17 Aug

Medical News Today: Box breathing for anxiety: Techniques and tips

Woman practicing meditation, mindfulness and breathing techniques.
Practicing breathing techniques, such as box breahting, may help to ease anxiety and manage panic attacks.
Box breathing, sometimes called square breathing, is a simple tool for managing anxiety.

A racing heart, rapid breathing, and dizziness can make people with anxiety feel out of control. Controlled, slow breaths can support a regained sense of control, offering relief from anxiety and panic attacks.


What is box breathing?

Like the four corners of a square, box breathing requires only four steps, each of which requires participants to count to four.

To try box breathing, a person should get into a comfortable position that makes it easy to breathe freely. They should then follow these steps:

  1. Breathe in through the nose while counting to four. Continue inhaling for the entire 4 seconds. The breath should be slow and steady.
  2. Hold the breath in the lungs for another count of four.
  3. Exhale through the mouth while counting to four. As with the inhale, the exhale should be slow and steady.
  4. Continue repeating this pattern for 4 minutes.

People with a history of fainting, who feel dizzy during deep breathing, or who have cardiovascular health problems should talk to a doctor before trying any breathing technique.


Tips and techniques for box breathing

Man practicing yoga and relaxation techniques.
When practicing box breathing, it is important to relax the body and find a comfortable position. This may be a sitting position, or lying down.

Breathing is something that everyone does naturally, but people with anxiety sometimes develop unhealthy breathing habits, during stressful or anxiety-provoking situations.

To get the most out of box breathing, people should practice mindful breathing, remaining conscious of each breath and how it feels.

Some strategies to increase the effectiveness of box breathing include the following:

Practice diaphragmatic breathing

Deep breathing uses the diaphragm, the muscle that helps the lungs pull in oxygen. This technique is also called diaphragmatic breathing.

To master diaphragmatic breathing, a person needs to practice expanding their abdomen when inhaling and contracting it when exhaling.

Diaphragmatic breathing does not always feel natural to people who are used to chest breathing, which is a shallower form of breathing where it is the chest muscles that move mostly, during inhalation and exhalation.

People with anxiety should practice diaphragmatic breathing, as frequently as possible. Taking 5-10 deep breaths throughout the day can supplement box breathing. It also helps the body “remember” how to breathe correctly during a box breathing session.

Choose a comfortable position

Bad posture can make it harder to take deep breaths. Being slumped over reduces the amount of oxygen the lungs can take in. It also makes it more difficult to breathe into the abdomen.

People should choose a comfortable position, but not one that means they slump over. A comfortable chair with a sturdy back is an ideal location to try box breathing. Lying flat on the back also works well.

Relax the body

Some people with anxiety unconsciously tense up their muscles. This can cause muscle pain, make it more difficult to breathe, and make anxiety worse. Before or after a box breathing session, people should try a simple strategy called progressive muscle relaxation.

Beginning with the toes, slowly and steadily tense and then relax each muscle in the body. This exercise supports awareness of muscle tension and, similarly to controlled breathing, can help people with anxiety regain a sense of control over their bodies.

Try visualization

Just as box breathing can help people with anxiety slow their breaths, visualization exercises can help slow a flood of anxious thoughts.

Try visualizing a relaxing and peaceful scene. It can be an imaginary place or a place that has always felt safe. Beaches, mountains, and quiet rooms are popular places to visualize.

People who have lots of overwhelming thoughts while breathing can find visualization particularly helpful because it gives the brain something else on which to focus.

Know that practice makes perfect

Box breathing is a skill just like throwing a ball or typing. It takes time to perfect. At first, it can feel uncomfortable. Some people even get dizzy because they are not used to slow, deliberate breathing.

It is important to understand that the effects of breathing techniques tend to get better with practice. Try several sessions each day to perfect the technique.

Remembering the steps during an anxiety attack

It is hard to think clearly during an anxiety attack, especially when the mind is flooded with anxious thoughts. Practicing box breathing during times of calm can make the process easier and more familiar when anxiety strikes.

Some people may also find that visualizing a physical box helps. This makes it more difficult for the mind to jump from one anxious thought to another and serves as a cue for the breathing technique.


How box breathing can treat anxiety

Group therapy
Other methods for treating anxiety include group therapy, medication, and psychotherapy.

Anxiety is more than just an emotion. It is a physical experience, as well.

People experiencing panic attacks may hyperventilate or take only shallow, quick breaths. Some even hold their breaths without realizing that is what they are doing. This lack of oxygen can make anxiety worse, creating a vicious cycle of oxygen deprivation and anxiety.

When there is less oxygen in the blood, the brain gets less oxygen. That makes it hard to think clearly and may even affect vision. As a result, people experiencing intense anxiety can benefit from simple techniques that are easy to remember.

Box breathing does not require special skills or equipment, and its emphasis on four steps and four counts makes it easy to remember, even in the middle of a panic attack.

Breathing techniques, including box breathing, do not treat the underlying cause of anxiety. Breathing techniques can, however, give people with anxiety a greater sense of control over their anxiety and help them manage their situation with less difficulty.

Anxious people often fear having an anxiety attack. Knowing that a simple technique can reduce their anxiety may help them to feel more secure.

Someone with an anxiety disorder, such as post-traumatic stress disorder (PTSD), or panic disorder may need other treatments to get relief. Those treatments include:

  • Psychotherapy – therapy can address the causes of anxiety, including trauma. CBT, or cognitive behavioral therapy, which helps people understand and control automatic thoughts, is particularly helpful.
  • Medication – a wide range of medications can help with anxiety. Anti-anxiety drugs such as Xanax and Klonopin work on an “as needed” basis. Some people with anxiety also use anti-depressants. These drugs can take several days or weeks to work and must be taken each day.
  • Self-help groups – support groups offer people with anxiety the chance to discuss their feelings and learn from the experiences of others, facing similar difficulties.
  • Lifestyle remedies – a range of lifestyle remedies can help, including dietary changes such as avoiding caffeine. Some people with anxiety find that their symptoms improve with regular exercise.
  • Managing stress – stress reduction, self-care strategies to manage times of stress, support from friends, and positive self-talk can help with anxiety.
  • Clinical trials – some people with anxiety cannot find relief with traditional methods. Clinical drug trials offer the possibility of relief from experimental drugs. Some clinical trials also use new therapeutic techniques or lifestyle remedies to tackle anxiety.

