Wednesday, December 30, 2009

Acetaminophen May Also Relieve Psychological Pain

From Medscape Medical News

Janis C. Kelly

December 30, 2009 — Opiates and other strong analgesics have long been known to numb psychological as well as physical pain, but new evidence suggests that even mild over-the-counter drugs like acetaminophen may relieve psychological discomfort, such as the stress of social rejection.

A research team led by psychologist C. Nathan DeWall, PhD, from the University of Kentucky College of Arts and Sciences, Department of Psychology, Lexington, examined the overlap between neural and psychological pain by randomly assigning healthy volunteers to 3 weeks of either daily acetaminophen or placebo, then comparing self-reports of social pain.

In a second study, the researchers used functional magnetic resonance imaging in an attempt to correlate changes in brain activity in regions believed to be associated with responses to social rejection with subjects' experiences of social pain.

"The idea that a drug designed to alleviate physical pain should reduce the pain of social rejection seemed simple and straightforward based on what we know about neural overlap between social and physical pain systems. To my surprise, I couldn't find anyone who had ever tested this idea," Dr. DeWall said.

He described "social pain" as "a painful affective response to a perceived threat to social belonging. Social rejection is one example of a socially painful event."

The research is due to be published in an upcoming edition of Psychological Science.

Hurt Feelings Measured

The first experiment included 62 healthy volunteers randomly assigned to 1000 mg/day of either acetaminophen or placebo. Each evening, participants used a version of the Hurt Feelings Scale to report how much social pain they experienced that day.

As expected, hurt feelings decreased significantly over time among participants who took acetaminophen (P < .05), but they were unchanged in the placebo group, the researchers report.

"These data provide some of the first evidence that reducing physical pain can reduce the pain of social rejection. They add to our understanding of how seemingly different types of painful experiences are processed through the same neurobiological systems," Dr. DeWall told Medscape Psychiatry.

In the second experiment, the acetaminophen dose was doubled to 2000 mg/day in an attempt to compensate for the lower statistical power associated with the smaller groups (10 participants randomly assigned to acetaminophen, 15 participants randomly assigned to placebo).

After 3 weeks of taking the pills, the subjects participated in a computer game rigged to create feelings of social rejection.

Functional magnetic resonance imaging findings showed that the acetaminophen group had significantly less neural activity than the placebo group during the game in brain regions associated with the distress of social pain and with the affective component of physical pain (the dorsal anterior cingulate cortex and anterior insula).

However, the acetaminophen and control groups "reported equal levels of social distress in response to the exclusion episode," the researchers report.

Potential to Reduce Violent Behavior?

Dr. DeWall said that despite the drug's lack of effect on the experience of social distress, the researchers concluded that acetaminophen reduced the pain of social rejection at the neural level.

The data "suggest that at least temporary mitigation of social pain–related distress may be achieved by means of an over-the-counter painkiller that is normally used for physical aches and pains."

The investigators further suggest that acetaminophen may prevent violent behavior, as "many studies have shown that being rejected can trigger aggressive and antisocial behavior, which could lead to further complications in social life.... If acetaminophen reduces the distress of rejection, the antisocial behavioral consequences of rejection may be reduced as well."

"This research has the potential to change how scientists and laypersons understand physical and social pain. Social pain, such as chronic loneliness, damages health as much as smoking and obesity. We hope our findings can pave the way for interventions designed to reduce the pain of social rejection," said Dr. DeWall.

Kudos

Asked by Medscape Psychiatry to comment on the study, Bruce G. Charlton, MD, applauded the investigators' research efforts.

"It is particularly difficult to get research funding to study old, cheap, unpatented, over-the-counter drugs, so I congratulate the authors on doing this," he said.

Dr. Charlton, who is editor-in-chief of Medical Hypotheses and professor of theoretical medicine at the University of Buckingham, United Kingdom, agreed that different sorts of pain are often related, so there is good reason to assume that acetaminophen or paracetamol may benefit those who suffer any type of pain of unpleasant feelings, including some types of depression.

However, he noted that the same effect would likely apply to aspirin, nonsteroidal anti-inflammatory drugs, and opiates, "about which there is more evidence," he said.

Alternative Interpretation

Magne Arve Flaten, MD, from the department of clinical research at University Hospital of North Norway, Tromso, also commented on the study for Medscape Psychiatry. Dr. Flaten, who recently published a study of cognitive and emotional factors in placebo analgesia, said that alternative interpretations of the data are possible.

"The authors seem to think that rejection induces 'social pain,' but it would probably, in my view, be more correct to say that both pain and social rejection are associated with unpleasantness and other negative emotions.

"Social pain is not pain as we ordinarily think of it, but it shares some of the emotional aspects that pain has, and aspects that probably other negative emotions also have," said Dr. Flaten.

He noted that the investigators' first experiment showed that acetaminophen reduced "hurt feelings," but that the effects, although significant, "seem small." He suspects that the researchers' inability to replicate the psychological effect in the second experiment may have been a result of lack of power because of the small sample size.

"I do not think this research tells us anything about pain, since pain, in a normal sense of the word, was not investigated in these experiments. The research tells us that acetaminophen could reduce some of the negative emotional consequences of social rejection, which is very interesting," Dr. Flaten said.

The study was funded by the National Institute of Mental Health and the Gulf Atlantic Group Incorporated. Dr. DeWall, Dr. Flaten, and Dr. Charlton have disclosed no relevant financial relationships.

Psychol Sci (in press).

note: acetaminophen = paracetamol or panadol

Saturday, December 26, 2009

ACP Issues Guidelines for Treatment of Erectile Dysfunction

From MedscapeCME Clinical Briefs

News Author: Laurie Barclay, MD
CME Author: Charles P. Vega, MD

October 21, 2009 — The American College of Physicians (ACP) has issued recommendations for the treatment of erectile dysfunction (ED), defined as the persistent inability to achieve or maintain penile erection sufficient for satisfactory sexual performance. Evaluation and consideration of treatment are indicated when ED persists for at least 3 months.

The new clinical practice guidelines, which are published early release in the October 20 issue of the Annals of Internal Medicine, strongly urge clinicians to begin therapy with an oral phosphodiesterase type 5 (PDE-5) inhibitor in men who seek treatment of ED, unless they are receiving nitrate therapy or have another contraindication to use of PDE-5 inhibitors.

"The evidence is insufficient to compare the effectiveness or adverse effects of different PDE-5 inhibitors for the treatment of ED because there were only a few head-to-head trials," lead author Amir Qaseem, MD, PhD, MHA, FACP, senior medical associate at the ACP, said in a news release.

Therefore, the guideline recommends that physicians decide on a specific PDE-5 inhibitor to prescribe based on individual patient preferences, taking into account convenience and ease of use, medication costs, and safety and adverse effects profile. Available PDE-5 inhibitors include sildenafil, vardenafil, tadalafil, mirodenafil, and udenafil.

Because available evidence is inconclusive about the efficacy of hormonal therapy for ED in patients with low testosterone levels, the ACP does not recommend for or against routine hormonal blood tests or treatment in patients with ED. Measurement of hormone levels may be appropriate in specific patients.

Clinicians should consider the presence or absence of symptoms of hormonal dysfunction, such as decreased libido, premature ejaculation, or fatigue, and of physical findings such as testicular or muscle atrophy, when considering whether to measure hormone levels in individual patients.

Risk factors for ED include advanced age, diabetes, vascular diseases, psychiatric disorders, and possibly hypogonadism. Worldwide prevalence of ED exceeded 152 million in 1995, and with the graying of the population, it is estimated that it will be approximately 322 million by the year 2025.

The accompanying review of evidence included an analysis of information from 130 randomized controlled trials of oral PDE-5 inhibitors used for ED as monotherapy or in combination. The study authors identified these trials by searching English-language publications in MEDLINE (from 1966 - May 2007), EMBASE (from 1980 - week 22 of 2007), the Cochrane Central Register of Controlled Trials (second quarter of 2007), PsycINFO (from 1985 - June 2007), AMED (from 1985 - June 2007), and SCOPUS (in 2006). The investigators further updated this search by searching for articles in MEDLINE and EMBASE published between May 2007 and April 2009.

Regardless of the specific cause of ED, such as diabetes, depression, or prostate cancer, or baseline severity, treatment with a PDE-5 inhibitor was associated with statistically significant and clinically meaningful improvements in sexual intercourse and in erectile function. For sildenafil and vardenafil, improvement in erectile functioning was related to higher doses, but this was not true for tadalafil. Higher doses were also linked to a higher risk for adverse effects.

The evidence review also showed a relatively good tolerability profile of PDE-5 inhibitors. Adverse effects were mostly mild or moderate, including headaches, flushing, dyspepsia, and rhinorrhea. Less common adverse effects were visual disturbances, myalgia, nausea, diarrhea, vomiting, dizziness, and chest pain.

Although trials reviewed as part of the evidence base for this guideline did not report priapism, this adverse effect was reported infrequently during postmarketing surveillance.

Various PDE-5 inhibitors did not differ significantly in the incidence of adverse events. There was high-quality evidence that men treated with a PDE-5 inhibitor are more likely to have at least 1 adverse event vs placebo. The incidence for more serious adverse events was less than 2%, and incidence did not differ between PDE-5 inhibitors and placebo.

Available testosterone formulations include oral, injection, gel, patch, and cream. Evidence regarding the efficacy of hormonal therapy for ED was inconclusive because trials comparing testosterone vs placebo in hypogonadal men with ED were small, of low quality, or showed inconsistent effects on erectile function.

"The evidence regarding the incidence of adverse events was limited and inconclusive, and more high-quality head-to-head trials are needed to explore differences in adverse events, especially severe adverse events," the guidelines authors write. "The evidence regarding the utility of routine hormonal blood tests was inconclusive given the limited number of studies and various methodological issues and needs to be further developed."

