Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia
Information source: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: Low dose Hydrocortisone (Drug); Placebo (Drug)
Phase: Phase 0
Status: Completed
Sponsored by: Ludwig-Maximilians - University of Munich Official(s) and/or principal investigator(s): Gustav Schelling, MD, PhD, Principal Investigator, Affiliation: Ludwig-Maximilians - University of Munich
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 Details
Official title: A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone 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
Primary outcome: Fibromyalgia symptoms
Secondary outcome: Chronic stress symptomsHealth-related quality of life Life satisfaction Infection
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Ludwig-Maximilians University, Muenchen, Bavaria 81377, Germany
Additional Information
Homepage of the Dept. of Anaesthesiology of the University of Munich
Related publications: 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.
Starting date: May 2003
Last updated: March 30, 2015
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