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At least 469 records · Page 26Linked to original sources

Episodic viral wheeze in preschool children: effect of topical nasal corticosteroid prophylaxis.

BACKGROUND: The effect of prophylactic nasal corticosteroids on wheezing episodes associated with colds was investigated in a 12 week parallel group, double blind, randomised controlled trial in preschool children. METHODS: Data were collected from 50 children aged 12-54 months with a history of at least three episodes of wheeze associated with colds over the previous winter, but few or no interval symptoms; 24 were given one dose of fluticasone aqueous nasal spray (50 micro g) into each nostril twice daily and 26 received an indistinguishable placebo spray. Episodes of lower respiratory illness occurring within 2 days of the onset of a cold were identified from daily symptom diaries. The main outcome was nocturnal symptom score during the first 7 days of an episode. RESULTS: The groups were well balanced on entry except that the treatment group had a history of more prolonged episodes. During the trial there was no significant difference in the number of episodes in the treatment and control groups (27 and 37, respectively), in the severity of nocturnal symptoms (mean score 1.33 and 1.22, respectively, confidence interval of difference -0.24 to +0.47) or in daytime symptoms, activity or total scores during episodes. Compliance was estimated to be over 50% in 43 of the children. CONCLUSIONS: Nasal corticosteroid treatment does not prevent acute wheezy episodes associated with upper respiratory infections (common colds) in preschool children.

Administration, Intranasal↗

Magnesium sulfate for treating exacerbations of acute asthma in the emergency department.

BACKGROUND: Treatment of acute asthma is based on rapid reversal of bronchospasm and arresting airway inflammation. There is some evidence that intravenous magnesium can provide additional bronchodilation when given in conjunction with standard bronchodilating agents and corticosteroids. No systematic review of this literature has been completed on this topic. OBJECTIVES: To examine the effect of additional intravenous magnesium sulfate in patients with acute asthma managed in the emergency department. SEARCH STRATEGY: Randomised controlled trials were identified from the Cochrane Airways Review Group register. Bibliographies from included studies, known reviews and texts were searched. Primary authors and content experts were contacted. SELECTION CRITERIA: Randomised controlled trials or quasi-randomised trials were eligible for inclusion. Studies were included if patients presented with acute asthma and were treated with IV magnesium sulfate vs placebo. DATA COLLECTION AND ANALYSIS: Data were extracted and methodological quality was assessed independently by two reviewers. Missing data were obtained from authors. MAIN RESULTS: Seven trials were included (5 adult, 2 pediatric). A total of 665 patients were involved. Patients receiving magnesium sulfate demonstrated non-significant improvements in peak expiratory flow rates when all studies were pooled (weighted mean difference: 29.4 L/min; 95% confidence interval: -3.4 to 62). In studies of people with severe acute asthma, peak expiratory flow rate improved by 52.3 L/min (95% confidence interval: 27 to 77.5). The forced expiratory volume in one second also improved by 9.8 % predicted (95% confidence interval: 3.8 to 15.8). Overall, admission to hospital was not reduced, odds ratio: 0.31 (95% confidence interval: 0.09 to 1.02). In the severe subgroup, admissions were reduced in those receiving magnesium sulfate (odds ratio: 0.10, 95% confidence interval: 0.04 to 0.27). No clinically important changes in vital signs or adverse side effects were reported. REVIEWER'S CONCLUSIONS: Current evidence does not support routine use of intravenous magnesium sulfate in all patients with acute asthma presenting to the emergency department. Magnesium sulfate appears to be safe and beneficial in patients who present with severe acute asthma.

Acute Disease↗

Randomised trials in the South African Medical Journal, 1948-1997.

OBJECTIVE: To describe randomised controlled trials (RCTs) published in the South African Medical Journal (SAMJ) over a 50-year period from 1948 to 1997 with regard to number, topic and quality. METHODS: We hand searched all issues of the SAMJ published during the study period to identify all published RCTs. OUTCOME MEASURES: Number, topic and quality of RCTs published from 1948 to 1997. RESULTS: Eight hundred and fifty-eight clinical trials were published during the period reviewed. Eighty-four per cent of RCTs were published as full articles. During the 1980s the number of RCTs published increased rapidly, with a peak of 35 in 1985, but then declined to only 5 in 1997. The majority (92%) of RCTs were conducted in a hospital setting. A varied range of subjects was covered, with gastroenterology taking the lead and no trials in public health. The sample size in more than 50% of RCTs was smaller than 50 patients. Fifty-one per cent (435 trials) used random allocation and 49% (423) quasi-random methods of allocation. Concealment of treatment allocation was judged to be adequate in 46% of studies (N = 200), blinding of observers assessing outcomes was adequate in 28% (123), and all the allocated test subjects were included in the primary analysis in 28% (123). The follow-up period was more than 1 year in 4% (17) and less than 6 days in 16% (71). CONCLUSIONS: Compared with other international journals the SAMJ is highly regarded in terms of the number of trials published. There are, however, a number of deficiencies in the quality of the trials.

Clinical Protocols↗

Topical application of honey in the management of radiation mucositis: a preliminary study.