Outlook

Practicing box breathing helps people get better at it and to know when to try using it. This means that, over time, box breathing may more quickly reduce anxiety symptoms. As a result, it is possible to see improvements in anxiety over time by using this technique.

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Source: medicalnewstoday

17 Aug

Medical News Today: Solar urticaria: Treatment, management, and symptoms

Woman in bikini at beach putting suncream onto skin.
Solar urticaria is a rash that occurs on the skin after exposure to sunlight.
Solar urticaria, also called sun allergy rash, is a rare dermatological condition. People with this condition develop an itchy, red rash when their skin is exposed to sunlight.

If solar urticaria is left untreated, it can cause pain, distress, and embarrassment. So, what treatments are available for this condition?

This article looks at the symptoms and treatments of solar urticaria as well as the various treatment options available to help manage solar urticaria symptoms.

Fast facts on solar urticaria:
  • There are treatment options available for solar urticaria including medication, which help people manage their symptoms.
  • The main symptom is a skin rash that can appear within minutes of exposure to sunlight.
  • The best way to prevent solar urticaria is to limit exposure to sunlight.
  • Solar urticaria can be hard to diagnose. It is rare and can look similar to other dermatological conditions, such as polymorphic light eruption.


What is solar urticaria?

It is a rash caused by the sun that can affect anyone at any age, but most commonly occurs in people aged 20-40.

Solar urticaria is different from heat rash, which occurs due to humidity. Solar urticaria is a specific response to the ultra violet rays (UV) in the light itself, rather than a response to heat.

Typically, skin that is often exposed to the sun does not react or does not react severely. The solar urticarial rash tends to occur on skin that is rarely uncovered. It can also affect people through their clothing if the fabric is thin.


What does it look like and what are the symptoms?

Man itching arm.
Solar urticarial is characterized by a red rash that may sting or feel itchy.

The rash in solar urticaria can be red, itchy, and uncomfortable. Each urticaria is a distinct circular bump. The rash is made up of clusters of these bumps that cover the exposed skin.

As swelling happens quickly, the rash looks quite aggressive and sore. It can sting and be quite distressing for the person experiencing it.

The symptoms of solar urticaria are:

  • a red rash that appears on the skin after exposure to sunlight
  • itching
  • stinging pain
  • a rash that disappears within a few hours of ceasing sun exposure

In severe cases, people with this condition may experience secondary symptoms.

These include:


Causes

The rash can occur within minutes of skin being exposed to the UV rays in sunlight, which is why it has the name solar urticaria. According to the British Association of Dermatologists, there are three types of light UV light responsible for solar urticaria:

  • long wavelength ultraviolet (UVA)
  • short wavelength ultraviolet (UVB)
  • visible light (sunlight not containing ultraviolet)

People with this condition can also experience symptoms when:

  • skin is exposed to artificial light sources that contain UV
  • skin is covered by thin clothing that sunlight can pass through

What causes the reaction?

Research into solar urticaria is ongoing, and the exact cause of the response to UV has not been established. However, it is understood to be a type of allergic reaction, known as allergic hypersensitivity.

The reaction occurs between the UV radiation and a type of chemical in the body, known as a photoallergen. The specific chemical that acts as a photoallergen remains unidentified.

Discovering this will help researchers better understand what causes the condition and may lead to more effective treatment and prevention of solar urticaria.

What causes the symptoms?

The reaction sends a chemical signal to particular cells in a person’s skin, telling them to produce histamine. Histamine is the body’s way of trying to get rid of the allergen that is causing a reaction.

Histamine works by causing the skin to swell and itch. Itching is a response that compels a person to scratch away any allergens, which is why hives appear, and a rash develops.

What aggravates the condition?

For some people with solar urticaria, sensitivity to a chemical substance on the skin could contribute to the reaction. Substances that can cause sensitivity include:

  • skin care products
  • dyes
  • sunscreens
  • detergents

Avoiding these irritants can help to reduce the severity of the reaction. If chemical sensitivity is the primary cause, ceasing to use certain products may stop the rash developing altogether.


How is it diagnosed?

Skin patch allergy test.
Various tests may be used to diagnose solar utricaria, including a photopatch test where allergens are applied to the skin, and are then exposed to UV light.

A doctor can diagnose solar urticaria using the following tests:

  • Diagnostic phototest – test where small areas of skin are exposed to different strengths of UV light. Doctors observe the skin to see if the specific rash reaction seen in solar urticaria develops.
  • Photopatch test – a test where small patches containing different allergens are applied to the skin. When they are removed, the skin is exposed to light, and doctors note any reaction.
  • Photoprovication test – patches of skin are exposed to different types and strengths of UV light over several days. Doctors observe any reactions.


Management and treatment

Methods or management and treatment include:

Antihistamines

These drugs help combat the histamines that cause the rash and can reduce the redness, stinging, and itching. Antihistamines are the best way to treat solar urticaria in the short-term as they provide quick relief from the main symptoms. However, they do not help to prevent the allergic skin reaction from happening.

Desensitization

Desensitization is a long-term treatment that aims to prevent the allergic skin reaction from happening. Desensitization involves treating the skin with a course of UV light exposure (phototherapy) to try to desensitize it. Over time this can prevent rash developing on exposure to light, or make it less severe.

