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PubMed2004

Thyroid hormone supplementation for the prevention of morbidity and mortality in infants undergoing cardiac surgery.

BACKGROUND: Paediatric studies have demonstrated that cardiopulmonary bypass is associated with a decline in thyroid hormone levels. Adult patients who undergo open heart surgery and receive triiodothyronine supplementation have demonstrated a dose-dependent increase in cardiac output which has been associated with an improved clinical outcome. Thyroid hormone supplementation in infants may also reduce post-operative morbidity and mortality. OBJECTIVES: To determine if peri-operative thyroid hormone supplementation or replacement in infants undergoing cardiac surgery on cardiopulmonary bypass improves post-operative and longer term morbidity and mortality. SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group was used. This included searches of The Oxford Database of Perinatal Trials, MEDLINE (1966 - December 2003), EMBASE (1980 - December 2003), CINAHL (1982 - December 2003), The Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2003), previous reviews including cross references, abstracts, conferences, symposia proceedings, expert informants and journal handsearching in the English language. SELECTION CRITERIA: All trials using random allocation to peri-operative thyroid hormone therapy (supplementation or replacement) compared to control (placebo or no therapy) in infants (birth to one year of age) undergoing cardiac surgery requiring cardiopulmonary bypass. Thyroid hormone therapy must be tri-iodothyronine. DATA COLLECTION AND ANALYSIS: Primary clinical outcomes included measures of post-operative morbidity and mortality. The standard methods of the Cochrane Neonatal Review Group were used in the assessment of trial quality. Treatment effects were expressed using relative risk (RR) and mean difference (MD). MAIN RESULTS: Two very small studies were identified that tested peri-operative thyroid hormone supplementation or replacement in infants aged less than one year undergoing cardiac surgery (Chowdhury 2001; Portman 2000). In the Chowdhury 2001 study, a subgroup of nine neonates was eligible for this review. No deaths occurred during either study. Chowdhury 2001 found no significant effect of peri-operative thyroid hormone supplementation in neonates on either length of hospital stay or duration of mechanical ventilation. Portman 2000 found no significant difference in dopamine requirements for the treatment versus control groups for the first 24 hours post operatively, while in the Chowdhury neonatal subgroup, inotrope requirements were significantly lower in the treatment group. Portman 2000 reported significant differences between the two groups at 1 and 24 hours post operatively for free T3 and at 1 hour post operatively for total T3 levels. Total T4 levels showed no significant difference between groups, either pre-cardiopulmonary bypass or up to 72 hours post operatively. REVIEWERS' CONCLUSIONS: At present, there is a lack of evidence concerning the effects of tri-iodothyronine supplementation in infants undergoing cardiac surgery. Further randomised controlled trials which include sufficiently large subject numbers in a variety of different age strata (neonates, infants and older children) need to be undertaken.

Humans↗
PubMed2005

Non-invasive positive pressure ventilation for treatment of respiratory failure due to severe acute exacerbations of asthma.

BACKGROUND: Non-invasive positive pressure ventilation (NPPV) has been shown to be effective in chronic obstructive pulmonary disease patients with acute respiratory failure. However, its role in patients with severe acute asthma is uncertain. The pathophysiologic condition of acute respiratory failure in asthma is in many ways similar to that of acute respiratory failure in COPD. Therefore, there is reason to believe that NPPV could also be successful in patients with severe acute asthma. OBJECTIVES: To determine the efficacy of NPPV in adults with severe acute asthma in comparison to usual medical care with respect to mortality, tracheal intubation, changes in blood gases and hospital length of stay. SEARCH STRATEGY: An initial search for studies was carried out using CENTRAL. Additional searches were also carried out on MEDLINE, EMBASE, CINAHL, Science Citation, web based clinical trials databases and key journals with web sites were also searched as well as respiratory conference proceedings. Following this, the bibliographies of each randomised controlled trial obtained (and any review articles) was searched for additional studies. Date of most recent search for trials was conducted on May 2004. SELECTION CRITERIA: Only RCTs in adults patients with severe acute asthma were considered for inclusion. Studies including patients with features of COPD were excluded unless data was provided separately for patients with asthma in studies recruiting both COPD and asthma patients. DATA COLLECTION AND ANALYSIS: All data was analysed using RevMan. For continuous variables, a weighted mean difference and 95% confidence interval (95%CI) was calculated for each study outcome. For dichotomous variables relative risk with 95% confidence interval was calculated. MAIN RESULTS: From an initial search of 696 abstracts, 11 trials were obtained in full-text for closer examination. Ten trials were excluded and one included. The one included trial, on 30 patients, showed benefit with NPPV when compared to usual medical care alone with significant improvements in hospitalisation rate, number of patients discharged from emergency department, percent predicted FEV(1), FVC, PEFR and respiratory rate. AUTHORS' CONCLUSIONS: The application of NPPV in patients suffering from status asthmaticus, despite some interesting and very promising preliminary results, still remains controversial. Large, prospective, randomised controlled trials are therefore needed to determine the role of NPPV in status asthmaticus.

