***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: Study Design . A prospect i ve , r and omized , single ( investigator ) blind , comparative efficacy trial was conducted . Objective . To compare the efficacy of continuous low-level heat wrap therapy ( 40 C , 8 hours/day ) with that of ibuprofen ( 1200 mg/day ) and acetaminophen ( 4000 mg/day ) in subjects with acute nonspecific low back pain . Summary of Background Data . The efficacy of topical heat methods , as compared with oral analgesic treatment of low back pain , has not been established . Methods . Subjects ( n = 371 ) were r and omly assigned to heat wrap ( n = 113 ) , acetaminophen ( n = 113 ) , or ibuprofen ( n = 106 ) for efficacy evaluation , or to oral placebo ( n = 20 ) or unheated back wrap ( n = 19 ) for blinding . Outcome measures included pain relief , muscle stiffness , lateral trunk flexibility , and disability . Efficacy was measured over two treatment days and two follow-up days . Results . Day 1 pain relief for the heat wrap ( mean , 2 ) was higher than for ibuprofen ( mean , 1.51;P = 0.0007 ) or acetaminophen ( mean , 1.32;P = 0.0001 ) . Extended mean pain relief ( Days 3 to 4 ) for the heat wrap ( mean , 2.61 ) also was higher than for ibuprofen ( mean , 1.68;P = 0.0001 ) or acetaminophen ( mean , 1.95;P = 0.0009 ) . Lateral trunk flexibility was improved with the heat wrap ( mean change , 4.28 cm ) during treatment ( P ≤ 0.009 vs acetaminophen [ mean change , 2.93 cm ] , P ≤ 0.001 vs ibuprofen [ mean change , 2.51 cm ] ) . The results were similar on Day 4 . Day 1 reduction in muscle stiffness with the heat wrap ( mean , 16.3 ) was greater than with acetaminophen ( mean , 10.5;P = 0.001 ) . Disability was reduced with the heat wrap ( mean , 4.9 ) , as compared with ibuprofen ( mean , 2.7;P = 0.01 ) and acetaminophen ( mean , 2.9;P = 0.0007 ) , on Day 4 . None of the adverse events were serious . The highest rate ( 10.4 % ) was reported in the ibuprofen group . Conclusion . Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain Objective Chronic low back pain ( CLBP ) is a widespread ailment . The aim of this study was to assess the efficacy of topiramate in the treatment of CLBP and the changes in anger status and processing , body weight , subjective pain-related disability and health-related quality of life during the course of treatment . Methods We conducted a 10-week , r and omized , double-blind , placebo-controlled study of topiramate in 96 ( 36 women ) patients with CLBP . The subjects were r and omly assigned to topiramate ( n=48 ) or placebo ( n=48 ) . Primary outcome measures were changes on the McGill Pain Question naire , State-Trait Anger Expression Inventory , Oswestry Low Back Pain Disability Question naire and SF-36 Health Survey scales , and in body weight . Results In comparison with the placebo group ( according to the intent-to-treat principle ) , significant changes on the pain rating index of McGill Pain Question naire ( Ps<0.001 ) , State-Trait Anger Expression Inventory Scales ( all Ps<0.001 ) , Oswestry Low Back Pain Disability Question naire ( P<0.001 ) , and SF-36 Health Survey scales ( all P<0.001 , except on the role-emotional scale ) were observed after 10 weeks in the patients treated with topiramate .  Weight loss was also observed and was significantly more pronounced in the group treated with topiramate than in those treated with placebo ( P<0.001 ) . Most patients tolerated topiramate relatively well but 2 patients dropped out because of side effects . Discussion Topiramate seems to be a relatively safe and effective agent in the treatment of CLBP . Significantly positive changes in pain sensitivity , anger status and processing , subjective disability , health-related quality of life , and loss of weight were observed CONTEXT Conventional nonsteroidal anti-inflammatory drugs ( NSAIDs ) are associated with a spectrum of toxic effects , notably gastrointestinal ( GI ) effects , because of inhibition of cyclooxygenase (COX)-1 . Whether COX-2-specific inhibitors are associated with fewer clinical GI toxic effects is unknown . OBJECTIVE To determine whether celecoxib , a COX-2-specific inhibitor , is associated with a lower incidence of significant upper GI toxic effects and