Thursday, July 29, 2021

Can I Stop Taking My Antidepressant or Antianxiety Meds?

The incidence of depression and anxiety has surged among adults in the United States over the course of the COVID-19 pandemic, according to the Centers for Disease Control and Prevention (CDC). The CDC survey suggested that from 2019 to 2020, symptoms of anxiety disorders and depression have tripled and quadrupled, respectively.

As you might expect, prescriptions for antidepressant and antianxiety drugs also have spiked, according to the telehealth platform iPrescribe.

While many patients with severe or chronic depression or anxiety may need to continue using these medications long term, you may think that, given the return of opportunities for working and socializing, habits that can help some people keep these diseases at bay, it may be time to talk with your doctor about tapering off the drug.  

“A lot of people that became depressed or anxious during COVID lockdowns are now starting to feel better without any medication, now that they’re able to re-engage with people and they may be able to go back to work,” says George Grossberg, MD, a psychiatrist and member of MedShadow’s medical advisory board. If your life feels more manageable, you might be thinking about stopping your antidepressants or antianxiety drugs. 

Patients Who Might Consider Tapering Off

Antidepressant and antianxiety meds do create a list of serious side effects. though. Along with the risk of dependence, both types of drugs can cause suicidal ideation, blurred vision, weight gain and sexual dysfunction.

“It is a good idea to periodically reassess the ongoing need for antidepressants or antipsychotic medication,” says Grossberg. “But I do advise patients to do that with the supervision and monitoring of their healthcare provider.”

Before making any decisions about tapering off of antidepressant or antianxiety medications, discuss it with your healthcare provider. He or she will review your history with depression or anxiety, by asking about how long you’ve been prescribed the drugs and if you’ve ever tried stopping them before.

“Some patients have had long histories of recurrent depression, where they may need to be maintained on antidepressant medicines over time, even now, to do their best,” says Grossberg. “Others, on the other hand, may do just as well with psychotherapy or counseling and can be weaned off their antidepressants.”

Your physician may also ask about other treatments and strategies you use for managing your condition, ranging from cognitive behavioral therapy to exercising and spending time with loved ones. You may want to think about what has changed in your life since you first received a prescription.

During the pandemic, many people experienced significant stress and loneliness or the traumatic loss of loved ones. These conditions can trigger or exacerbate mood disorders. At another point in the pandemic, you may not have been able to work a job that helped provide meaning in your life or to see friends and family that boosted your mood. If these situations have improved, you may be able to manage without the drugs.

One of Grossberg’s patients lost his job, which had provided him with structure and opportunities to socialize during the pandemic. Grossberg had prescribed antidepressants at first, but now that there are more opportunities for the patient to return to work, his adult daughter suggested that a new job might help him more than the drugs. Grossberg agreed.

Another person who experienced that shift is Daniel Hodges. He has struggled with depression, anxiety, chronic pain and a connective tissue disorder. Key to his recovery, he says, was finding purpose. “I can’t emphasize enough the pivotal role that service [and] volunteerism has played in my life. Finding what we’re good at, which, in my case, involves going to law school and creating a nonprofit, adds tremendous value to our lives. It doesn’t eradicate the struggle, but at least the struggle has purpose now,” he says.  

It’s not just the pandemic that has affected Americans. Sometimes trauma knocks us off our feet, and we need medicines to stabilize our moods so we can get back up. Channing Miller’s doctor prescribed him antidepressants in 2019 after a bad breakup. He started with therapy, but realized that it alone wasn’t enough to manage the ruminations that came with the experience. His therapist recommended the antidepressant Lexapro. While using the drug, Miller continued therapy, exercised consistently and was open with his friends about needing time alone when he’s stressed. Earlier this year, feeling like he had gained more control over both his emotions and his life, he and his doctor decided it was time to lower his dosage in preparation for quitting the drug altogether.  