Specific recommendations in this clinical practice guideline, and their accompanying level of evidence rating, are as follows:

The ACP recommends that clinicians begin treatment with a PDE-5 inhibitor in men who seek treatment of ED and who have no contraindication to use of PDE-5 inhibitors (grade: strong recommendation; high-quality evidence).
The ACP recommends that clinicians choose a specific PDE-5 inhibitor based on the individual preferences of men with ED, considering ease of use, cost of medication, and adverse effects profile (grade: weak recommendation; low-quality evidence).
The ACP does not recommend for or against routine use of hormonal blood tests or hormonal therapy for patients with ED (grade: insufficient evidence to determine net benefits and harms).
Financial support for the development of this guideline was provided exclusively from the ACP operating budget. The recommendations are not intended to represent an official position of the Agency for Healthcare Research and Quality or the US Department of Health and Human Services. Some of the guidelines authors have disclosed various financial relationships with Bristol-Myers Squibb, the Centers for Disease Control and Prevention, Novo Nordisk, Merck Vaccines, Boehringer Ingelheim, Wyeth, Sanofi Pasteur, Pfizer, and/or Up-to-Date.

Ann Intern Med. Published online October 20, 2009.

Clinical Context

ED is one of the most common medical conditions among men, occurring in approximately half of subjects of 1 study of men between the ages of 40 and 70 years. Multiple chronic diseases are associated with a higher risk for ED, and the worldwide prevalence of ED is expected to be 322 million by the year 2025. The annual cost of treatment of ED could reach $15 billion in the United States alone if all men with ED sought care.

Given the widespread prevalence of ED, evidence-based care is critically important to improve outcomes and control costs. The current guidelines provide recommendations from the ACP regarding the evaluation and management of ED.

Depression, Anxiety Major Factors in Neck Pain

From Reuters Health Information
News Author: Megan Rauscher
CME Author: Désirée Lie, MD, MSEd

February 13, 2009 — Psychosocial distress, specifically depression and anxiety, are closely linked to recurrent or persistent neck pain, clinicians from Germany report in the journal BMC Musculoskeletal Disorders posted online January 26.

"For successful long term results, it is essential to consider psychosocial factors and to include them into therapeutic strategies" for neck pain, Dr. Martin Scherer from the University of Gottingen noted in comments to Reuters Health.

The study involved 448 patients from a general practice setting in Germany with at least one episode of neck pain between March 2005 and April 2006. These patients completed a comprehensive questionnaire including the Neck Pain and Disability Scale and the Hospital Anxiety and Depression Scale (HADS).

Forty-four percent of the study subjects were 50 years or older and nearly 80% were female. About one third had basic education and a similar proportion was unemployed or retired. More than half of the subjects (56%) reported neck pain on the day they completed the questionnaire and 26% had constant neck pain during the past year.

Based on their HADS response, 20% of subjects were classified as having depressive mood, and 28% reported being anxious.

According to Dr. Scherer and colleagues, in both crude and adjusted regression analyses, depression and anxiety were highly significantly correlated with increasing levels of neck pain.

When levels of depression and anxiety were classified by quartiles of the Neck Pain and Disability Scale, subjects with depressive mood or anxiety were highly likely to be in the group with the highest levels of neck pain.

The results, the researchers say, suggest that the degree of neck pain is related to the degree of psychological distress. "To put it in other words," they write, "the higher the pain level in patients with cervical problems, the more attention should be paid to psychosocial distress as an additional burden."

Dr. Scherer and colleagues also note that their findings are consistent with a recent systematic review, which investigated determinants and risk factors for neck pain in the general population and found "consistent evidence only for psychological health factors and for other health problems like musculoskeletal complaints and poorer self-rated health."

"Findings of our study," Dr. Scherer told Reuters Health, "underline that neck pain therapies are more likely to be efficient if care for chronic patients is not only symptom-oriented but focuses on psychosocial factors that have been proved to be central for development and prognosis of neck pain."

BMC Musculoskelet Disord. Published online January 26, 2009.

Reuters Health Information 2009. © 2009 Reuters Ltd.

Clinical Context

Neck pain is highly prevalent, with two thirds of the adult population affected during their lifetime. However, only 10% of neck pain recurs or is persistent. Although many therapeutic approaches have been advocated, recommendations for management do not integrate all knowledge about psychosocial factors as prognostic factors to determine the outcomes and course of neck pain.

This is a cross-sectional survey of patients with neck pain seen in a general-practice setting to examine lifestyle and psychosocial factors associated with neck pain.

Stop Using Tamiflu for Healthy Flu Patients

Mark Reiter, MD, Emergency Medicine, Dec 14, 2009
Emergency Physician, Bethlehem, PA


Last week, The Cochrane Review, concluded that the existing literature (they looked at 5 higher quality studies out of 20 studies of antivirals for influenza) did not support the use of neuramidase inhibitors for healthy patients for treatment of influenza. They could not detect a statistically significant clinical impact, and did not an increase in side effects, particularly nausea. (www.medscape.com/viewarticle/713604) Many physicians had come to a similar conclusion, but Cochrane's findings certainly adds significant weight.

A few days ago, the World Health Organization endorsed The Cochrane Review's findings, and recommends that antivirals only be used in influenza at high risk for complications. (www.medscape.com/viewarticle/713775) The CDC has been offering similar advice for several months.

In the week ending October 31st, 587,960 prescriptions for antiviral flu medicines were filled in the U.S. (98% for Tamiflu), according to the LA Times.

Do we really think we are helping people? Are we hurting people? Are we trying to make satisfied patients what they think they want? Are we trying to avoid complaints or lawsuits? We need to do better....

Wednesday, December 23, 2009

Ten Minor Steps To Develop Your Wellbeing

By: Jayden Shemayah

Countless of us make wellbeing-related resolutions, such as to lose weight, to stop smoking or sign up for the neighborhood fitness center. While it is common to set excessive goals, trainers say that making lesser goals might do more for our health.

"Lesser steps are reachable and are easier to squeeze into your daily routine," says James O. Hill, Ph.D., Director of the Center for Human Nutrition at the University of Colorado Health Sciences Center. "They are less overpowering than a big, rapid conversion."

Here are 10 Steps to try:

1. Stop gaining weight. Even if you acquire only a pound or two each year, the extra weight adds up rapidly.

2. Walk more. Use a pedometer to add up your daily steps; after that add 2,000 extra steps into your day, the equivalent of one additional mile. Keep adding steps, 1,000 to 2,000 each month or so, until you take 10,000 steps on most days.

3. Eat breakfast. Breakfast eaters tend to have healthier diets and weigh less too. For a filling and nutrition-packed breakfast, top Whole Grain Total® with fresh fruit slices and low-fat or fat-free milk.

4. Replace three grain servings each day to whole grain. If you're like the average American, you eat fewer than one whole grain serving daily.

5. Have a minimum of one healthy green salad per day. Eating a salad (with low-fat or fat-free dressing) is filling and may help you eat a smaller amount during the meal. It also counts toward your five daily cups of fruits and vegetables.

6. Eliminate Fat. Fat has a lot of calories, and calories are a significant factor in weight loss. Purchase lean meats, eat poultry skinless, switch over to lower-fat cheeses, invest in a nonstick pan with just a dab of oil or butter.

7. Consider calcium by eating' two or three daily servings of low-fat or fat-free milk or yogurt. Dairy calcium is healthy for bones and may well also help you drop weight.

8. Downsize. If the package is small, the serving size will be smaller as well.

9. Aim to drop just 5 to 10 percent of your present weight. The benefits to losing weight are great-lower blood pressure, blood sugar, cholesterol and triglycerides.

10. Keep track of your eating. Jot down everything you eat over the next couple of days and be on the lookout for problem spots. Often, just writing things down can help you consume a reduced amount.


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Friday, December 18, 2009

Thousands of New Cancers Predicted Due to Increased Use of CT

From Medscape Medical News

Roxanne Nelson

December 17, 2009 — Computed tomography (CT) scans are widely used and are an invaluable tool for medical imaging. However, the possible overuse of CT scans and the variability in radiation doses might subsequently lead to thousands of cases of cancer, according to findings from 2 new studies published in the December 14/28 issue of the Archives of Internal Medicine.

In the first study, researchers found that radiation doses from common CT procedures are higher and more variable than what is typically cited. For example, the authors note that the median effective dose of an abdomen and pelvis CT scan is often cited as 8 to 10 mSv, but they found that the median dose of this type of scan was actually 66% higher, and the median dose of a multiphase CT scan of the abdomen and pelvis was nearly 4 times higher.

The authors also found a considerable range in doses within and across the institutions included in their study, with a mean 13-fold variation between the highest and lowest dose for each CT type studied.

In the second study, researchers estimated future cancer risks from current CT scan use in the United States, and projected that 29,000 future cancers will be directly attributable to CT scans that were performed in 2007. It is expected that the majority of these projected cancers will be caused by scans of the abdomen and pelvis (n = 14,000), chest (n = 4100), and head (n = 4000), and by CT coronary angiography (n = 2700).

What is becoming clear . . . is that the large doses of radiation from such scans will translate, statistically, into additional cancers.
More than 19,500 CT scans are performed every day in the United States; these expose each patient to the equivalent of 30 to 442 chest radiographs per scan, notes Rita F. Redberg, MD, MSc, professor of medicine at the University of California, San Francisco School of Medicine and editor of the Archives of Internal Medicine, in an accompanying editorial.

However, there is a question of benefit — whether these scans will lead to "demonstrable benefits through improvements in longevity or quality of life are hotly debated," she writes. "What is becoming clear, however, is that the large doses of radiation from such scans will translate, statistically, into additional cancers."

"We need to do something now, not wait 10 or 20 years to see the effects. It's not like radiation exposure can be undone after we find out that it does cause cancer," Dr. Redberg told Medscape Oncology.

Tuesday, December 1, 2009

Brain Care 101

Jan 11, 2008

It is Not Only Cars That Deserve Good Maintenance:
By: Alvaro Fernandez

Last week, the US Car Care Council released a list of tips on how to take care of your car and “save big money at the pump in 2008.”

You may not have paid much attention to this announcement. Yes, it’s important to save gas these days; but, it’s not big news that good maintenance habits will improve the performance of a car, and extend its life.

If we can all agree on the importance of maintaining our cars that get us around town, what about maintaining our brains sitting behind the wheel?

A spate of recent news coverage on brain fitness and “brain training” has missed an important constituency: younger people. Recent advancements in brain science have as tremendous implications for teenagers and adults of all ages as they do for seniors.

In a recent conversation with neuroscientist Yaakov Stern of Columbia University, he related how surprised he was when, years ago, a reporter from Seventeen magazine requested an interview. The reporter told Dr. Stern that he wanted to write an article to motivate kids to stay in school and not to drop out, in order to start building their Cognitive Reserve early and age more gracefully.