BACKGROUND: The aim of this study was to evaluate the effect of pure natural honey on radiation-induced mucositis. PATIENTS AND METHODS: Forty patients diagnosed with head and neck cancer requiring radiation to the oropharyngeal mucosal area were divided in to two groups to receive either radiation alone or radiation plus topical application of pure natural honey. Patients were treated using a 6-MV linear accelerator at a dose rate of 2 Gy per day five times a week up to a dose of 60-70 Gy. In the study arm, patients were advised to take 20 ml of pure honey 15 min before, 15 min after and 6 h post-radiation therapy. Patients were evaluated every week for the development of radiation mucositis using the Radiation Therapy Oncology Group (RTOG) grading system. MAIN RESULTS: There was significant reduction in the symptomatic grade 3/4 mucositis among honey-treated patients compared to controls; i.e. 20% versus 75% ( p 0.00058). The compliance of honey-treated group of patients was better than controls. Fifty-five percent of patients treated with topical honey showed no change or a positive gain in body weight compared to 25% in the control arm ( p 0.053), the majority of whom lost weight. CONCLUSIONS: Topical application of natural honey is a simple and cost-effective treatment in radiation mucositis, which warrants further multi-centre randomised trials to validate our finding.

Administration, Topical↗

A double-blind study of the efficacy of metronidazole gel in the treatment of malodorous fungating tumours.

A double-blind placebo-controlled trial was undertaken to assess the value of topical metronidazole gel preparation in the palliation of the offensive odour of fungating tumours. This 5 day trial was followed by a 6 day period during which all patients received the active gel. Subjective odour assessments were performed by both patients and medical staff. 11 patients were entered and the randomisation was then halted because of an obvious overall benefit over the whole 11 days. There was a non-significant trend in favour of the active treatment during the initial double-blind placebo-controlled phase of the trial, and no side-effects were observed.

Administration, Topical↗

Topical diclofenac patch in patients with knee osteoarthritis: a randomized, double-blind, controlled clinical trial.

OBJECTIVE: To assess the efficacy and safety of a diclofenac hydroxyethylpyrrolidine (DHEP) patch in the treatment of symptomatic osteoarthritis (OA) of the knee joint. METHODS: A double-blind, randomised, placebo-controlled trial was carried out on 103 outpatients for 2 weeks. The main efficacy parameters were spontaneous pain and Lequesne's Index. Secondary endpoints were walking time over a standard distance, global assessment of efficacy and tolerability, and paracetamol consumption. RESULTS: The active treatment group showed a significant improvement in pain, Lequesne's Index, and the physician's and patient's global assessment of efficacy. For these parameters the difference between groups was statistically significant in favour of the DHEP patch. Adverse reactions were seen in a small number of probands and were similar in both groups. CONCLUSIONS: The results of this trial suggest that the DHEP patch appears to be an effective and safe treatment for patients suffering from symptomatic knee OA.

Administration, Cutaneous↗

Macrolide antibiotics for cystic fibrosis.

BACKGROUND: Cystic Fibrosis is characterised by chest infection, the antibiotic treatment of which has significantly improved the outlook for people with this condition. The unusual nature of organisms that infect the chest of individuals with cystic fibrosis has restricted antibiotic choice. In particular the bacteria, Pseudomonas aeruginosa, is resistant to nearly all antibiotics that can be taken by mouth. There is laboratory evidence and evidence from other disease processes that macrolide antibiotics, whilst not directly active against Pseudomonas aeruginosa, may have indirect actions against this bacteria. OBJECTIVES: This review aimed to test the hypotheses that macrolide antibiotics; 1) Improve clinical status compared to placebo or another antibiotic 2) do not have unacceptable adverse effects If benefit was demonstrated, we aimed to assess the optimal type, dose and duration of macrolide therapy. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. In addition, Principal Investigators, known to work in the field and previous authors were contacted for unpublished or follow up data. Pharmaceutical companies, that manufacture macrolide antibiotics, were approached. SELECTION CRITERIA: Randomised controlled trials, published or unpublished, of macrolide compared to placebo, another class of antibiotic or another macrolide. Studies which compare regimes of the same macrolide at different doses will also be included. DATA COLLECTION AND ANALYSIS: No completed randomised controlled trials were identified. MAIN RESULTS: Three open studies excluded. Four ongoing randomised controlled trials were identified. No completed randomised controlled trials were identified. REVIEWER'S CONCLUSIONS: At present, there are no randomised controlled trials to evaluate the use of macrolide antibiotics for the treatment of chest infection in people with cystic fibrosis. Such trials, with clear outcome measures, are needed to properly evaluate this potentially useful treatment for cystic fibrosis.

Anti-Bacterial Agents↗

Calcium antagonists in the management of subarachnoid haemorrhage.

The development of delayed cerebral ischaemia and hence neurological deficit remains a serious problem following subarachnoid haemorrhage. Over recent years, attention has focussed on the use of the dihydropyridine class of calcium channel blocking agents ("calcium antagonists"), in particular nimodipine, as drug therapy in the prophylaxis and treatment of this condition. The theoretical basis for this is briefly discussed and then the clinical experience of the use of calcium antagonists following subarachnoid haemorrhage reviewed. In particular, attention is focussed on the randomised controlled trials that have eventually been able to show that such treatment is beneficial, both in terms of reduction of ischaemic deficit attributable to cerebral "vasospasm" and in clinical outcome, when given prophylactically, although not apparently therapeutically once deficit has developed. The evidence of the mode of action of calcium antagonists in this situation is discussed, again with particular reference to clinical data obtained in situ in the course of such trials. Although the mechanism of action remains unclear, it appears likely that it is at least in part due to the selective cerebral vasodilation induced by these compounds. The necessity for large well-controlled, prospective, randomised clinical trials in the assessment of therapeutic efficacy is stressed.

Brain Ischemia↗