FDA Approves Device To Treat Obesity

Recently, the U.S. Food and Drug Administration approved the very first weight loss device that controls satiety.  The Maestro Rechargeable System targets the neural pathway between the brain and the stomach that controls feelings of hunger and fullness.

However, this device will only be available to adults aged 18 years of age and older with a body mass index of 35-45 combined with at least one other obesity-related condition (i.e. type 2 diabetes) that have had no success with weight loss programs.

How does it work?

“The Maestro Rechargeable System consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown.”

In addition, health care professionals will have the ability to adjust settings on this surgically implanted device as required throughout treatment.

Is it safe?

A clinical trial consisting of 233 patients with a BMI of 35+ were tested over a period of 12 months to ensure the product is safe and effective.  The Maestro Rechargeable System was tested on all patients however, 76 of the devices were not activated. Results showed that those with the activated devices lost 8.5% more weight than those with inactive devices.  Remarkably, fifty-two and a half percent of the patients with the active device experienced a 20% weight loss and 38.3% lost 25% of their excess weight.

However, both groups experienced a weight loss.  In fact, participants with the active devices did not even lose at least 10% more than those with inactive devices.  In addition, reported side effects included nausea, pain at the neuroregulator site, vomiting, surgical complications, pain, heartburn, problems swallowing, belching, mild nausea and chest pain.

Despite these results, the FDA determined that the benefits outweigh any risk to a patient that meets the eligibility criteria.  An FDA-sponsored survey also indicated that individuals would be willing to use this device based on the presumed weight loss.  Still, the FDA requires that the manufacturer conduct a five year follow up study of a minimum of 100 patients to further review the device’s safety and effectiveness.

Facts on obesity:

• During the past 20 years, there has been a dramatic increase in obesity in the United States and rates remain high.
  
• More than one-third (34.9% or 78.6 million) of U.S. adults are obese.
  
• Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of preventable death.
  
• The estimated annual medical cost of obesity in the U.S. was $147 billion in 2008 U.S. dollars; the medical costs for people who are obese were $1,429 higher than those of normal weight.

FDA approves first-of-kind device to treat obesity
Centers for Disease Control and Prevention

© www.mentalhealthblog.com

More Than Two Drinks Per Day Can Increase Your Risk of Stroke

According to a new study, drinking more than 2 alcoholic drinks each day in middle-age increases a person’s risk of stroke more than typical risk factors such as high blood pressure and diabetes.

Researchers used data gathered between 1967 and 2010 from 11,644 individuals from the Swedish Twin Registry to compare the effects of heavy drinking on risk of stroke. Heavy drinking was defined as 2 or more drinks per day and light drinking as less than 0.5 drinks per day.  

Results demonstrated that heavy drinking increased the risk of stroke by 34% in comparison to light drinking.  The heavy drinkers were also more likely to have a stroke 5 years earlier than their counterparts, regardless of genetics or other factors.  In addition, middle-aged heavy drinkers exhibited a risk of stroke comparable to individuals with high blood pressure and diabetes.  Moreover, the study found that almost 30% of participants had suffered a stroke and by age 75, blood pressure and diabetes were regarded as the main cause of stroke. 

“Among identical twin pairs, siblings who had a stroke drank more than their siblings who hadn't had a stroke, suggesting that mid-life drinking raises stroke risks regardless of genetics and early lifestyle.”

Not only does regular heavy drinking increase the risk of stroke, it also affects blood pressure and causes various health complications.  

Effects of Alcohol:

Drinking too much – on a single occasion or over time – can take a serious toll on your health.  Here’s how alcohol can affect your body:

Heart: Drinking a lot over a long time or too much on a single occasion can damage the heart, causing problems including:

• Cardiomyopathy – Stretching and drooping of heart muscle
• Arrhythmias – Irregular heart beat
• Stroke
• High blood pressure  

* Research also shows that drinking moderate amounts of alcohol may protect healthy adults from developing coronary heart disease.

Liver: Heavy drinking takes a toll on the liver, and can lead to a variety of problems and liver inflammations including:

• Steatosis, or fatty liver
• Alcoholic hepatitis
• Fibrosis
• Cirrhosis

Pancreas: Alcohol causes the pancreas to produce toxic substances that can eventually lead to pancreatitis, a dangerous inflammation and swelling of the blood vessels in the pancreas that prevents proper digestion. 

