***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE To test the hypothesis that oral creatine supplements with exercise are more effective than exercise alone in improving muscle function in patients with established dermatomyositis or polymyositis receiving chronic medical therapies who are clinical ly weak yet stable . METHODS In a 6-month , 2-center , double-blind , r and omized controlled trial , patients were r and omized to receive oral creatine supplements  ( 8 days , 20 gm/day then 3 gm/day ) or placebo . All patients followed a home exercise program . The primary outcome was aggregate functional performance time ( AFPT ) , reflecting the ability to undertake high-intensity exercise . Secondary outcomes included a functional index measuring endurance and muscle bioenergetics on (31)P magnetic resonance spectroscopy ( (31)P MRS ) .  Patients were receiving stable immunosuppressive treatment and /or corticosteroids . RESULTS A total of 37 patients with polymyositis or dermatomyositis were r and omized ( 19 to creatine , 18 to placebo ) ; 29 completed 6 months . Intent-to-treat analyses demonstrated that AFPT improved significantly at 6 months with creatine ( median decrease 13 % , range -32 - 8 % ) compared with placebo ( median decrease 3 % , range -13 - 16 % ; P = 0.029 by Mann-Whitney U test ) . A completer analysis also showed significant benefits from creatine ( P = 0.014 ) . The functional index improved significantly with both creatine and placebo ( P < 0.05 by paired Wilcoxon 's rank sum test ) , with a significant benefit between groups in the completer analysis only . Phosphocreatine/beta-nucleoside triphosphate ratios using MRS increased significantly in the creatine group ( P < 0.05 ) but not in the control group . No clinical ly relevant adverse events were associated with creatine . CONCLUSION Oral creatine supplements combined with home exercises improve functional performance without significant adverse effects in patients with polymyositis or dermatomyositis . They appear safe , effective , and inexpensive BACKGROUND The therapeutic options for patients with polymyositis or dermatomyositis that is resistant to corticosteroids are limited , unproved , and often toxic . Uncontrolled trials concluded that both plasma exchange and leukapheresis are beneficial , but despite the considerable use of these approaches , proof of their efficacy is lacking . METHODS Thirty-nine patients with definite polymyositis or dermatomyositis were r and omly assigned to receive plasma exchange ( replacement of one volume of plasma with 5 percent albumin in saline ) , leukapheresis ( removal of 5 x 10(9 ) to 10 x 10(9 ) lymphocytes ) , or sham apheresis in a double-blind manner , with 12 treatments given over a one-month period . Muscle strength , functional capacity , and serum levels of muscle-associated enzymes were measured before and after the 12 procedures . RESULTS In each group 3 of 13 patients had improvements in strength and functional capacity . The condition of 3 patients treated with leukapheresis and 1 treated with plasma exchange deteriorated , and it was unchanged in the other 26 patients . Adverse effects of apheresis included the need for a central venous catheter ( 9 patients ) , major vasovagal episodes ( 3 patients ) , and severe citrate reactions ( 2 patients ) . Despite the occurrence of significant reductions in the serum levels of muscle enzymes with plasma exchange ( P less than 0.001 ) and significant decreases in lymphocyte counts with leukapheresis ( P = 0.002 ) , there were no significant differences among the three treatment groups in the final muscle strength or functional capacity of the patients . CONCLUSIONS As treatments for corticosteroid-resistant polymyositis or dermatomyositis , leukapheresis and plasma exchange are no more effective than sham apheresis BACKGROUND Dermatomyositis is a clinical ly distinct myopathy characterized by rash and a complement-mediated microangiopathy that results in the destruction of muscle fibers . In some patients the condition becomes resistant to therapy and causes severe physical disabilities . METHODS We conducted a double-blind , placebo-controlled study of 15 patients ( age , 18 to 55 years ) with biopsy-proved , treatment-resistant dermatomyositis . The patients continued to receive prednisone ( mean daily dose , 25 mg ) and were r and omly assigned to receive one infusion of immune globulin ( 2 g per kilogram of body weight ) or placebo per month for three months , with the option of crossing over to the alternative therapy for three more months . Clinical response was gauged by assessing muscle strength , neuromuscular