Postdoctoral research fellow, The University of Queensland
Disclosure statement
Leonie Kirszenblat does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.
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Many of us have experienced the effects of sleep deprivation: feeling tired and cranky, or finding it hard to concentrate. Sleep is more important for our brains than you may realise.
Although it may appear you’re “switching off” when you fall asleep, the brain is far from inactive. What we know from studying patterns of brain electrical activity is that while you sleep, your brain cycles through two main types of patterns: rapid eye movement (REM) sleep and slow-wave sleep.
Slow-wave sleep, which occurs more at the beginning of the night, is characterised by slow rhythms of electrical activity across large numbers of brain cells (occurring one to four times per second). As the night progresses, we have more and more REM sleep. During REM sleep we often have vivid dreams, and our brains show similar patterns of activity to when we are awake.
Sleep serves many different functions. One of these is to help us remember experiences we had during the day. REM sleep is thought to be important for emotional memories (for example, memories involving fear) or procedural memory (such as how to ride a bike). On the other hand, slow-wave sleep is thought to reflect the storing of so-called “declarative” memories that are the conscious record of your experiences and what you know (for example, what you had for breakfast).
We also know experiences are “replayed” in the brain during sleep – the memories of these experiences are like segments from a movie that can be rewound and played forward again. Replay occurs in neurons in the hippocampus – a brain region important for memory – and has been best studied in rats learning to navigate a maze. After a navigation exercise, when the rat is resting, its brain replays the path it took through the maze. Replay helps to strengthen the connections between brain cells, and is therefore thought to be important for consolidating memories.
While we’re asleep our brain does a tidy-up, only keeping what it needs.Sashank Saye/Unsplash
But is it that important for you to remember what you had for breakfast? Probably not – that’s why the brain needs to be selective about what it remembers. Sleep allows the brain to sift through memories, forgetting certain things so as to remember what’s important. One way it may do this is by “pruning away” or “scaling down” unwanted connections in the brain.
This is thought to counterbalance the overall strengthening of connections that occurs during learning when we are awake. By pruning away excess connections, sleep effectively “cleans the slate” so we can learn again the next day. Interfering with this scaling down process can, in some cases, lead to more intense (and perhaps unwanted) memories.
The importance of sleep for keeping our brains optimally active may be reflected in our changing sleep patterns as we age. Babies and children sleep much more than adults, probably because their developing brains are learning much more, and being exposed to new situations.
Later in life, sleep declines and becomes more fragmented. This may reflect either a reduced need for sleep (as we are learning less) or a breakdown in sleep processes as we age.
Sleep is also needed to do a bit of brain “housekeeping”. A recent study in mice found sleep cleanses the brain of toxins that accumulate during waking hours, some of which are linked to neurodegenerative diseases. During sleep, the space between brain cells increases, allowing toxic proteins to be flushed out. It’s possible that by removing these toxins from the brain, sleep may stave off neurodegenerative diseases like Alzheimer’s.
What happens if we have a bad night’s sleep?
Getting enough sleep is important for attention and learning during our waking hours. When we are sleep deprived, we can’t focus on large amounts of information or sustain our attention for long periods. Our reaction times are slowed. We are also less likely to be creative or discover hidden rules when trying to solve a problem.
When you haven’t had enough sleep, your brain may force itself to shut down for a few seconds when you’re awake. During this “micro-sleep” you may become unconscious for a few seconds without knowing it. Drowsiness while driving is a leading cause of motor vehicle accidents, with sleep deprivation affecting the brain just as much as alcohol. Sleep deprivation can also lead to fatal accidents in the workplace – a major issue in shift workers.
The beneficial effects of sleep on attention and concentration are particularly important for children, who often become hyperactive and disruptive in class when they don’t have enough sleep. One study found getting just one hour less sleep per night over several nights can adversely affect a child’s behaviour in class.
What are the long-term effects?
The longer-term effects of sleep deprivation are more difficult to study in humans for ethical reasons, but chronic sleep disturbances have been linked to brain disorders such as schizophrenia, autism and Alzheimer’s. We don’t know if sleep disturbances are a cause or symptom of these disorders.
Overall, the evidence suggests having healthy sleep patterns is key to having a healthy and well-functioning brain.
Estrogen Dominance and Hypothyroidism: Is it Hypothyroidism or Hormone Imbalance?
Women suffer from hypothyroid disease at a rate of almost ten times that of men. Though reasons remain unclear, the close link between estrogen and the thyroid is considered a factor. Some doctors suggest many hypothyroid cases are actually the consequence of “estrogen dominance”; a term which implies low progesterone. The estrogen/progesterone hormone imbalance directly affects thyroid function. The prevalence of estrogen dominance is higher than ever before and the causative factors are many. Environment, diet, and lifestyle are all contributors, as is chronic stress. Hypothyroidism itself can also lead to estrogen related issues, i.e. infertility, miscarriage, PMS, polycystic ovarian syndrome (PCOS), fibroids and cancer. The key is to look at the big picture and an individual’s unique case. Once estrogen, thyroid and stress are considered together, one can map out a customized action plan towards improved overall health.
Hormones: The Importance of Balance
Balance is the most important thing to keep in mind when it comes to hormones. Hormones are part of the endocrine system, which is a complex network of checks and balances. They regulate metabolism, energy, growth, temperature, and reproduction. Considered to be the “master regulator” is the thyroid. When the thyroid is sluggish, a variety of symptoms can ensue, including weight gain, moodiness, memory problems, hair loss, and dry skin. The connection between the symptoms and the thyroid often goes unrecognized. Other areas of the hormone network affect the thyroid too (i.e. blood sugar), but the focus of this discussion is the Hypothalamus-Pituitary-and Ovaries, (HPO-axis). Simply put, this translates to the thyroid, estrogen and the adrenals.
