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At least 703 records · Page 39Linked to original sources
PubMed2004

Drug treatment for facioscapulohumeral muscular dystrophy.

BACKGROUND: Facioscapulohumeral muscular dystrophy is a progressive muscle disease which has no agreed treatment. Early suggestions that corticosteroids might be helpful were not supported by a subsequent open label study. The beta 2 adrenergic agonist albuterol, also known as salbutamol, is known to have anabolic effects which might be beneficial for facioscapulohumeral muscular dystrophy. Creatine has been used as a muscle performance enhancer by athletes and it might be helpful in muscular dystrophies including facioscapulohumeral muscular dystrophy. OBJECTIVES: The objective of the review was to determine whether there is any drug treatment which alters the progression of facioscapulohumeral muscular dystrophy. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group specialised register (searched August 2003), MEDLINE (January 1966 to August 2003) and EMBASE (January 1980 to August 2003) for any references to facioscapulohumeral muscular dystrophy. Abstracts from the major neurological meetings and trial bibliographies were also searched for further references to trials. Experts were contacted for information regarding unpublished trials or trials in progress. SELECTION CRITERIA: We included all randomised or quasi-randomised trials of any drug treatment for facioscapulohumeral muscular dystrophy, in adults with a recognised diagnosis of facioscapulohumeral muscular dystrophy. Trials had to include an assessment of muscle strength at one year. DATA COLLECTION AND ANALYSIS: All identified trials were independently assessed by both reviewers to ensure that they fulfilled the selection criteria and were then rated for their quality. Trial data were extracted and entered by one reviewer and checked by the other. If appropriate data existed a weighted treatment effect was to be calculated across trials using the Cochrane statistical package, Review Manager. The results were to have been expressed as relative risks and 95% confidence intervals and risk differences and 95% confidence intervals for dichotomous outcomes, and weighted mean differences and 95% confidence intervals for continuous outcomes. MAIN RESULTS: Two published high quality randomised controlled trials fulfilled the selection criteria. One compared creatine supplementation with placebo and the other compared high and low-dose albuterol with placebo. A further unpublished randomised controlled trial of albuterol in facioscapulohumeral muscular dystrophy was identified. The creatine trial showed a non-significant difference in favour of creatine. The albuterol trial showed no significant difference in muscle strength at one year but some secondary measures such as lean body mass and handgrip strength did improve. REVIEWERS' CONCLUSIONS: There is no evidence from randomised controlled trials to support any drug treatment for facioscapulohumeral muscular dystrophy but only two randomised controlled trials have been published.

Adrenergic beta-Agonists↗
PubMed2003

Pulp treatment for extensive decay in primary teeth.

BACKGROUND: Dental decay in primary teeth remains a considerable health problem. Where decay extends to involve the dental pulp, pulp treatment techniques are often used to manage both symptomatic and symptom free teeth. OBJECTIVES: To assess the relative effectiveness of: various pulp treatment techniques in retaining primary molar teeth with decay involving the pulp for at least 12 months; pulp treatment techniques and extractions in avoiding long term sequelae. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register (August 2002); the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2002); MEDLINE (January 1966 to August 2002); EMBASE (1980 to August 2002); Science Citation Index Expanded (1981 to August 2002); Social Science Citation Index (1981 to August 2002); Index to Scientific and Technical Proceedings (1982 to August 2002); System for Information on Grey Literature in Europe (August 2002). Key journals were handsearched. There was no restriction on language of publication. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials (RCTs) comparing different pulp treatment techniques (with each other, with extraction or with no treatment) for extensive decay in primary molar teeth. Primary outcomes were extractions following pulp treatment and long term effects. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment were carried out independently and in duplicate. Authors were contacted for additional information where necessary. MAIN RESULTS: Eighty-two studies were identified but only three were suitable for inclusion. Nine studies meeting the inclusion criteria but with inappropriate study design or analysis are also described. Included trials investigated formocresol pulpotomy, ferric sulphate pulpotomy, electrosurgical pulpotomy or zinc oxide eugenol pulpectomy in symptom free, cariously exposed teeth. Data were unavailable on long term effects. Data on extraction following pulp treatment was available in all three studies and in two studies there was no statistically significant difference between the treatments. The difference seen in the other study, where more teeth treated by ferric sulphate pulpotomy were extracted compared to zinc oxide eugenol pulpectomy, must be viewed with caution. REVIEWER'S CONCLUSIONS: Based on the available RCTs, there is no reliable evidence supporting the superiority of one type of treatment for pulpally involved primary molars. No conclusions can be made as to the optimum treatment or techniques for pulpally involved primary molar teeth due to the scarcity of reliable scientific research. High quality RCTs, with appropriate unit of randomisation and analysis are needed.

Controlled Clinical Trials as Topic↗
PubMed1997

Randomised trials of new procedures: problems and pitfalls.

