Statins side effects quantified

A new study, published in the BMJ, to quantify the unintended effects of statins according to type, dose, and duration of use found that statin use was associated with increased risks of serious liver dysfunction, acute renal failure, moderate or serious myopathy ( muscle weakness) and cataracts.

Researchers examined the medical records of over 2 million patients who registered at GP practices in England and Wales, the patients were monitored over a period of 6 years. They found that Simvastatin was the most prescribed statin and the side effects are already known. Eestimates of the absolute risks were also provided : for 10,000 people, there would be 17 extra cases of kidney failure, 252 cataracts, 65 liver problems and 32 myopathy. The adverse effects were similar across the statin types for each outcome except liver dysfunction where fluvastatin was associated with the highest risks.

The accompanying editorial says that the benefits of statins seem to outweigh the risks. It is suggested that patients should not change their medication.

Source: Hippisley-Cox J, and C Coupland. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database. BMJ 2010;340:c2197 ( f/t via Athens)

Processed meat increased heart disease risk

A new systematic review and meta-analysis of 20 studies involving more than 1.2 millions people from 10 countries found that processed meat such as bacon, salami, sausages, hot dogs and processed deli, was linked to increased risk of heart disease and diabetes, but red meat was not.

Participants were followed up to 18 years and found that those who ate 50 gram a day of processed red meat had 42% higher risk of heart disease and 19% higher risk of type 2 diabetes than those who did not eat processed red meat.

Researchers said that the processed meat contain much higher salt and preservatives ( rather than fats) than unprocessed meat and this could explain the difference. They found the same even when lifestyle factors were taken into account and suggested that these types of meats should be studied separately in future research.

Source: "Red and Processed Meat Consumption and Risk of Incident Coronary Heart Disease, Stroke, and Diabetes Mellitus. A Systematic Review and Meta-Analysis". Circulation. 2010 Published online before print May 17, 2010 ( f/t via Athens)

Medical journals on Twitter

Twitter started as social networking or microblogging that combines blogging and instant messaging. Users can create a short message of up to 140 characters ( called “tweets”), send and receive updates from any computer or mobile devices with Internet access.

Tweets are instantly available to the “followers”, so it is a quick way of communicating with a group of people. Twitter has become a major distributor of timely information, particularly in the area of breaking news. The 1st reports of the crash of a US jetliner into the Hudson River in January 2009 were sent by witnesses on Twitter.

Many medical journals and organisations have started to use Twitter to disseminate information quickly to large groups of people.

For example - "Are probiotic drinks good for children? Looking at research we agree they may have small benefit for some illnesses " - was a tweet by NHS Choices

BMJ, The Lancet, NEJM, JAMA and many others also use Twitter to provide Table of Contents (TOC) service with links to the most current articles.

If you use Twitter to share medical information and opinion, beware of the issues of confidentiality.

Eating nuts may reduce cholesterol

Previous studies have shown that nut consumption reduces the risk of coronary heart disease, a new systematic review published in the May 10 issue of Archives of Internal Medicine found that diets rich in nuts were associated with reduced total cholesterol and bad cholesterol.


Researchers pooled data from 25 trials conducted in 7 countries that compared a control group to an experimental group assigned to consume nuts. An average of 67 grams of nuts per day were consumed over 3 to 8 weeks, they found that total cholesterol was reduced by 5.1% and bad cholesterol by 7.4%, but there was a lesser effect on reducing the cholesterol levels of people with higher BMIs.


Critics noted that the overall population of the studies was relatively small, the study results might have been affected by the different diets used in different studies. The experimental diet lasted only 3 to 8 weeks long, so it is not clear what effect it would have over the longer term. It is also unclear whether the reductions in cholesterol and LDL-cholesterol would be enough to lower the risk of coronary heart disease. Although nuts may reduce cholesterol, they are high in saturated fats and should be eaten in moderation.


Source: "Nut Consumption and Blood Lipid Levels - A Pooled Analysis of 25 Intervention Trials". Arch Intern Med. 2010;170(9):821-827. ( f/t via Athens)

Working overtime is bad for your heart

According to a study of 6000 British civil servants published online in the European Heart Journal, people who regularly work overtime have higher risk of developing coronary heart disease than those who do not.