Estrogen’s Role in Thyroid Function
The link between estrogen and hypothyroidism is hard to miss, considering the high rate of disparity between the sexes. It’s also noted that during transitory times in women’s reproductive status is when the risk of hypothyroidism is highest. Thyroid expert Dr. Sara Gottfried explains, it is the change in reproductive hormones that triggers hypothyroidism and the symptoms of fatigue, weight gain and depression. Since many of the symptoms overlap with imbalanced reproductive hormones, practitioners have nicknamed the condition “thyropause”.
Symptoms of estrogen dominance include:
PMS
Endometriosis
Cervical dysplasia
Breast cancer
Uterine fibroids
Overweight
Estrogen Dominance and Thyroid
It is important to note, estrogen levels are balanced proportionate to progesterone. This means, one can have estrogen dominance when estrogen levels are low if progesterone is deficient. The effect of having this hormone imbalance has the potential of causing hypothyroid in those susceptible. In many cases, hypothyroidism manifests as the autoimmune disease, Hashimoto’s thyroiditis. In order for Hashimoto’s to occur other factors must also be in place, namely genetic predisposition, a trigger, and “leaky gut” (intestinal hyperpermeability). The problem many patients have is ongoing symptoms despite treatment, which is typically Synthroid, levothyroxine or Armour Thyroid. Thyroid hormone replacement drugs are ranked the third most common prescribed in the county and yet many users continue to suffer. With the strong connection between the thyroid and estrogen, and the amount of hormone disrupting factors listed below, it is easy to see why the affected population is so high. Contributing factors include:
Poor diet, high in meat and dairy, low in fiber
Genetics
Liver and bilary congestion
Obesity
Medications
Synthetic hormone replacement therapy (HRT) and oral contraceptives
Pesticides
Stress
Xenohormones which are in foods, plastics, personal care items, air pollution, pesticides, etc.
*Xenohormones interfere with estrogen and they are everywhere: hormones in meats, pesticides on foods and in our yards, household products, and the polluted air that we breathe.
The causative factors listed impact every aspect of our daily lives. The degree to which these estrogen disruptors exist has increased in recent decades, which is of great concern to scientists who recognize the effects. Produce has more pesticides, livestock are injected with hormones, obesity is on the rise, and being “really busy” is the accepted norm. People are so busy they often don’t realize they are stressed, much less hurting their health. The good news is there is a lot one can do.
How to Avoid Excess Estrogen
Avoid diet high in meat and dairy, low in fiber. Eat fiber to flush out excess estrogen.
Minimize exposure to hormone disruptors, i.e. plastic water bottles, Styrofoam, pesticides, cosmetic products, and cadmium.
Avoid cigarettes.
Avoid oral contraceptives.
Avoid chronic stress.
Why Stress is so Important
When a person is stressed, it means the adrenals are secreting excess cortisol. When this becomes chronic, it disrupts the normal circadian rhythm and the stress response of the (HPA) Hypothalamus-Pituitary-Adrenal axis. When the body is so busy trying to keep up with cortisol production it takes priority over the sex hormones. Since estrogen and progesterone are made from the same chemical (pregnenolone) as cortisol, it becomes depleted affecting production. Other ways chronic stress impacts estrogen dominance and the thyroid include:
Reduces the liver’s ability to process and eliminate excess estrogen.
Increases thyroid binding globulin (TBG), which keeps it bound and inactive.
Hinders the function of the hypothalamus and pituitary reducing thyroid hormone production.
Interferes with T4 to active T3 production.
Weakens the intestinal lining causing leaky gut.
What Else Should I Do?
Have a full thyroid panel that includes TSH, freeT3, T3, T4, rT3, TPOAb and TgAb antibodies.
Check for iron deficiency with iron panel including ferritin.
Maintain vitamin D levels in the range of 50-70ug/dl.
Note: It’s important to have sufficient iron, zinc, iodine and selenium for thyroid support. However, since the threshold is low it is important to be informed of dosing and not to overdo it.
It’s impossible to avoid all the causes of estrogen dominance yet with proper maintenance, the body is equipped to handle much of it. When problems do occur seeing a health provider who recognizes symptoms in the context of the body as a whole, rather than segregating symptoms, can offer improved outcomes.
Deputy Director – Centre for Stem Cell Systems and Head of Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, University of Melbourne
Professor of Bioethics & Medicine, Centre for Values and Ethics and the Law in Medicine, University of Sydney
Disclosure statement
Megan Munsie receives funding from the Australian Research Council. Shee is a the recipient of an ARC Research Grant (along with Ian Kerridge and Cameron Stewart) to examine the ethics and regulation of stem cell therapies in Australia. She is affiliated with the International Society for Stem Cell Research, Australasian Society for Stem Cell Research and the International Society for Cellular Therapy.
Cameron Stewart receives funding from the NHMRC and ARC.
Ian Kerridge is a Bone Marrow Transplant physician, is on the Board of the NSW Stem Cell Network. He is also the recipient of an ARC Research Grant (along with MM and CS) to examine the ethics and regulation of stem cell therapies in Australia.
In a welcomed move, the Therapeutic Goods Administration (TGA) has this week announced reforms will be introduced in 2018 to address long held concerns about the provision of unproven stem cell treatments to increasing numbers of Australian and international patients.
Regulation of stem cell treatments being offered outside hospitals will be increased. It will acknowledge the risks of these treatments, and advertising of certain treatments will be prohibited.
While more specific details are not yet available, it seems at last possible the most egregious practices of suburban stem cell clinics will be severely curtailed.
Stem cell marketing
Over the last six years, the number of private “stem cell” clinics operating across Australia has grown from a handful to more than 60. These clinics offer treatments for myriad conditions, from anti-ageing “facial rejuvenation” to treatment for osteoarthritis, lung diseases, infertility, motor neurone disease, dementia and multiple sclerosis.
