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Effects of Treatment for Depression on Fatigue in Multiple Sclerosis
Introduction Fatigue is one of the most disabling symptoms associated with fibromyalgia that greatly impacts quality of life . Fatigue was assessed as a secondary objective in a 2-phase , 24-week study in out patients with American College of Rheumatology-defined fibromyalgia . Methods Patients were r and omized to duloxetine 60 - 120 mg/d ( N = 263 ) or placebo ( N = 267 ) for the 12-week acute phase . At Week 12 , all placebo-treated patients were switched to double-blind treatment with duloxetine for the extension phase . Fatigue was assessed at baseline and every 4 weeks with the Multidimensional Fatigue Inventory ( MFI ) scales : General Fatigue , Physical Fatigue , Mental Fatigue , Reduced Activity , and Reduced Motivation . Other assessment s that may be associated with fatigue included Brief Pain Inventory ( BPI ) average pain , numerical scales to rate anxiety , depressed mood , bothered by sleep difficulties , and musculoskeletal stiffness . Treatment-emergent fatigue-related events were also assessed . Changes from baseline to Week 12 , and from Week 12 to Week 24 , were analyzed by mixed-effects model repeated measures analysis . Results At Week 12 , duloxetine versus placebo significantly ( all p < .05 ) reduced ratings on each MFI scale , BPI pain , anxiety , depressed mood , and stiffness . Improvement in ratings of being bothered by sleep difficulties was significant only at Weeks 4 and 8 . At Week 24 , mean changes in all measures indicated improvement was maintained for patients who received duloxetine for all 24 weeks ( n = 176 ) . Placebo-treated patients switched to duloxetine ( n = 187 ) had significant within-group improvement in Physical Fatigue ( Weeks 16 , 20 , and 24 ) ; General Fatigue ( Weeks 20 and 24 ) ; Mental Fatigue ( Week 20 ) ; and Reduced Activity ( Weeks 20 and 24 ) . These patients also experienced significant within-group improvement in BPI pain , anxiety , depressed mood , bothered by sleep difficulties , and stiffness . Overall , the most common ( > 5 % incidence ) fatigue-related treatment-emergent adverse events were fatigue , somnolence , and insomnia . Conclusions Treatment with duloxetine significantly improved multiple dimensions of fatigue in patients with fibromyalgia , and improvement was maintained for up to 24 weeks . Trial registration Clinical Trials.gov registry NCT00673452 Fibromyalgia is a chronic syndrome characterized by widespread pain , sleep disturbance , stiffness , fatigue , headache , and mood disorders . Recent research has result ed in an improved underst and ing of fibromyalgia and its possible causes . This article highlights some of the current research , discusses a strategy for using yoga and meditation as a therapy for fibromyalgia sufferers , and presents the results of a preliminary 8-week study using yoga and meditation to help manage fibromyalgia symptoms . The study of 11 participants found significant improvement in the overall health status of the participants and in symptoms of stiffness , anxiety , and depression . Significant improvements were also seen in the reported number of days " felt good " and number of days " missed work " because of fibromyalgia . Nonsignificant improvements were seen in measures of pain , fatigue , and how one felt in the morning . Effect sizes were medium to large for most tested areas . This study supports the benefits of yoga and meditation for individuals with fibromyalgia and encourages further research to explore their use as st and ard therapies for fibromyalgia & NA ; The major objective of this research was to evaluate the predictors of fatigue in patients with fibromyalgia ( FM ) , using cross‐sectional and daily assessment method ologies . In the cross‐sectional phase of the research involving a sample of 105 FM patients , greater depression and lower sleep quality were concurrently associated with higher fatigue . While pain was correlated with fatigue , it did not independently contribute to fatigue in the regression equation . For a subset of patients from the cross‐sectional sample ( n=63 ) who participated in a week of prospect i ve daily assessment of their pain , sleep quality , and fatigue , multiple regression analysis of aggregated ( averaged ) daily scores revealed that previous day 's pain and sleep quality predicted next day 's fatigue . Depression from the cross‐sectional phase was not related to aggregated daily fatigue scores . A path analytic framework was tested with disaggregated ( removing between subjects variability ) data in which pain was predicted to contribute to lower sleep quality which , in turn , was predicted to lead to greater fatigue . The results revealed that poor sleep quality fully accounted for the positive relationship between pain and fatigue , thus substantiating the mediational role of sleep quality . The findings are indicative of a dysfunctional , cyclical pattern of heightened pain and non‐restful sleep underlying the experience of fatigue in FM The relationship of sleep complaints to mood , fatigue , disability , and lifestyle was examined in 69 chronic fatigue syndrome ( CFS ) patients without psychiatric disorder , 58 CFS patients with psychiatric disorder , 38 psychiatric out- patients with chronic depressive disorders , and 45 healthy controls . The groups were matched for age and gender . There were few differences between the prevalence or nature of sleep complaints of CFS patients with or without current DSM-IIIR depression , anxiety or somatization disorder . CFS patients reported significantly more naps and waking by pain , a similar prevalence of difficulties in maintaining sleep , and significantly less difficulty getting off to sleep compared to depressed patients . Sleep continuity complaints preceded fatigue in only 20 % of CFS patients , but there was a strong association between relapse and sleep disturbance . Certain types of sleep disorder were associated with increased disability or fatigue in CFS patients . Disrupted sleep appears to complicate the course of CFS . For the most part , sleep complaints are either attributable to the lifestyle of CFS patients or seem inherent to the underlying condition of CFS . They are generally unrelated to depression or anxiety in CFS Fibromyalgia is a chronic illness characterized by widespread pain , fatigue , sleep disturbance , and resistance to treatment . The purpose of this study was to evaluate the effectiveness of a meditation-based stress reduction program on fibromyalgia . Seventy-seven patients meeting the 1990 criteria of the American College of Rheumatology for fibromyalgia took part in a 10-week group outpatient program . Therapists followed a carefully defined treatment approach and met weekly to further promote uniformity . Patients were evaluated before and after the program . Initial evaluation included a psychiatric structured clinical interview ( SCID ) . Outcome measures included visual analog scales to measure global well-being , pain , sleep , fatigue , and feeling refreshed in the morning . Patients also completed a medical symptom checklist , SCL-90-R , Coping Strategies Question naire , Fibromyalgia Impact Question naire , and the Fibromyalgia Attitude Index . Although the mean scores of all the patients completing the program showed improvement , 51 % showed moderate to marked improvement and only they were counted as " responders . " These preliminary findings suggest that a meditation-based stress reduction program  is effective for patients with fibromyalgia BACKGROUND Chronic fatigue syndrome ( CFS ) , fibromyalgia ( FM ) , and multiple chemical sensitivities ( MCS ) are conditions associated with fatigue and a variety of other symptoms that appear to share many clinical and demographic features . Our objectives were to describe the similarities and differences among patients with CFS , FM , and MCS . Additional objectives were to determine how frequently patients with MCS and FM met the criteria for CFS and if they differed in their health locus of control . METHODS  Demographic , clinical , and psychosocial measures were prospect ively collected in 90 patients , 30 each with CFS , FM , and MCS . Patients were recruited from a university-based referral clinic devoted to the evaluation and treatment of chronic fatigue and three private practice s. Variables included demographic features , symptoms characteristic of each condition , psychological complaints , a measure of health locus of control , and information on health care use .  RESULTS Overall , the three patient groups were remarkably similar in demographic characteristics and the presence of specific symptoms . Patients with CFS and FM frequently reported symptoms compatible with MCS .  Likewise , 70 % of patients with FM and 30 % of those with MCS met the criteria for CFS . Health care use was substantial among patients with CFS , FM , and MCS , with an average of 22.1 , 39.7 , and 23.3 visits , respectively , to a medical provider during the prior year . Health locus of control did not differ among the three population s. CONCLUSIONS In general , demographic and clinical factors and health locus of control do not clearly distinguish patients with CFS , FM , and MCS . Symptoms typical of each disorder are prevalent in the other two conditions Fatigue , which may occasionally be the chief manifestation , is present in more than 90 % of patients with fibromyalgia . It is a significant cause of morbidity and is quite disabling in its ability to disrupt quality of life . The cause of fatigue is complex , but disturbances in sleep architecture may have a role to play . Modafinil , a nonamphetamine wake-promoting agent and a popular treatment of narcolepsy , displays its antifatigue properties through a potentially central prohistaminergic interplay and may conceptually be postulated to lower fatigue in fibromylagia patients as well . Modafinil , unlike amphetamines , is well tolerated with less peripheral hemodynamic alterations combined with low abuse and tolerance sequelae . It also improves vigilance in sleep-deprived patients . Modafinil has been suggested as a possible treatment of fatigue in multiple sclerosis , parkinsonism , depression , primary biliary cirrhosis among other disorders with some demonstrable benefit . Since fatigue constitutes a significant proportion of the morbidity associated with fibromyalgia , we have conducted a retrospective chart review of 98 patients who have fibromyalgia , were being treated by a rheumatologist and 2 nurse practitioners in a private practice setting , and had been given a prescription for modafinil .  Patients were involved in this usual practice setting , and the clinicians documented patient encounters in a st and ard medical record format . The charts were review ed by 5 outside psychiatric clinicians from SUNY Upstate Medical University ’s Depression and Anxiety Disorders Research Program . The study team attempted to exclude charts where there may have been other medical comorbidities that may have induced fatigue and also excluded charts where the initiation of modafinil coincided with the initiation of any other off-label fibromyalgia treatment ( i.e. , duloxetine , amytriptyline , tramadol , etc ) . An analog rating scale was created for this chart review as notes had to be read by study clinicians and retrospective assessment s were made regarding any change in fatigue . This simple scale used a method of visual quantitation of subjective symptomatology change with regard to fatigue . This ranged from a level of 1 , indicative of low fatigue , to 10 , as a representative of the diametrically opposite extreme of marked symptom fatigue . The 5 clinician raters were calibrated to 0.8 accuracy to decrease inter-rater reliability bias . Progress notes were also scanned for reported side effects and for reasons why modafinil may have been discontinued . The average age of the patients was 47 years , and the average dose of modafinil was 162 mg/d , with an average duration of treatment spanning 2 years . The average number of concomitant medications was eight . The mean pre and postfatigue analog scale scores were analyzed and significant statistical difference was demonstrated whereby modafinil augmentation lowered patient fatigue levels from 7.2 0.13 ( severe fatigue ) to 4.4 0.18 ( low-moderate fatigue ( P 0.001 ) . The net mean improvement in fatigue as a target symptom was approximately 28 % . There is often little focus on the fatigue that is commonly reported by these patients . Our simple , retrospective study may be the first that focuses on the use of modafinil for alleviating this symptom . In our retrospective chart review , we found a majority of patients to be involved in both polypharmacy regimens and nonpharmacologic treatment ( i.e. , biofeedback ) as well . The timing of modafinil addition and fatigue amelioration suggests that this agent may be able to effectively treat the fatigue associated with fibromyalgia . It is also a well-tolerated drug with a minimum of side effects reported . These observations should encourage the development of prospect i ve controlled studies Objective . To investigate the relationship between changes in clinical rating scale items and endpoint Patient Global Impression of Improvement ( PGI-I ) . Methods . Data were pooled from 4 r and omized , double-blind , placebo-controlled studies of duloxetine in patients with fibromyalgia ( FM ) . Variables included in the analyses were those that assessed symptoms in FM domains of pain , fatigue , sleep , cognitive difficulties , emotional well-being , physical function , and impact on daily living . The association of endpoint PGI-I with changes from baseline in individual variables was assessed using Pearson product-moment correlations ( r ) . Stepwise linear regression was used to identify those variables for which changes from baseline were statistically significant independent predictors of the endpoint PGI-I ratings . Results . Changes in pain variables and interference of symptoms with the ability to work were highly correlated ( r ≥ 0.5 or r ≤ −0.5 ) with endpoint PGI-I. Moderate correlation with endpoint PGI-I ( 0.30 ≤ r < 0.5 or −0.5 < r ≤ −0.30 ) included changes in variables that assessed physical functioning , depression , anxiety , fatigue , and several variables related to impact on daily living . Independent predictor variables of endpoint PGI-I identified by stepwise linear regression included assessment s for pain , physical function , vitality , anxiety , social function , and tender point thresholds . Conclusion . In addition to pain reduction , what makes patients with FM feel better may include improvement in fatigue , physical functioning , mood , and impact on daily living . An assessment of these domains may be important in clinical trials of FM and in the management of patients with FM In advanced cancer , when cure is impossible , symptoms should be the focus of attention . We report the first prospect i ve , systematic analysis of the severity of 37 symptoms  in 1000 patients with advanced cancer , using the Paradox relational data base . Pain , easy fatigue , and anorexia were consistently among the 10 most prevalent symptoms associated with cancer at all sites . When pain , anorexia , weakness , anxiety , lack of energy , easy fatigue , early satiety , constipation , and dyspnea were present , 60%-80 % of patients rated them as moderate or severe , i.e. of clinical importance . The most common symptoms were also the most severe . In general the same symptoms were clinical ly important at most primary sites . Clinical ly important dyspnea , hoarseness , hiccough , and dysphagia were more common in men ; anxiety , nausea , vomiting , and early satiety in women . Clinical ly important dyspepsia , nausea , and vomiting occurred more frequently in gynecological cancers The purpose of this study was to compare the effects of aerobic training with a muscle-strengthening program in patients with fibromyalgia . Thirty women with fibromyalgia were r and omized to either an aerobic exercise ( AE ) program or a strengthening exercise ( SE ) program for 8 weeks . Outcome measures included the intensity of fibromyalgia-related symptoms , tender point count , fitness ( 6-min walk distance ) , hospital anxiety and depression ( HAD ) scale , and short-form health survey ( SF-36 ) . There were significant improvements in both groups regarding pain , sleep , fatigue , tender point count , and fitness after treatment . HAD-depression scores improved significantly in both groups while no significant change occurred in HAD-anxiety scores . Bodily pain subscale of SF-36 and physical component summary improved significantly in the AE group , whereas seven subscales of SF-36 , physical component summary , and mental component summary improved significantly in the SE group . When the groups were compared after treatment , there were no significant differences in pain , sleep , fatigue , tender point count , fitness , HAD scores , and SF-36 scores . AE and SE are similarly effective at improving symptoms , tender point count , fitness , depression , and quality of life in fibromyalgia OBJECTIVE Cancer-related fatigue ( CRF ) is one of the most common , persistent , and disabling symptoms associated with cancer and its treatment . Evidence -based treatments that are acceptable to patients are critically needed . This study examined the efficacy of mindfulness-based stress reduction ( MBSR ) for CRF and related symptoms . METHOD A sample of 35 cancer survivors with clinical ly significant CRF was r and omly assigned to a 7-week MBSR-based intervention or wait-list control group . The intervention group received training in mindfulness meditation , yoga , and self-regulatory responses to stress .  