What is the Cognitive Reserve?

Emerging research since the 90s from the past decade shows that individuals who lead mentally stimulating lives, through their education, their jobs, and also their hobbies, build a “Cognitive Reserve” in their brains. Only a few weeks ago another study reinforced the value of intellectualy demanding jobs.

Stimulating the brain can literally generate new neurons and strengthen their connections which results in better brain performance and in having a lower risk of developing Alzheimer’s symptoms. Studies suggest that people who exercise their mental muscles throughout their lives have a 35-40% less risk of manifesting Alzheimer’s.

As astounding as these insights may be, most Americans still devote more time to changing the oil, taking a car to a mechanic, or washing it, than thinking about how to maintain, if not improve, their brain performance.

Further, better brain scanning techniques like fMRI (glossary) are allowing scientists to investigate healthy live brains for the first time in history. Two of the most important findings from this research are that our brains are plastic (meaning they not only create new neurons but also can change their structure) throughout a lifetime and that frontal lobes are the most plastic area. Frontal lobes, the part of our brains right behind the forehead, controls “executive functions” — which determine our ability to pay attention, plan for the future and direct behavior toward achieving goals. They are critical for adapting to new situations. We exercise them best by learning and mastering new skills.

This part of the brain is delicate: our frontal lobes wait until our mid to late 20s to fully mature. They are also the first part of our brain to start to decline, usually by middle age.

In my view, not enough young and middle-aged people are benefiting from this emerging research, since it has been perceived as something “for seniors.” Granted, there are still many unknowns in the world of brain fitness and cognitive training, we need more research, better assessments and tools. But, this does not mean we cannot start caring for our brains today.

Recent studies have shown a tremendous variability in how well people age and how, to a large extent, our actions influence our rate of brain improvement and/or decline. The earlier we begin the better. And it is never too late.

What can we do to maintain our brain, especially the frontal lobes? Focus on four pillars of brain health: physical exercise, a balanced diet, stress management, and brain exercise.
Stress management is important since stress has been shown to actually kill neurons and reduce the rate of creation of new ones.
Brain exercises range from low-tech (i.e. meditation, mastering new complex skills, lifelong learning and engagement) to high-tech (i.e. using the growing number of brain fitness software programs).

I know, this is starting to sound like those lists we all know are good for us but we actually don’t do. Let me make it easier by proposing a new New Year Resolution for 2008: every time you wash your car or have it washed in 2008, ask yourself, “What have I done lately to maintain my brain?”

Why Smart Brains Make Stupid Decisions

Jun 20, 2008

By: Alvaro Fernandez

It happens. Often.

Why?

We just secured an interview with Ori Brafman, co-author of Sway: The Irresistible Pull of Irrational Behavior (Doubleday Business, 2008), to discuss our Dark Side (well, he calls it “different hidden forces” and “psychological undercurrents”).

While reading some reviews about his book, I particularly enjoyed finding, after the usual impressive long collection of endorsements, this “disclaimer”:

*DISCLAIMER: If you decide to buy this book because of these endorsements, you just got swayed. One of the psychological forces you’ll read about in Sway is our tendency to place a higher value on opinions from people in positions of prominence, power, or authority. (But you should still buy the book.)


Alvaro Fernandez (AF): Ori, what is SWAY? can you give us a couple quick examples?

Ori Brafman (OB): Sway is about why perfectly rational people make irrational choices. We interviewed business executives, airline pilots, doctors, and even a Supreme Court Justice to uncover the psychological forces that affect our decision-making. What was especially interesting was to find out that we all get swayed, and that these psychological forces are much more ubiquitous than we thought.

Take, for instance, the story of Jacob Van Zanten who was the head of safety for KLM. One foggy afternoon, Van Zanten took off without getting tower clearance, causing the biggest airline accident in history. Why would this man, who’s the head of safety make such an irrational choice?

Or look at the story of Harvard Business School students who paid $204 for a twenty-dollar bill.

Â

AF: Happy to have attended Stanford… Now, how did that happen?

OB: The professor set up an auction for a $20 bill. But there was a twist. The winner would get the $20 bill. But the second place bidder, would still have to honor his bid, but would get nothing. At first there are lots of bidders, but then as the bidding approaches $20 people start pulling out. Inevitably, though two people stay in. As the bidding continued to rise, the second-place person became determined to not be the sucker who pays good money for nothing in return. The amazing thing is that time after time the auction continues well past the $20 point. People are just so determined not to lose, that they keep on bidding up.

AF: Why do people get Swayed?

OB: Without realizing it, we get swept up by a host of different hidden forces. I think of it like being in a boat in the middle of the ocean. It may look like we’re standing still, but underneath the surface, undercurrents move us without us realizing it. The same thing happens with psychological undercurrents. In Sway, we look at some of the major undercurrents and explore how they intersect triggering so many different irrational behaviors. The thing is that we’re prone to psychological sways all of the time–whether we’re conducting a job interview, going out on a first date, or deciding whether to sell a stock.

AF: Let’s be practical for a minute… what can people do to Sway other people?

OB: We’re constantly engaged in a hidden dance of sorts where we sway people around us and are swayed by others. One of the most unusual studies we encountered has to do with what we call the chameleon effect. In the study, a group of men and women–who had never met each other–were told to have a short phone conversation. Now, before the conversation, each man was shown a picture of the woman he’d be talking to. Unbeknownst to the men, the pictures were fake. And half the men were shown a picture of a beautiful woman, while the other half were shown a picture of a less attractive woman. The pictures had nothing to do with how the real women looked like, and the real women had no idea that there were any pictures shown. The kicker is that the women who the men thought were pretty ended up sounding beautiful on the phone. And the women who the men thought were less attractive ended up sounding less beautiful. We take on the roles others ascribe to us. Think about that with employees or even with your kids. If we think someone is smart, there’s a good chance they’ll live up to that role.

AF: And what can people do to prevent being Swayed?

OB: The biggest step is to recognize how often we get swayed. We have a tendency to think that our decisions are rational, when in fact, different sways may have informed the decision. Once we realize that we’re prone to get swayed, the second step is figuring out specific strategies to counter the sway.
It ranges from taking a long-term perspective to using empirical models for job interviews.

AF: For example?

OB: We have a propensity to “diagnose” a job candidate from the first moment we meet him or her. We assign a diagnosis, and are unable to see things in a different light despite objective evidence to the contrary. It’s for this reason that job interviews are terrible predictors of actual performance. A much more effective approach is to conduct very structured interviews that don’t allow managers to get swayed. In these interviews, the questions are pre-scripted and focus on experience and ability rather than vague things like “what’s your biggest strength?” We call these the Joe Friday interview (just the facts…) These interviews may seem less personal, but they’re actually much more effective for actually selecting a good candidate.

AF: Ori, thank you very much for your time.

OB: My pleasure!

http://www.sharpbrains.com/blog/2008/06/20/why-smart-brains-make-stupid-decisions/

Sunday, November 22, 2009

Management of Vitamin D Deficiency Reviewed

Am Fam Physician. 2009;80:841-846. Abstract

Clinical Context

Skeletal development, bone health, and neuromuscular function all require vitamin D. There are 2 forms of vitamin D: vitamin D2 (ergocalciferol), produced by irradiating ergosterol found in yeast and plants; and vitamin D3 (cholecalciferol), found in oily fish and synthesized in the skin in response to sunlight.

Because few foods contain vitamin D2, it is difficult to maintain adequate levels of vitamin D from dietary sources alone, and humans typically obtain 90% of vitamin D from sunlight. Because milk and other foods have been fortified with vitamin D, the rickets epidemic has subsided, but vitamin D deficiency and insufficiency are still linked to other pathologic conditions affecting persons of all ages.


Study Highlights

Signs and symptoms of vitamin D deficiency develop slowly or are nonspecific.
These may include symmetric low back pain in women, proximal muscle weakness, muscle aches, and throbbing bone pain.
Vitamin D deficiency is defined as a 25-hydroxyvitamin D level of less than 20 ng/mL (50 nmol/L).
Vitamin D insufficiency is defined as a serum 25-hydroxyvitamin D level of 20 to 30 ng/mL (50 - 75 nmol/L).
To prevent vitamin D deficiency, infants and children should have vitamin D intake of at least 400 IU/day from diet and supplements.
Unless infants are ingesting at least 1 L/day (33.8 fl oz) of vitamin D-fortified formula or milk, they should receive supplementation of 400 IU/day.
Vitamin D supplementation, 400 IU/day, is recommended for all children and adolescents who do not get regular sunlight exposure, who do not consume 1 L/day or more of vitamin D-fortified formula or milk, or who do not take a daily multivitamin supplement containing at least 400 IU of vitamin D.
In adults, vitamin D supplementation of 700 to 800 IU or more per day may reduce rates of falls and fractures.
Contraindications to vitamin D supplementation include tuberculosis or other granulomatous diseases, metastatic bone disease, sarcoidosis, or Williams syndrome.
Patients with vitamin D deficiency should receive oral ergocalciferol (vitamin D2), 50,000 IU per week for 8 weeks.
Serum 25-hydroxyvitamin D levels should be checked when this 8-week course is completed, and if these levels are not at least 30 ng/mL, the most likely cause is nonadherence to therapy or malabsorption.
A second 8-week course of ergocalciferol should be given if the level is not at least 30 ng/mL. Patients with suspected malabsorption may need gastroenterologic consultation.
Once vitamin D levels normalize in patients who were deficient, patients should receive maintenance dosages of cholecalciferol (vitamin D3), 800 to 1000 IU per day from dietary sources and/or supplements.
Because vitamin D is fat soluble, toxicity may result from excessive supplementation.
Signs and symptoms of vitamin D toxicity may include headache, metallic taste, nephrocalcinosis or vascular calcinosis, pancreatitis, nausea, and/or vomiting.

Clinical Implications

The diagnosis of vitamin D deficiency is often missed because the signs and symptoms develop slowly or are nonspecific, such as symmetric low back pain, proximal muscle weakness, muscle aches, and throbbing bone pain. Diagnosis of suspected vitamin D deficiency or insufficiency is confirmed with measurement of 25-hydroxyvitamin D levels.
In older adults, vitamin D supplementation of 700 to 800 IU per day is associated with a lower risk for falls and fractures. Suggested treatment in patients with vitamin D deficiency is oral ergocalciferol, 50,000 IU per week for 8 weeks. Adults with vitamin D deficiency, except for those with malabsorption syndromes, should receive maintenance dosages of 800 to 1000 IU of vitamin D per day.

