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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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PubMed2001

[Aranoza -- a new Russian antineoplastic drug].

Myelosuppression is a toxicity-related limitation for aranoza dosage. The drug proved effective in the treatment of uterine sarcoma, cancer of the head and neck, breast, Hodgkin's disease and lymphosarcoma during stage II of clinical studies. Complete regression was reported in the treatment of melanoma (ca. 12%). Good results of chemoimmunotherapy should be expected in untreated patients as well as intraarterial infusions for local lesions of the extremities. Clinical trials of aranoza used in combined modalities of therapy in various sites continue.

Antineoplastic Agents↗
PubMed2004

Gaboxadol. Lundbeck/Merck.

H Lundbeck A/S, in collaboration with Merck & Co Inc, is developing gaboxadol, a GABAA agonist, for the potential treatment of sleep disorders. The compound is currently undergoing phase III clinical trials.

Animals↗
PubMed2001

The puzzle of homeopathy.

Homeopathy is a branch of Western medicine that has mostly been rejected by Western orthodoxy for the last 200 years because of conceptual and scientific clashes. Homeopathy uses microdoses of potential toxins to provoke defense and self-regulatory responses, rather than the more orthodox approach of blocking body reactions. This approach hints at its clinical scope: it can help, at times resolve, conditions that are intrinsically reversible rather than mechanical problems, deficiencies, or irreversible breakdowns in body functions where it is only palliative. In recent years, there has been a renaissance of interest. Public demand has soared, and with it professional interest. Approximately 20% of Scotland's general practitioners have completed basic training. This is partly occasioned by public interest in complementary medicine and a sympathy with the more mind-body approach of homeopathy, and partly by recent scientific evidence. Some homeopathic dilutions are so extreme they are dismissed by critics as only placebo. Yet trials and meta-analyses of controlled trials are pointing toward real effects, mechanism of action unknown. Clinical outcome studies suggest useful clinical impact and excellent safety. There seems to be a potential to enhance patient care by integrating the two systems.

Evidence-Based Medicine↗
PubMed2006

[Abecedary of the "Annales". Part 14].

The terms included and detailed in the present part are: Median, Medline, MeSH, meta-analysis, fixed effects model, random effects model, Mean.

Clinical Trials as Topic↗
PubMed2004

Soy for the treatment of perimenopausal symptoms--a systematic review.

OBJECTIVES: Many women have turned to complementary and alternative medicines for relief from their perimenopausal symptoms. The prevalence of plant-based medicine use among perimenopausal women highlights the need for investigation into these interventions. The aim of this study was to evaluate the benefit of soy preparations for the treatment of perimenopausal symptoms by performing a systematic review of randomised clinical trials (RCTs). METHODS: Literature searches were performed using four computerised databases to identify RCTs of soy preparations for the treatment of perimenopausal symptoms. Manufacturers of soy products were contacted and our own files were also searched. There were no restrictions on the language of publication. Trials were considered if they used mono-preparations of soy or soy isoflavones, and if the outcome measures related to the physical and/or psychological impact of menopause in healthy women and scored at least three on the Jadad scale. RESULTS: Thirteen RCTs were identified that investigated the use of soy preparations for perimenopausal symptoms. Ten of these trials fitted our inclusion criteria. The results of these studies are not conclusive. Four of these randomised controlled trials were positive, suggesting soy preparations are beneficial for perimenopausal symptoms. Six were negative; with one of the six showing a positive trend. CONCLUSIONS: There is some evidence for the efficacy of soy preparations for perimenopausal symptoms. However, the heterogeneity of the studies performed to date means it is difficult to make a definitive statement. Adverse event data from the trials suggest that there are no serious safety concerns with soy products in short-term use.

Climacteric↗
PubMed2004

A Paradox-based data collection and management system for multi-center randomized clinical trials.

We have developed a Paradox-based data collection and management system for large-scale multi-site randomized clinical trials. The system runs under Windows operating system and integrates Symantec pcAnywhere32 telecommunications software for data transmission and remote control sessions, PKZIP utility for the compression/decompression of transmitted data, and Stat/Transfer for exporting the centralized Paradox database for analyses. We initially developed this system for VA Cooperative Study #399 'The Effect of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation', which collects over 1000 variables on 706 patients at 20 sites. Patient intake for this 5-year study began in March of 1998. We have also developed an enhanced version of this system, which is being used in the NIH-funded 'Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)' that collects over 1200 variables on 1588 patients at 13 sites. Patient intake for this 4-year study began in October of 2000.

