Thursday, December 09, 2010

Have you washed your hands - another study on patient safety

Since the report by the Institute of Medicine in 2000 that found high rates of medical mistakes in the US, most US hospitals had made efforts to improve patient safety. A new study, published in the NEJM found that patient harm in hospitals has not decreased over time!

Harvard researchers reviewed 2341 admission records obtained from 10 randomly selected hospitals in North Carolina between 2002 and 2007, they found 588 incidents of patient harm, ie 25.1 harms per 100 admissions, resulting from medical procedures, medications, or other causes.
The study found that infections was one of the most common complications, 42.7% required longer hospital stay for treatment, eg infected surgical incision. The types of patient harm varied widely and included falls, injury during surgery, low blood pressure and low blood sugar. Most of the complications were temporary and treatable, but 3% were permanent, eg brain damage from a stroke ( could have been prevented after an operation), 8.5% were life-threatening and 2.4% "caused or contributed to a patient's death."

The study's lead author, Dr. Christopher Landrigan, said "these harms are still very common, and there's no evidence that they're improving". Many of the problems were caused by the hospitals' failure to use protective measures that have been proven to improve care including computerizing patient records and drug prescription orders, using checklists for surgical procedures and other methods. He noted that the frequency of medical errors and injuries has been underestimated and there is a need for a mandatory monitoring system.

Some experts on hospital safety said heathcare providers should have a culture of strong communication and teamwork and it is essential that hospitals be more open about reporting problems. Some suggest that patients need cultural change too in ensuring their own safety, eg discussing about drug interactions with the doctor or asking if the doctor has washed his/her hands!

In the US, 27 state laws require public reporting of hospital-acquired infection rates. In 2005, all hospitals in New York were required by legislation to report hospital-acquired infections to the NY State Department of Health. In 2009, the NY Department of Health issued a state-wide report on hospital-by-hospital infection rates. They said that the information will help patients make more informed choices and allow hospitals to compare with other providers.

In the UK, despite promoting hand hygiene among staff, patients and visitors in NHS Trusts in England and Wales to reduce hospital acquired infections, infection rates and resulting harm are still very high.

In June 2010, the Health Secretary, Andrew Lansley, announced that as part of the new government's information revolution, infection figures for all hospitals in England will be published on a weekly basis from July on the government website . By making the data available to patients as well as hospital managers, he said people can make comparisons between different hospitals and healthcare organisations.

Have you washed your hands? Would you be offended if a patient or a colleague asks if you have washed your hands? What's your veiw?

Source : Temporal Trends in Rates of Patient Harm Resulting from Medical Care. N Engl J Med 2010; 363:2124-2134 ( full text via Athens )

Thursday, November 18, 2010

Antibiotics for pediatric ear infections - benefits and risks

Middle ear infections, known as acute otitis media (AOM), are the most common childhood illness in the US where antibiotics are routinely prescribed. According to a new study published in JAMA, using antibiotics to treat newly diagnosed acute ear infections among children is modestly more effective than no treatment, but causes adverse effects.


US researchers, requested by the American Academy of Pediatrics, to update practice guidelines for treating children's ear infections, reviewed 125 published previous on the effect of antibiotics and found that 80% of children with ear infections would recover within about 3 days without antibiotics. If all of the children were treated with antibiotics, an additional 12 would improve in 3 days, but 5 to 10% of the children would develop diarrhea.

They found no evidence that higher- priced antibiotics work better in general than generic ones and there is a wide variation in diagnosis and management of AOM, they suggested that using an otoscope may help improve the accuracy of diagnosis.

The authors concluded that doctors need to weigh the risks and benefits "before prescribing immediate antibiotics for uncomplicated AOM" and further research is needed.



Source: Diagnosis, Microbial Epidemiology, and Antibiotic Treatment of Acute Otitis Media in Children - A Systematic Review. JAMA. 2010;304(19):2161-2169. (f/t via Athens)

Wednesday, November 17, 2010

Do you need to find information for patients?

According to NHS Evidence, a recent research shows that 53% of professionals are most likely to be looking for patient information specifically when conducting a search for health and social care information.

NHS Evidence provides access to more than 8,000 pieces of accredited patient and public information including fact sheets, patient health questionnaires and guidance on conditions, treatment choices and support to help patints and carers make informed choices.

