Clinical trial NCT01087593: Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fibromyalgia
Keywords: estrogen
substitution
pain
hormonal levels
quantitative sensory testing
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 29
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain thresholds and pain tolerance
timeFrame: Before and after eight weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University hospital in Linköping
Study officials:
affiliation: University Hospital, Linkoeping
name: Mats Hammar, MD, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stening KD, Eriksson O, Henriksson KG, Brynhildsen J, Lindh-Astrand L, Berg G, Hammar M, Amandusson A, Blomqvist A. Hormonal replacement therapy does not affect self-estimated pain or experimental pain responses in post-menopausal women suffering from fibromyalgia: a double-blind, randomized, placebo-controlled trial. Rheumatology (Oxford). 2011 Mar;50(3):544-51. doi: 10.1093/rheumatology/keq348. Epub 2010 Nov 14.