While no clinical trial to date has specifically targeted fatigue , r and omized controlled trials , systematic review s , and meta-analyses indicate that treatment modalities studied in the context of other fibromyalgia symptoms could also improve fatigue .
Fatigue is a disabling , multifaceted symptom that is highly prevalent and stubbornly persistent .
Although fatigue is a frequent complaint among patients with fibromyalgia , it has not received the same attention as pain .
Reasons for this include lack of st and ardized nomenclature to communicate about fatigue , lack of evidence -based guidelines for fatigue assessment , and a deficiency in effective treatment strategies .
Fatigue does not occur in isolation ; rather , it is present concurrently in varying severity with other fibromyalgia symptoms such as chronic widespread pain , unrefreshing sleep , anxiety , depression , cognitive difficulties , and so on .
Survey-based and preliminary mechanistic studies indicate that multiple symptoms feed into fatigue and it may be associated with a variety of physiological mechanisms .
A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder.
OBJECTIVE To assess the efficacy and safety of duloxetine , a serotonin and norepinephrine reuptake inhibitor , in subjects with primary fibromyalgia , with or without current major depressive disorder . METHODS This study was a r and omized , double-blind , placebo-controlled trial conducted in 18 outpatient research centers in the US . A total of 207 subjects meeting the American College of Rheumatology criteria for primary fibromyalgia were enrolled ( 89 % female , 87 % white , mean age 49 years , 38 % with current major depressive disorder ) . After single-blind placebo treatment for 1 week , subjects were r and omly assigned to receive duloxetine 60 mg twice a day ( n = 104 ) or placebo ( n = 103 ) for 12 weeks . Co- primary outcome measures were the Fibromyalgia Impact Question naire ( FIQ ) total score ( score range 0 - 80 , with 0 indicating no impact ) and FIQ pain score ( score range 0 - 10 ) . Secondary outcome measures included mean tender point pain threshold , number of tender points , FIQ fatigue , tiredness on awakening , and stiffness scores , Clinical Global Impression of Severity ( CGI-Severity ) scale , Patient Global Impression of Improvement ( PGI-Improvement ) scale , Brief Pain Inventory ( short form ) , Medical Outcomes Study Short Form 36 , Quality of Life in Depression Scale , and Sheehan Disability Scale . RESULTS Compared with placebo-treated subjects , duloxetine-treated subjects improved significantly more ( P = 0.027 ) on the FIQ total score , with a treatment difference of -5.53 ( 95 % confidence interval -10.43 , -0.63 ) , but not significantly more on the FIQ pain score ( P = 0.130 ) . Compared with placebo-treated subjects , duloxetine-treated subjects had significantly greater reductions in Brief Pain Inventory average pain severity score ( P = 0.008 ) , Brief Pain Inventory average interference from pain score ( P = 0.004 ) , number of tender points ( P = 0.002 ) , and FIQ stiffness score ( P = 0.048 ) , and had significantly greater improvement in mean tender point pain threshold ( P = 0.002 ) , CGI-Severity ( P = 0.048 ) , PGI-Improvement ( P = 0.033 ) , and several quality -of-life measures . Duloxetine treatment improved fibromyalgia symptoms and pain severity regardless of baseline status of major depressive disorder . Compared with placebo-treated female subjects ( n = 92 ) , duloxetine-treated female subjects ( n = 92 ) demonstrated significantly greater improvement on most efficacy measures , while duloxetine-treated male subjects ( n = 12 ) failed to improve significantly on any efficacy measure . The treatment effect on significant pain reduction in female subjects was independent of the effect on mood or anxiety . Duloxetine was safely administered and well tolerated . CONCLUSION In this r and omized , controlled , 12-week trial ( with a 1-week placebo lead-in phase ) , duloxetine was an effective and safe treatment for many of the symptoms associated with fibromyalgia in subjects with or without major depressive disorder , particularly for women , who had significant improvement across most outcome measures
While no clinical trial to date has specifically targeted fatigue , r and omized controlled trials , systematic review s , and meta-analyses indicate that treatment modalities studied in the context of other fibromyalgia symptoms could also improve fatigue .
Fatigue is a disabling , multifaceted symptom that is highly prevalent and stubbornly persistent .
Although fatigue is a frequent complaint among patients with fibromyalgia , it has not received the same attention as pain .
Reasons for this include lack of st and ardized nomenclature to communicate about fatigue , lack of evidence -based guidelines for fatigue assessment , and a deficiency in effective treatment strategies .
Fatigue does not occur in isolation ; rather , it is present concurrently in varying severity with other fibromyalgia symptoms such as chronic widespread pain , unrefreshing sleep , anxiety , depression , cognitive difficulties , and so on .
Survey-based and preliminary mechanistic studies indicate that multiple symptoms feed into fatigue and it may be associated with a variety of physiological mechanisms .