***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: BACKGROUND AND OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review BACKGROUND Hydromorphone hydrochloride is a mu-opioid agonist with dose-dependent analgesic properties . Extended-release hydromorphone hydrochloride ( ER hydromorphone HCl ) capsules have been developed for administration every 24 hours . OBJECTIVES This prospect i ve evaluation focused on the first ( ie , conversion ) phase of 2 identically design ed , r and omized , controlled studies that compared the safety and efficacy of once-daily ER hydromorphone HCl capsules with immediate-release hydromorphone hydrochloride ( IR hydromorphone HCl ) tablets administered 4 times daily in the treatment of persistent moderate to severe cancer- and noncancer-related pain . METHODS Patients being treated with opioid analgesics for persistent moderate to severe pain were converted to ER hydromorphone HCl using an 8:1 conversion ratio . The dose was titrated to attain an average pain intensity ( API ) score < or = 4 on a 0- to 10-point numeric rating scale . Supplemental oral IR hydromorphone HCl tablets were used as rescue medication at a dose of one eighth to one sixth of the daily ER hydromorphone HCl dose . RESULTS A total of 343 patients ( 272 [ 79 % ] with cancer pain ; mean age , 57.8 years ) were enrolled and converted to ER hydromorphone HCl from their previous opioids . About half ( 51 % ) were women . At baseline , the mean ( SD ) API score  was 5.3 ( 2.1 ) . Mean ( SD ) API scores were 4.7 ( 2.0 ) after the first 48 hours and 3.4 ( 2.1 ) by the end of titration . After 4 to 21 days of titration , 239 ( 70 % ) patients reached stabilization defined as a > or = 48-hour period with an API score of < or = 4 , unchanged ER hydromorphone HCl dose , and < or = 2 rescue doses per day . The stabilized patients had mean ( SD ) API scores of 2.7 ( 1.1 ) at the end of titration . At stabilization , 102 ( 43 % ) of 239 patients remained at their initial conversion dose , 129 ( 54 % ) had a dose increase , and 8 ( 3 % ) had a dose decrease . Frequent ( > or = 10 % of patients ) adverse events that occurred within the first 48 hours after conversion and during the entire titration phase were nausea , somnolence , headache , constipation , vomiting , and dizziness . CONCLUSION In this prospect i ve evaluation of the conversion and titration phase of 2 r and omized , controlled studies , a conversion ratio of 8:1 mg of oral morphine to oral ER hydromorphone HCl was found to be clinical ly useful in patients with persistent moderate to severe cancer-related or noncancer-related pain Oral controlled-release oxycodone has been available for the treatment of  chronic pain in Germany since 1998 . Controlled trials have shown good clinical efficacy and tolerability . This survey reports results from six open prospect i ve multicenter trials . In these trials 4196 patients suffering from cancer pain and non-cancer-related pain with inadequate pain relief were treated with oral controlled-release oxycodone for 3 - 4 weeks . Only a few participating physicians were pain specialists . A total of 356 patients suffering from pain of the musculoskeletal system and receiving oxycodone therapy were monitored for 6 months . Exclusion from the studies was due mainly to inadequate analgesia , side effects , and noncompliance . The efficacy of oxycodone  was rated to be better than moderate by most of the patients , quality of life parameters increased significantly , and patient satisfaction was high . The treatment with oral controlled-release oxycodone was a safe and effective option even when used by nonspecialized physicians Background Some patients with long-st and ing low back pain will benefit from treatment with strong opioids . However , it would be helpful to predict which patients will have a good response . A fixed-term opioid trial has been recommended , but there is little evidence to suggest how long this trial should be . We assessed data from a large-scale r and omized comparison of transdermal fentanyl ( TDF ) and sustained-release oral morphine ( slow-release morphine ; SRM ) to determine characteristics of treatment responders . Methods This was a secondary analysis of a previously published 13-month r and omized trial involving 680 patients with long-st and ing low back pain ( median age 52 years , 61 % women , median duration of back pain 87 months ) .  Pain relief was recorded using visual analogue scales ( VAS ) . Treatment response was defined as pain relief of at least 30 % from baseline to any point during the trial . We used a step-wise logistic regression to identify variables that might predict response to treatment . Covariates included treatment group , sex , age , duration of pain , presence of neuropathic pain , baseline pain scores , educational/employment status , use of high doses of opioids , and social functioning (SF)-36 scores . Results Over half the patients in both groups ( n = 370 ; 54 % TDF , 55 % SRM ) were treatment responders . There were no differences between the TDF and SRM responders in terms of age , sex , type or duration of pain between responders and non-responders . The difference in response to treatment between responders and non-responders could be detected at 3 weeks . Lack of response after 1 month had a stronger negative predictive value ( i.e. , ability to detect non-responders ) than the presence of response after 1 month . The most influential factors for predicting a response were employment status ( χ2 = 11.06 , p = 0.0259 ) and use of high doses of opioids ( χ2 = 3.04 , p = 0.0811 ) . Conclusion No clear pattern of baseline pain ( type or severity ) or patient characteristics emerged that could be used to predict responders before the start of opioid treatment . However , a 1-month trial period appears sufficient to determine response and tolerability in most cases OBJECTIVE This study compared the efficacy and safety profile of buprenorphine transdermal delivery system ( BTDS ) and placebo in subjects with persistent noncancer-related pain who required opioid analgesics .  