You can browse the leaflets by subject, alphabet or publisher and you can print them.

Tuesday, November 16, 2010

Using pre-surgery checklists can reduce medical errors

At the end of a long day, Dr David Ring, a hand surgeon at Massachusetts General Hospital, walked into the operating room and performed the last operation - he did a carpal-tunnel release on his trigger finger patient!

In an extraordinary open admssion of performing wrong surgery in this week's NEJM, Dr Ring said leading up to the wrong surgery were a series of events and mistakes that occurred during the course of the day, such as poor scheduling and staffing, the patient's left arm was marked at the wrist, not at the finger, and the marking was washed away etc.

Dr. Ring realized his error while dictating the report, and immediately notified both the hospital and the patient of the error. He performed the correct procedure that day without complication. However, the patient lost faith in him and sought treatment elsewhere. The hospital waived all her charges and paid a financial settlement shortly after the event.

Dr. Ring asked the case be presented at the departmental conference and published in the Case Records of the Massachusetts General Hospital because he wanted to encourage others to follow procedures that would prevent similar errors in the future. He said "I hope that none of you ever have to go through what my patient and I went through. I no longer see these protocols as a burden. That is the lesson." Dr Ring was praised for his courage by patient safety advocates and his counterparts.

In the same issue of the NEJM, a team of Dutch researchers published a study showing the dramatic effect of implementing surgical safety checklists in reducing surgical errors. Comparing hospitals that use pre-surgery checklists with those that do not, the researchers found that surgical complications fell dramatically from a level of 27% to just 17%. In- hospital mortality decreased from 1.5 to 0.8%, but the outcomes in the 5 control hospitals did not change.

In an accompanying editorial, the author said studies have shown the use of surgical checklists can have dramatic effect in reducing both complications and mortality and believed that they have "crossed the threshold from good idea to standard of care".

Studies have found that serious errors such as wrong-site surgery or wrong patient did occur, often due to simple mistakes or surgical team failing to perform pre-operation checks. Wrong-site surgery occurs in all surgical specialties, 68% of claims in the US related to orthopedic surgery. The American Academy of Orthopaedic Surgeons (AAOS) developed the "Sign Your Site" initiative in 1998 advising surgeons to mark the surgical site with their initials in order to avoid errors.

In the UK, more than 129,000 surgical incidents were reported to the National Patient Safety Agency (NPSA) in 2007. Over 1,000 resulted in severe harm and 271 death. The NPSA issued a patient safety alert in January 2009, requiring NHS organisations to implement the WHO Surgical Safety Checklist for every patient undergoing a surgical procedure. All hospitals in England and Wales must implement use of the Surgical Checklist by February 2010.

The checklist focuses on basic good practice before anaesthesia is administered, before a patient is cut open, and before a patient is removed from the operating theatre, and is designed to promote effective teamwork and prevent infection and unnecessary blood loss. NHS organisations can adapt it for their own use.

Source:
"Case 34-2010 — A 65-Year-Old Woman with an Incorrect Operation on the Left Hand". NEJM 2010; vol 11, 363:1950-1957 ( full text via Athens )

"Effect of a Comprehensive Surgical Safety System on Patient Outcomes". NEJM 2010; vol 11, 363:1928-1937 ( Netherlands trial, full text via Athens)

Editorial : "Strategies for Improving Surgical Quality — Checklists and Beyond". NEJM 2010; vol 11, 363:1963-1965 ( full text via Athens)

Tuesday, November 09, 2010

Could stronger statins save lives?

Statin is one of the world's biggest selling drug for lowering LDL cholesterol, a new research suggests using more potent doses of statin could prevent thousands more heart attacks and strokes.


40,000 high-risk patients were assessed for major vascular events after one year of randomisation to either regular or intensive treatment statin. The results, published in The Lancet, found that stronger treatments reduced major heart attacks and strokes by 15%. This included a 13% cut in heart-related death or non-fatal heart attacks, a 19% drop in bypass and other coronary treatments, and a 16% drop in strokes.

However, the study warned that simply raising the dose of simvastain might lead to health problem as muscle weakness and muscle damage are some of the known side effects.

Source: "Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12 064 survivors of myocardial infarction: a double-blind randomised trial". The Lancet, Early Online Publication, 9 November 2010 (full text via Athens)

Monday, November 08, 2010

Does vitamin E increase stroke risk?