Acute Disease↗
PubMed2006

Methods of consumer involvement in developing healthcare policy and research, clinical practice guidelines and patient information material.

BACKGROUND: The importance of consumer involvement in health care is widely recognised. Consumers can be involved in developing healthcare policy and research, clinical practice guidelines and patient information material, through consultations to elicit their views or through collaborative processes. Consultations can be single events, or repeated events, large or small scale. They can involve individuals or groups of consumers to allow debate; the groups may be convened especially for the consultation or be established consumer organisations. They can be organised in different forums and through different media. We anticipated finding few comparative evaluations that reliably evaluated the effects of consumer involvement. OBJECTIVES: To assess the effects of consumer involvement and compare different methods of involvement in developing healthcare policy and research, clinical practice guidelines, and patient information material. SEARCH STRATEGY: We searched: the Cochrane Consumers and Communication Review Group's Specialised Register (4 May 2006); the Cochrane Controlled Trials Register (CENTRAL) (The Cochrane Library, Issue 1 2006), MEDLINE (1966 to January Week 2 2006); EMBASE (1980 to Week 03 2006); CINAHL (1982 to December Week 2 2005), PsycINFO (1806 to January Week 3 2006); Sociological Abstracts (1952 to 24 January 2006); and SIGLE (System for Information on Grey Literature in Europe) (1980 to 2003/1). We scanned reference lists from relevant articles and contacted authors. SELECTION CRITERIA: Randomised and quasi-randomised trials, interrupted time series analyses, and controlled before-after studies assessing methods for involving consumers in developing healthcare policy and research, clinical practice guidelines or patient information material. The outcome measures were: participation or response rates of consumers; consumer views elicited; consumer influence on decisions, healthcare outcomes or resource utilisation; consumers' or professionals' satisfaction with the involvement process or resulting products; impact on the participating consumers; costs. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, assessed their quality and extracted data. We contacted study authors for clarification and to seek missing data. We presented results in a narrative summary and pooled data as appropriate. MAIN RESULTS: Five randomised controlled trials of moderate or low methodological quality involving 1031 participants were included. There is moderate quality evidence that involving consumers in the development of patient information material results in material that is more relevant, readable and understandable to patients, without affecting their anxiety. This 'consumer-informed' material can also improve patients' knowledge. There is low quality evidence that using consumer interviewers instead of staff interviewers in satisfaction surveys can have a small influence on the survey results. There is very low quality evidence of telephone discussions and face-to-face group meetings engaging consumers better than mailed surveys in order to set priorities for community health goals, and resulting in different priorities being set for these goals. AUTHORS' CONCLUSIONS: There is little evidence from comparative studies of the effects of consumer involvement in healthcare decisions at the population level. The studies included in this review demonstrate that randomised controlled trials are feasible for providing evidence about the effects of consulting consumers to inform these decisions.

Community Participation↗
PubMed2006

Antipsychotic medication for elderly people with schizophrenia.

