Hydrocortisone — Informed Consent (Physiological Dose for HPA Axis Support / CFS)

Last updated: February 5, 2026

INFORMED CONSENT FOR HYDROCORTISONE — PHYSIOLOGICAL DOSE FOR HPA AXIS SUPPORT

§1 PURPOSE, CONTEXT, AND SCOPE

§1.1 This document constitutes an informed consent agreement between the Patient identified herein (the "Patient") and the Prescribing Physician acting on behalf of the Clinic. It is intended to document that the Patient has received, understood, and accepted comprehensive information regarding the proposed use of hydrocortisone at physiological (low) doses for suspected hypothalamic‑pituitary‑adrenal (HPA) axis dysfunction, chronic fatigue syndrome (CFS/ME), or related conditions.

§1.3 Health optimization context: The Patient understands that the Clinic operates as a proactive health optimization / longevity practice. The Clinic is not an emergency provider. The Patient is responsible for maintaining an appropriate relationship with a primary care physician and/or relevant specialist(s) for diagnosis and management of disease, acute care, and emergencies.

§1.4 This consent is governed by the laws of Denmark and the European Union, including but not limited to the Danish Health Act (Sundhedsloven) and Regulation (EU) 2016/679 (General Data Protection Regulation).

§1.5 By signing this document, the Patient confirms they have had adequate time to read, consider, and ask questions, and that their questions have been answered to their satisfaction.

§3 MEDICATION, CLASS, AND DESCRIPTION OF TREATMENT

§3.1 Hydrocortisone is a synthetic corticosteroid identical to cortisol, the primary glucocorticoid hormone produced by the adrenal glands. Cortisol is essential for stress response, metabolism, immune function, and numerous physiological processes.

§3.3 Intended use in this Clinic: The Patient understands that hydrocortisone is being prescribed at low/physiological doses (typically ≤15–20 mg/day, often 5–10 mg/day) for suspected HPA axis dysfunction, CFS/ME, or related conditions characterized by fatigue, reduced stress tolerance, and symptoms suggestive of relative hypocortisolism.

§3.4 Distinction from adrenal insufficiency: The Patient understands that:

Hydrocortisone is EMA‑authorised for adrenal insufficiency (Addison's disease, secondary adrenal insufficiency)
Use for CFS/ME, "adrenal fatigue," HPA axis dysfunction, or functional hypocortisolism without a formal diagnosis of adrenal insufficiency is off‑label
The concept of "adrenal fatigue" is not a recognized medical diagnosis by mainstream endocrine societies
Some patients with CFS/ME or related conditions may have blunted cortisol responses, and some clinicians use low‑dose hydrocortisone as a therapeutic trial

§3.5 The treatment will be administered orally, typically in divided doses (e.g., 5 mg morning, 2.5 mg afternoon, or similar) to mimic physiological cortisol rhythms, as determined by the Prescribing Physician.

§4 REGULATORY STATUS AND OFF‑LABEL USE

§4.1 Hydrocortisone has been authorised by the European Medicines Agency (EMA) for:

Replacement therapy in adrenal insufficiency (primary and secondary)
Anti‑inflammatory/immunosuppressive therapy (at higher doses) for various conditions

§4.2 Off‑label use: The Patient understands that prescribing low‑dose hydrocortisone for CFS/ME, HPA axis dysfunction, "functional hypocortisolism," or related syndromes without a formal diagnosis of adrenal insufficiency is off‑label and is not an EMA‑approved indication for these purposes.

§4.3 The Patient understands that evidence supporting off‑label low‑dose hydrocortisone use for CFS/ME is:

Limited to small clinical trials with mixed results
Some studies suggest modest short‑term improvement in fatigue; others show no significant benefit
Long‑term efficacy and safety for this use are not established
Mainstream endocrine societies do not endorse routine use of glucocorticoids for CFS/ME

§4.4 The Patient has been informed that the intended use in this Clinic is off‑label and accepts this information.

