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BMJ 2006;332:1146-1147 (13 May), doi:10.1136/bmj.332.7550.1146
Alison Tonks, associate editor
atonks{at}bmj.com
Statins work well in the long term, reducing serum concentrations of low density lipoprotein cholesterol and protecting patients from heart attacks, strokes, and death. There's some evidence that they also reduce vascular inflammation and stabilise vascular endothelium, although these fast acting physiological effects don't seem to translate into better short term outcomes for patients with acute coronary syndromes.
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In a meta-analysis of 12 randomised controlled trials, early treatment with statins did not reduce patients' short term risk of heart attack, stroke, or death compared with a placebo or usual care. The authors found a modest reduction in the risk of unstable angina four months after symptoms had started (206/4268, 4.8% v 256/4238, 6.0%; relative risk 0.80, 95% CI 0.64 to 1.00) but no other clinical benefits.
The patients were mostly men with a mean age of 55-70 years who had been admitted to hospital with a heart attack or unstable angina. They began treatment 1-10 days after admission, and for this analysis they were followed up for four months.
Despite these negative findings, it's still a good idea to prescribe statins earlier rather than later, say the authors. It does no harm, benefits will accumulate eventually, and it's likely that starting treatment in hospital improves adherence.
JAMA 2006;295: 2046-56
Worldwide, more than three million babies are born dead each year, according to recent estimates. Ninety nine per cent are born in developing countries. Half are born in India, China, Pakistan, and Bangladesh, and most of the rest in sub-Saharan Africa. Overall, the rate of stillbirths is five times higher in poor than in rich countries (25.5 v 5.3 per 1000 deliveries).
Stillbirths are hard to count, particularly in countries with a poor health infrastructure and the highest rates of stillbirth. These researchers used whatever data they could find in birth and death registers, demographic and health surveys, and published studies. Then they populated a complex statistical model to plug the gaps where data were missing. The results are probably an underestimate of the true rate in most poor countries.
This substantial effort is more than an exercise in epidemiology, however. Historically, stillbirths were excluded from most international statistics of neonatal and child deaths. They were effectively invisible, and so initiatives to reduce deaths missed an important target. Most stillbirths are avoidable. These new data, and the methods used to find them, should help. But the authors warn that "both the quality and the quantity of data are inadequate, and no modelling technique can overcome the fact that at the global level we are stumbling around in the dark."
Lancet 2006;367: 1487-94[CrossRef][ISI][Medline]
Ramipril, an angiotensin converting enzyme inhibitor, reduces the risk of cardiovascular events in people with peripheral arterial disease. It also improves symptoms, a randomised trial has found.
Forty Australians, mostly men, took part. All had stable intermittent claudication and objective evidence of infratinguinal arterial disease. They took 10 mg ramipril or an identical placebo once a day for six months. At the end of the study, the people who took ramipril did significantly better in a treadmill test, walking without pain for nearly four minutes longer than controls. Maximum walking times improved by more than seven minutes in the ramipril group compared with no improvement in controls. The authors estimate that ramipril helped patients walk an extra 400 m before having to stop, which compares favourably with established medical treatments, such as pentoxyfilline. They didn't measure, or didn't report side effects.
This trial was small and included carefully selected patients with infra-inguinal disease and no diabetes. And therefore these findings apply to only about half the general population of patients with claudication seen by doctors in developed countries. Bigger more diverse trials should now be done, perhaps including outcomes that are important to patients, such as their ability to get on with everyday activities.
Ann Int Med 2006;144: 660-4
Bariatric surgery is an established treatment for morbid obesity. A team from Australia think that surgery should also be an option for people with mild or moderate obesity because their randomised trial showed that laparoscopic gastric banding worked significantly better than an intensive programme of diet, exercise, and drugs over one year.
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The 80 participants had a mean body mass index of 33.6, well below the threshold for surgery recommended by the World Health Organization and others. Participants who had an adjustable gastric band lost 22% of their body weight in two years. Controls lost just 6% (P < 0.001). By the end of the study, the surgical group were healthier and had a better quality of life than controls.
The authors say that theirs is the first randomised trial that compares a modern surgical option with more traditional ways of losing weight and that the results are clear. But an editorial (pp 689-91) counsels against a wholesale shift towards surgery for people with mild or moderate obesity. Safety is still an issue: four people in this study needed revision surgery after their posterior gastric wall prolapsed through the band. Short term death rates vary between 0.05% and 0.4%; and the long term risks are unknown. There are also worries about the effect of surgery (relative to diet and exercise) on important determinants of cardiovascular risk, especially dyslipidaemia.
