Abstract
Purpose: To determine whether anthocyanidins when administered as a food supplement are effective in the treatment of primary fibromyalgia. Design: Double-blind, randomized, crossover trial comparing 3 doses of anthocyanidins and placebo. Materials and Methods: Twelve patients with moderate to severe primary fibromyalgia were treated with anthocyanidins, 120, 80, 40 mg day - 1 and placebo, each for 3 months after a one-month baseline observation period. All treatments were administered orally as identical capsules. Primary variables to assess the effectiveness of treatments were the severity of symptoms of pain, fatigue and sleep disturbance recorded by the patient on daily diary cards, the patient's assessment of the effectiveness of each treatment and the patient's treatment preference. Secondary variables were the investigator's assessment of symptom severity, and patient scores from a General Health Questionnaire (GHQ28). Results: Ten subjects completed the trial. Two withdrew, one owing to suspected adverse effects of treatment and one owing to concurrent illness. Friedman 2-way ANOVA test showed significant treatment effects on sleep disturbance recorded by the patient ( p = 0.01), fatigue as assessed by the investigator ( p = 0.01) and on the scores using the GHQ28 ( p = 0.03). Conclusions: This trial of anthocyanidins in the treatment of primary fibromyalgia has shown small but statistically significant benefits at a dose of 80 mg day - 1 , the dose that is recommended for these substances to be used as a food supplement. It may therefore be worthwhile patients suffering from this difficult chronic condition undergoing an individual therapeutic trial. A minimum of 3 months' treatment is recommended. Further trials of anthocyanidins in a larger number of patients should probably be undertaken.
