human
***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 The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports , including many studies identified by their authors as r and omized controlled trials . It has been noticed that these reports mostly present positive results , and their quality and authenticity have consequently been called into question . We investigated the adequacy of r and omization  of clinical trials published in recent years in China to determine how many of them met acceptable st and ards for allocating participants to treatment groups . Methods The China National Knowledge Infrastructure electronic data base was search ed for reports of r and omized controlled trials on 20 common diseases published from January 1994 to June 2005 . From this sample , a subset of trials that appeared to have used r and omization methods was selected . Twenty-one investigators trained in the relevant knowledge , communication skills and quality control issues interviewed the original authors of these trials about the participant r and omization methods and related quality -control features of their trials . Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure data base , we found 3137 apparent r and omized controlled trials . Of these , 1452 were studies of conventional medicine ( published in 411 journals ) and 1685 were studies of traditional Chinese medicine ( published in 352 journals ) . Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for r and omization and could on those grounds be deemed authentic r and omized controlled trials ( 6.8 % , 95 % confidence interval 5.9–7.7 ) . There was no statistically significant difference in the rate of authenticity between r and omized controlled trials of traditional interventions and those of conventional interventions . R and omized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals ( relative risk 1.58 , 95 % confidence interval 1.18–2.13 , and relative risk 14.42 , 95 % confidence interval 9.40–22.10 , respectively ) . The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals ( relative risk 9.32 , 95 % confidence interval 5.83–14.89 ) . All r and omized controlled trials of pre-market drug clinical trial were authentic by our criteria . Of the trials conducted at university-affiliated hospitals , 56.3 % were authentic ( 95 % confidence interval 32.0–81.0 ) . Conclusion Most reports of r and omized controlled trials published in some Chinese journals lacked an adequate description of r and omization . Similarly , most so called ' r and omized controlled trials ' were not real r and omized controlled trials owing toa lack of adequate underst and ing on the part of the authors of rigorous clinical trial design . All r and omized controlled trials of pre-market drug clinical trial included in this research were authentic . R and omized controlled trials conducted by authors in high level hospitals , especially in hospitals affiliated to medical universities had a higher rate of authenticity . That so many non-r and omized controlled trials were published as r and omized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed OBJECTIVES : This study aim ed to compare the effects of true and sham acupuncture in relieving symptoms of  irritable bowel syndrome ( IBS ) .  METHODS : A total of 230 adult IBS patients ( 75 % females , average age : 38.4 years ) were r and omly assigned to 3 weeks of true or sham acupuncture ( 6 treatments ) after a 3-week “ run-in ” with sham acupuncture in an “ augmented ” or “ limited ” patient – practitioner interaction . A third arm of the study included a waitlist control group . The primary outcome was the IBS Global Improvement Scale ( IBS-GIS ) ( range : 1–7 ) ; secondary outcomes included the IBS Symptom Severity Scale ( IBS-SSS ) , the IBS Adequate Relief ( IBS-AR ) , and the IBS Quality of Life ( IBS-QOL ) . RESULTS : Although there was no statistically significant difference between acupuncture and sham acupuncture on the IBS-GIS ( 41 vs. 32 % , P=0.25 ) , both groups improved significantly compared with the waitlist control group ( 37 vs. 4 % , P=0.001 ) . Similarly , small differences that were not statistically significant favored acupuncture over the other three outcomes : IBS-AR ( 59 vs. 57 % , P=0.83 ) , IBS-SSS ( 31 vs. 21 % , P=0.18 ) , and IBS-QOL ( 17 vs. 13 % , P=0.56 ) . Eliminating responders during the run-in period did not substantively change the results . Side effects were generally mild and only slightly greater in the acupuncture group . CONCLUSIONS : This study did not find evidence to support the superiority of acupuncture compared with sham acupuncture in the treatment of IBS AIM Irritable bowel syndrome ( IBS ) is a common disorder and many patients fail to find adequate relief from conventional therapies for their symptoms . This study tests the cl aim that acupuncture is effective for a majority of these patients . METHODS A prospect i ve , blinded , sham acupuncture-controlled trial of traditional Chinese acupuncture was performed at a single postgraduate teaching hospital in Europe . Sixty patients with