Fibromyalgia
Conditions
Brief summary
Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.
Interventions
DRUGT3
Patients receive T3 in a dose of 25mcg and 50mcg
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-50 2. Meet american college of rheumatology criteria for fibromyalgia 3. at baseline report an average pain of 4 or more on a brief Pain Inventory. 4. can climb 2 flights of stairs without shortness of breath.
Exclusion criteria
1. new medication change in the last 2 months 2. any cardiac disease at all 3. known thyroid disease before or after thyroid screening bloodwork 4. unstable medical or psychiatric disease. 5. Known inflammatory or rheumatic disease other than fibromyalgia 6. substance abuse in the last year 7. suicidality or depression as indicated by a Beck Depression Inventory of 30 or above 8. concomitant herbal medications 9. multiple severe medication allergies 10. the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study. 11. diabetes 12. smoking 13. Known uncontrolled hypertension 14. known uncontrolled hypercholesterolemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale of Pain Intensity | 12 weeks | Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Followed by T3 Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Did not meet study criteria | 33 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Participation put on hold | 4 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Placebo Followed by T3 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age, Continuous | 35.35 years STANDARD_DEVIATION 7.76 |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 1 / 51 |
| serious Total, serious adverse events | 1 / 51 |
Outcome results
Primary
Visual Analogue Scale of Pain Intensity
Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Followed by T3 | Visual Analogue Scale of Pain Intensity | Baseline | 6.75 Units on a scale | Standard Deviation 2.17 |
| Placebo Followed by T3 | Visual Analogue Scale of Pain Intensity | Placebo | 5.71 Units on a scale | Standard Deviation 1.82 |
| Placebo Followed by T3 | Visual Analogue Scale of Pain Intensity | T3 Treatment (25 mcg) | 5.13 Units on a scale | Standard Deviation 2.95 |
| Placebo Followed by T3 | Visual Analogue Scale of Pain Intensity | T3 Treatment (50 mcg) | 6.19 Units on a scale | Standard Deviation 2.37 |