Table 1

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

Study

Drug (mg/day)

Study design (no. of patients)

Duration (weeks)

Outcomes that significantly improved with treatment over placebo


SNRI

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)


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.

Arnold Arthritis Research & Therapy 2006 8:212   doi:10.1186/ar1971