Press releases Saturday 28 February 2004

Please remember to credit the BMJ as source when publicising an article and to tell your readers that they can read its full text on the journal's web site (http://bmj.com).

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(1) RISKS OF HRT COULD HAVE BEEN REVEALED MUCH EARLIER

(2) CONCERNS OVER THE VALUE OF ANIMAL EXPERIMENTS

(3) DRINKING EXTRA FLUIDS DURING A COLD MAY NOT BE BENEFICIAL

(1) RISKS OF HRT COULD HAVE BEEN REVEALED MUCH EARLIER

(Synthesising licensing data to assess drug safety)
http://bmj.com/cgi/content/full/328/7438/518

The risks of hormone replacement therapy would have been revealed much earlier if better use had been made of existing evidence. As such, women have been needlessly exposed to an increased risk of heart disease, argue researchers in this week's BMJ.

The large US Women's Health Initiative trial was stopped prematurely in 2002 after showing an increased risk of cardiovascular events from combined hormone replacement therapy.

However, well before the Women's Health Initiative trial was published, the authors analysed 23 small trials of hormone replacement therapies and found that they were not as protective as the observational data had shown. Many of these trials were done by pharmaceutical companies to obtain drug licences and were not publicly available.

When they published their findings in 1997, they were ridiculed. But extra data from six further studies confirmed their concerns. High Court dispensation was required to access these trials.

If trials done by pharmaceutical companies for licensing purposes had to include adequate data on harms and ineffectiveness, we could learn much more quickly what we need to know about new drugs, say the authors.

Regulators should require drug manufacturers to record adverse events and make the results public, they conclude.

Contact:

Klim McPherson, Visiting Professor in Public Health Epidemiology, Nuffield Department of Obstetrics and Gynaecology, Churchill Hospital, Oxford, UK
Email: klim.mcpherson@obstetrics-gynaecology.oxford.ac.uk

(2) CONCERNS OVER THE VALUE OF ANIMAL EXPERIMENTS

(Where is the evidence that animal research benefits humans?)
http://bmj.com/cgi/content/full/328/7438/514

Much animal research into potential human treatments is wasted because it is poorly conducted and not thoroughly evaluated, argue leading doctors in this week's BMJ.

They call for urgent, formal reviews of existing animal research.

They identified six comprehensive reviews of animal experiments from the scientific literature. All six highlighted deficiencies in the contribution that animal research makes to clinical medicine, such as poor design and animal and clinical trials being conducted simultaneously.

If animal experiments fail to inform medical research, or if the quality of the experiments is so poor as to render the findings inconclusive, then the research will have been conducted unnecessarily.

The scientists call for a programme of research to review existing animal data, to find out whether the animal research can be applied to humans.

Professor Ian Roberts, one of the authors of the report said, "We are only asking that the same standards as are applied in human research are applied to animal research. We would not tolerate haphazard potentially biased reviews of human research so why should we tolerate this for animal research? New research, whether in animals or humans, should only be carried out after a proper systematic review of the existing research.

What's more, comparing results from systematic reviews of animal and human research will allow us to assess the contribution of animal research to improving human health."

Contact:

Professor Ian Roberts, London School of Hygiene and Tropical Medicine, London, UK
Email: Ian.Roberts@lshtm.ac.uk

(3) ANTISOCIAL BEHAVIOUR SCHEMES MAY FAIL TO DELIVER

(Mentoring to reduce antisocial behaviour in childhood)
http://bmj.com/cgi/content/full/328/7438/512

Mentoring schemes to reduce antisocial behaviour among young people should not be recommended because, despite their popularity with politicians and policy makers, they are based on inconclusive evidence, say researchers in this week's BMJ.

Mentoring schemes typically involve a volunteer who provides support or guidance to someone younger or less experienced.

Last year, the UK government announced £850,000 of funding for mentoring schemes in England. In the United States, President Bush recently announced plans for a $450m expansion of mentoring programmes for young people.

The authors argue that research on mentoring programmes does not provide evidence of measurable gains in outcomes such as truanting or other antisocial behaviours. Mentoring programmes can also have a negative impact, and adverse effects associated with breakdowns of relationships with mentors have been reported.

On the basis of these findings, they conclude that non-directive mentoring programmes delivered by volunteers cannot be recommended as an evidence-based intervention for young people at risk of or already involved in antisocial behaviour or criminal activities.

The findings also highlight the potential dangers of rolling out national programmes based on inadequate evidence.

"Research and development in health and social care needs huge investment if we are to develop adequate social interventions for big problems," they conclude.

Contact:

Kristin Liabo, Research Fellow, Child Health Research and Policy Unit, Institute of Health Sciences, City University, London, UK
Email: k.liabo@city.ac.uk

(3) DRINKING EXTRA FLUIDS DURING A COLD MAY NOT BE BENEFICIAL

("Drink plenty of fluids": a systematic review of evidence for this recommendation in acute respiratory infections)
http://bmj.com/cgi/content/full/328/7438/499

Doctors should be cautious about advising patients with respiratory infections to drink plenty of fluids, warn researchers in this week's BMJ.

Their view is based on evidence that, during a respiratory infection such as a cold or bronchitis, the body releases large amounts of a water-conserving hormone (known as antidiruretic hormone). Thus giving extra fluids while antidiruretic hormone secretion is high may theoretically lead to salt loss and fluid overload.

They searched the scientific literature, but were unable to find any trials providing definite evidence that giving increased fluids to patients with respiratory infections may cause harm.

"Until we have this evidence, we should be cautious about universally recommending increased fluids to patients, especially those with infections of the lower respiratory tract," they conclude.

Contact:

Chris Del Mar, Professor of General Practice, University of Queensland, Australia
Email: c.delmar@cgp.uq.edu.au

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