Cancer: Drinking too much alcohol can increase your risk of developing certain cancers, including cancers of the:

• Mouth
• Esophagus
• Throat
• Liver
• Breast

Immune System: Drinking too much can weaken your immune system, making your body a much easier target for disease.  Chronic drinkers are more liable to contract diseases like pneumonia and tuberculosis than people who do not drink too much.  Drinking a lot on a single occasion slows your body’s ability to ward off infections – even up to 24 hours after getting drunk.

Brain: Alcohol interferes with the brain’s communication pathways, and can affect the way the brain looks and works. These disruptions can change mood and behavior, and make it harder to think clearly and move with coordination.  

People who have been drinking large amounts of alcohol for long periods of time run the risk of developing serious and persistent changes in the brain. Damage may be a result of the direct effects of alcohol on the brain or may result indirectly, from a poor general health status or from severe liver disease.

Up to 80 percent of alcoholics, however, have a deficiency in thiamine, and some of these people will go on to develop serious brain disorders such as Wernicke–Korsakoff syndrome (WKS).  WKS is a disease that consists of two separate syndromes, a short–lived and severe condition called Wernicke’s encephalopathy and a long–lasting and debilitating condition known as Korsakoff’s psychosis.

The symptoms of Wernicke’s encephalopathy include mental confusion, paralysis of the nerves that move the eyes (i.e., oculomotor disturbances), and difficulty with muscle coordination. For example, patients with Wernicke’s encephalopathy may be too confused to find their way out of a room or may not even be able to walk. 

Approximately 80 to 90 percent of alcoholics with Wernicke’s encephalopathy also develop Korsakoff’s psychosis, a chronic and debilitating syndrome characterized by persistent learning and memory problems. Patients with Korsakoff’s psychosis are forgetful and quickly frustrated and have difficulty with walking and coordination. Although these patients have problems remembering old information (i.e., retrograde amnesia), it is their difficulty in “laying down” new information (i.e., anterograde amnesia) that is the most striking. 

Heavy drinking in middle-age may increase stroke risk more than traditional factors
National Institute on Alcohol Abuse and Alcoholism

© www.mentalhealthblog.com

Samsung Develops Gadget to Detect Strokes

In recent news, engineers at the Samsung Electronics Creative Lab (C-Lab) have developed an Early Detection Sensor & Algorithm Package (EDSAP) that has the ability to detect strokes.

“The resulting headset is equipped with sensors that transfer data to algorithms that allow you to observe your brainwaves on your Smartphone, tablet or upright computer to make sure you are not at risk.”

Interestingly, this device could potentially save lives by ensuring that people obtain proper medical attention in a timely manner.  Samsung claims that it’s even more efficient than hospital equipment as it analyzes brainwaves more rapidly and detects more detail due to a rubber-like ultra-conductive material.

Apparently, the headset is merely a prototype and the sensors will actually function effectively in any type of headgear such as barrettes or even eyeglasses.

There is no word on when this device could be available to the general public; however they do suggest that this technology could lead to other applications such as monitoring heart muscle activity.

Despite the fact that the device is not approved or regulated, it is refreshing that companies like Samsung are spending some of their efforts on developing gadgets other than newer models of Smartphones and Tablets.

Until then…

“A stroke, sometimes referred to as a cerebrovascular accident (CVA), cerebrovascular insult (CVI), or colloquially brain attack is the loss of brain function due to a disturbance in the blood supply to the brain. This disturbance is due to either ischemia (lack of blood flow) or hemorrhage. As a result, the affected area of the brain cannot function normally, which might result in an inability to move one or more limbs on one side of the body, failure to understand or formulate speech, or a vision impairment of one side of the visual field.”

Warning Signs:

• Sudden numbness or weakness of face, arm or leg, especially on one side of the body.
  
• Sudden confusion, trouble speaking, or understanding.
  
• Sudden trouble seeing in one or both eyes.
  
• Sudden trouble walking, dizziness, loss of balance or coordination.
  
• Sudden severe headache with no known cause.

Some Statistics:

• In 2010, worldwide prevalence of stroke was 33 million, with 16.9 million people having a first stroke. 
• Stroke was the second-leading global cause of death behind heart disease, accounting for 11.13% of total deaths worldwide.
  
• Stroke is the No. 4 cause of death in the United States, killing nearly 129,000 people a year.
  
• Stroke kills someone in the U.S. about once every four minutes.
  
• African-Americans have nearly twice the risk for a first-ever stroke than white people, and a much higher death rate from stroke.
  