The study involved over 6000 men and women aged between 39 and 61 who did not have heart disease and worked full time at the start of the study. Researchers found those who worked 3 to 4 hours of overtime a day had 60% higher risk of developing heart disease, overtime work was also associated with lower HDL cholesterol ( good cholesterol).

Experts said the study highlights the importance of work-life balance but note that the link was only found in association with 3-4 hours oertime a day. The lead researcher said more research is needed.

Source: Overtime work and incident coronary heart disease: the Whitehall II prospective cohort study. Eur Heart J (2010). First published online: May 11, 2010 ( f/t via Athens)

Vitamin A does not reduce maternal mortality

A new study, (Obaapa VitaA) in Ghana showed that vitamin A supplementation to women of child-bearing age in poor nations does not reduce maternal death rates. The Ghana findings contradicted previous results from a trial in Nepal which showed a 44% decrease in maternal death among women given vitamin A.

The researchers conducted a randomised and double-blind trial in 7 districts in the Brong Ahafo Region of Ghana. Participants were randomly assigned to vitamin A supplement or placebo capsule orally every week. They found that there was no statistically significant difference between the intervention and the control groups.

The author, Professor B Kirkwood at The London School of Hygiene and Tropical Medicine concluded that "the results of this trial in Ghana vindicate the decision not to change safe motherhood policy immediately after the Nepal trial."

Source: Betty R Kirkwood et al. Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial. The Lancet, 2010; 375(9726):1640-1649 ( f/t via Athens)

Virgin olive oil changes gene activity

Previous studies have shown a Mediterranean diet is associated with lower risks of all major diseases, but a small size study published in the open access journal BMC Genomics shed new light on how virgin olive oil influences certain genes that promote inflammation and can lead to heart disease.

Spanish researchers gave 20 volunteers with metabolic syndrome 2 breakfasts containing virgin olive oil with either high or low levels of phenols randomly on 2 separate days with a week apart. Both researchers and participants did not know who had received which breakfast. The researchers then measured the changes in the gene expression after the breakfasts and found that 39 genes are involved in the inflammation process (that has a role in the build-up of fatty deposits in the blood vessels ) and 35 of them were less active after eating the high-phenol virgin olive oil.

The researchers concluded that the study could partly explain why the risk in cardiovascular disease is reduced in Mediterranean countries where the diet is rich in virgin oliver oil.

Critics say that this study helps our understanding of the effect of olive oil on gene activity but it is difficult to confirm that the changes in gene activity is responsible for the reduction in risk of cardiovascular disease. The small size of the study, all participants with metabolic syndrome, gene expression after one meal and the lack of follow up for long-term outcomes are just some of the limitations that may affect the results of the study.

Source : Antonio Camargo, Juan Ruano, Juan M Fernandez, Laurence D Parnell, Anabel Jimenez, Monica Santos-Gonzalez, Carmen Marin, Pablo Perez-Martinez, Marino Uceda, Jose Lopez-Miranda and Francisco Perez-Jimenez. "Gene expression changes in mononuclear cells from patients with metabolic syndrome after acute intake of phenol-rich virgin olive oil". BMC Genomics, 2010

Too much added sugars may increase heart disease risk

A new JAMA study found that consuming a higher amount of added sugars in processed foods may increase cardiovascular disease risk factors.

The study analysed the US government nutritional data and blood lipid levels in more than 6000 adults and found that the highest consumption of added sugars was 46 teaspoons per day and the lowest was about 3 teaspoons daily. It also found that high consumption of added sugars was significantly correlated to lower levels of good cholesterol (high-density lipoprotein cholesterol, HDL-C) and higher levels of triglycerides, which are important risk factors for cardiovascular disease.

The authors said that this is the first study that examined the the association between added sugars consumption and lipid measures and found that total consumption of sugars in the US has substantially increased. People should cut down their added sugars consumption and further studies on the effect of reducing added sugars and other carbohydrates on lipid profiles are needed.

Source: J. A. Welsh, A. Sharma, J. L. Abramson, V. Vaccarino, C. Gillespie, M. B. Vos. "Caloric Sweetener Consumption and Dyslipidemia Among US Adults". JAMA 2010; 303 (15): 1490 (Full text via Athens)

Should aspirin be used for migraine relief?

A new Cochrane systematic review found that high dose aspirin can reduce migraine headache within 2 hours.