Fatigue interference ( primary outcome ) and a variety of secondary outcomes ( e.g. , fatigue severity , vitality , disability , depression , anxiety , and sleep disturbance ) were assessed at baseline , post-intervention , and 1-month follow-up . Bonferroni correction was employed to account for multiple comparisons . Controls received the intervention after the 1-month follow-up . Participants in both groups were followed for 6 months after completing their respective MBSR courses to assess maintenance of effects . RESULTS Compared to controls , the MBSR group reported large post-intervention reductions as assessed by effect sizes ( d ) in the primary outcome , fatigue interference ( d = -1.43 , p < 0.001 ) , along with fatigue severity ( d = -1.55 , p < 0.001 ) , vitality ( d = 1.29 , p < 0.001 ) , depression ( d = -1.30 , p < 0.001 ) , and sleep disturbance ( d = -0.74 , p = 0.001 ) . Results were maintained or strengthened at 1-month follow-up , the point at which significant improvements in disability ( d = -1.22 , p < 0.002 ) and anxiety ( d = -0.98 , p = 0.002 ) occurred . Improvements in all outcomes were maintained 6 months after completing the course . MBSR adherence was high , with 90 % attendance across groups and high rates of participant-reported home practice of mindfulness . CONCLUSIONS Mindfulness-based stress reduction is a promising treatment for CRF and associated symptoms Abstract Purpose Women with breast cancer may experience symptoms of depression , anxiety , pain , fatigue and sleep disturbances during chemotherapy .  However , there are few modalities that address multiple , commonly occurring symptoms that may occur in individuals receiving cancer treatment .  Cranial electrical stimulation ( CES ) is a treatment that is FDA cleared for depression , anxiety and insomnia . CES is applied via electrodes placed on the ear that deliver pulsed , low amplitude electrical current to the head . Methods This phase III r and omized , sham-controlled study aim ed to examine the effects of cranial microcurrent stimulation on symptoms of depression , anxiety , pain , fatigue , and sleep disturbances in women receiving chemotherapy for early-stage breast cancer . Patients were r and omly assigned to either an actual or sham device and used the device daily for 1 h. The study was registered at clinical trials.gov , NCT00902330 . Results The sample included N = 167 women with early-stage breast cancer .  Symptom severity of depression , anxiety , and fatigue and sleep disturbances were generally mild to moderate . Levels of pain were low . Anxiety was highest prior to the initial chemotherapy and decreased over time . The primary outcome assessment ( symptoms of depression , anxiety , fatigue , pain , sleep disturbances ) revealed no statistically significant differences between the two groups , actual CES vs. sham . Conclusion In this study , women receiving chemotherapy for breast cancer experienced multiple symptoms in the mild to moderate range . Although there is no evidence for the routine use of CES during the chemotherapy period for symptom management in women with breast cancer , further symptom management modalities should be evaluated to mitigate symptoms of depression , anxiety , fatigue , pain and sleep disturbances over the course of chemotherapy CONTEXT Breast cancer survivors ( BCS ) face adverse physical and psychological symptoms , often co-occurring . Biologic and psychological factors may link symptoms within clusters , distinguishable by prevalence and /or severity . Few studies have examined the effects of behavioral interventions or treatment of symptom clusters . OBJECTIVES The aim of this study was to identify symptom clusters among post-treatment BCS and determine symptom cluster improvement following the Mindfulness-Based Stress Reduction for Breast Cancer ( MBSR(BC ) ) program . METHODS Three hundred twenty-two Stage 0-III post-treatment BCS were r and omly assigned to either a six-week MBSR(BC ) program or usual care .  Psychological ( depression , anxiety , stress , and fear of recurrence ) , physical ( fatigue , pain , sleep , and drowsiness ) , and cognitive symptoms and quality of life were assessed at baseline , six , and 12 weeks , along with demographic and clinical history data at baseline . A three-step analytic process included the error-accounting models of factor analysis and structural equation modeling . RESULTS Four symptom clusters emerged at baseline : pain , psychological , fatigue , and cognitive . From baseline to six weeks , the model demonstrated evidence of MBSR(BC ) effectiveness in both the psychological ( anxiety , depression , perceived stress and QOL , emotional well-being ) ( P = 0.007 ) and fatigue ( fatigue , sleep , and drowsiness ) ( P < 0.001 ) clusters . Results between six and 12 weeks showed sustained effects , but further improvement was not observed . CONCLUSION Our results provide clinical effectiveness evidence that MBSR(BC ) works to improve symptom clusters , particularly for psychological and fatigue symptom clusters , with the greatest improvement occurring during the six-week program with sustained effects for several weeks after MBSR(BC ) training . TRIAL REGISTRATION Name and URL of Registry : Clinical Trials.gov . Registration number : NCT01177124 Background Chronic fatigue syndrome ( CFS ) presents a challenge for patients , health care providers , and health insurance groups because of its incapacitating nature , unknown cause , and poorly understood prognosis . We conducted a longitudinal population -based study to characterize the clinical course of CFS . Methods Sixty-five CFS subjects were identified from a r and om-digit-dialing survey of Wichita , Kansas residents and followed for up to 3 years . We evaluated changes in CFS classification ( partial or total remission , alternative medical or psychiatric diagnoses ) , CFS case-defining criteria , wellness scores , hours of activities and sleep , and  treatments used to reduce fatigue . Associations between risk factors and outcomes were determined by use of logistic regression and generalized estimating equations models . Results Only 20%-33 % of the subjects were classified as having CFS at follow-up , 56.9 % ever experienced partial or total remission , 10 % sustained total remission , and 23.1 % received alternative diagnoses , of which 20 % were sleep disorders . Higher fatigue severity scores and total number of symptoms were negatively associated with ever remitting . Duration of illness ≤ 2 years was positively associated with sustained remission . Unrefreshing sleep persisted in at least 79 % of the subjects across all periods but , as with most of the CFS symptoms , tended to be less frequent over time . The number of activities affected by fatigue decreased over time , while wellness scores increased . At any follow-up , more than 35 % of subjects reporting reduced fatigue used complementary and alternative medicine therapies , and of those subjects , at least 50 % thought these therapies were responsible for reducing their fatigue . Conclusions The clinical course of CFS was characterized by an intermittent pattern of relapse and remission . Remission rates documented by our population -based study were similar to those reported in clinical studies . Shorter illness duration was a significant predictor of sustained remission , and thus early detection of CFS is of utmost importance . The persistence of sleep complaints and identification of sleep disorders suggest that CFS subjects be evaluated for sleep disturbances , which could be treated BACKGROUND Depression , anxiety , fatigue and sleep disorders occur commonly in patients with Parkinson 's disease ( PD ) . These non-motor symptoms often contribute to the reduction of functional abilities in PD patients . OBJECTIVE This study was design ed to evaluate the diagnostic accuracy of the treating neurologist for a variety of behavioral symptoms commonly associated with PD . METHODS A prospect i ve evaluation of 101 patients with PD selected in no particular order was conducted . All patients were evaluated with the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , Hoehn & Yahr Stage ( H/Y ) , and the Schwab & Engl and Scale ( S/E ) . The patients completed a brief screening question naire for depression and anxiety followed by the administration of a battery of st and ardized tests including the Beck Depression Inventory ( BDI ) , Beck Anxiety Inventory ( BAI ) , Fatigue Severity Scale ( FSS ) , and the Pittsburgh Sleep Quality Inventory ( PSQI ) .  RESULTS St and ardized testing showed evidence of a problem with depression in 44 % of patients , anxiety in 39 % , fatigue in 42 % and sleep disturbance in 43 % . The prevalence of these conditions , identified by the treating neurologist was lower : 21 % with depression , 19 % with anxiety , 14 % with fatigue and 39 % with sleep disturbance . The diagnostic accuracy for the treating neurologists was 35 % for depression , 42 % for anxiety , 25 % for fatigue , and 60 % for sleep disturbance . CONCLUSION This study demonstrates that during routine office visits , neurologists failed to identify the presence of depression , anxiety , and fatigue more than half of the time and failed to recognize sleep disturbance in 40 % of patients . Awareness of the likelihood of underrecognition of behavioral symptoms in PD should generate approaches to improve diagnostic accuracy and facilitate timely therapeutic interventions Fibromyalgia is a chronic condition characterized by widespread pain , fatigue , non-restorative sleep and cognitive difficulties that affects 2 - 4 % of the general population . Recently a possible relationship between the FMR1 premutation and fibromyalgia has been pointed out . In attempt to gather more data we screened for the  FMR1 CGG expansion 700 DNA sample s from unrelated fibromyalgia patients . This data might be useful for evaluating the incorporation of this test in rheumatologic procedures for women with fibromyalgia . The observed frequency of  FMR1 premutation carriers ( 3 of 700 , 0.4 % ) is not significantly different from the estimated rate in the general female population ( 1/250 - 1/400 ) ( P=0.539 , P=0.716 ) . Clinical examination of the FMR1 premutation carriers identified revealed that all of them had important neurological symptoms with regard to muscular symptoms , neurocognitive alterations and neurovegetative impairments . With regard to other clinical aspects of the disease the cases apparently did not differ from the average fibromyalgia patients . On the basis of our results an FMR1 screening among fibromyalgia female patients would not be recommended . However it would be worthwhile to further evaluate the different clinical presentations that fibromyalgia patients might present based on their FMR1 premutation carrier status OBJECTIVE To prospect ively evaluate for changes in objective cognitive performance ( attention , memory , and executive function ) and psychiatric symptom severity ( depression , anxiety , fatigue , and pain ) in patients before , during and after interferon-alpha based therapy ( IFN ) for chronic hepatitis C virus infection ( HCV ) . METHODS 33 HCV+ adults were evaluated two months before  IFN initiation ( baseline ) , three months into IFN , and six months following IFN termination ( IFN+ Group ) . 31 HCV+ adults who did not undergo IFN therapy were evaluated at baseline and six months later ( IFN- Group ) . At each evaluation , participants completed the  Neuropsychological Assessment Battery ( NAB ) Attention , Memory and Executive Functions Modules , the Beck Depression Inventory , Second Edition ( BDI ) , Generalized Anxiety Disorder Inventory ( GADI ) , Fatigue Severity Scale ( FSS ) , and Brief Pain Inventory ( BPI ) . RESULTS Compared with the IFN- Group , the IFN+ Group experienced significantly ( p<0.050 ) increased symptoms of depression , anxiety , fatigue and pain during IFN therapy relative to baseline . In the IFN+ Group , psychiatric symptoms generally returned to baseline levels following IFN termination . Sustained viral response was associated with significantly lower depression and fatigue . No significant changes in cognitive performance were observed . CONCLUSIONS During IFN , patients with HCV evidence significantly increased psychiatric symptoms , including symptoms of depression , anxiety , fatigue and pain . These psychiatric symptoms are generally short-term and remit following IFN termination , with increased benefit if viral clearance is achieved . However , IFN is not associated with significant declines in objective cognitive performance during or following IFN OBJECTIVE Fibromyalgia syndrome ( FMS ) is characterized by widespread musculoskeletal pain and lowered pain threshold . Other prominent symptoms include disordered sleep and fatigue . FMS affects an estimated 2 % of the population , predominantly women . This trial was design ed to evaluate the efficacy and safety of pregabalin , a novel alpha(2)-delta lig and , for treatment of symptoms associated with FMS . METHODS This multicenter , double-blind , 8-week , r and omized clinical trial compared the effects of placebo with those of 150 , 300 , and 450 mg/day pregabalin on pain , sleep , fatigue , and health-related quality of life in 529 patients with FMS . The primary outcome variable was the comparison of end point mean pain scores , derived from daily diary ratings of pain intensity , between each of the pregabalin treatment groups and the placebo group . RESULTS Pregabalin at 450 mg/day significantly reduced the average severity of pain in the primary analysis compared with placebo ( -0.93 on a 0 - 10 scale ) ( P < /= 0.001 ) , and significantly more patients in this group had > /=50 % improvement in pain at the end point ( 29 % , versus 13 % in the placebo group ; P = 0.003 ) . Pregabalin at 300 and 450 mg/day was associated with significant improvements in sleep quality , fatigue , and global measures of change .  Pregabalin at 450 mg/day improved several domains of health-related quality of life . Dizziness and somnolence were the most frequent adverse events . Rates of discontinuation due to adverse events were similar across all 4 treatment groups . CONCLUSION Pregabalin at 450 mg/day was efficacious for the treatment of FMS , reducing symptoms of pain , disturbed sleep , and fatigue compared with placebo . Pregabalin was well tolerated and improved global measures and health-related quality of life While fatigue is found to be an impairing symptom in functional motor disorders ( FMD ) in clinical practice , scientific evidence is lacking . We investigated fatigue severity and subtypes in FMD compared to organic neurological disease . Furthermore , the role of fatigue within FMD and its impact on quality of life and self-rated health were investigated . Data from 181 patients participating in the self-help on the internet for functional motor disorders , r and omised Trial were included . Data from 217 neurological controls with neuromuscular disorders ( NMD ) originated from a historical cohort .  