Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: 17β-estradiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with transdermal 17β-estradiol<br> | Drug: 17β-estradiol<br>* Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks<br>* Other names: provera;|
| Placebo Comparator: Control<br> | Drug: 17β-estradiol<br>* Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks<br>* Other names: provera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain thresholds and pain tolerance |  | Before and after eight weeks treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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estrogen, substitution, pain, hormonal levels, quantitative sensory testing