Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is based on clinical findings that some patients with fibromyalgia have a tendency
      towards lower levels of the stress hormone cortisol. The hypothesis to be tested in this
      study is that the administration of a very low-dose of cortisol which has no side effects
      corrects this deficiency and results in an improvement of symptoms
    

Detailed description: 
      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.
    

Intervention name(s): Low dose Hydrocortisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hydrocortisone 10 mg daily; Placebo
Other intervention name(s): Cortisol
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Cortisol; Hydrocortisone; Stress