other adverse effects compared with conventional NSAIDs . DESIGN The Celecoxib Long-term Arthritis Safety Study ( CLASS ) , a double-blind , r and omized controlled trial conducted from September 1998 to March 2000 . SETTING Three hundred eighty-six clinical sites in the United States and Canada . PARTICIPANTS A total of 8059 patients ( > /=18 years old ) with osteoarthritis ( OA ) or rheumatoid arthritis ( RA ) were enrolled in the study , and 7968 received at least 1 dose of study drug . A total of 4573 patients ( 57 % ) received treatment for 6 months . INTERVENTIONS Patients were r and omly assigned to receive celecoxib , 400 mg twice per day ( 2 and 4 times the maximum RA and OA dosages , respectively ; n = 3987 ) ; ibuprofen , 800 mg 3 times per day ( n = 1985 ) ; or diclofenac , 75 mg twice per day ( n = 1996 ) . Aspirin use for cardiovascular prophylaxis ( < /=325 mg/d ) was permitted . MAIN OUTCOME MEASURES Incidence of prospect ively defined symptomatic upper GI ulcers and ulcer complications ( bleeding , perforation , and obstruction ) and other adverse effects during the 6-month treatment period . RESULTS For all patients , the annualized incidence rates of upper GI ulcer complications alone and combined with symptomatic ulcers for celecoxib vs NSAIDs were 0.76 % vs 1.45 % ( P = .09 ) and 2 . 08 % vs 3.54 % ( P = .02 ) , respectively . For patients not taking aspirin  , the annualized incidence rates of upper GI ulcer complications alone and combined with symptomatic ulcers for celecoxib vs NSAIDs were 0.44 % vs 1.27 % ( P = .04 ) and 1.40 % vs 2.91 % ( P = .02 ) . For patients taking aspirin  , the annualized incidence rates of upper GI ulcer complications alone and combined with symptomatic ulcers for celecoxib vs NSAIDs were 2.01 % vs 2.12 % ( P = .92 ) and 4.70 % vs 6.00 % ( P = .49 ) . Fewer celecoxib-treated patients than NSAID-treated patients experienced chronic GI blood loss , GI intolerance , hepatotoxicity , or renal toxicity . No difference was noted in the incidence of cardiovascular events between celecoxib and NSAIDs , irrespective of aspirin use . CONCLUSIONS In this study , celecoxib , at dosages greater than those indicated clinical ly , was associated with a lower incidence of symptomatic ulcers and ulcer complications combined , as well as other clinical ly important toxic effects , compared with NSAIDs at st and ard dosages . The decrease in upper GI toxicity was strongest among patients not taking aspirin concomitantly . JAMA . 2000;284:1247 - Prompted by previously results of systemic steroid treatment of symptoms of prolapsed lumbar disc , which appeared to be promising , dexamethasone phosphate was tested in a controlled , double-blind clinical study . 52 patients were included in the study : 25 received dexamethasone phosphate , 24 received  placebo  and 3 patients dropped out . Upon termination of the study the two groups were found to be comparable as to age , sex , duration of symptoms and degree of heavy work . We were not able to demonstrate any effect of dexamethasone phosphate on the following parameters pain , paraesthesia , paresismuscular weakness , disturbances of reflexes , and Laseque . Nor was there any difference in the length of hospitalization Study Design . Prospect i ve cohort study . Objectives . To determine the characteristics of patients who take muscle relaxants for back pain after seeking care and to determine the relationship of muscle relaxant use with recovery from the episode of low back pain . Summary of Background Data . Low back pain is a common condition with a generally favorable short-term prognosis . Physicians in the acute setting commonly prescribe muscle relaxants . The indications for use and outcomes are not clear . Methods . We performed a secondary data analysis of a cohort of 1633 patients who sought care from a variety of practitioners ( primary care , physician of chiropractic , orthopedic surgeon , Health Maintenance Organization ) for low back pain . Patients were enrolled in the physician ’s office and interviewed at baseline , 2 , 4 , 8 , 12 , and 24 weeks . Pain , functional status , medication use , health care utilization , and satisfaction with care were assessed . Results . Muscle relaxants were used by 49 % of patients ; among those who sought care from doctors , 64 % used muscle relaxants . Muscle relaxant users were more impaired at baseline . Over time , among patients with greater functional status impairment ( Rol and disability score > 12 ) at baseline , muscle relaxant users had somewhat slower recovery from the episode of back pain . This finding persisted after controlling for baseline functional status , age , worker ’s compensation status , and use of nonsteroidal inflammatory agents . Conclusions . Use of muscle relaxants was very common among patients with acute low back pain .  