Thursday, November 19, 2009

Folate Supplementation Linked to Increased Cancer Incidence and Mortality

From Medscape Medical News

Zosia Chustecka

November 18, 2009 — Folic acid and vitamin B supplementation was associated with an increase in cancer incidence, cancer mortality, and all-cause mortality in a new analysis with long-term follow-up of data from 2 trials conducted in Norway, where there is no folic acid fortification of foods.

The results are reported in the November 18 issue of the Journal of the American Medical Association.

The authors, led by Marta Ebbing, MD, from Haukeland University Hospital in Bergen, Norway, say that these results, although in need of confirmation, suggest that there is a need for "safety monitoring" because there is now widespread folic acid fortification of foods and increasing use of folic acid in dietary supplements.

However, the authors of an accompanying editorial points out that data from the United States, where there has been mandatory folic acid fortification of flour and other foods since 1998, have been showing a significant decrease in cancer incidence. "These national incidence rates do not support a substantial population-wide adverse effect of the magnitude suggested in the study," write the editorialists, Bettina F. Drake, PhD, MPH, and Graham Colditz, MD, DrPH, both from the Washington University School of Medicine in St Louis, Missouri.

"The population data from the United States do not suggest that there is a problem," Dr. Drake said in an interview with Medscape Oncology. She pointed out that folate supplementation used in the study resulted in much higher blood levels than would be seen after eating foods fortified with folic acid. In addition, the study was conducted in individuals with heart disease and was of limited duration.

The findings from this study "do not nullify the potential long-term benefits that folic acid fortification may have on population health," Dr. Drake explained. The measure was introduced to reduce neural tube defects in newborns (which arise from folate deficiency during pregnancy). A reduction was seen within a "few years," the editorialists note.

Concerns about a link between cancer and folic acid supplementation have been raised previously, most recently with regard to colorectal cancer, as reported by Medscape Oncology. At that time, leading expert on nutrition and cancer Walter Willet MD, DrPH, from the Harvard School of Public Health in Boston, Massachusetts, said: "I am certain that we are not causing an epidemic of colorectal cancer with folic acid fortification of flour." He added that there was a small increase in the incidence of this cancer soon after fortification was introduced, but this coincided with an increase in colonoscopy, and he pointed out that mortality rates from this cancer have been declining steadily.

Latest Results from Norway

The latest results come from 2 trials conducted in 6837 patients with ischemic heart disease, in which half the participants took supplements of vitamin B (including folic acid) to lower homocysteine levels to see if this would reduce cardiovascular outcomes. It did not, and these results are in line with other large trials.

At the same time, both trials showed — independently — an increase in cancer in the supplementation group, compared with the placebo group, but this was not statistically significant.

In these 2 trials, participants took supplements containing folic acid (0.8 mg/d), vitamin B12 (0.4 mg/d), and B6 (40 mg/d), or various combinations of these. This dose of folic acid is 4 to 6 times higher than the average dose delivered by the mandatory fortification in the United States, and is twice the recommended daily allowance, the authors note, although they add that it is below the tolerable upper intake level of 1 mg/d set by the US Institute of Medicine.

The current analysis pooled results from the 2 trials, which had a median participation of 39 months, and added data from an observational posttrial follow-up of 38 months, giving a total duration of around 5.5 years. The authors note that pooling the data from the 2 trials is "justified" because they were nearly identical.

This pooled analysis found a statistically significant increase in cancer incidence, cancer mortality, and all-cause mortality.

These results for cancer outcomes are not supported by other studies of homocysteine-lowering vitamin B trials, the authors note.

Cancer Decreasing Significantly

In their editorial, Drs. Drake and Colditz write that these results indicate an excess of approximately 3.5 new cases of cancer per 1000 people per year, and 1 excess case of lung cancer per 1000 people per year. The excess deaths correspond to 1.7 cancer deaths per 1000 people per year.

"These numbers, if generalizable to the United States, would be substantial at the overall levels of total cancer incidence and mortality," they write. In addition, an increase in lung cancer incidence would be expected.

"However, the rates of total cancer incidence decreased significantly from 2001 to 2005, and the lung cancer incidence has also declined significantly," they point out.

Although the study suggests there is an association between folic acid supplementation and an increase in cancer, the US population data suggest that there isn't a problem with folic acid fortification of foods and cancer, Dr. Drake told Medscape Oncology. Folic acid fortification has been mandatory in the United States for more than 10 years and, given the results of this study, we would have expected a significant increase in the incidence of cancer by now, she suggested.

One of the issues with clinical trials is that observations are reported with a short time frame after the implementation of an intervention, the editorialists note. This can often lead to "looking for effects that fit the time frame," they add. "By analogy, when keys are missing it is common to look for them under the lamppost where the light is, rather than in the murky location where the keys were more likely to have been dropped."

One of the coauthors on the paper, Klaus Meyer, PhD, is employed at the laboratory of Bevital AS. The other authors and both editorialists have disclosed no relevant financial relationships.

JAMA. 2009;302:2119-2126, 2152-2153.

Friday, October 30, 2009

Oral contraceptives and adverse birth outcomes

It has been suggested that the use of oral contra­ceptives near to the time of conception may be as­sociated with an increased risk of some congenital anomalies. Now a study using Canadian data has indicated that oral contraceptive use at this time may increase the risk of low birthweight and pre-term birth.

The study included 1,540 pregnant women who had used oral contraceptives within 3 months of their last menstrual period and 6,108 controls unexposed to oral contraceptives. Oral contracep­tive use within 30 days before the last menstrual period significantly increased the risk of very low birthweight (<1,500 g) 3.2-fold, of low birthweight (<2,500 g) by 93% and of preterm birth (<37 weeks) by 61%. Oral contraceptive use during the period 31–90 days before the last menstrual period did not increase these risks.

Use of oral contraceptives in the month be­fore the last menstrual period increases the risks of low birthweight and preterm birth.

Chen X-K, et al. Recent oral contraceptive use and adverse birth outcomes. Eur J Obstet Gynecol Reprod Biol 2009;144:40–43.
http://www.mims.com/Page.aspx?menuid=RecentHL&RecentHeaderID=351

Wednesday, October 28, 2009

Contrary to Common Belief, Women Feel Same Heart-Attack Symptoms as Men

From Heartwire
Reed Miller

October 27, 2009 (Edmonton, Alberta) — Women are as likely as men to feel chest pain or other typical heart-attack symptoms, a study presented October 26, 2009 here at the Canadian Cardiovascular Congress shows [1].

In the study, presented by critical-care nurse Martha Mackay (University of British Columbia School of Nursing, Vancouver), 305 patients (39.7% women, average age 64) undergoing a nonemergent PCI were asked a series of open-ended questions about their sensations and experience while the angioplasty balloon was creating an ECG-evident ischemia.

Women and men were equally likely to report chest discomfort or other "typical" symptoms of acute coronary syndrome, regardless of ischemic status. However, women were significantly more likely to report nonchest discomfort such as pain in the neck, jaw, and throat. Older patients were more likely to report chest or throat discomfort. Patients who had undergone a PCI before were more likely to report jaw pain, and prior MI and older age increased the likelihood of neck pain.

Countering Common Misperceptions

Even as professional organizations such as the American Heart Association (AHA) have made a major push to make women aware of their risk for cardiovascular disease, the perception that women's heart-attack symptoms are different from men's persists. Recent retrospective research--subject to recall bias and the usual problems associated with reliance on written medical records--has suggested that this perception is misguided, so Mackay and her colleagues chose to conduct this study because the question "hadn't really been settled."

To rectify the methodological issues of the previous research, Mackay's group developed their questions for the study subjects carefully to ensure they weren't influencing them to report a particular symptom. For example, they did not tell the patients they were studying ACS symptoms but instead told them they were researching patients' overall experience during PCI.

The study underlines the importance of public-education campaigns aimed at women such as the AHA's Go Red for Women campaign or the Heart Truth campaign run by the Heart and Stroke Foundation in Canada, Mackay said.

The study also suggests a need for new protocols and tools that will help health providers get a better understanding of patients' symptoms. Patients may not say they are feeling chest pain if another pain is more dominant. So providers must ask questions that elicit a more complete description of the patient's symptoms in order to make an accurate diagnosis, she explained.

Monday, October 26, 2009

Exercise Improves Fatigue in Cancer Patients on Chemotherapy

From Medscape Medical News

News Author: Zosia Chustecka
CME Author: Désirée Lie, MD, MSEd

October 21, 2009 — A supervised exercise program significantly improved fatigue in cancer patients undergoing chemotherapy, according to a study published online October 13 in the British Medical Journal.

The study also found significant improvements in vitality, aerobic capacity, muscular strength, physical and functional activity, and emotional well-being. However, there was no improvement in quality of life.

"The effect size of the improvement in fatigue (0.33) suggests a small to medium clinically important change," say the researchers, headed by Lis Adamsen, PhD, professor of clinical nursing at the Copenhagen University Hospital in Denmark. This is in contrast to some previous studies that found only a small or no effect.

The researchers suggest that the larger effect on fatigue seen in their study was due to several elements of their exercise program, including the high-intensity training.

"Doctors may encourage patients to exercise, but the exercise must be supervised," Dr. Adamsen told Medscape Oncology. In addition, for patients who are undergoing chemotherapy, there must be "specific inclusion criteria and screening procedures" in place to prevent adverse reactions, she added.

For example, 1 participant in this study who had a brain tumor experienced a grade 3 seizure after cardiovascular training. "We must therefore advise patients with brain tumors or brain metastases not to participate in high-intensity exercise interventions," the researchers note.

Nine Hours of Training Each Week

The study involved 269 patients with a variety of different cancers being treated at 2 Copenhagen university hospitals. There was a broad range of diagnoses and disease statuses, the researchers note. There were 27 patients with ovarian cancer, 28 with hematological malignancies, and 15 with testicular cancer; the remainder had cancer affecting the esophagus, brain, cervix, pharynx, pancreas, or stomach.

