Hydrocortisone Dose Influences Pain, Depressive Symptoms and Perceived Health in Adrenal Insufficiency - A Randomized Controlled Trial.
Background: There is a major lack of randomized controlled trials (RCT) evaluating the effects of hydrocortisone (HC) substitution therapy in these patients. Therefore, we evaluated the effects of two different replacement doses of HC on HR-QoL in an RCT.
Methods: This RCT with double blind cross-over design was performed at the University Medical Center Groningen. Forty-seven patients (29 men; age 51 ± 14 years) with secondary AI participated. Patients received both a lower and a higher dose of HC (0.2-0.3 and 0.4-0.6 mg/kg body weight/day) for 10 weeks in random order. HR-QoL was assessed with a daily mood and symptom checklists (PHQ-15, GAD-7, PHQ-9) and with questionnaires assessing general well-being (RAND-36), mood (HADS) and fatigue (MFI-20). ClinicalTrials.gov Identifier: NCT01546922.
Results: Patients receiving the higher dose of HC reported significantly fewer symptoms of depression (p = 0.016 and p = 0.045 for HADS and PHQ-9), less general and mental fatigue (p = 0.004 and p = 0.003, both MFI-20), increased motivation (p = 0.021, MFI-20), better physical functioning (p = 0.041), better general health (p = 0.013) and more vitality (p = 0.025) (all RAND-36). In addition, while on the higher dose, fewer somatic symptoms (p = 0.022) and less pain (p < 0.001) (both PHQ-15) were experienced.
Conclusions: On the higher dose of HC, patients reported a better HR-QoL on various domains as compared to on the lower dose of HC. The fact that a higher dose of HC may improve patients well being should be taken into consideration when individualizing the HC substitution dose.