symptoms , and changes in the rash . Changes in immune-mediated muscle abnormalities were determined by repeated muscle biopsies . RESULTS The eight patients assigned to immune globulin had a significant improvement in sores of muscle strength ( P < 0.018 ) and neuromuscular symptoms ( P < 0.035 ) , whereas the seven patients assigned to placebo did not . With crossovers a total of 12 patients received immune globulin . Of these , nine with severe disabilities had a major improvement to nearly normal function . Their mean muscle-strength scores increased from 74.5 to 84.7 , and their neuromuscular symptoms improved . Two of the other three patients had mild improvement , and one had no change in his condition . Of 11 placebo-treated patients , none had a major improvement , 3 had mild improvement , 3 had no change in their condition , and 5 had worsening of their condition . Repeated biopsies in five patients of muscles whose strength improved to almost normal showed an increase in muscle-fiber diameter ( P < 0.04 ) , an increase in the number and a decrease in the diameter of capillaries ( P < 0.01 ) , resolution of complement deposits on capillaries , and a reduction in the expression of intercellular adhesion molecule 1 and major-histocompatibility-complex class I antigens . CONCLUSIONS High-dose intravenous immune globulin is a safe and effective treatment for refractory dermatomyositis Polymyositis ( PM ) , dermatomyositis ( DM ) , and inclusion body myositis ( IBM ) are acquired inflammatory muscle disorders of unknown etiology that are currently classified under the rubric of idiopathic inflammatory myopathy ( IIM ) . All forms of IIM are characterized clinical ly by muscle weakness and pathologically by chronic muscle inflammation , although systemic manifestations involving many organ systems are common . Clinical subgroups have been recognized for many years and include adult-onset and juvenile-onset forms of PM and DM , myositis associated with another connective tissue disorder or malignancy , and the more recently recognized entity termed inclusion body myositis ( 1,2 ) . The presence of characteristic cutaneous features such as Gottron ’s papules and sign or the classic heliotrope rash distinguish DM from PM , and skin lesions may dominate the clinical presentation in some instances . Although the IIMs are rare diseases with an estimated incidence of 10 cases per million per year ( 3 ) , they are associated with substantial morbidity and mortality . Currently available treatment of IIM is unsatisfactory . Corticosteroids are the only agents approved by the US Food and Drug Administration ( FDA ) for myositis . However , anecdotal reports and reports of case series do support the use of other immunosuppressive agents such as methotrexate and azathioprine in the treatment of myositis . Because of the rarity and heterogeneity of IIM , there is a paucity of controlled prospect i ve clinical trials , and most published studies are from single referral centers reporting retrospectively on small numbers of patients followed up for relatively brief periods of time . Furthermore , accurate assessment of the effects of therapeutic interventions in IIM has been hampered by unreliable and insensitive outcome measures , as well as the challenge of distinguishing active and reversible disease from irreversible damage to muscle and other organs . Although previously published trials have utilized predefined outcome measures , no uniform criteria have been used to guide the conduct of these trials . As a result , different inclusion and exclusion criteria , trial duration , frequency of assessment s , concomitant therapies , safety monitoring procedures , outcome measures , definitions of responses and disease flares , and stratifications of patients at outcome analysis have been used in almost all trials . Thus , it has been difficult to compare results from any two myositis trials even when the same agent is being studied , result ing in the current uncertainty regarding the safety and efficacy of most agents To determine if high-dose pulsed dexamethasone is more effective and safer than daily high-dose prednisolone in treatment-naive adult patients with inflammatory myopathies ( sporadic inclusion body myositis excluded ) we performed a multicenter , double-blind r and omised controlled clinical trial with 18 months follow-up . Sixty-two patients were r and omised into 28-day cycles of oral high-dose dexamethasone or daily high-dose prednisolone . Primary outcome measures included ( 1 ) seven point composite score of six clinical ly relevant outcomes and ( 2 ) ( time-to ) remission and ( time-to ) relapse . No difference between both treatment groups on the composite score was found . Side-effects occurred significantly less frequently in the dexamethasone group . Median time to relapse was 60 ( 2.9 ) weeks in the prednisolone and 44 ( 4.7 ) weeks in the dexamethasone group ( log-rank test p=0.03 ) . In conclusion , pulsed high-dose oral dexamethasone is not superior to daily prednisolone as first-line treatment of idiopathic inflammatory myopathies , but is a good alternative by causing substantially fewer side-effects Two groups of patients with polymyositis have been followed for approximately 3 years . One group was treated with prednisone alone and the other with prednisone plus azathioprine . Although the polymyositis of both groups has improved , no statistically significant difference was noted at the end of 3 months , as previously reported . Longer followup , however , has shown that the group given prednisone plus azathioprine has improved more with respect to functional disability ; this group also requires less prednisone for disease control A controlled , prospect i ve , double-blind , therapeutic trial of azathioprine was conducted in the initial therapy of polymyositis . Sixteen patients received 60 mg prednisone per day plus either azathioprine ( 2 mg/kg of body weight per day ) or placebo for a period of 3 months .  Creatine phosphokinase ( CPK ) levels fell to normal slightly sooner in the placebo group , but not significantly so . The azathioprine group did not become significantly stronger ( P = 0.58 ) and did not manifest significantly greater improvement of histopathologic features of muscle ( P = 0.80 ) than the placebo group . Initial CPK elevations were significantly related to the degree of muscle inflammation ( P = 0.037 ) , but this was not the case at 3 months ( P greater than 0.05 ) . Normalization of the CPK could not be equated with disease control . Type II fiber atrophy , attributed to steroid therapy , was more marked in women than in men ( P less than 0.03 ) OBJECTIVE To assess the safety and efficacy of rituximab in a r and omized , double-blind , placebo-phase trial in adult and pediatric myositis patients . METHODS Adults with refractory polymyositis ( PM ) and adults and children with refractory dermatomyositis ( DM ) were enrolled . Entry criteria included muscle weakness and ≥2 additional abnormal values on core set measures ( CSMs ) for adults . Juvenile DM patients required ≥3 abnormal CSMs , with or without muscle weakness . Patients were r and omized to receive either rituximab early or rituximab late , and glucocorticoid or immunosuppressive therapy was allowed at study entry . The primary end point compared the time to achieve the International Myositis Assessment and Clinical Studies Group preliminary definition of improvement ( DOI ) between the 2 groups . The secondary end points were the time to achieve ≥20 % improvement in muscle strength and the proportions of patients in the early and late rituximab groups achieving the DOI at week 8 . RESULTS Among 200 r and omized patients ( 76 with PM , 76 with DM , and 48 with juvenile DM ) , 195 showed no difference in the time to achieving the DOI between the rituximab late ( n = 102 ) and rituximab early ( n = 93 ) groups ( P = 0.74 by log rank test ) , with a median time to achieving a DOI of 20.2 weeks and 20.0 weeks , respectively . The secondary end points also did not significantly differ between the 2 treatment groups . However , 161 ( 83 % ) of the r and omized patients met the DOI , and individual CSMs improved in both groups throughout the 44-week trial . CONCLUSION Although there were no significant differences in the 2 treatment arms for the primary and secondary end points , 83 % of adult and juvenile myositis patients with refractory disease met the DOI . The role of B cell-depleting therapies in myositis warrants further study , with consideration for a different trial design OBJECTIVE To determine the effectiveness and tolerance of treatment with cyclosporine A ( CyA ) or methotrexate ( MTX ) added to corticosteroids in patients with severe , active polymyositis ( PM ) and dermatomyositis ( DM ) . PATIENTS AND METHODS Thirty-six patients ( 20 with DM , 16 with PM ) 
    Output:
    
The fourth study comparing pulsed oral dexamethasone with daily oral prednisolone and found that the dexamethasone regime had a shorter median time to relapse but fewer side effects .
Immunosuppressants were associated with significant side effects .
AUTHORS ' CONCLUSIONS This systematic review highlights the lack of high quality RCTs that assess the efficacy and toxicity of immunosuppressants in inflammatory myositis