§5 PROPOSED BENEFITS OF TREATMENT

§5.1 The Patient understands that the potential benefits of low‑dose hydrocortisone for HPA axis support are not guaranteed and evidence is limited. Proposed benefits may include:

§5.1.1 Symptom improvement: Potential improvement in:

Fatigue and reduced energy
Reduced tolerance to physical or mental stress
Orthostatic symptoms (lightheadedness, dizziness)
Cognitive symptoms ("brain fog")
General malaise

§5.1.2 Therapeutic trial: Some clinicians use low‑dose hydrocortisone as a time‑limited therapeutic trial to assess response. If no improvement is observed after a defined period (e.g., 8–12 weeks), discontinuation is typically recommended.

§5.2 No guarantee of benefit: The Patient acknowledges that:

Clinical evidence for this use is limited and mixed
Benefits are not guaranteed
Individual responses vary, and many patients may not experience any benefit
Absence of improvement does not necessarily indicate worsening of the underlying condition

§6 MATERIAL RISKS AND ADVERSE EFFECTS

§6.1 The Patient has been informed of the following risks and adverse effects. While risks are generally lower at physiological doses than at pharmacological (anti‑inflammatory) doses, they are not zero.

§6.2 HPA axis considerations:

§6.2.1 Background: Prolonged use of exogenous corticosteroids can, in some cases, reduce the body's own cortisol production (HPA axis suppression). However, the risk is dose‑ and duration‑dependent.

§6.2.2 Evidence at physiological doses: Clinical studies of low‑dose hydrocortisone (5–15 mg/day) in CFS/ME patients (e.g., McKenzie et al., Cleare et al.) have generally found minimal clinically significant HPA suppression at these doses. The threshold for significant HPA suppression is typically considered to be ≥7.5 mg prednisone equivalent (~30 mg hydrocortisone) for more than 3 weeks. At 5–10 mg/day — roughly what the body produces naturally — complete HPA shutdown is unlikely.

§6.2.3 Practical guidance: While the risk of HPA suppression is low at physiological doses, the Patient should be aware of the following sensible precautions:

Gradual discontinuation: If stopping after more than a few weeks of use, taper gradually rather than stopping abruptly. This allows the HPA axis to resume normal function smoothly.
Awareness during major illness or surgery: If the Patient experiences a major physiological stressor (severe infection, major surgery, significant trauma) while on hydrocortisone, they should inform healthcare providers. Temporary dose adjustment may be appropriate in these uncommon situations.
No need for routine stress dosing during minor illness (e.g., common cold) at physiological doses.

§6.2.4 Adrenal crisis: Adrenal crisis is a serious condition that can occur when someone with suppressed adrenal function faces severe stress without adequate cortisol. At truly physiological doses (5–10 mg/day) for typical treatment durations, this risk is very low. The residual adrenal function is usually preserved. Nevertheless, for prolonged use (many months to years), the Patient should be aware of symptoms of adrenal insufficiency (severe fatigue, nausea, dizziness, hypotension) and seek medical attention if these occur during significant illness.

§6.3 Possible minor effects at physiological doses:

Insomnia or sleep disturbance (especially if taken too late in the day — take morning doses only)
Mild increase in appetite
Slight fluid retention (usually minimal)
Mild mood changes (some patients report feeling "more alert" or slightly irritable)
Mild GI upset (uncommon)

§6.3.1 Important context: At truly physiological doses (5–10 mg/day), these effects are generally mild and often not noticeable. The body normally produces approximately 10–20 mg of cortisol daily, so physiological replacement is simply restoring normal levels, not creating excess.

§6.4 Theoretical concerns with prolonged use:

§6.4.1 The following risks are associated with corticosteroid therapy but are primarily seen at pharmacological (higher) doses used for anti‑inflammatory purposes, not typically at physiological replacement doses:

Weight gain / central adiposity — unlikely at physiological doses
Glucose intolerance — monitor if pre‑diabetic, but uncommon at low doses
Osteoporosis — data on physiological‑dose hydrocortisone and bone health is limited; monitoring may be appropriate for prolonged use in at‑risk individuals
Skin thinning — typically a high‑dose phenomenon
Significant immune suppression — not expected at physiological doses
Cataracts, glaucoma, avascular necrosis — these are pharmacological‑dose complications, not expected at 5–10 mg/day

§6.4.2 The main risk at physiological doses remains HPA axis suppression (see §6.2), which is why sick‑day rules and proper tapering are essential.