Differences Between Antidepressants and Antianxieties

Not all mood-boosting drugs are the same. The Food and Drug Administration (FDA) has approved antidepressants for both depression and anxiety, and they’re often frontline drugs for both conditions. Selective Serotonin Reuptake Inhibitors (SSRIs) are often the drug-of-choice for both conditions. However, benzodiazepines, such as Ativan, Lorazepam and Xanax, are specifically indicated for anxiety. Benzodiazepines are more likely to cause severe withdrawal effects than antidepressants, explains Grossberg. If you stop a benzodiazepine too abruptly, you could experience confusion, delirium and seizures.

Other withdrawal symptoms from benzodiazepines include:

Insomnia

Nightmares

Jitters

Poor memory

Dizziness

Palpitations

Hallucination

Muscle twitches

Tingling or numbness

Withdrawal symptoms from SSRIs are:

Flulike symptoms

Fatigue

Dizziness

Blurred vision

Sweating and chills

Nausea and vomiting

Insomnia

Anxiety and agitation

Confusion

What to Expect When You Stop Taking Antidepressants or Anti-Anxiety Drugs

One reason to work with your healthcare provider to wind down your drug dosage is that each drug is different. “For example, a medicine like Prozac (fluoxetine), which is a very popular antidepressant, has a long half-life in the body, so it’s easy to wean. It’s easy to wean, because it almost weans itself out of the system,” says Grossberg. Others, like Paxil (paroxetine), don’t last as long in the body, so the withdrawal symptoms may come on more abruptly after you stop taking them, meaning you need to lower your dosage more cautiously. 

As you wind down your dosage, be on the lookout for symptoms of withdrawal like gastrointestinal symptoms or jitters. These are signs that you may want to ease off the drug more slowly. If this happens, “We continue to wean the person to be it, but we do it even more slowly to try to minimize the withdrawal side effects,” says Grossberg. 

Other symptoms, like an increase in symptoms of depression or anxiety, may suggest you would feel better continuing the treatment instead of cutting down the dosage. Grossberg says he recommends including family members in the process, too, as they may notice changes you don’t. For example, he had a recent patient who thought he was doing well, but a family member pointed out that he had been low on energy and lost interest in socializing, both of which are subtle signs of a depressed mood.

Miller’s doctor had him start by cutting his daily dose in half. After about a month, the doctor recommended Miller take the drug every other day, and eventually every three or four days, before discontinuing it altogether. Miller says he didn’t notice side effects early on, but he adds, “When I reached the point of taking a pill every three days, I definitely noticed a few things. More than once, I experienced a fuzziness and slight buzzing in the space around my brain. . . after some research, I attributed it to withdrawal.” As he reduced taking the antidepressant to every four days, he noticed a change in his moods. He says he went from calm to angry quickly, and he “worried it meant I truly needed the antidepressants more than I thought simply to regulate my emotional responses.” He was able to work through the frustration using the coping mechanisms he developed while taking Lexapro.

Ultimately, he says, “I am 100% glad that I took the pills in conjunction with my cognitive (and running!) therapy. It’s what got me to the place I am at today in my life, which is truly wonderful. I also am glad I don’t need them now to continue feeling this way.”

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Wednesday, July 28, 2021

Here’s Why the CDC Recommends Wearing Masks Indoors Even if You’ve Been Fully Vaccinated Against COVID-19

Peter Chin-Hong, University of California, San Francisco

Vaccinated people need to mask up again, according to the U.S. Centers for Disease Control and Prevention. On July 27, 2021, the CDC recommended that everyone in areas with high COVID-19 infection rates wear masks in public indoor spaces, regardless of vaccination status.

It’s a reversal from the CDC’s May 2021 advice that the fully vaccinated could leave their masks at home and brought U.S. guidelines more in line with World Health Organization recommendations.

The Conversation asked Peter Chin-Hong, a physician who specializes in infectious diseases at the University of California, San Francisco, to help put into context the science behind the changing messages.

What science supports masking after vaccination?

Masks help stop the spread of the coronavirus. They’re a literal layer between you and any virus in the air and can help prevent infection.