Immunosuppression

Immunosuppressant drugs suppress the immune response that occurs when the skin reacts, preventing histamine being produced. These are potent drugs that may have other side effects. So, this course of treatment is only ever short-term and is only recommended for extreme cases.

Dietary changes

It could be that something in a person’s diet is aggravating the reaction to sunlight. They may find removing potential allergens from their diet helps. However, this is a complementary treatment as opposed to the first course of action. More research needs to be conducted to say whether diet is a key factor in this condition.


Prevention

The following methods can help a person avoid exposure to sunlight:

  • wearing loose, dark clothing that covers as much skin as possible
  • wearing hats with wide brims
  • carrying a parasol
  • sitting in the shade
  • trying to avoid going out during the day

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Source: medicalnewstoday

17 Aug

Medical News Today: Processed foods linked with cancer risk in slim older women

apple or cake
Energy-dense foods, such as those that are processed, are linked with an increased risk of cancer in postmenopausal women, regardless of their body weight, new research suggests.
A new study suggests that foods with higher dietary energy density – usually processed foods – may increase the risk of obesity-related cancers in women who are postmenopausal, even if they are actually physically fit.

Excess weight is often linked with additional severe disorders, including 13 different types of cancer, among which are endometrial cancer, kidney cancer, cancer of the liver, and pancreatic cancer.

It is also a well-established notion that postmenopausal breast cancer is associated with obesity.

This connection led researchers from the University of Arizona Mel and Enid Zuckerman College of Public Health in Tucson to focus their efforts on studying which dietary practices are liable to lead to cancers in postmenopausal women.

Surprisingly, they found that what might place some older women at risk of obesity-related cancers is not their body weight, but the quality of their nutrition. The findings have been published in the latest issue of the Journal of the Academy of Nutrition and Dietetics.

The researchers observed that dietary energy density (DED), which reflects the quality of someone’s nutrition, is what correlates with the risk of cancer in women, even when those women are otherwise physically fit.

The demonstrated effect in normal-weight women in relation to risk for obesity-related cancers is novel and contrary to our [initial] hypothesis.”

Lead investigator Dr. Cynthia A. Thomson,
University of Arizona in Tucson

DED measures diet quality by looking at the ratio of calories, or energy consumed, in relation to the nutrients received from a particular food.

For example, processed foods such as pizza and various sugary desserts have a high energy density as they have a lot of calories but are not very rich in nutrients, meaning that a person must consume higher quantities of these foods to get the essentials they need.

Conversely, whole foods such as fruits and vegetables tend to have lower energy density levels, meaning that they contain fewer calories, and they are more nutritious.

DED is calculated by dividing the number of calories in a food serving by its total weight.


Link between diet quality and cancer risk

Dr. Thomson and her colleagues analyzed data collected from a cohort of 90,000 postmenopausal women who participated in the Women’s Health Initiative. To determine the impact of DED on cancer risk for the participants, the researchers asked them to fill in a food frequency questionnaire.

In this way, they were able to collect data on the participants’ dietary habits, including their estimated energy intake, and the nutrient quality of the foods they consumed.

The weights of all the foods were taken from the United States Department of Agriculture database, allowing the researchers to calculate DED.

As for the participants’ cancer outcomes, Dr. Thomson explains that this information was obtained from the women’s medical records and was reviewed by specialists to confirm the diagnoses.

It was found that postmenopausal women on high DED diets had a 10 percent higher risk of developing a form of obesity-related cancer. This result was, surprisingly, limited to participants who reported a normal body weight at baseline.

“Among normal-weight women, higher DED may be a contributing factor for obesity-related cancers. Importantly, DED is a modifiable risk factor. Nutrition interventions targeting energy density as well as other diet-related cancer preventive approaches are warranted to reduce cancer burden among postmenopausal women,” suggests Dr. Thomson.


Women should mind nutritional value

The researchers advise that older women should consume fewer foods with high energy density in order to help prevent the risk of cancer. However, Dr. Thomson and her colleagues also acknowledge that DED, as such, may not be the direct cause of cancer risk.

In fact, the study advances the hypothesis that high DED may affect the women’s metabolisms, leading to dysregulations, which are a known factor in susceptibility to cancer.

Dr. Thomson suggests that future studies should aim to test whether the same link between DED and obesity-related cancer risk also holds true for younger women or men.

In the meantime, the researchers urge women to be mindful of the quality of their diets, regardless of their physical weight.

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Source: medicalnewstoday

17 Aug

Medical News Today: Jumping genes made us human, but can they cause disease?

DNA helix
When mobile DNA moves to a new location in the genome, it can have either beneficial or detrimental consequences.
What makes us human? Was it the discovery of fire, the industrial revolution, or the development of the Internet? Or are we human thanks to ancient bacterial and viral genes that are dotted throughout our DNA?

Every cell in our body contains around 3 billion DNA bases, but our genes only make up approximately 1 percent of this. So what about the rest?

Nearly half is made up of jumping genes, which are also called mobile DNA or mobile genetic elements. These stretches of DNA have the ability to move from one location in the genome to another, an ability that normal genes lack.

Most jumping genes are not technically genes, as their DNA does not contain the code to make functional proteins. However, they are thought to affect the expression and actions of other genes.

Long hailed as “junk DNA,” scientists are getting closer to figuring out the importance of jumping genes in shaping the modern human as well as their role in disease.


Remnants of evolution

Bacteria make frequent use of jumping genes. This allows them to adapt to environmental pressures such as gaining antibiotic resistance.

Genes can also jump when bacteria or viruses infect humans. Although our cells have mechanisms to counteract such events, some mobile DNA fragments become established in our cells, where they add genetic diversity.

The first jumping genes in our evolution can be traced back as far as 600 million years ago, to the human ancestor Giardi lamblia, a primitive parasite.

Once mammals arrived on the scene, insertions of mobile DNA into their genomes really took off. This happened between 40 and 12 million years ago.