Data Collection↗
PubMed2004

Designing an acupuncture study to meet evidence-based medical criteria: methodological considerations for logistic design and development of treatment interventions arising from the German randomized controlled acupuncture trial on chronic shoulder pain (GRASP).

The results from studies on potential treatment effects of acupuncture are often limited due to serious difficulties in methodology. Randomized controlled trials on acupuncture should test a widely accepted treatment strategy of verum and sham acupuncture. However, in clinical practice various patterns of acupuncture techniques are employed, and up to now no generally accepted guidelines on how to perform a reliable verum or sham treatment have been established. Another limitation is that in most studies the study populations are too small to obtain reliable data and to detect subtle differences between the unspecific needling of sham acupuncture and specific needling of verum acupuncture with sufficient statistical power. Moreover, only a multicenter trial in an outpatient setting would guarantee a naturalistic environment in which acupuncture is used in clinical practice. In the present report we discuss such methodological aspects in detail and summarize some practical considerations for planning an acupuncture trial that fulfills evidence-based medical criteria. The largest German study on the treatment effects of acupuncture in patients with chronic shoulder pain (recruited patients n = 452), might serve as an example for such a well-designed study. Before we could conduct our study, clear definitions and protocols for the verum and sham acupuncture treatments as well as adequate endpoints had to be developed. For this we used a combination of a comprehensive study of the literature and structured interviews with experienced physicians followed by an expert panel. A total of 41 physicians had to be trained to achieve a homogeneously high quality of acupuncture treatment. The latter represents a prerequisite for reproducibility, constituting a critical component of rigorous efficacy trials in scientific acupuncture research.

Acupuncture Therapy↗
PubMed1995

Evaluating surrogate markers.

We discuss approaches for efficiently evaluating potential surrogate markers; in particular, we focus on case-cohort designs in which marker evaluation is undertaken only for a random sample of subjects within a randomized trial and for all other subjects who develop a major clinical outcome. These designs will be useful in clinical trials in which a highly significant treatment difference on clinical outcome has been obtained. In addition, we describe a method for using data from all available studies using a meta-analysis to explore the association of treatment effects on the potential marker and on clinical outcome. This may be the most effective approach for marker evaluation because it uses data from both large and small trials and incorporates information from trials in which nonsignificant treatment differences on the major clinical outcome are obtained.

Biomarkers↗
PubMed1988

Meta-analysis of randomized controlled trials as a method of estimating rare complications of non-steroidal anti-inflammatory drug therapy.

The design of randomized controlled trials to assess the efficacy of pharmacological measures for the prevention of the gastrointestinal side-effects of anti-inflammatory drugs requires an accurate estimate of excess risk under controlled conditions. Photocopies of 952 randomized controlled trial publications were obtained after scanning titles and abstracts of a MEDLINE computer search, 427 were excluded for obvious reasons, and 525 were again photocopied after obliterating source and results. Selection criteria were: the presence of a non-anti-inflammatory drug control group; at least 4 days of therapy; at least 3 days without anti-inflammatory drugs before randomization; no complicating background drugs; mention of side-effects; and a clear differentiation of gastrointestinal complications. Observer error, with two independent readings, for inclusion suitability in the study was 19% for Methods and 9% for Results. For the 44 aspirin trials, the mean therapy duration was 357 days; the unweighted rate difference between therapy and control groups ( +/- 1 S.E.M.) for ulcer was 0.006 +/- 0.003, for gross haemorrhage 0.006 +/- 0.002 and for unspecified gastric symptoms 0.03 +/- 0.01. In 123 non-aspirin non-steroidal anti-inflammatory drug (NA-NSAID) trials, the mean duration was 67 days; the unweighted rate difference for ulcer was 0.0005 +/- 0.0003, for gross haemorrhage 0.007 +/- 0.004 and for unspecified gastric symptoms 0.02 +/- 0.005. Risk differences were also pooled using the DerSimonian and Laird method, which weights studies inversely according to variance. Using this method, only the unspecified gastric symptoms for non-aspirin non-steroidal anti-inflammatory drugs (NA-NSAIDs) and the haemorrhage for aspirin were found to be statistically significant. Longer studies have higher risk differences. Randomized control trials to determine prophylactic efficacy against haemorrhage (that is, to demonstrate a reduction of ulcer rate in the therapy group to the rate of controls) would require 190 patients in each group for NA-NSAIDs in studies of 2-6 months; 950 subjects would be needed to detect a 50% reduction. Randomized control trials to determine a reduction in ulcer rate to that of controls in patients on aspirin for more than 6 months would require 700 subjects in each group; 3346 subjects would be needed to detect a 50% reduction. Such studies are feasible.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2005