The reason public health officials are calling for more mask-wearing is that there is clear and mounting evidence that – though rarebreakthrough COVID-19 infections can occur in people who are fully vaccinated. This is particularly true with emerging variants of concern. The good news is that COVID-19 infection, if it does happen, is much less likely to lead to serious illness or death in vaccinated people.

Some conditions make a breakthrough infection more likely in a vaccinated person: more virus circulating in the community, lower vaccination rates and more highly transmissible variants.

If vaccinated people can get infected with the coronavirus, they can also spread it. Hence the CDC recommendation that vaccinated people remain masked in indoor public spaces to help stop viral transmission.

Where will the guidelines apply?

The CDC mask recommendation targets areas in the U.S. with more than 50 new infections per 100,000 residents or that had more than 8% of tests come back positive during the previous week. By the CDC’s own definitions “substantial” community transmission is 50 to 99 cases of infection per 100,000 people per week, and “high” is 100 or more.

Los Angeles County, for example, far surpassed that mark in mid-July, with more than 10,000 coronavirus cases per week.

Using these criteria, the CDC guidance applied to 63% of U.S. counties on the day it was announced.

Masking primarily protects those who are not vaccinated. © yurolaitsalbert / Adobe Stock

Who’s actually protected by masking recommendations?

The recommendation that fully vaccinated people continue wearing masks is primarily intended to protect the unvaccinated – which includes kids under age 12 who are not yet eligible for vaccines in the U.S. The CDC further recommends masking in public for vaccinated people with unvaccinated household members, regardless of local community transmission rates.

Unvaccinated people are at a substantially higher risk of getting infected with and transmitting SARS-CoV-2, and of developing complications from COVID-19.

How do new variants like delta change things?

Preliminary data suggests that the rise of variants like delta may increase the chance of breakthrough infections in people who received only their first vaccine dose. For instance, one study found that a single dose of the Pfizer vaccine had an effectiveness of just 34% against the delta variant, compared with 51% against the older alpha variant in terms of warding off symptomatic disease.

The data is more reassuring for those who have been fully vaccinated. After two doses, the Pfizer vaccine still provides strong protection against the delta variant, according to real-world data from Scotland and a variety of other countries; and in preliminary studies out of Canada and England, researchers noted only a “modest” decrease in effectiveness against symptomatic disease, from 93% for the alpha variant to 88% for delta.

Other recent preliminary reports from highly vaccinated countries like Israel and Singapore are sobering, however. Before the delta variant became widespread, from January to April 2021, Israel reported that the Pfizer vaccine was 97% effective in preventing symptomatic disease. Since June 20, 2021, with the delta variant circulating more widely, the Pfizer vaccine has been only 41% effective in preventing symptomatic disease, according to preliminary data reported by Israel’s Ministry of Health in late July. An analysis using government data from Singapore demonstrated that 75% of recent COVID-19 infections were in people who were at least partially vaccinated – though most of them were not severely ill.

In places with high transmission rates, masking guidelines will be uniform for everyone. © nao / Adobe Stock

In all reports and studies, however, vaccines remain very good at preventing hospitalizations and severe disease due to the delta variant – arguably the outcomes we most care about.

All of this emerging data supports the WHO’s global recommendation that even fully vaccinated individuals continue to wear masks. Most of the world still has low vaccination rates and uses a range of vaccines with variable efficacies, and countries have different burdens of circulating SARS-CoV-2 virus.

With U.S. case counts and breakthrough infection numbers headed in what public health officials consider the wrong direction, it makes sense that the CDC would modify its masking recommendations to be more conservative.

What conditions in the US warrant masking up (again)?

It makes sense that the CDC didn’t immediately change its recommendations to fall in line with the WHO’s June guidelines. With an overall high countrywide vaccination rate and a low overall COVID-19 hospitalization and death burden, the U.S. has a COVID-19 landscape very different from that in most of the world.

Additionally, some experts worried that an official message that the vaccinated should don masks might dissuade unvaccinated individuals from seeking vaccines.

