title: Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study.
abstract: 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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00791739.
authors.affiliation: Instituto de Neurociencias y Centro de Investigaciones Biomédicas, Universidad de Granada, Granada, Spain. calandre@gmail.com
authors.forename: Elena P
authors.initials: EP
authors.lastname: Calandre
authors.forename: Piedad
authors.initials: P
authors.lastname: Morillas-Arques
authors.forename: Rocío
authors.initials: R
authors.lastname: Molina-Barea
authors.forename: Carmen M
authors.initials: CM
authors.lastname: Rodriguez-Lopez
authors.forename: Fernando
authors.initials: F
authors.lastname: Rico-Villademoros
mesh_terms: D000328:Adult; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D000704:Analysis of Variance; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy / Q000209:etiology; D003863:Depression / Q000188:drug therapy / Q000209:etiology; D004359:Drug Therapy, Combination; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010147:Pain Measurement; D000069583:Pregabalin; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012890:Sleep / Q000187:drug effects; D013030:Spain; D011795:Surveys and Questionnaires; D013997:Time Factors; D014196:Trazodone / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D014151:Anti-Anxiety Agents; D018687:Antidepressive Agents, Second-Generation; D000069583:Pregabalin; D017367:Selective Serotonin Reuptake Inhibitors; D014196:Trazodone; D005680:gamma-Aminobutyric Acid