FAQ: Cortisol Pumping Method

What is Cortisol Pumping?

The concept of Cortisol Pumping is the use of solu-cortef (inject-able version of cortisol when mixed with saline or bacteriostatic water) used in an insulin pump programmed to disperse cortisol according to the natural circadian rhythm by programming rates of delivery into the pump. This method bypasses the gastric passage and is able to deliver cortisol in a more natural way. With an infusion pump, an adrenal insufficient patient can receive a constant supply of cortisol and can lesson the instability experienced with oral steroid cortisol replacement. Side effects due to malabsorption can be decreased and patients have reported to have improved sleep, weight management and experience an overall improvement in their energy levels and sense of well-being. This method has also been shown to lessen the prevalence of adrenal crises and hospitalizations due to low cortisol.

Though this method is not a cure for adrenal disease, it is an option and a ray of hope for those who are struggling with quality of life.

According to a survey done by the Adrenal Alternatives Foundation[1] concluded that 94.2% of the 52 anonymous cortisol pumping patients reported that the cortisol pump had improved their quality of life.

Is Cortisol Pumping FDA approved?

Adrenal Alternatives Foundation is actively working to gain FDA approval for the cortisol pumping method, but that involves years of clinical trials, patient studies and funding. We will achieve this one day, but until then, we are educating patients that FDA approval is not necessary to safely and legally begin cortisol pumping under the care of a licensed physician. Use of the infusion pump for adrenal insufficiency is considered “off label.”

Infusion pumps have long been approved for the administration of medications. According to the Department of Health and Human Services Centers for Medicare and Medicaid Services Medicare Coverage Issues Manual Section 60-14 A: “6. Other uses of external infusion pumps are covered if the contractor’s medical staff verifies the appropriateness of the therapy and of the prescribed pump for the individual patient.”

In addition, according to the recently passed Right to Try Act, patients have legal rights to access to life-saving treatments which are not yet FDA approved.  The act states the following:

(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561A (21 U.S.C. 360bbb–0) the following: ‘‘SEC. 561B. INVESTIGATION ‘‘SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGIBLE PATIENTS. ‘‘(a) DEFINITIONS.—For purposes of this section— ‘‘(1) the term ‘eligible patient’ means a patient— ‘‘(A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); ‘‘(B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— ‘‘(i) is in good standing with the physician’s licensing organization or board; and ‘‘(ii) will not be compensated directly by the manufacturer for so certifying; and ‘‘(C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent.”

According to the above legislation, adrenal patients meet the criteria for legal use of an infusion pump to administer glucocorticoid medication.

How do I get a pump?

The first step to cortisol pumping is establishing a care plan with a licensed medical professional. This can be a difficult challenge when trying to find a physician to manage your care with the pumping method, as most have never heard of it. This is why Adrenal Alternative Foundation has volunteers on our clinical advisory team willing to communicate with your healthcare team to help you establish a plan regarding your care on the cortisol pumping method.

It may take you many tries to find a physician willing to manage your care with the cortisol pumping method. Send your research, your health information, everything you can to the endocrinologist before your appointment so they are aware of your intentions beforehand. It may benefit you to write a letter to the endocrinologist prior to your appointment that explains your diagnosis, failed treatments and desire to be on the pump. They may or may not be receptive to your request and alerting them of your intentions beforehand may save you time, money and effort.

Will insurance cover pumps and supplies?

What your insurance will cover is completely dependent on your specific coverage plan and insurance company. If you are denied, you can always file an appeal. Visit this link to download the example appeal letter you can fill out with your information to appeal your insurance company’s denial.  

Adrenal Alternatives Foundation has also aligned with the organization CR3 to help adrenal patients acquire pumps in a safe and legal manner. Visit this link to apply for pump assistance.

It is also an option to cash purchase pumps and supplies specifically from companies such as Omnipod and Medtronic if you have a prescription from your overseeing physician.

Is cortisol pumping safe?

Adrenal insufficiency requires adequate cortisol replacement in the form of steroid medications. With the cortisol pumping method, patients can bypass the gastric pathway and absorb their life-sustaining medication better. This treatment is revolutionary for hypermetabolizers and for those with gastro-intestinal problems or malabsorption issues.

The pump truly puts adrenal patients in control of their cortisol distribution in a way that steroid pills cannot. In situations of physical or emotional stress where “updosing” is needed, the pump can immediately administer a bolus, which is extra cortisol administered through the pump canula at the amount you select. Instead of having to wait for pills to metabolize, the cortisol can be absorbed faster and can help prevent adrenal crisis.

Cortisol pumping is not a cure for adrenal insufficiency and is not a treatment that is right for everyone. If you are well managed on steroid replacement pills, being on the pump method may not be necessary to achieve quality of life.