• Over the past 10 years, the death rate from stroke has fallen about 35 percent and the number of stroke deaths has dropped about 21 percent.
  
• About 795,000 people have a stroke every year.
  
• Someone in the U.S. has a stroke about once every 40 seconds.
  
• Stroke causes 1 of every 20 deaths in the U.S.
  
• Stroke is a leading cause of disability.
  
• Stroke is the leading preventable cause of disability.

Samsung developing wearable headset to detect strokes
Stroke
American Heart Association

© www.mentalhealthblog.com

Depression May Be Linked to Inflammation in the Brain

New research in Canada reveals that inflammation deep in the brain may be linked to depression.  Specifically, the Centre for Addiction and Mental Health (CAMH) studied the brain scans of patients with depression and those without.  Results showed 30% more inflammation in the brains of patients with clinical depression.  In addition, symptoms worsened with the degree of inflammation.  Keeping in mind that researchers only studied the scans of 40 patients, concrete conclusions are a tad premature.

Nevertheless, this research does offer new ideas for investigation, which could uncover other possible causes for the illness as well as potential new treatments for depression.  In other words, perhaps reducing inflammation in the brain may alleviate or eliminate the symptoms.  This is exciting news for the individuals that do not respond to medication, which, according to this research, consists of 30 to 50 per cent of patients!

“Inflammation is part of the complex biological response of vascular tissues to harmful stimuli, such as pathogens, damaged cells, or irritants.

[…] The purpose of inflammation is to eliminate the initial cause of cell injury, clear out necrotic cells and tissues damaged from the original insult and the inflammatory process, and to initiate tissue repair.

[…] Too little inflammation could lead to progressive tissue destruction by the harmful stimulus (eg. bacteria) and compromise the survival of the organism. In contrast, chronic inflammation may lead to a host of diseases, such as hay fever, periodontitis, atherosclerosis, rheumatoid arthritis, and even cancer (e.g., gallbladder carcinoma).”

According to Dr. Jeffrey Meyer of CAMH, it is theorized that the body of patients that have suffered some type of infection or trauma may have healed, however the brain has not had the opportunity to recover.  This may explain why patients with certain types of inflammatory disease, such as lupus, are several times more likely to develop clinical depression.

Of course, it is still unclear whether the inflammation in the brain occurs before depression sets in or as a result of the illness.

_______________________________________________
Depression is a mood disorder that causes a persistent feeling of sadness and loss of interest. Also called major depression, major depressive disorder or clinical depression, it affects how you feel, think and behave and can lead to a variety of emotional and physical problems. You may have trouble doing normal day-to-day activities, and depression may make you feel as if life isn't worth living.

During these episodes, symptoms occur most of the day, nearly every day and may include:

• Feelings of sadness, emptiness or unhappiness
  
• Angry outbursts, irritability or frustration, even over small matters
  
• Loss of interest or pleasure in normal activities, such as sex
  
• Sleep disturbances, including insomnia or sleeping too much
  
• Tiredness and lack of energy, so that even small tasks take extra effort
  
• Changes in appetite — often reduced appetite and weight loss, but increased cravings for food and weight gain in some people
  
• Anxiety, agitation or restlessness — for example, excessive worrying, pacing, hand-wringing or an inability to sit still
  
• Slowed thinking, speaking or body movements
  
• Feelings of worthlessness or guilt, fixating on past failures or blaming yourself for things that are not your responsibility
  
• Trouble thinking, concentrating, making decisions and remembering things
  
• Frequent thoughts of death, suicidal thoughts, suicide attempts or suicide
  
• Unexplained physical problems, such as back pain or headaches

Facts: 

• Depression is a common mental disorder. Globally, more than 350 million people of all ages suffer from depression.
  
• Depression is the leading cause of disability worldwide, and is a major contributor to the global burden of disease.
  
• More women are affected by depression than men.
  
• At its worst, depression can lead to suicide.
  
• There are effective treatments for depression.

Study finds link between depression, brain inflammation
Inflammation
Depression (major depressive disorder)
Depression

© www.mentalhealthblog.com

Commonly Used Medications Linked to Dementia

A new study reveals that higher doses or prolonged use of medications with anticholinergic effects significantly increases the risk for developing dementia.  Although, this is not the first study to discover such a link, it is the first to suggest that the risk of dementia as a result of taking such medications may not be reversible.

