Press releases Monday 10 August to Friday 14 August 2009
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 website (http://www.bmj.com).
(1) No clear evidence that antivirals prevent complications in children with seasonal flu
(2) Risk of suicidal behaviour with antidepressants strongly linked to age
(3) Criminalising prostitution linked to violence against female sex workers
(4) Treatment for chronic illness must be less disruptive to people's daily lives
(5) Many women not using safest brands of contraceptive pill
(6) Questions over timely investigation of "alarm symptoms"
(1)No clear evidence that antivirals prevent complications in children with seasonal flu
(Research: Neuraminidase inhibitors for treatment and prophylaxis of influenza in children: systematic review and meta-analysis of randomised controlled trials)
http://www.bmj.com/cgi/doi/10.1136/bmj.b3172
The antivirals oseltamivir (Tamiflu) and zanamivir (Relenza) are unlikely to prevent complications in children who have seasonal flu, according to research published on bmj.com today.
The authors say that it is difficult to know the extent to which their findings can be generalised to children in the current swine flu pandemic but, based on current evidence, the effects of antivirals on reducing the course of illness or preventing complications might be limited.
While the study shows that antivirals shorten the duration of flu in children by up to a day and a half, it also shows that they have little or no effect on asthma flare-ups, increased ear infections or the likelihood of children needing antibiotics. The antiviral Tamiflu is also linked to an increased risk of vomiting.
The authors, led by Dr Matthew Thompson from the University of Oxford, add that the study reveals the effectiveness of using antivirals to contain the spread of flu. They conclude that 13 people need to be treated to prevent one additional case; therefore antivirals reduce transmission by 8%.
During seasonal flu epidemics children are at high risk, with over 4 in 10 (40%) preschool children getting the virus and 3 in 10 (30%) school age children doing so. School age children are also the main source of spread of flu into households, say the authors.
The main strategy to control flu is vaccination but coverage can be low and often there is not enough time to produce and distribute vaccines in response to emerging strains. Therefore current control strategies include using antiviral medications to prevent the virus spreading as well as treating infected individuals.
Thompson and his colleagues say the last review of this strategy was carried out in 2005 and a more up to date assessment of the benefits and harms of this treatment was now required in the light of widespread use of these drugs during the current swine flu pandemic.
So they carried out a review of four trials on the treatment of flu in 1,766 children (1,243 with confirmed flu, 55 to 69% with type A, the same strain as swine flu) and three trials involving the use of antiviral to limit the spread of flu.
"While morbidity and mortality in the current pandemic remain low, a more conservative strategy might be considered prudent, given the limited data, side effects such as vomiting, and the potential for developing resistant strains of influenza," they say.
Contacts:
Dr Matthew Thompson, Senior Clinical Scientist, Department of Primary Health Care, University of Oxford, UK
Email: matthew.thompson@dphpc.ox.ac.uk
Dr Carl Heneghan, Deputy Director CEBM & Clinical Lecturer, DPHC, University of Oxford, UK
Email: Carl.Heneghan@dphpc.ox.ac.uk
(2) Risk of suicidal behaviour with antidepressants strongly linked to age
(Research: Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration)
http://www.bmj.com/cgi/doi/10.1136/bmj.b2880
(Editorial: Risk of suicidal behaviour in adults taking antidepressants)
http://www.bmj.com/cgi/doi/10.1136/bmj.b3066
Adults taking antidepressants are not at greater risk of suicidal thoughts or behaviour, but young adults aged less than 25 years of age are at an increased risk, similar to that seen in children and adolescents, finds research published on bmj.com today.
The paper expands on analyses first made available by the US Food and Drug Administration (FDA) two years ago. It includes different methods, additional explorations of the data, and an expanded discussion of the implications of the findings.
Previous studies have shown that antidepressant drugs are linked with an increased risk of suicidal behaviour and thoughts in children and adolescents, particularly in the early stages of treatment. This led the FDA to add a black box warning to antidepressants in 2005 and to examine trials of antidepressants in adults to look for similar effects.
Dr Marc Stone and colleagues from the FDA asked eight manufacturers of antidepressant products to provide data on suicidal thinking and behaviour from published and unpublished randomised trials on antidepressants in adults. They reviewed data from 372 placebo controlled trials involving nearly 100,000 patients.