Advertising their services online and in social media, the clinics use claims of efficacy and expertise to lure patients. But they offer little, if any, scientific proof their treatments work, and charge patients exorbitant fees for their services.
Stem cell clinics often rely on anecdotes and patient ‘testimonials’.Screenshot, Swiss Medica website
How is it these clinics have been able to flourish in Australia and provide unproven, expensive and potentially risky treatments to such a wide group of potential patients?
They have been able to exploit a loophole in TGA regulations that permits doctors to “transplant” a patient’s own tissue back into their body, without that tissue having been subjected to ordinary controls and standards that apply to the transplantation of biological tissue products.
This “exclusion” was intended to enable doctors to use patients’ own tissue to repair bone, joint, ligament and other injuries.
Stem cell risks
Some may argue adults should be able to make choices about their own health care, including to use innovative or unproven treatments. But there are harms in allowing stem cell clinics to operate as they do.
First, the collection and administration of stem cells is not without risk – some are very serious. In 2013, an Australian woman, Sheila Drysdale, died following complications from a liposuction used to the extract “fat stem cells” to treat her dementia – an indication that is not supported by any evidence.
More recently, three women have been left blind following “treatment” in Florida for a type of retinal disease with their own “fat stem cells”.
Second, stem cell “treatments” may cause other harms – including the financial burdens of these treatments (which are not Medicare rebated) on patients and their families, and the psychological harms vulnerable patients may feel from being tricked into paying for something that didn’t work.
Third, there are broader societal harms, including the erosion of public trust in established stem cell science, medical research and health care more generally.
Private clinics shouldn’t be able to make claims without evidence.Screenshot, ASC Treatment website
This doesn’t mean all stem cells are bad
The TGA has recognised the importance of enabling research and innovation in stem cell medicine. There is good work being done within hospitals and laboratories around the country, and patients should still have access to unapproved treatments through clinical trials and special access schemes.
But there remain some concerns. The TGA’s loophole may have provided the impetus for the explosion in clinic numbers, but it’s not the cause of some of the questionable behaviours engaged in by some clinics.
Laws exist to stop misleading and deceptive advertising, and there are strict regulations on the advertising of medical services. To date, these existing regulations haven’t been employed by regulators such as the Australian Competition and Consumer Commission or the Australian Health Practitioner Regulation Agency to crack down on dodgy practices.
Mechanisms for registering clinical trials are already being manipulated by stem cell clinics and the stem cell industry more widely, to cloak themselves in the authority of science and “satisfy” regulatory and ethical concerns about their practices.
The dangers here are clear. While regulatory reform is welcome, they will remain ineffective unless the TGA and other regulatory bodies have the will, power and resources to enforce them. And unless this happens – patients will continue to be harmed.
Selling stem cells has been a big business in Australia for too long. After two public consultations and much deliberation, we have some action. Researchers, health practitioners, patients and regulators have an interest in making sure the proposed changes to the regulations work.
High-dose, immune-boosting or four-strain? A guide to flu vaccines for over-65s
We have come to the time of the year when we decide whether to have the flu shot or not. I had mine over the weekend, and have done so for the last 25 years. It has worked for 24 of those years (no flu) but last year I had a mild dose of the flu in spite of having the needle. It works, especially for older people. This article might help.
April 16, 2019 6.17am AEST
There are three types of flu vaccine available in Australia.
Image Point Fr/Shutterstock
Authors
Allen Cheng
Professor in Infectious Diseases Epidemiology, Monash University
Christopher Blyth
Paediatrician, Infectious Diseases Physician and Clinical Microbiologist, University of Western Australia
Disclosure statement
Allen Cheng receives funding from the Australian
government and from the Australian National Health and Medical Research
Council. He is the Co-Chair of the Australian Technical Advisory Group
on Immunisation and the Advisory Committee for Vaccines; the views
expressed in this article may not necessarily reflect those of these
committees.
Chris Blyth has received funding from the Australian
National Health and Medical Research Council, Commonwealth and State
Governments to conduct influenza surveillance and evaluate the
performance of the current influenza vaccination programs. He is the
Co-Chair of the Australian Technical Advisory Group on Immunisation; the
views expressed in this article may not necessarily reflect those of
the Commonwealth Government
Flu vaccines work by exposing the body to a component of the
virus so it can “practise” fighting it off, without risking infection.
The immune system can then mount a more rapid and effective response
when faced with a “real” virus.
Three types of influenza vaccines are available in Australia:
“standard” vaccines that contains four different strains of influenza
a “high-dose” vaccine (Fluzone High Dose) that contains three strains of influenza at a higher dose than standard vaccines
an “adjuvanted” vaccine (Fluad)
that contains the standard dose of three strains of influenza, along
with MF59, an immune stimulant designed to encourage a stronger immune
response to the vaccine.
The high-dose and adjuvanted vaccines are designed for use only in people aged 65 and over because they can stimulate a better immune response than the standard vaccine. Standard vaccines should be used those younger than 65 years.
This year, the Australian government is offering the adjuvanted
vaccine for free for over-65s. The standard vaccine is available for
free for some groups under 65 under national and state programs. The high-dose vaccine will only be available to buy through pharmacies and general practices on prescription.
Is the high-dose vaccine better?
Clinical trials have compared the high-dose vaccine with older forms of the standard vaccine that contained three strains.
One US study
in over-65s found 1.4% of recipients who were given the high-dose
vaccine were diagnosed with influenza, compared with 1.9% of those who
received the standard vaccine.
A flu vaccination doesn’t completely eliminate the risk of getting the flu, but it’s likely to make the illness less severe.