All of the patients were receiving chemotherapy, either as treatment for advanced disease or as adjuvant therapy, and there was a wide range of regimens in use.

Half of the patients were randomly assigned to the exercise program, which was supervised by trained nurse specialists and physiotherapists. It lasted for 6 weeks and involved 9 hours of training each week. The patients had to follow the program exactly; they could not pick and choose the activities they preferred, the researchers note. "The intervention was offered as a package and must be viewed as an entity [in which] each component has a role in the outcomes," they explain.

On Mondays, Wednesdays, and Fridays, there was a high-intensity physical training session lasting 90 minutes, followed by 30 minutes of relaxation training. The high-intensity session involved resistance training on machines, such as leg and chest presses, and cardiovascular training on a stationary exercise bike. On Tuesdays, there was a body awareness training session (which included stretching and exercises based on yoga and Pilates) lasting 90 minutes, followed by 30 minutes of relaxation training. On Mondays and Fridays, patients had 30 minutes of massage, which could include scar tissue massage and venous pump massage.

Larger Effect on Fatigue Than Seen in Previous Studies

Fatigue was the primary outcome, and was measured on a scale of 0 to 100. In this study, it was the most frequently reported symptom and, at baseline, 65% of study participants reported a fatigue level greater than that of the general population (mean score, 21), and 29% of participants reported severe fatigue (mean score, >60).

After 6 weeks on the exercise program, the patients who participated reported a significant improvement in fatigue, with ratings falling by an average of 6.6 points (P = .02; size effect, 0.33). The researchers note that this size effect could be clinically important. Although the intervention reduced fatigue, the mean score for these patients was 34.6, which is still higher than that for the general population.

This reduction in fatigue is greater than has been seen in previous studies, the researchers note. A meta-analysis of several studies (Cancer Epidemiol Biomarkers Prev. 2005;14:1588-1595) found an effect size of only 0.13, which may be "too small to be clinically meaningful," they write. In addition, 2 recent studies of moderate exercise in women with breast cancer who were receiving adjuvant therapy found no significant improvement in fatigue (BMJ. 2007;334:517-520; J Clin Oncol. 2007;25:4396-4404).

When asked about the differences between the results from the latest study and those from previous studies, Dr. Adamsen suggested that her team found a larger effect on fatigue because the exercise program they used involved high-volume training (9 hours per week) and because it involved a combination of high- and low-intensity elements.

The researchers believe that this is the first study to incorporate a high-intensity design; none of those mentioned in a review of 26 studies of exercise in cancer patients did (J Clin Oncol. 2005:23:899-909).

We found a reduction in fatigue that we consider to be of importance to the patients' daily lives.
"We found a reduction in fatigue that we consider to be of importance to the patients' daily lives, even though no change was seen in the global health status/quality of life," the researchers conclude.

"Being diagnosed with cancer and exposed to chemotherapy disrupts the patient's life, affecting physiological and psychological functioning and contributing to negative effects on global health status/quality of life," they point out. "Improvements in this measure may have been too ambitious a goal in this short-term clinical trial."

The researchers have disclosed no relevant financial relationships.

BMJ. 2009;339:b3410. Abstract

Thursday, October 22, 2009

Herpes Zoster Attacks Increase Stroke Risk By 30%

From Medscape Medical News CME
News Author: Susan Jeffrey
CME Author: Désirée Lie, MD, MSEd

October 20, 2009 — A new epidemiological study suggests that the risk for stroke, both ischemic and hemorrhagic, is increased by 30% after a herpes zoster attack. The risk is even higher, about 4-fold, if the attack involves the eye (herpes zoster ophthalmicus).

Herpes zoster infection, also known as shingles, has been shown in other studies to be associated with an increased risk for stroke, the researchers, with lead author Jiunn-Horng Kang, MD, from the Department of Physical Medicine and Rehabilitation and chair of the Sleep Physiological Lab at Taipei Medical University Hospital in Taiwan, point out. Their study is the first attempt to their knowledge to look at the exact risk and frequency of stroke after herpes zoster attacks.

There is still no established therapy to prevent herpes zoster vasculopathy and associated stroke, Dr. Kang told Medscape Neurology. Early antiviral medication could have an important role, he noted, but this role still needs to be studied.

"From the practical view, physicians should be aware of the potential elevated risk of stroke when they care [for] patients with acute herpes zoster attack," he said. "Furthermore, [careful] monitoring and management of the preexisting risk factors for stroke such as hypertension, hyperlipidemia, and diabetic mellitus could be helpful to reduce the risk for stroke."

The report was published online October 8 and will appear in the November issue of Stroke.

Large- and Small-Vessel VZV Vasculopathy

Primary varicella zoster virus (VZV) infection usually affects children and causes varicella or chicken pox, the researchers note. Although some children can have serious complications, varicella is usually benign and transient. The VZV then becomes inactive, sequestered in the sensory and autonomic ganglia. By mechanisms that are not entirely clear, the researchers note, spontaneous reactivation of VZV causes lesions with painful vesicles known as herpes zoster or shingles.

There have been numerous reports linking VZV vasculopathy and stroke syndrome after zoster attacks since the 1970s, the authors write, and VZV is the only recognized human virus able to replicate in cerebral arteries. "It is hypothesized to spread along the nerve fibers to the blood vessels, where it induces further inflammatory and thrombotic responses," Dr. Kang and colleagues note.

VZV vasculopathy can affect both the large and small vessels. In large-vessel VZV vasculopathy, vessels are damaged by inflammation induced by the virus, which can result in stroke. Small-vessel VZV vasculopathy, in contrast, can manifest as nonspecific symptoms including fever, headache, seizures, weakness, consciousness disturbances, and cognitive impairments, known as small-vessel encephalitis.

"To our knowledge, despite many case reports of conditions associated with VZV vasculopathy, large sample data regarding the exact frequency and risk of stroke occurring postherpes zoster attack are still lacking," the authors write.

In this study, the researchers used a data set released by the Taiwan National Health Research Institute in 2006, a representative sample of enrollees in Taiwan's National Health Insurance program. For this analysis, they identified a total of 7760 patients who received treatment for herpes zoster between 1997 and 2001 and matched them with 23,280 randomly selected subjects. The researchers then calculated the 1-year stroke-free survival for patients who received treatment for herpes zoster and for control subjects.

During the 1-year follow up, a total of 439 strokes occurred, 133 among those treated for herpes zoster (1.71%) and 306 from the control group (1.31%). The log rank test showed that those treated for herpes zoster had a significantly lower stroke-free survival rate (P < .001).

The risk for stroke after herpes zoster was increased by 31% compared with that for control patients and increased more than 4-fold for herpes zoster ophthalmicus.

http://cme.medscape.com/viewarticle/710960?sssdmh=dm1.546207&src=nldne&uac=71630FV


NOTES: Protect your child from chickenpox with the vaccine to be given at 15months and 4 1/2 year of age. If the unvaccinated child is known to have contact with a case of chickenpox or zoster, he should be vaccinated within 24 hours for maximal protection.

Wednesday, October 7, 2009

Oxygen Therapy Relieves Headache Pain in the ED, Cuts Length of Stay, Drug Use

From Reuters Health Information

By Marilyn Larkin

NEW YORK (Reuters Health) Oct 05 - Giving high-flow oxygen therapy for 15 minutes to emergency department patients with headaches provides rapid relief and reduces hospital stays, use of CT scans, and headache pharmacotherapy, according to a pilot study.

Dr. Boris Veysman of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School reported the results on Monday at the annual meeting of the American College of Emergency Physicians in Boston.

"Very often, when a patient comes to the emergency department with one complaint being headache, they're uncomfortable and symptomatic and they have to wait for a workup before anyone can determine the cause. A diagnosis may not even be made in the emergency department," Dr. Veysman told Reuters Health. "So we approached it from a different perspective and asked, 'What if therapy were the first thing you did (for a headache) before attempting to find a cause?' And so we tried giving oxygen therapy, because it's so widespread and safe."

In the placebo-controlled study, 17 patients were randomized to 100% oxygen at 15 L/min for 15 minutes; 14 received high flow air for 15 minutes; and 17 received no intervention prior to standard treatment. Headache intensity was assessed using a 10-point visual analog scale.

Median times to relief were significantly shorter for patients treated with oxygen (40 minutes) compared with those treated with high flow air (110 minutes) or nothing (120 minutes). Median length of stay was also significantly shorter for patients treated with oxygen (57.5 minutes) than for those treated with air (210 minutes) or nothing (180 minutes).

In addition, CT scans were ordered less frequently: for four of 17 patients (24%) who received oxygen; 11 of 14 (79%) who received air; and eight of 17 (47%) who got nothing.

Medication was given to 29% of those who received oxygen, 86% of those who received air, and 82% of those who received no treatment.

Headache intensity was significantly reduced at both 15 minutes and 30 minutes after initiation of treatment, with patients treated with oxygen realizing the greatest reductions.

"It was a small study, and our results are preliminary," Dr. Veysman stressed. "But the medical community is starting to recognize that it's important to treat discomfort even when you don't know what's causing it, as long as you feel confident the treatment won't make the patient worse. In this case, we found more relief with oxygen than with placebo, although the fact that the headache goes away doesn't necessarily mean the patient can go home."

Bayer Sued for Prostate Cancer Claims About Selenium in Multivitamin

From Medscape Medical News
Nick Mulcahy

October 6, 2009 — A consumer advocacy and industry watchdog group has filed suit against Bayer for claiming that an ingredient, selenium, in its One A Day Men's Health Formula multivitamin product might reduce the risk for prostate cancer.

The lawsuit was filed in the Superior Court of California in San Francisco, according to the filers, the Center for Science in the Public Interest (CSPI) of Washington, DC.

"Bayer has run radio ads that say their product may reduce the risk of prostate cancer. The packaging says the same. Even after the Selenium and Vitamin E Cancer Prevention Trial (SELECT) showed that selenium did not prevent prostate cancer, they continued to run TV ads that referred to a prostate health benefit," David Schardt, MS, senior nutritionist at CSPI, told Medscape Oncology.

Mr. Schardt explained that the company has never received approval from the US Food and Drug Administration (FDA) to make a specific prostate cancer claim.

He also said that any claim about prostate issues was an indirect reference to prostate cancer because selenium has never been shown to have any benefit for benign prostatic hyperplasia.