Findings showed eight completed suicides, 134 suicide attempts, 10 patients who had made preparations without attempting suicide, and 378 patients who had thoughts about suicide but had not acted on them.
Overall, drug type and diagnostic category made little difference to risk of suicidal behaviour, with the exception of some differences among selective serotonin reuptake inhibitors (SSRIs).
However, an increased risk was noted among adults under 25 years of age, similar to that reported in children and adults - this increased risk was greatest in those with psychiatric disorders other than depression.
These results suggest that, compared with placebo, the risks of suicidality associated with antidepressants are strongly age dependent - the risk is raised in people under 25, not affected in those aged 25-64, and reduced in those aged 65 and older, say the authors.
The findings also support the idea that antidepressant drugs can have two separate effects: an undesirable effect in some patients that promotes suicidal thoughts or behaviour, with a risk that appears to diminish with age, and a protective effect in others that alleviates depression and reduces any suicidal risk, they add. This should be the subject of further research, particularly in terms of possible mechanisms for age related differences.
In the meantime, the FDA has expanded the suicide warning on antidepressant drugs with this new information, including the strong age relatedness of the findings.
But in an accompanying editorial Professor John Geddes from the University of Oxford and colleagues warn that "fundamental uncertainty" remains. They point to important limitations in the analysis, such as the very low numbers of completed suicides in the primary trials and a lack of transparency in some of the methods used. They also discuss some important differences in risk between individual drugs.
It is becoming apparent that antidepressants vary in both their efficacy and adverse effects, they say. The increased risk of suicidal behaviour in adults taking antidepressants is probably restricted to younger people and varies greatly between individual drugs, they conclude.
Contacts:
Research: Dr Marc Stone, Medical Officer, Center for Drug Evaluation and Research, US Food and Drug Administration, MD, USA
Email: marc.stone@fda.hhs.gov
Editorial: John Geddes, Professor of Epidemiological Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK
Email: john.geddes@psych.ox.ac.uk
(3) Criminalising prostitution linked to violence against female sex workers
(Research: Prevalence and structural correlates of gender based violence among a prospective cohort of female sex workers)
http://www.bmj.com/cgi/doi/10.1136/bmj.b2939
Over half of female sex workers in Canada suffer an alarming prevalence of violence that could be stemmed by decriminalising the sex industry, according to research published on bmj.com today.
While gender-based violence has been identified as a global public health priority that can lead to ill-health and death, abuses against female sex workers are seldom debated, say the authors.
Lead author, Professor Kate Shannon at the BC Centre for Excellence in HIV/AIDS and the University of British Columbia, and her team interviewed over 250 female street-based sex workers in Vancouver. The average age of participants was 36 and most had begun prostitution at 15 years of age.
They were interviewed on up to three occasions and asked: "Have you been physically abused by someone (excluding clients) in the last six months?", "Have you been forced to have sex against your will (excluding clients) in the last six months?", "Have you experienced a ‘bad date’ in the last six months?"
Over half of participants (57%) had experienced violence at least once in the 18-month follow-up period. Almost four in ten (38%) reported physical violence, a quarter (25%) reported rape, and three in ten (30%) said their clients had been violent towards them.
The majority (87%) said they had lived on the street at least once in their lifetime, and one fifth had tried but been unable to access drug treatment in the last 18 months. A fifth had at least one dependent child and three in ten (32%) reported having a child removed by social services.
Shannon says: "The persistent relationship between enforcement of prostitution policies (e.g. enforced displacement to outlying areas) and violence suggests that criminalisation enhances the likelihood of violence against street-based female sex workers."
She adds that it is particularly worrying that so many female sex workers are unsuccessful in accessing drug treatment and this led to double the risk of physical and client-perpetrated violence. The authors say the demand for addiction treatment in British Columbia far outweighs availability - in 2008 there was a wait time of between four to twelve weeks and only a handful of beds were available for mothers with children.
To conclude, Shannon says that "the findings support global calls to remove criminal sanctions targeting sex workers."
Contact:
Kate Shannon, Assistant Professor, British Columbia Centre for Excellence in HIV/AIDS, Department of Medicine, University of British Colombia, Vancouver, Canada
Email: kshannon@cfenet.ubc.ca
(4) Treatment for chronic illness must be less disruptive to people’s daily lives
(Analysis: We need minimally disruptive medicine)
http://www.bmj.com/cgi/doi/10.1136/bmj.b2803
Many patients with complex chronic illnesses are overburdened by their treatment, according to a paper published on bmj.com today.