But as President Joe Biden put it on July 27, “new research and concerns about the delta variant” are behind the CDC’s change in masking recommendations.

Some locations are seeing further increase in community transmission, even among vaccinated people. New preliminary research yet to be peer reviewed suggests the delta variant is associated with a viral load a thousand times higher in patients than seen with older strains. And early reports show infected vaccinated people with the delta variant can carry just as high an amount of virus as the unvaccinated that they can in turn spread to others.

The shifting recommendations don’t mean that the old ones were wrong, necessarily, only that conditions have changed. The bottom line? Masks do help cut down on coronavirus transmission, but it’s still vaccines that offer the best protection.

This is an updated version of an article originally published on July 22, 2021.The Conversation

Peter Chin-Hong, Associate Dean for Regional Campuses, University of California, San Francisco

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Friday, July 23, 2021

Hate the Pill? Non-Hormonal Birth Control, While Effective, Has Side Effects, Too

Alice Queen used oral contraceptives for years, but they caused her “intense pain and swollen breasts all the time,” she says. Eventually, she switched to non-hormonal birth control options.

Hormonal birth control like oral contraceptives, the NuvaRing (a vaginal ring) and hormonal intrauterine devices (IUD) work to avert  pregnancy by preventing you from ovulating and by changing the cervical mucus and lining of the uterus to be less hospitable to a fertilized egg. Unfortunately, these treatments can come with a host of side effects. You might consider non-hormonal options, if you have “a history of clotting (deep vein thrombosis), migraines with aura [or] elevated blood pressure, or if you don’t like how you feel on hormones,” says Christine Greves, MD, OB-GYN, at Orlando Health Winnie Palmer Hospital for Women & Babies.

Pregnancy prevention is not the only reason people use hormonal birth control. It may be prescribed to help treat polycystic ovarian syndrome (PCOS), early symptoms of menopause or acne, for example. In those cases, the hormones are key to the treatment’s efficacy. [Listen to our Power to the Patient podcast about one woman’s journey treating her PCOS with and without birth control.]

If your goal is to avert a pregnancy, there are non-hormonal options available. IUDs with copper instead of hormones have been around since the 1980s. In 2020, the Food and Drug Administration (FDA) approved the vaginal gel Phexxi for birth control. Even without hormones, these options can produce side effects. Here’s what you need to know about them.

Copper IUDS

How They Work: Copper interferes with sperm’s ability to swim to an egg. The copper IUD retains its ability to prevent pregnancy for more than a decade, but can be removed at any time if you want to change birth control methods or decide you want to get pregnant.

Possible Side Effects: Upon insertion of the device, you may feel cramps and pain immediately. To treat pain, you can use over-the-counter treatments such as nonsteroidal anti-inflammatories (NSAIDs) like Advil, or acetaminophen (Tylenol), or you can ask your physician to prescribe stronger pain medications. In rare cases, the IUD can damage the uterus wall, and you’ll need to have the device surgically removed.

After any initial pain eases, you may experience more bleeding or pain during your period for the first three to six months. This, too, should decrease over time.

Queen says she was bedridden for two days after having the IUD inserted. “Strong pain killers and determination helped me through, but I won’t lie, I was very tempted to get it removed,” she says. After two days, the pain lessened, though her next two periods were heavier and more painful than usual. 

“Once the pain subsided, heavier periods were manageable for me. And the fact that I did not have sore and swollen breasts was a positive trade-off,” she says. In addition to heavier periods, some patients experience breakthrough bleeding between periods.

It’s also possible for the IUD to get infected, usually within the first month. This can cause symptoms like abdominal pain, foul-smelling discharge and fever. @Wealthyoptimist explains that she had to have hers removed after a serious infection spread to her blood.

