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Table 1 Randomized, double-blind, placebo-controlled trials of serotonin and norepinephrine reuptake inhibitors and alpha 2 delta ligands in fibromyalgia

From: Biology and therapy of fibromyalgia. New therapies in fibromyalgia

Study Drug (mg/day) Study design (no. of patients) Duration (weeks) Outcomes that significantly improved with treatment over placebo
   Arnold et al. [55] Duloxetine (120) Duloxetine v placebo, parallel (207) 12 Primary measure: FIQ total score (FIQ pain score improved in women only)
     Secondary measures: FIQ stiffness scores, BPI pain severity and interference from pain, tender points, CGI-S, PGI-I, QLDS, SDS, SF-36 physical subscore and bodily pain, general health perception, mental health, physical function, vitality scores
   Gendreau et al. [65] Milnacipran (up to 200) Milnacipran v placebo, parallel (125) 12 Secondary measures: Pain (weekly e-diary pain score, paper daily and weekly scores, present pain score), patient global impression of change, FIQ physical function, days felt good, pain, fatigue, and morning stiffness scores
   Arnold et al. [63] Duloxetine (60 and 120) Duloxetine v placebo, parallel (354) 12 Primary measure: BPI average pain severity
     Secondary measures: BPI interference from pain, FIQ total score, tender points (120 mg only), CGI-S, PGI-I, QLDS, SDS, SF-36 mental subscore and scores for social function (60 mg only), physical function (120 mg only), bodily pain, mental health, role limit emotional and physical, and vitality
Alpha 2 delta     
   Crofford et al. [67] Pregabalin (150, 300, and 450) Pregabalin v placebo, parallel (529) 8 Primary measure: mean daily pain score (daily diaries) (450 mg only)
     Secondary measures: sleep quality diary (300 mg, 450 mg), MAF global fatigue (300 mg, 450 mg), patient and clinician global impression of change (300 mg, 450 mg), SF-36 general health (150 mg, 300 mg, 450 mg), vitality (450 mg), bodily pain (450 mg), social functioning (450 mg)
  1. BPI, Brief Pain Inventory; CGI-S, Clinician global impression of severity; FIQ, Fibromyalgia Impact Questionnaire; MAF, Multidimensional Assessment of Fatigue; PGI-I, Patient global impression of improvement; QLDS, Quality of Life in Depression Scale; SDS, Sheehan Disability Scale; SF-36, Medical Outcomes Study Short Form.