***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: The aim of this study was to investigate if cognitive behavior therapy ( CBT ) based on exposure and mindfulness exercises delivered via the Internet would be effective in treating participants with irritable bowel syndrome ( IBS ) . Participants were recruited through self-referral . Eighty-six participants were included in the study and r and omized to treatment or control condition  ( an online discussion forum ) . One participant was excluded after r and omization . The main outcome measure was IBS-symptom severity and secondary measures included IBS-related quality of life , GI-specific anxiety , depression and general functioning . Participants were assessed at pre-treatment , post-treatment and 3 month follow-up ( treatment condition only ) . Four participants ( 5 % of total sample ) in the treatment condition did not participate in post-treatment assessment . Participants in the treatment condition reported a 42 % decrease and participants in the control group reported a 12 % increase in primary IBS-symptoms . Compared to the control condition , participants in the treatment group improved on all secondary outcome measures with a large between group effect size on quality of life ( Cohen 's d = 1.21 ) . We conclude that CBT-based on exposure and mindfulness delivered via the Internet can be effective in treating  IBS- patients  , alleviating the total burden of symptoms and increasing quality of life Twenty patients with irritable bowel syndrome ( IBS ) were r and omly assigned either to intensive , individualized cognitive therapy ( 10 sessions over 8 weeks ) or to 8 weeks of daily gastrointestinal ( GI ) symptom monitoring . Pre- to posttreatment evaluations showed significantly ( p = .005 ) greater GI symptom reduction for those receiving cognitive therapy than for those in symptom monitoring . At posttreatment , 80 % of the cognitive therapy group showed clinical ly significant improvement , whereas only 10 % of the monitoring group showed this . Results held up well at a 3-month follow-up . Within the cognitive therapy group , GI symptom reductions correlated significantly with increases in positive and reductions in negative automatic thoughts OBJECTIVES : Psychological treatments are considered to be useful in the irritable bowel syndrome ( IBS ) , although the evidence is based on small , often flawed trials . Although cognitive behavior therapy ( CBT ) and relaxation therapy have both been promising , we hypothesized that CBT would be superior to relaxation and st and ard care alone in IBS patients . The objective of this study was to test this assumption by comparing the effects of cognitive behavior therapy with relaxation therapy and routine clinical care alone in individuals with IBS . METHODS : Patients ( n = 105 ) with Rome I criteria for IBS were recruited from advertisement ( n = 51 ) and outpatient clinics ( n = 54 ) ; those patients with resistant IBS were not included . A r and omized controlled trial with three arms ( st and ard care for all groups plus either CBT or relaxation ) for 8 wk was conducted , which applied blinded outcome assessment s using vali date d measures with 1 yr of follow-up . The primary outcome for this study was bowel symptom severity . RESULTS : Of 105 patients at the commencement of treatment , the mean bowel symptom frequency score for the whole sample was 21.1 and at the end of treatment had fallen to 18.1 ; this persisted at the 52-wk follow-up , with a significant linear trend for scores to change over time ( F= 39.57 p < 0.001 ) . However , there were no significant differences among the three treatment conditions . Significant changes over time were found for physical functioning ( F= 4.37 , p < 0.001 ) , pain ( F= 3.12 , p < 0.05 ) , general health ( F= 2.71 , p < 0.05 ) , vitality ( F= 2.94 , p < 0.05 ) , and the social functioning scales on the Medical Outcomes Study Short Form 36 ( F= 4.08 , p < 0.05 ) ; however , all three arms showed similar improvement . There were significant reductions in anxiety , depression , and locus of control scales , but no significant differences among the treatment groups were detected . CONCLUSION : Cognitive behavior and relaxation therapy seem not to be superior to st and ard care alone in IBS CONTEXT Chronic tension-type headaches are characterized by near-daily headaches and often are difficult to manage in primary practice . Behavioral and pharmacological therapies each appear modestly effective , but data are lacking on their separate and combined effects . OBJECTIVE To evaluate the clinical efficacy of behavioral and pharmacological