From shutterstock.com
Subsequent studies also found people who got the high-dose vaccine were less likely to be hospitalised with influenza-related complications. A similar trial in nursing home residents also found a reduced risk of hospitalisation.
Although clinical trials are generally regarded as the gold standard
when testing vaccines, it’s also important to consider data from other
studies, where different flu strains circulate and where the vaccine may
be used in groups that were excluded from clinical trials.
These studies have generallyfound that the high-dose vaccine is better than the standard vaccine. However, somestudies have shown a lesser degree of benefit.
What about the adjuvanted vaccine?
Clinical trials have not been designed to show the different rates of
flu infection after taking the adjuvanted vaccine compared with the
standard vaccine. But studies have examined the effectiveness of this
vaccine in preventing hospitalisations with influenza.
One trial
found a small decrease in influenza infection in people who had been
given adjuvanted vaccine, compared with standard vaccine, but this
difference was not statistically significant.
Another recent trial has been performed in nursing home residents. Preliminary results suggest a very small reduction in hospitalisations compared with those who took the standard vaccine.
With different vaccination options available, it can be hard to work out which is likely to provide the most protection.
From shutterstock.com
Despite a lack of clinical trial data, several observational studies
have found getting the adjuvanated vaccine means you’re less likely to
be hospitalised with influenza than if you receive the standard vaccine.
As with the studies of the high-dose vaccine, the estimated degree of
protection varies between studies, reflecting differences in
circulating strains, study types, and populations.
Which is better?
There is not yet sufficient data to know whether one enhanced vaccine is better than the other.
One observational study
suggests the high-dose vaccine is more effective than the adjuvanted
vaccine at preventing hospital admissions with influenza. But this study
was not designed to address this question specifically, and the
differences observed were small.
Both enhanced vaccines are safe. Although a higher proportion of
patients who receive enhanced vaccines report a sore arm, compared to
those who receive the standard vaccine, this is generally mild and rarely requires medical attention.
The currently available enhanced vaccines protect against three flu
strains, whereas the standard vaccine protects against four.
But for most people, there is no evidence that receiving multiple
doses of different vaccines in any one year is any better than getting a
single dose of vaccine.
There’s no evidence that two shots are better than one.
By Nyvlt-art
In theory, the four-strain vaccines protect against one more strain
than the enhanced three-strain vaccines. But in most seasons, few
infections are caused by the fourth strain.
There are some specific groups of people for whom two doses may be
recommended, including young children receiving the vaccine for the
first time, and some people with bone marrow or organ transplants. Seek
advice from your doctor if this describes you or your children’s
situation.
It’s important to note that none of the standard or enhanced flu
vaccines are completely protective; they reduce, but don’t completely
eliminate, the risk of getting influenza.
A single dose of any influenza vaccine in each season is the most effective strategy to reduce your chance of getting influenza.
Postdoctoral Research Fellow, Adelaide Institute for Sleep Health, Flinders University
Disclosure statement
Nicole Lovato does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.
Republish this article Republish our articles for free, online or in print, under Creative Commons licence.
You may be familiar with that feeling of overwhelming sleepiness during the mid-afternoon. It’s common, occurs whether you’ve eaten lunch or not, and is caused by a natural dip in alertness from about 1 to 3pm. So, if you find yourself fighting off sleep in the middle of the day and you’re somewhere where you can have a nap, then do it.
Taking the time for a brief nap will relieve the sleepiness almost immediately and improve alertness for several hours after waking. And there are many other benefits too.
Understanding why we nap
People nap for lots of reasons, some which are:
to catch up on lost sleep
in anticipation of sleep loss to avoid feeling sleepy later on
for enjoyment, boredom or to pass time.
Napping is relatively common. In fact, about 50% of us report taking a nap at least once per week.
Napping rates are greater in countries like Greece, Brazil and Mexico that have a culture of siesta, which incorporate “quiet time” in the early afternoon for people to go home for a nap. In such countries, up to 72% of people will nap as often as four times per week.
Naps are not only beneficial because they make us feel less sleepy and more alert, but because they improve our cognitive functioning, reaction times, short-term memory and even our mood.
Our research (not yet published) has found those who regularly nap report feeling more alert after a brief nap in the afternoon when compared to those who only nap occasionally.
Another research group found that motor learning, which is where brain pathways change in response to learning a new skill, was significantly greater following a brief afternoon nap for regular nappers when compared to non-nappers.
In fact, the overall benefits of naps are similar to those experienced after consuming caffeine (or other stimulant medications) but without the side effects of caffeine dependence and possibly disrupted sleep at night time.
The amount of time you spend napping really depends on the time you have available, how you want the nap to work for you, and your plans for the coming night. Generally speaking, the longer a nap is, the longer you will feel rejuvenated after waking.
Long naps of one to two hours during the afternoon will mean you are less sleepy (and require less sleep) that night. This could mean it will take longer than usual to fall asleep.
A brief power nap is a great way to improve alertness.from shutterstock.com
If you are planning to stay up later than usual, or if taking a little longer to fall asleep at bedtime is not bothersome, time your nap for about 1.5 hours. This is the length of a normal sleep cycle. You will experience deep sleep for about an hour or so followed by light sleep for the last half an hour.
Waking up during light sleep will leave you feeling refreshed and alert. However, waking during deep sleep will not. If you sleep too long and miss the light sleep at the end of a nap, chances are you will wake up feeling sluggish and drowsy. If you do experience feeling drowsy after a nap, don’t worry – this feeling is temporary and will go away after a while.
Another option is to have a brief “power” nap. Brief naps of 10-15 minutes can significantly improve alertness, cognitive performance and mood almost immediately after waking. The benefits typically last for a few hours.
Power naps are great because you won’t experience any sluggish or drowsy feelings after waking. This is because you do not enter any deep sleep during this brief time.
