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 .
Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial.
BACKGROUND Pre clinical and clinical studies have suggested that milnacipran , a dual norepinephrine-serotonin reuptake inhibitor , may be efficacious in the treatment of fibromyalgia ( FM ) . OBJECTIVE This study was conducted to evaluate the efficacy and tolerability of milnacipran in treating the multiple domains of FM . METHODS This was a multicenter , double-blind , placebo-controlled trial . Adult patients ( age 18 - 70 years ) who met 1990 American College of Rheumatology criteria for FM were r and omized to receive milnacipran 100 mg/d , milnacipran 200 mg/d , or placebo for 15 weeks . Because this was a pivotal registration trial , the primary end points were chosen to investigate efficacy for 2 potential indications : the treatment of FM and the treatment of FM pain . Thus , the 2 primary efficacy end points were rates of FM composite responders and FM pain composite responders . FM composite responders were defined as patients concurrently experiencing clinical ly meaningful improvements in the following 3 domain criteria : pain ( > or = 30 % improvement , as recorded in an electronic diary ) ; patients ' global status ( a rating of very much improved or much improved on the Patient Global Impression of Change [ PGIC ] scale ) ; and physical function ( a > or = 6-point improvement on the 36-item Short-Form Health Survey [ SF-36 ] Physical Component Summary score ) . FM pain composite responders were defined as those who met the pain and PGIC criteria . Adverse events reported by patients or observed by investigators were recorded throughout the trial . RESULTS Of 2270 patients screened , 1196 were r and omized to receive milnacipran 100 mg/d ( n = 399 ) , milnacipran 200 mg/d ( n = 396 ) , or placebo ( n = 401 ) . The majority of patients were female ( 96.2 % ) and white ( 93.5 % ) . The population had a mean age of 50.2 years , a mean baseline weight of 180.8 pounds , and a mean baseline body mass index of 30.6 kg/m(2 ) . Compared with placebo , significantly greater proportions of milnacipran-treated patients were FM composite responders ( 100 mg/d : P = 0.01 ; 200 mg/d : P = 0.02 ) and FM pain composite responders ( 100 mg/d : P = 0.03 ; 200 mg/d : P = 0.004 ) . Milnacipran was associated with significant improvements in pain after 1 week of treatment ( 100 mg/d : P = 0.004 ; 200 mg/d : P = 0.04 ) , as well as significant improvements in multiple secondary efficacy end points , including global status ( PGIC : P<0.001 for both doses ) , physical function ( SF-36 physical functioning domain-100 mg/d : P < 0.001 ; 200 mg/d : P = 0.02 ) , and fatigue ( Multidimensional Fatigue Inventory- 100 mg/d : P = 0.04 ) . The most commonly reported adverse events with milnacipran were nausea ( 100 mg/d , 34.3 % ; 200 mg/d , 37.6 % ) , headache ( 18.0 % and 17.7 % , respectively ) , and constipation ( 14.3 % and 17.9 % ) . Adverse events result ed in premature study discontinuation in 19.5 % and 23.7 % of those who received milnacipran 100 and 200 mg/d , respectively , compared with 9.5 % of placebo recipients . CONCLUSION In these adult patients with FM , both doses of milnacipran ( 100 and 200 mg/d ) were associated with significant improvements in pain and other symptoms . Clinical Trials Identification Number : NCT00098124
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 .