Fatigue was measured using the checklist individual strength ( CIS ) . Motor symptom severity , depression and anxiety were correlated to fatigue . For multivariable regression analyses , physical functioning and pain were additionally taken into account . Severe fatigue was , respectively , present in 78 and 53 % of FMD and NMD patients ( p < 0.001 ) . FMD patients scored higher than NMD patients on all fatigue subdomains ( p < 0.001 ) . In the FMD group , fatigue subdomains were correlated to depression , anxiety and partly to motor symptom severity . Quality of life was negatively associated with fatigue [ OR 0.93 ( 0.90–0.96 ) , p < 0.001 ] and depression [ OR 0.87 ( 0.81–0.93 ) , p < 0.001 ] , but not self-rated motor symptom severity . Self-rated health was negatively associated with fatigue [ OR 0.92 ( 0.88–0.96 ) , p < 0.001 ] and pain [ OR 0.98 ( 0.97–0.99 ) , p < 0.001 ] . Fatigue was found to be a prevalent problem in FMD , more so than in organic neurological disease . It significantly affected quality of life and self-rated health , while other factors such as motor symptom severity did not . Fatigue should be taken into account in clinical practice and treatment trials Research on comorbidity across cancer symptoms , including pain , fatigue , and depression , could suggest if crossover effects from symptom-specific interventions are plausible . Secondary analyses were conducted on a survey of 268 cancer patients with recurrent disease from a northeastern U.S. city who were initiating palliative radiation for bone pain .  Moderator regression analyses predicted variation in depressive affect that could be attributed to symptom clusters . Patients self-reported difficulty controlling each physical symptom over the past month on a Likert scale and depressive symptoms on a vali date d depression measure ( Center for Epidemiologic Studies -Depression [ CES-D ] ) over the past week on a four-category scale . An index of depressive affect was based on items of negative and positive affect from the CES-D. In predicting depressive affect , synergistic interactions of pain with fever , fatigue , and weight loss suggest separate pathways involving pain . A similar interaction with fever occurs when nausea was tested in place of pain . Further , the interaction between pain and fatigue is similar in form to the interaction between difficulty breathing and fatigue ( when sleep is not a problem ) . Follow-up to the latter interaction reveals : 1 ) additional moderation by hypertension and palliative radiation to the hip/pelvis ; and 2 ) a similar cluster not involving hypertension when appetite problems and weight loss were tested in place of fatigue . The significance and form of these interactions are remarkably consistent . Similar sickness mechanisms could be generating : 1 ) pain and nausea during fever ; 2 ) pain and fatigue during weight loss ; and 3 ) pain and breathing difficulty when fatigue is pronounced . Crossover effects from symptom-specific interventions appear promising Background Several recent review s have evaluated evidence on the efficacy of Mindfulness-Based Stress Reduction ( MBSR ) among fibromyalgia sufferers , and concluded that more research should test effects on both psychological and physiological functioning . Purpose We conducted a r and omized prospect i ve trial of MBSR among female fibromyalgia patients . Methods Effects on perceived stress , pain , sleep quality , fatigue , symptom severity , and salivary cortisol were tested in  treatment ( n = 51 ) versus wait-list control participants ( n = 40 ) using data at baseline , post-program , and 2-month follow-up . Results Analyses revealed that MBSR significantly reduced perceived stress , sleep disturbance , and symptom severity , with gains maintained at follow-up . Greater home practice at follow-up was associated with reduced symptom severity .  MBSR did not significantly alter pain , physical functioning , or cortisol profiles . Conclusion MBSR ameliorated some of the major symptoms of fibromyalgia and reduced subjective illness burden . Further exploration of MBSR effects on physiological stress responses is warranted . These results support use of MBSR as a complementary treatment for women with fibromyalgia ( IS RCT N : 34628811 ) BACKGROUND Chronic fatigue syndrome ( CFS ) is a condition that may be associated with substantial disability . The Medical Outcomes Study Short-Form General Health Survey ( SF-36 ) is an instrument that has been widely used in outpatient population s to determine functional status . Our objectives were to describe the usefulness of the SF-36 in CFS patients and to determine if subscale scores could distinguish patients with CFS from subjects with unexplained chronic fatigue ( CF ) , major depression ( MD ) , or acute infectious mononucleosis ( AIM ) , and from healthy control subjects ( HC ) . An additional goal was to ascertain if subscale scores correlated with the signs and symptoms of CFS or the presence of psychiatric disorders and fibromyalgia . DESIGN Prospect ively collected case series . SETTING Patients with CFS and CF were seen in a university-based referral clinic and had undergone a complete medical and psychiatric evaluation . Other study subjects were recruited from the community to participate in research studies . PARTICIPANTS The study included 185 patients with CFS , 246 with CF , 111 with AIM , and 25 with MD . There were 99 HC subjects . MEASURES The  SF-36 and a structured psychiatric interview  were used . The SF-36 contains 8 subscales : physical , emotional , social , and role functioning , body pain , mental health , vitality , and general health- and a structured psychiatric interview .  RESULTS Performance characteristics ( internal reliability coefficients , convergent validity ) of the SF-36 were excellent . A strikingly consistent pattern was found for the physical functioning , role functioning , social functioning , general health , and body pain subscales , with the lowest scores in CFS patients , intermediate scores in AIM patients , and the highest scores in the HC subjects . The CFS patients had significantly lower scores than patients with CF alone on the physical functioning ( P < or = 0.01 ) , role functioning ( P < or = 0.01 ) , and body pain ( P < or = 0.001 ) subscales . The emotional functioning and mental health scores were worst among those with MD . The presence of fibromyalgia , being unemployed , and increasing fatigue severity all were associated with additional functional limitations across multiple functional domains , with increasing fatigue appearing to have the greatest effect . CONCLUSIONS The SF-36 is useful in assessing functional status in patients with fatiguing illnesses . Patients with CFS and CF have marked impairment of their functional status . The severity and pattern of impairment as documented by the SF-36 distinguishes patients with CFS and CF from those with MD and AIM , and from HC , but does not discriminate between CF and CFS CONTEXT A novel mind-body approach ( amygdala retraining ) is hypothesized to improve symptoms related to  fibromyalgia and chronic fatigue .  OBJECTIVE To examine the use of a mind-body approach for improving symptoms related to  fibromyalgia and chronic fatigue .  DESIGN This was a single-blind , r and omized controlled trial . SETTING The study was conducted in a tertiary-care fibromyalgia and chronic fatigue clinic . PATIENTS Patients with fibromyalgia , chronic fatigue , or both were included . INTERVENTIONS Patients were r and omly assigned to receive amygdala retraining along with st and ard care or st and ard care alone . St and ard care involved attending a 1.5-day multidisciplinary program . The amygdala retraining group received an additional 2.5-hour training course in which the key tools and techniques adapted from an existing program were taught to the patient . A home- study video course and associated text were provided to supplement the on-site program . Both groups received telephone calls twice a month to answer questions related to technique and to provide support . MAIN OUTCOME MEASURES Vali date d self-report question naires related to general health , well-being , and symptoms , including Short Form-36 , Measure Yourself Medical Outcome Profile , Multidimensional Fatigue Inventory , Epworth Sleepiness Scale , and Fibromyalgia Impact Question naire . RESULTS Of the 44 patients r and omly assigned who completed baseline assessment s , 21 patients completed the study ( 14 in the st and ard care group and 7 in the study group ) . Median age was 48 years ( range , 27 - 56 years ) , and female subjects comprised 91 % of the group . Analyses demonstrated statistically significant improvements in scores for physical health , energy , pain , symptom distress , and fatigue in patients who received the amygdala retraining compared with st and ard care BACKGROUND Fibromyalgia is a chronic pain syndrome associated with sleep disorders , fatigue and psychological symptoms . Combinations therapies , such as electrotherapy and therapeutic exercises have been used in the clinical practice . AIM To assess the efficacy of high-frequency transcutaneous electrical nerve stimulation ( TENS ) as an adjuvant therapy to aerobic and stretching exercises , for the treatment of fibromyalgia . DESIGN Controlled clinical trial . SETTING Unit of rehabilitation of a public hospital . POPULATION Twenty-eight women aged 52.4±7.5 years , with fibromyalgia . METHODS A visual analogue scale measured pain intensity ; tender points pain threshold , by dolorimetry ; and quality of life , by the Fibromyalgia Impact Question naire . All subjects participated in an eight-week program consisting of aerobic exercises , followed by static stretching of muscle chains . In TENS group , high-frequency ( 150 Hz ) was applied on bilateral tender points of trapezium and supraspinatus . RESULTS TENS group had a greater pain reduction ( mean change score=-2.0±2.9 cm ) compared to Without TENS group ( -0.7±3.7 cm ) . There was a difference between mean change scores of each group for pain threshold ( right trapezium : 0.2±1 kg/cm² in TENS group and -0.2±1.2 kg/cm² in Without TENS group ) . In the evaluation of clinical ly important changes , patients receiving TENS had relevant improvement of pain , work performance , fatigue , stiffness , anxiety and depression compared to those not receiving TENS . CONCLUSION It has suggested that high-frequency TENS as an adjuvant therapy is effective in relieving pain , anxiety , fatigue , stiffness , and in improving ability to work of patients with fibromyalgia . CLINICAL REHABILITATION IMPACT High-frequency TENS may be used as a short-term complementary treatment of fibromyalgia OBJECTIVE Insomnia is a debilitating comorbidity of chronic pain . This pilot trial tested the utility of a hybrid treatment that simultaneously targets insomnia and pain-related interference . METHODS Chronic pain patients with clinical insomnia were r and omly allocated to receive 4 weekly 2-h sessions of hybrid treatment ( Hybrid Group ;  n = 10 ) or to keep a pain and sleep diary for 4 weeks , before receiving the hybrid treatment ( Monitoring Group ; n = 10 ) . Participants were assessed at the beginning and end of this 4-week period . Primary outcomes were insomnia severity and pain interference . Secondary outcomes were fatigue , anxiety , depression and pain intensity . Ancillary information about the hybrid treatment 's effect on psychological processes and sleep ( as measured with sleep diary and actigraphy ) are also presented , alongside data demonstrating the treatment 's clinical significance , acceptability and durability after one and six months . Data from all participants ( n = 20 ) were combined for this purpose . RESULTS Compared to symptom monitoring , the hybrid intervention was associated with greater improvement in sleep ( as measured with the Insomnia Severity Index and sleep diary ) at post-treatment . Although pain intensity did not change , the Hybrid Group reported greater reductions in pain interference , fatigue and depression than the Monitoring Group . Overall , changes associated with the hybrid intervention were clinical ly significant and durable at 1- and 6-month follow-ups . Participants also rated highly on treatment acceptability . CONCLUSION The hybrid intervention appeared to be an effective treatment for chronic pain patients with insomnia . It may be a treatment approach more suited to tackle challenges presented in clinical practice , where problems seldom occur in isolation OBJECTIVES To provide preliminary information on whether a regimen of 30 chiropractic treatments that combines ischemic compression and spinal manipulation effectively reduces the intensity of pain , sleep disturbance , and fatigue associated with fibromyalgia . In addition , to study the dose-response relation and identify the baseline characteristics that may serve as predictors of outcome . DESIGN Subjects were assessed with self-administered question naires taken at baseline , after 15 and 30 treatments , and 1 month after the end of the treatment trial . SETTING Private practice . METHODS Participating subjects were adult members of a regional Fibromyalgia Association . Participating subjects had fibromyalgia for more than 3 months . They received 30 treatments including ischemic compression and spinal manipulation . The 3 outcomes being evaluated were pain intensity , fatigue level , and sleep quality . A minimum 50 improvement in pain intensity from baseline to the end of the treatment trial was needed to include the patient in the respondent category . RESULTS Fifteen women ( mean age 51.1 years ) completed the trial . A total of 9 ( 60 ) patients were classified as respondents . A statistically significant lessening of pain intensity and corresponding improvement in quality of sleep and fatigue level were observed after 15 and 30 treatments . After 30 treatments , the respondents showed an average lessening of 77.2 ( st and ard deviation = 12.3 ) in pain intensity and an improvement of 63.5 ( st and ard deviation = 31.6 ) in sleep quality and 74.8 ( st and ard deviation = 23 . 1 ) in fatigue level . The improvement in the 3 outcome measures was maintained after 1 month without treatment . Subjects with less than 35 improvement after 15 treatments did not show a satisfactory response after 30 treatments . A trend , determined as not statistically significant , suggests that older subjects with severe and more chronic pain and a greater number of tender points respond more poorly to treatment . CONCLUSION This study suggests a potential role for chiropractic care in the management of fibromyalgia . A r and omized clinical trial should be conducted to test this hypothesis BACKGROUND Disability is a defining feature of chronic conditions , and it is an increasingly used measure of therapy effectiveness . The  Work and Social Adjustment Scale ( WSAS )  is a simple and clear measure of disability . Although the scale is widely used , no study has yet investigated its psychometric properties in patients with chronic fatigue syndrome ( CFS ) . METHODS Data from two sample s of patients were used , one from a multicenter r and omized controlled clinical trial of treatments for CFS ( n = 639 ) and the other from a clinic that specializes in CFS ( n=384 ) . All patients completed the WSAS as well as other measures . RESULTS Internal consistency and the Spearman-Brown split-half coefficient values indicated that the scale is reliable . CFS patients who had comorbid diagnoses of depression , anxiety or fibromyalgia had higher WSAS scores . High levels of disability were associated with high number of physical symptoms , severe fatigue , depression , anxiety , poor sleep quality and poor physical fitness , with correlation coefficients ranging between 0.41 and 0.11 . Lower scores on the WSAS were modestly associated with better physical functioning as well as higher levels of physical capacity as assessed by a walking test . Sensitivity to change was evaluated in a subgroup of patients who had undergone a course of cognitive behavioral therapy .  