“An anticholinergic agent is a substance that blocks the neurotransmitter acetylcholine in the central and the peripheral nervous system. Anticholinergics inhibit parasympathetic nerve impulses by selectively blocking the binding of the neurotransmitter acetylcholine to its receptor in nerve cells. The nerve fibers of the parasympathetic system are responsible for the involuntary movement of smooth muscles present in the gastrointestinal tract, urinary tract, lungs, etc.”

Anticholinergic agents are used to treat a variety of conditions such as gastrointestinal disorders, respiratory disorders, insomnia, dizziness etc.  Some of these commonly used medications include Diphenhydramine (Benadryl, Advil PM etc.), Bupropion (Zyban, Wellbutrin), Dextromethorphan (cough suppressant) and the list goes on.  In addition, some of these medications can be acquired without a prescription and can have very strong anticholinergic effects.

Moreover, many older patients, already at higher risk of developing dementia, are frequently using these types of medications.  Doctors should be taking a proactive approach and monitoring the use of these drugs, including non-prescription use.

“For instance, the most commonly used medications in the study were tricyclic antidepressants like doxepin (Sinequan), first-generation antihistamines like chlorpheniramine (Chlor-Trimeton), and antimuscarinics for bladder control like oxybutynin (Ditropan). The study estimated that people taking at least 10 mg/day of doxepin, 4 mg/day of chlorpheniramine, or 5 mg/day of oxybutynin for more than three years would be at greater risk for developing dementia.”

Consequently, the study suggests that medical professionals should seek substitutes such as citalopram (Celexa) or fluoxitene (Prozac) for depression or loratadine (Claritin) for allergies or behavioral changes for urinary incontinence.  However, if substitutes are not available, the suggestion is to prescribe the lowest dose possible, monitor its effectiveness closely and cease use if there is no real benefit to the patient.

This study differs from other research as it used more rigorous methods, longer follow-up periods and better assessment of medication use by using pharmacy records of both prescription and non-prescription use.  It is also the first of its kind to link anticholinergic medication dosages to dementia risk.  Results were obtained by tracking nearly 3,500 Group Health seniors participating in the long-running Adult Changes in Thought study (a longitudinal population-based prospective cohort study of brain aging and incident dementia in the Seattle metropolitan area), some of which have also agreed to have their brains autopsied after they die.  Stay tuned.

Quick Facts:

Dementia is a general term for a decline in mental ability severe enough to interfere with daily life.

Alzheimer's is the most common type of dementia.

While symptoms of dementia can vary greatly, at least two of the following core mental functions must be significantly impaired to be considered dementia:

• Memory
• Communication and language
• Ability to focus and pay attention
• Reasoning and judgment
• Visual perception

Many dementias are progressive, meaning symptoms start out slowly and gradually get worse.
Dementia is caused by damage to brain cells, which interferes with the ability of brain cells to communicate with each other.

There is no one test to determine if someone has dementia. Doctors diagnose Alzheimer's and other types of dementia based on a careful medical history, a physical examination, laboratory tests, and the characteristic changes in thinking, day-to-day function and behavior associated with each type.

Some risk factors for dementia, such as age and genetics, cannot be changed, however some of the most active areas of research in risk reduction and prevention include cardiovascular factors, physical fitness, and diet.

The total number of new cases of dementia each year worldwide is nearly 7.7 million, implying one new case every four seconds. The number of people with dementia is expected to nearly double every 20 years, to 65.7 million in 2030 and 115.4 million in 2050.

The costs are estimated at US$ 604 billion per year at present and are set to increase even more quickly than the prevalence.

Caring for dementia patients is overwhelming for caregivers. The stresses include physical, emotional and economic pressures. Care givers require support from the health, social, financial and legal systems.

People with dementia are frequently denied the basic rights and freedoms available to others. For example, physical and chemical restraints are used extensively in aged-care facilities and acute-care settings.

Improving the awareness and understanding of dementia across all levels of society is needed to decrease discrimination and to improve the quality of life for people with dementia and their caregivers.

More research is needed to develop new and more effective treatments and to better understand the causes of dementia. Research that identifies the modifiable risk factors of dementia is still scarce.

Higher dementia risk linked to more use of common drugs
Anticholinergic
alz.org
World Health Organization

© www.mentalhealthblog.com

Daily affirmations

  

Stuart Miles/FreeDigitalPhotos.net

I’ve come up with a little routine lately. It’s simple, but more powerful than I imagined it would be: I say affirmations out loud every single day.

