Heart attacks 'worse in the morning'

?Heart attacks are far more dangerous in the mornings than at any other time of the day,? reported the Daily Mail. It said that patients who had an attack between 6am and midday suffered a fifth more damage to their heart muscle compared with those who had a heart attack later on.

The story comes from a study of more than 800 heart attack patients, examining the possible association between the time of day that heart attacks happen and the levels of two enzymes in the blood. These enzymes are markers of damage to the heart tissue, and higher levels indicate larger areas of damage.

Patients who had a heart attack between 6am and noon were found to have higher blood levels of these enzymes than those who had heart attacks later in the day, with increases in peak levels of 18.3% and 24.6%. The researchers suggest that these patients had significantly larger heart attacks than those whose heart attacks occurred at other times of the day.

The study was well-conducted and its findings add to what is known about circadian rhythms (the body?s internal 24-hour cycle) and heart risk. The study has several factors that limit its interpretation, however, including the use of a surrogate marker for damage to the heart (enzyme levels), rather than looking at heart damage directly. There may also have been other factors affecting how much damage took place, for example, how quickly people received treatment due to the time of day of their attack.

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Where did the story come from?

The study was carried out by researchers from the Hospital Clinico San Carlos and the Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), both in Madrid, Spain. There is no report of external funding.

Coverage in the media was generally accurate, although there was little reporting of the study?s limitations. Reports that patients who have heart attacks between 6am and noon suffer one-fifth more damage to their heart muscle comes from an estimate by the researchers, rather than directly from the study results.

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What kind of research was this?

The aim of this study was to investigate whether the time of day affected the severity of damage caused by a type of heart attack called ST segment elevation myocardial infarction (STEMI). This was a retrospective cross-sectional analysis of 811 STEMI patients admitted to hospital between 2003 and 2009. This type of heart attack is caused by a prolonged blockage of blood supply to the coronary artery and usually causes large areas of damage to the heart muscle.

The researchers point out that the circadian clock (the body?s internal 24-hour cycle) is known to influence a number of cardiovascular factors, including blood pressure and heart rate, and that heart attacks peak in incidence during the early morning hours. As yet, little research has been carried out in patients to look at whether the degree of damage caused by a heart attack is affected by the time of day it occurs.

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What did the research involve?

Researchers looked at the data on 811 patients who were admitted to hospital between 2003 and 2009 with a STEMI, as defined in current clinical practice guidelines. They obtained information on the time of onset of symptoms from patients? medical histories, the site of the STEMI (divided into those in the heart?s anterior wall and other locations) and the levels of creatine kinase (CK) and troponin I (TnI), measured on admission and then every four hours. These two enzymes are chemical markers for damage to the heart tissue (infarct) and higher levels of enzymes indicate greater damage.

The researchers divided the 24-hour clock into four equal periods, in phase with circadian rhythms. These were midnight to 6am, 6am to noon (dark-to-light transition), noon to 6pm and 6pm to midnight. The time of day that patients had a heart attack was categorised into one of these four periods. Standard statistical methods were used to assess whether there was a relationship between peak enzyme levels in the blood and the time heart attacks occurred. The results were also adjusted for other factors that could affect the size of someone?s heart attack, such as the presence of diabetes, history of hypertension and the time of year it happened.

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What were the basic results?

The researchers say they found a ?circadian variation? in the extent of the damage to heart tissue, as measured by peak levels of the two enzymes, CK and TnI.

• They report that the ?curves? of both CK and TnI showed similar patterns across time, with a maximum in patients who had heart attacks in the 6am to noon period and a minimum in patients who had heart attacks in the noon to 6pm period.
• The amount of damage to heart tissue (the infarct), as measured by CK and Tnl levels, was largest in patients who had a heart attack between 6am and noon. These people had CK concentrations in their blood that were 18.3% higher than those who had attacks between 6pm and midnight, and Tnl readings that were 24.6% higher for the same period.
• Patients with anterior wall STEMI had significantly more damage than those with STEMI in other parts of the heart.

In their conclusion, the researchers say that, overall, there is an expected increase of about 20% in the size of infarct in patients with STEMI during the dark-to-light transition period, compared with any other time of day.

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How did the researchers interpret the results?

The researchers say that the amount of damage caused by heart attacks, as measured by their enzyme levels, was significantly larger in patients who had a heart attack between 6am and noon, than at other times of the day.

They say that, although the reason is not fully understood, it may be due to natural changes in the body during the 24-hour period, so that at certain times there is less ?cardioprotection?. For example, circadian variations in heart rate, blood pressure and coronary flow may all be involved.

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Conclusion

This study was well-conducted and its findings add to what is known about circadian rhythms and heart risk. As the researchers themselves point out, it also has several limitations.

• The analysis was retrospective, meaning that it used data from patients who had had heart attacks in the past. Retrospective studies are considered less reliable than those that follow people over time.
• The researchers used a surrogate marker of heart damage (enzyme levels), rather than looking at damage to the heart directly, for example by using MRI scans.
• The results may have been affected by ?survivor bias?, as it is known that the incidence of irregular heartbeats and sudden death are higher in the early morning hours, so by only analysing those who were alive, the researchers may have missed from their analysis some of the largest heart attacks, i.e. those that led to death.
• Although the researchers tried to adjust their findings for possible confounders it is still possible that factors other than the time of day or night they occurred influenced the size of people?s heart attacks. It is also possible that some people got to the hospital and were treated more quickly than others due to the time of day, which would have had an influence on the results.

As experts are reported as saying, whatever time of day a heart attack happens, the more quickly someone is treated, the less damage to the heart they will have. Anyone who experiences heart attack symptoms or observes them in someone else should call 999 immediately.