Do I still need an emergency injection on the pumping method?

An adrenal crisis is defined as a life- threatening, medical emergency caused by insufficient levels of the hormone, cortisol. It will lead to death if left untreated and must be quickly addressed with the administration of an emergency cortisol injection. The pump is not a replacement for acute adrenal crisis care. Adrenal patients should always carry an emergency injection and administer it immediately in the event of an adrenal crisis.

More information on cortisol pumping can be found on the cortisol pump advocacy tab on our website and also in the book A patient’s guide to managing adrenal insufficiency.


[1] CORTISOL PUMPING SURVEY

In-text: (adrenalalternatives.com, 2020) adrenalalternatives.com. (2020). Cortisol Pumping Survey. [online] Available at: https://docs.google.com/forms/d/1eWYZjIFP9HRJDosvdimJnOr8p54Rmpx_2A4Xz40f77A/edit#responses

THE ADRENAL ALTERNATIVES FOUNDATION IS REGISTERED WITH THE IRS AS A 501(C)3 NONPROFIT ORGANIZATION. WE ARE A PATIENT EMPOWERMENT ORGANIZATION THAT ENCOURAGES, EDUCATES AND ADVOCATES FOR SUFFERERS OF ALL ADRENAL DISEASES AND ARE GUIDING ADRENAL DISEASE SUFFERERS TO EVERY POSSIBLE RESOURCE TO MANAGE THEIR HEALTH.
EIN: 83-3629121.

We appreciate all contributions which allow us to further our mission, Education, Advocacy and Awareness for all adrenal disease.

Donate to Adrenal Alternatives Foundation

Adrenal Insufficiency 101: A Patient’s Guide to Managing Adrenal Insufficiency

When someone has adrenal insufficiency, they are faced with the task of not only replacing a life-sustaining hormone, but also replicating a failed body system. Artificially managing cortisol is a complex task and is vital to quality of life. An adrenal patient’s personal cortisol needs may differ from day to day depending on physical, emotional and environmental stressors. This book is a patient’s guide to managing adrenal insufficiency.

We are proud to announce this book as a collaborative project of the Adrenal Alternatives Foundation, Inc.

This book contains factual information supported by credible medical sources, patient surveys and personal testimonies of real adrenal patients.

 

This book contains the following:

Chapter 1:Understanding the Adrenals 

Introduction

Terms to Know

Adrenal Conditions/Diseases

Symptoms

Diagnostics

Standard Treatment for Adrenal Insufficiency

Steroid Equivalent Dose Conversion Chart

 

Chapter 2:Managing Life with Adrenal Insufficiency 

Exercise

Nutrition

Weight

Mindset

Alternative Options

 

Chapter 3:For Family Members/Caregivers/Spouses 

Basic Necessities

Managing an Adrenal Crisis

Emergency Medical Protocols

 

Chapter 4:Critical Care 

Patient Perspective VS Outdated Research

Emergency Room Guidelines

Surgical Guidelines

 

Chapter 5:The Cortisol Pump 

Subcutaneous Cortisol Injections

What is the Cortisol Pump

How to Start the Cortisol Pumping Method

Pre-pump Lab Assessments

Establishing a Pumping Care Plan

Life with the Cortisol Pump

 

Chapter 6:Miscellaneous Care Concerns 

Blood Donation

Pregnancy

Alcohol

Cannabis and CBD

Hyperbaric Oxygen Therapy

 

Chapter 7:Conclusion

Adrenal Alternatives Foundation

Sources/References

About the Author

Dedications

It’s time the truth of adrenal disease was told.

Can you donate blood with adrenal disease?

Donating blood is one of the most selfless acts a person can do, but when you have a life-threatening illness such as adrenal insufficiency, there are questions as to whether you are allowed to donate blood or not.

Can adrenal disease patients donate blood?

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The answer is complicated.

Some countries/territories allow blood donation from adrenal patients and others do not. It is ultimately dependent on the regional medical director’s decision of a particular organization.

According to the Pituitary Foundation, Addison’s disease is listed as a permanent deferral which means those with this diagnosis are permanently banned from donating blood.

The Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee states that anyone diagnosed with any form of adrenal failure “Must not donate.” 
When we searched the American Red Cross website for adrenal disease information, we found no search results that pertained to whether adrenal patients could donate or not.
You can review the full eligibility requirements here.
To answer, the original question, Can you give blood with adrenal disease?
It depends on where you live and what organization is accepting blood donations.
If you are eligible to donate in your area, remember it is also a personal choice.  You should discuss it with your doctor to determine your risks and benefits of blood donation. 

