Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

NCT ID: NCT00236925

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2007-06-30

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low dose Hydrocortisone

Low Dose Hydrocortisone

Group Type: ACTIVE_COMPARATOR

Low dose Hydrocortisone

Intervention Type: DRUG

Hydrocortisone 10 mg daily

Placebo

Intervention Type: DRUG

Placebo

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Low dose Hydrocortisone

Intervention Type: DRUG

Hydrocortisone 10 mg daily

Placebo

Intervention Type: DRUG

Placebo

Interventions

Low dose Hydrocortisone

Hydrocortisone 10 mg daily

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Cortisol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Gustav Schelling,MD

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustav Schelling, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

Ludwig-Maximilians University

Munich, Bavaria, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 15285979 (View on PubMed)

Related Links

http://ana.klinikum.uni-muenchen.de/

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

Other Identifiers

348/02

Identifier Type: -

Identifier Source: org_study_id