Previous studies suggested taking vitamin E can protect the heart from coronary heart disease, but a BMJ study found that taking vitamin E could slightly increase the risk of haemorrhagic stroke - bleeding in the brain. Stroke is the third biggest cause of death in the UK

Researchers identified 9 studies with about 119,000 people randomised either to vitamin E or placebo on the outcome of stroke. They found that vitamin E increased the risk of haemorrhagic stroke by 22%, also found that vitamin E reduced the risk of ischaemic stroke by 10%. Given the small reduction in the risk of ischaemic stroke is exceeded by the incraese in the risk of haemorrhagic stroke, the researchers concluded that the widespread use of vitamin E should be avoided.

Critics say the findings are of small statistical significance, more research is needed to determine the level of Vitamin E that can become harmful. They "urge people to maintain a lifestyle of a balanced diet, regular exercise and monitoring their blood pressure to reduce their risk of a stroke."

Source: "Effects of vitamin E on stroke subtypes: meta-analysis of randomised controlled trials". BMJ 2010; 341:c5702 (Published 4 November 2010) free f/t.

Alcohol is more harmful than heroin or crack cocaine

A new study, published in the Lancet, found that alcohol is the most harmful drug above heroin and crack cocaine based on harm caused to the user and others.

The investigation was led by David Nutt, former government drugs adviser sacked after criticising government policies on cannabis. The team reviewed a range of drug harms using the multicriteria decision analysis modelling, drugs were scored with 100 being the most harmful and 0 being no harm at all. They found that overall alcohol scored 72, heroin 55 and crack cocaine 54. The authors said "the present drug classification systems have little relation to the evidence of harm" and that the findings showed that ‘aggressively targeting alcohol harms is a valid and necessary public health strategy."

Some newspapers reported the DH said it is determined to prevent alcohol abuse without disadvantaging those who drink sensibly.

In an accompanying commentary, "Ranking of drugs: a more balanced risk-assessment" The Lancet, 376(9752): 1524-25, the Dutch experts said "the new data provide a valuable contribution for the re-evaluation of current drug classification in the UK", but the study did not address the polydrug use which can make some drugs much more dangerous. However this was outside the scope of the study.

Source: Drug harms in the UK: a multicriteria decision analysis. The Lancet 376(9752):1558-1565 ( full text va Athens)

Thursday, October 14, 2010

Tips on MRCP, PACES, MRCGP exams

The following "The way I see it" articles published in BMJ Careers may be of interest to those who are preparing for the MRCP, FACES, MRCGP exams.

"When should I sit the MRCP?" - a consultant nephrologist suggested that taking the exams early has competitive advantage.

"Taking the MRCP early on" - a founadtion doctor thought that taking the exam early will help stand out from the crowd and has many advantages.

"Passing the MRCP written papers" - a SpR gave useful tips on passing the exam.


"The new MRCP PACES station 5" - 2 SpRs wrote about the changes and format of the new station 5 and offered advice on how to prepare for the exam - "the key is timing and maintaing professional behaviour throughout."

"Passing PACES" - a SpR offered Dos and Don'ts to help you "don't fall at the final hurdle - the PACES exam".

"MRCGP applied knowledge test" - a GP trainee offered advice on preparing for the new MRCGP AKT.

See also previous post on Passing postgraduate exam techniques

Share your views and experience to help others better prepare for the exams! If you like to add more information on this topic, click on "comment" and "send."






Friday, October 08, 2010

Is light drinking during pregnancy safe?

The finding from a UCL study suggesting that a glass of wine a week during pregnancy will not harm your child's development has caused controversy but the lead author said that the more the social factors were taken into account, the weaker the association became.


The study involved over 11,000 women who were asked about their drinking habits and their child's development until they were 5 years old. They found that children born to light drinkers were 30% less likely to have behavioural problems and achieve higher scores on cognitive tests than those whose mothers did not drink during pregnancy.

Some experts said that the study was flawed because it only looked at children up to the age of 5. The Dep of Health said "After assessing the available evidence, we cannot say with confidence that drinking during pregnancy is safe and will not harm your baby...... Our advice to pregnant women and women trying to conceive is to avoid alcohol", reported in the Telegraph.