well-established IBS were recruited . The blinded comparator was sham acupuncture administered by the second of two acupuncturists who alone was aware of the r and omization , and who otherwise followed the prescription of the first . The primary end-point was a defined fall in the symptom score at 13 wk ( by intention to treat ) . The prior expectation was a 30 % placebo response , and a response rate of 70 % from acupuncture , for which the study was adequately powered . RESULTS Patients in treated and sham groups improved significantly during the study -mean improvement in scores being equal ( minus 1.9 ) and significant for both ( P<0.05 ; one-tailed t test ) . There was a small numeric but non-significant difference between the response rate in patients receiving acupuncture ( 40.7 % ) and sham treatment ( 31.2 % ) . Several secondary end-points marginally favored active treatment , but an improved symptom score of any degree of magnitude occurred more often with sham therapy ( 65.6 % vs 59.2 % ) . For no criterion was statistical significance approached . CONCLUSION Traditional Chinese acupuncture is relatively ineffective in IBS in the European hospital setting , and the magnitude of any effect appears insufficient to warrant investment in acupuncture services Abstract Objective To investigate whether a sham device ( a vali date d sham acupuncture needle ) has a greater placebo effect than an inert pill in patients with persistent arm pain . Design A single blind r and omised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls . Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study . Setting Academic medical centre . Participants 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored ≥3 on a 10 point pain scale . Interventions Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks . Main outcome measures Arm pain measured on a 10 point pain scale . Secondary outcomes were symptoms measured by the Levine symptom severity scale , function measured by Pransky 's upper extremity function scale , and grip strength . Results Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups , but changes were not different between the groups ( −0.14 , 95 % confidence interval −0.52 to 0.25 , P = 0.49 ) . Changes in severity scores for arm symptoms and grip strength were similar between groups , but arm function improved more in the placebo pill group ( 2.0 , 0.06 to 3.92 , P = 0.04 ) . Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group ( −0.33 ( −0.40 to −0.26 ) v −0.15 ( −0.21 to −0.09 ) , P = 0.0001 ) and on the symptom severity scale ( −0.07 ( −0.09 to −0.05 ) v −0.05 ( −0.06 to −0.03 ) , P = 0.02 ) . Differences were not significant , however , on the function scale or for grip strength . Reported adverse effects were different in the two groups . Conclusions The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in . Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals We cringe at the pervasive notion that a r and omised trial needs to yield equal sample sizes in the comparison groups . Unfortunately , that conceptual misunderst and ing can lead to bias by investigators who force e quality , especially if by non-scientific means . In simple , unrestricted , r and omised trials ( analogous to repeated coin-tossing ) , the sizes of groups should indicate r and om variation . In other words , some discrepancy between the numbers in the comparison groups would be expected . The appeal of equal group sizes in a simple r and omised controlled trial is cosmetic , not scientific . Moreover , other r and omisation schemes , termed restricted r and omisation , force e quality by departing from simple r and omisation . Forcing equal group sizes , however , potentially harms the unpredictability of treatment assignments , especially when using permuted-block r and omisation in non-double-blinded trials . Diminished unpredictability can allow bias to creep into a trial . Overall , investigators underuse simple r and omisation and overuse fixed-block r and omisation . For non-double-blinded trials larger than 200 participants , investigators should use simple r and omisation more often and accept moderate disparities in group sizes . Such unpredictability reflects the essence of r and omness . We endorse the generation of mildly unequal group sizes and encourage an appreciation of such inequalities . For non-double-blinded r and omised controlled trials with a sample size of less than 200 overall or within any principal stratum or subgroup , urn r and omisation enhances unpredictability compared with blocking . A simpler alternative , our mixed r and omisation approach , attains unpredictability within the context of the currently understood simple r and omisation and permuted-block methods . Simple r and omisation contributes the unpredictability whereas permuted-block r and omisation contributes the balance , but avoids the perfect balance that can result in selection bias OBJECTIVE To assess the method ological quality of the design and reporting of  r and omized controlled trials published in one major dermatology specialty journal . DESIGN AND DATA SOURCES In a survey of all published parallel group r and omized controlled trials , we found 73 reports with allocation described as r and omized from all issues of Clinical and Experimental Dermatology from its inception in 1976 through 1997 . MAIN OUTCOME MEASURES Direct and indirect measures of the adequacy of r and omization , trial sample size , baseline comparisons , and intention-to-treat analysis . RESULTS H and search ing identified 73 r and omized controlled trials , but only 31 of these were found by search ing MEDLINE for the publication type clinical trials . Of the 73 r and omized controlled trials , 68 contained sufficient information to include in the analysis . Only 1 study ( 1 % ) reported the method of r and om sequence generation , and only 5 studies ( 7 % ) reported adequate concealment of allocation . Among 38 trials that used simple r and omization , the sample sizes in the comparison groups were identical in 22 occasions , raising the possibility that simple r and omization might not have been adequately generated or concealed . Most trials ( 88 % ) excluded some r and omized participants from their analysis . The median sample size was 23 per trial . Only 1 trial reported sample size and statistical power considerations and had an a priori main hypothesis . CONCLUSIONS H and search ing is important for locating all relevant trials . There is the need for higher method ological quality in clinical trial reporting in dermatology journals . The adoption of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports OBJECTIVES : This prospect i ve , r and omized controlled trial explored the feasibility and efficacy of a group program of mindfulness training , a cognitive-behavioral technique , for women with irritable bowel syndrome ( IBS ) . The technique involves training in intentionally attending to present-moment experience and non-judgmental awareness of body sensations and emotions . METHODS : Seventy-five female IBS patients were r and omly assigned to eight weekly and one half-day intensive sessions of either mindfulness group ( MG ) training or a support group ( SG ) . Participants completed the IBS severity scale ( primary outcome ) , IBS- quality of life , brief symptom inventory-18 , visceral sensitivity index , treatment credibility scale , and five-facet mindfulness question naire before and after treatment and at 3-month follow-up . RESULTS : Women in the MG showed greater reductions in IBS symptom severity immediately after training ( 26.4 % vs.  
    Output:
    
agent
***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 The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports , including many studies identified by their authors as r and omized controlled trials . It has been noticed that these reports mostly present positive results , and their quality and authenticity have consequently been called into question . We investigated the adequacy of r and omization  of clinical trials published in recent years in China to determine how many of them met acceptable st and ards for allocating participants to treatment groups . Methods The China National Knowledge Infrastructure electronic data base was search ed for reports of r and omized controlled trials on 20 common diseases published from January 1994 to June 2005 . From this sample , a subset of trials that appeared to have used r and omization methods was selected . Twenty-one investigators trained in the relevant knowledge , communication skills and quality control issues interviewed the original authors of these trials about the participant r and omization methods and related quality -control features of their trials . Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure data base , we found 3137 apparent r and omized controlled trials . Of these , 1452 were studies of conventional medicine ( published in 411 journals ) and 1685 were studies of traditional Chinese medicine ( published in 352 journals ) . Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for r and omization and could on those grounds be deemed authentic r and omized controlled trials ( 6.8 % , 95 % confidence interval 5.9–7.7 ) . There was no statistically significant difference in the rate of authenticity between r and omized controlled trials of traditional interventions and those of conventional interventions . R and omized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals ( relative risk 1.58 , 95 % confidence interval 1.18–2.13 , and relative risk 14.42 , 95 % confidence interval 9.40–22.10 , respectively ) . The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals ( relative risk 9.32 , 95 % confidence interval 5.83–14.89 ) . All r and omized controlled trials of pre-market drug clinical trial were authentic by our criteria . Of the trials conducted at university-affiliated hospitals , 56.3 % were authentic ( 95 % confidence interval 32.0–81.0 ) . Conclusion Most reports of r and omized controlled trials published in some Chinese journals lacked an adequate description of r and omization . Similarly , most so called ' r and omized controlled trials ' were not real r and omized controlled trials owing toa lack of adequate underst and ing on the part of the authors of rigorous clinical trial design . All r and omized controlled trials of pre-market drug clinical trial included in this research were authentic . R and omized controlled trials conducted by authors in high level hospitals , especially in hospitals affiliated to medical universities had a higher rate of authenticity . That so many non-r and omized controlled trials were published as r and omized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed OBJECTIVES : This study aim ed to compare the effects of true and sham acupuncture in relieving symptoms of  irritable bowel syndrome ( IBS ) .  