TABLE.

Summary of Treatment Regimens for Pharmacological and Nonpharmacological Therapies Used in Multimodal Management of Patients With Fibromyalgia ^a

Therapy	Representative treatment regimen	Outcomes b
Pharmacotherapy
Pregabalin (alpha2delta ligand)	Start at 75 mg BID and up-titrate to 300-450 mg/d (150-225 mg twice a day) c	•Significant reduction in pain (11-point NRS) •Improvement in other subjective ratings of fibromyalgia symptoms (PGIC; FIQ total score) vs placebo 34 •Most common AEs b: dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, abnormal thinking (primarily difficulty with concentration/attention) c •Discontinuation from clinical trials of fibromyalgia due to AEs: 19% for patients treated with pregabalin (150-600 mg/d) vs 10% for placebo c •AEs most often leading to discontinuation of pregabalin: dizziness (6%) and somnolence (3%) c
Duloxetine (SNRI)	Start at 30 mg/d and up-titrate to 60 mg once daily d	•Significant reduction in pain (BPI and pain interference) •Improvement in other subjective ratings of fibromyalgia symptoms (PGIC; FIQ total score) vs placebo 31 •Most common AEs b: nausea, dry mouth, somnolence, fatigue, constipation, decreased appetite, hyperhidrosis d •Discontinuation from clinical trials of fibromyalgia due to AEs: 18.7% for patients treated with duloxetine (60-120 mg/d) vs 10.8% for placebo d •AEs most commonly leading to discontinuation of duloxetine: nausea (2.1%), somnolence (1.2%), and fatigue (1.1%) d
Milnacipran (SNRI)	Start at 12.5 mg/d and up-titrate to 50 mg twice a day e	•Significant reduction in pain (VAS) and in composite responder rate •Significant improvement in other subjective ratings of fibromyalgia symptoms (PGIC, SF-36 domains; FIQ total score) vs placebo 33 •Most common AEs b: nausea, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, vomiting, palpitations, increased heart rate, dry mouth, hypertension e •Discontinuation from clinical trials of fibromyalgia due to AEs: 23% and 26% for patients treated with milnacipran (100 and 200 mg/d), respectively, vs 12% for placebo e •AEs most commonly leading to discontinuation of milnacipran: nausea (6%), palpitations (3%), and headache (2%) e
Nonpharmacological
Education	Provide core information about fibromyalgia diagnosis, physiology, treatment, prognosis, importance of exercise, sleep. Manage expectations	•Varied degrees of improvement in patient symptoms and/or functions through education (often in combination with CBT and/or exercise programs) 15,17
Physical activity	Start low, go slow; eg, walk 10 min/d, build to 30-60 min of low or moderate activity up to 2-3 times/wk	•Improvement in physical function and HRQoL and symptoms of fibromyalgia, including pain, depressed mood, and fatigue 40
CBT/Web-based CBT	CFIDS and Fibromyalgia Self-Help (www.cfidsselfhelp.org; www.treatcfsfm.org) Arthritis Foundation's Fibromyalgia Self-Help Course Online self-help courses, tools, books, and CDs Face-to-face CBT counseling	•Improved knowledge about fibromyalgia and how to cope with pain 37 •Significant improvement in physical (pain, fatigue, and functional disability) and psychological (negative mood and anxiety) functioning and in impact of fibromyalgia in patients treated with CBT combined with exercise vs no CBT 41 •Significantly greater improvement in pain, physical functioning, and overall global improvement reported by patients randomized to standard care plus access to an Internet-enhanced behavioral self-management program designed for use in routine clinical care compared with patients receiving standard care alone 29 •Improvements often sustained for months after CBT stopped 38
Sleep hygiene	Make sleep routine a priority. Optimize relaxing sleep environment. Provide advice on diet and exercise: avoid nighttime stimulants (eg, coffee); exercise during the day; hide clock	•Improving sleep hygiene can increase favorable outcomes on measures of pain (BPI) and mental well-being (SF-36) 39

^aAE = adverse event; BPI = Brief Pain Inventory; CBT = cognitive behavioral therapy; CFIDS = chronic fatigue and immune dysfunction syndrome; FIQ = Fibromyalgia Impact Questionnaire; HRQoL = health-related quality of life; NRS = numerical rating scale; PGIC = Patient Global Impression of Change; SF = short form; SNRI = serotonin and norepinephrine reuptake inhibitor; VAS = visual analog scale.

^bSafety is based on the most frequently occurring adverse reactions (≥5% and twice placebo for pregabalin^c and duloxetine^d or ≥5% and greater than placebo for milnacipran^e).

^cFor further detail, see prescribing information: http://labeling.pfizer.com/ShowLabeling.aspx?id=561.

^dFor further detail, see prescribing information: http://pi.lilly.com/us/cymbalta-pi.pdf.

^eFor further detail, see prescribing information: http://www.frx.com/pi/Savella_pi.pdf.