Bayer was allowed to make a "qualified claim" that "selenium may reduce the risk of certain cancers" on the basis of guidance from the FDA, said Mr. Schardt, but was not allowed to make a claim about prostate cancer.

Large Trial Showed No Benefit
Selenium has been promoted as potentially offering protection against prostate cancer by many different health supplement companies, but last year a large trial showed no benefit, and more recently, a smaller trial suggested that selenium is harmful if prostate cancer is already present.

SELECT is the 35,000-patient trial that found that neither selenium nor vitamin E, taken alone or together, prevented prostate cancer after 5 years of use, as reported by Medscape Oncology. In October 2008, the trial's Data and Safety Monitoring Committee made the decision to stop the use of the supplements.

A Bayer spokesperson told Medscape Oncology in an email that the FDA's guidance on the qualified health claim about selenium changed earlier this year. The company is now "in the process of revising the packaging and promotional materials for its One A Day Men's and One A Day Men's 50+ [Advantage products] to exclude reference to the qualified health claim regarding the relationship between selenium intake [and] the reduced risk for certain cancers."

The main support for FDA's earlier qualified claim about selenium was "data relating to prostate cancer," the email noted.

There have been a number of studies suggesting that selenium protected against prostate cancer, including the Nutritional Prevention Cancer Trial, a skin cancer study that incidentally revealed prostate cancer data (JAMA.1996;276;1957-1963). However, SELECT has been called the "definitive" trial on the subject by SELECT author and investigator Larry Baker, MD, from the University of Michigan in Ann Arbor.

Packaging and Ads Refer to Prostate Benefit

Although the company says that it is revising its promotional materials, a One A Day Men's Health Formula package bought today in Philadelphia by Medscape Oncology suggests a possible prostate cancer benefit.

Emerging research suggests Selenium may reduce the risk of prostate cancer.
"Did you know that prostate cancer is the most frequently diagnosed in men and that emerging research suggests Selenium may reduce the risk of prostate cancer?" says the label. "One A Day Men's Health Formula is a complete multivitamin plus key nutrients including Selenium to support a healthy prostate."

The packaging also includes the disclaimer that the "product is not intended to diagnose, treat, cure, or prevent any disease."

A One A Day radio ad with a prostate cancer claim is posted on the CSPI site; the date of the airing is not specified. The site also has a link to a TV ad for One A Day that refers to the benefits of selenium for prostate health.

Before filing its lawsuit, the CSPI filed a complaint in June 2009 with the FDA over the prostate cancer claim on One A Day Men's Health Formula labelling.

"The claim that the selenium in One A Day Men's Health Formula reduces the risk of prostate cancer gives the product the status of an unapproved drug, and is therefore illegal," according to a CSPI press statement.

Also in June, the CSPI urged the FDA to seize stockpiles of the men's vitamin.

The impetus behind the drastic recommendation was a new study on selenium and prostate cancer that suggested potential harm, according to a CSPI press statement.

In that study, researchers from the Dana-Farber Cancer Institute in Boston, Massachusetts, found that a high level of selenium in the blood was associated with a slightly elevated risk for aggressive prostate cancer in men who have the disease.

"If you already have prostate cancer, it may be a bad thing to take selenium,
" the senior author of the study told Medscape Oncology at the time.

Major League Baseball and One A Day

One A Day Men's Health Formula multivitamin has also been associated with prostate cancer through a charitable campaign with Major League Baseball (MLB).

"The main promotional platform with baseball is the 'One A Day Men's Strikeout Prostate Cancer Challenge,' in which One A Day and MLB combine to donate $10 to the Prostate Cancer Foundation for every strikeout thrown throughout the regular season and the playoffs," an MLB spokesperson told Medscape Oncology in an email.

The One A Day Web site features the campaign but also notes that the product is "not intended to prevent or treat prostate cancer."

Although nothing about the fundraising campaign is illegal, in June 2009, the CSPI encouraged both MLB and the Prostate Cancer Foundation to drop their ties to One A Day and Bayer because of the misleading advertising.

The CSPI estimates that the charitable contributions from this program with MLB should be around $350,000.

According to an article published October 1 in the New York Times , One A Day Men's Health Formula had sales of $23.3 million for the 52 weeks ending September 6. The source of the figure was Information Resources, a market research firm.

Bayer and Other Claims Issues

Bayer will be in big trouble if they are found to be in violation of the law.
"Bayer will be in big trouble if they are found to be in violation of the law," said Mr. Schardt about the prostate cancer claims. In 2007, the company signed a court order to not misrepresent any of their multivitamins, he explained.

This followed an action that resulted in Bayer paying a $3.2 million fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice over weight-loss claims made in connection with another One A Day product, according to a CSPI press statement.

Bayer is also running a $20-million corrective advertising campaign about its birth control pill Yaz under the order of the FDA and a number of state attorneys general, according to the same press statement.

Sunday, September 27, 2009

Consensus Statement Updated on Management of Hyperglycemia in Type 2 Diabetes

From Medscape Medical News
Laurie Barclay, MD

Diabetologia. Published online October 22, 2008.

Clinical Context

Good glycemic control can significantly lower morbidity rates related to type 2 diabetes and is therefore a vitally important treatment goal. Lowering and keeping glucose levels as close to the normal range as possible has been shown to reduce microvascular complications of diabetes, including retinopathy, nephropathy, and neuropathy.

In August 2006, the ADA and EASD published a consensus algorithm for the medical management of type 2 diabetes. An update in January 2008 specifically highlighted safety concerns regarding the thiazolidinediones, whereas this current update focuses on new classes of medications for which more clinical data and wider experience are now available.

Study Highlights

In type 2 diabetes, an important therapeutic goal is to achieve and to maintain hemoglobin A1c levels of less than 7.0%.

For most patients with type 2 diabetes, the initial treatment approach (tier 1, step 1) with well-validated therapies should include lifestyle intervention and use of metformin, titrated to its maximally effective dose at 1 to 2 months.

Lifestyle changes should aim to improve glucose levels, blood pressure, lipid levels, and weight control.

When tier 1, step 1 fails to achieve or maintain target glycemic goals, other medications should be added rapidly, and new regimens should be started.

If target hemoglobin A1c level is not achieved with step 1, or if metformin is contraindicated or poorly tolerated, step 2 is to add another medication, either insulin or a sulfonylurea.
Insulin, typically a basal (intermediate- or long-acting) insulin, is preferred for patients who have a hemoglobin A1c level of more than 8.5% or hyperglycemic symptoms.
Insulin plus metformin is a particularly effective means to lower glycemia while limiting weight gain.
In step 3, insulin therapy is started or intensified by giving additional injections, usually a short- or rapid-acting insulin given before selected meals, to reduce postprandial glucose levels.
Once insulin injections are started, insulin secretagogues (sulfonylurea or glinides) should be discontinued, or tapered and then discontinued.
In selected clinical settings, the tier 2 algorithm, which consists of less well-validated therapies, may be considered.
For patients with hazardous jobs that would make hypoglycemia particularly dangerous, exenatide or pioglitazone may be added, but rosiglitazone is not recommended.
Exenatide may be considered for patients who need to lose weight and in whom hemoglobin A1c level is close to target (< 8.0%).
If these interventions do not achieve target hemoglobin A1c levels or are not tolerated, tier 2 interventions should be stopped and basal insulin started.
The amylin agonists, alpha-glucosidase inhibitors, glinides, and dipeptidyl peptidase 4 inhibitors may be appropriate for selected patients.
However, they are not included in the 2 tiers of preferred agents because their efficacy to lower glucose is less or equivalent vs the first- and second-tier agents, they are relatively expensive, and clinical data regarding their use are limited.
Selecting individual agents should be based on their efficacy to lower glucose and on other characteristics.
When adding second antihyperglycemic medications, the synergy of particular combinations and other drug interactions should be considered.
Antihyperglycemic drugs with different mechanisms of action typically have the greatest synergy.

Pearls for Practice

In type 2 diabetes, an important therapeutic goal is to achieve and to maintain hemoglobin A1c levels less than 7.0%. For most patients, step 1 is lifestyle intervention and metformin. When this fails to achieve or maintain target glycemic goals, other medications should be added rapidly, and new regimens should be started. Step 2 is to add another medication, either insulin or a sulfonylurea. In step 3, insulin therapy is started or intensified.

The tier 2 algorithm using less well-validated therapies may be considered in selected patients. For those in whom hypoglycemia would be particularly dangerous, exenatide or pioglitazone may be added, but rosiglitazone is not recommended. Exenatide may be considered for patients who need to lose weight and in whom hemoglobin A1c level is close to target (< 8.0%),

Rapid Flu Tests Miss Many Swine Flu Cases: CDC

From Reuters Health Information

By Julie Steenhuysen

CHICAGO (Reuters) Sep 24 - A study of rapid influenza tests found they miss many cases of swine flu and U.S. health experts said on Thursday they are not worth the trouble for this flu season.

A study looking at the effectiveness of a rapid flu test in the first few weeks of the H1N1 pandemic in May found it detected less than half of the cases later confirmed by more sophisticated tests.

The findings, which appeared in the U.S. Centers for Disease Control and Prevention's MMWR, confirm the CDC's current guidelines, which stress that people with flu-like symptoms should get quick treatment, before getting a flu test.

Health and Human Services Secretary Kathleen Sebelius told reporters at a briefing that doctors should simply treat symptoms and not bother with testing.

"The flu is the flu is the flu," she said.

In September, the CDC said doctors should not wait for laboratory confirmation of H1N1 because quick treatment is important, and because a negative rapid test does not rule out the flu.

The latest study, conducted by Dr. James Sabetta and colleagues at the Greenwich Hospital and the Greenwich Department of Health in Connecticut, shows why.

They collected data on patients from two school outbreaks of pandemic H1N1 flu in May. They did rapid flu diagnostic tests on 63 patients using the Xpect Flu A&B test by Remel, a unit of Thermo Fisher Scientific, and more sophisticated lab tests.

They found the rapid flu test detected just 47 percent of the pandemic flu cases later confirmed by the slower, but highly accurate real-time reverse transcription-polymerase chain reaction, or rRT-PCR.
The findings confirm an earlier study by the CDC that found quick flu tests caught just 40 to 69 percent of swine flu cases. That study, released in August, looked at three popular flu tests -- BinaxNow, made by Inverness Medical Innovations, Becton Dickinson's Directigen EZ Flu A+B test and Quidel's QuickVue.