Disability significantly decreased after therapy and remained stable at follow-ups . CONCLUSION The WSAS is a reliable and valid assessment tool for disability in patients with CFS & NA ; Chronic pain is associated with a range of other problems , including disturbed sleep , depression , anxiety , fatigue , reduced quality of life , and an inability to work or socialise . We investigated whether good symptom control of pain ( using definitions of moderate and substantial benefit ) is associated with improvement in other symptoms . Individual patient data from four r and omised trials in fibromyalgia ( 2575 patients ) lasting 8–14 weeks were used to calculate  percentage  pain reduction  for each completing patient ( 1858 ) , divided into one of five groups according to pain reduction , irrespective of treatment : substantial benefit – ≥50 % pain reduction ; moderate – 30 % to < 50 % ; minimal – 15 % to < 30 % ; marginal – 0 % to < 15 % ; worse – < 0 % ( increased pain intensity ) . We then calculated change from baseline to end of trial for measures of fatigue , function , sleep , depression , anxiety , ability to work , general health status , and quality ‐adjusted life year ( QALY ) gain over a 12‐month period . Substantial and moderate pain intensity reductions were associated with statistically significant reduction from baseline by end of trial in all measures , with values by trial end at or approaching normative values . Substantial pain intensity reduction result ed in 0.11 QALYs gained , and moderate pain intensity reduction in 0.07 QALYs gained over a 12‐month period . Substantial and moderate pain intensity reduction predicts broad beneficial outcomes and improved quality of life that do not occur without pain relief . Pain intensity reduction is a simple and effective predictor of which patients should continue treatment , and which should discontinue and try an alternative therapy In numerous studies of symptoms in patients with chronic hepatitis C there has been no systematic assessment of both fatigue and extrahepatic manifestations . Our objective was to assess the prevalence of fatigue in patients with hepatitis C virus ( HCV ) infection , and to identify associations between fatigue and clinical and biological hepatic and extrahepatic manifestations . We studied 1614 patients . Data were prospect ively recorded during the first visit of patients infected with HCV  and the prevalence of fatigue and its association with dermatological , rheumatological , neurological and nephrological manifestations ; diabetes ; arterial hypertension ; auto-antibodies , and cryoglobulinaemia were assessed . Then , using multivariate analysis , we identified demographic , biochemical , immunological , virological , and histological factors associated with the presence of fatigue . Fatigue was present in 53 % of patients ( 95 % confidence interval 51 - 56 ) . In 17 % of patients ( 95 % confidence interval 15 - 19 ) fatigue was severe , impairing activity . Five other extrahepatic manifestations had a prevalence above 10 % including , in decreasing order : arthralgia , paresthesia , myalgia , pruritus , and sicca syndrome . In univariate and multivariate analyses , fatigue , in comparison with the absence of fatigue , was associated with female gender , age over 50 years , cirrhosis , depression and purpura . Independent of these associations , fatigue was associated with arthralgia , myalgia , paresthesia , sicca syndrome and pruritus . The prevalence of fibromyalgia ( as defined by the association of fatigue with arthralgia or myalgia ) was 19 % ( 95 % confidence interval 17 - 21 ) . There was no significant association between fatigue and the following characteristics : viral load or genotype , alcohol consumption , abnormal thyroid function , and type and level of cryoglobulinaemia . Hence , fatigue is the most frequent extrahepatic manifestation in patients infected with HCV . Fatigue is independently associated with female gender , age over 50 years , cirrhosis , depression and purpura Background : Chemotherapy is frequently administered in repetitive cycles . Adolescents with cancer have multiple symptoms related to chemotherapy , but knowledge of symptom trajectories across a cycle is limited . Examining trajectories over a cycle may reveal key periods to manage symptoms . Objectives : The aims of this pilot were to describe the trajectory of symptoms ( pain , sleep , appetite , nausea , fatigue ) and biological and behavioral variables ( anxiety , stress , hematologic function ) across 1 cycle and examine relationships between variables . Methods : Nine adolescents with cancer within 6 months of diagnosis participated . Data were collected by surveys , chart review , and biologic measures on days 1 and 2 of the cycle , 1 week later ( nadir ) , and day 1 of the following cycle . To evaluate the trajectory , a simple r and om-effects repeated- measures analysis was computed . Results : The significant trajectories were fatigue ( P = .003 ) , difficulty sleeping ( P = .032 ) , and nausea ( P = .04 ) . Most of the adolescents reported some anticipatory anxiety about receiving chemotherapy . Significant correlations between symptoms and biobehavioral variables included anticipatory anxiety and nausea ( r = .86 , P = .003 ) , trait anxiety and fatigue ( r = −0.82 , P < .001 ) , and stress and pain ( r = 0.78 , P = .039 ) . Conclusions : Multiple symptoms were experienced across the cycle . Three symptoms displayed significant trajectories indicating that patterns of symptoms may be anticipated . Implication s for Practice : Pilot findings suggest that monitoring symptoms , stress , and anxiety across a cycle is important , not only during chemotherapy administration , but also prior to being admitted for chemotherapy PURPOSE / OBJECTIVES To evaluate the feasibility of a patient-controlled cognitive-behavioral intervention for  pain , fatigue , and sleep disturbance during treatment for advanced cancer and to assess initial efficacy of the intervention . DESIGN One group pre- and post-test design . SETTING Outpatient oncology clinics at a comprehensive cancer center in the midwestern United States . SAMPLE 30 adults with advanced ( recurrent or metastatic ) colorectal , lung , prostate , or gynecologic cancer receiving chemotherapy or radiotherapy . METHODS Participants completed baseline measures ( e.g. , demographics , symptom inventory ) and received education and training to use an MP3 player loaded with 12 cognitive-behavioral strategies ( e.g. , relaxation exercises , guided imagery , nature sound recordings ) . Participants used the strategies as needed for symptom management for two weeks , keeping a log of symptom ratings with each use . Following the two-week intervention , participants completed a second symptom inventory and an evaluation of the intervention . MAIN RESEARCH VARIABLES Feasibility , patient-controlled cognitive-behavioral intervention , pain , fatigue , and sleep disturbance . FINDINGS Thirty of 43 eligible patients ( 73 % ) agreed to participate ; of them , 27 ( 90 % ) completed the study . Most reported that they enjoyed the intervention , had learned useful skills , and perceived improvement in their symptoms . Symptom scores at two weeks did not differ significantly from baseline ; however , significant reductions in pain , fatigue , and sleep disturbance severity were found in ratings made immediately before and after use of a cognitive-behavioral strategy . CONCLUSIONS The patient-controlled cognitive-behavioral intervention appears to be feasible for additional study and could reduce day-to-day severity of co-occurring pain , fatigue , and sleep disturbance . IMPLICATION S FOR NURSING A r and omized , controlled trial is needed to test efficacy of the intervention for co-occurring pain , fatigue , and sleep disturbance . Meanwhile , based on previous efficacy studies , cognitive-behavioral strategies can be recommended for certain individual symptoms OBJECTIVE To evaluate the efficacy of a novel variant of electroencephalograph biofeedback , the Low Energy Neurofeedback System ( LENS ) , that utilizes minute pulses of electromagnetic stimulation to change brainwave activity for the amelioration of fibromyalgia ( FM ) symptoms . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING Tertiary referral academic medical center , outpatient . PATIENTS Thirty-four patients diagnosed with FM according to 1990 American College of Rheumatology classification criteria . INTERVENTIONS Active or sham LENS , depending on r and omization , for 22 treatment sessions . OUTCOME MEASURES Primary outcome measure was the Fibromyalgia Impact Question naire total score . Secondary outcome measures included number of tender points ( TPs ) and pressure required to elicit TPs on physical examination , quantitative sensory testing heat pain threshold , and self-reported cognitive dysfunction , fatigue , sleep problems , global psychological distress , and depression obtained at baseline , immediate post-treatment , and 3- and 6-month follow-up . RESULTS Participants who received the active or sham interventions improved ( Ps < 0.05 ) on the primary and a variety of secondary outcome measures , without statistically significant between group differences in evidence at post-treatment or 3- or 6-month follow-up . Individual session self-reported ratings of specific symptoms ( cognitive dysfunction , fatigue , pain , and sleep , and overall activity level ) over the course of the 22 intervention sessions indicated significant linear trends for improvement for the active intervention condition only ( Ps < 0.05 ) . CONCLUSION LENS can not be recommended as a single modality treatment for FM . However , further study is warranted to investigate the potential of LENS to interact synergistically with other pharmacologic and nonpharmacologic therapies for improving symptoms in FM OBJECTIVE A subset of fibromyalgia ( FM ) patients have a dysfunctional hypothalamic-pituitary-insulin-like growth factor 1 ( IGF-1 ) axis , as evidence d by low serum levels of IGF-1 and a reduced growth hormone ( GH ) response to physiologic stimuli . There is evidence that pyridostigmine ( PYD ) improves the acute response of GH to exercise in FM patients . The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms . METHODS FM patients were r and omized to 1 of the following 4 groups : PYD plus exercise , PYD plus diet recall but no exercise , placebo plus exercise , and placebo plus diet recall but no exercise . The primary outcome measures were the visual analog scale ( VAS ) score for pain , tender point count , and total myalgic score . Secondary outcome measures were the total score on the Fibromyalgia Impact Question naire ( FIQ ) and FIQ VAS scores for individual symptoms ( fatigue , poor sleep , stiffness , and anxiety ) , as well as quality of life ( QOL ) and physical fitness ( lower body strength/endurance , upper and lower body flexibility , balance , and time on the treadmill ) . RESULTS A total of 165 FM patients completed baseline measurements ; 154 ( 93.3 % ) completed the study . The combination of PYD and exercise did not improve pain scores .  PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups . Compared with the nonexercise groups , the 2 exercise groups demonstrated improvement in fatigue and fitness .  PYD was generally well tolerated . CONCLUSION Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms . However , PYD did improve anxiety and sleep , and exercise improved fatigue and fitness . We speculate that PYD may have improved vagal tone , thus benefiting sleep and anxiety ; this notion warrants further study Background Fatigue is a major clinical problem in many patients with primary biliary cirrhosis ( PBC ) and primary sclerosing cholangitis ( PSC ) . An effective treatment has not been defined . Recently , a large proportion of patients with these diseases was found to have symptoms of depression . Because fatigue is a frequent symptom of depression and there is some evidence that treatment with an antidepressant improves fatigue in patients with fibromyalgia , we hypothesised that the antidepressant fluvoxamine might improve fatigue related to PBC and PSC . Methods Fatigued patients were r and omised to receive fluvoxamine ( 75 mg BID ) or placebo for a six-week period . Fatigue and quality of life were quantified using a visual analogue scale , the Fisk Fatigue Severity Scale , the Multidimensional Fatigue Inventory and the SF-36 . Results Seventeen and 16 patients were allocated to fluvoxamine and placebo , respectively . There was no statistically significant beneficial effect of fluvoxamine on fatigue or quality of life . The median VAS scores in the fluvoxamine and placebo groups were 7.40 and 7.45 at day 0 , 6.9 and 7.15 at day 14 , 7.45 and 7.65 at day 42 and 7.8 and 8.0 four weeks after treatment discontinuation . Conclusion We found no evidence for a beneficial effect of fluvoxamine on fatigue in these patients with cholestatic liver disease and severe chronic fatigue Objective : The aim of the present study is to evaluate the effectiveness of spa therapy in the management of  fibromyalgia .  Methods : Thirty women with fibromyalgia were r and omly assigned to either a spa therapy group or a control group . The spa therapy group ( n = 16 ) had spa treatment for 2 weeks in addition to their medical treatment . The control group ( n = 14 ) continued to have their medical treatment and /or daily exercises . An investigator who was blinded for the intervention assessed all the patients for 9 months . Improvements in Fibromyalgia Impact Question naire ( FIQ ) , pain and number of tender points were primary outcomes . Secondary outcome measures were improvement in sleep disturbance , fatigue , gastrointestinal symptoms , anxiety , Beck Depression Inventory and patient ’s global evaluation . Results : the spa group was found to be superior to the control group at the end of intervention in terms of FIQ , pain , tender point count , fatigue and patients ’ global assessment . This superiority remained for 6 months in FIQ , 1 month in pain and tender point count . Conclusion : It was concluded that the addition of spa therapy to medical therapy has both short- and long-term beneficial effects in female patients with fibromyalgia Low energy lasers are widely used to treat a variety of musculoskeletal conditions including fibromyalgia , despite the lack of scientific evidence to support its efficacy . A r and omised , single-blind , placebo-controlled study was conducted to evaluate the efficacy of low-energy laser therapy in 40 female patients with fibromyalgia . Patients with fibromyalgia were r and omly allocated to active ( Ga-As ) laser or placebo laser treatment daily for two weeks except weekends . Both the laser and placebo laser groups were evaluated for the improvement in pain , number of tender points , skinfold tenderness , stiffness , sleep disturbance , fatigue , and muscular spasm . In both groups , significant improvements were achieved in all parameters ( p<0.05 ) except sleep disturbance , fatigue and skinfold tenderness in the placebo laser group ( p>0.05 ) . It was found that there was no significant difference between the two groups with respect to all parameters before therapy whereas a significant difference was observed in parameters as pain , muscle spasm , morning stiffness and tender point numbers in favour of laser group after therapy ( p<0.05 ) . None of the participants reported any side effects . Our study suggests that laser therapy is effective on pain , muscle spasm , morning stiffness , and total tender point number in fibromyalgia and suggests that this therapy method is a safe and effective way of treatment in the cases with fibromyalgia Background Unexplained Chronic Fatigue is a medical condition characterized by the presence of persistent , severe and debilitating medically unexplained fatigue , leading to impaired functioning and lower quality of life . Research suggests that physical activity can contribute to the reduction of fatigue and other somatic symptoms and can thus significantly improve physical functioning and quality of life in these patients . Based on the self-regulation ( SR ) theory of behaviour change , we developed a brief physical activity program for patients suffering from unexplained chronic fatigue which