Anor-Exit(R) Blog
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, most 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.