Pick something you do every day that requires minimal thinking. For me, it’s washing myself in the shower (so it’s accompanied by wonderful aromas from my shower gels). It could be doing the dishes, putting on make up, shaving, getting dressed, whatever. Just choose a time where you have a few minutes and make sure it’s something that you do daily.

The way I’ve been doing it is picking a theme each day. Today it was communication for me. In the time I set aside, I say as many affirmations as I can on that topic. I’ve been challenging myself by choosing affirmations that push my belief in myself. This has helped me grow. As an example, here are some of mine from today:

“I have a voice that deserves to be heard.”

“I can speak freely.”

“I show love in the things that I say.”

“I am powerful when I speak my truth.” 

See how they go along with the theme? Sticking to one topic each day allows me to explore what I am talking about in depth. You might want to do something kind for yourself afterwards. I make myself a nice cup of tea and journal. Do whatever works for you.

It sounds like a small thing, but it makes a big difference. It’s made me more comfortable with myself and more willing to do things that are difficult. You believe what you are repeatedly exposed to, so rehash themes as needed. I have a general cycle with a broader theme for each day of the week and then pick a subsection of that day’s message. 

For more information on affirmations, read this. There is also a list here of some affirmations you can try out until you develop your own.

Do you use affirmations? What has changed in your life as a result of them? Share your thoughts in the comments. 

A Problem with Brain-based Models

We are living in a time of obsession with the brain.  It is true that neuroscience is producing discoveries which are interesting an may be useful (time will tell), though humans will always amount to much more than what we carry in the cranium.  On a daily basis I see in my news feeds items like "Gene found responsible for chronic tardiness", or "CAT scan shows region involved in ADHD", or "Bipolar Disorder rise attributed to increase in brain abnormality".

A problem I have with research like this, and like so much that we consume, is that it does not appear to take into account developmental, contextual, and environmental factors. Because of this the dialog focuses on a reductionist and brain-based model as though the person-in-environment does not exist. This facilitates intrusive and authoritarian “treatments” and is often a dead end in improving human welfare. To say that diagnosis X is rising really does not tell us what we need to know, which is why or how. And that’s putting aside all the arguments involving inadequate support for diagnoses and the inter-rater reliability problems associated with them. Sometimes it seems as though the research paradigm is oriented toward simplistic goals for the purpose of developing efficient delivery of interventions, mainly drugs. And by efficient I mean not having to develop human relationships or spending much face time with people.

The "innovations" all seem to actually reduce time spent in human contact, thereby increasing the ROI in billing.

I am not an expert in the technicalities of diagnosing, though I think I do well in the formulation of human life problems.  I do know that our young adults are functioning in a context which is often pathogenic in and of itself. Here are some of the factors we see as relevant:

• Stress related to global political and marketplace influences
• Extremely poor sleep routines and hygiene
• Arrhythmic lifestyles, or more simply put, chaos
• Too much screen time, not enough play and exercise
• A paucity of trusting, mutually satisfactory relationships, in any sphere
• Racism and discrimination
• Increased sense of threat and diminished opportunity for affiliation
• Poverty
• Alcohol and drug abuse
• Poor nutrition
• The inherent “volatility” of the late adolescent and young adult
• The seasonal nature of the stresses in the academic environment
• Corruption, or at least mutual and self-serving contamination, among our leaders including those involved in healthcare and the Pharma-Insurance conglomerate
• Violence, rape, sexual assault, harassment
• Environmental toxins and their suspected role in some diagnoses (see http://bit.ly/1kRI8Dw)

If I bathed your brain in even half of these factors, what would you look like?

I have personally worked with many young folks who “looked” Bipolar (or ADHD or Whatever 209.45), but who were really experiencing intense emotion which they could not articulate in language nor act to soothe. The intense emotion was, more often than not, a result of a pathogenic environment of people, places and things, some of which they created themselves.

This is not a new problem.  Some years back we hanged and drowned and burned some women in Salem, MA.  It wasn't even thought until the 1970s that there might have been a fungus in the rye they ate which caused some alarming behavior.  Never mind whatever proportion of them were being assaulted.  But they were killed, because it was easier to attribute behavior to the individual rather than her context.  This is still the case.

Please recall Seurat and his pointillism, the painting style consisting of a series of dots.  A diagnosis is a few dots.  You have to stand back from the painting to see the darn thing.  It is much the same with humans.

I am sure there are other views. This is mine, and it does not necessarily foreclose on the concept of serious illness.  But I submit the threshold for this is much higher than what many appear to believe, especially those with an investment in the "treatment" for the illness.