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Background: The Fibromyalgia Diagnostic Screen was developed for use by primary care clinicians to assist in the diagnostic evaluation of fibromyalgia, a disorder that predominantly affects women., Methods: The screen was designed to have a patient-completed questionnaire and a clinician-completed section, which included a brief physical examination pertinent to the differential diagnosis of fibromyalgia. The items in the questionnaire were based on patient focus groups and clinician and patient Delphi exercises, which resulted in a ranking of the most common and troublesome fibromyalgia symptoms. One hundred new chronic pain patients (pain > 30 days) and their primary care physicians completed the screen. The patients were grouped as fibromyalgia or nonfibromyalgia by an independent fibromyalgia specialist, who was blind to screen responses. Logistic regression was used to model the probability of fibromyalgia as a function of physician-reported and patient-reported variables. Best subset regression was used to identify a subset of symptoms that were summed to form a single measure. Receiver operating characteristic (ROC) analysis was then used to select thresholds for continuous variables. The symptom and clinical variables were combined to create candidate prediction rules that were compared in terms of sensitivity and specificity to select the best criterion., Results: Two final models were selected based on overall accuracy in predicting fibromyalgia: one used the patient-reported questionnaire only, and the other added a subset of the physical examination items to this patient questionnaire., Conclusion: A patient-reported questionnaire with or without a brief physical examination may improve identification of fibromyalgia patients in primary care settings.

Objective: To assess the efficacy and safety of gabapentin in patients with fibromyalgia., Methods: A 12-week, randomized, double-blind study was designed to compare gabapentin (1,200-2,400 mg/day) (n=75 patients) with placebo (n=75 patients) for efficacy and safety in treating pain associated with fibromyalgia. The primary outcome measure was the Brief Pain Inventory (BPI) average pain severity score (range 0-10, where 0=no pain and 10=pain as bad as you can imagine). Response to treatment was defined as a reduction of >or=30% in this score. The primary analysis of efficacy for continuous variables was a longitudinal analysis of the intent-to-treat sample, with treatment-by-time interaction as the measure of effect., Results: Gabapentin-treated patients displayed a significantly greater improvement in the BPI average pain severity score (P=0.015; estimated difference between groups at week 12=-0.92 [95% confidence interval -1.75, -0.71]). A significantly greater proportion of gabapentin-treated patients compared with placebo-treated patients achieved response at end point (51% versus 31%; P=0.014). Gabapentin compared with placebo also significantly improved the BPI average pain interference score, the Fibromyalgia Impact Questionnaire total score, the Clinical Global Impression of Severity, the Patient Global Impression of Improvement, the Medical Outcomes Study (MOS) Sleep Problems Index, and the MOS Short Form 36 vitality score, but not the mean tender point pain threshold or the Montgomery Asberg Depression Rating Scale. Gabapentin was generally well tolerated., Conclusion: Gabapentin (1,200-2,400 mg/day) is safe and efficacious for the treatment of pain and other symptoms associated with fibromyalgia.

Purpose: To assess the efficacy of fluoxetine in the treatment of patients with fibromyalgia., Subjects and Methods: Sixty outpatients (all women, aged 21-71 years) with fibromyalgia were randomly assigned to receive fluoxetine (10-80 mg/d) or placebo for 12 weeks in a double-blind, parallel-group, flexible-dose study. The primary outcome measures were the Fibromyalgia Impact Questionnaire total score (score range, 0 [no impact] to 80) and pain score (score range, 0-10). Secondary measures included the McGill Pain Questionnaire, change in the number of tender points, and total myalgic score., Results: In the intent-to-treat analysis, women who received fluoxetine (mean [+/- SD] dose, 45 +/- 25 mg/d) had significant (P = 0.005) improvement in the Fibromyalgia Impact Questionnaire total score compared with those who received placebo, with a difference of -12 (95% confidence interval [CI]: -19 to -4). They also had significant (P = 0.002) improvement in the Fibromyalgia Impact Questionnaire pain score (difference, -2.2 [95% CI: -3.6 to -0.9]), as well as in the Fibromyalgia Impact Questionnaire fatigue (P = 0.05) and depression (P = 0.01) scores and the McGill Pain Questionnaire (P = 0.01), when compared with subjects who received placebo. Although counts for the number of tender points and total myalgic scores improved more in the fluoxetine group than in the placebo group, these differences were not statistically significant., Conclusions: In a 12-week, flexible-dose, placebo-controlled trial, fluoxetine was found to be effective on most outcome measures and generally well tolerated in women with fibromyalgia.

Fibromyalgia is a common musculoskeletal pain disorder associated with mood disorders. Antidepressants, particularly tricyclics, are commonly recommended treatments. Randomized, controlled trials of antidepressants for treatment of fibromyalgia were reviewed by methodology, results, and potential predictors of response. Twenty-one controlled trials, 16 involving tricyclic agents, were identified; 9 of these 16 studies were suitable for meta-analysis. Effect sizes were calculated for measurements of physician and patient overall assessment, pain, stiffness, tenderness, fatigue, and sleep quality. Compared with placebo, tricyclic agents were associated with effect sizes that were substantially larger than zero for all measurements. The largest improvement was associated with measures of sleep quality; the most modest improvement was found in measures of stiffness and tenderness. Further studies are needed utilizing randomized, double-blind, placebo-controlled, parallel designs with antidepressants administered at therapeutic dose ranges, using standardized criteria for fibromyalgia and systematically assessed for co-occurring psychiatric illness.