The CDC said the findings confirm their current guidelines, and stress that treating flu -- whether seasonal or pandemic -- is more important than knowing what kind a person has.
"Almost everybody will almost certainly not know what kind of flu they had," Dr. Anne Schuchat of the CDC told the briefing.

Many companies are working on better rapid tests including GlaxoSmithKline and Enigma Diagnostics, Seegene, a company based in South Korea and Maryland, DxNA based in Utah, and Osmetech PLC, based in California.

MMWR September 24, 2009.

Friday, September 25, 2009

Extended Physiotherapy, High-Dose Vitamin D Reduces Post-Hip Fracture Falls

From Medscape Medical News
Nancy A. Melville

September 22, 2009 (Denver, Colorado) — Extended physiotherapy, along with high-dose supplementation of vitamin D, after hip fracture can significantly improve the rate of falls and hospital readmissions for the elderly, according to a study presented here at the American Society for Bone and Mineral Research (ASBMR) 31st Annual Meeting.

High rates of post-hip-fracture morbidity and mortality are a heavy socioeconomic burden, yet there are no well-established guidelines for postfracture care among the elderly, said lead author Heike A. Bischoff-Ferrari, MD, professor of medicine at the University of Zurich in Switzerland. "Guidelines for postfracture care of elderly hip-fracture patients are not established, despite the fact that in the first 12 months after hip fracture, 5% to 10% of patients fracture their other hip, 30% are readmitted to acute care, 50% are left with permanent functional decline, 25% require long-term care, and 10% to 25% die," Dr. Bischoff-Ferrari said in an interview with Medscape Ob/Gyn & Women's Health.


To determine whether a strategy combining a home-based physiotherapy program and a vitamin D regimen could reduce some of the sequelae of hip fracture, the researchers enrolled 173 acute hip-fracture patients in their study; 79% were women with a mean age of 84 years and 77% were living in the community.

The researchers compared the effects of extended physiotherapy, which consisted of 1 hour of supervised physiotherapy per day during acute care plus an unsupervised home physiotherapy program, with those of standard physiotherapy, which consisted of 30 minutes of supervised physiotherapy per day during acute care and no home program.

The home-based physiotherapy involved basic exercises, such as getting in and out of a chair, balancing on 1 leg, walking up and down stairs, and a simple rubber-band exercise for upper-arm strength, Dr. Bischoff-Ferrari said.

The researchers also assessed the effects of 2000 IU of vitamin D3 per day, compared with 800 IU units per day, and the effect that the combined physiotherapy and vitamin D3 components had on the rate of falls and readmissions to the hospital.

Over the course of a 12-month follow-up, the researchers documented a total of 212 falls, with a rate of 1.43 falls per observed patient-year, and 74 hospital readmissions, with a rate of 0.5 per observed patient-year.

Falls among patients in the extended physiotherapy group were significantly reduced by 25%. Patients taking 2000 IU of vitamin D had a rate of hospital readmission that was 39% lower than those taking 800 IU of vitamin D per day.

The lower readmission rate could be explained by the 60% reduction in fall-related injuries and the 90% reduction in infections leading to inpatient care seen among the higher-dose vitamin D group, Dr. Bischoff-Ferrari said.

"Our study demonstrated that an extended physiotherapy program, together with 2000 IU of vitamin D, has complementary benefits for post-hip-fracture care, including a significant 25% reduction in falls and a 39% reduction in hospital readmission," she said. "This regimen could have an exceptional benefit on improving post-hip-fracture care for the elderly."

Jonathan D. Adachi, MD, professor of medicine at McMaster University in Hamilton, Ontario, said the study is particularly notable, not just for the improvements seen with the extended physiotherapy, but for the role of vitamin D.

"The study is very important because it demonstrates the benefit of both vitamin D and physiotherapy," said Dr. Adachi, who was not involved in the study.

"What is particularly important is the dose of vitamin D; most guidelines do not recommend this high a dose of vitamin D and many doctors do not recommend this dose of 2000 IU."

American Society for Bone and Mineral Research (ASBMR) 31st Annual Meeting: Abstract 1097. Presented September 12, 2009.

Monday, September 14, 2009

Depression Affects Survival in Cancer Patients

From Medscape Medical News
Roxanne Nelson

September 14, 2009 — The presence of depression might adversely affect outcomes in cancer patients. According to the findings of a meta-analysis, published online September 14 in Cancer, depression is a small but significant predictor of mortality in cancer patients.

Among patients experiencing depressive symptoms, mortality rates were up to 26% higher (unadjusted risk ratio [RR], 1.25; 95% confidence interval [CI], 1.12 - 1.40; P < .001) and among patients diagnosed with major or minor depression were up to 39% higher (unadjusted RR, 1.39; 95% CI, 1.10 - 1.89; P =.03) than those without these symptoms.

Conversely, depressive symptoms did not appear to significantly predict disease progression.

"Our meta-analysis did show an increased risk of risk of death in patients who report more depressive symptoms than others, and also in patients who have been diagnosed with a depressive disorder, compared with patients who have not," said first author Jillian R. Satin, MA, a doctoral student in clinical psychology at the University of British Columbia in Vancouver.

However, she emphasized that this study only shows that a link exists. "We cannot prove with this evidence that depression actually causes the increase in mortality," she told Medscape Oncology. "More research will be needed in order to potentially conclude this."

It is never too early in the course of cancer for patients to begin a dialogue with their physicians about mental-health issues.

A certain level of distress is expected after the diagnosis of cancer, Ms. Satin explained. "In our study, we restricted our analysis to studies that measure depression at least 1 month after diagnosis," she said. "Therefore, this is the time frame that our study makes conclusions about."

It can be difficult to define what a "normal" response to a cancer diagnosis looks like, Ms. Satin added, "but it is never too early in the course of cancer for patients to begin a dialogue with their physicians about mental-health issues."

Inconclusive Evidence Prompts Meta-Analysis

Depression has been widely studied in cancer patients, and is the most commonly studied psychological variable with respect to cancer progression and mortality in this population, the authors report. Depression is also the only psychological condition that is more commonly found in cancer patients than in the general population, and is the psychological problem most likely to persist throughout the illness trajectory.

The authors also point out that "a plausible model exists to link depression with cancer progression and mortality through both behavioral and biological pathways." An example is chronic activation of the hypothalamo-pituitary–adrenal axis, which has been implicated as a possible mediator of the effect of depression on disease progression in cancer. Depression has also been associated with inflammation, as previously reported by Medscape Oncology.

Although cancer patients and oncologists believe that psychological variables can influence the course of cancer, the evidence remains inconclusive. For this reason, Ms. Satin and colleagues conducted a meta-analysis to evaluate the extent to which depressive symptoms and major depressive disorder predict disease progression and mortality in cancer patients.

Depression Linked to Mortality but Not Progression

To examine the effects of depression on survival, the researchers identified 27 observational studies (n = 9417), conducted from 1990 to 2009, which met all of their inclusion criteria. Of this group, 25 independent studies were based on measures of depressive symptoms, 3 were based on major or minor depression, 16 evaluated survival at less than 5 years postdiagnosis, and 11 examined survival at 5 years postdiagnosis or more.

"There is no evidence that the effect weakens when adjustments are made for other known risk factors, suggesting that depression may be an independent risk factor in cancer mortality, rather than merely correlating with biological factors associated with a poor prognosis," they write.

Only 3 studies were available for an analysis of the risk for depression on cancer progression, and depressive symptoms did not significantly predict disease progression (unadjusted RR,= 1.23; 95% CI, 0.85 - 1.77; P = .28).

The authors found it "surprising" that depression appeared to predict mortality but not disease recurrence, and postulated that the difference was primarily due to the limited number of studies in their analysis and the corresponding low power.

What Are the Latest Childhood Vaccine Recommendations?

From Medscape Nurses > Ask the Experts
Wendy L. Wright

Pediatric

All children aged 6 months to 18 years should be immunized against influenza. In the past, only high-risk children were immunized against seasonal influenza. Now, all children, regardless of risk, should receive this immunization. It is estimated that this recommendation means that approximately 50 million children will need the influenza vaccination this year. It is important, particularly in 2009, that clinicians begin to immunize against influenza as soon as the vaccines are received in the office. This will make way for the receipt of the H1N1 vaccine, which is anticipated in October or November of this year. Clinicians can be assured that although we will begin the immunization campaign in early September, much earlier than in the past, it will protect children throughout flu season.[1]

Patients aged 6 months to 24 years as well as those at high risk as a result of pulmonary or cardiac conditions should receive the H1N1 vaccination when it becomes available. At the time of this writing, this vaccination will probably be a series of 2 vaccinations, separated by 3 weeks. The first injection may be administered at the same time as the seasonal influenza vaccine, if it has not already been given. The vaccine will be purchased by the federal government and shipped to the states for distribution and administration. Each state is in charge of implementing the distribution and administration of the vaccine. While we are anticipating release of the vaccine in October, clinical trials for efficacy and safety are still under way.[1,2]

A combination vaccine named Pentacel is now available for infants. This combination vaccine provides protection against diphtheria, tetanus, and pertussis; polio; and Haemophilus influenzae type B. Depending on the state in which you practice and the vaccines to which you have access, this series may decrease the number of injections given to children by up to 7 shots. It consists of 4 injections administered at 2, 4, 6, and 15-18 months.[1]

The restrictions on H. influenzae type B vaccination have now been relaxed. Healthcare providers should attempt to "catch up" the children who missed dose number 4 of the series due to a lengthy shortage of the vaccine.[1]

There are currently 2 rotavirus vaccines available. RotaTeq is a series of 3 oral vaccinations given at 2, 4, and 6 months and Rotarix is a series of 2 oral vaccinations administered at 2 and 4 months. Providers must be aware of which vaccine product they are using to make certain that the correct schedule is followed

Adolescents

All adolescents age 11-18 years should receive the meningococcal (MCV4 or Menactra) vaccine. In the past, this vaccine was often recommended to be given just before a student went to college. However, the Advisory Committee on Immunization Practices now recommends that all children be immunized with MCV4 to provide protection against 4 strains of Neisseria meningitidis beginning at 11 years. It should be noted that children at high risk due to travel or immunosuppressive conditions may receive the vaccine as early as 2 years of age and may have it repeated, if high risk, 5 years after the initial vaccination.[1]

HPV (human papillomavirus) vaccine is recommended for all young women age 9-26 years as a 3-part series. The series is frequently initiated at 11 years of age but may be given as early as 9 years of age. It is administered according to the following schedule: day 0, 2 months after day 0, and 6 months after day 0. Healthcare providers should observe the recipient for 15 minutes following administration of the vaccine. In addition, the vaccinator may wish to place the child in a semirecumbent position during administration due to reports of syncope after vaccine administration.[1]

Tdap (combined tetanus, diphtheria, and pertussis) should be administered to all adolescents age 11 years and older. This additional pertussis protection should be given once to all adolescents and adults who have not received a pertussis booster.