Exactly how these ancient jumping genes contributed to the development of the modern human is unclear. Scientists think that their step-wise integration coincided with the emergence of an increasingly complex brain structure, possibly giving us a crucial advantage during primate evolution. And their influence can still be felt today.


Not just along for the ride

Today, we know that jumping genes are important for placental development and actively regulate gene expression during early embryonic development.

The jumping gene known as HERVK is thought to be a remnant of an infection by an ancient retrovirus that took up residence in the genome around 200,000 years ago.

HERVK is switched on at the very early stage of human embryonic development and triggers a precise antiviral response, even though no virus is present.

Scientists think that this event may provide the developing embryo with some level of viral resistance, which is, of course, a favorable trait.

Jumping genes are also known to play crucial roles in brain function. One such gene contains a regulatory RNA molecule that is important for normal human brain development. If this is mutated, it causes infantile encephalopathy.

While we now know that jumping genes contribute to normal body functions, they also have the potential to wreak serious havoc with our genes.


Jumping genes and disease

Mobile DNA can jump to another location on the same chromosome or a different chromosome each time a cell divides. If this happens in sperm or egg cells, it will be passed on to the next generation. The current estimate of such events occurring ranges from 1 in 20 to 1 in 1,000 births.

These jumps can disrupt normal gene function and result in spontaneous emergence of heritable diseases, such as blood disorders, neurodegeneration, and age-related macular degeneration.

Other cell populations also seem particularly prone to mobile DNA rearrangements. Several epithelial cancers, such as those lining the gastrointestinal tract, are known to harbor mobile genetic elements at diverse locations.

Whether these events are at the root of the cancer or a side effect is not currently known, and the human genome is much more complex than previously thought. While jumping genes are just one part of the puzzle, scientists are beginning to appreciate the genetic contribution that microbes make to human diversity and disease.

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Source: medicalnewstoday

17 Aug

Medical News Today: Subchondral bone cyst: Causes, treatment, and symptoms

Swollen knee
A swollen joint may be a symptom of a subchondral bone cyst.
Subchondral bone cysts are sacs of fluid that form inside a person’s joints. The cysts occur in the subchondral bone, the layer of bone just under the cartilage.

The subchondral bone acts as a shock absorber in weight-bearing joints, such as the knees, hips, and shoulders. The liquid inside subchondral bone cysts (SBCs) is hyaluronic acid, a component found in synovial fluid, which is the thick substance that lubricates joints, allowing the bones to slide past one another without friction.

Risk factors for SBCs include obesity and smoking, but the precise cause is unknown. Symptoms include joint pain and discomfort. Lifestyle changes help symptom relief and may prevent the formation of other SBCs.

Fast facts on SBCs:
  • Initially discovered in the 1940s, SBCs are a sign of osteoarthritis (OA).
  • The exact cause of SBCs is not known.
  • Engaging in high-impact activities can contribute to injury and damage to the joint and cartilage over time, possibly leading to SBCs.
  • SBCs are diagnosed using imaging tests, such as X-rays.


What is the link between SBCs and OA?

obese written on scales
Carrying excess weight may be a risk factor for SBC.

Some experts believe that SBCs are a precursor to osteoarthritis (OA), which itself is a painful condition affecting more than 30 million adults in the United States.

OA causes the cartilage and bones within a joint to gradually break down. SBCs are considered one of the four cardinal or key radiological findings for OA.

However, in one large study of 806 people with OA in the knee, SBCs were found in only 30.6 percent of them. Other conditions besides OA, such as rheumatoid arthritis, also cause cysts to form on the bone joints.


Causes

Though the cause is unknown, it is thought SBCs are the result of repeated stress to the bone. This stress is caused by increased pressure from quicker blood flow to the subchondral bone, something that is seen in people with OA.


What are the risk factors?

Certain characteristics and behaviors can increase the risk of developing an SBC. These include:

  • Sex – women may have a higher risk than men of SBC formation, according to some research.
  • Heredity – as certain forms of OA may be hereditary, people with a family member with the condition are more likely to develop OA and SBCs.
  • Joint alignment and shape – abnormal joint shape or alignment can increase friction, leading to greater damage and a higher risk of cyst formation.
  • Obesity – carrying excess weight puts additional pressure on the joints of the body, increasing the risk of joint problems.
  • Smoking – tobacco contains chemicals that contribute to cartilage damage. Some research has shown that male smokers with OA experience greater cartilage loss.
  • Activity and injury – joint injuries increase the risk of joint problems later, including the development of SBCs.


Treatment and management

older lady doing water aerobics
Low-impact activities may help to treat and manage SBC and OS.

It is recommended that SBCs are not treated directly. Due to the risk of infection, these cysts should not be removed. However, they can regress on their own.

As a result, treatment typically involves making lifestyle changes and providing symptom relief. Some people may benefit from replacing the joint if problems are ongoing or progressive.

Treatments for SBCs include the following:

Nonsteroidal anti-inflammatory drugs (NSAIDs)

These over-the-counter painkillers, such as ibuprofen and aspirin, may reduce symptoms of SBCs. It is always advisable to check with a doctor before taking NSAIDs. Long-term use should be avoided.

Low-impact activities

It may be recommended to choose low-impact activities such as swimming, aqua aerobics, and cycling. These put less pressure on the knees and hips joints than high-impact activities, such as running and jumping, which can exacerbate the symptoms of OS and SBCs and lead to further joint damage over time.

Weight management

Maintaining a healthy weight reduces excess stress on the joints and may reduce the rate of cartilage loss.

Quit smoking

As this is a risk factor for the development of osteoarthritis, quitting smoking and avoiding secondhand smoke may reduce the symptoms of SBCs and OA.

Ultrasound therapy

At least one study suggests that delivering localized ultrasonic therapy to cartilage and subchondral bone may help treat OA. However, much more research is needed in this area.