focuses on the training of self-regulation skills , the " 4-STEPS to control your fatigue " program . Methods / Design This is a multi-centre , r and omised controlled trial ( RCT ) that will be carried out in local primary care centres and at the Portuguese Fibromyalgia and Chronic Fatigue Syndrome Patients Association . Patients aged between 18 and 65 and fulfilling operationalized criteria for Idiopathic Chronic Fatigue ( ICF ) and Chronic Fatigue Syndrome ( CFS ) will be recruited and r and omly allocated to st and ard care ( SC ) or st and ard care plus a self-regulation based physical activity program ( 4-STEPS ) . Patients will be assessed at baseline , after the intervention ( 3 months ) and at 12 months follow-up . The primary outcome is fatigue severity . Discussion The results of the RCT will provide information about the effectiveness of a brief self-regulation intervention for promoting physical activity in patients with unexplained chronic fatigue . If the program proves to be effective , it may be considered as an adjunctive treatment for these patients .Trial Registration IS RCT N : IS RCT OBJECTIVES To document 1 ) the content validity and 2 ) measure improvements in fatigue , using the  Fatigue Visual Analogue Scale ( VAS ) assessment tool in patients with fibromyalgia . METHODS The relevance and comprehensiveness of the Fatigue VAS were tested through a qualitative analysis of 20 subjects ' verbatim transcripts from semi-structured qualitative interviews . Data from two r and omised , controller trials in fibromyalgia ( n=1121 ) were used to conduct correlation analyses with the  Fatigue and Tiredness  items from the Fibromyalgia Impact Question naire ( FIQ ) and the Short Form-36 Vitality scale . Known-groups and cross classification analyses were conducted to demonstrate the ability to measure improvement in fatigue using the Fatigue VAS . RESULTS All subjects spontaneously reported that fatigue was an important symptom to capture in fibromyalgia . The Fatigue VAS was well understood by most subjects ( n=18/20 ) . High correlations ( Pearson r>0.75 ) and good agreement ( k>0.66 ) were found between the Fatigue VAS and the FIQ tiredness items no. 16 and 17 and SF-36 ™ Vitality scale . In both clinical trials there was a substantial separation of approximately 20 points on the mean change in the Fatigue VAS score between responders ( > 30 % improvement in pain VAS ) and non-responders . CONCLUSIONS Previous studies have confirmed that fatigue is a major component of the fibromyalgia experience . This current study reports that fibromyalgia patients spontaneously rated fatigue as a highly significant feature of their illness , and supports the use of the Fatigue VAS as a valid question naire in fibromyalgia clinical trials The incidence and mortality of cancer are increasing . In advanced cancer when cure is impossible , symptoms should be the focus of attention . We review our recent prospect i ve studies on symptom prevalence and severity in 1,000 patients with advanced cancer . Advanced cancer patients are polysymptomatic . Symptom prevalence differs with age , gender , and cancer site . The pattern of gastrointestinal symptoms is related to gender and severe weight loss . Specific symptoms are associated with reduced survival . There is a gender difference in survival favoring females . Pain , easy fatigue , and anorexia are consistently among the 10 most prevalent symptoms at all 17 primary sites . When pain , anorexia , weakness , anxiety , lack of energy , easy fatigue , early satiety , constipation , and dyspnea were present , 60 % to 80 % of patients rated them as moderate or severe , ie , of clinical importance . The most common symptoms also are the most severe . In general , the same symptoms are clinical ly important at most primary sites OBJECTIVE To evaluate the effects of using a gamma-hydroxybutyrate ( GHB ) administered in divided doses at night in 11 patients previously diagnosed with fibromyalgia ( FM ) . METHODS Subjects completed daily diaries assessing their pain and fatigue levels and slept in the sleep laboratory before and one month after initiating GHB treatment . Polysomnographic recordings were evaluated for sleep stages , sleep efficiency and the presence of the alpha anomaly in non-REM sleep . RESULTS There was a significant improvement in both fatigue and pain , with an increase in slow wave sleep and a decrease in the severity of the alpha anomaly . CONCLUSION Further controlled studies are needed to characterize the clinical improvement and the polysomnographic changes we observed OBJECTIVE Fibromyalgia ( FM ) is associated with the sleep phenomenon of alpha intrusion , and with low growth hormone secretion . Sodium oxybate has been shown to increase both slow-wave sleep and growth hormone levels . This double blind , r and omized , placebo controlled crossover trial was conducted to evaluate the effects of sodium oxybate on the subjective symptoms of pain , fatigue , and sleep quality and the objective polysomnographic ( PSG ) sleep variables of alpha intrusion , slow-wave ( stage 3/4 ) sleep , and sleep efficiency in patients with FM . METHODS Patients received either 6.0 g/day sodium oxybate or placebo for 1 month , with an intervening 2 week washout period . Efficacy measures included PSG evaluations , tender point index ( TPI ) , and subjective measurements from daily diary entries . Safety measures included clinical laboratory values , vital signs , and adverse events . RESULTS Twenty-four female patients were included in the study ; 18 completed the trial .  TPI was decreased from baseline by 8.5 , compared with an increase of 0.4 for placebo ( p = 0.0079 ) . Six of the 7 pain/fatigue scores ( overall pain , pain at rest , pain during movement , end of day fatigue , overall fatigue , and morning fatigue ) were relieved by 29 % to 33 % with sodium oxybate , compared with 6 % to 10 % relief with placebo ( p < 0.005 ) . Alpha intrusion , sleep latency , and rapid-eye-movement sleep were significantly decreased , while slow-wave ( stage 3/4 ) sleep was significantly increased , compared with placebo ( p < 0.005 ) . Two of the 5 subjective sleep related variables were significantly different from placebo :  morning alertness ( improved by 18 % with sodium oxybate , compared with 2 % for placebo ; p = 0.0033 ) and quality of sleep ( improved by 33 % and 10 % , respectively ; p = 0.0003 ) . CONCLUSION Sodium oxybate effectively reduced the symptoms of pain and fatigue in patients with FM , and dramatically reduced the sleep abnormalities ( alpha intrusion and decreased slow-wave sleep ) associated with the nonrestorative sleep characteristic of this disorder OBJECTIVE Patients with fibromyalgia ( FM ) consistently have adrenal hyporesponsiveness and low dehydroepi and rosterone ( DHEA ) levels . DHEA is promoted for and used by patients with FM . We tested the efficacy and safety of DHEA supplementation in ameliorating the symptoms of FM . METHODS In a double-blind crossover study , postmenopausal women with FM were r and omized to DHEA supplementation  ( 50 mg/day ) or placebo for 3 months , with a one-month washout period in between . Patients were assessed monthly for well-being and pain and by medical evaluations at the beginning and the end of each treatment period . The primary outcome was well being ; secondary outcomes were pain , fatigue , cognition , sexuality , functional impairment , depression , and anxiety . RESULTS A total of 52 patients were r and omized , 47 patients completed the  DHEA  treatment period , and 45 the placebo treatment period . After 3 months of treatment with 50 mg of DHEA , median DHEA sulfate blood levels had tripled , but there was no improvement in well-being , pain , fatigue , cognitive dysfunction , functional impairment , depression , or anxiety , nor in objective measurements made by physicians . And rogenic side effects ( greasy skin , acne , and increased growth of body hair ) were more common during the DHEA treatment period ( p = 0.02 ) . CONCLUSION DHEA does not improve quality of life , pain , fatigue , cognitive function , mood , or functional impairment in FM Background : Pain and fatigue are 2 of the most common symptoms experienced by individuals undergoing treatment for cancer . It has been hypothesized that older adults experience lower levels of severity and interference from pain and fatigue when compared with younger adults . Objective : The purpose of this study was to identify how pain and fatigue , severity , and interference may vary between younger and older adults undergoing cancer treatment over time . Methods : This study is a secondary analysis of data of 2 different r and omized controlled trials that examined the symptom experience in adults undergoing treatment for cancer .  A linear mixed model analysis was used to determine the differences based on age across 6 contacts over 8 weeks . Results : Results indicate that pain severity is significantly ( P < .01 ) related to age . Age was not found to be significantly related to the level of interference associated with pain or the severity or interference associated with fatigue . Conclusion : Symptoms of pain and fatigue are prevalent across age groups and will vary across time . Older and younger adults do not necessarily experience symptoms differently . Interference associated with pain and fatigue impacts all age groups ; interference may not be directly related to the level of severity . Implication s for Practice : This study highlights the importance of assessing both severity and interference associated with symptoms in all adults undergoing treatment for cancer . Further research is needed to better underst and the relationship between age and symptoms in individuals undergoing treatment for cancer OBJECTIVES This study aim ed to examine the associations between bodily pain , pain catastrophizing , depression , activity limitations /participation restrictions , employment status , and exercise performance in female patients with chronic fatigue syndrome ( CFS ) who experience widespread pain . DESIGN Cross-sectional observational study . SETTING A university-based clinic . PATIENTS Thirty-six female CFS patients who experienced widespread pain . OUTCOME MEASURES Patients filled in the  Medical Outcomes Short-Form 36 Health Status Survey ,  the  Chronic Fatigue Syndrome Activities and Participation Question naire , the Beck Depression Inventory , and the Pain Catastrophizing Scale , and underwent a maximal exercise stress test with continuous monitoring of electrocardiographic and ventilatory parameters . RESULTS Pain catastrophizing was related to bodily pain ( r = -0.70 ) , depression ( r = 0.55 ) , activity limitations /participation restrictions ( r = 0.68 ) , various aspects of quality of life ( r varied between -0.51 and -0.64 ) , and exercise capacity ( r varied between -0.41 and -0.61 ) . Based on hierarchical multiple regression analysis , pain catastrophizing accounted for 41 % of the variance in bodily pain in female CFS patients who experience chronic widespread musculoskeletal pain . Among the three subscale scores of the Pain Catastrophizing Scale , helplessness and rumination rather than magnification were strongly related to bodily pain . Neither pain catastrophizing nor depression was related to employment status . CONCLUSIONS These data provide evidence favoring a significant association between pain catastrophizing , bodily pain , exercise performance , and self-reported disability in female patients with CFS who experience widespread pain . Further prospect i ve longitudinal study ing of these variables is required Objective : To evaluate if mental fatigue is a symptom that appears independently from other clinical features in patients with Parkinson disease ( PD ) , and to study if fatigue is persistent over time in these patients . Methods : In 1993 , 233 patients with PD were included in a community-based study of fatigue and followed prospect ively over 8 years . Fatigue was measured by a combination of a seven-point scale and parts of the Nottingham Health Profile ( NHP ) at baseline and after 4 and 8 years . In addition , the  Fatigue Severity Scale ( FSS )  was used to evaluate fatigue in 2001 . Population -averaged logistic regression models for correlated data were performed to study the relationship between fatigue and various demographic and clinical variables . Results : In patients who were followed throughout the 8-year study period , fatigue increased from 35.7 % in 1993 to 42.9 % in 1997 and 55.7 % in 2001 . Fatigue was related to disease progression , depression , and excessive daytime sleepiness ( EDS ) . However , the prevalence of fatigue in patients without depression and EDS remained high and increased from 32.1 % to 38.9 % during the study period . For about 44 % of the patients with fatigue the presence of this symptom varied during the study period , as it was persistent in 56 % of the patients with fatigue . Conclusions : The authors confirmed the high prevalence of mental fatigue in patients with Parkinson disease ( PD ) .  Fatigue is related to other non-motor features such as depression and excessive daytime sleepiness , but can not be explained by this comorbidity alone . In more than half of the patients mental fatigue is persistent and seems to be an independent symptom that develops parallel to the progressive neurodegenerative disorder of PD Abstract : The aim of the study was to determine the possible effect of melatonin treatment on disturbed sleep , fatigue and pain symptoms observed in fibromyalgia ( FM ) patients . Twenty-one consecutive patients with FM were included in an open 4-week- duration pilot study . Before and after treatment with melatonin 3 mg at bedtime , patients were evaluated using tender point count by palpation of 18 classic anatomical regions , pain score in four pre design ated areas , pain severity on a 10 cm visual analogue scale ( VAS ) , sleep disturbances , fatigue , depression , anxiety , and patient and physician global assessment s , also by a VAS . Urine 6-sulphatoxymelatonin levels ( aMT-6S ) were measured in the patients and 20 age- and sex-matched controls . Nineteen patients completed the study . One patient withdrew because of migraine and another was lost to follow-up . At day 30 , median values for the tender point count and severity of pain at selected points , patient and physician global assessment s and VAS for sleep significantly improved with melatonin treatment . Other variables improved but did not reach statistical significance . Adverse events were mild and transient . Lower levels of aMT-6S were found in FM patients compared with normal median controls ( ±SD , 9.16 ± 7.9 μg/24 h vs 16.8 ± 12.8 μg/24 h ) ( p= 0.06 ) . Although this is an open study , our preliminary results suggest that melatonin can be an alternative and safe treatment for patients with FM . Double-blind placebo controlled studies are needed The purpose of this study was to determine if breast cancer survivors ( BCS ) with insomnia  can be grouped according to their level of fatigue . A secondary data analysis was conducted on baseline data obtained from a r and omized clinical trial that focused on a cognitive-behavioral intervention for insomnia in BCS . Participants were BCS ( n = 86 ) with insomnia who were at least 3 months after completion of primary treatment without current evidence of disease . Three subgroups of women were identified with significant differences in fatigue , including exhausted ( 35 % ) , tired ( 41 % ) , and restored ( 24 % ) . Results suggest that most women have moderate to severe fatigue many years after completion of treatment . Severe fatigue was associated with higher levels of other symptoms and poorer quality of life ( exhausted subgroup ) . Significant differences in insomnia severity , anxiety , depression , and quality of life were noted among the exhausted , tired , and restored subgroups . The existence of fatigue-based subgroups offers important information when providing care to BCS . By determining symptoms associated with fatigue , patient care will benefit through a shift in focus from treatment of a single symptom such as fatigue to the delivery of a tailored intervention that targets multiple symptoms PURPOSE / OBJECTIVES To evaluate the changes in reports of fatigue , sleep disturbances , and depressive symptoms and serum cortisol , melatonin , serotonin , and bilirubin during adjuvant chemotherapy in women with breast cancer and to determine whether any correlations exist between the symptom parameters and biomarkers . DESIGN Prospect i ve longitudinal , correlational , repeated- measures pilot study . SETTING Large southwestern , university-based , National Cancer Institute- design ated cancer center . SAMPLE 22 subjects ( 11 women with stage II breast cancer receiving adjuvant chemotherapy and 11 cancer-free women who were matched by age , ethnicity , and menopausal status ) . METHODS Question naires ( fatigue , sleep , depressive symptoms ) , wrist sleep actigraphy , and laboratory analysis of serum sample s.  