Quetiapine extended-release (Seroquel-XR) versus amitriptyline monotherapy for treating patients with fibromyalgia: a 16-week, randomized, flexible-dose, open-label trial.

RATIONALE: Previous open-label studies have suggested that quetiapine could be a valuable alternative for treating fibromyalgia. OBJECTIVE: This study aims to compare the efficacy and tolerability of extended-release quetiapine with amitriptyline for treating fibromyalgia. METHODS: This study was a randomized, open-label, flexible-dose, non-inferiority trial. Patients with fibromyalgia were randomized to receive quetiapine extended-release (XR) (N = 45) (50 to 300 mg daily) or amitriptyline (N = 45) (10 to 75 mg daily) for 16 weeks. The primary endpoint was the change from baseline to endpoint in the Fibromyalgia Impact Questionnaire (FIQ) total score; the non-inferiority threshold was established at 8 points. The secondary outcomes included sleep quality, anxiety, depression, and quality of life. RESULTS: Twenty-two (49%) patients in the quetiapine group and 34 (76%) patients in the amitriptyline group completed the study. We found a reduction of 9.8 points in the total FIQ score at the endpoint for the quetiapine-treated patients compared to 13.9 points for the amitriptyline-treated patients, for a difference of 4.14 points (80% confidence interval (CI) -0.70 to 8.98). No significant differences were found between the quetiapine XR and amitriptyline groups for any of the secondary outcomes. The proportion of patients discontinuing treatment due to adverse events was higher in the quetiapine group (n = 14, 31.1%) than the amitriptyline group (n = 3, 6.6%). CONCLUSIONS: Our results appear to indicate that quetiapine XR does not provide similar efficacy to amitriptyline for treating patients with fibromyalgia. Quetiapine XR had a worse tolerability than amitriptyline in this population, possibly due to a relatively high starting dose.

Ozone therapy as add-on treatment in fibromyalgia management by rectal insufflation: an open-label pilot study.

OBJECTIVES: The objectives of this study were to evaluate the effectiveness and tolerability of ozone therapy by rectal insufflation as add-on therapy in fibromyalgia management. DESIGN: Patients with fibromyalgia received 24 sessions of ozone therapy during a 12-week period. At each session, the administered dose of ozone was 8 mg (200 mL of gas, at a concentration of 40 µg/mL). Ozone sessions were given 5 days a week during the first 2 weeks, twice a week from weeks 3-6, and weekly from weeks 7-12. Fibromyalgia Impact Questionnaire (FIQ) was the main outcome measure, and was administered at baseline and at weeks 4, 8, and 12. Secondary outcome measures, administered at baseline and at endpoint, were the Pittsburgh Sleep Quality Index, the Beck Depression Inventory, the State and Trait Anxiety Inventory, and the SF-12, the abbreviated form of the Short Form Health Survey. Emergent adverse reactions to treatment were recorded. RESULTS: FIQ total scores decreased significantly during the study period, with the decrease being observed in the first 4 weeks of the study. Significant improvement was also seen both in depression scores and in the Physical Summary Score of the SF-12. Transient meteorism after ozone therapy sessions was the most frequently reported side-effect. CONCLUSIONS: At the dose and number of sessions used in this study, ozone therapy by rectal insufflation seems to be beneficial for physical symptoms and depression of fibromyalgia.