An US alcohol epidemiologist said that alcohol is the leading fetal neurotoxin in the world, there is no safe amount of alcohol a pregnant woman can drink based on the evidence that alcohol kills brain cells in the developing fetus, reported in White Coat Note.

So the debate goes on.

Source: Light drinking during pregnancy: still no increased risk for socioemotional difficulties or cognitive deficits at 5 years of age? Journal of Epidemiology and Community Health 2010, October


Mild Alzheimer's patients to get treatment on NHS

BBC News reported that following a U-turn by the health watchdog, patients in the early stages of Alzheimer's disease could get drug treatments that were previously only available to patients with more advanced cases.

NICE has now given new draft guidance for the treatment of Alzheimer's disease that people with mild symptoms should also get the drugs and recommends a 4th drug, Ebixa, for patients with severe Alzheimer's. The final decision will be made later this year.

Latest data shows that about 380,000 people in England and Wales have Alzheimer's and more than 50% are estimated to have mild to moderately severe disease.

Wednesday, October 06, 2010

Hands-only CPR saves more lives

According to a study published in JAMA this week, hands-only CPR saves more lives in cardiac arrests.

Out of hospital cardiac arrest is a major public health problem in the US, in 2005, Arizona launched a programme to encourage the public to use compression-only CPR (COCPR) to improve survival.

The study included 2900 patients who received no bystander CPR, 666 conventional CPR and 849 COCPR. The researchers found that "among patients who received bystander CPR, the proportion with COCPR increased significantly over time, from 19.6% in 2005 to 75.9% in 2009", COPR was associated with a 60% improved odds of survival comapred with no bystander CPR or conventional CPR. The authors said that COPR has the advantage of minimizing interruptions in chest compressions during CPR.

In an accompanying editorial, the author said that the findings should encourage continuing investigations into the compressio-only CPR method. "Healthcare professionals involved in resuscitation should look to new Guidelines 2010 dodcuments for the international consensus on the science of compression-only CPR ........ to encourage the general public to learn this simple and potentially lifesaving skills".


However, a Lancet article published in April 2010 (17;375(9723):1347-54. Epub 2010 Mar 2. )states that "for children who have out-of-hospital cardiac arrests from non-cardiac causes, conventional CPR by bystander is the preferable approach to resuscitation. For arrests of cardiac causes, either conventional or compression-only CPR is similarly effective".


The 2010 Resuscitation guidelines will be available at Resuscitation Council (UK) website on 18 October 2010.

Source : Chest Compression–Only CPR by Lay Rescuers and Survival From Out-of-Hospital Cardiac Arrest. JAMA. 2010;304(13):1447-1454. doi:10.1001/jama.2010.1392 (f/t via Athens)

Editorial : Compression-Only CPR . JAMA. 2010;304(13):1493-1495. doi:10.1001/jama.2010.1420 (f/t via Athens)

Want to be happy?

A popular theroy of happiness states that happiness is 50% genetic but a new study finds that the choices you make in life can equally affect long-term happiness.

The findings are based on the data collected from a 25-year study on 60,000 Germans from 1984 to 2008. The researchers found that choices relating to partner, balance between work and leisure, participation in social activities and healthy lifestyle are key factors in determining satisfaction in life. For example, the findings show that having neurotic partners significantly reduce life happiness. People who prioritise altruistic and family goals are happier than those who prioritise career and material success. Church attendance, getting involved in social and community events and regular exercises are equally important in affecting happiness.

The authors says the study is the most extensive of its kind and a breakthrough in psychological research. They concluded that life happiness is chosen not predetermined, it has a lot to do with life choices and people can change their life goals. Although the study was based on Germans, the findings can also be applied in other parts of the world. The study is published in Proceedings of the National Academy of Sciences (PNAS).

Source: Long-running German panel survey shows that personal and economic choices, not just genes, matter for happiness. PNAS. doi: 10.1073/pnas.1008612107 . Published online before print October 4, 2010, free open access article

Tuesday, October 05, 2010

Look AHEAD trial - lifestyle intervention for diabetes

Following the Avandia scandal in July 2010, the European Medicines Agency (EMA) on 23 Sept recommended the suspension of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, they will be banned in Europe within the next few months. At the same time, the US government put toughened resrictions on the use of the drug. Critics say these "decisions will virtually eliminate use of the drug around the world".