Links To The Headlines

Morning heart attacks cause more damage.�The Independent, April 28 2011

Morning heart attacks 'are a fifth more severe than later in the day'.�Daily Mail, April 28 2011

Heart attacks 'are worse' if they happen in the morning.�BBC News, April 28 2011�

Links To Science

Su�rez-Barrientos A, L�pez-Romero P, Vivas D, et al.�Circadian variations of infarct size in acute myocardial infarction. Heart 2011, Published Online First April 27

Source: http://www.nhs.uk/news/2010/04April/Pages/heart-attacks-worse-in-the-morning.aspx

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Pelvic Laparoscopy

Has you doctor told you that you need a laparoscopy? Laparoscopy is a minimally invasive surgical technique used in procedures such as tubal ligation, gallbladder removal or hiatal hernia repair. It is normally performed in the outpatient surgery unit of a hospital. In most cases, patients can return home a few hours after a laparoscopic procedure. Learn more about the laparoscopy procedure.

Have you had a pelvic laparoscopy? Share your comments!

Source: http://womenshealth.about.com/b/2011/03/21/pelvic-laparoscopy.htm

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Body shape 'increases heart risk'

?People with coronary artery disease have an increased risk of death if they have fat around the waist,? BBC News has reported.

This news story is based on a systematic review that combined five observational studies�which looked at different measures of obesity (BMI, waist circumference and waist-hip ratio) and the risk of mortality in almost 16,000 people with coronary artery disease. The research found that total weight measured by BMI was not associated with an increased risk of dying over the average 2.3-year study follow-up, but did find that storing fat around the waist increased the risk of death, even in people within a normal weight range.

This research is in keeping with advice that people should try to maintain a healthy weight, but it raises the question of whether weight around the middle ? the apple shape ? poses a particular risk. It also adds to the debate over whether waist-hip ratio and waist circumference are of equal, or possibly greater, importance than BMI ? an unresolved issue that has been examined by numerous pieces of past research.

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Where did the story come from?

The study was carried out by researchers from the Mayo Clinic in the US. No sources of external funding were reported. The study was published in the peer-reviewed Journal of the American College of Cardiology.

This study was reported accurately by the BBC News.

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What kind of research was this?

This systematic review assessed which measures of obesity most accurately predicted survival rates in people with coronary artery disease.

Obesity is associated with increased risk of cardiovascular death, as well as of death due to other causes in the general population. There are various ways in which obesity is measured, including the body mass index (BMI), waist circumference (WC) and waist-hip ratio (WHR), which may better describe body fat distribution.

The researchers say that although obesity has been found to be associated with the risk of developing coronary artery disease (CAD), some studies have reported that lower BMI is associated with a higher risk of dying from CAD. This is known as the ?obesity paradox?, and has largely been attributed to residual confounders (where other factors have contributed to the increased risk of death from CAD in thinner individuals).

The researchers were interested in how the risk of death from CAD is associated with WC and WHR, as these may be better indicators of ?central obesity? (fat around the middle of the body) than BMI.

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What did the research involve?

The researchers searched various scientific and medical databases for entries between 1980 and� 2008 that reported the association of either WC or WHR with mortality in patients who had established CAD.

The researchers looked at data from prospective cohort studies that had measured the WC or WHR of people with CAD and followed participants for at least six months. They also looked at studies where the risk of mortality during follow-up had been calculated using these obesity measurements.

The researchers pooled the data from five studies in order to calculate the risks of CAD associated with increased WC or WHR.

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What were the basic results?

Of the five included studies, three had information on both WC and WHR, one measured WC only, and one measured WHR only. In the pooled analysis, there were 14,282 participants for which WC data was available and 12,835 subjects in which WHR data was available. In total, data was available for 15,923 participants.

The average age of all participants was 66 years, and 59% of them were men. Out of the 15,923 participants 6,648 were normal weight (BMI 18.5 to 24.9), 6,879 were overweight (BMI 25 to 29.9) and 2,396 were obese with a BMI of over 30.

On average, the participants were followed for 2.3 years, during which time there were 5,696 deaths.

The researchers looked at the range of values in the three measurements and divided the participants into three groups based on their WC, WHR and BMI, grouping them into the highest third, middle third and lowest third categories.

In men the cut-offs were:

• WC: lowest third below 89cm, second third over 89cm, highest third over 99cm
• WHR: lowest third below 0.94, second third over 0.94, highest third over 0.98
• BMI (kg/m2): lowest third below 24.1, second third over 24.1, highest third over 27.1

In women the cut-offs were:

• WC: lowest third below 84cm, second third over 84cm, highest third over 96cm
• WHR: lowest third below 0.86, second third over 0.86, highest third over 0.93
• BMI: lowest third below 23.7, second third over 23.7, highest third over 27.9

The researchers adjusted the participants? data for age, gender smoking, diabetes, high blood pressure, heart failure and BMI. They found there was an association between having a WHR or WC in the highest or middle third and an increased risk of death compared to those people whose measurements were in the lowest third:

• highest WHR had a 69% increased risk (hazard ratio [HR] 1.69, 95% confidence interval [CI] 1.55 to 1.84)
• highest WC had a 29% increased risk (HR 1.29, 95% CI 1.20 to 1.39)

However, similar to the findings of some previous research studies, they found that the risk of death decreased with increasing BMI.

The researchers combined the WHR and WC data into a measure of ?central obesity? and found that people who were in the top two-thirds of carrying fat around their middles, had a 30.8% increased risk of mortality (43.2% in women, 19.4% in men). They also looked at participants who were of normal weight but carried more weight around their middle. They found that the risk of mortality associated with central obesity was 33.1% (61.5% for women and 19.9% in men).

