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: For clinical trials of acupuncture , it would be desirable to have a sham procedure that is indistinguishable from the real treatment , yet inactive . A sham needle has been design ed which telescopes instead of penetrating the skin . The Park Sham Device involves an improved method of supporting the sham needle and requires validation . The objective of these studies was to test whether the sham procedure using the new device was 1 ) indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and 2 ) inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . The studies were design ed as subject and assessor blind , r and omised controlled trials . Study 1 ) included 58 patients enrolled in a clinical trial of acupuncture for acute stroke . Study 2 ) included 63 healthy , acupuncture naïve , adult volunteers . The interventions used were real or sham acupuncture using the Park Sham Device . Study 1 ) was set in a district general hospital , and study 2 ) in a university laboratory . The outcome measure in study 1 ) was the form of treatment that patients believed they had received . In study 2 ) the outcome measure was experience of de qi , as judged by three acupuncture experts . No patient in either group ( study 1 ) believed he or she had been treated with the sham needle . In 40 volunteers ( study 2 ) for whom experts achieved consensus , the relative risk of experiencing de qi with real acupuncture to that with sham acupuncture was 15.38 ( 95 % CI 2.26 to 104.86 ) . The inter-rater reliability of all 13 experts ( study 2 ) , calculated from their judgements on 10 subjects selected by r and omisation , was 0.52 ( 95 % CI 0.19 to 0.61 ) . In conclusion , the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and is inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . It is therefore a valid control for acupuncture trials . The findings also lend support to the existence of de qi , a major concept underlying traditional Chinese acupuncture The analgesic effect of acupuncture was evaluated by a double-blind controlled trial in 90 patients undergoing gastroscopy .  The endoscopy was much easier and better tolerated after real acupuncture had been performed Background : Acupuncture has traditionally been used in the treatment of inflammatory bowel disease in China and is increasingly being applied in Western countries . The purpose of this study was to investigate the efficacy of acupuncture in the treatment of active Crohn ’s disease ( CD ) . Methods : A prospect i ve , r and omized , controlled , single-blind clinical trial was carried out to analyze the change in the CD activity index ( CDAI ) after treatment as a main outcome measure , and the changes in quality of life and general well-being , serum markers of inflammation ( α1-acid glycoprotein , C-reactive protein ) as secondary outcome measures . 51 patients with mild to moderately active CD were treated in a single center for  complementary medicine  by three trained acupuncturists and r and omly assigned to receive either traditional acupuncture ( TCM group , n = 27 ) or control treatment at non-acupuncture points ( control group , n = 24 ) . Patients were treated in 10 sessions over a period of 4 weeks and followed up for 12 weeks . Results : In the TCM group the CDAI decreased from 250 ± 51 to 163 ± 56 points as compared with a mean decrease from 220 ± 42 to 181 ± 46 points in the control group ( TCM vs. control group : p = 0.003 ) . In both groups these changes were associated with improvements in general well-being and quality of life . With regard to general well-being  , traditional acupuncture was superior to control treatment ( p = 0.045 ) . α1-acid glycoprotein concentration fell significantly only in the TCM group ( p = 0.046 ) . Conclusions : Apart from a marked placebo effect , traditional acupuncture offers an additional therapeutic benefit in patients with mild to moderately active CD At a comparison among 5 therapy methods the  small psychotherapy  with a success-rate of 74 % is high-significantly more prospero us than the other examined methods . The acupuncture with 31 % long-term success is significantly superior to the  pseudoacupuncture  ( 17.2 % ) . The papaverine therapy results in a long-lasting status free of symptoms in 17.2 % of the patients and is significantly different from the results of the