The review compared the use of aspirin to placebo or other migraine drugs including 13 studies and 4222 patients with migraine attacks. The amount of aspirin used in these studies varied between 900 - 1000 mg. Patients were randomly assigned to either a single dose of aspirin or a placebo or an active drug.

Researchers found that 24% of aspirin users were pain-free within 2 hours comapred to 11% of placebo users, aspirin also reduced the symptoms of nausea and vomiting, but aspirin plus antiemetic reduced these symptoms significantly compared with placebo. They concluded that 1000 mg of aspirin is effective for migraine relief, similar to the effect with sumatriptan.


Critics say that it is important to note that the over-the-counter standard aspirin is only 75mg and evidence has shown that regular use of aspirin may increase stomach problem or bleeding, taking high dose aspirin may increase these side effects. Also the effectiveness of aspirin may not apply to everyone as only a quarter of patients in these studies were pain-free after 2 hours.


Source : Kirthi V, Derry S, Moore RA, McQuay HJ. "Aspirin with or without an antiemetic for acute migraine headaches in adults (Review)". The Cochrane Library 2010, Issue 4

Do multivitamin tablets increase breast cancer risk?

Multivitamin supplements are widely used, but a large study involving 35,000 Swedish women aged 49 to 83 found that those who regularly took multivitamins had a higher risk of breast cancer than women who did not.


Based on self-reported questionnaire data, the researchers analysed the women's use of multivitamins as well as details about their health and lifestyle, followed up for 9.5 years until December 2007 to assess the cancer risk. They found that women who took multivitamins were 19% more likely to develop breast cancer than non-users. They also found that women who had taken these supplements for 3 years or more and those who took 7 or more pills a week were at increased risk of breast cancer than non-users, however the increase was very small.

The researchers concluded that "multivitamin use is associated with an increased risk of breast cancer" but they noted that other studies have had conflicting results. The authors said that this study carries an important public health message and recommend women to eat healthy diet instead of using supplements.

Critics say that this study was based on self-reported data that could affect the results. Further research is needed, it is not possible to say which of the supplements may contribute to breast cancer risk.

Source: "Multivitamin use and breast cancer incidence in a prospective cohort of Swedish women". American Journal of Clinical Nutrition, March 24 2010 (full text via Athens)

Brisk walking can reduce stroke risk in women

A large study published in Stroke found that women who walked two or more hours a week or walked briskly lowered the risk of stroke by more than a third.


The researchers followed nearly 40000 women aged over 44 for about 12 years to investigate the link between the levels of physical actitivity and the risk of having a stroke. The participants reported periodically on their physical activities via a questionnaire. 579 women had a stroke during the follow-up years.


The researchers said they have found a borderline significant link between the time spent on physical activities and stroke risk but they did not find a link between vigorous activity and reduced stroke risk. The lead author said the study was observational and physical activity was self-reported, further study is needed on more hemorrhagic strokes and with more ethnically diverse women.

Source: "Physical Activity and Risk of Stroke in Women". Stroke, published online April 2010 DOI

High GI food may increase women's heart risk

According to a study published in the Archives of Internal Medicine, consuming carbohydrates with high glycemic index (GI) such as white bread, sweets and sugary cereals appears to be associated with the risk of coronary heart disease in women but not men. However, not all carbohydrates have the same effect on blood glucose levels.

Italian researchers studied 47,749 adult men and women who completed dietary questinnaires. They found that women who consumed the most carbohydrates overall had approximately twice the risk of heart disease as those consumed the least. Women whose diet had the highest glycemic load had 2.24 times the risk of heart disease than those with the lowest glycemic load.

The researchers concluded "we tentatively suggest that the adverse effects of a high GI diet in women are medicated by sex-related differences in lipoprotein and glocuse metabolism" and that further studies are needed to verify the link between high-glucose foods and cardiovascular disease in men.

Source: "Dietary Glycemic Load and Index and Risk of Coronary Heart Disease in a Large Italian Cohort: The EPICOR Study". Arch Intern Med, 2010; 170 (7): 640-647

Maternal deaths drop worldwide

The Lancet published an article online on 12 April that has found significant decline in maternal deaths worldwide. This finding however is very different from a new UN study claiming that the number of women dying in childbirth remains high at 500,000 a year.

The Lancet study is based on the data collected from 181 countries between 1980 and 2008 provided by the Univeristy of Washington and found that maternal deaths have fallen from about 500,000(1980) to about 343,000 (2008). Many experts are surprised by the finding as they have assumed little progress made in this area.