Research suggests, a brief, early-to-mid-afternoon nap provides the greatest rejuvenation when compared to naps at any other time of the day. However, if you’re struggling to stay awake, a brief nap taken at any time can be help keep you alert.
Editor’s note: This post is part of a Health Affairs Blog series titled “ORBITA: Lessons From A Landmark Trial,” which focuses on the recent study
finding that coronary stenting did not improve exercise time compared
with a placebo procedure in patients with angina and severe arterial
narrowing who received optimal medical therapy. The series, which began
Tuesday, October 9 and concludes today, features posts from participants
in a recent conference
on the ORBITA study sponsored by the Institution for Social and Policy
Studies at Yale University and organized by Alan Gerber (Yale
University) and Eric Patashnik (Brown University). The posts discuss
what ORBITA and its aftermath tell us about the cultural, political,
regulatory, and financial factors that influence how clinicians respond
to new evidence, and how they don’t. The views expressed by the
contributors to this symposium are their own and do not represent the
views of Yale, ISPS, Brown, or their respective institutions.
What can be done to encourage doctors and other clinicians to heed
new evidence when it shows the tests or procedures they are delivering
are in fact not helping their patients—and may even harm them? This
question has become increasingly relevant in the face of a growing
number of studies casting doubt on the safety and efficacy of commonly
used treatments and tests. Even when new evidence is clearly negative,
clinicians often resist abandoning a service they have believed in, and
developed expertise in, especially when that service provides a
significant portion of their livelihoods.
Take the PSA, or Prostate Specific Antigen test, widely promoted for
more than three decades to screen for prostate cancer. Most patients and
physicians assumed that catching cancer early leads to a lower risk of
death. But results from several large randomized controlled clinical trials,
which compared men who received regular PSA screening versus usual
care, showed little to no difference between the two groups in terms of
their risk of dying of prostate cancer. The PSA test, it turns out,
leads to the diagnosis of unthreatening tumors in 20 to 40 percent of cases.
Other recently discredited procedures and tests include arthroscopic knee surgery, no better than placebo (or sham) surgery for relieving arthritis pain. Likewise veterbroplasty,
which involves injecting a kind of superglue into the patient’s
vertebrae and is also intended to relieve arthritis pain. And now, the
mother of all medical reversals, the ORBITA trial,
whose publication last year ignited a firestorm of controversy. ORBITA
found that implanting a cardiac stent to relieve angina, or chest pain
due to heart disease, is no better than a sham stent procedure.
One might think that such strong negative evidence would be enough to
get doctors to give up a practice, or at least be more judicious in
choosing their patients. After all, negative evidence says the procedure
is more likely to harm their patients than help them.
Instead, clinicians often persist
in delivering services long after the data say they should have scaled
back or stopped. Eventually, truly useless interventions go the way of
bloodletting, but, in the meantime, patients are exposed to the
potential risk of harm with little or no chance of having their symptoms
or conditions effectively treated. So the question of how to motivate
clinicians to cease and desist should concern anyone who wants to reduce
overuse and ensure that patients get the right care.
A Personal Encounter With The Persistence Of Overuse
I came up against this problem in a very personal way about eight
years ago, after one of my brothers called to tell me our then
80-year-old father, Mick Brownlee, had been hospitalized with a stroke. A
vascular surgeon was recommending a carotid endarterectomy, Could I get on the phone to help decide what to do?
At the time, carotid endarterectomy had been a topic of intense
debate in the neurology and vascular surgery communities for nearly a
decade. In use since the 1950s, the procedure is a sort of Roto-Rooter
for the arteries in the neck that supply the brain with blood. Built-up
plaque inside the carotids can break free and move into smaller arteries
in the brain, where it can block the flow of blood and cause a stroke.
Endarterectomy removes some of that plaque in the carotids, reducing the
risk of a stroke over the next five years.
Unfortunately, the procedure itself can actually cause a stroke or even death in about 4 percent
of patients. A string of studies had shown that the surgery is worth
doing only for some patients; for many others, the potential benefit is
marginal. For most of the patients who were getting it, the risk of
stroke was greater any potential protective effect the surgery might
provide. In 2005, as many as 92 percent
of the 135,701 carotid endarterectomies in the United States were still
being performed on patients who stood a greater chance of being harmed
by the procedure, not helped.
By the time my father had his stroke, the total number of
endarterectomies had declined, but there was not a lot of information
about whether or not surgeons were paying attention to the data and
offering the procedure only to the right patients. I was pretty sure
Mick was not an appropriate patient. For one thing, he was growing
increasingly frail. For another, he’d fallen several times in the last
year. He had lost weight, and his short-term memory was shot—all signs
that he was unlikely to live five years more and thus was not a good
candidate.
When I got on the phone with brothers, stepmother, father, and the
surgeon, my family shared the impression that the endarterectomy might
somehow, magically, bring back the Mick of just a couple of years
before, when he was still sculpting, and struggled less with memory and
balance. My saying otherwise would have no effect. The doctor had to say
it.
The vascular surgeon began by pronouncing Mick an “appropriate
candidate” for this “highly effective surgery.” Then he asked if we had
any questions. Eventually, I asked the question that hit home: “What
will this surgery do for his quality of life?”
“Nothing,” said the surgeon. “It’s all about preventing another stroke.”
There was murmuring on the line. “Are you saying the surgery won’t
help him with his memory? Or walking?” asked my stepmother. Eventually
my family understood that the surgery would not change Mick’s current
situation and decided against it.
Resistance To ORBITA Mirrors Resistance To Vertebroplasty Studies
Maybe this surgeon had not been reading his medical journals, and was
recommending an endarterectomy because he was unaware of the evidence. I
think the real reason has less to do with knowledge than psychology.
