Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia|
- Fibromyalgia symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Chronic stress symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Health-related quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Life satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2003|
|Study Completion Date:||June 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Active Comparator: Low dose Hydrocortisone
Low Dose Hydrocortisone
Drug: Low dose Hydrocortisone
Hydrocortisone 10 mg daily
Other Name: CortisolDrug: Placebo
Placebo Comparator: Placebo
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
2 x 5 mg of hydrocortisone given at noon and in the evening
Double-blind, randomized, cross-over, within-subject
Presumed mechanism of main hydrocortisone effect:
- Improvements in FMS symptoms representing (functional) hypocortisolism
- Increased pain threshold
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236925
|Muenchen, Bavaria, Germany, 81377|
|Principal Investigator:||Gustav Schelling, MD, PhD||Ludwig-Maximilians - University of Munich|