All subjects ( i.e. , women with breast cancer receiving chemotherapy and a comparison group of cancer-free women who were matched by age , ethnicity , and menopausal status ) were admitted to a general clinical research center for two nights during cycles 1 and 4 for data collection . MAIN RESEARCH VARIABLES Biomarkers ( serum cortisol , melatonin , serotonin , and bilirubin ) , fatigue , sleep , and depressive symptoms . FINDINGS Mean fatigue scores of the subjects with cancer were significantly higher than the healthy comparison group . Subjects with cancer had a significantly lower mean actual sleep time compared to the comparison group at cycle 1 . No significant difference was found between the groups at cycle 4 . Depression scores also differed significantly between the cancer group and comparison group . Select biomarkers changed over time and were associated with subjective parameters of fatigue , sleep , and depressive symptoms . CONCLUSIONS Findings suggest that fatigue , sleep , and depressive symptoms are more prevalent in women with cancer than a cancer-free comparison group . Biomarkers changed over time and provide a possible explanatory mechanism for the three related symptoms . IMPLICATION S FOR NURSING Data help to explain a mechanism that may underlie fatigue , sleep , and depressive symptoms and provide a theoretical framework from which to establish evidence -based interventions for symptom management CONTEXT Breast cancer patients often experience multiple symptoms and substantial discomfort . Some symptoms may occur simultaneously and throughout the duration of chemotherapy treatment . OBJECTIVES The aim of this study was to investigate symptom severity and symptom cluster trajectories during chemotherapy in out patients with breast cancer in Taiwan . METHODS This prospect i ve , longitudinal , repeated measures study administered a st and ardized question naire ( M. D. And erson Symptom Inventory Taiwan version ) to 103 breast cancer patients during each day of the third 21-day cycle of chemotherapy . Latent class growth analysis was performed to examine symptom cluster trajectories . RESULTS Three symptom clusters were identified within the first 14 days of the 21-day chemotherapy cycle : the neurocognition cluster ( pain , shortness of breath , vomiting , memory problems , and numbness/tingling ) with a trajectory of Y = 2.09 - 0.11 ( days ) , the emotion-nausea cluster ( nausea , disturbed sleep , distress/upset , drowsiness , and sadness ) with a trajectory ofY = 3.57 - 0.20 ( days ) , and the fatigue-anorexia cluster ( fatigue , lack of appetite , and dry mouth ) with a trajectory of Y = 4.22 - 0.21 ( days ) . The " fatigue-anorexia cluster " and " emotion-nausea cluster " peaked at moderate levels on chemotherapy days 3 - 5 , and then gradually decreased to mild levels within the first 14 days of the 21-day chemotherapy cycle . CONCLUSION Distinct symptom clusters were observed during the third cycle of chemotherapy . Systematic and ongoing evaluation of symptom cluster trajectories during cancer treatment is essential . Healthcare providers can use these findings to enhance communication with their breast cancer patients and to prioritize symptoms that require attention and intervention BACKGROUND AND PURPOSE Fatigue is a common and disabling non-motor symptom in Parkinson 's disease ( PD ) . The pathogenesis is unknown , and the treatment options are limited . The aim of the present study was to investigate the development of fatigue during the first year after diagnosis . METHODS The study design was a prospect i ve , controlled population -based longitudinal cohort study , comprising 181 de novo , drug-naïve patients with PD and 162 control participants . PD was diagnosed according to the Gelb criteria .  Fatigue was assessed by the Fatigue Severity Scale ( FSS ) . Both groups were assessed for fatigue at baseline and after 1 year . RESULTS Patients reported more fatigue than the control subjects at baseline and at the 1-year follow-up evaluation . The FSS scores in the patient group improved from a mean score of 4.4 ( SD 1.6 ) to 4.0 ( SD 1.6 ) . Patients with fatigue at baseline received higher doses of dopaminergic medication during follow-up . Patients who received dopamine agonists improved slightly more than patients who received levodopa . A regression analysis did not show a correlation between an improvement in fatigue and a change in disease severity , depressive symptoms , sleep problems , apathy or cognitive impairment . CONCLUSION Fatigue is a common symptom in PD , also in early , untreated patients . During the first year of observation , an improvement in the fatigue scores was found . The improvement could not be attributed to a change in disease severity or depressive symptoms . The results indicate a better effect of dopamine agonists than of levodopa . This may have implication s for treatment in patients with PD-associated fatigue PURPOSE / OBJECTIVES To examine the relationships among pain , fatigue , insomnia , and gender while controlling for age , comorbidities , and stage of cancer in patients newly diagnosed with lung cancer within 56 days of receiving chemotherapy .  DESIGN Secondary data analysis . SETTING Accrual from four sites : two clinical community oncology programs and two comprehensive cancer centers . SAMPLE 80 patients newly diagnosed with lung cancer . METHODS Analysis from baseline observation of a r and omized clinical intervention trial . Multinomial log-linear modeling was performed to explain the relationships among pain , fatigue , insomnia , and gender . MAIN RESEARCH VARIABLES Pain , fatigue , insomnia , and gender . FINDINGS For all people with lung cancer , fatigue ( 97 % ) and pain ( 69 % ) were the most frequently occurring symptoms ; insomnia occurred 51 % of the time . A model containing all main effects ( two-way interactions of pain and fatigue , pain and insomnia , and insomnia and gender ; and the three-way interaction of pain , fatigue , and insomnia , along with three covariates [ age , comorbidities , and stage of cancer ] ) was a good fit to the data . Parameter estimates indicated that a statistically significant effect from the model was the three-way interaction of pain , fatigue , and insomnia . Gender did not make a difference . Age , comorbidities , and stage of cancer were not significant covariates . CONCLUSIONS For people newly diagnosed with lung cancer undergoing chemotherapy  , multiple symptoms occur simultaneously rather than in isolation ; a symptom cluster exists , consisting of pain , fatigue , and insomnia ; and no relationship was found among gender , pain , fatigue , and insomnia . IMPLICATION S FOR NURSING By underst and ing this symptom cluster , healthcare providers can target specific troublesome symptoms to optimize symptom management and achieve the delivery of high- quality cancer care BACKGROUND Fatigue is a frequently occurring symptom in patients with chronic obstructive pulmonary disease ( COPD ) . Despite this , relatively few studies have objective ly assessed patients ' perceptions of fatigue and the impact of perceived fatigue on their everyday lives . OBJECTIVE The purpose of this study was to describe the prevalence , duration and severity of fatigue among patients with COPD and the impact of perceived fatigue on cognitive , physical and psychosocial functioning in comparison with controls . METHOD The  Fatigue Impact Scale , including physical , psychosocial and cognitive dimension and structured questions about the frequency , duration , and severity of fatigue  was mailed to 44 out patients with COPD and 88 r and omly selected age- and sex-matched controls . In total 36 patients and 37 controls completed the question naire . RESULTS Almost half of the patients ( 47.2 % ) , reported fatigue every day during the preceding month compared with 13.5 % of the control group ( P < 0.001 ) . The duration of fatigue was more than 6 hours in 52.7 % of the patients and 44.4 % reported that fatigue was either the worst or one of the worst symptoms they had , compared with 18.9 % ( P < 0.001 ) and 10.8 % ( P < 0.01 ) in the control group . The patients reported a significantly greater impact of fatigue on cognitive , physical and psychosocial functioning compared with the control group ( P < 0.001 ) . CONCLUSION These findings indicate that fatigue is a highly prevalent symptom , which impacts on patients ' functional condition and needs to be professionally assessed and managed Purpose Cancer-related fatigue ( CRF ) is a disruptive symptom for many survivors . Despite promising evidence for efficacy of mindfulness-based stress reduction ( MBSR ) in reducing CRF , no trials comparing it to an active comparator for fatigued survivors have been published . The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms . Methods Breast ( n = 60 ) and colorectal ( n = 11 ) cancer survivors ( stage 0–III ) with clinical ly significant CRF after completing chemotherapy and /or radiation therapy an average of 28 months prior to enrollment were r and omized to MBSR or psychoeducation/support groups ( PES ) . MBSR focused on mindfulness training ; PES focused on CRF self-management . Outcomes included CRF interference ( primary ) , CRF severity and global improvement , vitality , depression , anxiety , sleep disturbance , and pain . Outcomes were assessed at baseline ( T1 ) , post-intervention ( T2 ) , and 6-month follow-up ( T3 ) using intent-to-treat analysis . Results Between-group differences in CRF interference were not significant at any time point ; however , there was a trend favoring MBSR ( d = −0.46 , p = 0.073 ) at T2 . MBSR participants reported significantly greater improvement in vitality ( d = 0.53 , p = 0.003 ) and were more likely to report CRF as moderately to completely improved compared to the PES group ( χ2 ( 1 ) = 4.1765 , p = 0.041 ) at T2 . MBSR participants also reported significantly greater reductions in pain at T2 ( d = 0.53 , p = 0.014 ) . In addition , both MBSR and PES produced moderate-to-large and significant within-group improvements in all fatigue outcomes , depression , anxiety , and sleep at T2 and T3 compared to T1 . Conclusion MBSR and PES appear efficacious for CRF and related symptoms . Larger trials including a usual care arm are warranted . Trial Registration Clinical Trials.gov Identifier : NCT01724333 To investigate prevalence and severity of symptoms and symptom clustering in breast cancer survivors who attended MBSR(BC ) .  Women were r and omly assigned into MBSR(BC ) or Usual Care ( UC ) . Eligible women were ≥ 21 years , had been diagnosed with breast cancer and completed treatment within 18 months of enrollment . Symptoms and interference with daily living were measured pre- and post-MBSR(BC ) using the M.D. And erson Symptom Inventory . Symptoms were reported as highly prevalent but severity was low . Fatigue was the most frequently reported and severe symptom among groups . Symptoms clustered into 3 groups and improved in both groups . At baseline , both  MBSR(BC ) and the control groups showed similar mean symptom severity and interference ; however , after the 6-week post-intervention , the MBSR(BC ) group showed statistically-significant reduction for fatigue and disturbed sleep ( P < 0.01 ) and improved symptom interference items , compared to the control group . For the between-group comparisons , 11 of 13 symptoms and 5 of 6 interference items had lower means in the MBSR(BC ) condition than the control condition . These results suggest that MBSR(BC ) modestly decreases fatigue and sleep disturbances , but has a greater effect on the degree to which symptoms interfere with many facets of life . Although these results are preliminary , MBSR intervention post-treatment may effectively reduce fatigue and related interference in QOL of breast cancer survivors Background and Purpose — Fatigue is a common , persistent consequence of stroke , and no evidence -based treatments are currently available to alleviate fatigue . A new treatment combining cognitive therapy ( CO ) with grade d activity training ( GRAT ) , called COGRAT , was developed to alleviate fatigue and fatigue-related symptoms . This study compared the effectiveness of the COGRAT intervention with a CO-only intervention after a 3-month qualification period without intervention . Methods — This r and omized , controlled , assessor-blind clinical trial was conducted in 8 rehabilitation centers . Eighty-three stroke patients ( > 4 months after stroke ) were r and omly assigned to 12 weeks of CO or COGRAT after qualification . Seventy-three patients completed treatment and 68 were available at follow-up . Primary outcomes ( Checklist Individual Strength – subscale Fatigue ( CIS-f ) ; self-observation list – fatigue ( SOL-f ) ) and secondary outcomes ( Hospital Anxiety and Depression Scale , Stroke-Adapted Sickness Impact Profile , SOL-pain , SOL-sleep-D , 6-minute walk test ) were collected at baseline ( before and after qualification period ) and after treatment ( immediate and 6-month follow-up ) . Results — The qualification period showed stable outcome measures . Both treatments showed significant beneficial effects on fatigue ( CIS-f : & eegr;p2=0.48 , P<0.001 ) and other outcomes ( except pain and anxiety ) with intention-to-treat analyses . Gains for the COGRAT group exceeded those in the CO group on number of individuals showing clinical improvement on the CIS-f ( ≥8 points : 58 % versus 24 % ) and on physical endurance ( & eegr;p2=0.20 , P<0.001 ) . Conclusions — A 12-week cognitive therapy program can alleviate persistent fatigue after stroke . The best results are obtained when cognitive therapy is augmented with grade d activity training . Clinical Trial Registration — URL : http://www.trialregister.nl . Unique identifier : NTR2704 Abstract Background Fibromyalgia is a prevalent and disabling disorder characterized by widespread pain and other symptoms such as insomnia , fatigue or depression . Catastrophization is considered a key clinical symptom in fibromyalgia ; however , there are no studies on the pharmacological or psychological treatment of catastrophizing . The general aim of this study is to assess the effectiveness of cognitive-behaviour therapy and recommended pharmacological treatment for fibromyalgia ( pregabalin , with duloxetine added where there is a comorbid depression ) , compared with usual treatment at primary care level . Method / design Design : A multi-centre , r and omized controlled trial involving three groups : the control group , consisting of usual treatment at primary care level , and two intervention groups , one consisting of cognitive-behaviour therapy , and the other consisting of the recommended pharmacological treatment for fibromyalgia . Setting : 29 primary care health centres in the city of Zaragoza , Spain . Sample : 180 patients , aged 18–65 years , able to underst and and read Spanish , who fulfil criteria for primary fibromyalgia , with no previous psychological treatment , and no pharmacological treatment or their acceptance to discontinue it two weeks before the onset of the study . Intervention : Psychological treatment is based on the manualized protocol developed by Prof. Escobar et al , from the University of New Jersey , for the treatment of somatoform disorders , which has been adapted by our group for the treatment of fibromyalgia . It includes 10 weekly sessions of cognitive-behaviour therapy . Pharmacological therapy consists of the recommended pharmacological treatment for fibromyalgia : pregabalin ( 300–600 mg/day ) , with duloxetine ( 60–120 mg/day ) added