 

@wealthyoptimist⚠️My HORRIBLE Copper IUD experience! (Full story up now on my TikTok) ⚠️ #copperiud #iudexperience #fyp #GoBoldColorista #sepsis #birthcontrol #nhs♬ original sound – Sarah Hall

 

@wealthyoptimistCopper IUD horror story UPDATE ‼️ #copperiud #iudexperience #iudremoval #pelvicinflammatorydisease #ovariancystawarness #fyp♬ original sound – Sarah Hall

 

Lastly, while the copper IUD is more than 99% effective, a small number of women may become pregnant while using it. These women are at a heightened risk of experiencing a dangerous ectopic pregnancy, one in which the fertilized egg implants itself outside the uterus.

Removal: When you want to stop taking oral contraceptives, you simply stop taking them. However, to cease using an IUD, you need to have it removed by your healthcare provider. Once it’s out of your body, your period and fertility will immediately go back to normal. The extraction process should be very quick, as a physician or nurse grasps the device’s strings and gently pulls it out.

 

@jennifersharkReply to @allietee IUD out! #iud #iudremoval #larc #paragard #mirena #midwife #midwifelife #MakeMomEpic #mirena #liletta #birthcontrol #contraception

♬ Monkeys Spinning Monkeys – Kevin MacLeod

 

When the IUD came out, some patients on Twitter described extremely painful experiences without anesthesia and little or no other pain relief. Some said cramping and pain continued after the removal.

 

 

However, others, like Harmony Major, who had her IUD in for 15 years, said they “barely felt” the removal. Queen had a similarly uneventful extraction. She received general anesthetic and said removal was “a breeze. . . It really made me think that the insertion should also have been under some sort of anesthetic – I find it hard to believe that option is not offered more often!”

Phexxi

Phexxi is a gel that you apply using a tamponlike applicator up to an hour before sex. On its own, it is 86% to 93% effective, but it can also be used with other birth control methods like condoms and oral contraceptives.

How it Works: Semen raises the pH of the vagina, making it less acidic and more welcoming to sperm. Phexxi brings the pH back down to its normal acidity, making it harder for sperm to swim toward an egg. “Sperm cannot thrive in the acidic pH environment,” says Aparna Sridhar, MD, a gynecologist at David Geffen School of Medicine at the University of California, Los Angeles (UCLA). “This is a completely non-hormonal option.”

Possible Side Effects: 

The most common side effects are vaginal itching, yeast infection, urinary tract infection, vaginal discomfort, vaginal discharge, bacterial vaginosis and vaginal burning. Also, the male partner may have genital itching, pain or burning,” says Greves. 

Alternatives

There are several other options that can be used in conjunction with or in lieu of the method, above.

Barrier Methods

You can use barrier methods like condoms, diaphragms and birth control sponges, which physically block sperm from staying in your body and finding an egg to fertilize. These can be used along with hormonal birth control, Phexxi, spermicides and IUDs. Pay attention to the materials the devices are made of. Some people are allergic to latex, the plastic that most condoms are made from, and some come with lubrication or other coatings that may irritate your skin.

Surgery

For those looking for a long-term, or even permanent, form of birth control, there are surgical procedures for both men and women. Men can undergo vasectomies, a procedure in which the tubes that carry sperm out of the scrotum are cut so sperm cannot leave the body. Women can have a tubal ligation, in which the Fallopian tubes are disconnected from the uterus, making it impossible for an egg to get from the ovaries to the uterus to be fertilized. These are minor surgical procedures, but come with the usual risks, such as negative reactions to anesthesia. 

Breastfeeding

If you’ve recently given birth and are breastfeeding your infant regularly every four to six hours, your body won’t release an egg. If an egg isn’t released, it can’t be fertilized. Like oral contraceptives, this strategy is about 98% effective. Be aware that this method works only for six months and only if you’re feeding your baby a strict diet of your breast milk. That means, no formula.

Spermicide

Similar to Phexxi, you apply spermicide with your fingers or an applicator before having sex. The chemical makes it difficult for the sperm to move, and the gel itself can serve as a barrier to your cervix.

