Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

Condition(s) targeted: Fibromyalgia

Intervention: Hydrocortisone (low-dose) (Drug)

Phase: N/A

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

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome:

Fibromyalgia symptoms

Pain scores

Tenderness at tender points

Secondary outcome:

Chronic stress symptoms

Health-related quality of life

Life satisfaction

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.

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

Ludwig-Maximilians University, Muenchen, Bavaria 81377, Germany

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
Ending date: June 2007
Last updated: June 18, 2007