Ann Int Med 2006;144: 625-33
About half of all women in Western societies have hot flushes around the time of the menopause. Among women who need treatment, increasing numbers are looking for an alternative to hormonal therapies based on oestrogen. A thorough systematic review of a generally weak body of research shows that antidepressants may help some women, but their effects are modest, and side effects are a problem. Paroxetine, for example, consistently reduced hot flushes by one or two a day compared with placebo. The results for venlafaxine were mixed.
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The anticonvulsant gabapentin and the antihypertensive clonidine also reduced hot flushes, but not much. An editorial (pp 2076-8) says that they both cause unpleasant side effects, including drowsiness, and long term safety is an unresolved issue. Research on isoflavones from soya beans or red clover is weaker still. The authors excluded other herbal remedies, such as black cohosh and evening primrose oil, because they probably don't work.
What should women do? The authors say that for the time being women should stick with oestrogen. The risks are low if women take as little as possible for as short a time as possible. Women with severe symptoms who cannot take oestrogen could try an antidepressant, clonidine, or gabapentin, "but they are not optimal choices for most women."
JAMA 2006;295: 2057-71
Stents can work well for patients with diseased coronary arteries, but they seem to work less well in peripheral arteries. Restenosis is a serious problem, although a newer stent made of nitinol looked promising in a recent randomised trial.
The 104 participants had severely diseased superficial femoral arteries, and most (88%) had severe claudication. They were treated with balloon angioplasty or a nitinol stent. After six months, restenosis had occurred in 24% (12/51) of patients treated with a stent and 43% (23/53) of patients treated with angioplasty, a significant benefit that persisted to a year and was matched by an improvement in walking distance (363 v 270 m at six months, P = 0.04).
Nitinol is an alloy of nickel and titanium. Nitinol stents are more flexible and harder to crush than those made of stainless steel. Theoretically, they should be less prone to fracture, although this study didn't last long enough to find out.
A linked editorial (pp 1944-7) catalogues other limitations too, such as the lack of a control group treated medically, the small number of participants, and the fact that few had limb threatening disease. Research devoted to treatments for peripheral vascular disease has a long way to go before it catches up in quality or quantity with the research effort devoted to coronary artery disease, writes the author.
N Engl J Med 2006;354: 1879-88
Almost one in five US citizens have no health insurancean estimated 45 million people. This large and growing minority miss out on many recommended healthcare services, particularly those aimed at preventing disease, such as screening. Having a higher income does not seem to help.
In a recent nationwide survey, being uninsured was significantly associated with being young, male, black, Hispanic, poorly educated, and unmarried. Uninsured respondents reported a lower uptake of cancer screening services than did respondents with insurance. They were less likely to have had advice or treatment to reduce their cardiovascular risk. People with diabetes had missed out on eye and foot examinations and blood tests for glycosylated haemoglobin.
A higher income did not close this gap for any of the services examined. For some services, including cervical screening and mammography, the gap became wider as household income went up.
The survey included 194 943 US citizens aged less than 64 years, who were not eligible for Medicare insurance. The response rate was about 75%, and authors say that the sample is a true representation of citizens from every state. Their findings imply that a higher income does not cushion US citizens from the adverse effects of not having insurance.
JAMA 2006;295: 2027-36
Spending more on health services doesn't necessarily improve outcomes for patients, such as survival. But does more money in the system mean happier doctors doing a "better" job of caring for their patients? Probably not, says the latest in a series of papers from the US to have examined variations in spending on health care and the experiences of patients and doctors.
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Researchers surveyed 10 577 doctors, and 61% responded. They used per capita expenditure on Medicare to stratify US regions according to "intensity" of healthcare services. High intensity regions spent more per head, had more doctors overall, had more specialists, and had more hospital beds per head than low intensity regions despite a similar burden of illness in their populations.
Even so, doctors in high intensity regions, such as Miami in Florida, said that it was harder to find hospital beds, harder to find high quality specialist services, harder to maintain a good doctor patient relationship, and harder to provide a good service than doctors practising in lower intensity regions, such as Albany in New York. Doctors in high intensity regions were also significantly less satisfied with their careers (74% v 81%, P < 0.001).
Ann Int Med 2006;144: 641-9
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Israeli students are refusing to perform intimate examinations on anaesthetised women without their informed consent.