Aerobic fitness, fatigue, and physical disability in systemic lupus erythematosus. A pilot study on the effects of exercise in patients with systemic lupus erythematosus. Assessments of fatigue and disease activity in patients with systemic lupus erythematosus enrolled in the Phase 2 clinical trial with blisibimod Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial Fatigue in systemic lupus erythematosus: a randomized controlled trial of exercise. Effects of supervised cardiovascular training program on exercise tolerance, aerobic capacity, and quality of life in patients with systemic lupus erythematosus. Placebo-controlled randomized clinical trial of fish oil’s impact on fatigue, quality of life, and disease activity in Systemic Lupus Erythematosus Factors determining participation in prevention trials among systemic lupus erythematosus patients: a qualitative study. Effectiveness of minimally supervised home aerobic training in patients with systemic rheumatic disease. The effect of dehydroepiandrosterone on lumbar spine bone mineral density in patients with quiescent systemic lupus erythematosus. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Consistency and validity of patient administered assessment of quality of life by the MOS SF-36; its association with disease activity and damage in patients with systemic lupus erythematosus. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis The different immunomodulation of indirect moxibustion on normal subjects and patients with systemic lupus erythematosus. A randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus. Design, quality, and bias in randomized controlled trials of systemic lupus erythematosus. Vitamin D intake and risks of systemic lupus erythematosus and rheumatoid arthritis in women Treatment of systemic lupus erythematosus (SLE) with piroxicam (Hotemin-Egis). Menstrual disorders in girls with systemic lupus erythematosus treated with cyclophosphamide. The use of methotrexate in steroid-resistant systemic lupus erythematosus. Phase I, randomized, double-blind, placebo-controlled, multiple intravenous, dose-ascending study of sirukumab in cutaneous or systemic lupus erythematosus. The Effects of Exercise Training on Fatigue and Dyspnea in Heart Failure
OBJECTIVE To measure aerobic fitness , muscle strength , fatigue , and physical disability in patients with systemic lupus erythematosus ( SLE ) . METHODS Ninety-three patients with SLE and 41 sedentary controls were recruited into the study . Aerobic fitness was assessed by monitoring peak and submaximal oxygen uptake , heart rate , duration of exercise , and perceived exertion during a treadmill-walking test . Strength was measured using voluntary isometric quadriceps contraction . Symptomatic measures included physical and mental fatigue , mood , sleep , and functional incapacity . RESULTS Compared to sedentary controls patients with SLE had significantly reduced levels of aerobic fitness ( mean VO2peak SLE patients , 23.2 ml/kg/min vs controls , 29.6 ml/kg/min ; p < 0.001 ) and reduced exercise capacity ( mean exercise duration SLE patients , 10.4 min vs controls , 13.1 min ; p < 0.001 ) . The SLE patients also had reduced muscle strength ( mean maximum voluntary quadriceps contraction SLE patients , 298 N vs controls , 376 N ; p = 0.003 ) . Resting lung function was also significantly worse in the SLE patients ( mean FEV , SLE patients , 2.6 l vs controls , 2.9 l ; p = 0.002 ) . Fatigue ( p < 0.001 ) , depressed mood ( p < 0.001 ) , poor sleep quality ( p < 0.001 ) , and functional incapacity ( p < 0.001 ) were all significantly greater in the SLE patients . Linear regression models suggested that physical disability correlated with aerobic fitness ( p < 0.001 ) , fatigue ( p = 0.005 ) , body mass index ( p = 0.01 ) , and depression ( p = 0.05 ) and that fatigue correlated with depression ( p < 0.001 ) . CONCLUSION Patients with SLE were less fit with reduced exercise capacity , reduced muscle strength , more fatigue , and greater disability compared to sedentary controls . Treatments developed to manage depression and improve aerobic fitness should be considered in the overall treatment of fatigue and disability in SLE OBJECTIVE A pilot study was design ed to assess the efficacy and safety of different exercise therapies on  patient-reported fatigue and functional status .  METHODS Ten patients with systemic lupus erythematosus ( SLE ) were r and omly placed in either an aerobic exercise group ( group 1 : n = 5 ) or a range of motion/muscle strengthening ( ROM/MS ) exercise group ( group 2 : n = 5 ) . Outcome measures assessed at baseline and the end of the study were fatigue , functional status , disease activity , cardiovascular fitness , isometric strength , bone mineral density ( BMD ) of the lumbar spine and femoral neck , and parathyroid hormone and osteocalcin as representative bone biochemical markers for bone resorption and bone formation , respectively . RESULTS Both aerobic and ROM/MS types of exercise were safe and did not worsen SLE disease activity . Patients in both exercise groups showed some improvement in fatigue , functional status , cardiovascular fitness , and muscle strength . Both groups showed increased bone turnover , but BMD was unchanged . Eighty percent of the patients met the compliance st and ard for the study . CONCLUSIONS This pilot study shows the feasibility of exercise for SLE patients . The potential value of this approach shows promise in the routine management of these patients This report evaluates the effects of blisibimod ( A-623 , AMG 623 ) , a potent and selective inhibitor of B-cell activating factor ( BAFF ) , on patient-reported fatigue and disease activity in the Phase 2b PEARL-SC clinical trial in patients with systemic lupus erythematosus ( SLE ) . A total of 547 individuals who met the American College of Rheumatology ( ACR ) classification criteria for SLE , were positive for anti-double-str and ed DNA or antinuclear antibodies , and had a Safety of Estrogens in Lupus Erythematosus National Assessment -Systemic Lupus Erythematosus Disease Activity Index ( SELENA-SLEDAI ) score ≥6 at baseline , were r and omized to receive placebo or blisibimod for at least 24 weeks . Patient self-reported fatigue was evaluated using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale , and disease activity was evaluated using Physician ’s Global Assessment , SELENA-SLEDAI , and British Isles Lupus Assessment Group Score . Statistically significant improvements in FACIT-Fatigue score were observed among individuals r and omized to blisibimod , especially in the 200 mg QW group where favorable effects on disease activity with blisibimod compared to placebo were observed as early as Week 8 . The mean improvement from baseline of 6.9 points at Week 24 , compared with 4.4 points with placebo , met the criteria for minimal clinical ly important improvement difference defined for patients with SLE . Despite concomitant improvements in FACIT-Fatigue , SLE Responder Index ( SRI ) and SLE biomarkers ( reported previously ) , FACIT-Fatigue score correlated only weakly with disease activity . While poor correlation between fatigue and disease activity is not new , the observation that correlation remains poor despite concurrent population improvements in disease and fatigue brings a new facet to our underst and ing of SLE Objective Dehydroepi and rosterone ( DHEA ) has been reported to improve fatigue and reduced well-being . Both are major problems in patients with systemic lupus erythematosus ( SLE ) , even with quiescent disease . Low serum DHEA levels are common in SLE . The present work investigates the effects of DHEA administration on fatigue , well-being and functioning in women with inactive SLE . Methods In a double-blind , r and omised , placebo-controlled study , 60 female patients with inactive SLE received 200 mg oral DHEA or placebo . Primary outcome measures were general fatigue , depressive mood , mental well-being and physical functioning . Assessment s were made before treatment , after 3 , 6 and 12 months on medication , and 6 months after cessation of treatment . Results Patients from the DHEA and placebo group improved on general fatigue ( p<0.001 ) and mental well-being ( p=0.04 ) . There was no differential effect of DHEA .  The belief that DHEA had been used was a stronger predictor for improvement of general fatigue than the actual use of DHEA ( p=0.04 ) . Conclusions The trial does not indicate an effect of daily 200 mg oral DHEA on fatigue and well-being , and therefore DHEA treatment is not recommended in unselected female patients with quiescent SLE . Clinical Trials Registration Number OBJECTIVE To test the efficacy of a grade d aerobic exercise programme in treating  fatigue in systemic lupus erythematosus . METHODS Ninety-three patients with systemic lupus erythematosus without active disease in any major organ were r and omized , using a minimization protocol , to 12 weeks of grade d exercise therapy , relaxation therapy or no intervention . RESULTS Analysis by intention to treat showed that 16 of the 33 ( 49 % ) patients in the exercise group rated themselves as ' much ' or ' very much ' better compared with eight out of 29 ( 28 % ) in the relaxation group and five out of 32 ( 16 % ) in the control group ( chi2=8.3 , df=2 , P=0.02 ) . Fatigue improved significantly on one out of three measures after exercise therapy and there was a trend for fatigue to improve on all measures after exercise . CONCLUSION These findings support the use of appropriately prescribed grade d aerobic exercise in the management of patients with fatigue and systemic lupus erythematosus OBJECTIVE To determine if supervised cardiovascular training improves exercise tolerance , aerobic capacity , depression , functional capacity , and quality of life in patients with systemic lupus erythematosus ( SLE ) . METHODS Sixty women with SLE ( ages 18 - 55 years ) were evaluated using Short Form 36 , visual analog scale for pain , scale for fatigue , Beck Depression Inventory , and Health Assessment Question naire ( HAQ ) , and participated in a training protocol of incremental load on a treadmill with computed gas metabolic analysis .  