People who had a high WC and a high WHR were 75% more at risk of dying during follow-up than people with low WC and WHR measurements (HR 1.75, 95% CI 1.57 to 1.95).

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How did the researchers interpret the results?

The researchers found that carrying weight around the centre of the body was associated with increased risk of mortality in people with CAD, and this pattern was found in both people who were obese and those who were of normal weight but carried their weight predominantly around their middles.

The researchers found that BMI, which measures your weight relative to your height, was inversely associated with mortality in people with CAD, meaning that people with lower BMIs were at higher risk of mortality. They say that a relationship between increasing BMI and mortality has been demonstrated in the general population, but in people with CAD the association is more complex. The researchers say that the ?association between fatness and mortality is complex and might rely more on measures of fat distribution than on the amount of body fat?, highlighting that, in their study ?central obesity is associated with higher mortality even in individuals with a normal BMI?.

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Conclusion

This systematic review pooled data from five studies and demonstrated that central obesity, measured by waist circumference or a higher waist-to-hip ratio, was associated with higher mortality in people with coronary artery disease. The research also showed that this increased risk was not seen with increasing BMI, and suggests that fat distribution rather than total fat is important in determining mortality risk in this group of patients with CAD.

The systematic review benefited from being able to pool data from a large number of individuals. However, as the data came from different studies, the participants? characteristics and how data was collected may have varied greatly.

Overall, this study has shown that central obesity may be associated with an increased risk of mortality in patients with CAD. It is recommended that people maintain their weight within a healthy range to lower the risks of a multitude of diseases. This study again questions whether it is weight around the middle (the ?apple? shape) that is a particular risk factor, and whether waist-to-hip ratio and waist circumference are of equal, or possibly greater, importance than BMI ? an issue that has been debated in numerous past research studies.

Links To The Headlines

Waist fat 'increases heart risk'. BBC News, May 3 2011

'Muffin Tops' or a beer belly double heart disease risk. Daily Mail, May 3 2011

Links To Science

Coutinho T, Goel K, Corr�a de S� D et al. Central Obesity and Survival in Subjects With Coronary Artery Disease - A Systematic Review of the Literature and Collaborative Analysis With Individual Subject Data. Journal of the American College of Cardiology, 2011; 57:1877-1886

Source: http://www.nhs.uk/news/2011/05May/Pages/twin-study-heart-risk-body-shape.aspx

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Asthma pill tested against inhalers

?A once-a-day pill may be better than an inhaler at combating asthma,? according to the Daily Mail.�The newspaper said the tablet could free patients from dependence on inhalers and ?revolutionise treatment for the condition?.

The pills in question, called leukotriene receptor antagonists, or LTRA tablets, were tested in two trials in 650 patients that compared the drugs to inhaled treatments, both as an initial treatment for newly diagnosed asthma and for asthma that could not be controlled with a single inhaler.

Researchers found in both circumstances that all treatments produced a similar (equivalent) improvement on patients? quality of life in the initial months of treatment. However, after two years, the quality of life scores were slightly higher in those using inhalers. This means that the tablets did not show better performance than inhalers, as many news sources have reported. The researchers did, however, find that people found it easier to use tablets than inhalers.

LTRA tablets have been available for some years, and this study looked to test their use in a real-world setting rather than under the strictly controlled conditions of an experimental trial. As such, the research can help inform us about factors such as patient?s adherence to their medication, but means that only limited conclusions can be drawn from its results.

LTRA tablets have their uses, just as inhalers do, and doctors can prescribe them when appropriate for an individual patient. However, the results of this research do not support the newspapers? view that the pills are a better option for most patients.

�

Where did the story come from?

The study was carried out by researchers from a number of academic institutions in the UK and at McMaster University, Canada. It was funded by the UK?s Health Technology Assessment Programme; Clement Clark International; Research in Real Life Ltd, and grants from the pharmaceutical companies AstraZeneca and Merck Sharp and Dohme. The study was published in the peer-reviewed New England Journal of Medicine.

The study was reported uncritically in the papers, which seemed to use an accompanying press release as the basis for their articles. The Daily Mail?s headline said that pills were more effective than inhalers, a claim not supported by this research. The Mail also referred to the pill as a potential 'wonder drug' despite it performing no better than an inhaler.

�

What kind of research was this?

This research comprised two separate pragmatic randomised controlled trials, designed to evaluate the effectiveness of LTRA tablets for treating the asthma of patients under the care of their GPs, in what the researchers say are real-world conditions. A pragmatic trial is a randomised trial designed to reflect a drug?s performance when used in normal clinical practice, as opposed to looking at the effectiveness of a drug in the ideal, highly regulated conditions of an experimental trial. The patients selected for a pragmatic study will also reflect those found in any normal clinical practice rather than being drawn from a specifically defined population.

Pragmatic trials can be useful for looking at whether patients adhere to treatments (the ability to keep taking the treatment), although they do have drawbacks that can affect their results. These include their use of a mixed-patient population, the absence of a placebo group for comparison and a lack of blinding, which is�the process of preventing researchers and patients from knowing which treatment they are getting.

The two trials looked at whether the performance of LTRA tablets was equivalent to that of treatment with inhalers. The first trial compared the tablets with inhaled steroids in patients who were beginning asthma therapy and the second compared LTRA tablets and LABA inhalers as add-on therapies to inhaled steroids. The researchers? hypothesis was that initial treatment with LTRA or using it as an addition to steroid inhalers, would lead to improvements in ?quality of life? (a patient-oriented measure of effectiveness) and that it would be equivalent to the alternative treatments tested.