The authors argue that some of these problems are induced by healthcare systems themselves and that, to be effective, care must be less disruptive to the daily lives of patients.
Chronic disease is the great epidemic of our times, but the strategies we have developed to manage it have created a growing burden for patients, write Professors Carl May, Victor Montori, and Frances Mair. This treatment burden leads to poor adherence, wasted resources, and poor outcomes.
For example, they describe a man being treated for heart failure in UK primary care who rejected the offer to attend a specialist heart failure clinic to optimise management of his condition. He stated that in the previous two years he had spent the equivalent of one full day every two weeks making 54 visits to specialist clinics for consultant appointments, diagnostic tests, and treatment.
Against this background, they call for minimally disruptive medicine that seeks to tailor treatment regimens to the realities of the daily lives of patients. Such an approach could greatly improve the care and quality of life for patients.
The work of being a patient includes much more than drug management and self monitoring, they explain. It includes organising doctors’ visits and laboratory tests. Patients may also need to take on the organisational work of passing basic information about their care between different healthcare providers and professionals. And in some countries, they must also take on the contending demands of insurance and welfare agencies.
Patients are thus overwhelmed not just by the burden of illness, but by the ever present and expanding burden of treatment, say the authors.
Furthermore, some of these problems are induced by healthcare systems themselves, and clinicians don't have the tools to respond adequately to this problem.
They suggest that clinicians and researchers need reliable tools to identify overburdened patients. They also call for a shift towards improved coordination of care and the development of clinical guidelines for managing multiple chronic conditions.
They also argue that patients and their caregivers must play a central role in improving the coordination of their care.
"We need to think more about the burdens of treatment," conclude the authors. "Thinking seriously about the burden of treatment may help us begin to think about minimally disruptive medicine - forms of effective treatment and service provision that are designed to reduce the burden of treatment on their users."
Contacts:
Carl May, Professor of Medical Sociology, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK
Email: c.r.may@ncl.ac.uk
Professor Frances Mair, Division of Community Based Sciences, University of Glasgow, Glasgow, UK
Tel: +44 (0)7958 200 174
Professor Victor M Montori, Knowledge and Encounter Research Unit, Mayon Clinic, Rochester MN, USA
Tel: +1 507 284 2511
(5) Many women not using safest brands of contraceptive pill
(Research: The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study)
http://www.bmj.com/cgi/doi/10.1136/bmj.b2921
(Research: Hormonal contraception and risk of venous thromboembolism: national follow-up study)
http://www.bmj.com/cgi/doi/10.1136/bmj.b2890
(Editorial: Oral contraceptives and venous thromboembolism)
http://www.bmj.com/cgi/doi/10.1136/bmj.b3164
Many women are not using the safest brands of oral contraceptive pill with regard to the risk of venous thrombosis (deep vein thrombosis and pulmonary embolism), finds a study published on bmj.com today.
The risk differs by type of progestogen and dose of oestrogen, and the safest option is an oral contraceptive containing levonorgestrel combined with a low dose of oestrogen, say the authors.
Since 1961, several large studies have shown a twofold to sixfold increased risk of deep venous thrombosis associated with oral contraceptive use. As a result, the oestrogen dose in combined oral contraceptives has been reduced. But it is still unclear which hormonal contraceptive is safest with regard to the risk of venous thrombosis.
So a team of researchers at Leiden University Medical Center in the Netherlands assessed the thrombotic risk associated with currently available oral contraceptives. Their focus was on dose of oestrogen and type of progestogen.
The findings are based on data from a large study of 1,524 women aged 18-50 years with a first deep venous thrombosis and 1,760 healthy controls.
In line with results of previous studies, they found that women taking oral contraceptives have a five-fold increased risk of venous thrombosis compared with non users.
This risk differed by type of progestogen. For example, pills containing desogestrel were associated with a twofold increased risk of venous thrombosis compared with pills containing levonorgestrel. The risk of venous thrombosis was also positively associated with oestrogen dose and was highest during the first three months of use, irrespective of the type of pill used.
The authors conclude that the choice of oral contraceptive should be based on the smallest increase of side effects and, as such, the safest option with regard to the risk of venous thrombosis is an oral contraceptive containing levonorgestrel combined with a low dose of estrogen.
