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Results for “Randomised controlled trials as topic”

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At least 253 records · Page 14Linked to original sources
PubMed2001

Topical negative pressure for treating chronic wounds: a systematic review.

Some wounds take a long time to heal, fail to heal or recur, causing significant pain and discomfort to the patient and cost to the National Health Service. This review assesses the effectiveness of topical negative pressure (TNP) in treating chronic wounds. The Cochrane Wounds Group Specialised Trials Register was searched for randomised controlled trials (RCTs) that evaluated the effectiveness of TNP on chronic-wound healing. Eligibility for inclusion, data extraction and details of trial quality were conducted by two reviewers independently. A narrative synthesis of results was undertaken as only two small trials, with different outcome measures, fulfilled the selection criteria. Trial 1 considered any type of chronic wound, trial 2 considered diabetic foot ulcers. Both trials compared TNP with saline-gauze dressings. Trial 1 reported a statistically significant difference in the percentage change in wound volume after 6 weeks, in favour of TNP. Trial 2 reported a difference in the number of days to healing and a difference in the percentage change in wound surface area after 2 weeks, in favour of TNP. These two small trials provide weak evidence to suggest that TNP may be superior to saline-gauze dressings in terms of wound healing. However, due to the small sample sizes and the methodological limitations of the studies, these findings must be interpreted with extreme caution. The effects of TNP on cost, quality of life, pain and comfort were not reported. It was not possible to determine the optimum TNP regimen. Further high-quality RCTs that address these issues are required.

Chronic Disease↗
PubMed2004

Interventions for treating oral leukoplakia.

BACKGROUND: Oral leukoplakia is a relatively common oral lesion that in a small but significant proportion of cases changes into cancer. Since most leukoplakias are asymptomatic, the primary objective of treatment should be to prevent such malignant transformation. OBJECTIVES: To assess effectiveness, safety and acceptability of treatments for leukoplakia. SEARCH STRATEGY: The following databases were searched for relevant trials: Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE, EMBASE. Handsearching was performed for the main oral medicine journals. References of included studies and reviews were checked. Oral medicine experts were contacted through an European mailing list (EURORALMED). SELECTION CRITERIA: Randomised controlled trials (RCTs), enrolling patients with a diagnosis of oral leukoplakia, were included. Any surgical or medical (topical and systemic) treatment was included. The primary outcome considered was malignant transformation of leukoplakia. Other outcomes considered were clinical resolution, histological modification and frequency of adverse effects. DATA COLLECTION AND ANALYSIS: Data were collected using a specific extraction form. Malignant transformation of leukoplakia, demonstrated by histopathological examination, was the main outcome considered. Secondary outcomes included clinical resolution of the lesion and variation in dysplasia severity. The validity of included studies was assessed by two reviewers, on the basis of the method of allocation concealment, blindness of the study and loss of participants. Data were analysed by calculating relative risk. When valid and relevant data were collected, a meta-analysis of the data was undertaken. MAIN RESULTS: The possible effectiveness of surgical interventions, including laser therapy and cryotherapy, has never been studied by means of a RCT. Nineteen potentially eligible RCTs of non-surgical interventions were identified: eight were excluded for different reasons, four were ongoing studies, leaving seven studies to be included in the review. Two studies resulted at low risk of bias, four at moderate risk of bias and one at high risk of bias. Vitamin A and retinoids were tested by five RCTs (245 patients), the other drugs tested were bleomycin (one study), mixed tea (one study) and beta carotene (one study). Malignant transformation was recorded in just two studies: none of the treatments tested showed a benefit when compared with the placebo. Treatment with beta carotene and vitamin A or retinoids, was associated with significant rates of clinical resolution, compared with placebo or absence of treatment. Whenever reported, a high rate of relapse was a common finding. Side effects of variable severity were often described; however, interventions were well accepted by patients, since drop-out rates were similar between treatment and control groups. REVIEWERS' CONCLUSIONS: To date there is no evidence of effective treatment in preventing malignant transformation of leukoplakia. Treatments may be effective in the resolution of lesion, however relapses and adverse effects are common.

Humans↗
PubMed2006

Interventions for treating oral leukoplakia.

