Clinical trial NCT00236925: Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia
Official title: A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Cortisol
Hydrocortisone
Stress
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2005-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Fibromyalgia symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Chronic stress symptoms
timeFrame: 3 months
measure: Health-related quality of life
timeFrame: 3 months
measure: Life satisfaction
timeFrame: 3 months
measure: Infection
timeFrame: 3 months
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Ludwig-Maximilians University
state: Bavaria
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Gustav Schelling, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.