ABSTRACT TRUNCATED)

Coronary Disease↗