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 .
Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial.
OBJECTIVE To evaluate the efficacy , tolerability , and safety of multiple fixed dosages of esreboxetine for the treatment of fibromyalgia . METHODS Patients meeting the American College of Rheumatology criteria for fibromyalgia were r and omized to receive esreboxetine at dosages of 4 mg/day ( n=277 ) , 8 mg/day ( n=284 ) , or 10 mg/day ( n=283 ) or matching placebo ( n=278 ) for 14 weeks . The primary efficacy outcomes were the weekly mean pain score and the Fibromyalgia Impact Question naire ( FIQ ) total score at week 14 . Secondary efficacy measures included scores for the Patient 's Global Impression of Change ( PGIC ) scale , the Global Fatigue Index ( GFI ) , and the 36-item Short-Form health survey ( SF-36 ; physical function scale only ) at week 14 . The safety profile of esreboxetine was evaluated based on adverse events and other safety measures . RESULTS Patients receiving all dosages of esreboxetine demonstrated statistically significant improvements in the pain score ( P≤0.025 ) , the FIQ score ( P≤0.023 ) , and the PGIC score ( P≤0.007 ) compared with patients in the placebo group . Additionally , patients receiving esreboxetine at dosages of 4 mg/day and 8 mg/day showed statistically significant improvements in the GFI score compared with those receiving placebo ( P=0.001 ) . No significant differences in SF-36 physical function scores were observed between patients receiving esreboxetine ( any dosage ) and those receiving placebo . Adverse events were mostly mild to moderate in severity ; insomnia , constipation , dry mouth , nausea , dizziness , hot flush , headache , hyperhidrosis , and palpitations were reported most frequently . CONCLUSION Esreboxetine was generally well tolerated and was associated with significant improvements in pain , FIQ , PGIC , and fatigue scores compared with placebo . The lack of a dose-response relationship in both the efficacy and safety analyses suggests that esreboxetine at a dosage of 4 mg/day would offer clinical benefit with the least risk of drug exposure
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 .