Most clinicians believe in their treatments and take pride in what they
do. They don’t like to imagine that a service they’ve been delivering
might be useless or harmful. Add to that the fact that physicians get
paid to do what they do, and new evidence threatens both their sense of
being good doctors and their livelihoods.
Not surprisingly, when strong evidence is published showing a
cherished procedure is ineffective, many physicians who perform that
procedure initially express shock and disbelief. Then they come up with
numerous, often unsubstantiated reasons to cast doubt on the results and
continue business as usual.
When the ORBITA trial was published in December of last year,
surgeons who perform stent procedures expressed their doubts in the
journals and on social media. The study was too small, they claimed. The
patients in it weren’t suffering from serious disease; there was a
subgroup in the study that benefited. Some said their personal
experience showed their patients benefit from stents. Others claimed to
already know everything the trial showed.
Some surgeons argued that sham-controlled trials are unethical because we just know
stenting works. At one point, one of the principal investigators of
the trial, Darrell Francis, a British interventional cardiologist, wrote
on Twitter, “I would like to thank the patients for participating in
#ORBITA without realizing what a low level of intellect would be put
into criticizing their efforts.”
The arguments
clinicians raise against results they don’t like are often similar to
those raised against ORBITA, regardless of the procedure. A prime
example is the response spine surgeons and radiologists had to two
high-quality, randomized trials published in 2009, showing that
vertebroplasty is no better than sham surgery.
Some faulted the trials for enrolling patients too early in the course
of their condition. Others said patients were enrolled too late;
patients were not in as much pain as their patients; the studies were
too small, too big, and, unbelievably, “too rigorous.” In an editorial, The Spine Journal editor-in-chief, Eugene J. Carragee, called the reactions, “imperious.”
Imperious or not, what’s more astonishing is how willingly physicians
take up new procedures and tests on the basis of the slimmest of
evidence that they work. In the case of vertebroplasty, early reports
claiming “immediate” and “complete pain relief” in the vast majority of
patients should have raised at least some suspicion that the results
were too good to be true. Instead, physicians made perfunctory remarks
about the need for better evidence and then proceeded to perform
hundreds of thousands of vertebroplasties, even as increasingly rigorous
studies showed a decreasing size of the procedure’s effect. In 2008,
there were more than 100,000 vertebroplasties performed in the US. Five
years after the negative trials were published, that number had dropped
only 25 percent.
Additional Ways To Promote Evidence-Based Practice
This should be depressing news for anybody who thinks simply
publishing new evidence is enough to ensure that patients get the right
care. If we want physicians to heed evidence, we should probably
consider multiple other approaches.
Research First, Then Expand The Use Of New Procedures
First, we should be doing the research before the procedure
or test is widely used—and paid for, which tends to reinforce
physicians’ attachment to it. It took a decade for vertebroplasty to be
put to a real test, and that’s fast compared to how long it has taken to
mount rigorous studies of other procedures.
Stents have been around for 40 years and we’re only now getting
around to the definitive studies. If the ORBITA trial is confirmed by
other studies, we will have spent hundreds of billions of dollars over
the last four decades on a treatment that at best adds only the slimmest
of additional benefit to optimal medical therapy for heart disease
(drugs, lifestyle changes) and at worst is no better than a placebo.
Carotid endarterectomy was performed for nearly 40 years before real
studies were launched. The need to do pivotal studies early applies even
more to procedures that relieve pain—like vertebroplasty and
stenting—and psychiatric illnesses; these conditions are particularly
susceptible to placebo effect, which can fool patients and doctors
alike.
Don’t Pay For It Unless It Works
Second, isn’t it time to stop paying for inappropriate care?
Physicians don’t like to contemplate this solution, and neither do
insurers, because they know that doctors and patients will wave the
rationing flag. But this is one incentive that actually reduces useless
care. In 2014, both Canada and Australia stopped paying for Vitamin D
testing, which was leading to high rates of prescriptions for Vitamin D
for patients who did not need it. Australia’s Medicare program was
spending $12 million a year on Vitamin D testing. In Canada, more than 25,000
tests a year were being performed. Once the authority stopped paying
for it, testing in Canada dropped by 80 percent within six months.
Patients Are Not Consumers And Physicians Are Not Used Car Salesmen
Third, let’s stop using marketing language. Calling patients
“consumers” who need to be “engaged” reinforces an attitude that says
being a person who is sick, frightened, in pain, and in need of care is
no different from a customer buying a used car. That means the doctor is
merely a “provider” of a medical service and has a diminished duty to
serve the patient’s needs first. One day, patients won’t trust doctors
any more than they trust used car salesmen.
The Importance Of Fully Informed Patients
Finally, patients and families need unbiased, understandable
information in order to make choices about treatments. We can’t leave
the transmission of that information to their doctors, because many of
them are not very good at making sure patients and families understand
the tradeoffs involved in different treatment choices. Several studies
have found that patients giving consent are largely uninformed
about a wide variety of medical decisions. The reason is not that they
can’t understand what’s at stake; it’s that doctors don’t convey information effectively.
Making sure patients understand their treatment choices has turned
out to be a difficult problem to solve. For 30 years, proponents of shared decision making
have been advocating the use of decision aids—booklets, video, and
other forms of clear, simple information—to help patients understand
treatment options, and then for clinicians to share the decision based
in part on what the patient cares about. In my father’s case, he cared
about not being harmed by a surgery that offered only the slimmest
chance of benefit more than preventing a stroke that he might never
have. But maybe shared decision making is a little like Brazil (which
has been famously called “the country of the future” for last several
decades): It would improve care dramatically, but its time has not yet
come. Perhaps the only way to get shared decision making into common
practice is for patients to start asking uncomfortable questions.