§6.5 Rare but serious adverse effects:

§6.5.1 Adrenal crisis: As described above, this is a medical emergency. The Patient must seek immediate emergency care for severe symptoms such as collapse, severe hypotension, or altered consciousness.

§6.5.2 Psychiatric effects: Rarely, corticosteroids can cause significant mood disturbance, psychosis, or suicidal ideation. The Patient must report significant mood changes to the Clinic.

§6.5.3 Allergic reactions: Rare allergic reactions can occur. The Patient must seek urgent care for swelling of face/tongue/throat, difficulty breathing, or widespread rash.

§7 CONTRAINDICATIONS AND PRECAUTIONS

§7.1 The Patient confirms that they have disclosed all relevant medical history to the Prescribing Physician. Hydrocortisone may be contraindicated or require special caution in the following circumstances:

§7.2 Contraindications:

Systemic fungal infections (relative contraindication)
Known hypersensitivity to hydrocortisone or excipients
Live vaccines (generally contraindicated with significant immunosuppression, though low‑dose hydrocortisone may be acceptable — requires assessment)

§7.3 Precautions (require careful assessment):

Diabetes or glucose intolerance (corticosteroids can worsen glucose control)
Hypertension (corticosteroids can raise blood pressure)
Osteoporosis or significant fracture risk
Glaucoma or family history of glaucoma
Active peptic ulcer disease
Active or latent infections (tuberculosis, herpes simplex, varicella)
Psychiatric history (depression, psychosis)

§8 DRUG INTERACTIONS

§8.1 The Patient has disclosed all current medications, including prescription drugs, over‑the‑counter medications, supplements, and herbal products.

§8.2 Significant interactions:

NSAIDs (increased GI bleeding risk)
Anticoagulants (effects may be altered)
Diabetes medications (glucose control may worsen; doses may need adjustment)
CYP3A4 inducers (e.g., rifampin, phenytoin) — may reduce hydrocortisone levels
CYP3A4 inhibitors (e.g., ketoconazole) — may increase hydrocortisone levels
Diuretics (increased risk of hypokalemia)

§8.3 The Patient agrees to inform the Clinic before starting any new medication.

§9 MONITORING REQUIREMENTS

§9.1 The Patient agrees to undergo monitoring as recommended by the Prescribing Physician, which may include:

§9.2 Baseline assessments:

Clinical assessment of symptoms and baseline function
Morning cortisol (if not already done)
Fasting glucose and/or HbA1c (if diabetic or pre‑diabetic)
Blood pressure

§9.3 Ongoing monitoring:

Clinical assessment of symptoms, adverse effects, and treatment response (typically at 4–8 weeks, then periodically)
Periodic glucose monitoring only if indicated (pre‑diabetes, diabetes)
Blood pressure check at follow‑ups
Assessment of HPA axis recovery if discontinuation is planned after prolonged use (may require ACTH stimulation test)
Bone density (DEXA) is generally not required for short‑term physiological‑dose use but may be considered for use >1 year in postmenopausal women or those with osteoporosis risk factors

§9.4 Duration of treatment: The Patient understands that:

Low‑dose hydrocortisone for CFS/ME is often used as a time‑limited therapeutic trial (e.g., 8–12 weeks)
If no benefit is observed, discontinuation (with appropriate taper) is typically recommended
Prolonged use (months to years) increases the risk of HPA suppression and other adverse effects
The Prescribing Physician will regularly reassess the need for continued treatment

§10 GUIDANCE DURING ILLNESS

§10.1 Context: At physiological doses (5–10 mg/day), the body's own adrenal glands typically continue to function, and formal "sick‑day rules" as used in primary adrenal insufficiency are usually not required. The following guidance is provided for awareness:

§10.2 During minor illness (e.g., cold, mild infection):

No dose change is typically needed
Continue as normal

§10.3 During significant illness (high fever, severe infection, major surgery, significant trauma):

Inform treating healthcare providers that you are taking hydrocortisone
Temporary dose adjustment may be considered at the discretion of the treating clinician
Contact the Clinic if you have concerns

§10.4 Medical alert identification: For short‑term physiological‑dose use (8–12 weeks), a medical alert bracelet is generally not necessary. For prolonged use (many months or more), the Patient may optionally carry a card noting hydrocortisone use.

§11 ALTERNATIVE TREATMENTS

§11.1 The Patient has been informed of the following alternatives:

§11.2 Non‑pharmacological interventions:

Pacing and energy management
Sleep optimization
Stress management techniques
Graded exercise therapy (controversial in CFS/ME; requires careful individualization)
Cognitive behavioral therapy
Nutritional support

§11.3 Other pharmacological interventions:

Low‑dose naltrexone (LDN)
Other medications targeting specific symptoms
Adaptogens and nutraceuticals (limited evidence)

§11.4 Further investigation: The Patient understands that CFS/ME is a complex condition and that further investigation to identify treatable causes may be appropriate.

§11.5 No treatment: The Patient may choose not to receive hydrocortisone, understanding that symptoms may persist.

§11.6 The Patient confirms that these alternatives have been discussed and that they have chosen to proceed with hydrocortisone.

§13 LIMITATION OF LIABILITY / NO GUARANTEE

§13.1 The Patient understands that medicine is not an exact science and no outcomes can be guaranteed.

§13.2 The Patient understands that:

Clinical evidence for low‑dose hydrocortisone in CFS/ME is limited; some studies show modest benefit, others show no significant effect
Benefits are not guaranteed and individual responses vary
At physiological doses, the safety profile is generally favorable, but awareness of HPA axis considerations is appropriate for prolonged use

§13.3 The Patient understands that adverse effects may occur despite appropriate prescribing and monitoring.

§13.4 Nothing in this consent excludes liability that cannot be excluded under applicable Danish law.

§14 WITHDRAWAL OF CONSENT

§14.1 The Patient may withdraw consent at any time by contacting the Clinic. The Prescribing Physician will provide guidance on appropriate discontinuation.

§14.2 Discontinuation guidance: If stopping after more than a few weeks of use, a gradual taper is recommended to allow smooth HPA axis recovery. This is a precautionary measure; at physiological doses, the risk of significant problems from stopping is low.

§15 DATA PROTECTION AND RECORDKEEPING

§15.1 The Patient's personal data and health information will be processed in accordance with GDPR and applicable Danish law.

§15.2 This consent may be retained as part of the Patient's medical record.

§16 ACKNOWLEDGMENTS AND DECLARATIONS

By consenting, the Patient confirms the following:

I have read this consent document in its entirety, or it has been read to me, and I understand its contents.
I understand that low‑dose hydrocortisone is being used off‑label for HPA axis support/CFS, not for a confirmed diagnosis of adrenal insufficiency.
I understand that clinical evidence for this use is limited and that benefit is not guaranteed.
I understand the medication prescribed (the prescribed medication) and the purpose of treatment.
I understand that HPA axis suppression is possible with prolonged use, though risk is low at physiological doses.
I understand that if stopping after more than a few weeks, I should taper gradually rather than stopping abruptly.
I understand I should inform healthcare providers about hydrocortisone use if I face major illness or surgery.
I understand that while physiological doses carry lower risk than pharmacological doses, I should report any concerning symptoms.
I have disclosed all relevant medical history and current medications to the Clinic.
I understand I must seek urgent/emergency care for severe symptoms (especially signs of adrenal crisis) and that the Clinic is not an emergency service.
I have had the opportunity to ask questions and my questions were answered.
I voluntarily consent to commence or continue treatment with the prescribed medication under the regimen agreed with my clinician.