February 29, 2024
Patient Registries & Why Anor-Exit® Has Started One
Anor-Exit® has begun a patient registry and we would like to explain here what a patient registry is and why we began one. A “patient registry” is simply the collection, storage, and analysis of medical data from a group of patients who share the same disease. There are many possible reasons to develop a registry -- discern the natural history of a disease; document response to a specific treatment; identify side effects of a specific treatment; and assess risk factors for development of the disease. Patient registries are different from clinical trials because there is no comparison to a control group (individuals without the disease). Therefore, results indicated by a Patient Registry do not carry the same weight as those indicated from a clinical trial. However, patient registries provide real-world insights into how well various treatments work, potential side effects, and the effectiveness of the treatment in different populations. Historically, patient registries were aimed at patients with rare diseases and were often started by patient support groups. The FDA strongly encourages patient registries.
So, why undertake a Patient Registry for the novel treatment for anorexia advanced by Anor-Exit®?-- We believe anorexia is primarily a metabolic disease that can be eased or even eliminated in some patients by a metabolic ketogenic intervention. Anorexia certainly does not appear to be a “rare disease”. Is it? For decades, the best epidemiological work examining incidence and prevalence has been performed in Scandinavia because Denmark, Finland, Norway, and Sweden keep copious health records of the entire population. Hans Hoek, MD PhD has spent decades focused on anorexia nervosa and bulimia nervosa. His latest report from 2021 noted;
“The overall incidence rate of anorexia nervosa is considerably stable over the past decades, yet the incidence among young persons less than 15 years has increased. For bulimia nervosa, the incidence rate has been declining over the decades. The lifetime prevalence rates for anorexia nervosa might be up to 4% among females and 0.3% among males. Regarding bulimia nervosa, up to 3% of females and slightly more than 1% of males suffer from this disorder during their lifetime. Both eating disorders carry a five or more increased mortality risk.” (emphasis added).
Annelies Evan Eeden, Daphne van Hoeken, Hans W. Hoek, Incidence, Prevalence, and Mortality of Anorexia Nervosa and Bulimia Nervosa, 2021 Nov. 1:34(6):515-534 National Library of Medicine https://pubmed.ncbi.nlm.nih.gov/34419970/
The last sentence of the quote is very alarming. While not rare, anorexia can be a deadly disease, particularly if it becomes chronic. Indeed, it is the only mental illness for which a terminal diagnosis, allowing patients access to hospice and medically assisted suicide, has been proposed in the US. Perhaps chronic anorexia should be a stand-alone disease as distinguished from milder versions of the disease. While the reason for allowing assisted suicide for severe and chronic anorexia is because those unfortunate patients failed to improve with traditional treatment, we at Anor-Exit® believe those patients did not fail. Traditional treatment failed them. It is hard to envision any disease more deserving of a Patient Registry designed to gather data to improve treatment.
To our knowledge, traditional ED treatment sites neither keep patient registries (or if they do, the data is not shared), nor release information on how many patients are “return customers.” At Anor-Exit® we generally treat patients who are not responding to traditional therapy. If traditional treatment had been effective, most Anor-Exit® clients would not be searching for a new treatment method. And we would be happy to close up shop if traditional treatment got the job done, and eliminated or substantially eased anorexia in most of the patients. Sadly, traditional treatment is always long and arduous, often leading to many relapses, and far too often leads to a chronic condition.
At Anor-Exit® we endeavor to be science-based and to continually adjust the ketogenic metabolic program to maximize the best outcome for each client. To do this, we are continually studying all clinical trial outcomes and are eagerly awaiting the outcome of the UC San Diego trial testing the ketogenic diet for “weight-restored” persons with anorexia who continue to be plagued by anorexic thoughts, voices, and obsessions. We advise all callers to Anor-Exit® about the UC San Diego trial and encourage them to participate in the clinical trial if they meet the recruitment criteria. We are so grateful UCSD received funding to enable this clinical trial to go forward. We want to do everything we can to move the science forward as best we can. So we ask all Anor-Exit® clients to voluntarily consent to be part of a patient registry. We will follow all clients, who have consented to be part of the registry, for two years and assess their mood, eating behaviors, and enjoyment of life every six months. We do not want repeat customers! Although the names of the clients will not be published, the results of our research will be and we encourage everyone involved in the treatment of anorexia to look at the results when they are published.
