Fibromyalgia Syndrome Review

Ang DC, Jensen MP, Steiner JL, Hilligoss J, Gracely RH, Saha C: Combining cognitive-behavioral therapy and milnacipran for fibromyalgia: A feasibility randomized-controlled trial. Clin J Pain 2013; epub ahead of print. This study intended to evaluate the feasibility of a randomized-controlled trial and to obtain estimates of the effects of combined cognitive-behavioral therapy [CBT] and milnacipran for the treatment of fibromyalgia syndrome [FMS]. Fifty-eight patients with FMS were randomized to one of the three treatment arms: (1) combination therapy [n1⁄4 20], (2) milnacipranþ education [n1⁄4 19] and (3) placeboþCBT [n1⁄4 19]. Patients received either milnacipran [100 mg/d] or placebo. Patients also received eight sessions of phonedelivered CBT or educational instructions, but only from baseline to week 9. Assessments were conducted at baseline, week 9 and week 21. The primary endpoints were baseline to week 21 changes in weekly average pain intensity and physical function [Short Form-36 physical function scale]. Compared with milnacipran, combination therapy demonstrated a moderate effect on improving SF-36 physical function [SE1⁄4 9.42 (5.48), p1⁄4 0.09, effect size1⁄4 0.60] and in reducing weekly average pain intensity [mean difference (SE)1⁄4 1.18 (0.62), p1⁄4 0.07, effect size1⁄4 0.67]. Compared with milnacipran, CBT had a moderate to large effect in improving Short Form-36 physical function [mean difference (SE)1⁄4 11.0 (5.66), p1⁄4 0.06, effect size 1⁄4 0.70]. Despite the presence of concomitant centrally acting therapies, dropout rate was lower than anticipated [15% at week 21]. Importantly, at least six of the eight phone-based therapy sessions were successfully completed by 89% of the patients and adherence to the treatment protocols was greater than 95%. From these results, the authors conclude that a therapeutic approach that combines phone-based CBT and milnacipran was feasible and acceptable. Moreover, the preliminary data supports conducting a fully powered randomized-controlled trial.