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Background: Although trazodone is frequently used by fibromyalgia patients, its efficacy on this disease has not been adequately studied. If effective, pregabalin, whose beneficial effects on pain and sleep quality in fibromyalgia have been demonstrated, could complement the antidepressant and anxiolytic effects of trazodone. The aim of the present study was to assess the effectiveness of trazodone alone and in combination with pregabalin in the treatment of fibromyalgia., Methods: This was an open-label uncontrolled study. Trazodone, flexibly dosed (50-300 mg/day), was administered to 66 fibromyalgia patients during 12 weeks; 41 patients who completed the treatment accepted to receive pregabalin, also flexibly dosed (75-450 mg/day), added to trazodone treatment for an additional 12-week period. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients' Global Improvement scale (PGI). Emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test., Results: Treatment with trazodone significantly improved global fibromyalgia severity, sleep quality, and depression, as well as pain interference with daily activities although without showing a direct effect on bodily pain. After pregabalin combination additional and significant improvements were seen on fibromyalgia severity, depression and pain interference with daily activities, and a decrease in bodily pain was also apparent. During the second phase of the study, only two patients dropped out due to side effects., Conclusions: Trazodone significantly improved fibromyalgia severity and associated symptomatology. Its combination with pregabalin potentiated this improvement and the tolerability of the drugs in association was good., Trial Registration: ClinicalTrials.gov: NCT00791739.

Objectives: Studies concerning the prophylactic treatment of chronic migraine are scarce, with topiramate being the most thoroughly studied drug at this respect. The aim of our study was to assess if pregabalin could be useful in the preventive management of chronic migraine., Methods: Thirty consecutive chronic migraine patients, 24 women and 6 men, aged 24 to 75 years and not receiving any other prophylactic medication, were treated with pregabalin for 12 weeks. The initial daily dosage was 75 mg, subsequently adjusted according to the drug's efficacy and the individual patients' tolerability at 2-week intervals. Patients kept a headache diary from 4 weeks before drug administration until the study ended, and headache impact test (HIT-6) was administered at baseline and at 4-week intervals. The main outcome variable was the change from baseline to end point in headache frequency. The secondary outcome variables included changes in headache severity, rescue medication intake, HIT-6 scores, and adverse reactions to pregabalin., Results: Pregabalin treatment was associated to significant decreases in headache frequency (P < 0.0001) and severity (P = 0.0005), rescue medication intake (P < 0.0001), and HIT-6 scores (P < 0.0001). Patients with daily headache performed worse than those with nondaily headache, showing no change in headache frequency and less relevant reduction of HIT-6 scores. The most frequent adverse reactions were dizziness (40%), somnolence (29%), abnormal thinking (16.7%), constipation and fatigue (13.3%)., Conclusions: Despite the limitations of an open-label design, our data suggest that pregabalin may be a useful alternative prophylaxis for chronic migraine. These promising results should be confirmed in randomized clinical trials.

Introduction: Quetiapine has been shown to improve fibromyalgia symptoms, especially sleep disturbance, fatigue, morning stiffness, and mental well-being, but lacks an effect on pain. The purpose of this study was to evaluate if pregabalin, which has shown antialgic activity in fibromyalgia, added to quetiapine treatment additionally improved fibromyalgia symptomatology., Methods: This was an open-label, 12-week study. Pregabalin was administered to 19 female fibromyalgia patients at a starting dose of 75 mg/day subsequently adjusted in according to the drug's efficacy and tolerability. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index, the Beck Depression Inventory, the State and Trait Anxiety Inventory, and the SF-12 Health Survey., Results: Data analysis was done on the Intention-To-Treat sample which included 18 patients. Pregabalin significantly improved the pain and tiredness after awakening subscales of the FIQ as well as the physical component of the SF-12. Six patients withdrew from the study, 3 because of side effects., Conclusions: Our results suggest that the use of pregabalin can be a useful augmentation strategy in fibromyalgia patients partially responding to quetiapine.