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Thursday, July 22, 2021

Weight Loss Drug Wegovy Could Offer More Risks Than Benefits

The Food and Drug Administration (FDA) has now approved the diabetes drug Wegovy (semaglutide), previously okayed for diabetes, for weight loss. I wonder why? I was the consumer representative on the FDA advisory panel that voted to approve Wegovy (semaglutide) for diabetes. I voted for it reluctantly and only because the drug helped slightly improve life for those with diabetes. 

A small weight loss is one benefit of Wegovy. Patients given Wegovy in clinical trials lost between five and 10 pounds. That’s helpful for a person with type-1 diabetes, but for the average person, it’s minor. The average weight of an American man is 199 pounds, women are 171 pounds. Experts tell me a weight loss, even that small, can improve the health of people with diabetes. But for everyone else, what is the difference between 199 and 189 or 171 and 166 pounds? 

The side effects of Wegovy are very scary and, in my opinion, would outweigh the benefits of someone taking the drug just for weight loss. Below are my blog and thoughts when the FDA approved Wegovy in 2017 for diabetes. I have even more concerns now. 

(2017) A Trail of Clues to a New Diabetes Drug

Last week, I sat on an FDA panel as the lone consumer rep to discuss and vote on an application for a diabetes drug, semaglutide, from Novo Nordisk. This is a new entry in the category of GLP-1 agonists, six of which are already approved for use in diabetes.

The benefits are clear and strong: semaglutide lowers glucose levels and helps patients drop weight by [what I thought at the time was] a significant level, five to 10 pounds on average. Lowering glucose levels is the surrogate marker that the FDA uses to measure the benefits of new diabetes drugs. The FDA allows surrogate markers because waiting to prove or disprove that a drug lengthens or improves the lives of diabetics would take decades. 

However, the side effects are pretty bad. At least 20% of the trial participants had to drop out because they couldn’t take the nausea, diarrhea and constipation. (This is a problem with other GLP-1 agonists, too.) These symptoms could lead to using drugs for side effects. At least one doctor on the panel voiced the obvious: with so much gastric distress, no wonder patients lost weight.  

The primary killer of people suffering with diabetes is CVD (cardiovascular disease). https://www.cdc.gov/features/diabetes-heart-disease/index.html The FDA looks closely at the effects of any diabetes drug that could impact CVD. For that reason, in addition to five other clinical trials, Novo Nordisk ran a two-year trial called SUSTAIN 6 that focused on CVD, with a secondary consideration on diabetic retinopathy, a problem that blinds half of all diabetics.

SUSTAIN 6 had mixed results. Happily, it showed a significant decrease in most of the CVD measurements. Compared to the placebo and to comparator drugs, those taking semaglutide had substantially lower rates of non-fatal MI (myocardial infarction, or heart attack), non-fatal stroke, revascularization (needed surgery for bypass or other heart vascular issue) or hospitalization for an unstable angina (poor blood flow to heart). 

Unfortunately, data also showed semaglutide slightly increased the risk of being hospitalized for heart failure and had about the same risk (as compared to a placebo) of a cardiac death. Deaths from all causes were about the same as with a placebo. On balance, the drops were significant and the increases small.

Of concern was that diabetic retinitis showed a definite increase among users of semaglutide compared to the placebo. In tests of other GLP-1 agonist drugs, this same pattern had been shown and named “Early Worsening.” In years three and four, the rapid onset slowed, and soon the placebo group’s retinitis symptoms increased well past the tested drug group. However, Novo Nordisk didn’t continue the test to prove or disprove that this drug, semaglutide, would follow the same pattern. In addition, the quality of the research conducted on retinopathy wasn’t good. The preferred tests for retinopathy were not conducted and the data collection was inconsistent. We can hope, but cannot assume, the rapid increase in retinopathy that semaglutide causes will level off. Therefore, the doctors on the panel agreed that retinitis progression at a rapid rate is a real possibility.  

The eye doctors on the panel discussed and assured the rest of us that there were many procedures for doctors to slow retinitis, and, in their opinion, this was a manageable problem. The greater concern to diabetics, they all agreed, was CV risk, where semaglutide showed a clear benefit. 