According to a new study published in the Archives of Internal Medicine, 27 September, lifestyle interventions are recommended to improve glycemic control and risk factors in type 2 diabetes to prevent long-term complications, but the evidence of their efficacy is limited to short-term studies.

The authors said that the Look AHEAD study, a 4-year non-drug approach using intensive lifestyle interventions helped reduce cardiovascular risk factors in type 2 diabetics. The trial randomized 5145 patients with type 2 diabetes to following an intensive lifestyle- intervention program or to receive standard diabetes support and education. The intensive program including a combination of diet modification and physical exercises, with training and group support, was designed to achieve 7% weight loss in the first year and to maintain the weight in subsequent years.

After 4 years, the intensive intervention group maintained a weight loss of 6.15% of their weight compared with 0.88 % in the standard support group. They also experienced greater improvements in fitness, blood sugar, blood pressure, triglycerides and good cholesterol. The standard group had lower levels of bad cholesterol.

The authors said that the result indicated that the intensive intervention group had been exposed to lower cardiovascular disease risk factors during the trial, although it would be too early to say that intensive intervention can prevent heart attacks, there may be long-term benefits from the 4-year period. The study is continuing for several more years.

Should we look beyond Avandia and other drugs for diabetes treatment and invest in more preventive efforts?

Source: Long-term Effects of a Lifestyle Intervention on Weight and Cardiovascular Risk Factors in Individuals With Type 2 Diabetes Mellitus - Four-Year Results of the Look AHEAD Trial. The Look AHEAD Research Group. Arch Intern Med. 2010;170(17):1566-1575. (f/t via Athens)

Wednesday, September 22, 2010

Less invasive cancer surgery is safe and effective

In most cancer patients, axillary-lymph-node dissection (ALND) involves the removal of most of the lymph nodes in the underarm region to improve the chances of survuval, but sometimes it causes damages to the patients' arm and shoulder.

American scientists found that sentinel-lymph-node surgery (SLN), a less invasive technique that only removes the sentinel nodes, the ones closest to the breast, is safe and effective.


5,611 American women whose breast cancer did not appear to have spread to their lymph nodes were recruited to assess their differences in survival rates between the 2 types of surgery. Half of the patients had ALND surgery to remove all of the lymph nodes in the underarm area, while the other half had SLN surgery to remove the sentinel lymph nodes only. Patients were tracked over the next eight years.

The researchers found no significant differences in the patients' survival rates between the two groups. Patients who underwent the SLN procedure were less likely to experience arm problems or lymphoedema (chronic swelling of the arm). The authors concluded that "SLN surgery alone with no further ALND is an appropriate, safe, and effective therapy for breast cancer patients with clinically negative lymph nodes" and that SLN surgery "represents the next major step in reducing the extent of surgical procedures to treat breast cancer".

An accompanying comment said that the paper "vindicates contemporary practice of SLN biopsy and provides support for a reduction in extent of axillary surgery for most patients with breast cancer".


Source: Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncology, 11(10):927 - 933. Published Online: 21 September 2010 (f/t via Athens)

Monday, September 20, 2010

Is glucosamine effective in reducing OA joint pain?

A BMJ study found that 2 popular supplements, glucosamine, chondroitin and their combination are no better than placebo at reducing joint pain.

The study, funded by the Swiss National Science Foundation, was a meta-analysis based on 10 randomised controlled trials with more than 3800 patients with hip or knee osteoarthritis treated with either glucosamine, chondroitin or both, followed up for 1 to 36 months. The outcome measures were pain intensity and joint structure. The analysis of data was by network meta-analysis, a relatively new statistical technique.

The researchers found that all these 2 supplements have been prescribed by GPs and rheumatologists and used widely by patients for treating osteoarthritis (OA), their study showed that glucosamine, chondroitin and their combination do not have a useful clinical effect in treating osteoarthritis. They wrote "we believe it unlikely that future trials will show a clinically relevant benefit of any of the evaluated preparations".

Critics say that the study results may be biased by the heterogeneity of the varying studies included and the network meta-analysis it used to do the calculation. Furthermore, the small size of the trials could also have large effect on the overall results.

Some patients, based on their own experience, are convinced that these supplemnets are beneficial and have written to the BMJ in response to the findings, some doctors pointed out that glucosamine has 2 different formulation, the favourable response of glucosamine to knee OA involves glucosamine sulphate not hydrochloride and that many of the recommendations of use of glucosamine are on knee OA not hip, but the study included both knee and hip OA in the analysis.