where there is a comorbid depression ) . Measurements : The following socio-demographic data will be collected : sex , age , marital status , education , occupation and social class . The diagnosis of psychiatric disorders will be made with the Structured Polyvalent Psychiatric Interview . Other instruments to be administered are the Pain Catastrophizing Scale , the Hamilton tests for Anxiety and for Depression , the Fibromyalgia Impact Question naire ( FIQ ) , the EuroQuol-5 domains ( EQ-5D ) , and the use of health and social services ( CSRI ) . Assessment s will be carried out at baseline , 1 , 3 , and 6 months . Main variable : Pain catastrophizing . Analysis : The analysis will be per intent to treat . We will use the general linear models of the SPSS version 15 statistical package , to analyse the effect of the treatment on the result variable ( pain catastrophizing ) . Discussion It is necessary to assess the effectiveness of pharmacological and psychological treatments for pain catastrophizing in fibromyalgia . This r and omized clinical trial will determine whether both treatments are effective for this important prognostic variable in patients with fibromyalgia . Trial registration Current Controlled Trials IS RCT OBJECTIVE The aim of this study was to investigate the effectiveness of a 6-week traditional exercise program with supplementary whole-body vibration ( WBV ) in improving health status , physical functioning , and main symptoms of fibromyalgia ( FM ) in women with FM . METHODS Thirty-six ( 36 ) women with FM ( mean + /- st and ard error of the mean age 55.97 + /- 1.55 ) were r and omized into 3 treatment groups : exercise and vibration ( EVG ) , exercise ( EG ) , and control ( CG ) . Exercise therapy , consisting of aerobic activities , stretching , and relaxation techniques , was performed twice a week ( 90 min/day ) . Following each exercise session , the EVG underwent a protocol with WBV , whereas the EG performed the same protocol without vibratory stimulus . The Fibromyalgia Impact Question naire ( FIQ ) was administered at baseline and 6 weeks following the initiation of the treatments . Estimates of pain , fatigue , stiffness , and depression were also reported using the visual analogue scale . RESULTS A significant 3 x 2 ( group x time)-repeated measures analysis of variance interaction was found for pain ( p = 0.018 ) and fatigue ( p = 0.002 ) but not for FIQ ( p = 0.069 ) , stiffness ( p = 0.142 ) , or depression ( p = 0.654 ) . Pain and fatigue scores were significantly reduced from baseline in the EVG , but not in the EG or CG . In addition , the EVG showed significantly lower pain and fatigue scores at week 6 compared to the CG , whereas no significant differences were found between the EG and CG ( p > 0.05 ) . CONCLUSION Results suggest that a 6-week traditional exercise program with supplementary WBV safely reduces pain and fatigue , whereas exercise alone fails to induce improvements Abstract . The aim of this study was to evaluate the effectiveness of balneotherapy on patients with fibromyalgia ( FM ) at the Dead Sea . Forty-eight patients with FM were r and omly assigned to a treatment group receiving sulfur baths and a control group .  All participants stayed for 10 days at a Dead Sea spa .  Physical functioning , FM-related symptoms , and tenderness measurements ( point count and dolorimetry ) were assessed at four time points : prior to arrival at the Dead Sea , after 10 days of treatment , and 1 and 3 months after leaving the spa . Physical functioning and tenderness moderately improved in both groups . With the exception of tenderness threshold , the improvement was especially notable in the treatment group and it persisted even after 3 months . Relief in the severity of FM-related symptoms ( pain , fatigue , stiffness , and anxiety ) and reduced frequency of symptoms ( headache , sleep problems , and subjective joint swelling ) were reported in both groups but lasted longer in the treatment group . In conclusion , treatment of FM at the Dead Sea is effective and safe and may become an additional therapeutic modality in FM . Future studies should address the outcome and possible mechanisms of this treatment in FM patients OBJECTIVE Multidisciplinary treatments ( MTs ) are usually recommended for reducing fibromyalgia ( FM ) symptoms and include physical exercise , drug management , education , and cognitive behavior therapy ( CBT ) . However , there is no evidence that CBT adds efficacy to the other therapeutic components . This r and omized controlled trial analyzed the response of FM patients to two MTs , with and without CBT , according to the presence of concurrent symptoms . METHODS Eighty-three women with FM were r and omly assigned to MT or combined MT and CBT . The MT included medical intervention , physical training , education , and discussion of the syndrome . The CBT focused on coping with stress , modifying lifestyles , and changing pain behaviors . Demographic and clinical data , information regarding tender points , and question naire responses about functional capability [ Fibromyalgia Impact Question naire ( FIQ ) ] , health status [ 36-item Short Form Health Survey ( SF-36 ) ] , and mental health [ Symptom Checklist-90-Revised ( SCL-90-R ) ] were obtained at the beginning , at the end of the 15-week treatment , and at 6-month follow-up . Subgroups are identified in relation to treatment response . RESULTS Sixty-six women ( 80 % ) completed treatment . Although the variance of the total sample had changed at posttreatment ( F=2.67 , P=.031 ) , there was no significant effect for the TimexTreatment interaction ( F=1.65 , P=.16 ) . Univariate tests detected a significant fall in the FIQ score . The subgroup of patients with fatigue showed a better response with MT+CBT than with MT . At 6-month follow-up , the statistical differences had been maintained . Intention-to-treat analysis ratified these results . CONCLUSIONS MT improves functional capability and reduces symptom impact . CBT increases mildly the effect of MT in patients with fatigue Sleep disturbances play an important role in the exacerbation of pain and other troubling symptoms reported by patients with fibromyalgia ( FM ) . The objective of this trial was to analyze the efficacy of a cognitive-behavioral therapy for insomnia ( CBT-I ) versus a sleep hygiene ( SH ) education program at improving sleep and other clinical manifestations in FM . Sixty-four FM women with insomnia were r and omly assigned to the CBT-I or the SH groups , and 59 completed the treatments ( 30 in the CBT-I group and 29 in the SH group ) . Participants completed several self-report question naires at pre- , post-treatment and follow-ups . The CBT-I group reported significant improvements at post-treatment in several sleep variables , fatigue , daily functioning , pain catastrophizing , anxiety and depression . The SH group only improved significantly in subjective sleep quality . Patients in the CBT-I group showed significantly greater changes than those in the SH group in most outcome measures . The findings underscore the usefulness of CBT-I in the multidisciplinary management of FM Summary Pain and fatigue during movement , but not at rest , are reduced by a onetime 30‐m treatment with active transcutaneous electrical nerve stimulation ( TENS ) in individuals with fibromyalgia . Abstract Because transcutaneous electrical nerve stimulation ( TENS ) works by reducing central excitability and activating central inhibition pathways , we tested the hypothesis that TENS would reduce pain and fatigue and improve function and hyperalgesia in people with fibromyalgia who have enhanced central excitability and reduced inhibition . The current study used a double‐blinded r and omized , placebo‐controlled cross‐over design to test the effects of a single treatment of TENS with people with fibromyalgia . Three treatments were assessed in r and om order : active TENS , placebo TENS and no TENS . The following measures were assessed before and after each TENS treatment : pain and fatigue at rest and in movement ; pressure pain thresholds , 6‐m walk test , range of motion ; 5‐time sit‐to‐st and test , and single‐leg stance . Conditioned pain modulation was completed at the end of testing . There was a significant decrease in pain and fatigue with movement for active TENS compared to placebo and no TENS . Pressure pain thresholds increased at the site of TENS ( spine ) and outside the site of TENS ( leg ) when compared to placebo TENS or no TENS . During active TENS  , conditioned pain modulation was significantly stronger compared to placebo TENS and no TENS . No changes in functional tasks were observed with TENS . Thus , the current study suggests TENS has short‐term efficacy in relieving symptoms of fibromyalgia while the stimulator is active . Future clinical trials should examine the effects of repeated daily delivery of TENS , similar to the way in which TENS is used clinical ly on pain , fatigue , function , and quality of life in individuals with fibromyalgia & NA ; Both pharmacological and non‐pharmacological interventions have demonstrated efficacy in the management of fibromyalgia ( FM ) .  Non‐pharmacological interventions however are far less likely to be used in clinical setting s , in part due to limited access . This manuscript presents the findings of a r and omized controlled trail of an Internet‐based exercise and behavioral self‐management program for FM design ed for use in the context of a routine clinical care . 118 individuals with FM were r and omly assigned to either ( a ) st and ard care or ( b ) st and ard care plus access to a Web‐Enhanced Behavioral Self‐Management program ( WEB‐SM ) grounded in cognitive and behavioral pain management principles . Individuals were assessed at baseline and again at 6 months for primary endpoints : reduction of pain and an improvement in physical functioning . Secondary outcomes included fatigue , sleep , anxiety and depressive symptoms , and a patient global impression of improvement . Individuals assigned to the WEB‐SM condition reported significantly greater improvement in pain , physical functioning , and overall global improvement . Exercise and relaxation techniques were the most commonly used skills throughout the 6 month period . A no‐contact , Internet‐based , self‐management intervention demonstrated efficacy on key outcomes for FM . While not everyone is expected to benefit from this approach , this study demonstrated that non‐pharmacological interventions can be efficiently integrated into routine clinical practice with positive outcomes Fibromyalgia syndrome is a systemic disorder of widespread pain which is thought to result from abnormal pain processing within the central nervous system . There are no currently approved treatments for this indication . Antidepressants appear , however , to be effective , especially those with an action on noradrenergic neurotransmission . The objective of the present study was to test the efficacy of the dual action noradrenaline and serotonin reuptake inhibitor antidepressant , milnacipran , in the treatment of fibromyalgia . The 125 patients , who were enrolled in a double-blind , placebo-controlled , flexible dose escalation trial , were r and omized to receive placebo or milnacipran for 4 weeks of dose escalation ( up to 200 mg/day ) , followed by 8 weeks at a constant dose . The study evaluated the efficacy and safety of milnacipran for the treatment of pain and associated symptoms such as fatigue , depressed mood and sleep . 75 % of milnacipran-treated patients reported overall improvement , compared with 38 % in the placebo group ( p < 0.01 ) . Furthermore , 37 % of twice daily milnacipran-treated patients reported at least 50 % reduction in pain intensity , compared with 14 % of placebo-treated patients ( p < 0.05 ) . 84 % of all milnacipran patients escalated to the highest dose ( 200 mg/day ) with no tolerability issues . Most adverse events were mild to moderate in intensity , and transient in duration . These results suggest that milnacipran may have the potential to relieve not only pain but several of the other symptoms associated with fibromyalgia The aim of this exploratory study was to systematic ally assess the potential effectiveness and tolerability of quetiapine , an atypical antipsychotic , for the treatment of patients with fibromyalgia . This was a unicentre , open-label study conducted in thirty-five out patients , 18 years or older , who met the ACR criteria for fibromyalgia and who had not satisfactorily responded to their previous fibromyalgia treatment .  Quetiapine , flexibly dosed ( 25 - 100 mg/day ) , was added to their original treatment regimen for 12 weeks . The primary outcome measure was the mean change from baseline to endpoint in the Fibromyalgia Impact Question naire ( FIQ ) total score . Secondary efficacy measures included mean changes from baseline to endpoint in the scores of the Clinical Global Impression ( CGI ) of Severity scale , Pittsburgh Sleep Quality Index ( PSQI ) , Beck Depression Inventory ( BDI ) , State-Trait Anxiety Inventory ( STAI ) , 12-Item Short Form Health Survey ( SF-12 ) , and individual items of the FIQ .  Thirty ( 85.7 % ) patients ( mean age 47+/-7.9 , 93.3 % females ) had a postbaseline evaluation and constituted the intent-to-treat efficacy sample . Mean FIQ total score decreased significantly by 10.2 points from a baseline of 63.2 to 53.0 at study endpoint ( p<0.001 ) . A statistically significant reduction was observed in FIQ stiffness and FIQ fatigue subscores but not in FIQ pain subscore . Large effect sizes were observed for the FIQ total ( 1.04 ) , CGI-severity ( 1.00 ) and PSQI ( 1.07 ) , while moderate effect sizes ( i.e. > or = 0.50 ) were encountered in the FIQ fatigue , FIQ stiffness and SF-12 mental component summary .  Quetiapine was safely administered and well tolerated . Despite the lack of effect on pain , the significant and relevant improvement in overall efficacy measures and quality of life suggests that quetiapine may be a valuable drug for treatment of patients with fibromyalgia that should be further tested in double-blind , placebo-controlled trials Objective : To determine the incidence and duration of response of clinical ly meaningful improvements with pregabalin across several key symptoms of fibromyalgia ( FM ) . Methods : This was a post hoc analysis of data from a multicenter , double-blind , placebo-controlled , r and omized , withdrawal study , originally design ed to evaluate the efficacy of pregabalin monotherapy for durability of effect on FM pain based on pain and Patient Global Impression of Change ( PGIC ) criteria . Responder criteria for Fibromyalgia Impact Question naire total score ( ≥16-point change ) , Medical Outcomes Study Sleep Scale Sleep Disturbance subscale ( ≥15.8-point change ) , and the 36-item Short-Form Health Survey Vitality scale ( ≥10-point change ) were used to evaluate the incidence and duration of improvements in function , sleep , and fatigue  for pregabalin versus placebo among pain and PGIC responders . A composite responder index consisting of pain , PGIC , function , and sleep endpoints was used to explore multidimensional response . Results : Approximately 80 % of patients meeting pain and PGIC improvement criteria at r and omization had clinical ly meaningful improvement in fatigue , sleep , or function . Higher proportions of patients in the pregabalin group maintained a clinical ly meaningful response , and pregabalin-treated patients had a significantly longer time to loss of therapeutic response  compared with the placebo group . Composite responder Kaplan-Meier analysis , performed with patients demonstrating clinical ly meaningful improvements in pain , PGIC , function , and sleep at r and omization showed a significantly longer median time to loss of therapeutic response for pregabalin-treated patients . Discussion : The results from this post hoc analysis indicate that pregabalin provides long-term effects across multiple domains of FM ( Clinical Trials.gov registry ID : NCT00151489 ) BACKGROUND Fatigue is a common symptom for which patients consult their doctors in primary care . With usual medical management the majority of patients report that their symptoms persist and become chronic . There is little evidence for the effectiveness of any