Individuals 65 years of age and older should be given Td only, as the pertussis component has not been deemed safe or efficacious for this age cohort.

Saturday, September 12, 2009

New Review Endorses Cardiovascular Benefits of Fish Oil

From Heartwire
Lisa Nainggolan

August 10, 2009— A new review concludes that there is extensive evidence from three decades of research that fish oils, or more specifically the omega-3 polyunsaturated fatty acids (PUFAs) contained in them, are beneficial for everyone.

This includes healthy people as well as those with heart disease — including postmyocardial infarction (MI) patients and those with heart failure, atherosclerosis, or atrial fibrillation — say Dr Carl J Lavie (Ochsner Medical Center, New Orleans, LA) and colleagues in their paper published online August 3, 2009, in the Journal of the American College of Cardiology.

"We reviewed everything that was published on omega-3 that was clinically important, and the major finding is that there are a tremendous amount of data to support the benefits of omega-3, not just as a nutritional supplement — people have known that for years — but evidence that it prevents and treats many aspects of cardiovascular disease," Lavie told heartwire .

Lavie said he believes physicians are not as familiar with the omega-3 studies as they should be: "Clinicians know the findings of many statin trials even if they do not know all the details — they know that there are a ton of statin data. The omega-3 data may not be as impressive or as plentiful as this, but it should be 'promoted' to clinicians."

Omega-3 PUFA, says Lavie, "is a therapy that clinicians should be considering prescribing to their patients. Not just as something healthy but as something that may actually prevent the next event. In HF [heart failure], it may prevent death or hospitalization and the same thing post-MI." He and his colleagues reiterate the advice of the American Heart Association (AHA): that those with known coronary heart disease (CHD) or HF eat four or five oily-fish meals per week or take the equivalent in omega-3 supplements; healthy people should consume around two fatty-fish meals per week or the same in supplements.

Most Data on EPA and DHA

In their review, Lavie and colleagues explain that most of the data on omega-3 have been obtained in trials using docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the long-chain fatty acids in this family. The most compelling evidence for cardiovascular benefits comes from four controlled trials of almost 40,000 participants randomized to receive EPA with or without DHA in studies of primary prevention, after MI, and most recently with HF, they note.

They discuss the results for each specific cardiovascular condition in turn. For CHF, three large randomized trials — the Diet and Reinfarction Trial (DART), the Gruppo Italiano per lo Studio della Sopravvivenza nell' Infarto Miocardico (GISSI)-Prevenzione, and the Japan EPA Lipid Intervention Study (JELIS) — have indicated that omega-3 PUFAs lower CV risk in both the primary- and secondary-prevention settings, they note.

Lavie elaborated to heartwire : "The benefit is different in different studies but can be as much as 30%." The effects are seen on total mortality, sudden death, CHD mortality, and cardiovascular mortality.

But there are some studies that have not shown favorable results, although there are generally methodological reasons for this, they say. However, they do flag the most recent study of post-MI patients, OMEGA, which suggests there may not be additional short-term benefit of omega-3 PUFAs in low-risk patients already receiving optimal modern therapy.

There is also evidence of benefit in atherosclerosis and in a wide range of arrhythmias, with the most significant effect and potential benefit seen in "the current epidemic" of atrial fibrillation (AF), note the researchers. But more studies are needed to explore the effects of various doses of omega-3 PUFAs on the primary and secondary reduction of AF and to determine whether the benefits are caused by antiarrhythmic effects, benefits on autonomic tone, or even anti-inflammatory effects, they observe.

Benefit of Fish Oils Also Extend to HF

Recently, the potential benefits of omega-3 PUFAs "have been extended to the prevention and treatment of HF," say Lavie et al. Although the reduction in events was "only 8% to 9% in the recent GISSI-HF trial, which is not huge," Lavie admits, "when you think of HF, it's a very serious disorder, and in GISSI-HF, those patients were treated vigorously for their HF, so they were on good therapy, and adding just one [omega-3 PUFA] pill a day reduced deaths by between 8% and 9%, which is a pretty nice additional benefit."

But he and his colleagues say further studies are needed to determine the optimal dosing of omega-3 PUFA for different stages of HFand to investigate the underlying mechanisms for the benefits. However, in the meantime, omega-3 PUFA supplements "should join the short list of evidence-based life-prolonging therapies for HF."

They also discuss the data on omega-3 PUFAs in hyperlipidemia, noting that the FDA has approved one such supplement for the treatment of very high triglyceride levels.

And they note that more studies are needed to determine the optimal mix of DHA relative to EPA in various populations.

Finally, they state that this review does not focus on the plant-based precursor of EPA, alpha-linolenic acid (ALA), which is found in abundance in flaxseed and to a lesser extent in other plants. But they observe "the overall evidence is much weaker for ALA than for EPA and DHA."

Recommendations for Omega-3 Consumption

Mirroring recommendations from the AHA, European Society of Cardiology, and the World Health Organization (WHO), Lavie and colleagues recommend that healthy people consume at least 500 mg per day of EPA/DHA — equal to around two fatty-fish meals per week — and that those with known CHD or HF get 800 to 1000 mg per day EPA/DHA.

Asked by heartwire whether people should try to consume more fish or alternatively take supplements, Lavie says: "If somebody really were eating salmon and tuna and mackerel and sardines, and they were doing that several times a week, then they wouldn't need to be taking a supplement. But in the US, at least, very few people are going to eat the therapeutic doses of fatty fish."

Other good reasons to take supplements include the fact that they have usually had impurities, such as mercury, removed, he notes.

If people are trying to improve their consumption of oily fish, they could take supplements only on the days they were not eating such fish or every other day to try to get up to the recommended amount of omega-3 PUFAs, Lavie says.

But he warns that regimens that are too complex might result in underconsumption: "I would tend to think that most people are getting very little omega-3 PUFAs in the diet. There's no harm in taking extra — the only negative of extra is the calories. I don't think anyone thinks now that fish oil is doing any harm."

Thursday, September 10, 2009

Soluble Fiber May Be Effective for Symptoms of IBS

From Medscape Medical News CME
Laurie Barclay, MD & Charles P. Vega, MD

BMJ. 2009;339:b3154. Abstract

Clinical Context

IBS has a population-wide prevalence of approximately 10%, according to the authors of the current study. However, only a minority of individuals with IBS seek medical care for their symptoms. Most patients with IBS are women, and, although most cases of IBS are managed in primary care practices, few primary care clinicians use formal criteria to diagnose IBS.

Dietary advice and fiber supplements are considered mainstays of therapy for IBS. The current study compares a soluble fiber (psyllium) and insoluble fiber (bran) vs placebo in the treatment of IBS.


Study Highlights

Study participants included adults between the ages of 18 and 65 years who had been diagnosed with IBS in the previous 2 years. The study was conducted in primary care practices in the Netherlands. Diagnoses of IBS were identified through billing data, and researchers evaluated whether patients met formal diagnostic criteria for IBS as well.
Patients who had received fiber treatment in the past 4 weeks, who had a psychiatric disorder, or who had another diagnosis of organic bowel disease were excluded from study participation.
Participants were randomly assigned to receive 10 g of psyllium, 10 g of bran, or rice flour placebo in 2 daily dosages. Each study treatment was mixed with food, preferably yogurt. The treatment period was 3 months.

The main outcome of the study was adequate symptom relief for at least 2 weeks of the previous month, which was defined as response to treatment. Secondary outcomes included a measurement of IBS symptom severity, the severity of abdominal pain specifically, and disease-specific quality of life.
275 patients underwent randomization. 78% of participants were women, and 94% were white. The mean age of participants was 34.4 years.
Only 39% of participants fulfilled the Rome II diagnostic criteria for IBS. Most subjects had constipation-predominant IBS.
The mean intake of daily fiber before study treatment was 26.9 g/day, which was consistent with national average consumption in the Netherlands.

Only 60% of participants attended the final visit at the end of the 3-month study period. Most patients who left the trial did not provide a reason for discontinuing their participation, but study discontinuation was most common among the bran group in the first study month. Most of these patients complained of a worsening of IBS symptoms.
Among patients who remained in the trial, adherence to study therapy was similar in the psyllium and bran groups, as were the consumption of dietary fiber and total fluids.

57% of participants receiving psyllium experienced a treatment response at 1 month vs 35% of participants receiving placebo. The respective response rates at month 2 were 59% and 41%, and psyllium was significantly superior to placebo in both months. The superiority of psyllium was lost in the third month of the trial.
Subgroup analysis focusing on patients who met Rome II criteria for IBS suggested that psyllium may be even more effective for these patients. Psyllium remained more effective than placebo in an analysis limited to participants with constipation-predominant IBS.
Bran was superior to placebo in the main study outcome only in the third month of the trial.
Psyllium was associated with a significant overall reduction in IBS symptoms vs placebo, whereas bran was not.
Neither psyllium nor bran relieved IBS abdominal pain or improved quality of life vs placebo.
The percentages of participants who remained in the study and reported adverse events were 74%, 64%, and 66% in the psyllium, bran, and placebo groups, respectively. Diarrhea and constipation were the most commonly reported adverse events and were common in all treatment groups.

Clinical Implications

The prevalence of IBS is approximately 10%, with a predilection for women. Most patients with IBS do not seek medical care for their symptoms, and most primary care physicians do not use formal criteria to diagnose IBS.
The current study suggests that psyllium may relieve IBS symptoms, whereas bran may worsen symptoms.