Hormonal Replacement Therapy Does Not Affect Self-estimated Pain or Experimental Pain Responses in Postmenopausal Women Suffering From Fibromyalgia: A Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Pain thresholds and pain tolerance
研究概览
简要总结
In order to evaluate the potential effects of estrogen treatment in postmenopausal women with fibromyalgia, the investigators used quantitative sensory tests before and after eight weeks of estrogen treatment as compared with placebo treatment.
详细描述
Fibromyalgia is a condition that preferentially affects women. Sex hormones, and in particular estrogens, have been shown to affect pain processing and pain sensitivity, and estrogen deficit has been considered a potential promoting factor for fibromyalgia. However, the effects of estrogen treatment in patients suffering from fibromyalgia have not been studied. Twenty-nine postmenopausal women were randomized to either eight weeks of treatment with transdermal 17β-estradiol (50 ug daily) or placebo according to a double-blind protocol. A self-estimation of pain, a set of quantitative sensory tests measuring thresholds to temperature, thermal pain, cold pain and pressure pain, and a cold pressor test were performed at three occasions: before treatment, after eight weeks of treatment, and twenty weeks after cessation of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 49-60 years
- •Body mass index (BMI) of < 30
- •Met the ACR-90 criteria for the diagnosis of fibromyalgia
- •Postmenopausal state since at least six months
- •Not been using any hormonal treatments for the past three months
- •Had normal mammography screenings
排除标准
- •Using psychotropic drugs or having a history of thromboembolism
- •Diabetes mellitus, polyneuropathy, chronic liver disease,
- •Alcohol or substance abuse, hemoglobinopathy,
- •Endometrial adenomatous hyperplasia, or malignancy.
- •Presence of untreated hypertension (>160/95).
- •Undiagnosed vaginal bleedings
研究组 & 干预措施
Treatment with transdermal 17β-estradiol
干预措施: 17β-estradiol (Drug)
Control
干预措施: 17β-estradiol (Drug)
结局指标
主要结局
Pain thresholds and pain tolerance
时间窗: Before and after eight weeks treatment
次要结局
未报告次要终点