Physical therapy

According to the American Academy of Family Physicians, mild degenerative joint disease, of which SBCs may be a feature, can be treated with physical therapy.


Symptoms

If present, symptoms of SBCs can include:

  • discomfort
  • pain
  • lack of flexibility in the joint
  • swelling or bulging around the joint

There are only a few symptoms associated with SBCs, as they are typically considered to be a symptom of OA, particularly progressive OA.


Outlook

SBCs are considered a symptom of OA or other joint conditions. They may resolve on their own or persist long-term. SBCs may cause pain and contribute to disease progression.

The best way to treat these cysts is to manage the symptoms of OA and other joint conditions.

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Source: medicalnewstoday

17 Aug

Could Big Lifestyle Changes Be Key to Managing Type 2 Diabetes?

News Picture: Could Big Lifestyle Changes Be Key to Managing Type 2 Diabetes?By Serena Gordon
HealthDay Reporter

Latest Diabetes News

TUESDAY, Aug. 15, 2017 (HealthDay News) — When it comes to type 2 diabetes management, a new study finds that more is definitely better for lowering blood sugar levels.

The study showed that adding intensive lifestyle management to standard diabetes care (diabetes medication and usual lifestyle change advice) brought blood sugar into a nondiabetic range.

The intensive intervention worked so well that “half of the intervention group did not need glucose-lowering medications to maintain or even improve [blood sugar] control,” said the study’s senior researcher, Mathias Ried-Larsen.

So, what exactly constitutes an “intensive” intervention?

“Patients were prescribed exercise five to six times per week for 30 to 60 minutes per session. That included both endurance and resistance training,” said Ried-Larsen, of Rigshospitalet in Copenhagen, Denmark.

“In the beginning, the exercise was supervised by a coach, but gradually, they were left on their own. Moreover, they received a dietary program with focus on foods rich in fiber, low in saturated fats, lots of fruit and no processed food. We designed the diet for patients to lose weight,” he said.

The study included nearly 100 people from Denmark. All had had type 2 diabetes for less than 10 years, and none had complications from the disease.

The average age of the participants was 55, and nearly half were women. Average A1C level at the start of the study was 6.7 percent. A1C is a blood test that estimates average blood sugar levels over two to three months. An A1C of 6.5 percent or higher indicates diabetes, according to the American Diabetes Association.

Study participants were randomly placed into the usual care group or the intensive lifestyle management group.

After a year, the intensive group lost 13 pounds compared to 4 pounds in the standard management group, the findings showed. LDL cholesterol (the bad kind) and triglycerides (another type of bad blood fat) were reduced more in the intensive group than in the standard group. HDL cholesterol (the good kind) rose more in the intensive group than in the standard group, according to the report.

Average A1C dropped from 6.65 to 6.34 percent in the intensive intervention group, and from 6.74 percent to 6.66 percent in the standard group, the investigators found.

In addition, three-quarters of those in the intensive group needed less diabetes medication, while only one-quarter of the standard care group lowered their medications, the researchers reported.

Not every expert agrees that lowering or stopping diabetes medications is a good idea, however.

Dr. Joel Zonszein is director of the clinical diabetes center at Montefiore Medical Center in New York City.

Zonszein noted that study participants were taking metformin and GLP-1 analogues. “These are good agents. That’s why their A1C was so good at the start. I also treat my patients with lifestyle changes. But it’s not one or the other. Both medicine and lifestyle changes are important,” he said.

“When you use the two together, they work much better,” he added.

Zonszein also noted that the Denmark group was “an unusual population.” None took insulin, and no one had complications. And, at the start of the study, their blood sugar was already fairly well-managed. That would likely be much different in a U.S. population with type 2 diabetes.

One reason Ried-Larsen hoped to lower the need for medication is to save money. Although metformin is available in a generic form and isn’t generally expensive, some of the newer type 2 diabetes medications can be costly.

“I think this study calls for a thorough discussion about the resources we need to allocate to help people to adhere to a lifestyle treatment and what responsibility the society has in this regard,” Ried-Larsen said.

“We do acknowledge that the lifestyle treatment is extensive and could be regarded as not economically viable in clinical care,” Ried-Larsen noted. “However, consider the willingness to introduce newer classes of drugs that come with extreme prices. If we could get doctors and patients to allocate that sort of money and resources to lifestyle treatment, I think we could change things.”

Zonszein added that when people rely solely on lifestyle management, it doesn’t always bring blood sugar levels down enough.

“It’s important to consider the cost-effectiveness of medications along with their cost. A lot of expense comes from treating diabetes complications,” he said.

The report was published Aug. 15 in the Journal of the American Medical Association.

MedicalNews
Copyright © 2017 HealthDay. All rights reserved.

SOURCES: Mathias Ried-Larsen, Ph.D., group leader, Rigshospitalet, Copenhagen, Denmark; Joel Zonszein, M.D., director, clinical diabetes center, Montefiore Medical Center, New York City; Aug. 15, 2017, Journal of the American Medical Association

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Source: MediciNet

17 Aug

Is FDA Taking Close Enough Look at Fast-Tracked Drugs?

News Picture: Is FDA Taking Close Enough Look at Fast-Tracked Drugs?By Dennis Thompson
HealthDay Reporter

Latest Prevention & Wellness News

TUESDAY, Aug. 15, 2017 (HealthDay News) — Many cutting-edge drugs and updated medical devices are not receiving the rigorous scientific scrutiny needed to ensure their safety and effectiveness, two new studies contend.

Medications fast-tracked to market under the U.S. Food and Drug Administration’s “accelerated approval” process are not receiving proper follow-up clinical trials that are required to confirm their benefits, one study reported.

“Our concern is that a lot of newer drugs approved through this pathway are not then being subjected to rigorous confirmatory trials in a timely fashion,” said senior researcher Dr. Aaron Kesselheim, an associate professor at Harvard Medical School.