It was also noted that the conclusion of the study on the efficacy of glucosamine on knee OA is questionable because it does not include the data of the LEGS trial which investigates glucosamine sulphate in knee OA, the study is yet to be completed.

Source:

1). Wandel S, Jüni P, Tendal B et al. Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: network meta-analysis. BMJ 2010; 341:c4675 ( f/t via Athens)

2). The Long-term Evaluation of Glucosamine Sulphate Study (LEGS) - study to be completed in October 2011






Revised UK guidelines for melanoma 2010

According to Cancer Research UK, the latest statistics show that 5,697 cases of malignant melanoma were diagnosed in women and 4,975 in men in the UK in 2007. If melanoma is diagnosed early, the survival statistics are very good.

Many guidelines have been drawn up by various groups and professional bodies to promote good standards of care. Last month, the British Journal of Dermatology published revised consensus guidelines for treatment and a brief overview of epidemiology, diagnosis, investigation and follow up.

The guidelines were drawn up by a multidisciplinary working party with representatives from various groups or organisations in the UK. Levels of evidence to support the guidelines are given, but the authors said that care should be individualized wherever appropriate. Where no level of evidence is quoted, it is regarded as a consensus statement, represented level IV.

Summary of the guidelines:
  • Melanoma patients who must be referred from the local skin cancer multidisciplinary team to specialist skin cancer multidisciplinary team
  • Recommendations for local skin cancer team record keeping of clinical features
  • Recommendations for sscreening and surveillance of high-risk individuals
  • Requirements for microscopy of melanoma
  • Surgical wider excision margins for primary melanoma
  • Staging investigations for melanoma
  • Recommendations for the management of clinically node-negative patients
  • Recommendations for locoregional recurrent melanoma
  • Recommendations for metastatic disease
  • Pregnancy, oral contraceptives and HRT
  • Follow up of melanoma patients
Source:
"Revised U.K. guidelines for the management of cutaneous melanoma 2010". Published in the British Journal of Dermatology, August 2010 Vol. 163, PP.238-256. Free full text


Thursday, September 16, 2010

Low-carb diet rich in meat may may cause higher health risks

Studies show that a low-carbohydrate diet produces weight loss and improves some cardiovascular risk factors, but there has been concern about the Atkin-type low-carb diet that is based on animal fat and animal protein.

Harvard reserachers examined 2 types of low-carb diets in relation to long-term health impact. They examined the data of 2 prospective cohort studies involving 85,168 women for 26 years and 44,548 men 20 yaers on a low-carbohydrate diet, either an animal-based or a vegetable-based low-carbohydrate diet. Diet was assessed via a questionnaire.

The researchers found that animal-based low-carb diets were associated with higher all-cause mortality in both men and women. A vegetable-based low-carbohydrate diet was associated with lower all-cause and cardiovascular disease mortality rates. They said the results suggest that the health effects of a low-carb diet may depend on the type of protein and fat. The mixed effects on lipid profiles may have been due to the varying amount of plant or animal fat consumed in low-carb diets.

An accompanying editorial cautioned the interpretation of this study saying that it "addresses a critical, unresolved public health question of diet but cannot satisfy us with a definitive answer", a large- scale randomised clinical trial with meaningful clinical endpoints is needed.

Source: Low-Carbohydrate Diets and All-Cause and Cause-Specific Mortality - Two Cohort Studies. Annals of Internal Medicine. September 7, 2010 vol. 153 no. 5 289-298 (f/t via Athens)

Thursday, September 09, 2010

Should I take vitamin B supplements for mild memory problems?

Oxford scientists investigated the effects of vitamin B on brain atropy ( the loss of neurones and their connections) in people with mild memory problems. Studies have found that high levels of homocysteine (tHcy), an amino acid in the blood, affect the rate of brain atropy and that raised levels of tHcy increase the risk of Alzheimer's disease.

168 elderly people with mild cognitive impairment but not taking anti-dementia drugs were recruited in the Oxford area. Both the volunteers and researchers were unaware of the treatment received, either high dose of vitamin B tablets ( a combination of folic acid, B12 and B6) or placebo pills for a 2 year period.