These findings are supported in a second study, also published today. Researchers in Denmark assessed the risk of venous thrombosis among healthy Danish women aged 15-49 years who were using different types of hormonal contraception from 1995 to 2005. A total of 10.4 million woman years were recorded and 4,213 venous thrombotic events were observed.
They found that the risk of venous thrombosis decreased with duration of use and decreasing oestrogen dose. For the same dose of oestrogen and the same length of use, oral contraceptives containing levonorgestrel conferred a significantly lower risk of venous thrombosis than pills containing other types of progestogens.
Progestogen only pills and hormone releasing intrauterine devices were not associated with any increased risk of venous thrombosis.
The authors stress that the absolute risk of venous thrombosis with use of any types of combined oral contraceptives in young women is less than one in 1,000 user years. And for women of normal weight and without known genetic predispositions, they recommend a low dose combined pill as first choice for contraception.
Despite their different designs, these two studies produce remarkably similar results and confirm past studies of the risk of venous thromboembolism with the pill, says Dr Nick Dunn from the University of Southampton in an accompanying editorial. However, he points out that the absolute risk of having venous thromboembolism is low, even when taking the pill, and agrees that the products of choice should be those containing either levonorgestrel or norethisterone, with as low a dose of oestrogen as possible.
An evidence based review of information on all contraceptive methods currently available for women is also published on bmj.com.
Click here for a list of different pill brands and their oestrogen dose: http://www.nhs.uk/Conditions/Combined-contraceptive-pill/Pages/Names.aspx
Contact:
Research: Professor F R Rosendaal, Professor of Clinical Epidemiology, or Dr Astrid van Hylckama Vlieg, Research Fellow, Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands
Email: f.r.rosendaal@lumc.nl or a.van_hylckama_vlieg@lumc.nl
Research: Professor Øjvind Lidegaard, Gynaecological Clinic, Rigshospitalet, Copenhagen, Denmark
Email: lidegaard@dadlnet.dk
Editorial: Nick Dunn, Senior Lecturer in Medical Education, Biomedical Sciences Building, University of Southampton Medical School, Southampton, UK
Email: nick.dunn@soton.ac.uk
(6) Questions over timely investigation of "alarm symptoms"
(Research: Alarm symptoms and identification of non-cancer diagnoses in primary care: cohort study)
http://www.bmj.com/cgi/doi/10.1136/bmj.b3094
Many patients presenting to their doctor with certain alarm symptoms, such as difficulty swallowing or rectal bleeding, may not be receiving a timely diagnosis, finds a study published on bmj.com today.
Certain symptoms, such as blood in the urine (haematuria), coughing up blood (haemoptysis), difficulty swallowing (dysphagia), and rectal bleeding, are generally regarded as "red flags" because of their association with serious disease.
They should prompt clinicians to conduct investigations in order to make an early accurate diagnosis.
The predictive value of these red flag or alarm symptoms for a diagnosis of cancer have now been established, but little is known about their predictive value for non-cancer diagnoses, which might also have considerable implications for patients’ health.
So researchers based at King’s College London tracked 762,325 patients presenting to general practice with first episodes of haematuria, haemoptysis, dysphagia or rectal bleeding in 1994.
A list of potentially important diagnoses associated with each of the alarm symptoms were identified and these were compared with actual diagnoses recorded at 90 days and three years after the first recorded alarm symptom.
In patients with haematuria, haemoptysis, dysphagia, and rectal bleeding around one in five had an associated diagnosis at 90 days.
However, after three years, over three quarters of patients presenting with rectal bleeding did not have a definite diagnosis, with comparable figures of about 67% for dysphagia, 64% for haematuria, and 46% for haemoptysis.
The authors estimate that for every four to seven patients evaluated for haematuria, haemoptysis, dysphagia, or rectal bleeding, relevant diagnoses will be identified in one patient within 90 days.
The authors point out that this proportion would almost certainly have been higher in patients with multiple symptoms. However, they suggest that patients presenting with these symptoms merit timely investigation for non-cancer diagnoses and potential cancer diagnoses, rather than a policy of watchful waiting.
Contact:
Roger Jones, Wolfson Professor of General Practice, Department of General Practice and Primary Care, Division of Health and Social Care Research, King’s College London School of Medicine at Guy's, King's College and St Thomas' Hospitals, London, UK
Email: roger.jones@kcl.ac.uk
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