At the same time, high-risk medical devices like pacemakers, stents and artificial heart valves regularly undergo next-model updates and modifications based on weak clinical evidence, according to a second study from researchers at the University of California, San Francisco (UCSF).

Both reports were published in the Aug. 15 issue of the Journal of the American Medical Association.

The upshot is that doctors and patients can’t rely on the research to figure out just how safe and effective these drugs and devices are, said Dr. Joseph Ross, an assistant professor with Yale School of Medicine.

“We never get the robust large studies that can determine how well something works,” said Ross, who wasn’t involved with the studies.

“Accelerated approval” allows the FDA to fast-track approval of drugs that fill an unmet medical need, particularly if the medication is for a life-threatening illness and there are no other treatment options, Kesselheim explained.

Under this process, the FDA can approve a drug based on weaker-than-usual evidence showing that the medication is reasonably likely to be beneficial to patients, without actually proving real benefit, the researchers said in background notes.

But manufacturers are then required to produce follow-up studies within three years that confirm the drugs work, Ross said.

“There’s sort of a bargain at work. The FDA permits a drug to be approved on the basis of much weaker evidence to get the product out there to patients,” Kesselheim said. “In exchange, the manufacturer is supposed to conduct confirmatory, much more rigorous post-approval studies.”

Kesselheim and his colleagues reviewed 22 drugs granted accelerated approval between 2009 and 2013, 19 of which were intended for cancer treatment.

As a condition of accelerated approval, the FDA ordered that 38 follow-up studies be performed after these drugs hit the market, the researchers said.

But three years after the last drug’s approval in 2013, only half of the required 38 confirmatory studies had been completed, the researchers found.

Further, about 42 percent of the studies that had been completed were not performed to a higher standard, but instead relied on the same weaker sort of evidence used to get the drugs fast-track approval in the first place, the study showed.

For example, the studies would rely on blood tests or screening examinations as indications of effectiveness, rather than proving that the drug improved symptoms or prolonged patients’ lives, the researchers said.

“If you don’t get the confirmatory large-scale study down the line after those first three years, we’re still in the same situation we were in at the time of approval,” Ross said. “We think it works, but we don’t really know.”

The FDA also allows high-risk medical devices already on the market to be updated or modified based on supporting evidence less strict than the studies required for first approval. In the second study, UCSF researchers took a look at the strength of the studies used in product update applications.

The research team found 83 studies that supported the approval of 78 applications for post-market modifications to medical devices.

Of the studies, only 45 percent involved randomized clinical trials, in which patients are randomly assigned to receive the updated device. Only 30 percent were “blinded,” or conducted so patients did not know whether they received the new version of the device.

“Studies without randomization are prone to various types of bias, making it difficult to ascertain whether these modified devices are safer or more effective,” the UCSF researchers wrote.

Part of the problem is that strict follow-up studies are hard to conduct on products already available to patients, particularly when those products treat conditions for which there are no other available therapies, said Dr. Robert Califf, a professor of cardiology at Duke University School of Medicine.

“If you had a rare disease with no effective treatment and a therapy got on the market, you would jump at the chance,” said Califf, a former FDA commissioner. “You wouldn’t jump at the chance to take a placebo.”

To improve post-market studies, doctors and researchers need to do a better job recruiting patients to participate in these studies, said Califf, who wrote an editorial that accompanied the studies.

Electronic medical records that closely track drug and device use among patients also could help, but researchers have found that separate databases don’t always link up effectively to produce the needed data, Ross said.

For example, some insurance-claims databases do not contain unique device identifiers that would let researchers track how well a pacemaker or stent works in the patient who received it, he said.

Improving standards for these electronic records could help researchers access real-world information on how drugs and devices work, Ross said.

MedicalNews
Copyright © 2017 HealthDay. All rights reserved.

SOURCES: Aaron Kesselheim, M.D., associate professor, Harvard Medical School, Boston; Joseph Ross, M.D., assistant professor, Yale School of Medicine, New Haven, Conn.; Robert Califf, M.D., professor, cardiology, Duke University School of Medicine, Durham, N.C., and former commissioner, U.S. Food and Drug Administration; Journal of the American Medical Association, Aug. 15, 2017

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17 Aug

U.S. Antidepressant Use Jumps 65 Percent in 15 Years

News Picture: U.S. Antidepressant Use Jumps 65 Percent in 15 YearsBy E.J. Mundell
HealthDay Reporter

Latest Depression News

TUESDAY, Aug. 15, 2017 (HealthDay News) — The number of Americans who say they’ve taken an antidepressant over the past month rose by 65 percent between 1999 and 2014, a new government survey finds.

By 2014, about one in every eight Americans over the age of 12 reported recent antidepressant use, according to a report released Tuesday from the U.S. Centers for Disease Control and Prevention.

Women are nearly twice as likely as men to be taking the medications, the report found, with antidepressants used by 16.5 percent of females compared to just under 9 percent of males.

Also, “long-term antidepressant use was common,” said a team led by Laura Pratt of the CDC’s National Center for Health Statistics (NCHS).

The researchers noted that “one-fourth of all people [surveyed] who took antidepressants over the past month reported having taken them for 10 years or more.”

Why the steep rise in antidepressant use? Two psychiatrists offered up possible theories.

“Keeping in mind that antidepressants are used for a multitude of reasons — not simply depression — we should expect to see increased use of these medications as the FDA approves more indications for their use,” said Dr. Ami Baxi, director of inpatient psychiatry at Lenox Hill Hospital in New York City.

But Baxi also credited the rise in use of the drugs as “a sign of decreasing mental health stigma,” where more people feel comfortable asking for help against depression and anxiety.

Another expert believes Americans could simply be living more stress-filled lives.