Maximum oxygen consumption ( VO(2max ) ) and anaerobic threshold VO(2 ) were calculated with a SensorMedics Vmax29C analyzer ( Sensor Medics , Yorba Linda , CA ) , and heart rate was measured by electrocardiogram . Patients were divided into 2 groups : a training group ( 41 patients ) that participated in the supervised cardiovascular training program and a control group ( 19 patients ) that did not participate in the program . All variables were analyzed at baseline and after 12 weeks for both groups . The training program occurred in the morning for 60 minutes , 3 times a week for 12 weeks . Statistical analysis included Wilcoxon 's rank sum test , Mann-Whitney U test , chi-square test , and Fisher 's exact test . P values < 0.05 were considered to be statistically significant . RESULTS The 2 groups were homogeneous and comparable at baseline . The training group showed a significant improvement of aerobic capacity measured by anaerobic threshold VO(2 ) ( 14.67 + /- 3.03 versus 17.08 + /- 3.35 ml/kg/minute , P < 0.001 ) . Comparison of the training group and control group after 12 weeks showed a significant difference relating to VO(2max ) ( 24.31 + /- 4.61 versus 21.21 + /- 3.88 ml/kg/minute , P = 0.01 ) and anaerobic threshold VO(2 ) ( 17.08 + /- 3.35 versus 13.66 + /- 2.82 ml/kg/minute , P < 0.0001 ) . After cardiovascular training , we found a significant improvement of Beck inventory score ( 8.37 + /- 12.79 versus 2.90 + /- 3.00 , P < 0.001 ) and HAQ score ( 0.14 + /- 0.21 versus 0.06 + /- 0.19 , P < 0.01 ) in the training group . CONCLUSION This study showed significant improvement in exercise tolerance , aerobic capacity , quality of life , and depression after a supervised cardiovascular training program in patients with SLE Introduction A recent metabolomic screen of sera from patients with Systemic Lupus Erythematosus ( SLE ) found reduction of antioxidants and substrates for energy generation . These metabolic alterations may underlie one of the most common features of SLE - fatigue . The metabolomic studies also noted reduced omega-3 fatty acids , which are powerful anti- oxidants . This deficiency may be causally related to oxidative stress , inflammation , disease activity , and fatigue in SLE . Supplementation of omega-3 fatty acids using fish oil in SLE has been shown to reduce oxidative stress in other studies . The objective of this study is to evaluate the effect of fish oil supplementation on clinical measures of fatigue , quality of life , and disease activity as part of a r and omized clinical trial . Methods Fifty SLE patients recruited in outpatient clinics were r and omized 1:1 to fish oil supplementation or olive oil placebo , and blinded to their treatment group . At baseline and after 6 months of treatment , R AND Short Form-36 ( R AND SF-36 ) , Fatigue Severity Scale ( FSS ) , SLE Disease Activity Index ( SLEDAI ) , and Physician Global Assessment ( PGA ) were completed ; serum was also collected for soluble mediator analysis . Results Thirty-two patients completed the study .  PGA improved significantly in the fish oil group compared with the placebo group ( p = 0.015 ) . The R AND SF-36 Energy/fatigue and Emotional well-being scores demonstrated improvement trends ( p = 0.092 and 0.070 ) . No clear difference was seen in FSS and SLEDAI ( p = 0.350 and p = 0.417 ) . Erythrocyte sedimentation rate and serum IL-12 were reduced ( p = 0.008 and p = 0.058 ) ; while serum IL-13 was increased by fish oil supplementation ( p = 0.033 ) . Conclusions In this r and omized , placebo-controlled 6-month trial , SLE patients r and omized to fish oil supplementation demonstrated improvement in their PGA , R AND SF-36 , and some circulating inflammatory markers . Trial registration Clinical Trials.gov Identifier : NCT02021513 ( registered 13 December 2013 ) OBJECTIVE A feasibility study for a trial of strategies for the prevention of atherosclerosis in patients with systemic lupus erythematosus ( SLE ) was stopped because of inadequate recruitment . There is little underst and ing of the factors influencing patients ' decisions about participation in prevention trials . Our goal was to determine factors that patients with SLE consider in deciding about participating in prevention trials , to uncover concerns about SLE trials , and to investigate how study design and purpose affect participation decisions . METHODS We conducted focus groups with trial participants ( n = 13 ) , trial non participants ( n = 8) , and a group of patients with diabetes ( n = 9 ) . We conducted telephone interviews with SLE patients who refused participation in the trial and the focus groups ( n = 10 ) . A trained facilitator elicited factors influencing participation decisions . Transcripts were coded and grouped into themes using grounded theory . RESULTS Demographic characteristics of the groups were similar . Seven factors emerged as important in decision making : current health status , study design , physician involvement , personal benefit , altruism , time , and incentives . These factors were considered by individuals who elected to participate and those who did not , but weighed differently . Among the trial participants , good health status , encouragement from one 's physician , and desires to learn and to contribute stimulated participation . Reasons for nonparticipation included current