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Hormonal contraceptives and arterial thrombosisAlthough several studies have assessed the risk of venous
thromboembolism with newer hormonal contraception, few have examined thrombotic
stroke and myocardial infarction. This historical cohort study from Denmark
followed 1,626,158 women aged between 15 and 49 years of age over a 15-year
period. Subjects with a history of cancer or cardiovascular disease were
excluded. Data concerning the use of contraceptives and the clinical end points
were obtained from national registries.
The conclusions reached were that although the absolute
risks of thrombotic stroke and myocardial infarction associated with the use of
hormonal contraception were low, the risk was increased by a factor of 0.9 to
1.7 with oral contraceptives that included ethinyl estradiol at a dose of 20
µg and by a factor of 1.3 to 2.3 with those that included ethinyl estradiol
at a dose of 30–40 µg, with relatively small differences in risk
according to progestin type. An editorial commentator applauded the study and
notes that women should be reassured by the results which document the small
magnitude of the problem of arterial thrombotic events in women using
estrogen/progestin contraception.
N Engl J Med
2012;366:2257–66 & 2316–18.
Zinc as an adjunct to antibiotic treatment in Asian infants with serious bacterial infectionSerious bacterial infections are a major cause of death in
early infancy in developing countries. Inexpensive and accessible interventions
that can add to the effect of standard antibiotic treatment could reduce infant
mortality. This randomised trial report from Delhi, India concerns 700 infants
aged between 7 and 120 days who were considered to have a serious bacterial
infection. Half were treated with antibiotics and 10 mg of zinc daily orally or
antibiotic and placebo. Significantly fewer treatment failures occurred in those
taking zinc than placebo (10% vs 17% – relative risk reduction 40%). Ten
receiving zinc died compared with 17 given placebo (relative risk 0.57).
Lancet
2012;379:2072–78.
Egg allergy in children alleviated by oral immunotherapyEgg allergy has a cumulative prevalence of approximately
2.6% by 2.5 years of age, with allergic reactions varying in severity from mild
urticaria to systemic anaphylaxis. This report concerns a randomised trial
evaluating oral immunotherapy using egg-white powder for the treatment of
children with egg allergy. 55 children, 5–11 years of age were randomised
to an escalating dose of egg-white powder or placebo. In the oral-immunotherapy
group, 28% (11 of 40 children) passed the oral food challenge at 24 months and
were considered to have sustained unresponsiveness.
At 30 months and 36 months, all children who had passed the
oral food challenge at 24 months were consuming egg. Very good news for a
proportion of the subjects, bearing in mind how difficult it is to maintain an
egg-free diet.
N Engl J Med
2012;367:233–43.
Total hip arthroplasty versus resurfacing arthroplastyThis randomised trial attempts to elucidate whether
resurfacing arthroplasty provide better hip function than total hip arthroplasty
in patients with severe arthritis of the hip. 126 patients were randomised to
either total hip arthroplasty (replacement of femoral head and neck) or hip
resurfacing arthroplasty (replacement of the articular surface of femoral head
only). Both procedures replaced the articular surface of the acetabulum.
The researchers report that they saw no evidence of a
difference in hip function in patients with arthritis of the hip, 1 year after
receiving a total hip arthroplasty versus resurfacing arthroplasty. We can
assume that the researchers will follow these patients for an extended period
and report upon longer term outcomes.
BMJ 2012;344:e2147.
Exclusion of older people from clinical researchExclusion of older people from clinical research, and of
under-recruitment to clinical trials, is widespread. This problem has stark
consequences, according to an expert committee of the European Medicines Agency
(EMA). “The drugs we are using in older people have not been properly
evaluated.” This is clearly of great importance considering the fact that
the older generation are the fastest growing sector of the population.
There are several reasons for the exclusion. Exclusion of
patients with comorbidity and cognitive impairment tends to keep older people
out of trials. In addition, elderly patients were discouraged by a dislike of
randomisation, concerns about the consent procedure, and practicalities such as
transport. These are the problems but what is the solution? The EMA suggests
that as the drug manufacturers sponsor drug trials they should be proactive.
Simplification of information about trials and consent procedures would be
helpful according to the EMA.
BMJ 2012;344:e3445.
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