***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 r and omized controlled trial . Objectives . To evaluate the efficacy of infliximab , a monoclonal antibody against tumor necrosis factor (TNF)-&agr ; in a r and omized controlled setting . Summary of Background Data . Recently , we obtained encouraging results in an open-label study of infliximab in patients with disc herniation-induced sciatica . Furthermore , the results of experimental studies support the use of infliximab in sciatica . Therefore , we initiated a r and omized , controlled trial ( FIRST II , Finnish Infliximab Related STudy ) to confirm the efficacy of a single infusion of infliximab for sciatic pain . Methods . Inclusion criteria were unilateral moderate to severe sciatic pain with an MRI-confirmed disc herniation concordant with the symptoms and signs of radicular pain . Patients had to be c and i date s for discectomy , as evaluated by an independent orthopedic surgeon . Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo . Assessment s at baseline and various time points included clinical examination with measurement of straight leg raising restriction ; question naires related to subjective symptoms ( leg and back pain by 100-mm visual analog scale , Oswestry disability ) ; sick leaves ; number of discectomies ; and adverse effects possibly related to treatment . The primary endpoint was a reduction in leg pain from baseline to 12 weeks , which was analyzed using a Mann-Whitney U test and repeated- measures analysis . Results . A significant reduction in leg pain was observed in both groups , with no significant difference between treatment regimens . Similar efficacy was observed between treatment groups for secondary endpoints . Seven patients in each group required surgery . No adverse effects related to treatment were encountered . Conclusions . The results of this r and omized trial do not support the use of infliximab for lumbar radicular pain in patients with disc herniation-induced sciatica Study Design . An open-label trial . Objectives . To test the long-term efficacy of infliximab , a monoclonal antibody against tumor necrosis factor-alpha ( TNF-α ) , in disc herniation-induced sciatica . Summary of Background Data . Our recent trial indicated that a single infusion of 3 mg/weight-kg of infliximab produced a rapid curative effect in disc herniation-induced sciatica . Here , we describe the 1-year effect of a 3 mg/kg of infliximab in these 10 patients and our experience with a lower dose of 1 mg/kg of infliximab for the same indication in 2 additional patients . Methods . Patients with severe sciatica were treated with a single infusion of infliximab , 3 mg/weight-kg in 10 patients and 1 mg/kg in 2 patients , intravenously over 2 hours . The outcomes ( leg and back pain on a 100-mm visual scale , Oswestry disability , clinical signs ) were assessed at 1 week , 2 weeks , 1 month , 3 months , 6 months , and 1 year after the infusion . The outcomes with 3 mg/kg of infliximab were compared to 62 patients who received periradicular saline for sciatica in a previous trial . The resorption rate of disc herniations from baseline to 1 year was compared between infliximab and control groups . Results . The response to 1 mg/kg of infliximab  for leg pain was good only in 1 of the 2 patients treated , whereas the response to 3 mg/kg of infliximab for leg pain was sustained in most patients over the 1-year follow-up . The 1-year response significantly favored 3 mg/kg of infliximab over periradicular saline in leg pain ( P = 0.005 ) and disability ( P = 0.003 ) . Neurologic abnormalities normalized more comprehensively in the infliximab group ( P = 0.001 ) . Reduction in disc herniation volume did not differ between the infliximab-treated patients and controls . Conclusions . The results showed that the beneficial effect of a single infusion of 3 mg/kg of infliximab for herniation-induced sciatica is sustained in most patients over a 1-year follow-up period . Furthermore , infliximab does not seem to interfere with the spontaneous resorption of disc herniations Policy decisions often require synthesis of evidence from multiple sources , and the source studies typically vary in rigour and in relevance to the target question . We present simple methods of allowing for differences in rigour ( or lack of internal bias ) and relevance ( or lack of external bias ) in evidence synthesis . The methods are developed in the context of reanalysing a UK National Institute for Clinical Excellence technology appraisal in antenatal care , which includes eight comparative studies . Many were historically controlled , only one was a r and omized trial and doses , population s and outcomes varied between studies and differed from the target UK setting . Using elicited opinion , we construct prior distributions to represent the biases in each study and perform a bias-adjusted meta- analysis . Adjustment had the effect of shifting the combined estimate away from the null by approximately 10 % , and the variance of the combined estimate was almost tripled . Our generic bias modelling approach allows decisions to be based on all available evidence , with less rigorous or less relevant studies downweighted by using computationally simple methods Study Design . Prospect i ve , double-blind , reference-controlled , investigator-initiated , single center . Objective . To evaluate the efficacy of Autologous Conditioned Serum ( ACS ; Orthokine ) for the treatment of lumbar radicular compression in comparison to triamcinolone . Summary of Background Data . Evidence from animal studies indicates that cytokines such as interleukin-1 play a decisive role in the pathophysiology of lumbar radiculopathy . ACS is enriched in the interleukin-1 receptor antagonist and other anti-inflammatory cytokines . Methods . Thirty-two patients were treated by epidural perineural injections with ACS ; 27 patients were treated with 5 mg triamcinolone and 25 patients with 10 mg triamcinolone .  