The researchers point out that while double-blind randomised controlled trials are the bedrock of evidence in determining a treatment?s effectiveness, they do not guarantee a particular treatment will be effective in clinical practice. In the case of asthma treatments, this effectiveness is often influenced by how easy a treatment is to take and what type of technique patients prefer.

The researchers also point out that current asthma treatment guidelines recommend inhaled steroids as the first line treatment in managing chronic asthma, with the option of an additional LTRA or an add-on inhaler (LABA) if needed. Results from clinical trials of the different approaches have been mixed.

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What did the research involve?

The two trials were conducted at 53 GP practices in the UK and enrolled 650 patients between the ages of 12 and 80, who had been diagnosed with asthma. Eligible patients completed a validated asthma symptom diary for two weeks before the start of the trial and were also screened and assessed by telephone and in their clinic.

• In the first line 'controller trial', eligible patients had asthma symptoms their doctors considered to need treatment with a new course of asthma therapy. The participants were randomised to take either an inhaled steroid or an LTRA tablet.
• In the add-on therapy trial, patients were already taking inhaled steroids for their asthma (for at least 12 weeks) and had symptoms requiring an increase in therapy. Alongside an inhaled steroid they were randomly assigned either an LABA inhaler or an LTRA tablet.

Other eligibility criteria included evidence of impaired asthma-related quality of life or impaired asthma control, as measured using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and the Asthma Control Questionnaire (ACQ).

The effectiveness of the different treatments was primarily defined using MiniAQLQ scores, although the researchers also looked at secondary measurements including ACQ scores and the frequency of asthma exacerbations. Patients who met eligibility criteria completed a validated symptom diary before the start and were screened and assessed regularly by telephone and in the clinic.

The researchers used statistical methods to determine whether the different treatments were equivalent or not. This meant that they had to predefine what level of improvement and difference between treatments should be considered clinically significant. The researchers decided the two therapies are considered equivalent if the two treatments produced a difference of less than 0.3 points in the MiniAQLQ score.

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What were the basic results?

In both trials, the average quality of life scores increased by 0.8-1.0 points over a period of two years.

• At two months, differences in the MiniAQLQ scores between the two treatment groups met the researchers? definition of equivalence (defined as 95% confidence interval [CI] for an adjusted mean difference of 0.3 points in either direction).
• At two years, mean MiniAQLQ scores for the two treatments approached equivalence, with an adjusted mean difference between treatment groups of ?0.11 (95% CI, ?0.35 to 0.13) in the first-line controller therapy trial and of ?0.11 (95% CI, ?0.32 to 0.11) in the add-on therapy trial. The confidence interval ranges for these results meant they were just outside the predetermined range for equivalence.
• Exacerbation rates and ACQ scores did not differ significantly between the two groups.

�

How did the researchers interpret the results?

The researchers say their study results at two months suggest that LTRA pills are as effective as inhaled steroids as a first-line therapy and as effective as LABA as an add-on therapy in this group of patients. However, equivalence was not proved at two years.

The researchers say that their findings suggest there is little difference in ?real-world effectiveness? between LTRA pills and inhaled steroids as a first-line treatment and between an LTRA and LABA as an add-on treatment to steroid inhalers.

They note that adherence to tablets was better than it was to other drugs in the trials, with 65% of patients adhering to tablets, compared to 41% for inhaled steroids in the first line trial and 74% versus 46% in the add-on therapy trial.

In the add-on therapy trial, one-quarter of patients in the LTRA tablet group were switched to a LABA inhaler or received it as an add-on.

�

Conclusion

The LTRA drugs tested in these two studies are not new, as some newspapers have incorrectly reported, and this research has not shown that they perform better than inhaled treatments. Rather, this research is of benefit for helping to compare how the two types of existing treatment might perform in a clinical setting.

This pragmatic trial is useful for providing data on factors such as the adherence rates for the two therapies, although its study design also means there are a number of limitations that must also be considered when interpreting its results:

• As a pragmatic trial it defines how successful treatments are in practice, rather than under the ideal conditions of an experimental trial.
• It did not measure treatment effectiveness against a placebo and the patients were not ?blinded? to prevent them knowing which treatment they were allocated.
• The patients were allowed to ?cross over? between different treatments during the study, which affects the reliability of the results. Since more patients starting the LTRA treatment switched medications, it could suggest this treatment was less effective or problematic to use.

As with any medication, both inhalers and LTRA tablets can have benefits and drawbacks associated with their use, which doctors will weigh up when choosing a medication for an individual patient.�
Anyone who is concerned about the treatments for controlling asthma should not stop taking them but instead go see their doctor to discuss alternatives.

Links To The Headlines

Once-a-day asthma pill 'is more effective than inhaler'. Daily Mail, May 5 2011

Pills better for treating asthma than inhalers. The Daily Telegraph, May 5 2011

Asthma pills on par with inhalers. Daily Mirror, May 5 2011

A pill a day keeps an inhaler away. The Sun, May 5 2011

Links To Science

Price D, Musgrave SD, Shepstone L et al. Leukotriene Antagonists as First-Line or Add-on Asthma-Controller Therapy. New England Journal of Medicine 2011; 364:1695-1707 May 5 2011

Source: http://www.nhs.uk/news/2011/05May/Pages/ltra-asthma-pill-vs-asthma-inhaler.aspx

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Bin Laden's death: How should we feel?

Emotions high after bin Laden's death

STORY HIGHLIGHTS

• Osama bin Laden was killed by U.S. troops in Pakistan, President Obama announced Sunday
• Bin Laden's death may come with feelings of relief for many people
• Reactions likely tied to emotions felt on September 11, 2001

(CNN) -- You may be relieved or even ecstatic about the end of a symbol of terror, or maybe it seems like the pain is just beginning all over again.