papaverine-placebo-therapy ( 0 % ) . Distinct differences in the success-rates of the  small psychotherapy  with different therapists prove the role of the personality and the perfection in mastering the methods with psychotherapeutic procedures . Comparable differences between the examiners were not found among the effects of a spasmolytic therapy 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 The results of the large acupuncture studies initiated by the German Federal Committee of Physicians and Health Insurers raised several new questions concerning acupuncture effects . Based on the current evidence it is postulated that not yet entirely defined specific und unspecific factors contribute to outcome in acupuncture treatment . Consequently , acupuncture has to be regarded as a ' complex intervention ' consisting of several components . A phased approach to evaluate ' complex intervention ' is presented and transferred to acupuncture research . According to this phased approach unspecific factors contributing to acupuncture effects have to be identified and increasingly considered in future acupuncture research . Thus , several research methods to identify and evaluate unspecific  acupuncture effects are suggested , e.g. qualitative methods . Therefore , the particular German situation of acupuncture , provided by physicians and state-licensed non-medical therapists ( ' Heilpraktiker ' ) , is taken into account . Furthermore , it is discussed to what extent unspecific  acupuncture effects can be assessed within r and omized controlled trials 36 patients ( 18 males and 18 females , mean age 51 [ 21 - 76 ] years ) were prepared for colonoscopy  with acupuncture ( points : Hegu , Neiguan , Zusanli and Gongsun bilaterally ) , without acupuncture or pretend acupuncture at points not expected to bring about pain relief . In the 12  acupuncture patients  mean pain sensitivity , estimated during the examination by means of a visual analog scale , was significantly ( P = 0.003 ) lower ( 1.4 + /- 0.4 ) than in the groups without acupuncture ( n = 12 ; 2.7 + /- 0.3 ) or pretend acupuncture ( n = 12 ; 3.0 + /- 0.3 ) . In addition , analgesics and sedatives needed to be given significantly less to those with acupuncture ( one patient each ; P = 0.005 ) than those without ( analgesics to five , sedatives to eight patients ) or with pretend acupuncture ( analgesics to four , sedatives to five patients ) . These data demonstrate that pain connected with colonoscopy can be reduced by preceding acupuncture Objective Postpr and ial symptoms in irritable bowel syndrome are common and relate to an exaggerated motor and sensory component of the gastrocolonic response . We investigated whether this response can be affected by hypnotherapy . Methods We included 28 patients with irritable bowel syndrome refractory to other treatments . They were r and omized to receive gut-directed hypnotherapy 1 hour per week for 12 weeks ( N = 14 ) or were provided with supportive therapy ( control group ; N = 14 ) . Before r and omization and after 3 months , all patients underwent a colonic distension trial before and after a 1-hour duodenal lipid infusion .  Colonic sensory thresholds and tonic and phasic motor activity were assessed . Results Before r and omization , reduced thresholds after vs. before lipid infusion were seen in both groups for all studied sensations . At 3 months , the colonic sensitivity before duodenal lipids did not differ between groups . Controls reduced their thresholds after duodenal lipids for gas ( 22 ± 1.7 mm Hg vs. 16 ± 1.6 mm Hg , p < .01 ) , discomfort ( 29 ± 2.9 mm Hg vs. 22 ± 2.6 mm Hg , p < .01 ) , and pain ( 33 ± 2.7 mm Hg vs. 26 ± 3.3 mm Hg , p < .01 ) , whereas the hypnotherapy group reduced their thresholds after lipids only for pain ( 35 ± 4.0 mm Hg vs. 29 ± 4.7 mm Hg , p < .01 ) . The colonic balloon volumes and tone response at r and omization were similar in both groups . At 3 months , baseline balloon volumes were lower in the hypnotherapy group than in controls ( 83 ± 14 ml vs. 141 ± 15 ml , p < .01 ) . In the control group , reduced balloon volumes during lipid infusion were seen ( 141 ± 15 ml vs. 111 ± 19 ml , p < .05 ) , but not after hypnotherapy ( 83 ± 14 ml vs. 80 ± 16 ml , p > .20 ) . Conclusion Hypnotherapy reduces the sensory and motor component of the gastrocolonic response in patients with irritable bowel syndrome . These effects may be involved in the clinical efficacy of hypnotherapy in IBS Objective . Acupuncture has traditionally been used in the treatment of inflammatory bowel disease in China and is increasingly applied in Western countries . The objective of this study was to investigate the efficacy of acupuncture and moxibustion in the treatment of active ulcerative colitis ( UC ) . Material and methods . In a prospect i ve , r and omized , controlled clinical trial 29 patients with mild to moderately active UC ( mean age 37.8±12.0 years ) were r and omly assigned to receive either traditional acupuncture and moxa ( TCM group , n=15 ) , or sham acupuncture consisting of superficial needling at non-acupuncture points ( control group , CG , n = 14 ) . All patients were treated in 10 sessions over a period of 5 weeks and followed-up for 16 weeks . The main outcome measure was the change in the Colitis Activity Index ( CAI ) after treatment ; secondary outcome measures were changes in quality of life , general well-being and serum markers of inflammation . Results . In the TCM group , the CAI decreased from 8.0 ( ±3.7 ) to 4.2 ( ±2.4 ) points and in the control group from 6.5 ( ±3.4 ) to 4.8 ( ±3.9 ) points ( TCM versus CG : p=0.048 ) . In both groups these changes were associated with significant improvements in general well-being ( TCM group : from 3.0 ( ±1.8 ) to 1.8 ( ±1.0 ) ; CG : from 3.2 ( ±1.9 ) to 2.2 ( ±1.7 ) ) and quality of life ( TCM group : from 146 ( ±23 ) to 182 ( ±18 ) ; CG : from 157 ( ±20 ) to 183 ( ±23 ) ) . No significant differences between the TCM and CG were found regarding these secondary outcome measures . Conclusions . Differences in efficacy between traditional acupuncture and sham acupuncture were small and significant only for CAI as the main outcome measure . Both traditional and sham acupuncture seem to offer an additional therapeutic benefit in patients with mild to moderately active UC 62 patients with chronic colitis were r and omly divided into two groups . Acupuncture and moxibustion at acupoints such as Tianshu ( St 25 ) , Guanyuan ( Ren 4 ) were applied in the treatment group , and western drugs were applied in the control 
    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: For clinical trials of acupuncture , it would be desirable to have a sham procedure that is indistinguishable from the real treatment , yet inactive . A sham needle has been design ed which telescopes instead of penetrating the skin . The Park Sham Device involves an improved method of supporting the sham needle and requires validation . The objective of these studies was to test whether the sham procedure using the new device was 1 ) indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and 2 ) inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . The studies were design ed as subject and assessor blind , r and omised controlled trials . Study 1 ) included 58 patients enrolled in a clinical trial of acupuncture for acute stroke . Study 2 ) included 63 healthy , acupuncture naïve , adult volunteers . The interventions used were real or sham acupuncture using the Park Sham Device . Study 1 ) was set in a district general hospital , and study 2 ) in a university laboratory . The outcome measure in study 1 ) was the form of treatment that patients believed they had received . In study 2 ) the outcome measure was experience of de qi , as judged by three acupuncture experts . No patient in either group ( study 1 ) believed he or she had been treated with the sham needle . In 40 volunteers ( study 2 ) for whom experts achieved consensus , the relative risk of experiencing de qi with real acupuncture to that with sham acupuncture was 15.38 ( 95 % CI 2.26 to 104.86 ) . The inter-rater reliability of all 13 experts ( study 2 ) , calculated from their judgements on 10 subjects selected by r and omisation , was 0.52 ( 95 % CI 0.19 to 0.61 ) . In conclusion , the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and is inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . It is therefore a valid control for acupuncture trials . The findings also lend support to the existence of de qi , a major concept underlying traditional Chinese acupuncture The analgesic effect of acupuncture was evaluated by a double-blind controlled trial in 90 patients undergoing gastroscopy .  