“People have become increasing stressed and depressed in our society,” said Dr. Seth Mandel, who directs psychiatry at Northwell Health’s Huntington Hospital in Huntington, N.Y.

“Social media continues to paradoxically cause people to be more isolated and out of touch with their feelings,” he said.

“In addition, direct-to-consumer advertising, coupled with an evolving societal mindset to just take a pill to make things better, both contributed to the growth in antidepressant use over this time period,” Mandel said.

The new report is based on replies by more than 14,000 Americans, aged 12 and older, to a federal government health survey conducted between 2011 and 2014. Results were compared to those from prior surveys stretching back to 1999.

Besides the notable gender gap in antidepressant use, the survey also found that whites were much more likely than blacks, Hispanics or Asian-Americans to avail themselves of the drugs. For example, while 16.5 percent of whites took an antidepressant over the past 30 days, that was true for just 5.6 percent of blacks, 5 percent of Hispanics and 3.3 percent of Asians, the study found.

According to Mandel, “there are two factors at play here, one being that whites tend to have greater access to psychiatric services than do minority groups. The other is cultural — it is often considered more OK culturally for whites to take antidepressants than for blacks or Hispanics, especially for men.”

The fact that women are twice as likely as men to take an antidepressant may also have cultural roots, Mandel said.

“Despite our society being progressive, there are still ongoing gender stigma related to seeking treatment for depression. It is more ‘OK’ for a woman to be depressed and seek out treatment for this, whereas men are supposed to be tough, suck it up and move on,” Mandel noted.

“One other possible confounder is that males, in my experience, are more upset by the sexual side effects associated with antidepressants — such as erectile dysfunction and delayed ejaculation — and could make them more reluctant to take these medications,” he explained.

And while some people with chronic depression may need to stay on the drug for years, in many cases long-term therapy may not be warranted. “I always re-evaluate whether these medications should be continued on at least a yearly basis,” Mandel said.

The study was published Aug. 15 as an NCHS Data Brief.

MedicalNews
Copyright © 2017 HealthDay. All rights reserved.

SOURCES: Ami Baxi, M.D., director, inpatient psychiatry, Lenox Hill Hospital, New York City; Seth A. Mandel, chairman of psychiatry, Northwell Health’s Huntington Hospital, Huntington, N.Y.; U.S. Centers for Disease Control and Prevention’s National Center for Health Statistics NCHS Data Brief, Aug. 15, 2017

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17 Aug

Could Big Lifestyle Changes Be Key to Managing Type 2 Diabetes?

News Picture: Could Big Lifestyle Changes Be Key to Managing Type 2 Diabetes?By Serena Gordon
HealthDay Reporter

Latest Diabetes News

TUESDAY, Aug. 15, 2017 (HealthDay News) — When it comes to type 2 diabetes management, a new study finds that more is definitely better for lowering blood sugar levels.

The study showed that adding intensive lifestyle management to standard diabetes care (diabetes medication and usual lifestyle change advice) brought blood sugar into a nondiabetic range.

The intensive intervention worked so well that “half of the intervention group did not need glucose-lowering medications to maintain or even improve [blood sugar] control,” said the study’s senior researcher, Mathias Ried-Larsen.

So, what exactly constitutes an “intensive” intervention?

“Patients were prescribed exercise five to six times per week for 30 to 60 minutes per session. That included both endurance and resistance training,” said Ried-Larsen, of Rigshospitalet in Copenhagen, Denmark.

“In the beginning, the exercise was supervised by a coach, but gradually, they were left on their own. Moreover, they received a dietary program with focus on foods rich in fiber, low in saturated fats, lots of fruit and no processed food. We designed the diet for patients to lose weight,” he said.

The study included nearly 100 people from Denmark. All had had type 2 diabetes for less than 10 years, and none had complications from the disease.

The average age of the participants was 55, and nearly half were women. Average A1C level at the start of the study was 6.7 percent. A1C is a blood test that estimates average blood sugar levels over two to three months. An A1C of 6.5 percent or higher indicates diabetes, according to the American Diabetes Association.

Study participants were randomly placed into the usual care group or the intensive lifestyle management group.

After a year, the intensive group lost 13 pounds compared to 4 pounds in the standard management group, the findings showed. LDL cholesterol (the bad kind) and triglycerides (another type of bad blood fat) were reduced more in the intensive group than in the standard group. HDL cholesterol (the good kind) rose more in the intensive group than in the standard group, according to the report.

Average A1C dropped from 6.65 to 6.34 percent in the intensive intervention group, and from 6.74 percent to 6.66 percent in the standard group, the investigators found.

In addition, three-quarters of those in the intensive group needed less diabetes medication, while only one-quarter of the standard care group lowered their medications, the researchers reported.

Not every expert agrees that lowering or stopping diabetes medications is a good idea, however.

Dr. Joel Zonszein is director of the clinical diabetes center at Montefiore Medical Center in New York City.

Zonszein noted that study participants were taking metformin and GLP-1 analogues. “These are good agents. That’s why their A1C was so good at the start. I also treat my patients with lifestyle changes. But it’s not one or the other. Both medicine and lifestyle changes are important,” he said.

“When you use the two together, they work much better,” he added.

Zonszein also noted that the Denmark group was “an unusual population.” None took insulin, and no one had complications. And, at the start of the study, their blood sugar was already fairly well-managed. That would likely be much different in a U.S. population with type 2 diabetes.

One reason Ried-Larsen hoped to lower the need for medication is to save money. Although metformin is available in a generic form and isn’t generally expensive, some of the newer type 2 diabetes medications can be costly.

“I think this study calls for a thorough discussion about the resources we need to allocate to help people to adhere to a lifestyle treatment and what responsibility the society has in this regard,” Ried-Larsen said.

“We do acknowledge that the lifestyle treatment is extensive and could be regarded as not economically viable in clinical care,” Ried-Larsen noted. “However, consider the willingness to introduce newer classes of drugs that come with extreme prices. If we could get doctors and patients to allocate that sort of money and resources to lifestyle treatment, I think we could change things.”