Both of these reactions to the death of Osama bin Laden, who was killed by U.S. troops in Pakistan, are natural, experts say.

From the celebrations in Washington and New York, it looks like lots of people are happy. Chants of "USA! USA!" reverberated outside the White House and at New York's ground zero as crowds celebrated the death of the terrorist leader, President Obama announced Sunday.

As far as the collective American psyche goes, it makes sense that this is a moment of celebration, says Columbia University psychiatrist Dr. Jeffery Lieberman. The country has been experiencing emotional malaise, with a slow-moving economy, a sense of America losing its No. 1 status in the world, and a decade of pent-up anguish about the threat of terrorism. Much like the World War II years, these have been uncertain times.

Then, rumors of bin Laden's death, confirmed by an announcement from the president, lifted that burden of pain and helplessness.

"In the blink of an eye, the gloom and doom and pessimism has dissipated," Lieberman said.

After bin Laden: What does it mean to you?

But wait a minute: Should we rejoice in the death of another human being?

But although bin Laden claimed responsibility for the destruction of the World Trade Center and the deaths of thousands of Americans, the outpouring of celebration doesn't feel right for everyone.

David Sirota, a newspaper columnist and a contributor to Salon felt uncomfortable with the jubilation because he said there is a "difference between relief and euphoria."

"A euphoric response instead of somber relief suggests that we are celebrating revenge. We are not celebrating an end to the war," he said, comparing it to the public's euphoria when World War II ended.

"What's a little scary about this: We were once a country that saw violence as regrettable, but sometimes necessary act. But we're not celebrating end of violence, but the exercise of it."

Josh Pesavento, 22, a journalism student in New York who photographed the cheering crowds in Times Square on Monday morning, also felt conflicted about the celebrations he witnessed.

"I don't believe that any person has the right to kill anyone, and I don't think that we should be cheering for yet more loss of life. However, I tell myself that in this situation, these people may be cheering for the end of an icon who led to the death of far, far too many," Pesavento said.

For some, bin Laden represents an idea more than a person who lived and died. More than the death of a human being, this ends the life of a powerful symbol of terrorism and destruction, said Nadine Kaslow, psychologist at Emory University. Bin Laden's death hits closer to home in the U.S. than the capture and execution of Saddam Hussein, for example, because the Iraqi dictator did not directly attack American soil, she said.

The celebratory mood reflects a sense that fairness and justice had been restored and that a terrorist got his comeuppance, said Kaslow.

"I think people feel like this guy got what he deserved. It was a sense that it was 'our family' that was killed," she said.

But there are likely others who aren't chanting on the streets for whom the death of bin Laden brings back painful memories of the September 11, 2001, terrorist attacks, she said.

People who lost loved ones on September 11, 2001, may have symptoms of post-traumatic stress disorder, and the killing of bin Laden may open old wounds, Lieberman said.

"It doesn't bring their loved ones back. It doesn't ease their pain. There was so much more to this than catching bin Laden. At best, they would be bittersweet: It feels good to have the relief of this guy being gone, but the pain of their loss is very strong and very real to them," said Dr. Susan Nolen-Hoeksema, a Yale University psychologist.

Is it morally right to celebrate bin Laden's death?

Diana Massaroli, who lost her husband, Michael Massaroli, in the World Trade Center on September 11, 2001, said the news of bin Laden's death made her feel an "overall calm that I haven't felt in 10 years."

"I feel better ... like I can start a new chapter in my life."

Sirota and Kaslow likened bin Laden's death to the execution of a convicted murderer of someone's family, which may bring a sense of closure for some. In the case of bin Laden, though, there is fear of retaliation from terrorist groups.

"Relief also comes with a kind of sadness that the victims can never be brought back and sadness at the world that creates such a perpetrator," Sirota said.

Even people who didn't feel the direct impact of the attacks on September 11, 2001, will feel relief, Kaslow said. After all, everyone gets reminded of the global insecurity that resulted whenever they go to the airport.

The terrorist leader's living situation also doesn't bring about any sympathy -- he wasn't starving and struggling in a cave, but rather lived in a mansion, which adds to his perceived arrogance, Kaslow said.

The news of bin Laden's death "allows us to put some sort of order" to the horror of 9-11 because otherwise, "it's upsetting, disconcerting when we're reminded how unpredictable life, death and the world around us could be," said Sam Sommer, associate professor of psychology at Tufts University.

People's reactions are likely tied to how emotionally and personally they felt to the events 10 years ago, Sommer said.

"It seems to me that the emotional reaction had a lot to do with the differences in how people view this -- whether it's the right triumphing over evil -- a lot of young people are viewing this in that way," Nolen-Hoeksema said.

She noted that her teenage son and his friends were enthusiastically tweeting about the news in a tone that "this is a bad guy, the good guys got him finally -- that's all they are seeing." After, all Jack Bauer of "24" was trending on Twitter.

But the one common factor was that everyone felt a need to share the news and their observations -- whether it was rallying in front of the White House, or tweeting or updating their Facebook page.

"These emotionally charged events send us back to our social roots and make us need to affiliate with other people," Sommer said.

CNN's Nicole Saidi contributed to this report.

Source: http://rss.cnn.com/~r/rss/cnn_health/~3/uGitUpDu26s/index.html

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Asthma pill tested against inhalers

?A once-a-day pill may be better than an inhaler at combating asthma,? according to the Daily Mail.�The newspaper said the tablet could free patients from dependence on inhalers and ?revolutionise treatment for the condition?.