METHODS : A total of 230 adult IBS patients ( 75 % females , average age : 38.4 years ) were r and omly assigned to 3 weeks of true or sham acupuncture ( 6 treatments ) after a 3-week “ run-in ” with sham acupuncture in an “ augmented ” or “ limited ” patient – practitioner interaction . A third arm of the study included a waitlist control group . The primary outcome was the IBS Global Improvement Scale ( IBS-GIS ) ( range : 1–7 ) ; secondary outcomes included the IBS Symptom Severity Scale ( IBS-SSS ) , the IBS Adequate Relief ( IBS-AR ) , and the IBS Quality of Life ( IBS-QOL ) . RESULTS : Although there was no statistically significant difference between acupuncture and sham acupuncture on the IBS-GIS ( 41 vs. 32 % , P=0.25 ) , both groups improved significantly compared with the waitlist control group ( 37 vs. 4 % , P=0.001 ) . Similarly , small differences that were not statistically significant favored acupuncture over the other three outcomes : IBS-AR ( 59 vs. 57 % , P=0.83 ) , IBS-SSS ( 31 vs. 21 % , P=0.18 ) , and IBS-QOL ( 17 vs. 13 % , P=0.56 ) . Eliminating responders during the run-in period did not substantively change the results . Side effects were generally mild and only slightly greater in the acupuncture group . CONCLUSIONS : This study did not find evidence to support the superiority of acupuncture compared with sham acupuncture in the treatment of IBS AIM Irritable bowel syndrome ( IBS ) is a common disorder and many patients fail to find adequate relief from conventional therapies for their symptoms . This study tests the cl aim that acupuncture is effective for a majority of these patients . METHODS A prospect i ve , blinded , sham acupuncture-controlled trial of traditional Chinese acupuncture was performed at a single postgraduate teaching hospital in Europe . Sixty patients with well-established IBS were recruited . The blinded comparator was sham acupuncture administered by the second of two acupuncturists who alone was aware of the r and omization , and who otherwise followed the prescription of the first . The primary end-point was a defined fall in the symptom score at 13 wk ( by intention to treat ) . The prior expectation was a 30 % placebo response , and a response rate of 70 % from acupuncture , for which the study was adequately powered . RESULTS Patients in treated and sham groups improved significantly during the study -mean improvement in scores being equal ( minus 1.9 ) and significant for both ( P<0.05 ; one-tailed t test ) . There was a small numeric but non-significant difference between the response rate in patients receiving acupuncture ( 40.7 % ) and sham treatment ( 31.2 % ) . Several secondary end-points marginally favored active treatment , but an improved symptom score of any degree of magnitude occurred more often with sham therapy ( 65.6 % vs 59.2 % ) . For no criterion was statistical significance approached . CONCLUSION Traditional Chinese acupuncture is relatively ineffective in IBS in the European hospital setting , and the magnitude of any effect appears insufficient to warrant investment in acupuncture services Abstract Objective To investigate whether a sham device ( a vali date d sham acupuncture needle ) has a greater placebo effect than an inert pill in patients with persistent arm pain . Design A single blind r and omised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls . Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study . Setting Academic medical centre . Participants 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored ≥3 on a 10 point pain scale . Interventions Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks . Main outcome measures Arm pain measured on a 10 point pain scale . Secondary outcomes were symptoms measured by the Levine symptom severity scale , function measured by Pransky 's upper extremity function scale , and grip strength . Results Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups , but changes were not different between the groups ( −0.14 , 95 % confidence interval −0.52 to 0.25 , P = 0.49 ) . Changes in severity scores for arm symptoms and grip strength were similar between groups , but arm function improved more in the placebo pill group ( 2.0 , 0.06 to 3.92 , P = 0.04 ) . Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group ( −0.33 ( −0.40 to −0.26 ) v −0.15 ( −0.21 to −0.09 ) , P = 0.0001 ) and on the symptom severity scale ( −0.07 ( −0.09 to −0.05 ) v −0.05 ( −0.06 to −0.03 ) , P = 0.02 ) . Differences were not significant , however , on the function scale or for grip strength . Reported adverse effects were different in the two groups . Conclusions The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in . Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals We cringe at the pervasive notion that a r and omised trial needs to yield equal sample sizes in the comparison groups . Unfortunately , that conceptual misunderst and ing can lead to bias by investigators who force e quality , especially if by non-scientific means . In simple , unrestricted , r and omised trials ( analogous to repeated coin-tossing ) , the sizes of groups should indicate r and om variation . In other words , some discrepancy between the numbers in the comparison groups would be expected . The appeal of equal group sizes in a simple r and omised controlled trial is cosmetic , not scientific . Moreover , other r and omisation schemes , termed restricted r and omisation , force e quality by departing from simple r and omisation . Forcing equal group sizes , however , potentially harms the unpredictability of treatment assignments , especially when using permuted-block r and omisation in non-double-blinded trials . Diminished unpredictability can allow bias to creep into a trial . Overall , investigators underuse simple r and omisation and overuse fixed-block r and omisation . For non-double-blinded trials larger than 200 participants , investigators should use simple r and omisation more often and accept moderate disparities in group sizes . Such unpredictability reflects the essence of r and omness . We endorse the generation of mildly unequal group sizes and encourage an appreciation of such inequalities . For non-double-blinded r and omised controlled trials with a sample size of less than 200 overall or within any principal stratum or subgroup , urn r and omisation enhances unpredictability compared with blocking . A simpler alternative , our mixed r and omisation approach , attains unpredictability within the context of the currently understood simple r and omisation and permuted-block methods . Simple r and omisation contributes the unpredictability whereas permuted-block r and omisation contributes the balance , but avoids the perfect balance that can result in selection bias OBJECTIVE To assess the method ological quality of the design and reporting of  r and omized controlled trials published in one major dermatology specialty journal . DESIGN AND DATA SOURCES In a survey of all published parallel group r and omized controlled trials , we found 73 reports with allocation described as r and omized from all issues of Clinical and Experimental Dermatology from its inception in 1976 through 1997 . MAIN OUTCOME MEASURES Direct and indirect measures of the adequacy of r and omization , trial sample size , baseline comparisons , and intention-to-treat analysis . RESULTS H and search ing identified 73 r and omized controlled trials , but only 31 of these were found by search ing MEDLINE for the publication type clinical trials . Of the 73 r and omized controlled trials , 68 contained sufficient information to include in the analysis . Only 1 study ( 1 % ) reported the method of r and om sequence generation , and only 5 studies ( 7 % ) reported adequate concealment of allocation . Among 38 trials that used simple r and omization , the sample sizes in the comparison groups were identical in 22 occasions , raising the possibility that simple r and omization might not have been adequately generated or concealed . Most trials ( 88 % ) excluded some r and omized participants from their analysis . The median sample size was 23 per trial . Only 1 trial reported sample size and statistical power considerations and had an a priori main hypothesis . CONCLUSIONS H and search ing is important for locating all relevant trials . There is the need for higher method ological quality in clinical trial reporting in dermatology journals . The adoption of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports OBJECTIVES : This prospect i ve , r and omized controlled trial explored the feasibility and efficacy of a group program of mindfulness training , a cognitive-behavioral technique , for women with irritable bowel syndrome ( IBS ) . The technique involves training in intentionally attending to present-moment experience and non-judgmental awareness of body sensations and emotions . METHODS : Seventy-five female IBS patients were r and omly assigned to eight weekly and one half-day intensive sessions of either mindfulness group ( MG ) training or a support group ( SG ) . Participants completed the IBS severity scale ( primary outcome ) , IBS- quality of life , brief symptom inventory-18 , visceral sensitivity index , treatment credibility scale , and five-facet mindfulness question naire before and after treatment and at 3-month follow-up . RESULTS : Women in the MG showed greater reductions in IBS symptom severity immediately after training ( 26.4 % vs.  
    Output:
    