Abstract
BackgroundAlthough 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.MethodsThis 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.ResultsTreatment 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.ConclusionsTrazodone 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 RegistrationClinicalTrials.gov: NCT00791739
Highlights
Trazodone is frequently used by fibromyalgia patients, its efficacy on this disease has not been adequately studied
Disturbed sleep is a prominent feature of fibromyalgia symptomatology and has been proposed as one of the core symptoms that should be systematically assessed in clinical trials for the treatment of fibromyalgia [1]
The 39 patients who had at least a post-baseline assessment after starting pregabalin constituted the ITT sample
Summary
Trazodone is frequently used by fibromyalgia patients, its efficacy on this disease has not been adequately studied. 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. Trazodone is an old second-generation antidepressant with strong sedative activity, widely used as a hypnotic drug depression and anxiety are frequently found in fibromyalgia patients, the acknowledged antidepressant and anxiolytic properties of trazodone [5] could be useful in treating other symptoms of fibromyalgia in addition to insomnia. The efficacy of trazodone for fibromyalgia, either as a hypnotic or as an antidepressant, has not been adequately investigated. Their study included only 13 patients and they did no mention the daily dosage of trazodone that was used
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