health status , medication and r and omization concerns , and personal factors . CONCLUSION We observed that similar factors were weighed differently by participants and non participants . Our results suggest that strategies such as health education , enlistment of personal physicians , and limitation of time requirements may enhance recruitment of patients with SLE into clinical prevention trials The effectiveness of an exercise prescription and unsupervised home exercise programme was tested on 37 subjects with rheumatoid arthritis and 34 with systemic lupus erythematosus . Subjects were r and omly assigned to control or stationary bicycling at home , using loaned bicycles . Exercise subjects ( with bicycles ) did better than controls , but not significantly , on all outcome d measures ( exercise tolerance test , fatigue , depression and helplessness ) at 3 months . Bicycles were recl aim ed at 3 months and all subjects in both groups given instructions for home exercise . Exercise in the second 3 months was predicted primarily by baseline exercise habits and fatigue . It is concluded that although safe , unsupervised home exercise programmes may benefit few patients . Future research should address methods of stimulating and maintaining unsupervised exercise programmes in patients with systemic rheumatic disease OBJECTIVE Because dehydroepi and rosterone ( DHEA ) is an adrenal steroid hormone with weak intrinsic and rogenic properties that can be converted in peripheral tissues into more potent sex hormones , one might expect a positive effect of DHEA on bone mineral density ( BMD ) . We evaluated the effects on lumbar BMD of oral DHEA , 200 mg/day , for 1 year in female patients with quiescent systemic lupus erythematosus ( SLE ) . METHODS The study subjects were 60 women with SLE . All participants gave informed consent to participate in a double-blind , placebo-controlled study on the effects of DHEA on fatigue and general well-being . BMD was measured with dual-energy x-ray absorptiometry ( DEXA ) at baseline and after 12 months . RESULTS Fifty-eight patients ( mean age 42.6 years ) could be evaluated ; 2 patients ( both in the DHEA group ) refused to undergo DEXA a second time . In premenopausal women , DHEA did not influence BMD significantly . There was a significant increase in BMD with use of DHEA in postmenopausal women who were not receiving bisphosphonates or estrogen-containing medications . This increase was not observed in the group receiving placebo . CONCLUSION In premenopausal women with quiescent SLE , use of DHEA does not have a significant effect on BMD .  DHEA may increase BMD in postmenopausal SLE patients if they are not already protected from bone loss by use of estrogens or bisphosphonates . Small numbers , due to the absence of stratification for menopausal status , and the use of antiresorptive agents at r and omization preclude firmer conclusions based on the results of this study Objective Assess the effects of belimumab treatment plus st and ard systemic lupus erythematosus ( SLE ) therapy on health-related quality of life ( HRQOL ) in patients with active , autoantibody-positive SLE . Methods Patients received st and ard therapy plus placebo or belimumab 1 or 10 mg/kg in two multicentre , r and omised controlled trials of 52 ( BLISS-52 ; N=865 ) and 76 ( BLISS-76 ; N=819 ) weeks ’ duration . Responders were evaluated by SLE Responder Index at week 52 . Patient-reported outcome assessment s included SF-36 , Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue , and EQ-5D . Results Mean SF-36 Physical Component Summary ( PCS ) scores at week 24 was a major secondary endpoint . Baseline SF-36 scores were 1.5 SDs below age-/sex-matched US norms with similar improvement at week 24 across treatment groups . Mean changes from baseline in PCS scores were significantly ( p<0.05 ) greater with belimumab 1 mg/kg ( 4.20 ) and 10 mg/kg ( 4.18 ) versus placebo ( 2.96 ) in BLISS-52 , week 52 . In BLISS-76 , significantly ( p<0.05 ) greater improvements were seen with belimumab 1 mg/kg in PCS ( belimumab 1 mg/kg=4.37 , 10 mg/kg=3.41 vs placebo=2.85 ) and Mental Component Summary ( MCS ) scores ( belimumab 1 mg/kg=3.14 , 10 mg/kg=2.70 vs placebo=1.40 ) at week 52 , and in MCS score at week 76 ( belimumab 1 mg/kg=3.05 , 10 mg/kg=2.28 vs placebo=1.36 ) . In pooled analysis , significantly greater improvements in PCS , SF-36 vitality domain , and FACIT-Fatigue scores at week 52 were evident with both belimumab doses . Conclusions The clinical ly meaningful improvements in HRQOL in autoantibody-positive patients with active SLE treated with belimumab and st and ard therapy are consistent with the reductions in disease activity observed in these trials . Clinical Trials.gov number NCT00424476 , NCT00410384 OBJECTIVE B cells are likely to contribute to the pathogenesis of systemic lupus erythematosus ( SLE ) , and rituximab induces depletion of B cells . The Exploratory Phase II/III SLE Evaluation of Rituximab ( EXPLORER ) trial tested the efficacy and safety of rituximab versus placebo in patients with moderately-to-severely active extrarenal SLE . METHODS Patients entered with > or=1 British Isles Lupus Assessment Group ( BILAG ) A score or > or=2 BILAG B scores despite background immunosuppressant therapy , which was continued during the trial . Prednisone was added and subsequently tapered . Patients were r and omized at a ratio of 2:1 to receive rituximab ( 1,000 mg ) or placebo on days 1 , 15 , 168 , and 182 . RESULTS In the intent-to-treat analysis of 257 patients , background treatment was evenly distributed among azathioprine , mycophenolate mofetil , and methotrexate . Fifty-three percent of the patients had > or=1 BILAG A score at entry , and 57 % of the patients were categorized as being steroid dependent . No differences were observed between placebo and rituximab in the primary and secondary efficacy end points , including the BILAG-defined response , in terms of both area under the curve and l and mark analyses . A beneficial effect of rituximab on the primary end point was observed in the African American and Hispanic subgroups . Safety and tolerability were similar in patients receiving placebo and those receiving rituximab . CONCLUSION The EXPLORER trial enrolled patients with moderately-to-severely active SLE and used aggressive background treatment and sensitive cutoffs for nonresponse . No differences were noted between placebo and rituximab in the primary and secondary end points . Further evaluation of patient subsets , biomarkers , and exploratory outcome models may improve the design of future SLE clinical trials OBJECTIVE To investigate the metric properties and validity of the assessment of  quality of life by the MOS Short Form 36 ( SF-36 ) in patients with systemic lupus erythematosus ( SLE ) and to examine the effect of disease on quality of life . METHODS Cross sectional study of 150 patients with SLE ( age : mean 39.7 yrs , SD 11.4 yrs ; 95 % female ) attending 2 specialist lupus clinics between November 1994 and April 1995 . Shortly before or after the consultation patients completed the SF-36 and the  MOS SF-20  with an additional question about fatigue ( SF-20 + ) in r and om order . Disease activity was measured by the  British Isles Lupus Activity Group System ( BILAG ) , disease damage by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology ( SLICC/ACR ) damage index ( SLICC ) . RESULTS SF-36 domains were shown to be internally consistent ( Cronbach 's coefficient alpha > or = 0.71 ) . Significant associations of the SF-36 domains with the corresponding domains of the SF-20 + and with global disease activity measured by BILAG were observed . SF-36 scores in patients with SLE were significantly lower than in controls . Different disease activity levels were significantly associated with different quality of life scores , with excellent ability to record the continuum from good health to serious illness by the SF-36 . Disease activity had greater effect on quality of life than age , cumulative damage , or disease duration . CONCLUSION This study shows the SF-36 is internally consistent and proves construct , discriminatory , and criterion validity for the SF-36 and construct validity for the SF-20 + in patients with SLE . The SF-36 is preferred because of its broader scope of questions , its widespread use , and previous international validation for a wide variety of diseases In the United States , approximately 35 % of adults with Systemic Lupus Erythematosus ( SLE ) have clinical evidence of nephritis at the time of diagnosis ; with an estimated total of 50–60 % developing nephritis during the first 10 years of disease [ 1–4 ] . The prevalence of nephritis is significantly higher in African Americans and Hispanics than in Caucasians , and is higher in men than in women . Renal damage is more likely to develop in non-Caucasian groups [ 2–4 ] . Overall survival in patients with SLE is approximately 95 % at 5 years after diagnosis and 92 % at 10 years [ 5 , 6 ] . The presence of lupus nephritis significantly reduces survival , to approximately 88 % at 10 years , with even lower survival in African Americans [ 5 , 6 ] . The American College of Rheumatology ( ACR ) last published guidelines for management of systemic lupus erythematosus ( SLE ) in 1999 [ 7 ] . That publication was design ed primarily for education of primary care physicians and recommended therapeutic and management approaches for many manifestations of SLE . Recommendations for management of lupus nephritis ( LN ) consisted of pulse glucocorticoids followed by high dose daily glucocorticoids in addition to an immunosuppressive medication , with cyclophosphamide viewed as the most effective immunosuppressive medication for diffuse proliferative glomerulonephritis . Mycophenolate mofetil was not yet in use for lupus nephritis and was not mentioned . Since that time , many clinical trials of glucocorticoids-plus-immunosuppressive interventions have been published , some of which are high quality prospect i ve trials , and some not only prospect i ve but also r and omized . Thus , the ACR determined that a new set of management recommendations was in order . A combination of extensive literature review and the opinions of highly qualified experts , including rheumatologists , nephrologists and pathologists , has been used to reach the recommendations . The management strategies discussed here apply to lupus nephritis in adults , particularly to those receiving care in the United States of America , and include interventions that were available in the United States as of April 2011 . While these recommendations were developed using rigorous methodology , guidelines do have inherent limitations in informing individual patient care ; hence the selection of the term “ recommendations . ” While they should not supplant clinical judgment or limit clinical judgment , they do provide expert advice to the practicing physician managing patients with lupus nephritis Moxibustion has been thought to enhance immunity in healthy condition , but suppress abnormal immune response in disease status . We collected 12 patients with systemic lupus erythematosus ( SLE ) and 12 healthy women who received indirect moxibustion on acupuncture points ST-36 ( Zusanli ) and SP-6 ( Sanyinjiao ) 20 minutes per day for 1 week . During the course , there were no changes of their regular medications or intercurrent infections in normal subjects and SLE patients . We found that indirect moxibustion for 1 week could elevate CD3 + and CD4 + T-lymphocytes in normal subjects , whereas decrease relative proportions of CD8 + T-lymphocytes in patients with SLE . This result confirms that indirect moxibustion has different immunomodulation in normal condition and autoimmune status . However , whether immunomodulatory effects of indirect moxibustion are beneficial for normal subjects and patients with SLE require further confirmation OBJECTIVE In a cross-sectional study , we previously identified 2 potentially modifiable risk factors for adverse outcomes in systemic lupus erythematosus ( SLE ) :  self-efficacy and social support . The goal of this study was to evaluate in a r and omized controlled trial a theory-based intervention to improve patient self-efficacy and partner support to manage SLE . METHODS Patients with SLE ages 18 years and older who met the American College of Rheumatology criteria and were able to identify a partner ( spouse or family member ) were recruited from 2 academic medical centers and r and omized into an experimental group or a control group . Patients in the experimental group and their partners received an intervention design ed to enhance self-efficacy , couples communication about lupus , social support , and problem solving , in the form of a 1-hour session with a nurse educator followed by monthly telephone counseling for 6 months . Patients in the control group and their partners received an attention placebo , including a 45-minute video presentation about lupus , and monthly telephone calls .  Measures of physical and mental health status , disease activity , and psychosocial factors were collected at baseline , 6 months , and 12 months . The effect of the intervention on physical and mental health and disease activity at 6 and at 12 months was modeled with linear regression and adjusted for baseline health status , disease activity , sociodemographic factors , treatment change , and psychosocial factors . RESULTS One hundred twenty-two patients ( plus their partners ) were enrolled and r and omized as follows : 64 to the experimental intervention and 58 to the attention control group . The participants were predominantly white , approximately half were college educated , and the groups were balanced for sociodemographic factors . At 6 months , significantly higher scores for couples communication ( P = 0.01 ) and problem-focused coping ( P = 0.03 ) were seen in the experimental group compared with the control group . At 12 months ( 6 months after the intervention ended ) , social support was higher ( 4.4 versus 4.1 ; P = 0.03 ) , self-efficacy was higher ( 7.2 versus 6.2 ; P = 0.02 ) , couples communication was higher ( 3.5 versus 3.1 ; P = 0.03 ) , and fatigue was lower ( 5.1 versus 6.3 ; P = 0.02 ) in the experimental group compared with the control group . Global mental health status at 12 months , as measured by the Short Form 36 survey , was 69 points in the experimental group compared with 58 points in the control group ( P = 0.04 ) . In multivariate models , adjusting for baseline covariates , scores for couple communication ( P = 0.01 ) were significantly higher at 6 months , and scores for self-efficacy ( P = 0.004 ) and global mental health status ( P = 0.03 ) were significantly higher at 12 months in the experimental group compared with the control group , and the mean score for global physical function was higher by 7 points , which was a clinical ly meaningful change ( P = 0.2 ) . The mean score for fatigue was also significantly lower in the experimental group than in the control group ( P = 0.05 ) . SLE disease activity was unchanged by this intervention . CONCLUSION This r and omized , controlled trial of a theory-based educational intervention in SLE demonstrated significantly higher scores for couple communication , self-efficacy , and mental health status , and lower fatigue scores in the experimental group compared with the control group . Because couple communication and self-efficacy appear to be modifiable risk factors , they may also be potential targets