Randomised trials that compare new procedures with established ones must avoid prerandomisation bias and must allocate patients to treatment groups based on objective or quantitative criteria, not on subjective clinical judgment. Risk, length of follow up, and sample size must be used to calculate the statistical power of the study, so that a significant difference between treatments does not remain undetected (a type II error). There should already be sufficient experience with the new procedure so that complication rates have stabilised, and participating operators are equally comfortable with all procedures being studied. Even with the above stipulations, randomised trials that compare medical with procedural treatment pose additional problems (many of which have been omitted from this necessarily brief discussion); few such studies have had a major impact on clinical practice. The most useful randomised studies of procedures are those that compare one procedure with another, or those that assess a specific refinement in an established procedure, such as the use of different anticoagulation regimens for coronary stents. Fortunately, clinically useful information has always been available from non-randomised studies. The recent trend towards meta-analysis of large clinical series can substitute for those randomised studies that are unlikely to be helpful.

Drug Therapy↗
PubMed2002

[The influence of study results on therapeutic decisions - experience in 35years].

This is a critical review on the influence of large multicenter studies on therapeutic decisions in rheumatology. Every prescription in rheumatology relies on such studies, because study results have to be presented for the approval of each new drug. Large randomized trials are rated highest within the evidence based medicine (EBM). They are nearly exclusively performed by pharmaceutical companies aiming at approval of drugs with the potential to gain high rewards. Old (and cheap) drugs known to be effective based on clinical experience are not included into modern trials. Therefore, they cannot meet the EBM standards, are no longer mentioned by authorities in the field of rheumatology and are rarely prescribed. Large patient numbers required by statisticians can only be reached by including inappropriate patients and centers more interested in the (very good) honorarium than in the scientific problem rendering questionable results because the quality of clinical investigation cannot be controlled. Statistical evaluation, study report, preparing the manuscript and publication are supervised by the sponsor. Negative studies are not published. Often studies are not comparable due to differences in inclusion criteria, patient population, disease activity, drug dosage, withdrawal rates and many other factors. Even similarly designed studies may come to contradictory results. Parameters measured in clinical trials may be unreliable indicators of the true longterm outcome. Metaanalyses, also highly ranked within the EBM, may come to controversial conclusions on the same subject, because different studies are selected, complex studies have to be simplified and condensed and pooled with other studies that cannot even be compared. Very often the true performance of a drug becomes evident only after broad clinical use (i.e. Auranofin) or is known due to clinical experience long before randomised studies were performed (i.e. MTX). Open longterm observational studies are undispensable in the field of rheumatology and may render more important knowledge than randomised studies.

Antirheumatic Agents↗
PubMed1997

A comparative study of Ocusert Pilo 40, intensive pilocarpine and low-dose pilocarpine in the initial treatment of primary acute angle-closure glaucoma.

Acetazolamide and pilocarpine have a central role in the initial management of primary acute angle closure glaucoma (PACG), but there is no consensus concerning their mode of delivery, as borne out by a recent survey of senior UK ophthalmologists reported below. Ocusert Pilo 40 was developed to remain in situ releasing pilocarpine for up to one week. In view of its potential advantages, a trial of Ocusert Pilo 40's efficacy in PACG was conducted. In two separate controlled studies, eyes diagnosed with PACG were randomised to receive Ocusert Pilo 40, and either an intensive pilocarpine regimen or a low-dose pilocarpine treatment. All patients also received Diamox 500 mg i.v. Two hours after starting topical treatment, the study was terminated and ocular and systemic response to treatment and the eventual outcome were assessed. In both studies, intravenous Diamox caused a fall of intraocular pressure (IOP) within 30 min. Over the treatment period, a comparable reduction in IOP was seen in the Ocusert-treated, the intensive-pilocarpine-treated, and the low-dose-pilocarpine-treated groups. No damage to the corneas were observed.

Acetazolamide↗
PubMed2001

Closed suction surgical wound drainage after orthopaedic surgery.

BACKGROUND: Closed suction drainage systems are frequently used to drain fluids, particularly blood, from surgical wounds. The aim of these systems is to reduce the occurrence of wound haematomas and infection. OBJECTIVES: To evaluate the effectiveness of closed suction drainage systems for orthopaedic surgery. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (May 2001), MEDLINE (1996-May 2001) and references from articles. SELECTION CRITERIA: All randomised or quasi-randomised trials comparing the use of closed suction drainage systems with no drainage systems for all types of elective and emergency orthopaedic surgery. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality, using a nine item scale, and extracted data. Wherever appropriate and possible, the data are presented graphically. MAIN RESULTS: Twenty-one studies involving 2772 patients with 2971 wounds were included in the analysis. The types of surgery involved were hip and knee replacement, shoulder surgery, hip fracture surgery, spinal surgery, cruciate ligament reconstruction, open meniscectomy and fracture fixation surgery. Many of the studies had poor methodology and reporting of outcomes. Pooling of results indicated no difference in the incidence of wound infection, haematoma or dehiscence between those allocated to drains and the un-drained wounds. There was a tendency to an increased risk of re-operation for wound complications in the group with drains (relative risk (RR) 2.25, 95% confidence intervals (CI) 0.95 to 5.33), but due to the small numbers of cases involved definite conclusions cannot be made for this outcome. Blood transfusion was required more frequently in those who received drains (RR 1.41, 95% CI 1.10 to 1.80). The need for reinforcement of wound dressings (RR 0.22, 95% CI 0.13 to 0.40) and bruising around the operation site was more common in the group without drains. REVIEWER'S CONCLUSIONS: There is insufficient evidence from randomised trials to support or refute the routine use of closed suction drainage in orthopaedic surgery. Further randomised trials are required before definite conclusions can be made.