Failing to explain tradeoffs allows doctors to avoid thinking hard
about the potential negative effect of their procedure on the patient
and family. On paper, my father might have been an appropriate candidate
for carotid endarterectomy, if marginally so. Until the surgeon was
confronted with the unrealistic expectations of a worried family, he did
not have to consider the increasing frailty of the man in front of him.
Unfortunately, most families don’t have as a member someone who studies
overuse of medical procedures for a living, and who can help ensure
that the conversation includes the negatives of a treatment as well as
the positives.
I need to know: ‘are Kegel exercises actually good for you?’
March 27, 2019 4.58am AEDT
The good thing about Kegel exercises is that you can do them pretty much anywhere.
Nina Maile Gordon/The Conversation, CC BY-NC-ND
Author
Melissa Kang
Associate professor, University of Technology Sydney
Disclosure statement
Melissa Kang does not work for, consult, own shares in
or receive funding from any company or organisation that would benefit
from this article, and has disclosed no relevant affiliations beyond
their academic appointment.
Republish our articles for free, online or in print, under Creative Commons licence.
t
I Need to Know
is an ongoing series for teens in search of reliable, confidential
advice about life’s tricky questions. If you’re a teen, send us your
questions about sex, drugs, health and relationships and we’ll ask an
expert to answer it for you.
Are kegel exercises actually beneficial?
– Anonymous
Key points
Yes, they are very beneficial
They are super easy to do (once you know how)
Childbirth is the common reason why pelvic floor muscles weaken.
Hi, and thanks for your question. Kegel exercises are also known as
pelvic floor exercises and were introduced back in the 1940s by a
gynaecologist (a medical doctor specialising in women’s reproductive
health) named, you guessed it, Dr Kegel. He developed these exercises as
a method for improving control of urine leakage after childbirth.
These are the female pelvic floor
muscles (click on the image if you’re having a little trouble seeing
it). Even if you’re not thinking of having a kid any time soon, it’s
still a good idea to get into a good routine of exercising them.
Shutterstock
Your pelvic floor muscles
are quite an amazing collection of layers of muscle. The work they do
also involves the bones of the pelvis (hip bones and lower end of the
spine), ligaments and nerves. Together, they work a bit like a hammock
across the bottom of your pelvis not only to keep your organs from
sagging but also work in sync with your bladder, rectum (the last part
of your large intestine) and the vagina, making sure urine and poo are
stored and released when you’re ready for it.
You might not want a kid today (or ever!) and you might be of any
gender – it doesn’t matter because keeping your pelvic floor muscles fit
is good for now and the future. There is much less research on whether
Kegels make sex more enjoyable or easier to orgasm, despite what you may
have read online or heard from friends. However, what we do know is
having a strong pelvic floor helps with sexual enjoyment after giving birth, and might also help men experiencing erection problems.
Doing Kegel exercises is super easy once you know how. Because there
are several pelvic floor muscles, it’s good to work out where they are
and to exercise all of them.
If you sit on the toilet to wee, try stopping the wee half way
through and holding it like that for a few seconds, then let go. If you
do that successfully, you’ve found some of your pelvic floor muscles.
Next try squeezing the muscles around your anus as though you are holding in some wind.
When you do pelvic floor exercises, you lift and squeeze all
these muscles at once. Hold the squeeze for eight to ten seconds then
relax for the same amount of time.
Repeat this eight to ten times, and do it three times a day. That’s a pretty good daily workout.
The good thing about Kegel exercises is that you can do them pretty
much anywhere. Sitting in class, on the bus or train, driving, watching
TV, or reading The Conversation.
All people have pelvic floor muscles (not just women), but childbirth
is a common reason why the pelvic floor muscles weaken. Ageing and
surgery to the pelvic floor area can also weaken these muscles. This can
lead to incontinence (involuntary leaking of urine, or less commonly
leaking of poo) as well as sagging of the organs inside the pelvis.
Research
shows doing Kegel exercises early in pregnancy can reduce incontinence
later in pregnancy and after childbirth. It’s not certain how long the
benefit lasts, but that’s because the research hasn’t extended beyond a
few months.
If you do have problems with urine leakage, or have concerns about
weakness of your pelvic floor muscles for some other reason, you might
need help from a physiotherapist to get more personalised advice.
Recent position statements and guidelines have raised the distinction between a true and false, age-related hypogonadism (HG) or late-onset hypogonadism (LOH). The former is the consequence of congenital or acquired “organic” damage of the brain centers or of the testis. The latter is mainly secondary to age-related comorbidities and does not require testosterone (T) therapy (TTh). In addition, concerns related to cardiovascular (CV) safety have further increased the scepticism related to TTh. In this paper, we reviewed the available evidence supporting the efficacy of TTh in non-organic HG and its long termsafety.
A large amount of evidence has documented that sexual symptoms are the most specific correlates of T deficiency. TTh is able to improve all aspects of sexual function independent of the pathogenetic origin of the disease supporting the scientific demonstration that LOH does exist according to an “ex-juvantibus” criterion. Although the presence of metabolic derangements could mitigate the efficacy of TTh on erectile dysfunction, the positive effect of TTh on body composition and insulin sensitivity might counterbalance the lower efficacy. CV safety concerns related to TTh are essentially based on a limited number of observational and randomized controlled trials which present important methodological flaws.
When HG(Hypogonadism) is properly diagnosed and Testosterone therapy correctly performed no Cardoivascular and prostate risk have been documented.
In spite of the evidence that estrogens produce the greatest dose
dependent increase in bone density and that they have been shown
to be effective in preventing osteoporotic fractures of the
hip and spine their use has been relegated to second line or even
unacceptable therapy in the hands of bone physicians and rheumatologists.