The endoscopy was much easier and better tolerated after real acupuncture had been performed Background : Acupuncture has traditionally been used in the treatment of inflammatory bowel disease in China and is increasingly being applied in Western countries . The purpose of this study was to investigate the efficacy of acupuncture in the treatment of active Crohn ’s disease ( CD ) . Methods : A prospect i ve , r and omized , controlled , single-blind clinical trial was carried out to analyze the change in the CD activity index ( CDAI ) after treatment as a main outcome measure , and the changes in quality of life and general well-being , serum markers of inflammation ( α1-acid glycoprotein , C-reactive protein ) as secondary outcome measures . 51 patients with mild to moderately active CD were treated in a single center for  complementary medicine  by three trained acupuncturists and r and omly assigned to receive either traditional acupuncture ( TCM group , n = 27 ) or control treatment at non-acupuncture points ( control group , n = 24 ) . Patients were treated in 10 sessions over a period of 4 weeks and followed up for 12 weeks . Results : In the TCM group the CDAI decreased from 250 ± 51 to 163 ± 56 points as compared with a mean decrease from 220 ± 42 to 181 ± 46 points in the control group ( TCM vs. control group : p = 0.003 ) . In both groups these changes were associated with improvements in general well-being and quality of life . With regard to general well-being  , traditional acupuncture was superior to control treatment ( p = 0.045 ) . α1-acid glycoprotein concentration fell significantly only in the TCM group ( p = 0.046 ) . Conclusions : Apart from a marked placebo effect , traditional acupuncture offers an additional therapeutic benefit in patients with mild to moderately active CD At a comparison among 5 therapy methods the  small psychotherapy  with a success-rate of 74 % is high-significantly more prospero us than the other examined methods . The acupuncture with 31 % long-term success is significantly superior to the  pseudoacupuncture  ( 17.2 % ) . The papaverine therapy results in a long-lasting status free of symptoms in 17.2 % of the patients and is significantly different from the results of the papaverine-placebo-therapy ( 0 % ) . Distinct differences in the success-rates of the  small psychotherapy  with different therapists prove the role of the personality and the perfection in mastering the methods with psychotherapeutic procedures . Comparable differences between the examiners were not found among the effects of a spasmolytic therapy 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 The results of the large acupuncture studies initiated by the German Federal Committee of Physicians and Health Insurers raised several new questions concerning acupuncture effects . Based on the current evidence it is postulated that not yet entirely defined specific und unspecific factors contribute to outcome in acupuncture treatment . Consequently , acupuncture has to be regarded as a ' complex intervention ' consisting of several components . A phased approach to evaluate ' complex intervention ' is presented and transferred to acupuncture research . According to this phased approach unspecific factors contributing to acupuncture effects have to be identified and increasingly considered in future acupuncture research . Thus , several research methods to identify and evaluate unspecific  acupuncture effects are suggested , e.g. qualitative methods . Therefore , the particular German situation of acupuncture , provided by physicians and state-licensed non-medical therapists ( ' Heilpraktiker ' ) , is taken into account . Furthermore , it is discussed to what extent unspecific  acupuncture effects can be assessed within r and omized controlled trials 36 patients ( 18 males and 18 females , mean age 51 [ 21 - 76 ] years ) were prepared for colonoscopy  with acupuncture ( points : Hegu , Neiguan , Zusanli and Gongsun bilaterally ) , without acupuncture or pretend acupuncture at points not expected to bring about pain relief . In the 12  acupuncture patients  mean pain sensitivity , estimated during the examination by means of a visual analog scale , was significantly ( P = 0.003 ) lower ( 1.4 + /- 0.4 ) than in the groups without acupuncture ( n = 12 ; 2.7 + /- 0.3 ) or pretend acupuncture ( n = 12 ; 3.0 + /- 0.3 ) . In addition , analgesics and sedatives needed to be given significantly