Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00236925
Study type	Interventional
Source	Ludwig-Maximilians - University of Munich
Contact
Status	Completed
Phase	Early Phase 1
Start date	May 2003
Completion date	June 2007

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.