Fibromyalgia
Conditions
Keywords
Fibromyalgia, Omega-3, Chronic Pain, Fatigue, Mood, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA)
Brief summary
The purpose of this study is to find out if omega-3 fatty acid supplements are more effective than an inactive placebo at reducing pain, reducing fatigue and elevating mood in patients with fibromyalgia.
Interventions
DIETARY_SUPPLEMENTOmega-3 (oil)
5ml daily with breakfast for 56 days.
DIETARY_SUPPLEMENTFatty Acids (placebo)
5ml daily with breakfast for 56 days.
Sponsors
McGill University
Dr. Yoram Shir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-65. * A diagnosis of FM according to the American College of Rheumatology classification criteria(Wolfe et al., 1990) * Negative urine pregnancy test at enrolment and willingness not to become pregnant for the duration of the study. * Pain levels of at least 4 on 10-cm VAS at the time of recruitment. * Ability to communicate in English or in French. * Willing to sign an informed consent. * If the patient is taking medication or natural health product (excluding omega-3 containing products) to treat fibromyalgia, she must be on a stable regimen for a minimum of two weeks before recruitment and be willing to keep this stable medication or natural health product regimen throughout the study period. * If the patient is using other therapies to treat fibromyalgia such as TENS, acupuncture, exercise, psychotherapy, massage, physiotherapy, etc, she must be doing so for a minimum of two weeks before recruitment and be willing to continue those therapies throughout the study period.
Exclusion criteria
* Use of anticoagulants (Coumadin® or Plavix®), having a bleeding disorder or being scheduled for a surgical procedure. This is because omega-3 fatty acids can prolong bleeding time, although doses we propose to use are safe (see Risks section) * Allergy to fish, olive oil, medium chain triglycerides, lemon, green tea, vitamin E or tylenol * Past (within the last year) or present specific dietary supplementation with omega-3 fish oil or other natural health products containing omega-3 fatty acids (e.g. flax seed oil, krill oil, etc) or regularly eating more than two fatty fish meals/week (salmon, mackerel, sardine, flounder, herring, or any other fish considered to have a high level of omega-3 fatty acids). * Patient enrolled in another research study involving any treatment. * Patient engaged in active litigation * Regular use of recreational drugs * Alcohol consumption \> 10 units/week * Morbidly obese patients * Pregnancy or breastfeeding * Uncontrolled major medical conditions. Neurological problems. Current psychiatric condition. Chronic pain condition other than FM.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) | 2 months | Pain intensity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scales (VAS) | 2 months | Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion. |
| Fibromyalgia Impact Questionnaire | 2 months | — |
| Use of rescue medication | 2 months | — |
| Multidimensional Fatigue Inventory (MFI-20) | 2 months | — |
| Beck Depression Inventory (BDI) | 2 months | — |
| Profile of Mood States (POMS) | 2 months | — |
Countries
Canada
Outcome results
None listed