Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Low dose Hydrocortisone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose Hydrocortisone<br>Low Dose Hydrocortisone | Drug: Low dose Hydrocortisone<br>* Hydrocortisone 10 mg daily<br>* Other names: Cortisol;Drug: Placebo<br>* Placebo<br>|
| Placebo Comparator: Placebo<br>Placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia symptoms |  | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Cortisol, Hydrocortisone, Stress