A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fibromyalgia symptoms
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FMS diagnosis according to the American College of Rheumatology 1990 Criteria.
- •Age between 18 and 60 years
排除标准
- •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
研究组 & 干预措施
Low dose Hydrocortisone
Low Dose Hydrocortisone
干预措施: Low dose Hydrocortisone (Drug)
Low dose Hydrocortisone
Low Dose Hydrocortisone
干预措施: Placebo (Drug)
Placebo
Placebo
干预措施: Low dose Hydrocortisone (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Fibromyalgia symptoms
时间窗: 3 months
次要结局
- Infection(3 months)
- Chronic stress symptoms(3 months)
- Life satisfaction(3 months)
- Health-related quality of life(3 months)
研究者
Gustav Schelling,MD
Senior Researcher
Ludwig-Maximilians - University of Munich