The pills in question, called leukotriene receptor antagonists, or LTRA tablets, were tested in two trials in 650 patients that compared the drugs to inhaled treatments, both as an initial treatment for newly diagnosed asthma and for asthma that could not be controlled with a single inhaler.

Researchers found in both circumstances that all treatments produced a similar (equivalent) improvement on patients? quality of life in the initial months of treatment. However, after two years, the quality of life scores were slightly higher in those using inhalers. This means that the tablets did not show better performance than inhalers, as many news sources have reported. The researchers did, however, find that people found it easier to use tablets than inhalers.

LTRA tablets have been available for some years, and this study looked to test their use in a real-world setting rather than under the strictly controlled conditions of an experimental trial. As such, the research can help inform us about factors such as patient?s adherence to their medication, but means that only limited conclusions can be drawn from its results.

LTRA tablets have their uses, just as inhalers do, and doctors can prescribe them when appropriate for an individual patient. However, the results of this research do not support the newspapers? view that the pills are a better option for most patients.

�

Where did the story come from?

The study was carried out by researchers from a number of academic institutions in the UK and at McMaster University, Canada. It was funded by the UK?s Health Technology Assessment Programme; Clement Clark International; Research in Real Life Ltd, and grants from the pharmaceutical companies AstraZeneca and Merck Sharp and Dohme. The study was published in the peer-reviewed New England Journal of Medicine.

The study was reported uncritically in the papers, which seemed to use an accompanying press release as the basis for their articles. The Daily Mail?s headline said that pills were more effective than inhalers, a claim not supported by this research. The Mail also referred to the pill as a potential 'wonder drug' despite it performing no better than an inhaler.

�

What kind of research was this?

This research comprised two separate pragmatic randomised controlled trials, designed to evaluate the effectiveness of LTRA tablets for treating the asthma of patients under the care of their GPs, in what the researchers say are real-world conditions. A pragmatic trial is a randomised trial designed to reflect a drug?s performance when used in normal clinical practice, as opposed to looking at the effectiveness of a drug in the ideal, highly regulated conditions of an experimental trial. The patients selected for a pragmatic study will also reflect those found in any normal clinical practice rather than being drawn from a specifically defined population.

Pragmatic trials can be useful for looking at whether patients adhere to treatments (the ability to keep taking the treatment), although they do have drawbacks that can affect their results. These include their use of a mixed-patient population, the absence of a placebo group for comparison and a lack of blinding, which is�the process of preventing researchers and patients from knowing which treatment they are getting.

The two trials looked at whether the performance of LTRA tablets was equivalent to that of treatment with inhalers. The first trial compared the tablets with inhaled steroids in patients who were beginning asthma therapy and the second compared LTRA tablets and LABA inhalers as add-on therapies to inhaled steroids. The researchers? hypothesis was that initial treatment with LTRA or using it as an addition to steroid inhalers, would lead to improvements in ?quality of life? (a patient-oriented measure of effectiveness) and that it would be equivalent to the alternative treatments tested.

The researchers point out that while double-blind randomised controlled trials are the bedrock of evidence in determining a treatment?s effectiveness, they do not guarantee a particular treatment will be effective in clinical practice. In the case of asthma treatments, this effectiveness is often influenced by how easy a treatment is to take and what type of technique patients prefer.

The researchers also point out that current asthma treatment guidelines recommend inhaled steroids as the first line treatment in managing chronic asthma, with the option of an additional LTRA or an add-on inhaler (LABA) if needed. Results from clinical trials of the different approaches have been mixed.

�

What did the research involve?

The two trials were conducted at 53 GP practices in the UK and enrolled 650 patients between the ages of 12 and 80, who had been diagnosed with asthma. Eligible patients completed a validated asthma symptom diary for two weeks before the start of the trial and were also screened and assessed by telephone and in their clinic.

• In the first line 'controller trial', eligible patients had asthma symptoms their doctors considered to need treatment with a new course of asthma therapy. The participants were randomised to take either an inhaled steroid or an LTRA tablet.
• In the add-on therapy trial, patients were already taking inhaled steroids for their asthma (for at least 12 weeks) and had symptoms requiring an increase in therapy. Alongside an inhaled steroid they were randomly assigned either an LABA inhaler or an LTRA tablet.

Other eligibility criteria included evidence of impaired asthma-related quality of life or impaired asthma control, as measured using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and the Asthma Control Questionnaire (ACQ).

The effectiveness of the different treatments was primarily defined using MiniAQLQ scores, although the researchers also looked at secondary measurements including ACQ scores and the frequency of asthma exacerbations. Patients who met eligibility criteria completed a validated symptom diary before the start and were screened and assessed regularly by telephone and in the clinic.

The researchers used statistical methods to determine whether the different treatments were equivalent or not. This meant that they had to predefine what level of improvement and difference between treatments should be considered clinically significant. The researchers decided the two therapies are considered equivalent if the two treatments produced a difference of less than 0.3 points in the MiniAQLQ score.

�

What were the basic results?

In both trials, the average quality of life scores increased by 0.8-1.0 points over a period of two years.

• At two months, differences in the MiniAQLQ scores between the two treatment groups met the researchers? definition of equivalence (defined as 95% confidence interval [CI] for an adjusted mean difference of 0.3 points in either direction).
• At two years, mean MiniAQLQ scores for the two treatments approached equivalence, with an adjusted mean difference between treatment groups of ?0.11 (95% CI, ?0.35 to 0.13) in the first-line controller therapy trial and of ?0.11 (95% CI, ?0.32 to 0.11) in the add-on therapy trial. The confidence interval ranges for these results meant they were just outside the predetermined range for equivalence.
• Exacerbation rates and ACQ scores did not differ significantly between the two groups.