fatigue management in primary care . AIM To compare the effectiveness of cognitive behaviour therapy ( CBT ) with counselling for patients with chronic fatigue and to describe satisfaction with care . DESIGN OF STUDY R and omised trial with parallel group design . SETTING Ten general practice s located in London and the South Thames region of the United Kingdom recruited patients to the trial between 1996 and 1998 . Patients came from a wide range of socioeconomic background s and lived in urban , suburban , and rural areas . METHOD Data were collected before r and omisation , after treatment , and six months later . Patients were offered six sessions of up to one hour each of either CBT or counselling . Outcomes include : self-report of fatigue symptoms six months later , anxiety and depression , symptom attributions , social adjustment and patients ' satisfaction with care . RESULTS One hundred and sixty patients with chronic fatigue entered the trial , 45 ( 28 % ) met research criteria for chronic fatigue syndrome ; 129 completed follow-up . All patients met Chalder et al 's st and ard criteria for fatigue . Mean fatigue scores were 23 on entry ( at baseline ) and 15 at six months ' follow-up . Sixty-one ( 47 % ) patients no longer met st and ard criteria for fatigue after six months . There was no significant difference in effect between the two therapies on fatigue ( 1.04 [ 95 % CI = -1.7 to 3.7 ] ) , anxiety and depression or social adjustment outcomes for all patients and for the subgroup with chronic fatigue syndrome . Use of antidepressants and consultations with the doctor decreased after therapy but there were no differences between groups . CONCLUSION Counselling and CBT were equivalent in effect for patients with chronic fatigue in primary care . The choice between therapies can therefore depend on other considerations , such as cost and accessibility Abstract Eight women who were in treatment for breast cancer ( n = 4 ) or breast cancer survivors ( n = 4 ) , presenting with 1 or more of 4 symptoms ( chronic pain , fatigue , hot flashes , and sleep difficulties ) , were given 4 to 5 sessions of self-hypnosis training for symptom management . Analyses revealed ( a ) significant pre- to posttreatment decreases in pain intensity , fatigue , and sleep problems and ( b ) that pain intensity continued to decrease from posttreatment to 6-month follow-up . Although there was a slight increase in fatigue severity and sleep problems from posttreatment to 6-month follow-up , the follow-up scores did not return to pretreatment levels . The findings provide initial support for using hypnosis to manage symptoms in women who are breast cancer survivors . Clinical trials evaluating hypnosis efficacy over and above other treatments are warranted The present study examined the symptom cluster of fatigue , pain , and depression , and its direct and indirect prediction of physical  activity  behavior in a sample of individuals with multiple sclerosis ( MS ) using a prospect i ve research design and the Theory of Unpleasant Symptoms . The sample included 292 individuals with a definite diagnosis of MS . The participants completed self-report measures of fatigue , depression , pain , self-efficacy , and functional limitations at baseline and six months later , wore an accelerometer for seven days and completed a self-report measure of physical activity behavior .  The data analysis indicated that : 1 ) fatigue , depression , and pain represented a symptom cluster ; 2 ) the symptom cluster had a strong and negative predictive relationship with physical activity behavior ; and 3 ) functional limitations , but not self-efficacy , accounted for the predictive relationship between the symptom cluster and physical activity behavior . Such findings provide preliminary support to the importance of considering symptom clusters as a meaningful correlate of physical activity behavior in persons with MS Objective . Sleep disturbance and chronic fatigue are common in rheumatoid arthritis ( RA ) and contribute to disability , symptomatology , and healthcare use . It has long been recognized in other population s that exercise can improve sleep and diminish fatigue . The effect of exercise on sleep quality and fatigue in RA has not been evaluated . Methods . Ours is a r and omized controlled study in RA to determine the effect of an exercise program on sleep quality and fatigue . These were measured using the Pittsburgh Sleep Quality Index and the Fatigue Severity Scale .  Patients were r and omized to either a 12-week , home-based exercise intervention or usual care . The exercise program consisted of specific exercises to target individual deficiencies identified using the Health Assessment Question naire ( HAQ ) with cardiovascular work as per the guidelines . The intervention group was evaluated on a 3-week basis . Full evaluation was carried out at baseline and at 12 weeks . Results . Forty patients were r and omized to the intervention with 38 controls . In the exercise intervention group , there was a statistically significant improvement in HAQ ( p = 0.00 ) , pain ( p = 0.05 ) , stiffness ( p = 0.05 ) , sleep quality ( p = 0.04 ) , and fatigue ( p = 0.04 ) . In our control group , there was a statistically significant improvement demonstrated in their overall perceptions of the benefits of exercise , but none of the other variables . Conclusion . Our study demonstrates that an exercise program result ed in significant improvement in sleep quality and fatigue . This is particularly interesting given the importance of fatigue as an outcome measure in RA and gives us yet another reason to prescribe exercise in this population OBJECTIVE To evaluate the effectiveness of a modified Myers ' formula of intravenous nutrient therapy ( IVNT ) on the symptoms of fibromyalgia ( FM ) in therapy-resistant FM patients . METHODS In this pilot clinical trial , 7 participants with therapy resistant FM were given IVNT once per week for 8 weeks . Patient 's pain levels , fatigue , and activities of daily living were evaluated weekly . RESULTS All participants reported decreased pain levels , decreased fatigue , and increased activities of daily living . Participants noted increased energy levels within 24 - 48 hours of the initial infusion . At the end of the study , all participants reported increased energy and activities of daily living as well as a 60 % reduction in pain ( P=.005 ) and an 80 % decrease in fatigue ( P=-.005 ) . No participants , however , reported complete or lasting resolution of pain or fatigue . No side effects were reported . DISCUSSION Anecdotal reports have indicated benefit for IVNT for patients with chronic pain , including FM . However , except for 2 reports , the medical literature is devoid of any studies of IVNT for the treatment of FM . In this pilot study , 7 participants received  IVNT  once a week for 8 weeks . All participants had long-st and ing FM ( at least 8 years ) and had tried conventional therapies , such as antidepressants , nonsteroidal anti-inflammatory drugs , and exercise , without significant or lasting relief . All had improvement in symptoms and increases in their activities of daily living , although no participant reported complete resolution of symptoms .  IVNT appears to be safe to reduce FM symptoms Abstract Objective : To assess the efficacy of an educational intervention explaining symptoms to encourage grade d exercise in patients with chronic fatigue syndrome . Design : R and omised controlled trial . Setting : Chronic fatigue clinic and infectious diseases outpatient clinic . Subjects : 148 consecutively referred patients fulfilling Oxford criteria for chronic fatigue syndrome . Interventions : Patients r and omised to the control group received st and ardised medical care .  Patients r and omised to intervention received two individual treatment sessions and two telephone follow up calls , supported by a comprehensive educational pack , describing the role of disrupted physiological regulation in fatigue symptoms and encouraging home based grade d exercise . The minimum intervention group had no further treatment , but the telephone intervention group received an additional seven follow up calls and the maximum intervention group an additional seven face to face sessions over four months . Main outcome measure : A score of 25 or an increase of 10 on the SF-36 physical functioning subscale ( range 10 to 30 ) 12 months after r and omisation . Results : 21 patients dropped out , mainly from the intervention groups . Intention to treat analysis showed 79 ( 69 % ) of patients in the intervention groups achieved a satisfactory outcome in physical functioning compared with two ( 6 % ) of controls , who received st and ardised medical care ( P<0.0001 ) . Similar improvements were observed in fatigue , sleep , disability , and mood . No significant differences were found between the three intervention groups . Conclusions : Treatment incorporating evidence based physiological explanations for symptoms  was effective in encouraging self managed grade d exercise . This result ed in substantial improvement compared with st and ardised medical care Opioid-induced sedation is a major complication in patients with cancer pain . This study assessed the effectiveness of donepezil in opioid-induced sedation and related symptoms in patients with cancer pain . Twenty-seven patients who were receiving strong opioids for pain and reported sedation were enrolled .  Donepezil 5 mg was given every morning for 7 days . Changes between baseline and Day 7 in sedation , pain , fatigue and other symptoms were evaluated using the Edmonton Symptom Assessment Scale . Fatigue was also measured using the Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-Fatigue ) . Overall usefulness of donepezil was measured by the patient at the end of the study . In 20 evaluable patients , sedation , fatigue , anxiety , well-being , depression , anorexia and problems with sleep were significantly improved . Side effects included nausea , vomiting , diarrhea , muscle and abdominal cramps , and anorexia . Overall , however , the treatment was well tolerated .  Donepezil appears to improve sedation and fatigue in patients receiving opioids for cancer pain . R and omized controlled trials of this agent are justified Background : Few studies have evaluated an individualized home-based exercise prescription during and after cancer treatment . Objective : The purpose of this study was to evaluate the effectiveness of a home-based exercise training intervention , the Pro-self Fatigue Control Program on the management of cancer-related fatigue . Interventions / Methods : Participants ( N = 119 ) were r and omized into 1 of 3 groups : group 1 received the exercise prescription throughout the study ; group 2 received their exercise prescription after completing cancer treatment ; and group 3 received usual care . Patients completed the Piper Fatigue Scale , General Sleep Disturbance Scale , Center for Epidemiological Studies -Depression Scale , and Worst Pain Intensity Scale . Results : All groups reported mild fatigue levels , sleep disturbance , and mild pain , but not depression . Using multilevel regression analysis , significant linear and quadratic trends were found for change in fatigue and pain ( ie , scores increased , then decreased over time ) . No group differences were found in the changing scores over time . A significant quadratic effect for the trajectory of sleep disturbance was found , but no group differences were detected over time . No significant time or group effects were found for depression . Conclusions : Our home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment . The optimal timing of exercise remains to be determined . Implication s for Practice : Clinicians need to be aware that some physical activity is better than none , and there is no harm in exercise as tolerated during cancer treatment . Further analysis is needed to examine the adherence to exercise . More frequent assessment s of fatigue , sleep disturbance , depression , and pain may capture the effect of exercise OBJECTIVE To investigate prognostic factors in the course of the fibromyalgia syndrome ( FM ) from baseline to post-treatment . METHODS Fifty-seven patients with FM were examined in a r and omized intervention study . Pre-treatment variables were entered into linear regression analyses : gender , age , duration of disease , allocation to treatment , pain distribution ( based on a patient-made drawing ) , fatigue , sleep disturbance , and depressed mood ( based on visual analog scores ) , with pain distribution at treatment completion as the dependent variable . RESULTS Depressed mood at baseline was a significant predictor of sustained widespread pain at treatment completion . CONCLUSION The findings indicate a role for depressed mood as a predictive factor for treatment response OBJECTIVES This secondary analysis of data from a r and omised controlled trial explores associations between common symptom clusters and evaluates pre-treatment to post-treatment changes in clinical levels of these symptoms following cognitive behaviour therapy for insomnia ( CBT-I ) . METHODS Baseline data from 113 participants with insomnia were explored to establish rates of and associations between clinical levels of fatigue , anxiety and depression across the sample . Effects of CBT-I on this symptom cluster were also explored by examining changes in pre-treatment to post-treatment levels of fatigue , anxiety and depression . RESULTS At baseline , the most common symptom presentation was insomnia + fatigue , and 30 % of the sample reported at least three co-morbid symptoms . Post-CBT , the number of those experiencing clinical insomnia and clinical fatigue decreased . There were no changes in anxiety rates from baseline to post-treatment in the CBT group and modest reductions in rates of those with clinical depression . Seven individuals ( 9.6 % ) from the CBT group were completely symptom free at post-treatment compared with 0 % from the treatment as usual condition . Chi-square analysis revealed a significant relationship between group allocation and changes in symptoms of insomnia and fatigue . No such relationship was found between group allocation and mood variables . CONCLUSIONS These findings confirm the high rate of symptom co-morbidities among cancer patients and highlight strong associations between sleep and fatigue .  CBT-I appears to offer generalised benefit to the symptom cluster as a whole and , specifically , is effective in reducing fatigue , which exceeded clinical cut-offs prior to implementation of the intervention . This has implication s for the diagnosis/management of common symptoms in cancer patients Objective : There has long been a belief that depression contributes to fatigue in multiple sclerosis ( MS ) although supporting data are minimal at best . Clinical guidelines for the treatment of fatigue include recommendations for the treatment of depression in the absence of clear empirical support . The goal of this study was to examine the effects of treatment for depression on fatigue in MS . Methods : Sixty patients with a relapsing form of MS and moderate to severe depression were r and omly assigned to one of three vali date d 16‐week treatments for depression : individual cognitive behavioral therapy , group psychotherapy , or sertraline . Assessment s at baseline and treatment cessation included the primary outcome measure , fatigue assessment instrument ( FAI ) , and Beck depression inventory ( BDI ) . Results : The total FAI and the global fatigue severity subscale were significantly reduced over the course of treatment ( p values < .02 ) . Other subscales did not change significantly . Secondary analyses showed change in global fatigue severity was associated with change in BDI ( p = .03 ) but change in total FAI was only marginally related to change in BDI ( p = .05 ) . These relationships were due entirely to change in mood ( p values < .02 ) and not to change in cognitive or vegetative symptoms ( p values > .17 ) . Conclusions : These findings suggest that treatment for depression is associated with reductions in the severity of fatigue symptoms , and that this relationship is due primarily to treatment related changes in mood
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 .