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PubMed2004

Antifibrinolytic drugs for acute traumatic injury.

BACKGROUND: Uncontrolled bleeding is an important cause of death in trauma victims. Antifibrinolytic treatment has been shown to reduce blood loss following surgery and may also be effective in reducing blood loss following trauma. OBJECTIVES: To quantify the effect of antifibrinolytic drugs in reducing blood loss, transfusion requirement and mortality after acute traumatic injury. SEARCH STRATEGY: We searched the Cochrane Injuries Group's Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, PubMed, EMBASE, Science Citation Index, National Research Register, Zetoc, SIGLE, Global Health, LILACS, and Current Controlled Trials. SELECTION CRITERIA: We included all randomised controlled trials of antifibrinolytic agents (aprotinin, tranexamic acid [TXA] and epsilon-aminocaproic acid) following acute traumatic injury. DATA COLLECTION AND ANALYSIS: The titles and abstracts identified in the electronic searches were screened by two independent reviewers to identify studies that had the potential to meet the inclusion criteria. The full reports of all such studies were obtained. From the results of the screened electronic searches, bibliographic searches, and contacts with experts, two reviewers independently selected trials meeting the inclusion criteria, with any disagreements resolved by consensus. MAIN RESULTS: Two studies met the inclusion criteria. The study by Auer (1979), with 20 randomised patients, provided no useable outcome data. The study by McMichan (1982), with 77 randomised patients, was reported in four separate reports. Outcome data were reported for death, the proportion undergoing surgical intervention and the volume of blood transfused. Because of the small number of randomised participants, the estimates for each of these outcomes were highly imprecise. Data on the proportion undergoing re-operation and the proportion receiving blood transfusion were not reported. REVIEWERS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials of antifibrinolytic agents in trauma to either support or refute a clinically important treatment effect. Further randomised controlled trials of antifibrinolytic agents in trauma are required.

Antifibrinolytic Agents↗
PubMed2002

The role of phytotherapy in treating lower urinary tract symptoms and benign prostatic hyperplasia.

Despite their traditional popularity in many European countries and their increasing use as dietary supplements in the United States, the role of phytotherapeutic agents in treating lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH) is continuously debated. If strict criteria of evidence-based medicine are applied, the available data have not yet provided clear evidence of efficacy for most phytotherapeutic preparations. Different extraction procedures used by the different manufacturers, the variations of the raw products (plants) used and the fact that the potentially active component(s) of the final product and its (their) mechanism(s) of action are still under investigation make comparisons between the various products impossible. Thus, one product might have clinical efficacy while another might not. Therefore, as long as the composition of the final product of the various preparations is not proven to be identical, each manufacturer's preparation must be evaluated separately, using the gold standard of placebo-controlled studies according to accepted guidelines. Conclusions of meta-analyses that include products from different plants undergoing different extraction procedures and that are used in different dosages may be misleading. A number of short-term randomised trials and some metaanalyses in the recent literature suggest clinical efficacy and good tolerability for some preparations, mainly extracts from Serenoa repens and also Pygeum africanum, products with high concentrations of beta-sitosterol, and pumpkin seeds. It is also claimed that the efficacy of an extract from S. repens is comparable to that of finasteride and alpha-blockers. However, as has been demanded by the International Consultations on BPH, additional randomised, placebo-controlled trials are needed before phytotherapeutic agents can be recommended as an effective option in treating LUTS and BPH.

Aged↗
PubMed2000

The impact of patients' preferences on the treatment of atrial fibrillation: observational study of patient based decision analysis.

OBJECTIVE: To investigate the impact of patients' preferences for the treatment of atrial fibrillation, by using individualised decision analysis combining probability and utility assessments into a decision tree. DESIGN: Observational study based on interviews with patients. SETTING: Eight general practices in Avon. PARTICIPANTS: 260 randomly selected patients aged 70-85 years with atrial fibrillation. MAIN OUTCOME MEASURES: Patients' treatment preferences regarding anticoagulation treatment (warfarin) after individualised decision analysis; comparison of these preferences with treatment guidelines on the basis of comorbidity and absolute risk and compared with current prescription. RESULTS: Of 195 eligible patients, 97 participated in decision making using decision analysis. Among these 97, the decision analysis indicated that 59 (61%; 95% confidence interval 50% to 71%) would prefer anticoagulation treatment-considerably fewer than those who would be recommended treatment according to guidelines. There was marked disagreement between the decision analysis and guideline recommendations (kappa=0.25 or less). Of 38 patients whose decision analysis indicated a preference for anticoagulation, 17 (45%) were being prescribed warfarin; on the other hand, 28 (47%) of 59 patients were not being prescribed warfarin although the results of their decision analysis suggested they wanted to be. CONCLUSIONS: In the context of shared decision making, individualised decision analysis is valuable in a sizeable proportion of elderly patients with atrial fibrillation. Taking account of patients' preferences would lead to fewer prescriptions for warfarin than under published guideline recommendations. Decision analysis as a shared decision making tool should be evaluated in a randomised controlled trial.