�

How did the researchers interpret the results?

The researchers say their study results at two months suggest that LTRA pills are as effective as inhaled steroids as a first-line therapy and as effective as LABA as an add-on therapy in this group of patients. However, equivalence was not proved at two years.

The researchers say that their findings suggest there is little difference in ?real-world effectiveness? between LTRA pills and inhaled steroids as a first-line treatment and between an LTRA and LABA as an add-on treatment to steroid inhalers.

They note that adherence to tablets was better than it was to other drugs in the trials, with 65% of patients adhering to tablets, compared to 41% for inhaled steroids in the first line trial and 74% versus 46% in the add-on therapy trial.

In the add-on therapy trial, one-quarter of patients in the LTRA tablet group were switched to a LABA inhaler or received it as an add-on.

�

Conclusion

The LTRA drugs tested in these two studies are not new, as some newspapers have incorrectly reported, and this research has not shown that they perform better than inhaled treatments. Rather, this research is of benefit for helping to compare how the two types of existing treatment might perform in a clinical setting.

This pragmatic trial is useful for providing data on factors such as the adherence rates for the two therapies, although its study design also means there are a number of limitations that must also be considered when interpreting its results:

• As a pragmatic trial it defines how successful treatments are in practice, rather than under the ideal conditions of an experimental trial.
• It did not measure treatment effectiveness against a placebo and the patients were not ?blinded? to prevent them knowing which treatment they were allocated.
• The patients were allowed to ?cross over? between different treatments during the study, which affects the reliability of the results. Since more patients starting the LTRA treatment switched medications, it could suggest this treatment was less effective or problematic to use.

As with any medication, both inhalers and LTRA tablets can have benefits and drawbacks associated with their use, which doctors will weigh up when choosing a medication for an individual patient.�
Anyone who is concerned about the treatments for controlling asthma should not stop taking them but instead go see their doctor to discuss alternatives.

Links To The Headlines

Once-a-day asthma pill 'is more effective than inhaler'. Daily Mail, May 5 2011

Pills better for treating asthma than inhalers. The Daily Telegraph, May 5 2011

Asthma pills on par with inhalers. Daily Mirror, May 5 2011

A pill a day keeps an inhaler away. The Sun, May 5 2011

Links To Science

Price D, Musgrave SD, Shepstone L et al. Leukotriene Antagonists as First-Line or Add-on Asthma-Controller Therapy. New England Journal of Medicine 2011; 364:1695-1707 May 5 2011

Source: http://www.nhs.uk/news/2011/05May/Pages/ltra-asthma-pill-vs-asthma-inhaler.aspx

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Asthma pill tested against inhalers

?A once-a-day pill may be better than an inhaler at combating asthma,? according to the Daily Mail.�The newspaper said the tablet could free patients from dependence on inhalers and ?revolutionise treatment for the condition?.

The pills in question, called leukotriene receptor antagonists, or LTRA tablets, were tested in two trials in 650 patients that compared the drugs to inhaled treatments, both as an initial treatment for newly diagnosed asthma and for asthma that could not be controlled with a single inhaler.

Researchers found in both circumstances that all treatments produced a similar (equivalent) improvement on patients? quality of life in the initial months of treatment. However, after two years, the quality of life scores were slightly higher in those using inhalers. This means that the tablets did not show better performance than inhalers, as many news sources have reported. The researchers did, however, find that people found it easier to use tablets than inhalers.

LTRA tablets have been available for some years, and this study looked to test their use in a real-world setting rather than under the strictly controlled conditions of an experimental trial. As such, the research can help inform us about factors such as patient?s adherence to their medication, but means that only limited conclusions can be drawn from its results.

LTRA tablets have their uses, just as inhalers do, and doctors can prescribe them when appropriate for an individual patient. However, the results of this research do not support the newspapers? view that the pills are a better option for most patients.

�

Where did the story come from?

The study was carried out by researchers from a number of academic institutions in the UK and at McMaster University, Canada. It was funded by the UK?s Health Technology Assessment Programme; Clement Clark International; Research in Real Life Ltd, and grants from the pharmaceutical companies AstraZeneca and Merck Sharp and Dohme. The study was published in the peer-reviewed New England Journal of Medicine.

The study was reported uncritically in the papers, which seemed to use an accompanying press release as the basis for their articles. The Daily Mail?s headline said that pills were more effective than inhalers, a claim not supported by this research. The Mail also referred to the pill as a potential 'wonder drug' despite it performing no better than an inhaler.

�

What kind of research was this?

This research comprised two separate pragmatic randomised controlled trials, designed to evaluate the effectiveness of LTRA tablets for treating the asthma of patients under the care of their GPs, in what the researchers say are real-world conditions. A pragmatic trial is a randomised trial designed to reflect a drug?s performance when used in normal clinical practice, as opposed to looking at the effectiveness of a drug in the ideal, highly regulated conditions of an experimental trial. The patients selected for a pragmatic study will also reflect those found in any normal clinical practice rather than being drawn from a specifically defined population.

Pragmatic trials can be useful for looking at whether patients adhere to treatments (the ability to keep taking the treatment), although they do have drawbacks that can affect their results. These include their use of a mixed-patient population, the absence of a placebo group for comparison and a lack of blinding, which is�the process of preventing researchers and patients from knowing which treatment they are getting.