BACKGROUND: A large and growing number of older people across the world suffer from schizophrenia. Recommendations for their treatment are largely based on data extrapolated from studies of the use of antipsychotic medications in younger populations. In addition most manufacturers of such medications recommend prescription of reduced doses to the elderly. The evidence base for these assumptions is unclear and raises obvious questions regarding the appropriateness of such prescribing practice. OBJECTIVES: To find and assimilate good evidence of the effects of antipsychotic medication for treatment of schizophrenia in people over 65 years of age. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's Register (May 2003). We inspected references of all included studies for further trials and contacted relevant pharmaceutical companies. SELECTION CRITERIA: All clinical randomised trials evaluating antipsychotic drugs for schizophrenia and schizophrenia-like psychoses in older people. DATA COLLECTION AND ANALYSIS: We extracted data independently. For homogenous dichotomous data, the random effects, relative risk (RR), and 95% confidence interval (CI) and, where appropriate, the numbers needed to treat (NNT) were calculated on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). MAIN RESULTS: Two hundred and fifty two elderly people with schizophrenia participated in three relevant randomised controlled studies. We were unable to extract usable data on quality of life, satisfaction, service use, or economic outcomes. One small study (n=18) compared thioridazine with remoxipride (RR leaving the study early 1.0 CI 0.07 to 13.6). A second study (n=175) compared risperidone with olanzapine. Global state 'not improved/worse' was not significantly different between treatments (n= 171, RR 1.26 CI 0.8 to 1.9); mental state PANSS total endpoint scores were also equivocal (n=171, RR 0.98 CI 0.76 to 1.26) as were all cognitive function tests. The third study (subset n=59) compared olanzapine with haloperidol and mental state change scores (BPRS WMD -3.60 CI -10.8 to 3.6; PANSS WMD -6.00 CI -18.3 to 6.3) were equivocal. AUTHORS' CONCLUSIONS: Antipsychotics may be widely used in the treatment of elderly people with schizophrenia, however, based on this systematic review, there are little robust data available to guide the clinician with respect to the most appropriate drug to prescribe. Clearly reported large short, medium and long-term randomised controlled trials with participants, interventions and primary outcomes that are familiar to those wishing to help elderly people with schizophrenia are long overdue.

Aged↗
PubMed2005

Handwashing in the intensive care unit: a big measure with modest effects.

Handwashing is widely accepted as the cornerstone of infection control in the intensive care unit. Nosocomial infections are frequently viewed as an indicator of poor compliance of handwashing. The aim of this review is to evaluate the effectiveness of handwashing on infection rates in the intensive care unit, and to analyse the failure of handwashing. A literature search identified nine studies that evaluated the impact of handwashing or hand hygiene on infection rates, and demonstrated a low level of evidence for the efforts to control infection with handwashing. Poor compliance cannot be blamed as the only reason for the failure of handwashing to control infection. Handwashing on its own does not abolish, but only reduces transmission, as it is dependent on the bacterial load on the hand of healthcare workers. Finally, recent studies, using surveillance cultures of throat and rectum, have shown that, under ideal circumstances, handwashing can only influence 40% of all intensive care unit infections. A randomised clinical trial with the intensive care as randomisation unit is required to support handwashing as the cornerstone of infection control.

Clinical Trials as Topic↗
PubMed2004

Methodology and reporting of randomised controlled trials.

A systematic review of the literature will fail to provide information needed for evidence-based medicine (EBM) if the design, execution and reporting of individual trials do not adhere to strict guidelines. Experience gained while conducting systematic literature reviews have revealed serious shortcomings in current literature. These limitations pertain to randomisation, blinding, outcome assessments and data reporting. The principles related to these issues are discussed with solutions and improvements provided.

Arthroplasty, Replacement, Hip↗
PubMed1998

Clinical trials: study design and analysis.

To enable doctors to select the best therapeutic strategy, the value of the various options needs to be determined. The best approach to the evaluation of therapeutic effectiveness and side effects is a randomised clinical trial. Traditionally, such trials have been mainly conducted to evaluate new drugs. However, other medical interventions, such as surgical and radiological procedures and lifestyle changes, also require methodologically sound evaluation. In this article, some of the basic principles of the study design of randomised clinical trials will be discussed, such as study group comparability, treatment, data collection and statistical analysis, as well as issues relating to randomisation, outcome and blinding. Attention is also paid to some of the ethical aspects.

Data Collection↗
PubMed2000

Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature.

