Objective To describe the potential benefits and harms of oseltamivir by reviewing all clinical study reports (or similar document when no clinical study report. Anyone can learn for free on OpenLearn, but signing-up will give you access to your personal learning profile and record of achievements that you earn while you study.
Characteristics of trials of oseltamivir for post-exposure prophylaxis of influenza. Another explanation for this finding may be that symptom relief results from bias introduced by unblinding due to toxicity of the active principle. Despite the enormous amount of information at our disposal we noted items that were not included in all full clinical study reports see risk of bias.
To deal with the problem of reporting bias, we accessed data from clinical study reports and regulatory information. For these analyses we used logistic regression, adjusting for study effects if appropriate that is, for the two treatment trials and testing for trend using a likelihood ratio test. No dates for unblinding of the trial database were reported.
Owing to the risk of reporting bias there are legitimate reasons to doubt the stated benefits of oseltamivir and the results of previous Cochrane reviews of neuraminidase inhibitors in adults and children.Objective To describe the potential benefits and harms of oseltamivir by reviewing all clinical study reports (or similar document when no clinical study report.
Internal consistency —all parts for example, denominators of the same clinical study reports or unpublished reports are consistent.
Oseltamivir in the treatment of adults was associated with an increased risk of nausea 1. Oseltamivir may have anti-inflammatory properties that make people with influenza-like illness feel better by shortening the duration of symptoms and reducing the occurrence of symptoms.
BMJ ; Neuraminidase inhibitors for treatment and prophylaxis of influenza in children: However the proportion of censored patients was low in all trials and similar in both treatment groups, hence we do not believe this has led to bias. This allowed us to identify missing important text or data.
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Unblinding is closely linked to the exaggeration of symptoms. Anyone can learn for free on OpenLearn, but signing-up will give you access to your personal learning profile and record of achievements that you earn while you study. Rethinking credible evidence synthesis.
Random effects meta-analysis is known to be overly conservative with sparse data. Table 4 Oseltamivir versus placebo for treatment of influenza in healthy adults and children. We have also rewritten the objective twice, tightening up the text to bring it in line with our initial intentions and clarifying its meaning. The Open University is authorised and regulated by the Financial Conduct Authority in relation to its secondary activity of credit broking.
All oseltamivir studies except for three collected data on complications through participant self reporting, mediated by an investigator who filled out a form see web extra table 1. Exposure had to be naturally occurring influenza, with or without symptoms. What is already known on this topic Neuraminidase inhibitors are used globally for the treatment and prophylaxis of influenza The evidence for their effectiveness in preventing complications of influenza is sparse, and information on their adverse events are lacking.
Discussion The evidence we have presented shows that oseltamivir has symptom relieving effects. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: The issues are described and debated elsewhere.
The story of the review is long and complex and our methods often reflected the circumstances at the time. Neuraminidase inhibitors are used globally for the treatment and prophylaxis of influenza. If you found this interesting you could explore more free Psychology courses or view the range of currently available OU Psychology courses.
Tamiflu oseltamivir phosphate capsule. Oseltamivir was also associated with a decreased risk of diarrhoea 0.
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Oseltamivir versus placebo for treatment of influenza in healthy adults and children. Oseltamivir in the treatment of children induced vomiting compared with placebo 1.
The certificates are vital as they furnish a visual description and content of both active and placebo capsules. Given the low numbers, we did not meta-analyse the data, but a rate of 4 per is high enough to be worrying.
Because of the novelty and size of clinical study reports we subdivided the extraction, appraisal, and analysis of the data into a two stage exercise. Clinical study reports are considered the most exhaustive summaries of randomised controlled trials of drugs. Although the substances seemed to be in low doses, no discussion of their potential effects in people with fever as in the treatment trials was reported.
In a primary or secondary prophylaxis indication the postulated central effect of oseltamivir is confined to suppressing symptoms, because infection, according to Roche, is not prevented see web extra. In prophylaxis trials there was an increased risk of headaches on-treatment 1.
Introduction Influenza antivirals oseltamivir and zanamivir of the neuraminidase inhibitor class are commonly used and stockpiled drugs employed against seasonal and pandemic influenza on the basis of international and national recommendations; these recommendations partly justified by the claimed and assumed ability of oseltamivir to reduce complications and transmission of influenza.
There was high risk of bias for included outcomes as a result of missing data symptoms , selective reporting influenza outcomes , potentially active placebo harms , lack of outcome definitions complications of influenza , suboptimal measurement complications , and incomplete reporting in the clinical study reports.
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We also updated our searches of the electronic databases of published studies previously carried out for the Cochrane reviews on neuraminidase inhibitors in children 12 and in healthy adults 13 and then updated the searches again on 22 July Identifiable CONSORT statement specified results primary outcomes, tables, appendices must be available see web extra appendix 3 for index and expected content of a Roche clinical study report.
Conclusions In prophylactic studies oseltamivir reduces the proportion of symptomatic influenza. We used a variety of methods applied to different sources publications, registries, correspondence with manufacturers, and review of regulatory documents to identify and retrieve manufacturer funded and non-manufacturer funded clinical trials and their clinical study reports.
Five deaths were reported, only one of these was for a respiratory cause in a chronically ill patient without influenza who was treated with placebo. We used the Cochrane risk of bias tool 9 to appraise clinical study reports and a custom built data extraction form for recording information relevant to this appraisal for example, dates of participant recruitment and date of trial protocol.
We identified 83 eligible trials. Data extraction Because of the novelty and size of clinical study reports we subdivided the extraction, appraisal, and analysis of the data into a two stage exercise.
The evidence of clinically significant effects on complications and viral transmission is limited because of rarity of such events and problems with study design.