Zonszein added that when people rely solely on lifestyle management, it doesn’t always bring blood sugar levels down enough.

“It’s important to consider the cost-effectiveness of medications along with their cost. A lot of expense comes from treating diabetes complications,” he said.

The report was published Aug. 15 in the Journal of the American Medical Association.

MedicalNews
Copyright © 2017 HealthDay. All rights reserved.

SOURCES: Mathias Ried-Larsen, Ph.D., group leader, Rigshospitalet, Copenhagen, Denmark; Joel Zonszein, M.D., director, clinical diabetes center, Montefiore Medical Center, New York City; Aug. 15, 2017, Journal of the American Medical Association

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17 Aug

Is FDA Taking Close Enough Look at Fast-Tracked Drugs?

News Picture: Is FDA Taking Close Enough Look at Fast-Tracked Drugs?By Dennis Thompson
HealthDay Reporter

Latest Prevention & Wellness News

TUESDAY, Aug. 15, 2017 (HealthDay News) — Many cutting-edge drugs and updated medical devices are not receiving the rigorous scientific scrutiny needed to ensure their safety and effectiveness, two new studies contend.

Medications fast-tracked to market under the U.S. Food and Drug Administration’s “accelerated approval” process are not receiving proper follow-up clinical trials that are required to confirm their benefits, one study reported.

“Our concern is that a lot of newer drugs approved through this pathway are not then being subjected to rigorous confirmatory trials in a timely fashion,” said senior researcher Dr. Aaron Kesselheim, an associate professor at Harvard Medical School.

At the same time, high-risk medical devices like pacemakers, stents and artificial heart valves regularly undergo next-model updates and modifications based on weak clinical evidence, according to a second study from researchers at the University of California, San Francisco (UCSF).

Both reports were published in the Aug. 15 issue of the Journal of the American Medical Association.

The upshot is that doctors and patients can’t rely on the research to figure out just how safe and effective these drugs and devices are, said Dr. Joseph Ross, an assistant professor with Yale School of Medicine.

“We never get the robust large studies that can determine how well something works,” said Ross, who wasn’t involved with the studies.

“Accelerated approval” allows the FDA to fast-track approval of drugs that fill an unmet medical need, particularly if the medication is for a life-threatening illness and there are no other treatment options, Kesselheim explained.

Under this process, the FDA can approve a drug based on weaker-than-usual evidence showing that the medication is reasonably likely to be beneficial to patients, without actually proving real benefit, the researchers said in background notes.

But manufacturers are then required to produce follow-up studies within three years that confirm the drugs work, Ross said.

“There’s sort of a bargain at work. The FDA permits a drug to be approved on the basis of much weaker evidence to get the product out there to patients,” Kesselheim said. “In exchange, the manufacturer is supposed to conduct confirmatory, much more rigorous post-approval studies.”

Kesselheim and his colleagues reviewed 22 drugs granted accelerated approval between 2009 and 2013, 19 of which were intended for cancer treatment.

As a condition of accelerated approval, the FDA ordered that 38 follow-up studies be performed after these drugs hit the market, the researchers said.

But three years after the last drug’s approval in 2013, only half of the required 38 confirmatory studies had been completed, the researchers found.

Further, about 42 percent of the studies that had been completed were not performed to a higher standard, but instead relied on the same weaker sort of evidence used to get the drugs fast-track approval in the first place, the study showed.

For example, the studies would rely on blood tests or screening examinations as indications of effectiveness, rather than proving that the drug improved symptoms or prolonged patients’ lives, the researchers said.

“If you don’t get the confirmatory large-scale study down the line after those first three years, we’re still in the same situation we were in at the time of approval,” Ross said. “We think it works, but we don’t really know.”

The FDA also allows high-risk medical devices already on the market to be updated or modified based on supporting evidence less strict than the studies required for first approval. In the second study, UCSF researchers took a look at the strength of the studies used in product update applications.

The research team found 83 studies that supported the approval of 78 applications for post-market modifications to medical devices.

Of the studies, only 45 percent involved randomized clinical trials, in which patients are randomly assigned to receive the updated device. Only 30 percent were “blinded,” or conducted so patients did not know whether they received the new version of the device.

“Studies without randomization are prone to various types of bias, making it difficult to ascertain whether these modified devices are safer or more effective,” the UCSF researchers wrote.

Part of the problem is that strict follow-up studies are hard to conduct on products already available to patients, particularly when those products treat conditions for which there are no other available therapies, said Dr. Robert Califf, a professor of cardiology at Duke University School of Medicine.

“If you had a rare disease with no effective treatment and a therapy got on the market, you would jump at the chance,” said Califf, a former FDA commissioner. “You wouldn’t jump at the chance to take a placebo.”

To improve post-market studies, doctors and researchers need to do a better job recruiting patients to participate in these studies, said Califf, who wrote an editorial that accompanied the studies.

Electronic medical records that closely track drug and device use among patients also could help, but researchers have found that separate databases don’t always link up effectively to produce the needed data, Ross said.

For example, some insurance-claims databases do not contain unique device identifiers that would let researchers track how well a pacemaker or stent works in the patient who received it, he said.

Improving standards for these electronic records could help researchers access real-world information on how drugs and devices work, Ross said.

MedicalNews
Copyright © 2017 HealthDay. All rights reserved.

SOURCES: Aaron Kesselheim, M.D., associate professor, Harvard Medical School, Boston; Joseph Ross, M.D., assistant professor, Yale School of Medicine, New Haven, Conn.; Robert Califf, M.D., professor, cardiology, Duke University School of Medicine, Durham, N.C., and former commissioner, U.S. Food and Drug Administration; Journal of the American Medical Association, Aug. 15, 2017

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Source: MediciNet