BACKGROUND: Clinical trials are the principal means by which new treatment approaches are evaluated in medicine. It has been argued that randomised clinical trials provide the highest standard of care and at the same time help to contribute to scientific knowledge. However, only a relatively small proportion of cancer patients receive treatment as part of a formal clinical trial. This article provides a broad review of the issues pertinent to physician and patient participation in randomised clinical trials. METHODS: Search of computerised electronic databases (Medline, Psychlit, Cinhail, Embase). RESULTS: There are a variety of physician and patient characteristics which have previously been shown to influence participation in randomised clinical trials. Additionally, ethical concerns about randomised trials in general and the additional requirements of informed consent for clinical trials, may impact on recruitment. Whilst there is some research examining strategies to improve patient understanding about clinical trials and promote patient involvement in clinical decision-making, there are deficiencies in these areas. In particular there is a paucity of research examining the association between knowledge about clinical trials, anxiety associated with a new cancer diagnosis and willingness to participate in randomised clinical trials. CONCLUSIONS: Further research also is needed to evaluate strategies to better inform patients about clinical trials.

Attitude↗
PubMed2004

Evaluating treatments for the mood disorders: time for the evidence to get real.

OBJECTIVE: To detail limitations to level I evidence derived from randomised controlled trials of antidepressant treatments and which is held to be fundamental to the development and validity of treatment guidelines. METHOD: Recent efficacy studies and meta-analyses of treatments of major depression are considered. RESULTS: The largest database in psychiatry--demonstrating that all principal treatments are of similar efficacy, and that antidepressant drugs are not distinctly superior to placebo treatment--is unlikely to be valid. CONCLUSION: Excessive belief in and weighting of the evidence emerging from randomised controlled trials deserves to be criticized. An argument is put for adopting alternative approaches to evaluating the likely effectiveness of any antidepressant treatment.

Antidepressive Agents↗
PubMed2006

Dose escalation for insufficient response to standard-dose selective serotonin reuptake inhibitors in major depressive disorder: systematic review.

BACKGROUND: Although selective serotonin reuptake inhibitors (SSRIs) are frequently used for major depressive disorder, only 50-60% of patients respond to a standard dose. For non-responders, dose escalation is often applied. AIM: To systematically review the evidence for dose escalation of SSRIs. METHOD: A systematic literature search in MEDLINE, EMBASE, CINAHL and PsycInfo was performed. Randomised controlled trials and meta-analyses investigating dose escalation of SSRIs were identified. Relevant articles were retrieved and critically appraised. Results were summarised in an evidence table. Pooling was not justified because of heterogeneity of the identified studies. RESULTS: Eight true dose-escalation studies and three meta-analyses were identified. The available data provided no unequivocal base for dose escalation. Dose escalation before 4 weeks of treatment at a standard dose appeared to be ineffective. CONCLUSIONS: Dose escalation of SSRIs is equivocally supported by evidence of randomised controlled trials; methodological difficulties in the studies may account for this lack of evidence.

Major Depressive Disorder↗
PubMed2001

Sample size and statistical power of randomised, controlled trials in orthopaedics.

We reviewed all 717 manuscripts published in the 1997 issues of the British and American volumes of the Journal of Bone and Joint Surgery and in Clinical Orthopaedics and Related Research, from which 33 randomised, controlled trials were identified. The results and sample sizes were used to calculate the statistical power of the study to distinguish small (0.2 of standard deviation), medium (0.5 of standard deviation), and large (0.8 of standard deviation) effect sizes. Of the 33 manuscripts analysed, only three studies (9%) described calculations of sample size. To perform post-hoc power assessments and estimations of deficiencies of sample size, the standard effect sizes of Cohen (small, medium and large) were calculated. Of the 25 studies which reported negative results, none had adequate power (beta < 0.2) to detect a small effect size and 12 (48%) lacked the power necessary to detect a large effect size. Of the 25 studies which did not have an adequate size of sample to detect small differences, the average used was only 10% of the required number Our findings suggest that randomised, controlled trials in clinical orthopaedic research utilise sample sizes which are too small to ensure statistical significance for what may be clinically important results.

Humans↗
PubMed2001

Penile cancer: a case for guidelines.