The above issues I had to leave to the experts. These doctors were trained in medical research and statistics. However, I know that the population upon which a drug is tested must reasonably compare to the population that will likely use the drug. Diabetes is much more common among the non-Hispanic Black and Hispanic populations. Yet the trial participants were 80% white (with the exception of the two trials that were conducted in Japan). 

The appropriate patient population is just as important as correct dosing and timing. I was the first panelist to raise this question, and only one doctor added his concern to mine. He abstained from voting yes or no. I wish I’d thought of abstaining as an option. I voted yes, but I remain very worried. Here are my remarks to the committee (lightly edited for clarity): 

“Semaglutide does show a lowering of glycemic levels and body weight. It doesn’t seem to cause hypoglycemia as often as its comparator drugs [the drugs to which semaglutide was tested against]. The committee has convinced me that retinopathy is manageable and that the lack of CV harm is a greater benefit. It has significant side effects and adverse events that cause a large percent of patients to stop using the drug.

“I am concerned about the race and ethnic makeup of the trial participants and the lack of subgroup analysis. Black non-Hispanics have the second-highest rate of diabetes, but are so underrepresented in these trials that the actual black patients number in the low 100s.

“The lack of significant subgroup analysis also concerns me. With such small samples it is impossible to know if it has differing effects and safety among women or ethnic groups.

“Considering the commonality of retinopathy with diabetes, it is surprising to me that the research was not gathered in a standardized method and which made it not of the best quality. The applicant seems to be depending on other studies of other drugs to conclude that the “Early Worsening” of retinopathy shown in their trials is temporary and that there will ultimately be a benefit to the patient. If semaglutide follows the pattern of other diabetes drugs, continuing the study for only one more year would have confirmed a pattern similar to other drugs. As it stands, the study stopped at two  years, which doesn’t allow any confirmation of benefit.

“The trial was particularly overwhelmingly white. Cardiovascular disease is the Number One killer of women, and it’s very high on the list of cause of death for black people; diabetes has a higher incidence rate in blacks and Hispanics, and they’re not well represented.

“History has shown that drugs tested on only one ethnic group or one sex can sometimes have surprising, and detrimental, effects on subgroups. 

“The lack of ability to do subgroup analysis concerns me. I’m going to feel pretty bad if we don’t go on record saying there should be more trial participants, and the trial should reflect the people who need the drug.

“I strongly recommend further study with better demographic representation that allows subgroup analysis to determine efficacy with blacks, Hispanics, women, etc. 

“We also need further tracking to find out about the long-term effect on retinopathy. 

“I think these further studies should be required, because the public has the right to full safety information.” 

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Thursday, July 8, 2021

Mind - Body Connection in Health and Illness

The mind is the master of the human body. It directs and controls every function of the human body. Every condition, every experience of life is the result of our mental attitude. The mind creates 50,000 thoughts a day. Every person has a powerful mind. The mind is the forerunner of all actions (Buddha). Human beings use only 10% of their mind power. The mind is a great big magnet. The greatest discovery of all time is the mind. The mind can be consciously built-up, cultivated, developed and used. Meditation, reflection or prayer can quiet the restless nature of the mind. Optimal health is a manifestation of harmony within the body, mind, and spirit. Psychological health, which encompasses both our emotional and mental health, is instrumental in determining physical health. Mind - emotion - behavior interconnections of health and illness are going to fundamentally change our approach to health care.




The mind has 3 aspects:

  1. The aspect of being or substance
  2. The aspect of thought with the subdivisions of reason, feeling, emotion, desire, and will
  3. The aspect of acting


The mind has 3 divisions:

  1. The conscious mind - the center of human thoughts, emotions, feelings, sensations, and behaviors
  2. The subconscious mind - the center of habits, skills, behaviors, reflexes, conditional responses, and emotional reactions
  3. The higher conscious mind/universal mind - it controls the 'awareness of awareness'



Definitions


Emotional well-being is defined as the ability to feel and express the entire range of human emotions from anger to love and to control them, not to be controlled by them.


