The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms

• Use of rescue medication [ Time Frame: 2 months ] [ Designated as safety issue: No ]
• Visual analog scales (VAS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion.
• Fibromyalgia Impact Questionnaire [ Time Frame: 2 months ] [ Designated as safety issue: No ]
• Profile of Mood States (POMS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
• Multidimensional Fatigue Inventory (MFI-20) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
• Beck Depression Inventory (BDI) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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.

• Dietary Supplement: Omega-3 (oil)
  5ml daily with breakfast for 56 days.
  Other Name: NutraSea HP
• Dietary Supplement: Fatty Acids (placebo)
  5ml daily with breakfast for 56 days.

• Placebo Comparator: Colored olive oil
  Intervention: Dietary Supplement: Fatty Acids (placebo)
• Active Comparator: Omega-3 (oil)
  Intervention: Dietary Supplement: Omega-3 (oil)

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.