This may be the result of the post WHI recommendations that
HRT should be used as a short term treatment for menopausal symptoms,
using the lowest dose for the shortest time necessary.
HRT may be used as a second line treatment for osteoporosis for
those who are unable to tolerate other osteoporosis drugs.
If so the advice is inappropriate for women under the age of 60
and in reality the physician’s objection to HRT ante dated
the WHI studies by many years .Could it be that they were not comfortable
with the minor side effects of HRT such as mastalgia, endometrial
hyperplasia, and the PMS symptoms of progestogen intolerance which
could be dealt with by any competent general practitioner?.
It is worth considering the pros and cons of hormone therapy in
this age group as well as outlining the disadvantages of non hormonal
therapy. Although the benefits on the skeleton may be small it is
not disputed that such patients be given life style advice on alcohol,
smoking and exercise as well as calcium and vitamin D supplementation.
In this article the value or otherwise of estrogen therapy will be
discussed.
The beneficial effects of estrogens should be considered noting
that different symptoms need different hormone in different does
by different routes depending on the age and surgical status of the
woman. The one dose fits all treatment of asymptomatic 50-79 year
olds of the WHI study was a decision of monumental clinical incompetence
from which women now denied HRT continue to suffer.
Typical menopausal symptoms of flushes, night sweats, insomnia,
tiredness together with pelvic atrophy causing dyspareunia and recurrent
cystitis respond well to low dose estrogens. Depression, loss of
libido and other quality of life issues usually are helped with estrogens
often with the addition of testosterone. In fact most patients on
the correct dose and mixtures of hormones feel so well that they
are unwilling to discontinue HRT after 5 or 10 years if this is the
duration ultimately recommended by advisory bodies. Hence there is
a reluctance to take bisphosphanates
In the first three years after the menopause women lose 25% of their
body collagen most notable from the skin, ligaments, tendons, nails,
the intervertebral discs and the bone matrix. It has been shown that
estrogens can replace the missing skin collagen and skin thickness
but how does the skeletal system benefit from preservation or replacement
of collagen?
Histomorphometric studies of biopsies of 16 osteoporotic women taken
before and after 6 years percutaneous estradiol, when the spinal
bone density has increased by 28% showed a 26% increase in collagen
in cancellous bone and a 7% increase in cortical bone. There was
also an increase in intermediate and mature collagen cross links
indicating continuing collagen production. Similar biopsy studies
of 22 patients with a mean increase vertebral bone density of 29%
showed an increase in wall thickness, volume of cancellous bone increased
trabecular thickness The repair of the microfractures of osteoporotic
bone is strongly suggested by the increase in trabecular buds and
the decrease in trabecular ends. This indicates that the therapy
is not merely thickening broken trabeculae but new strong bone is
being produced All of these quantifiable beneficial changes have
a direct significant correlation with the plasma estradiol levels
achieved during therapy. There are no such studies of bone
histology showing similar benefits from bisphosphanates
More recent work on the intervertebral disc is equally reassuring.
The discs are 100% collagen and make up ¼ of the length of
the spine. Two studies performed independently have shown
that estrogens protect the spine by maintaining the size of the disc
space and the length of the spine. Bisphosphanates do not. This information
publishes in journals o gynaecological endocrinology have not yet
come to the attention of bone physicians
On this evidence HRT would seem to have a better effect on flesh
and bone , general wellbeing , mood and sexuality than non hormonal
options. But is it safe?
The optimism of HRT has been challenged by the much criticised WHI
and Million Women studies which revealed an increase in breast cancer
and surprisingly an increase in heart attacks and strokes when all
but one case control studies indicated a considerable decrease in
heart attacks. Indeed the data on heart attacks was so convincing
that the prevention of coronary disease became a principle indication
for HRT particularly in the USA
The data collection from a single questionnaire of the Million Women’s
Study is so eccentric and has been so severely criticised that it
is difficult to judge the value of any of the conclusions from these
papers. The extrapolation of data over time from the single
questionnaire is completely unsound and it is fair to say that internationally
this is recognised. A comprehensive analysis of these reviews
has recently been published.
On the other hand the epidemiology of the WHI study as a randomised
control study was sound but they chose asymptomatic patients of the
wrong age, with 22% starting therapy over the age of 70, using the
wrong dose and coming to the wrong conclusions. Even though
Prempro combination of Premarin 0.625 mgs and Provera 2.5 mgs as
continuous therapy is not available in this country, there was still
an excellent result in patients who start this therapy below the
age of 60 with fewer heart attacks occurring, a slight increase in
breast cancer and a significant reduction in fracture of the hip
(spine), colon cancer and mortality.
It seems from various studies it is the progestogen which is the
risk factor for breast cancer. This the oestrogen only arm
of the WHI study showed a decrease in breast cancer, heart attacks,
osteoporotic fractures and mortality. As 97% of our patients
on HRT start this therapy below the age of 60, this is the important
group in our clinical practice. Thus there should be no proscription
on the use of oestrogens, particularly oestrogens alone for the prevention
and treatment of osteoporosis in women under the age of 60.
Oestrogens would be the correct first line therapy in women under
the age of 60 and the less effective bisphosphanates, which are not
without long term side effects should be used in women where there
is the rare contraindication to oestrogen therapy or those that are
non responders. It should be remembered that 25% of women do
not have an increase in bone density with the use of Bisphosphonates
although this is a very rare occurrence in patients using HRT.
The rejection of oestrogens as a simple safe and effective therapy
in patients below the age of 60 is incorrect. It is also clear that
the thrombogenic potential of Prempro with its continuous daily progestogen
and oral oestrogen is not reproduced by the use of transdermal oestradiol.
The future for the older osteoporotic patient with osteoporosis may
be by this route of oestradiol as much as by non hormonal preparations
with their own side effects.