Journal of the New Zealand Medical Association, 10-August-2012, Vol 125 No 1359
Although 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.
Serious 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).
Egg 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.
This 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.
Exclusion 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.
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