METHODS This was a multicenter , double-blind , parallel-group study in adult subjects ( age > /=18 years ) with at least a 2-month history of noncancer-related pain for which they received oral opioid combination agents .  The study employed a maintenance-of-analgesia , or r and omized-withdrawal , design . During a 7- to 21-day open-label run-in phase , all subjects received BTDS , titrated as needed . Subjects who achieved stable pain control and were able to tolerate BTDS in the run-in phase were r and omly assigned to continue BTDS at the dose achieved during the run-in phase or to receive placebo for up to 14 days . Acetaminophen 500-mg tablets were provided as escape ( rescue ) medication . Subjects completed the study on day 14 or when they met predefined criteria for ineffective treatment : requiring > 1 g of acetaminophen as escape medication on any day of the double-blind evaluation phase , requiring a change in study drug dose , having difficulty keeping the patch affixed , or discontinuing because of ineffective treatment without meeting any of the first 3 criteria . The primary efficacy variable was the proportion of subjects with ineffective treatment . Secondary efficacy variables were the time to ineffective treatment ; the proportion of subjects who reached ineffective treatment or discontinued for any reason other than ineffective treatment ; and the amount of escape medication used . Assessment of the safety profile was based on adverse events and changes in vital signs and physical and laboratory findings . RESULTS Five hundred eighty-eight subjects entered the open-label run-in phase , and 267 ( 129 BTDS , 138 placebo ) were subsequently r and omized to doubleblind treatment . Demographic characteristics were similar between the double-blind BTDS and placebo groups ( 61.2 % and 63.8 % female , respectively ; 99.2 % and 98.6 % white ; mean [ SD ] age , 56.2 [ 13.3 ] and 59.2 [ 11.5 ] years ) . In the primary efficacy analysis , the proportion of subjects with ineffective treatment was lower with BTDS than with placebo ( 51.2 % vs 65.0 % ; 95 % CI , 1.09 - 2.95 ) ; the odds of ineffective treatment were 1.79 times greater for placebo relative to BTDS ( P = 0.022 ) . In the secondary efficacy analyses , the median time from the first dose of double-blind study drug to ineffective treatment was significantly longer with BTDS than with placebo ( median , 10 vs 3 days ; P = 0.011 ) . The proportion of subjects who reached ineffective treatment or discontinued for reasons other than ineffective treatment was lower in the BTDS group compared with the placebo group ( 55.0 % vs 67.9 % ) ; the odds of ineffective treatment or discontinuation for a reason other than ineffective treatment was 1.76 times greater with placebo compared with BTDS ( P = 0.028 ) . The mean amount of escape medication used was significantly lower in the BTDS group than in the placebo group ( 1.7 vs 2.2 acetaminophen tablets per day ; P = 0.015 ) . The most common adverse events in the open-label run-in or double-blind phase occurring at a higher incidence with BTDS than with placebo were pruritus at the patch application site ( 9.3 % vs 5.1 % , respectively ) , headache ( 3.9 % vs 2.2 % ) , and somnolence ( 2.3 % vs 0.7 % ) . CONCLUSION In this population of adult subjects with persistent noncancer-related pain who required opioid therapy , BTDS use was associated with analgesic efficacy and was generally well tolerated . Results of this study were presented in part at the annual meeting of the American Pain Society , March 30-April 2 , 2005 , Boston , Massachusetts Abstract Objective : To demonstrate non-inferior/superior efficacy of flupirtine modified release ( MR ) compared with tramadol/placebo for the management of moderate to severe chronic low back pain ( LBP ) . Research design : R and omized , double-blind , active-/placebo-controlled double-dummy multicenter study , performed in 31 German study centers . LBP patients ( n = 363 ) with moderate pain intensity were r and omized 1:1:1 to receive flupirtine MR 400 mg , tramadol extended release ( ER ) 200 mg , or matching placebo ( each given OD in the evening ) over 4 weeks . Clinical trial registration : EudraCT 2009 - 013268 - 38 . Main outcome measures : Primary endpoint was change from baseline in the LBP intensity index ( LBPIX ; 11-point NRS ) at week 4 ; last observation carried forward was used to impute missing scores . Results : Least square ( LS ) mean ± SD LBPIX changes from baseline at week 4 were clinical ly significant for all three treatment groups of the intent-to-treat ( ITT ) and the per- protocol ( PP ) population ( n = 326/276 ) : placebo ( n = 110/96 ) : −1.81 ± 1.65/−1.77 ± 1.59 ; flupirtine MR ( n = 109/95 ) : −2.23 ± 1.73/−2.28 ± 1.68 ; and tramadol ER ( n = 107/85 ) : −1.92 ± 1.84/2.03 ± 1.83 ( p < 0.001 for each ) . ITT/PP treatment effects for flupirtine MR were non-inferior when compared with tramadol ER and superior when compared with placebo ( p = 0.003/0.033 ) . Significantly more ITT patients treated with flupirtine MR ( 59.6/37.6 showed a ≥30/50 % LBPIX relief in comparison to placebo ( 46.4/24. 
    Output:
    
In general , the effect sizes were medium for pain and small for function .
There is some evidence ( very low to moderate quality ) for short-term efficacy ( for both pain and function ) of opioids to treat CLBP compared to placebo .
The very few trials that compared opioids to non-steroidal anti-inflammatory drugs ( NSAIDs ) or antidepressants did not show any differences regarding pain and function .
There are no placebo- RCTs supporting the effectiveness and safety of long-term opioid therapy for treatment of CLBP