BACKGROUND: Oral leukoplakia is a relatively common oral lesion that in a small but significant proportion of cases changes into cancer. Since most leukoplakias are asymptomatic, the primary objective of treatment should be to prevent such malignant transformation. OBJECTIVES: To assess effectiveness, safety and acceptability of treatments for leukoplakia. SEARCH STRATEGY: The following databases were searched for relevant trials: Cochrane Oral Health Group's Trials Register (to April 2006), CENTRAL (TheCochrane Library 2006, Issue 1), MEDLINE (from 1966 to December 2005), and EMBASE (from 1980 to December 2005). Handsearching was performed for the main oral medicine journals. References of included studies and reviews were checked. Oral medicine experts were contacted through an European mailing list (EURORALMED). SELECTION CRITERIA: Randomised controlled trials (RCTs), enrolling patients with a diagnosis of oral leukoplakia, were included. Any surgical or medical (topical and systemic) treatment was included. The primary outcome considered was malignant transformation of leukoplakia. Other outcomes considered were clinical resolution, histological modification and frequency of adverse effects. DATA COLLECTION AND ANALYSIS: Data were collected using a specific extraction form. Malignant transformation of leukoplakia, demonstrated by histopathological examination, was the main outcome considered. Secondary outcomes included clinical resolution of the lesion and variation in dysplasia severity. The validity of included studies was assessed by two review authors, on the basis of the method of allocation concealment, blindness of the study and loss of participants. Data were analysed by calculating risk ratio. When valid and relevant data were collected, a meta-analysis of the data was undertaken. MAIN RESULTS: The possible effectiveness of surgical interventions, including laser therapy and cryotherapy, has never been studied by means of a RCT with a no treatment/placebo arm. Twenty-five eligible RCTs of non-surgical interventions were identified: 11 were excluded for different reasons, five were ongoing studies, leaving nine studies to be included in the review (501 patients). Two studies resulted at low risk of bias, six at moderate risk of bias and one at high risk of bias. Vitamin A and retinoids were tested by five RCTs, two studies investigated beta carotene or carotenoids, the other drugs tested were bleomycin (one study), mixed tea (one study) and ketorolac (one study). One study tested two treatments. Malignant transformation was recorded in just two studies: none of the treatments tested showed a benefit when compared with the placebo. Treatment with beta carotene, lycopene and vitamin A or retinoids, was associated with significant rates of clinical resolution, compared with placebo or absence of treatment. Whenever reported, a high rate of relapse was a common finding. Side effects of variable severity were often described; however, interventions were well accepted by patients, since drop-out rates were similar between treatment and control groups. AUTHORS' CONCLUSIONS: To date there is no evidence of effective treatment in preventing malignant transformation of leukoplakia. Treatments may be effective in the resolution of lesion, however relapses and adverse effects are common.

Humans↗
PubMed2002

[Placebo: an unappreciated factor in medicine].

Placebo is a provoking factor in medicine that is discussed controversially and not fully understood so far. From the scientific point of view and according to evidence-based medicine a proved indication to prescribe a placebo does not exist. Therapy of pain may be an exclusion. In our daily work we consciously use the placebo-effect, but on the other hand we are committed to the placebo-phenomenon. This article gives an overview of various aspects of placebo. The currently supported theory about the placebo response, conditioning and expectancy, are discussed. Further, the side effects (nocebo-phenomenon) and the utility of placebo in randomised clinical trials is highlighted.

Controlled Clinical Trials as Topic↗
PubMed2005

[Psychiatry in the journal "Der Nervenarzt" 1928-2000].

By analysing the complete edition of the German-language psychiatric journal "Der Nervenarzt" from 1928 to 2000 we examined basic trends in the historical and scientific orientation of psychiatry in this journal. All published articles (n=3270) were classified under formal aspects and were assigned to one of 30 categories by content. Inter-rater reliability was determined in 3 years from different eras (1957, 1977, 1997). With kappa values between 0.65 and 0.81 the inter-rater reliability was moderate to good. The mean number of authors and the mean number of references in the articles has been increasing continuously, particularly within the last decade. The mean number of words per article has been relatively constant. In nearly all 5-year periods, most of the articles came from Heidelberg, Munich and Berlin. In addition to original articles, review articles were introduced in 1971 and medical education articles in 1978. Since 1955 the "Nervenarzt" has been publishing the communications of the German Psychiatric and Neurological Society. Original articles with data reports and articles using statistics have been increasing continuously since the 1960s, reflecting an increasing evidence-based orientation of psychiatry. The currently accepted scientific standard was introduced in the early 1990s. The last decade, the "decade of the brain", not only yielded a high proportion of articles on biological issues but also indicated an increasing interest in institutions of psychiatric care and psychotherapy. On the other hand, links to related disciplines such as philosophy, sociology and psychology seem to have got lost. The percentage of articles from abroad has been decreasing within the last 2 decades. In comparison, the American Journal of Psychiatry, the Archives of General Psychiatry and the British Journal of Psychiatry have been publishing a higher percentage of original articles, particularly randomised controlled trials.

Germany↗
PubMedDate not supplied

Effective instructions for patients.

Information designed for patients aims to educate them. This means that the written word must be both read and understood. In whatever format patient information is presented it must influence patient behaviour and favourably affect compliance and morbidity if it is to be of value. The production of patient information should take account of the needs of the audience as well as the aims of the educators. Prototypes should be field tested to ensure that they are effective and that the material can be revised before general use. Patient information and its effect on the understanding of disease processes and management can be assessed by various standard techniques. Their effectiveness must ultimately be validated in randomised controlled trials.

Health Behavior↗