Aged↗
PubMed1999

Randomisation in clinical trials.

BACKGROUND: Several studies of papers published in non-psychiatric medical journals that report on randomised controlled trials (RCTs) indicate that there is inadequate reporting of the process by which randomisation is carried out. AIMS: To examine the adequacy of the reporting of the procedure of randomisation in clinical trials of parallel design published in the British Journal of Psychiatry (BJP) and the American Journal of Psychiatry (AJP). METHODS: All issues of the BJP and the AJP published between January 1990 and December 1998 were surveyed, and papers that reported on RCTs were examined to judge the adequacy of the reporting of the process of randomisation. RESULTS: We found 183 papers which claimed to report on RCTs (73 in the BJP and 110 in the AJP). Nine (8.2%) of those in the AJP and six (8.2%) in the BJP described the technique of creating the randomisation sequence. Two (1.8%) of those in the AJP and 11 (15.1%) of those in the BJP described the mechanism of allocating treatment. One paper in the AJP and five papers in the BJP described both the generation of random numbers and allocation. CONCLUSIONS: Adequate reporting of the method of randomisation was uncommon. The RCT status of some of the papers must therefore be in doubt.

Humans↗
PubMed2000

Tamoxifen for relapse of ovarian cancer.

BACKGROUND: Tamoxifen is an important drug for treating breast cancer. Ovarian cancer cells are known to possess receptors for hormones and may thus also respond to tamoxifen. OBJECTIVES: Tamoxifen is used to treat breast cancer in women whose tumours have oestrogen receptors. Since ovarian cancers also commonly have oestrogen receptors, it has been suggested that tamoxifen may be of some benefit. The objective of this review was to assess the effects of tamoxifen in women with relapsed ovarian cancer. SEARCH STRATEGY: We searched the Cochrane Gynaecological Cancer Group trials register and references from relevant articles. We also contacted researchers and drug companies. SELECTION CRITERIA: Randomised and non-randomised studies of tamoxifen in women with ovarian cancer who have not responded to conventional chemotherapy. Only trials involving 10 or more patients were included. DATA COLLECTION AND ANALYSIS: One reviewer assessed eligibility and extracted data from non-randomised studies. Two reviewers were to have independently assessed the quality and extracted data from any randomised trials found. MAIN RESULTS: Eleven non-randomised series, one non-randomised phase two study and one randomised trial were included. Only observational data from women treated with tamoxifen are reported. Fifty-nine of 568 women (10.4%) treated with tamoxifen achieved an objective response to treatment. However this varied from 0% to 56% in different studies. Stable disease, for variable periods of four weeks or more, was observed in 109 of 356 (30.6%) women from eight studies. There were not enough data to assess duration of response, survival, or the palliative effect of tamoxifen on symptom control or quality of life. REVIEWER'S CONCLUSIONS: There is some evidence from observational studies that tamoxifen may produce a response in a modest proportion of women with relapsed ovarian cancer. However, there are no reliable data from randomised controlled trials.

Antineoplastic Agents, Hormonal↗
PubMed2001

Extracorporeal shockwave therapy (ESWT) in the treatment of plantar fasciitis--a biometrical review.

The application of extracorporeal shockwave therapy (ESWT) as a treatment for conservatively unsuccessfully treated plantar fasciitis has experienced a rapid increase over the last years. However, the efficacy of ESWT has not yet been established unequivocally, as published studies have led to inconsistent results. Furthermore, reviews on clinical trials on ESWT are either not up to date, incomplete, or methodologically inadequate. As a consequence, a systematic literature search was conducted which yielded 21 relevant articles on ESWT in the treatment of plantar fasciitis. These were rated according to biometrical criteria for the conduct of therapeutic trials based on international guidelines. None of the rated trials fulfilled all of the criteria, and it is concluded that at this point the efficacy of ESWT can be neither confirmed nor excluded. Randomised and controlled clinical trials are required to adequately estimate the value of ESWT as a treatment for plantar fasciitis.

Biometry↗
PubMed2002

The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome.