Treatment was applied once per week for 3 consecutive weeks and followed for 6 months . The Visual Analogue Scale ( VAS ) of low back pain was the primary outcome measure . The Oswestry Disability Index ( ODI ) was the secondary endpoint of the study . All statistical analyses were performed in an exploratory manner using SAS for Windows , version 8.2 , on a personal computer . Descriptive statistics were calculated for the VAS and ODI by treatment group and time point . The data were su bmi tted to a repeated- measurements analysis of variance with effects on treatment group , time , and treatment group-by-time interaction . Results . Patients with lumbar back pain who were treated with ACS or the 2 triamcinolone concentrations showed a clinical ly remarkable and statistically significant reduction in pain and disability , as measured by patient administered outcome measurements . From Week 12 to the final evaluation at Week 22 , injections with ACS showed a consistent pattern of superiority over both triamcinolone groups with regard to the VAS score for pain , but statistical significance was observed only at Week 22 in direct comparison to the triamcinolone 5 group . However , there was no statistically significant difference between the 2 triamcinolone dosages during the 6 months of the study . Conclusion . ACS is an encouraging treatment option for patients with unilateral lumbar radicular compression . The decrease in pain was pronounced , clinical ly remarkable , and potentially superior to steroid injection Background : Recent evidence implicates the inflammatory cytokine tumor necrosis factor as a major cause of radiculopathy . Yet , whereas open-label studies with systemically delivered tumor necrosis factor inhibitors have yielded positive results , a placebo-controlled study failed to demonstrate efficacy . One variable that may have contributed to poor outcomes is low drug levels at the site of nerve inflammation . To date , no studies have evaluated the efficacy or safety of epidurally administered anti-tumor necrosis factor agents . Methods : A double-blind , placebo-controlled , dose-response study was conducted to evaluate an epidural tumor necrosis factor inhibitor .  Twenty-four patients with subacute lumbosacral radiculopathy were r and omly assigned to receive two transforaminal epidural injections of 2 , 4 , or 6 mg of entanercept 2 weeks apart in successive groups of eight . In each group , two patients received epidural saline . A parallel epidural canine safety study was conducted using the same injection doses and paradigm as in the clinical study . Results : The animal and human safety studies revealed no behavioral , neurologic , or histologic evidence of drug-related toxicity . In the clinical arm , significant improvements in leg and back pain were collectively noted for the etanercept-treated patients , but not for the saline group , one month after treatment . One patient in the saline group ( 17 % ) , six patients in the 2-mg group ( 100 % ) , and four patients each in the 4-mg and 6-mg groups ( 67 % ) reported at least 50 % reduction in leg pain and a positive global perceived effect one month after treatment . Six months after treatment , the beneficial effects persisted in all but one patient . Conclusion : Epidural entanercept holds promise as a treatment for lumbosacral radiculopathy This article introduces the approach of GRADE to rating  quality of evidence .  GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence OBJECTIVES To explore the efficacy of a tumour necrosis factor alpha ( TNFalpha ) inhibitor ( etanercept , Enbrel ) in patients with severe sciatica . METHODS A pilot study of etanercept was conducted in patients admitted to hospital for acute severe sciatica . Ten consecutive patients received three subcutaneous injections of etanercept ( 25 mg every 3 days ) in addition to st and ard analgesia . Response was evaluated at day 10 ( T1 ) and week 6 ( T2 ) using a visual analogue scale for leg pain ( VASL ) and for low back pain ( VASB ) , and two vali date d functional scores : the Oswestry disability index ( ODI ) and the Rol and Morris disability question naire ( RMDQ ) . The control group consisted of 10 patients with severe sciatica , who took part in an observational study on i.v . methylprednisolone . RESULTS In the etanercept group all variables improved : VASB from 36 to 7 ; VASL from 74 to 12 ; RMDQ from 17.8 to 5.8 , and ODI from 75.4 to 17.3 ; all p<0.001 . Pain ( VASL and VASB : p<0.001 ) and ODI ( p<0.05 ) were significantly better in the etanercept group than in the methylprednisolone group . CONCLUSION In this open , historical group controlled study , patients with severe sciatica had sustained improvement after a short treatment with etanercept that was better than st and ard care plus a short course of methylprednisolone . These results suggest that inhibition of TNFalpha is beneficial in the treatment of sciatica and support a pathological role for TNFalpha in the pathogenesis of sciatica . These results need to be confirmed by a r and omised controlled trial To study the natural history of acute sciatica , 208 patients with obvious symptoms and signs of a lumbar radiculopathy ( L5 and S1 ) were examined within 14 days of onset . A concomitant double-blind investigation of the effect of the nonsteroidal anti-inflammatory drug piroxicam was performed . The results measured by visual analog scale and Rol and 's functional tests showed a satisfactory improvement throughout the 4 weeks of observation . The piroxicam-treated group had same results as the control group . Based on question naires at months 3 and 12 approximately 30 % of the patients still complained about back trouble and 19.5 % were out of work after 1 year . Four patients underwent surgery during this period OBJECTIVE Sciatica is thought to have a good clinical outcome , but in fact , its natural history is not well known . STUDY DESIGN AND SETTING We studied a prospect i ve cohort of 3,164 workers from the French national electricity and gas company . In this cohort , 622 subjects suffered from sciatica in 1991 . The predictive factors of the persistence or recurrence of sciatica after 2 years were identified by multivariate analysis ( logistic regression ) . RESULTS Of the 622 subjects with sciatica in 1991 , 55 % still reported its symptoms in 1993 and 53 % in 1995 . Of those who had recovered from sciatica in 1993 , 61 % still had low back pain and 27 % of them long-lasting low back pain in 1993 . The factors predictive of the persistence or recurrence of sciatica in 1993 , identified by multivariate analysis , were : driving at least 2 hr/day , carrying heavy loads at work , a high level of psychosomatic problems , and sciatica symptoms the year before study inclusion . CONCLUSION Recovery from sciatica is less frequent than expected 
    Output:
    
There was heterogeneity in the leg pain intensity and ODI results and improvements were no longer statistically significant when studies were restricted to RCTs .
There was a reduction in the need for discectomy , which was not statistically significant , and no difference in the number of adverse effects .