less to those with acupuncture ( one patient each ; P = 0.005 ) than those without ( analgesics to five , sedatives to eight patients ) or with pretend acupuncture ( analgesics to four , sedatives to five patients ) . These data demonstrate that pain connected with colonoscopy can be reduced by preceding acupuncture Objective Postpr and ial symptoms in irritable bowel syndrome are common and relate to an exaggerated motor and sensory component of the gastrocolonic response . We investigated whether this response can be affected by hypnotherapy . Methods We included 28 patients with irritable bowel syndrome refractory to other treatments . They were r and omized to receive gut-directed hypnotherapy 1 hour per week for 12 weeks ( N = 14 ) or were provided with supportive therapy ( control group ; N = 14 ) . Before r and omization and after 3 months , all patients underwent a colonic distension trial before and after a 1-hour duodenal lipid infusion .  Colonic sensory thresholds and tonic and phasic motor activity were assessed . Results Before r and omization , reduced thresholds after vs. before lipid infusion were seen in both groups for all studied sensations . At 3 months , the colonic sensitivity before duodenal lipids did not differ between groups . Controls reduced their thresholds after duodenal lipids for gas ( 22 ± 1.7 mm Hg vs. 16 ± 1.6 mm Hg , p < .01 ) , discomfort ( 29 ± 2.9 mm Hg vs. 22 ± 2.6 mm Hg , p < .01 ) , and pain ( 33 ± 2.7 mm Hg vs. 26 ± 3.3 mm Hg , p < .01 ) , whereas the hypnotherapy group reduced their thresholds after lipids only for pain ( 35 ± 4.0 mm Hg vs. 29 ± 4.7 mm Hg , p < .01 ) . The colonic balloon volumes and tone response at r and omization were similar in both groups . At 3 months , baseline balloon volumes were lower in the hypnotherapy group than in controls ( 83 ± 14 ml vs. 141 ± 15 ml , p < .01 ) . In the control group , reduced balloon volumes during lipid infusion were seen ( 141 ± 15 ml vs. 111 ± 19 ml , p < .05 ) , but not after hypnotherapy ( 83 ± 14 ml vs. 80 ± 16 ml , p > .20 ) . Conclusion Hypnotherapy reduces the sensory and motor component of the gastrocolonic response in patients with irritable bowel syndrome . These effects may be involved in the clinical efficacy of hypnotherapy in IBS Objective . Acupuncture has traditionally been used in the treatment of inflammatory bowel disease in China and is increasingly applied in Western countries . The objective of this study was to investigate the efficacy of acupuncture and moxibustion in the treatment of active ulcerative colitis ( UC ) . Material and methods . In a prospect i ve , r and omized , controlled clinical trial 29 patients with mild to moderately active UC ( mean age 37.8±12.0 years ) were r and omly assigned to receive either traditional acupuncture and moxa ( TCM group , n=15 ) , or sham acupuncture consisting of superficial needling at non-acupuncture points ( control group , CG , n = 14 ) . All patients were treated in 10 sessions over a period of 5 weeks and followed-up for 16 weeks . The main outcome measure was the change in the Colitis Activity Index ( CAI ) after treatment ; secondary outcome measures were changes in quality of life , general well-being and serum markers of inflammation . Results . In the TCM group , the CAI decreased from 8.0 ( ±3.7 ) to 4.2 ( ±2.4 ) points and in the control group from 6.5 ( ±3.4 ) to 4.8 ( ±3.9 ) points ( TCM versus CG : p=0.048 ) . In both groups these changes were associated with significant improvements in general well-being ( TCM group : from 3.0 ( ±1.8 ) to 1.8 ( ±1.0 ) ; CG : from 3.2 ( ±1.9 ) to 2.2 ( ±1.7 ) ) and quality of life ( TCM group : from 146 ( ±23 ) to 182 ( ±18 ) ; CG : from 157 ( ±20 ) to 183 ( ±23 ) ) . No significant differences between the TCM and CG were found regarding these secondary outcome measures . Conclusions . Differences in efficacy between traditional acupuncture and sham acupuncture were small and significant only for CAI as the main outcome measure . Both traditional and sham acupuncture seem to offer an additional therapeutic benefit in patients with mild to moderately active UC 62 patients with chronic colitis were r and omly divided into two groups . Acupuncture and moxibustion at acupoints such as Tianshu ( St 25 ) , Guanyuan ( Ren 4 ) were applied in the treatment group , and western drugs were applied in the control 
    Output:
    