 

 

 

 

 

Sources:

https://www.mskcc.org/about/get-involved/donating-blood/additional-donor-requirements/medical-conditions-affecting-donation

https://www.pituitary.org.uk/information/living-with-a-pituitary-condition/donating-blood/

https://www.redcrossblood.org/donate-blood/how-to-donate/eligibility-requirements/eligibility-criteria-alphabetical.html

https://www.transfusionguidelines.org/dsg/wb/guidelines/ad003-adrenal-failure

 

Is hyperbaric oxygen therapy safe with adrenal disease?

Hyperbaric oxygen therapy is an alternative treatment used to promote healing. With this treatment, a patient is placed in a hyperbaric oxygen therapy chamber, in which the air pressure is increased to higher than normal air pressure so that the patient’s lungs can absorb more oxygen.
The pressurized oxygen expelled within the chamber is believed to help your blood carry more oxygen and therefore promote healing and wellness.
Hyperbaric oxygen therapy increases the amount of oxygen the blood can carry. It is believed this increase in blood oxygen temporarily restores normal levels of blood gases and allows tissue function to promote healing and fight infections.

Hyperbaric oxygen therapy is considered a generally safe procedure, but this treatment does carry risks for adrenal disease patients.

It is important to thoroughly research any treatment, medication or alternative therapy and discuss it with your doctor before you begin any new regiment.

It is the objective of the Adrenal Alternatives Foundation to educate all adrenal patients on the risks and benefits of all possible treatments. Upon our research, we discovered the risks of hyperbaric oxygen therapy as it pertains to adrenal insufficiency. Below are a few extracts from two studies that address these concerns. Further reading/studies are in the sources at the end of this post.

(NOTE- There is no cure for adrenal insufficiency, except in the cases of steroid induced adrenal suppression. Never discontinue your steroid medication. Any alternative treatment/medication/therapy that claims to cure adrenal insufficiency is false.)

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Abstract of the Undersea & Hyperbaric Medical Society 2008 Annual Scientific Meeting June 26-28, 2008 Salt Lake City Marriott Downtown, Salt Lake City, Utah.

RESULTS: The attendant with Addison’s disease was found to have a drop from a morning level of 16.5 ug/dl to a critical level of 1.4 ug/dl. Subsequent testing without HBOT showed a lesser, non-critical drop of 29.1ug/dl to 9 ug/dl (normal range for the circadian cycle).

US National Library of Medicine National Institutes of Health – Effect of hyperbaric conditions on plasma stress hormone levels. Department of Anesthesiology, Turku University Hospital, Finland.

Cortisol levels decreased significantly (P = 0.001) during the treatments. No significant changes were found in other analyzed hormones.

It is important to be aware that hyperbaric oxygen therapy has been shown to decrease serum cortisol levels, therefore making this treatment a concern for those with adrenal disease.

Discuss any treatments, alternative therapies and medications with your doctor before trying any new regiment.

If you are a cortisol pump user, you will not be able to have your pump within the hyperbaric chamber to administer your cortisol. Due to the high oxygen concentration, any battery operated devices are a fire concern.

If you are considering any alternative therapies, please research them thoroughly and discuss them with your doctor before you begin any medication, treatment or regiment.

Sources:

https://www.ncbi.nlm.nih.gov/pubmed/10372427

http://archive.rubicon-foundation.org/xmlui/handle/123456789/7867

https://www.todayswoundclinic.com/articles/oxygen-wound-healing-going-beyond-hyperbaric-therapy

https://www.mayoclinic.org/tests-procedures/hyperbaric-oxygen-therapy/about/pac-20394380

The Crucial Role of Oxygen for Health

https://www.ncbi.nlm.nih.gov/pubmed/20737929

How does Hyperbaric Oxygen Therapy (HBOT) help with Stress?

https://www.canr.msu.edu/news/understanding_cortisol_the_stress_hormone

https://www.todayswoundclinic.com/articles/oxygen-wound-healing-going-beyond-hyperbaric-therapy

Cortisol Pumping Survey

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Calling all cortisol pumpers!

Adrenal Alternatives Foundation is conducting research on the current method of cortisol pumping in order to further technology developments to manage adrenal insufficiency.

We have created a short survey to collect information for future advancements.  Please click the link below to participate in the cortisol pumping survey.

 

https://docs.google.com/forms/d/e/1FAIpQLSeSrF2vsx9zlYtsHKumTOrTw9cqg8vZmnliRqUcEVfWKOHoFw/viewform?vc=0&c=0&w=1&fbclid=IwAR1L88KDRMdOZBSHrwSl6jkYO7NM2rEYod_8s5sgTZLLsKAMAliFhKRseNw

 

Thank you for your continued support of Adrenal Alternatives Foundation.

We cannot further our mission of Education, Advocacy and Encouragement without members like you!

 

 

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Adrenal Alternatives Foundation is registered with the IRS as a 501(c)3 nonprofit organization. EIN: 83-3629121.  All donations are tax deductible.