INTRODUCTION: Aspects of the management of penile cancer remain controversial. In the management of early T1 N0 disease, treatments are divided between amputation and a variety of penis conserving techniques (PCT); local excision, laser techniques, chemotherapy and radiotherapy. We report on a retrospective series of patients with penile cancer. PATIENTS AND METHODS: Thirty-seven patients were diagnosed between 1987-1996. All patients records were retrieved. Data recorded included TNM stage, histological grade and treatment. The end-points were death, nodal progression and local recurrence. RESULTS: Median survivor follow-up of 42 months was obtained. Twenty-six patients (70%) presented with T1 disease, 7 (19%) T2 and 4 (11%) T3 or T4. Inguinal nodal disease was seen in 11 (30%). The mean age was 63 years. Overall, 13 penile amputations were performed, 13 underwent radiotherapy, 6 were locally excised in combination with radiotherapy and 3 underwent local excision alone. Two patients were unsuitable for treatment. Of the total (37 patients) 15 have died; 12 from penile cancer. Ten have suffered disease progression and 12 remain alive with no evidence of disease. Twenty-three patients presented with early T1 NO disease. They were treated with radiotherapy (12), local excision (2), combined radiotherapy and excision (2) and partial amputation (4). Outcome was not significantly related to treatment modality. Spread to the inguinal nodes or local recurrence has occurred in 10, of whom 2 have died. Only 13 (57%) appear disease-free. CONCLUSIONS: The characteristics of the patients and the disease in this series are similar to published series in Europe and North America. There is significant variability in the modalities of treatment used within this series. Local recurrence and disease progression occurs in 43% of T1 N0 lesions. There would seem to be some room for improvement. International data are retrospective and inconclusive with regard to best practice. There is an urgent requirement for randomised controlled trials to improve the outcome of these patients.

Adult↗
PubMed1996

[Prevention of osteoporosis: estrogen substitution paradigm].

There is an increasing belief among most physicians that hormone replacement therapy (HRT) is unquestionable efficacious to prevent osteoporotic fractures in women after the menopause. However, an analysis of the studies which are regarded as efficacy proof of HRT concerning the prevention of hip fractures--as the most important manifestation of osteoporosis--shows that the data are weaker than generally assumed: there are no randomised trials with regard to hip fracture prevention by HRT and the protective effect which is seen in the observational studies is inversely related to the methodical state of the respective type of study. Consequently, a bias cannot be excluded, while the so-called 'selection-by-health'-bias could play an outstanding role. For the efficacy proof of a treatment randomised controlled trials cannot be replaced by results of observational studies, however impressive they may be.

Bias↗
PubMed2000

Antipsychotic medication for those with both schizophrenia and learning disability.

BACKGROUND: Antipsychotic medication is the standard treatment for people with learning disability and schizophrenia. OBJECTIVES: To determine the efficacy of any antipsychotic medication for treating people with a dual diagnosis of learning disability and schizophrenia. SEARCH STRATEGY: Electronic searching of Biological Abstracts, the Cochrane Schizophrenia Group's Register of trials, the Cochrane Library, EMBASE, PsycLIT and MEDLINE. Unpublished data were sought from pharmaceutical companies. Both authors independently selected the relevant studies from the reports identified in this way. SELECTION CRITERIA: 1. All randomised controlled trials of antipsychotic medication, regardless of dosage, versus a placebo control, of longer than one month's duration. 2. Anyone over 18 years of age with both learning disability and schizophrenia. Learning disability was defined as a measured IQ of 70 or less. Any mode of diagnosis of schizophrenia was acceptable. DATA COLLECTION AND ANALYSIS: The two reviewers independently attempted to select and then extract data but it was not possible to do this with the single study that met the inclusion criteria. MAIN RESULTS: Only one relevant randomised trial was found by the searches. This study included four people with a dual diagnosis of schizophrenia and learning disability, but results were available for only two. The groups to which the other two people were allocated were unclear. In order to display the data, too many assumptions would have to have been made about these other two people and any results would be uninformative and potentially misleading. REVIEWER'S CONCLUSIONS: Using the methods described the reviewers found no randomised controlled trial evidence to guide the use of antipsychotic medication for those with both learning disability and schizophrenia. Until the urgent need for randomised controlled trials is met clinical practice will continue to be guided by extrapolation of evidence from randomised controlled trials involving people with schizophrenia but without learning disability and non-randomised trials of those with learning disability and schizophrenia.