in more disadvantaged population OBJECTIVE To appraise systematic ally the study design and quality of reporting of r and omized controlled trials ( RCT ) on systemic lupus erythematosus ( SLE ) and to identify potential defects and biases . METHODS RCT with at least 5 patients with SLE were retrieved from MEDLINE , EMBASE , and the Cochrane Library . We analyzed study design , quality of reporting , and trial results . RESULTS Ninety-four trial reports ( 37 on lupus nephritis ) were eligible with 2,257 SLE patients ( n = 795 in lupus nephritis trials ) . Median sample size was 28 patients . Fifty-one trials ( 54.3 % ) were double blind , but only 31 ( 33.0 % ) mentioned the r and omization mode , only 19 ( 20.2 % ) described allocation concealment , and only 7 ( 7.5 % ) were adequately powered . Sixty-three trials ( 67 % ) described adequately reasons for withdrawals . Nephritis trials had on average longer followup ( p = 0.001 ) and were less likely to be double blind ( p < 0.001 ) , to describe reasons for withdrawals [ both overall ( p = 0.008 ) and per arm ( p = 0.009 ) ] and to involve a comparison against placebo or no treatment ( p < 0.001 ) . Larger trials scored higher on several quality characteristics . Significant efficacy or trend for efficacy was cl aim ed in 72 reports ( 76.6 % ) and this was even more common in trials published in 1999 - 2002 ( 89.5 % ) . Significant efficacy was found more frequently in trials that clearly specified withdrawals per arm ( p = 0.001 ) and outcomes ( p = 0.001 ) and used intention-to-treat analyses ( p = 0.03 ) . Besides outcome specification , no other quality variables seemed to improve significantly over time . CONCLUSION Several aspects of the design and reporting of RCT on SLE can be improved . Larger , adequately powered , and accurately reported trials are needed Objectives : Vitamin D has immune-modulating effects and may protect against the development of systemic lupus erythematosus ( SLE ) and rheumatoid arthritis ( RA ) . Methods : We identified incident cases of SLE and RA among 186 389 women followed from 1980 to 2002 in the Nurses ’ Health Study and Nurses ’ Health Study II cohorts . We excluded subjects where SLE or RA was not confirmed by medical record review , and those who failed to return question naires . Semi-quantitative food frequency question naires assessed  vitamin D intake from food and supplements .  We used cumulative-up date d total energy-adjusted dietary exposures for each 2-year cycle . Relationships between vitamin D  intake and incident SLE and RA were examined in age-adjusted and Cox proportional hazards models , adjusted for confounders . Results were pooled using meta- analysis r and om effects models . Results : We confirmed 190 incident cases of SLE and 722 of RA with dietary information . Increasing levels of  vitamin D  intake had no relationship to the relative risk of developing either SLE or RA . Conclusions : Vitamin D intake was not associated with risk of SLE or RA in these large prospect i ve cohorts of women Thirty patients suffering from systemic lupus erythematosus ( SLE ) were treated with daily 20 mgs of piroxicam ( Hotemin ) . The patients were in a mildly active stage of the disease , taking maintenance doses of corticosteroids . The duration of piroxicam therapy was 3 months . Allergy was observed in one case , intolerance ( gastrointestinal symptoms , nausea , vomiting ) in two ; these result ed in the cessation of therapy . Twenty seven patients were on piroxicam therapy for 3 months . Signs of clinical activity diminished , corticosteroid requirement decreased , subjective complaints were reduced . The drug was tolerated . In 3 cases , due to mild water retention , diuretics were given . Gastrointestinal symptoms , transaminase elevation , changes in blood cell counts were not observed during the 3 months period To study the ovarian toxicity associated with cyclophosphamide in girls with systemic lupus erythematosus ( SLE ) , we retrospectively review ed the charts of 30 SLE girls aged 16 yr or younger at diagnosis , followed at three university hospitals . Gynaecological history was extracted from the charts or obtained prospect ively . Ten had not received cyclophosphamide therapy , six were treated with daily oral cyclophosphamide , 10 with intravenous pulses and four with daily oral and intravenous pulses . Median oral cyclophosphamide dose was 38 g ( inter-quartile range 75 ) and median intravenous dose 12.95 g ( inter-quartile range 6.2 ) . Six girls had oligomenorrhoea ( 20 % ) and one amenorrhoea ( 3 % ) . Two treated with oral cyclophosphamide had oligomenorrhoea ( 33 % ) and one amenorrhoea ( 17 % ) , two treated with both oral and intravenous pulses had oligomenorrhoea ( 50 % ) , and none of those treated with intravenous pulses alone had menstrual disturbances ( 50 % oral vs 0 % intravenous pulses ; P = 0.016 ) . Girls who had menstrual disturbances had received higher doses of cyclophosphamide than those who did not ( medians : 63 vs 15 g ; P < 0.05 ) . In summary , menstrual disturbances in SLE girls treated with cyclophosphamide are related to the total dose and perhaps to the administration method Although