According to the journal editor, The Lancet was pressured by some advocate groups to delay the publication of the new finding fearing loss of funding, but he said that the new data shows improvements and should encourage politicians to spend more on women's health.

Source: "Maternal mortality for 181 countries, 1980—2008: a systematic analysis of progress towards Millennium Development Goal 5". The Lancet, Early Online Publication, 12 April 2010

Should patients be given a voice in drug-safety reporting?

An oncologist, Ethan Basch, wrote in the March 11 issue of NEJM, that current clinician-based approach to adverse symptom reporting is based on clinicians’ impressions of patients’ symptoms, not on patients’ direct symptom reports. He said that evidence has shown that clinicians responsible for collecting and reporting adverse symptoms in clinical trials systematically downgrade the severity of patients’ symptoms and often miss the side effects, as a result vital information about drug safety is missing .

He argued that doctors, researchers and regulators should pay more attention to patients’ symptom reports while taking a drug because it could help identify symptoms earlier during a course of treatment and reduce preventable harm.

He said that technologies are now available for collecting information directly from patients and patients should be given the tools to self-report adverse symptoms in clinical trials such as online reporting between clinic visits, this can capture a lot of baseline symptoms before the drug is approved including those symptoms that researchers did not anticipate.

He concluded that “patient self-reporting would enhance the capture of subjective elements of safety information and patients are entitled to know the impressions of their peers”, such information would also help clinicians to evaluate the drugs.

Source: "The Missing Voice of Patients in Drug-Safety Reporting". NEJM 362(10):865-869 (full text via Athens)

Statins raise small diabetes risk

Statins have been used as cholesterol-lowering drugs to prevent heart attacks and strokes although trials of statins have produced conflicting results.

A new report based on a meta-analysis of 13 randomised controlled trials of statins between 1994 and 2009 involving 91,000 patients showed that there was a clear link between statin treatment and a small but significant increased risk of diabetes - 9% increase over 4 years in those using the drug than those without the treatment. The researchers said that the risk is very low and outweighed by the benefits of this drug and concluded that patients with moderate or high cardiovascular risk should not stop taking this drug.

Critics say this is a well-conducted review, when all the results were combined into a meta-analysis, the diabetes risk was relatively small, however various unidentified cofounding factors may have affected the observed results. The study was published in The Lancet online.

Source: "Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials". The Lancet, Early Online Publication, 17 February 2010

Can aspirin reduce breast cancer recurrence?

According to a new study published online in the Journal of Clinical Oncology, there was an association between frequent use of aspirin and lower risk of dying from cancer.

Researchers used survey data from US Nurses' Health Study to examine the effect of aspirin on breast cancer recurrence and survival including over 4000 nurses between 1980 and 2006. They found that women who took aspirin after finishing breast cancer treatment were half as likely to die from the disease compared with those who did not use aspirin regularly. However, the researchers pointed out that the participants were all nurses, the results may not be applied to the general population and they called for a randomised controlled trial to establish whether aspirin really caused the reduced risks they had found.

Previous studies on aspirin's anticancer effects have come to mixed conclusions, experts warned that patients should not start taking aspirin as there are risks associated with taking aspirin including bleeding and gastrointestinal complications.

Source: Holmes MD, Chen WY, Li L, et al. "Aspirin Intake and Survival After Breast Cancer". Journal of Clinical Oncology 2010 ( f/t via Athens)

Gastric banding achieved more weight loss in obese teens

According to a study published in the February 10 issue of JAMA, gastric banding achieved significant weight loss than lifestyle intervention in severely obese adolescents.


Australian researchers conducted a randomised controlled trial to compare the outcomes of gastric banding with a lifestyle program on adolescent obesity including 50 people aged between 14 and 18 with a BMI >35. The study, carried out between 2005 and 2008, was followed up for 2 years.


The researchers found that more than 50% weight loss was achieved by 84% in the gastric banding group compared with just 12% in the lifestyle group. The average weight loss was about 34 kg in the gastric banding group and only 3 kg in the lifestyle group. The differences between the 2 groups were significant for all weight measures at 24 months with 24 in the gastric banding group and 18 in the lifestyle group completed the study.


The authors concluded that "Among obese adolescent participants, use of gastric banding compared with lifestyle intervention resulted in a greater percentage achieving a loss of 50% of excess weight" and "There were associated benefits to health and quality of life".