Antipsychotic Agents↗
PubMed2004

Prostacyclin and analogues for acute ischaemic stroke.

BACKGROUND: Prostacyclin is an agent with a number of effects on platelets, blood vessels and nerve cells which might improve outcome after acute ischaemic stroke. NOTE: This review covers an area where no active research is taking place. It will be updated if relevant information becomes available, e.g. on completion of an appropriate study. OBJECTIVES: The objective of this review was to assess the effect of prostacyclin or analogues on survival in people with acute ischaemic stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched November 2003). For the first version, we also searched EMBASE (1980 to 1999), MEDLINE (1966 to 1999), Science Citation Index (1981 to 1999) and the Ottawa Stroke Trials Registry. We also contacted the manufacturers of prostacyclin and the principal investigators of the identified trials. SELECTION CRITERIA: Randomised trials comparing prostacyclin or analogues with placebo or control. Trials where people were entered within one week of stroke onset were included. DATA COLLECTION AND ANALYSIS: Information on the methods of randomisation, blinding, analysis, the number of patients randomised, dose and timing of prostacyclin or analogue, patient withdrawals, the number of deaths occurring in each trial, and trial quality, were collected and assessed. MAIN RESULTS: Five trials involving 191 people were included. Six early deaths (within four weeks) occurred with prostacyclin, and nine with placebo (odds ratio (OR) 0.63, 95% confidence interval (CI) 0.22 to 1.85). One trial of 32 patients reported late deaths (by 10 to 18 months) in 50% of patients in each group. REVIEWERS' CONCLUSIONS: Too few patients have been studied in randomised trials to allow conclusions to be drawn about the effect of prostacyclin treatment on survival of people with acute stroke.

Brain Ischemia↗
PubMed2004

Non-steroidal anti-inflammatory drugs for preventing heterotopic bone formation after hip arthroplasty.

BACKGROUND: Heterotopic bone formation (HBF) in the soft tissues surrounding the hip joint is a frequent complication of hip surgery. Non-steroidal anti-inflammatory drugs (NSAIDs) administered in the immediate perioperative period reduce the risk of HBF. However, the magnitude of the effect on HBF, and the effects on other associated outcomes, such as pain and physical function, are uncertain. OBJECTIVES: To determine the effects of perioperative NSAID therapy versus control on the risk of HBF and other outcomes in patients undergoing hip arthroplasty. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (October 2002), the Cochrane Central Register of Controlled Trials (The Cochrane Library issue 3, 2002), MEDLINE (1966 to October 2002), EMBASE (1988 to 2002 Week 43), CURRENT CONTENTS (1993 Week 27 to 2002 Week 44) and reference lists of articles. We also contacted trialists and drug manufacturers. SELECTION CRITERIA: All trials which enrolled patients scheduled to undergo hip arthroplasty with random or quasi-random allocation to perioperative NSAID or control and that recorded post-operative radiographically determined HBF. The primary outcome was post-operative radiographic HBF. Secondary outcomes were pain, function (including range of motion), gastro-intestinal and other bleeding complications, and other causes of major morbidity or mortality. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality and extracted data. All analyses were conducted on dichotomised outcomes. MAIN RESULTS: Sixteen randomised and two quasi-randomised trials involving a total of 4,763 patients were included. Overall, in 17 trials that examined the effects of medium to high doses of NSAIDs, there was a reduced risk of developing HBF after hip surgery (59% reduction, 95% confidence interval 54% to 64% reduction). In contrast, one large trial examining low-dose aspirin, demonstrated no effect on the risk of HBF (2% reduction, 95% confidence interval 15% reduction to 12% increase). There was strong evidence of differences in the size of the treatment effects observed between the trials examining medium to high doses of NSAIDs, but reasons were not clearly identified. There was a non-significant one third increased risk of gastro-intestinal side effects among patients assigned NSAIDs (29% increase, 95% confidence interval 0% to 76% increase). Most of this increase was due to an increased risk of minor gastro-intestinal complications. Data on the late post-operative outcomes of pain, impaired physical function and range of joint movement were few and no formal overviews of the effects of NSAIDs on these outcomes were possible. REVIEWERS' CONCLUSIONS: Perioperative NSAIDs, apart from low dose aspirin, appear to produce between a one half and two thirds reduction in the risk of HBF. With routine use, such agents may be able to prevent 15-20 cases of HBF among every 100 total hip replacements performed. However, while medium to high doses of perioperative NSAIDs clearly produce a substantial reduction in the incidence of radiographic HBF, there remains some uncertainty about short-term side effects of treatment and substantial uncertainty about effects on long-term clinical outcomes such as chronic pain and impaired physical function. The net effect of routine HBF prophylaxis with NSAIDs requires formal assessment in a randomised trial designed to determine the balance of benefits and risks for all outcomes.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2001

Laser resurfacing for facial acne scars.