the use of methotrexate ( MTX ) is gaining acceptance in the treatment of several connective tissue diseases , there is little evidence of its therapeutic value in systemic lupus erythematosus ( SLE ) . We examined the response to MTX  in patients with steroid-resistant SLE in an open , unblinded study . Of 10 SLE patients treated with MTX ( 7.5 mg/weekly ) , 7 showed improvement . The other 3 stopped therapy because of lack of response or because of side effects . Improvements were noted within 3 months in responding patients . These promising observations suggest that controlled studies of MTX for the treatment of SLE are justified OBJECTIVE We undertook a 2-part , phase I , double-blind , placebo-controlled study to evaluate the safety and pharmacokinetics of multiple intravenous infusions of sirukumab , a human anti-interleukin-6 monoclonal antibody , in patients with cutaneous lupus erythematosus ( CLE ) or systemic lupus erythematosus ( SLE ) . METHODS In part A , patients with histologically confirmed CLE were r and omized to 4 infusions of placebo or 1 , 4 , or 10 mg/kg sirukumab every 2 weeks . In part B , SLE patients diagnosed according to American College of Rheumatology criteria with a score of 5 - 12 on the Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index were r and omized to 4 infusions of placebo or 10 mg/kg sirukumab every 2 weeks . RESULTS We treated 31 CLE patients ( 23 with sirukumab , 8 with placebo ) and 15 SLE patients ( 10 with sirukumab , 5 with placebo )  . Adverse events ( AEs ) occurred more often with sirukumab than placebo in CLE patients ( 91 % versus 63 % ) and in SLE patients ( 90 % versus 80 % ) . Sirukumab led to sustained , dose-independent decreases in white blood cell counts , absolute neutrophil counts ( neutropenia ) , and platelet counts ( thrombocytopenia ) and to minor elevations in total cholesterol levels . The majority of infections were mild respiratory infections . which were reported similarly across CLE cohorts but more often in sirukumab-treated than in placebo-treated SLE patients . Two serious AEs of infection occurred ( pneumonia in the 10 mg/kg-treated group and iatrogenic wound infection in the 4 mg/kg-treated group ) . Sirukumab showed linear pharmacokinetics in CLE patients . Systemic exposure and half-life were comparable between CLE and SLE patients . No patient developed antibodies to sirukumab through 22 weeks . C-reactive protein and serum amyloid A mean concentrations were suppressed with sirukumab from week 1 to week 14 . CONCLUSION Treatment with intravenous sirukumab infusions was generally well tolerated in both CLE and SLE patients with mild , stable , active disease . Sirukumab demonstrated linear pharmacokinetics over the dose range studied and comparable systemic exposure and half-life in CLE and SLE patients Background : Physiological benefits of exercise training for heart failure ( HF ) patients have been demonstrated , however little is known about the effects of training on the symptoms of fatigue and dyspnea . Aim : The purpose of this study was to examine HF symptoms of fatigue and dyspnea in response to a 24-week exercise training intervention . Methods : This pilot study was a r and omized , two-group repeated measures design . Fifteen subjects in the intervention group completed a combination of aerobic and resistance training three times per week in a st and ard cardiac rehabilitation setting . The control group consisted of 6 subjects who were instructed not to begin any formal exercise program during the 24-week intervention . Results : Subjects ( 19 males and 2 females ) had a mean age of 66.2 ± 10.2 years and mean ejection fraction ( EF ) of 28.4 ± 7.4 % . Non-parametric Friedman Analysis of Variance by Ranks showed the exercise group significantly decreased sensory fatigue ( Piper Fatigue Scale ) over time ( χ 2 = 6.49 , p = .04 ) while the control group did not change ( χ 2 = 0.93 , p = .63 ) . Dyspnea showed a non-significant decrease over time for the exercise group ( χ 2 = 4.16 , p = .13 ) while the control group showed a decrease from baseline to 12 weeks but an increase to above baseline values by week 24 ( χ 2 = 0.18 , p = .91 ) . Conclusion : These results provide support for the beneficial effects of exercise training  on symptoms of fatigue and dyspnea in HF patients . Larger studies to evaluate symptom response to exercise are needed
The subgroup analysis indicated that 12 weeks of exercise training and exercise under a supervised setting significantly benefited fatigue .
Linking Evidence to Action : The pooled data indicate that 12 weeks of an aerobic exercise program that is supervised by health professionals could reduce fatigue and increase vitality for patients with SLE .
Background : Fatigue is the most common and unpleasant symptom of patients with systemic lupus erythematosus ( SLE ) .
However , there is limited information regarding how exercise affects fatigue .
Aims : The purpose of this study is to review and synthesize the current knowledge concerning the effectiveness of exercise training for treating fatigue  among adults with SLE .
The characteristics of beneficial exercise training are further evaluated .