January 29, 2024
Is it Sensible to Consider Palliative Care for Chronic Anorexia When There is Treatment Available that has not been Considered?
Did you see the New York Times article in the magazine section on January 7, 2024? “Should patients be allowed to die from Anorexia?”, by journalist Katie Engelhart. https://www.nytimes.com/2024/01/03/magazine/palliative-psychiatry.htm
There is a growing movement to offer palliative care for “chronic” patients with anorexia nervosa who suffer immensely and seem to be “resistant” to all treatment. The long article describes the sad saga of Naomi who got sick as a young girl, and at 40 was entering palliative terminal care for intractable anorexia.
Katie Engelhart wrote, “When she was a teenager Naomi believed that treatment programs might save her. As the years passed, Naomi found it harder to be ‘compliant’ with standard treatment. She refused to participate in group sessions. Or she disengaged during therapy which she found infantile and pointless.”
Perhaps the problem was not so much that Naomi was “resistant to treatment” but rather that the treatment offered to her was indeed infantile and pointless.
Perhaps all the talk therapy was simply aiming at the wrong target.
Perhaps Naomi never set out to starve herself. She simply experienced a brief period of time when she did not eat enough food to meet her nutritional requirement for energy, so her body did what is healthy and normal ---it ramped up fat metabolism which leads to the liver making small compounds called ketones. These ketones are vital because they are used as cellular fuel for all the organs in our bodies. Perhaps this short time of insufficient nutrition was because Naomi was exercising a lot as a young teen and was not stopping to eat because she was so engaged and having fun. Or perhaps she had a mild GI disturbance, so she ate less for a few days.
We will never know the initial spark that caused her to experience a brief time of insufficient nutrition to cause her body to enter the very natural state of ketosis, meaning her body and her brain use ketones for fuel rather than glucose. We do know it must have occurred, and while most people enter ketosis when they are temporarily eating less than usual, and then move out of ketosis when food is plentiful, Naomi had a different metabolic response to ketosis than most people. This response, which is driven by her unique genetic makeup, caused her to fall down a rabbit hole. And she was trapped down that hole for decades.
Why?
Maybe it initially had nothing to do with “control issues’ or “family issues” or “self-esteem”. Due to her genetic predisposition, Naomi’s brain “preferred” to obtain cellular fuel from ketones rather than the default fuel supply to the brain which is glucose.
When she was using ketones to fuel her brain cells, her brain was functioning more optimally. She was not anxious; she felt energized and creative. It was a good feeling.
Initially.
So, she formed more ketones. The way humans form ketones is to eat less, or fast and to exercise. So, she ate less, and she exercised more. And in a short period of time, her brain was “hooked” “addicted.” It was no longer fun, but she was now trapped.
And this went on for years. The treaters never talked about it. They focused on self-esteem, and “control.” But they did not offer her a way out.
This may sound like science fiction. But there is over 100 years of research on the effects of ketosis on the brain.
By offering Naomi nutritional ketosis (with a high fat, low carbohydrate and moderate protein) diet, she can remain in ketosis, but she does not have to starve or obsessively exercise to achieve that state. She can likely be weaned off the anorexic obsessions and she can heal herself through the proper nutrition.
But her treatment providers did not tell her this. They told her to eat 3 meals and 2 snacks a day, and were not concerned about the macronutrient (protein, fat, carbohydrate) content of the meals. Stuck in chronic anorexia, unaware of metabolic nutritional therapy, Naomi feels doomed.
There is hope however for anorexia treatment that can stop the revolving cycle of weight gain sufficient to be discharged from a residential program only to recycle back in not long later. Known as metabolic nutritional therapy, the first patient to undergo it for anorexia did so in 2019. Her name is Caroline Beckwith. She had anorexia for over 15 years. Now, in 2024, she remains well, eats without restriction, and at times returns to the medical diet.
When she embarked on this new treatment, she explained that as a young teen, when the illness began, she had hoped and expected the treatment she was offered at eating disorder programs and facilities would get her well. Only after years of failure did she also disengage and think it was useless.
Caroline Beckwith is the main peer support counselor for this treatment offered by Anor-Exit®.
With this exciting treatment now available, this is not the time to think about palliative care.
It is time to try something radically different.