[Intensive care medicine -- update 2004].

This manuscript gives a review about important studies addressing problems in intensive care medicine that have been published in journals focussing on critical care medicine and surgery in 2004. Only clinical studies are included in this review, mostly metaanalyses, randomized controlled trials and a few important or interesting observational studies. In addition to describing major results a critical appraisal of each study is undertaken, which, however, is neither comprehensive nor complete. It is merely intentioned to address some important aspects for the reader that should be accounted for while interpreting the results. It is important to note that among the large number of excellent studies there is a substantial proportion of trials with negative results that significantly add to our knowledge. Some of the topics addressed in this manuscript include vasopressin as an alternative to epinephrine during cardiopulmonary resuscitation, a specification concerning the use of activated protein C in patients with sepsis, the role of steroids in the treatment of sepsis and traumatic brain injury, the epidemiology of ALI and ARDS, the role of sedation protocols, weaning protocols and the timing of tracheostomy for the duration of mechanical ventilation, the potential benefit of catheters with antimicrobial coating to reduce catheter-related sepsis, and the benefit of enteral nutrition as compared to the parenteral application.

Critical Care↗
PubMed2003

A cost comparison of oral tegafur plus uracil/folinic acid and parenteral fluorouracil for colorectal cancer in Canada.

BACKGROUND: Two randomised, controlled trials (n = 1396) comparing (i) intravenous fluorouracil (FU) plus oral folinic acid (leucovorin) and (ii) oral tegafur plus uracil (UFT) plus folinic acid for the treatment of metastatic colorectal carcinoma found both regimens to have equivalent efficacy in terms of survival, tumour response and time to disease progression. The UFT/folinic acid regimen was associated with a better toxicity profile than FU/folinic acid. OBJECTIVE: To determine the comparative frequencies and costs of healthcare resources utilised in the treatment of patients with these two regimens from a hospital and government perspective. DESIGN: A cost-minimisation analysis of a subgroup of patients from the trials (n = 154) was conducted. Costs considered included those for hospital admissions, outpatient clinics, laboratories, imaging modalities, other diagnostic procedures, physician resources, other health professionals, other procedures such as surgery and transfusion, and concomitant medications. The cost of study medications was not included in the analysis. The endpoint was a total average cost per patient per treatment and per cycle. RESULTS: Patients on the oral UFT regimen had fewer outpatient clinic visits and used fewer laboratory resources than patients treated with FU. However, those on the oral regimen had more days of hospitalisation than the patients treated with the intravenous regimen. Patients treated with UFT used 21% less concomitant medication; however, in both groups these medications accounted for a similar percentage compared with the total costs of the treatment. Physicians' fees were similar for both groups but patients treated with UFT were seen more often by an attending physician. Patients on the UFT regimen visited outpatient oncology clinics less often and this was reflected by a maximum 826 Canadian dollars (Canadian dollars; 1996 values) total cost savings per patient per cycle and 3221 Canadian dollars per patient per treatment. An efficiency analysis showed that the use of the UFT/folinic acid regimen saved 4.5 hours per patient per month in the chemotherapy treatment unit compared with the FU regimen. CONCLUSIONS: In regard to the two therapeutic approaches, the cost of treatment per patient and per cycle using oral UFT/folinic acid was less than that using intravenous FU/folinic acid.

Administration, Oral↗