The researchers found that taking B vitamins for 24 months led to brain shrinkage and the rate of shrinkage in the treatment group was 30% less than the placebo group. They concluded that a simple and safe treatment can slow down the rate of brain atropy in people with mild cognitive impairment. The study was published in PLoS One, a peer-reviewed journal. A study published in 2008 in JAMA showed conflicting results.

Critics say that this is well-conducted randomised controlled trial with promising results. However the evidence did not show brain shinkage may lead to improvement in symptoms or that the B vitamins can prevent Alzheimer's disease, but warrant more research.

Source: David Smith A, Smith SM, de Jager CA et al. Homocysteine-Lowering by B Vitamins Slows the Rate of Accelerated Brain Atrophy in Mild Cognitive Impairment: A Randomized Controlled Trial. PLoS One 5(9): e12244

The Avandia scandal

An investigation by the BMJ published this week calls for the withdrawal of the daibetes drug, Avandia, immediately from the market because of the concerns that it may increase the risk of myocardial infarction and the paucity of good evidence to support its use.

Rosiglitazone, also known as Avandia, was GSK's second biggest selling drug, introduced in 1999 and is widely used to lower blood glucose levels in patients with type 2 diabetes. It was approved by the EMA in 2000 despite concerns over its safety.

In 2007, several studies found Avandia having harmful effects and issued serious health warnings. The researchers questioned why Avandia is still available on the market and why physicians would prescribe it to diabetic patients when there are other drugs without these side effects. They called for Avandia to be withdrawn from the market. Since then, the sales of Avandia fell sharply.

The BMJ investigators found that in July, the UK Commission on Human Medicines advised the MHRA to withdraw Avandia as the risks of Rosiglitazone outweigh its benefits. This has raised a lot of questions about the quality of the data used in the studies and the lack of trial results made available to the public. The investigators also ask why the regulators accept such poor evidence on benefit and safety, why patients in the UK and Europe are not make aware of the concerns about this drug and whether the current regulatory body is doing its job properly. They said that doctors are advising that no new patients shoud use this drug, existing diabetic patients should review their options and those at high risk of heart disease should stop taking it.

In the accompanying editorial, the authors said that clinicians had focused on the wrong endpoint and lost sight of the main reason for treating this disease, "which is not to reduce glycaemia but to prevent complications". They went on to say that clinicians need to be "absolutely certain that the long term treatment for type 2 diabetes are not causing the harm they are meant to prevent" and should insist on robust evidence of benefits and harms.

Professor Freemantle noted in the accompanying commentary that the Avandia studies were hindered by inadequate data due to high levels of loss to follow-up. He wrote "In order to learn from our mistakes, we must improve the quality of safety data from clincal trials on all new healthcare interventions, not just antidiabetic drugs" and an overhall in the standards of regulatory trials is needed.


Sources : free f/t
Rosiglitazone: what went wrong? BMJ 2010; 341:c4848 (Published 6 September 2010) Editorial - Licensing drugs for diabetes BMJ 2010; 341:c4805 (Published 6 September 2010)
Commentary: What can we learn from the continuing regulatory focus on the thiazolidinediones?BMJ 2010; 341:c4812 (Published 6 September 2010)

Friday, August 20, 2010

Is chocolate good for the heart?

Previous studies have shown that chocolate can reduce blood presure, a strong risk factor for heart failure. Harvard reserachers carried out a large prospective cohort study, including more than 39,000 Swedish women, investigating if chocolate intake is linked to the risk of heart failure.


The data were obtained from a questionnaire on health and lifestyle including details about diet and chocolate intake. After 9 years follow up, the researchers found that women who ate 1 - 2 servings a week or 1 -3 servings a month had lower risk of hear failure than those who ate 3 or more servings a week. They suggest that flavenoids in chocolate may have a beneficial effect on cardiovascular risk factor.


Critics said that the study relied on participants self-reporting of their chocolate intake, it is also unclear how much chocolate was consumed in one "serving". Although this was a large study, it is felt that the evidence was not strong enough to tell if chocolate reduces the risk of heart failure. Furthermore, flavenoids in chocolate can be found in fruit and vegetables.


Source: Mostofsky E, Levitan EB, Wolk A, et al. Chocolate Intake and Incidence of Heart Failure: A Population-Based, Prospective Study of Middle-Aged and Elderly Women. Circulation: Heart failure 2010; Published online before print August 16 ( f/t via Athens)