Muscle relaxant use was not associated with more rapid functional recovery Although not recommended for low back pain , the efficacy of systemic corticosteroids has never been evaluated in a general low back pain population . To test the efficacy of systemic corticosteroids for Emergency Department ( ED ) patients with low back pain , a r and omized , double-blind , placebo-controlled trial of long-acting methylprednisolone was conducted with follow-up assessment 1 month after ED discharge . Patients with non-traumatic low back pain were included if their straight leg raise test was negative . The primary outcome was a comparison of the change in a numerical rating scale ( NRS ) 1 month after discharge . Of 87 subjects r and omized , 86 were successfully followed to the 1-month endpoint . The change in NRS between discharge and 1 month differed between the two groups by 0.6 ( 95 % confidence interval -1.0 to 2.2 ) , a clinical ly and statistically insignificant difference . Disability , medication use , and healthcare re sources utilized were comparable in both groups . Corticosteroids do not seem to benefit patients with acute non-radicular low back pain The roles of bedrest , antiinflammatory medication , and analgesic medication in the treatment of acute back strain were objective ly analyzed to determine whether they have a measurable effect on the return of  patients  to full daily activities as well as on the relief of pain . Two hundred patients were studied prospect ively . Each patient had the diagnosis of acute back strain , which was defined as nonradiating low-back pain . The results of the patient 's neurologic examination , straight leg raising test , and lumbosacral spine roentgenograms had to be within normal limits for the patient to be included in the study . The results showed that bedrest , as compared with ambulation , will decrease the amount of time lost from work by 50 % . Bedrest will also decrease the amount of discomfort by 60 % . Analgesic medication , when combined with bedrest , will further decrease the amount of pain incurred , particularly when used in the first three days of the healing process . However , analgesic medication will not allow a more prompt return to work .  Antiinflammatory medication , when added to bedrest in the treatment of lumbago , does not provide an advantage over bedrest alone UNLABELLED This multicenter , r and omized , double-blind , placebo- and active-controlled trial was conducted to compare the analgesic efficacy and safety of oxymorphone extended release ( ER ) with placebo and oxycodone controlled release ( CR ) in ambulatory patients with moderate to severe chronic low back pain requiring opioid therapy . Patients ( N = 213 ) aged 18 to 75 years were r and omized to receive oxymorphone ER ( 10 to 110 mg ) or oxycodone CR ( 20 to 220 mg ) every 12 hours during a 7- to 14-day dose-titration phase . Patients achieving effective analgesia at a stable opioid dose entered an 18-day double-blind treatment phase and either continued opioid therapy or received placebo . With stable dosing throughout the treatment phase , oxymorphone ER ( 79.4 mg/day ) and oxycodone CR ( 155 mg/day ) were superior to placebo for change from baseline in pain intensity as measured on a visual analog scale ; the LS mean differences were -18. 
    Output:
    
Methods for Grading the Overall Strength of the Evidence for an Intervention Consistent results from many higher- quality studies across a broad range of population s support a high degree of certainty that the results of the studies are true ( the entire body of evidence would be considered good quality ) .