OBJECTIVE: To study the issues raised during the review of drug applications submitted to the European Medicines Evaluation Agency for approval in the European Union and to identify important predictors of outcome. METHODS: All consecutive applications submitted since September 1997 and which had reached an outcome by May 2001 were included. The factors considered in this exploratory analysis were: year of submission, anatomical therapeutic chemical classification (ATC code), type of medicinal product (biopharmaceuticals vs. new chemical entities), and common "major objections" raised during the review. Predictors were identified using multivariate logistic regression on outcome (positive opinion vs. negative opinion or withdrawal). Examples have been provided to illustrate some of the weaknesses of the applications received, the types of objections raised by the reviewers, and the strategies used to address them. RESULTS: This series consisted of 111 successive applications for which the review had started between September 1997 and April 2000. It included 73 (66%) new chemical entities and 38 (34%) biopharmaceuticals, the most represented agents being anti-neoplastic and immunomodulating agents, and anti-infectives for systemic use, with 25 (22%), and 19 (17%) applications, respectively. Overall the proportion of drug applications that failed to reach a positive outcome was 32/111 (29%). The most frequent major objections raised were those related to the safety database and to serious adverse events. These clinical safety objections were raised in 54 (48.6%) applications. Another frequent objection was the clinical efficacy objection on the lack of adequate randomised controlled trials, which was raised in 47 (42.3%) applications. This clinical efficacy objection was the only factor that was retained after multivariate selection (P<0.01). The odds of a positive outcome for an application lacking adequate randomised controlled trials were: 0.46 (95% confidence interval 0.29-0.71) times the odds of an application without this objection (P=0.0006). CONCLUSIONS: Despite the existence of various mechanisms that allow important deficiencies to be resolved, failure to establish clinical efficacy due to the lack of adequate randomised controlled trials remained problematic, leading to a high risk of rejection.

Clinical Trials as Topic↗
PubMed1998

[Maintenance chemotherapy in the treatment of small cell lung cancer: the advocate's view].

The role of maintenance chemotherapy in the treatment of small cell lung cancer remains controversial. We have collected the arguments in favor of that approach by performing a quantitative and qualitative overview of the studies published on this topic in the French and English literatures since 1980. On the thirteen prospective randomized trials reported, six demonstrated a significant survival advantage in favor of maintenance, no difference was observed in 6 and 1 study had a significant survival advantage for no maintenance. Due to the heterogeneity of the study designs and to the lack of published data, no meta-analysis could be performed. A qualitative overview of the different trials showed that the quality scores of the positive trials was similar to the negative ones, allowing us to conclude that they could be considered at the same level. No negative trial with a similar design can be opposed to each particular positive trial that is thus not conterbalanced. Moreover the trials not in favor of maintenance could be falsely negative by a lack of power, the publications mentioning no statistical consideration. There are thus a series of arguments in favor of maintenance chemotherapy for small-cell lung cancer, which require to be confirmed by randomised trials of adequate quality.

Antineoplastic Agents↗
PubMed1996

Hand searching the Journal of Epidemiology and Community Health as part of th Cochrane Collaboration.

STUDY OBJECTIVE: To identify randomised controlled trials (RCTs) published in the Journal of Epidemiology and Community Health and to explore the contribution of these to the evaluation of public health issues. DESIGN: Hand searching of the journal by both authors with independent assessment of topics of the reports and of their relevance to the Cochrane Collaboration. Agreement was assessed using kappa scores. SETTING: All papers and letters published in the journal from the first issue to the end of 1994. SUBJECTS: Reports that might be RCTs were collected and classified into seven categories: definitely/probably/possibly RCTs or quasi-RCTs; or none of these. MAIN RESULTS: Eighty two definite RCTs were identified and a further 23 were probably/possibly RCTs or quasi-RCTs. Most reports dealt with health education, drug treatments, or "other" health service interventions. Both authors failed to identify a number of trials on hand searching. CONCLUSIONS: The journal has published many trials of importance to the development of evidence-based public health policy. Hand searching may need to be done independently by more than one person.

Information Storage and Retrieval↗
PubMed2000

Benzodiazepine prescribing by GP registrars. A trial of educational outreach.

BACKGROUND: Despite ongoing concern about adverse effects and dependence on benzodiazepines, approximately 2% of Australians are still taking them on a regular basis. The aim of this study was to evaluate the effectiveness of an educational outreach or 'academic detailing' program about prescribing of benzodiazepines. METHOD: In this randomised trial general practice registrars (n = 157) in New South Wales were allocated to an intervention group (n = 79), which received a 20 minute educational outreach visit; or a control group (n = 78) which received an intervention on an unrelated topic. Prescribing behaviour was monitored by a pre-intervention and two post-intervention practice activity surveys. MAIN OUTCOME MEASURES: These were the rate of benzodiazepine prescribing for all indications, for anxiety and for sleep disorders. RESULTS: Overall benzodiazepine prescribing by the intervention group declined from 2.3 to 1.7 per 100 encounters, while the control group also declined from 2.2 to 1.6 per 100 encounters. Analysis of variance showed this was a significant drop over time (P = 0.042) but there was no difference between groups (P = 0.99). The prescribing decrease observed was in continuing rather than initial prescriptions. CONCLUSIONS: A marked decrease in benzodiazepine prescribing was seen over the course of the study in both intervention and control groups but no differential effect due to the educational outreach visit was found.

Analysis of Variance↗