Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236925
• Other study ID #: 348/02
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2003
• Est. completion date: June 2007

Study information

• Verified date: March 2024
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Low dose Hydrocortisone
Hydrocortisone 10 mg daily
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Ludwig-Maximilians University	Muenchen	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	University of Zurich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90. doi: 10.1176/appi.ajp.161.8.1488. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia symptoms		3 months
Secondary	Chronic stress symptoms		3 months
Secondary	Health-related quality of life		3 months
Secondary	Life satisfaction		3 months
Secondary	Infection		3 months

External Links

•   Homepage of the Dept. of Anaesthesiology of the University of Munich