BACKGROUND: Most people have acne at some stage during their life, with about one per cent being left with permanent acne scars. Recent laser techniques are thought to be more effective than chemical peels and dermabrasion. OBJECTIVES: To assess the effects of laser resurfacing for treating facial acne scars. SEARCH STRATEGY: We searched MEDLINE (1966 to April 1999), EMBASE (1980 to April 1999), Science Citation Index (1981 to April 1999), the Cochrane Controlled Trials Register (April 1999), DARE (April 1999), INAHTA (April 1999), NHS HTA Internet site (April 1999). Dermatological Surgery (1995 to March 1999) and the British Journal of Dermatology (1995 to September 1999) were handsearched. We searched the reference lists of relevant articles and contacted experts and commercial laser manufacturers. SELECTION CRITERIA: Randomised controlled trials which compare different laser resurfacing techniques for treating patients with facial acne scars, or compare laser resurfacing with other resurfacing techniques or no treatment. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected studies, assessed the quality of studies and extracted data. MAIN RESULTS: No randomised controlled trials where laser treatment was compared to either placebo or a different type of laser were found. Most of the 27 studies uncovered were poor quality case series with small numbers of acne-scarred patients. REVIEWER'S CONCLUSIONS: The lack of good quality evidence does not enable any conclusions to be drawn about the effectiveness of lasers for treating atrophic or ice-pick acne scars. Well designed randomised controlled comparisons of carbon dioxide versus Erbium:YAG laser are urgently needed.

Acne Vulgaris↗
PubMed2005

Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases.

BACKGROUND: Alcohol and hepatotoxic viruses cause the majority of liver diseases. Randomised clinical trials have assessed whether extracts of milk thistle, Silybum marianum (L) Gaertneri, have any effect in patients with alcoholic and/or hepatitis B or C virus liver diseases. OBJECTIVES: To assess the beneficial and harmful effects of milk thistle or milk thistle constituents versus placebo or no intervention in patients with alcoholic liver disease and/or viral liver diseases (hepatitis B and hepatitis C). SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and full text searches were combined (December 2003). Manufacturers and researchers in the field were contacted. SELECTION CRITERIA: Only randomised clinical trials in patients with alcoholic and/or hepatitis B or C virus liver diseases (acute and chronic) were included. Interventions encompassed milk thistle at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published and no language limitations were applied. DATA COLLECTION AND ANALYSIS: The primary outcome measure was mortality. Binary outcomes are reported as relative risks (RR) with 95% confidence interval (CI). Subgroup analyses were performed with regard to methodological quality. MAIN RESULTS: Thirteen randomised clinical trials assessed milk thistle in 915 patients with alcoholic and/or hepatitis B or C virus liver diseases. The methodological quality was low: only 23% of the trials reported adequate allocation concealment and only 46% were considered adequately double-blinded. Milk thistle versus placebo or no intervention had no significant effect on mortality (RR 0.78, 95% CI 0.53 to 1.15), complications of liver disease (RR 0.95, 95% CI 0.83 to 1.09), or liver histology. Liver-related mortality was significantly reduced by milk thistle in all trials (RR 0.50, 95% CI 0.29 to 0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28 to 1.19). Milk thistle was not associated with a significantly increased risk of adverse events (RR 0.83, 95% CI 0.46 to 1.50). AUTHORS' CONCLUSIONS: Our results question the beneficial effects of milk thistle for patients with alcoholic and/or hepatitis B or C virus liver diseases and highlight the lack of high-quality evidence to support this intervention. Adequately conducted and reported randomised clinical trials on milk thistle versus placebo are needed.

Hepatitis B↗