Hematoma↗
PubMedDate not supplied

Antioxidant supplements for prevention of gastrointestinal cancers: a systematic review and meta-analysis.

BACKGROUND: Oxidative stress can cause cancer. Our aim was to establish whether antioxidant supplements reduce the incidence of gastrointestinal cancer and mortality. METHODS: With the Cochrane Collaboration methodology, we reviewed all randomised trials comparing antioxidant supplements with placebo for prevention of gastrointestinal cancers. We searched electronic databases and reference lists (February, 2003). Outcome measures were incidence of gastrointestinal cancers, overall mortality, and adverse effects. Outcomes were analysed with fixed-effect and random-effects model meta-analyses and were reported as relative risk with 95% CIs. FINDINGS: We identified 14 randomised trials (n=170,525). Trial quality was generally high. Heterogeneity of results was low to moderate. Neither the fixed-effect (relative risk 0.96, 95% CI 0.88-1.04) nor random-effects meta-analyses (0.90, 0.77-1.05) showed significant effects of supplementation with beta-carotene, vitamins A, C, E, and selenium (alone or in combination) versus placebo on oesophageal, gastric, colorectal, pancreatic, and liver cancer incidences. In seven high-quality trials (n=131727), the fixed-effect model showed that antioxidant significantly increased mortality (1.06, 1.02-1.10), unlike the random-effects meta-analysis (1.06, 0.98-1.15). Low-quality trials showed no significant effect of antioxidant supplementation on mortality. The difference between the mortality estimates in high-quality and low-quality trials was significant (Z=2.10, p=0.04 by test of interaction). beta-carotene and vitamin A (1.29, 1.14-1.45) and beta-carotene and vitamin E (1.10, 1.01-1.20) significantly increased mortality, whereas beta-carotene alone only tended to increase mortality (1.05, 0.99-1.11). In four trials (three with unclear or inadequate methodology), selenium showed significant beneficial effect on the incidence of gastrointestinal cancer. INTERPRETATION: We could not find evidence that antioxidant supplements can prevent gastrointestinal cancers; on the contrary, they seem to increase overall mortality. The potential preventive effect of selenium should be studied in adequate randomised trials.

Anticarcinogenic Agents↗
PubMed1998

Systematic review of the treatment of upper respiratory tract infection.

OBJECTIVES: To assess the risks and benefits of antibiotic treatment in children with symptoms of upper respiratory tract infection (URTI). DESIGN: Quantitative systematic review of randomised trials that compare antibiotic treatment with placebo. DATA SOURCES: Twelve trials retrieved from a systematic search (electronic databases, contact with authors, contact with drug manufacturers, reference lists); no restriction on language. MAIN OUTCOME MEASURES: The proportion of children in whom the clinical outcome was worse or unchanged; the proportion of children who suffered complications or progression of illness; the proportion of children who had side effects. RESULTS: 1699 children were randomised in six trials that contributed to the meta-analysis. Six trials were not used in the meta-analysis because of different outcomes or incomplete data. Clinical outcome was not improved by antibiotic treatment (relative risk 1.01, 95% confidence interval (CI) 0.90 to 1.13), neither was the proportion of children suffering from complications or progression of illness (relative risk 0.71, 95% CI 0.45 to 1.12). Complications from URTI in the five trials that reported this outcome was low (range 2-15%). Antibiotic treatment was not associated with an increase in side effects compared with placebo (relative risk 0.8, 95% CI 0.54 to 1.21). CONCLUSIONS: In view of the lack of efficacy and low complication rates, antibiotic treatment of children with URTI is not supported by current evidence from randomised trials.

Anti-Bacterial Agents↗
PubMed2003

Barriers to conducting randomised controlled trials: lessons learnt from the Horsechestnut & Venous Leg Ulcer Trial (HAVLUT).

The RCT is considered the gold standard for testing a therapeutic intervention. However, the conduct of an RCT is not without numerous obstacles. As illustrated through the recent Horsechestnut and Venous Leg Ulcer Trial (HAVLUT), these barriers can be attributed to randomisation, recruitment, retention, blinding and sampling procedures, and to gate keeping. These obstacles, together with strategies to prevent and overcome them, are detailed throughout this article, and are aimed at ameliorating the future design and conduct of RCTs.

Aesculus↗