Objectives: 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.
Methods: Fifty-eight patients with fibromyalgia were randomized to 1 of the 3 treatment arms: (1) combination therapy (n=20); (2) milnacipran+education (n=19); and (3) placebo+CBT (n=19). Patients received either milnacipran (100 mg/d) or placebo. Patients also received 8 sessions of phone-delivered CBT or educational instructions, but only from baseline to week 9. Assessments were conducted at baseline, week 9, and 21. The primary endpoints were baseline to week 21 changes in weekly average pain intensity and physical function (SF-36 physical function scale).
Results: Compared with milnacipran, combination therapy demonstrated a moderate effect on improving SF-36 physical function (SE=9.42 [5.48], P=0.09, effect size=0.60) and in reducing weekly average pain intensity (mean difference [SE]=−1.18 [0.62], P=0.07, effect size=0.67). Compared with milnacipran, CBT had a moderate to large effect in improving SF-36 physical function (mean difference [SE]=11.0 [5.66], P=0.06, effect size=0.70). Despite the presence of concomitant centrally acting therapies, dropout rate was lower than anticipated (15% at week 21). Importantly, at least 6 out of the 8 phone-based therapy sessions were successfully completed by 89% of the patients; and adherence to the treatment protocols was >95%.
Conclusions: In this pilot study, 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.
Clinical Trial Registration: NCT01038323.
*Department of Medicine, Division of Rheumatology
∥Department of Biostatistics, Indiana University
‡Department of Psychology, Indiana University Purdue University Indianapolis, Indianapolis, IN
†Department of Rehabilitation Medicine, University of Washington, Seattle, WA
§Center for Neurosensory Disorders, University of North Carolina, Chapel Hill, NC
National Institute of Arthritis and Musculoskeletal and Skin Diseases (Grant number: 1R21AR056046-01A2). The authors declare no conflict of interest.
Reprints: Dennis C. Ang, MD, MS, Department of Medicine, Division of Rheumatology, Indiana University, 541 Clinical Drive, Room 370, Indianapolis, IN 46202 (e-mail: firstname.lastname@example.org).
Received June 29, 2012
Accepted October 22, 2012