The two trials looked at whether the performance of LTRA tablets was equivalent to that of treatment with inhalers. The first trial compared the tablets with inhaled steroids in patients who were beginning asthma therapy and the second compared LTRA tablets and LABA inhalers as add-on therapies to inhaled steroids. The researchers? hypothesis was that initial treatment with LTRA or using it as an addition to steroid inhalers, would lead to improvements in ?quality of life? (a patient-oriented measure of effectiveness) and that it would be equivalent to the alternative treatments tested.

The researchers point out that while double-blind randomised controlled trials are the bedrock of evidence in determining a treatment?s effectiveness, they do not guarantee a particular treatment will be effective in clinical practice. In the case of asthma treatments, this effectiveness is often influenced by how easy a treatment is to take and what type of technique patients prefer.

The researchers also point out that current asthma treatment guidelines recommend inhaled steroids as the first line treatment in managing chronic asthma, with the option of an additional LTRA or an add-on inhaler (LABA) if needed. Results from clinical trials of the different approaches have been mixed.

�

What did the research involve?

The two trials were conducted at 53 GP practices in the UK and enrolled 650 patients between the ages of 12 and 80, who had been diagnosed with asthma. Eligible patients completed a validated asthma symptom diary for two weeks before the start of the trial and were also screened and assessed by telephone and in their clinic.

• In the first line 'controller trial', eligible patients had asthma symptoms their doctors considered to need treatment with a new course of asthma therapy. The participants were randomised to take either an inhaled steroid or an LTRA tablet.
• In the add-on therapy trial, patients were already taking inhaled steroids for their asthma (for at least 12 weeks) and had symptoms requiring an increase in therapy. Alongside an inhaled steroid they were randomly assigned either an LABA inhaler or an LTRA tablet.

Other eligibility criteria included evidence of impaired asthma-related quality of life or impaired asthma control, as measured using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and the Asthma Control Questionnaire (ACQ).

The effectiveness of the different treatments was primarily defined using MiniAQLQ scores, although the researchers also looked at secondary measurements including ACQ scores and the frequency of asthma exacerbations. Patients who met eligibility criteria completed a validated symptom diary before the start and were screened and assessed regularly by telephone and in the clinic.

The researchers used statistical methods to determine whether the different treatments were equivalent or not. This meant that they had to predefine what level of improvement and difference between treatments should be considered clinically significant. The researchers decided the two therapies are considered equivalent if the two treatments produced a difference of less than 0.3 points in the MiniAQLQ score.

�

What were the basic results?

In both trials, the average quality of life scores increased by 0.8-1.0 points over a period of two years.

• At two months, differences in the MiniAQLQ scores between the two treatment groups met the researchers? definition of equivalence (defined as 95% confidence interval [CI] for an adjusted mean difference of 0.3 points in either direction).
• At two years, mean MiniAQLQ scores for the two treatments approached equivalence, with an adjusted mean difference between treatment groups of ?0.11 (95% CI, ?0.35 to 0.13) in the first-line controller therapy trial and of ?0.11 (95% CI, ?0.32 to 0.11) in the add-on therapy trial. The confidence interval ranges for these results meant they were just outside the predetermined range for equivalence.
• Exacerbation rates and ACQ scores did not differ significantly between the two groups.

�

How did the researchers interpret the results?

The researchers say their study results at two months suggest that LTRA pills are as effective as inhaled steroids as a first-line therapy and as effective as LABA as an add-on therapy in this group of patients. However, equivalence was not proved at two years.

The researchers say that their findings suggest there is little difference in ?real-world effectiveness? between LTRA pills and inhaled steroids as a first-line treatment and between an LTRA and LABA as an add-on treatment to steroid inhalers.

They note that adherence to tablets was better than it was to other drugs in the trials, with 65% of patients adhering to tablets, compared to 41% for inhaled steroids in the first line trial and 74% versus 46% in the add-on therapy trial.

In the add-on therapy trial, one-quarter of patients in the LTRA tablet group were switched to a LABA inhaler or received it as an add-on.

�

Conclusion

The LTRA drugs tested in these two studies are not new, as some newspapers have incorrectly reported, and this research has not shown that they perform better than inhaled treatments. Rather, this research is of benefit for helping to compare how the two types of existing treatment might perform in a clinical setting.

This pragmatic trial is useful for providing data on factors such as the adherence rates for the two therapies, although its study design also means there are a number of limitations that must also be considered when interpreting its results:

• As a pragmatic trial it defines how successful treatments are in practice, rather than under the ideal conditions of an experimental trial.
• It did not measure treatment effectiveness against a placebo and the patients were not ?blinded? to prevent them knowing which treatment they were allocated.
• The patients were allowed to ?cross over? between different treatments during the study, which affects the reliability of the results. Since more patients starting the LTRA treatment switched medications, it could suggest this treatment was less effective or problematic to use.

As with any medication, both inhalers and LTRA tablets can have benefits and drawbacks associated with their use, which doctors will weigh up when choosing a medication for an individual patient.�
Anyone who is concerned about the treatments for controlling asthma should not stop taking them but instead go see their doctor to discuss alternatives.

Links To The Headlines

Once-a-day asthma pill 'is more effective than inhaler'. Daily Mail, May 5 2011

Pills better for treating asthma than inhalers. The Daily Telegraph, May 5 2011

Asthma pills on par with inhalers. Daily Mirror, May 5 2011

A pill a day keeps an inhaler away. The Sun, May 5 2011

Links To Science

Price D, Musgrave SD, Shepstone L et al. Leukotriene Antagonists as First-Line or Add-on Asthma-Controller Therapy. New England Journal of Medicine 2011; 364:1695-1707 May 5 2011

Source: http://www.nhs.uk/news/2011/05May/Pages/ltra-asthma-pill-vs-asthma-inhaler.aspx

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