Mental well-being is the ‘psychological state of someone who is functioning at a satisfactory level of emotional and behavioral adjustment.’


Physical well-being is defined as the optimal condition of each of the body’s physiological systems.


The Mind - Body concept


The mind body concept is defined as the interaction that takes place between our thoughts, our body and our external world. A new science that studies this link is called psychoneuroimmunology (PNI). PNI seeks to understand the complex communications between and among the nervous system, the psyche and the immune system and their implications for health. PNI describes ways in which our emotions and attitude, can affect our health and also the outcome of medical treatment.


Psychosomatics


The term ‘psychosomatic’ refers to the connection or interaction between the body and mind. The terms psychosomatics, (meaning that the mind can influence the health of the body), and psychogenic, (meaning that mind can cause diseases in the body,) often interchange. Well-being integrates mental health (mind) and physical health (body) resulting in more holistic approaches to disease prevention and health promotion. In terms of health and wellness, the whole is made up of four components: mind, body, spirit and emotions. The holistic wellness is composed of the integration, balance, and harmony of these four components.


Power of emotions


Emotions are very strong feelings within the human mind. Emotions are states of mind that arise as a result of specific life experiences. Emotions are critical to our survival. There are 5 basic emotions: anger, fear, gladness, sorrow, and shame. These main emotions branch into secondary emotions, and then branch into a third set, called tertiary emotions.  Emotions have many facets: they involve feelings and experience, they involve physiology and behavior and they involve cognitions and conceptualizations.


Emotions change the way the human mind solves problems. The emotional system changes how the cognitive system operates. The emotions are neuropeptides that affect the functioning, reproduction and health of the cell. Positive emotions tend to open us up to our environment for exploration and discovery. They encourage us to discover a purpose and seek intimacy. They help us to understand others through empathy and compassion. They teach us our beliefs, desires and values.


Negative emotions can cause disease. Anxiety, depression, anger and frustration are some of the mind’s negative emotions that greatly affect the body’s health. Chronic stress may prevent body’s homeostasis and lead to ill health.


                         Stress > Fatigue > Exhaustion > Lowered immunity > Ill health




Mind –body medicine


The intimate connection between mental and physical health has long been recognized; mental health can affect illness and disease while illness may affect mental health. The mind-body medicine has provided evidence that psychological factors can play a major role in reducing the risk of most major diseases.


There are four interacting information processing systems in humans: the mind (the functioning of the brain), the endocrine system, the nervous system, and the immune system. These information processing systems become the part of the mind-body network - nervous, hormonal, digestive, and immune - and they communicate with one another via peptides and their receptors.


The mind-body network is composed of neuropeptides, short chains of amino acids that extend “to every molecular corner of the body” and transmit messages across organs, cells, tissues, and DNA. Over 100 molecules of neuropeptides have been identified that carry messages between the brain, the endocrine system and the immune system. Neuropeptides therefore act as a type of informational molecules that unites and coordinates all the cells, tissues, glands, organs and systems of the body. Their unique ability to modulate chemical and physical responses in the body has earned them the title ‘healing molecule’.


Peptide rich areas are not only present in the brain, but also in the gut, which is why many of us experience emotions there such as “gut reactions.” Since there is undoubtedly bidirectional communication between the brain and the body, thoughts and feelings may manifest as physical symptoms. Our mind and emotions play a critical role in our health. Mind-body therapies can help to improve psychological functioning and quality of life and may help to ease symptoms of diseases. Mind-body medicine focuses on treatments that promote health including relaxation, hypnosis, visual imagery, meditation, yoga, and biofeedback.





"There is no illness of the body apart from the mind." - SOCRATES


“Mind moves matter.” - VIRGIL, the Roman poet


"A sound mind in a sound body is a short but full

  description of a happy state in this world."  - JOHN LOCKE, Philosopher, 1693.


Original article appeared first here:

https://bonvictor.blogspot.com/2014/03/mental-literacy-your-mind-creates-you.html

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