Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

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

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Placebo; Drug: Low dose Hydrocortisone

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Muenchen, Bavaria, Germany, 81377
      • Ludwig-Maximilians University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo; Drug: Low dose Hydrocortisone; Hydrocortisone 10 mg daily; Other Names: Cortisol
Active Comparator: Low dose Hydrocortisone; Low Dose Hydrocortisone	Drug: Placebo; Placebo; Drug: Low dose Hydrocortisone; Hydrocortisone 10 mg daily; Other Names: Cortisol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fibromyalgia symptoms	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Chronic stress symptoms	3 months
Health-related quality of life	3 months
Life satisfaction	3 months
Infection	3 months

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Gustav Schelling, MD, PhD, Ludwig-Maximilians - University of Munich

Publications and helpful links

General 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. doi: 10.1176/appi.ajp.161.8.1488.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: October 10, 2005
• First Submitted That Met QC Criteria: October 10, 2005
• First Posted (Estimated): October 12, 2005

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Stress; Cortisol; Fibromyalgia; Hydrocortisone
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: 348/02