Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

Fibromyalgia (FMS) is regarded as one of the most important chronic pain syndromes with a high prevalence in the general population.

Hypotheses to be tested in this study:

• Impaired glucocorticoid signaling is associated in a failure to terminate the chronic stress response seen in patients with FMS.
• Low-dose hydrocortisone in patients with FMS results in a reduction in pain and other stress-related symptoms of FMS

Intervention:

2 x 5 mg of hydrocortisone given at noon and in the evening

Study design:

Double-blind, randomized, cross-over, within-subject

Presumed mechanism of main hydrocortisone effect:

• Improvements in FMS symptoms representing (functional) hypocortisolism
• Increased pain threshold

Expected results:

• Moderate reductions in physical impairment, fatigue, and stiffness
• Improvements in sleep quality
• Decline in pain intensity Inclusion criteria
• FMS diagnosis according to the American College of Rheumatology 1990 Criteria
• Age between 18 and 60 years

Exclusion criteria

• Disease states representing contraindications to the administration of glucocorticoids (tuberculosis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy and lactation, psychosis, glaucoma, diabetes mellitus, thrombophilia, active or chronic bacterial or viral infections, hypothyreosis, cirrhosis).
• Severe or chronic somatic diseases.
• Psychiatric diseases according to DSM-IV (except PTSD, minor depressive episodes, minor personality disorders).
• Body weight >20% above or below normal.
• Changes in pharmacologic or psychotherapeutic management less than 3 months ago.
• Age < 18 years

Proposed outcome measures

• Primary: FMS symptoms, pain scores, tenderness at tender points
• Secondary: Chronic stress symptoms, health-related quality of life

Possible benefit and use of data from the trial

This trial could help to identify glucocorticoid resistance as a major mechanism underlying the sustained stress - reactions seen in FMS and establish low-dose hydrocortisone as a useful drug for treatment of stress-related disorders.

Inclusion criteria

• FMS diagnosis according to the American College of Rheumatology 1990 Criteria.
• Age between 18 and 60 years

Exclusion criteria

• Disease states representing contraindications to the administration of glucocorticoids (tuberculosis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy and lactation, psychosis, glaucoma, diabetes mellitus, thrombophilia, active or chronic bacterial or viral infections, hypothyreosis, cirrhosis)
• Severe or chronic somatic diseases
• Psychiatric diseases according to DSM-IV (except PTSD, minor depressive episodes, minor personality disorders)
• Body weight >20% above or below normal
• Changes in pharmacologic or psychotherapeutic management less than 3 months ago
• Age < 18 years