Critics say there are limitations to the study including recruitment bias, small number of participants and short follow-up period. An accompanying editorial "Surgical Treatment of Obesity in Adolescence" notes that this study provides important evidence about the bebefits and risks of bariatric surgery.


Source:"Laparoscopic Adjustable Gastric Banding in Severely Obese Adolescents : A Randomized Trial" JAMA. 2010;303(6):519-526 (f/t via Athens)

Serotonin deficit may cause SIDS

A new study published in JAMA found that the brainstems of babies who have died from Sudden Infant Death Syndrome (SIDS) had lower level of serotonin than those babies who died from other causes. SIDS is still the leading cause of death in infants.

Previous studies had found that serotonin levels have been linked to SIDS, but this study sheds light on the defect in the infants' brain that might account for SIDS.

The researchers found that in 35 of the 41 SIDS babies, serotonin levels were 26 % lower than in those who died of other causes and levels of an enzyme that stimulates serotonin production were 22 % lower. Serotonin receptor was 50 % lower in SIDS babies.

Experts say that this is an important advance in the understanding of what's wrong with the brainstem of SIDS babies but there is still a long way to go to finding a detection test and then a treatment. The authors emphasized avoiding known risk factors such as bed sharing, soft bedding and smoking.

Source: "Brainstem Serotonergic Deficiency in Sudden Infant Death Syndrome" JAMA 2010;303(5):430-437. ( f/t via Athens)

The Lancet retracted the MMR and autism paper

The Lancet issued a press release on Tuesday 2 February 2010 following the GMC's decision on the paper by Wakefield et al in 1998 stating that several elements of the paper are incorrect. "In particular, the claims in the original papaer that children were consecutively referred and that investigations were approved by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record."


The study, published in The Lancet, claimed 8 of the 12 children showed signs of autism within days of receiving the MMR vaccine. The lead author, Andrew Wakefield, suggested that there might be a link between the vacciantion and autism. Although it was a very small study with only 12 children, the findings had caused a massive drop in the uptake of the MMR vaccine and sparked panic over the MMR vaccine around the world.


In the same issue of The Lancet, a commentary " Vaccine adverse events: causal or incidental?" written by 2 American vaccine specialists was also published. They pointed out that Wakefield's paper lacked epidemiological evidence to support the causal association with MMR vaccine and warned that such claim would cause confusion and fear among the media and the public. Unfortunately their message was not picked up by the media and the general public had little access to research articles.


The GMC found that Wakefield had no ethical approval nor relevant qualifications to carry out the tests on children. He also failed to declare that he had received money from a law firm representing the parents to carry out the research. Questions were raised on how Wakefield's research was scrutinised by the Royal Free and UCL Medical School where he worked at the time. A subsequent investigation by The Royal Free Hospital in 2004 reported that Wakefield's work on children was "appropriate". However, The Lancet issued a partial retraction of the interpretation from 10 of the 12 authors except Wakefield and one other author. See "The lessons of MMR" The Lancet, 363, 6 March 2004, pp 747–749 ( full text via Athens)

Some critics say the Lancet retraction is a bit too late while others say that the retraction will not change the situation as the MMR-autism debate continues.

See also: "The Lancet retracts controversial MMR research paper". Independent ,2 February 2010

Concerns raised on high prescription errors in children

A study, carried out in 2005 by the Univeristy of London involving a children's hospital, 3 general teaching hospital and 1 non-teaching hospital in London, looked at prescription errors given to children in hospital. The study was published in Archives of Disease in Childhood.


During the study, pharmacists found 391 prescription errors and 429 administration errors in the 3000 prescriptions they exmined over a 2-week period. Errors included incomplete prescriptions, wrong dose, how the drugs should be prepared or how they should given to the patients. One mistake was picked up by the nurse, on 5 occasions, the researchers intervened to prevent the patient suffering the harm.

The researchers believe that their findings show a general picture across Britain and still stand today. The author said prescribing for children is very difficult because most drugs are formualted for adults, doctors have to calculate the dose for children. Much more needs to be done to improve prescribing to children.


They call for better education for doctors on prescription skills and electronic prescribing to be introduced in hospitals. See also post on GMC study on prescription errors in hospitals.

Source: "Minimising medication errors in children”Archives of Disease in Childhood 2009 ;94:161-164