therapies , singly and combined , for chronic tension-type headaches . DESIGN AND SETTING R and omized placebo-controlled trial conducted from August 1995 to January 1998 at 2 outpatient sites in Ohio . PARTICIPANTS Two hundred three adults ( mean age , 37 years ; 76 % women ) with diagnosis of chronic tension-type headaches ( mean , 26 headache d/mo ) . INTERVENTIONS Participants were r and omly assigned to receive tricyclic antidepressant ( amitriptyline hydrochloride , up to 100 mg/d , or nortriptyline hydrochloride , up to 75 mg/d ) medication ( n = 53 ) , placebo ( n = 48 ) , stress management ( eg , relaxation , cognitive coping ) therapy ( 3 sessions and 2 telephone contacts ) plus placebo ( n = 49 ) , or stress management therapy plus antidepressant medication ( n = 53 ) . MAIN OUTCOME MEASURES Monthly headache index scores calculated as the mean of pain ratings ( 0 - 10 scale ) recorded by participants in a daily diary 4 times per day ; number of days per month with at least moderate pain ( pain rating > /=5 ) , analgesic medication use , and Headache Disability Inventory scores , compared by intervention group . RESULTS Tricyclic antidepressant medication and stress management therapy each produced larger reductions in headache activity , analgesic medication use , and headache-related disability than placebo , but antidepressant medication yielded more rapid improvements in headache activity . Combined therapy was more likely to produce clinical ly significant ( > /=50 % ) reductions in headache index scores ( 64 % of participants ) than antidepressant medication ( 38 % of participants ; P = .006 ) , stress management therapy ( 35 % ; P = .003 ) , or placebo ( 29 % ; P = .001 ) . On other measures the combined therapy and its 2 component therapies produced similar outcomes . CONCLUSIONS Our results indicate that antidepressant medication and stress management therapy are each modestly effective in treating chronic tension-type headaches . Combined therapy may improve outcome relative to monotherapy Study Design . A 14-week , r and omized , double-blind , multicenter , placebo-controlled study of Japanese patients with chronic low back pain ( CLBP ) who were r and omized to either duloxetine 60 mg once daily or placebo . Objective . This study aim ed to assess the efficacy and safety of duloxetine monotherapy in Japanese patients with CLBP . Summary of Background Data . In Japan , duloxetine is approved for the treatment of depression , diabetic neuropathic pain , and pain associated with fibromyalgia ; however , no clinical study of duloxetine has been conducted for CLBP . Methods . The primary efficacy measure was the change in the Brief Pain Inventory ( BPI ) average pain score from baseline to Week 14 . Secondary efficacy measures included BPI pain ( worst pain , least pain , pain right now ) , Patient 's Global Impression of Improvement , Clinical Global Impressions of Severity , and Rol and -Morris Disability Question naire , among other measures , and safety and tolerability . Results . In total , 458 patients were r and omized to receive either duloxetine ( n = 232 ) or placebo ( n = 226 ) . The BPI average pain score improved significantly in the duloxetine group compared with that in the placebo group at Week 14 [ −2.43 ± 0.11 vs. −1.96 ± 0.11 , respectively ; between-group difference ( 95 % confidence interval ) , − 0.46 [ −0.77 to−0.16 ] ; P = 0.0026 ] . The duloxetine group showed significant improvement in many secondary measures compared with the placebo group , including BPI pain ( least pain , pain right now ) ( between-group difference : −1.69 ± 0.10 , P = 0.0009 ; −2.42 ± 0.12 , P P = 0.0230 , respectively ) , Patient 's Global Impression of Improvement ( 2.46 ± 0.07 , P = 0.0026 ) , Clinical Global Impressions of Severity ( −1.46 ± 0.06 , P = 0.0019 ) , and Rol and -Morris Disability Question naire ( −3.86 ± 0.22 , P = 0.0439 ) . Adverse events occurring at a significantly higher incidence in the duloxetine group were somnolence , constipation , nausea , dizziness , and dry mouth , most of which were mild or moderate in severity and were resolved or improved . Conclusion . Duloxetine 60 mg was effective and well tolerated in Japanese CLBP patients . Level of Evidence : BACKGROUND Recent guidelines for the treatment of irritable bowel syndrome ( IBS ) emphasize the need for research to facilitate home-based self-management for these patients in primary care . The aim of the current study was to test the efficacy of a manualized cognitive behavioural therapy (CBT)-based self-management programme for IBS in a pilot r and omized controlled trial ( RCT ) . METHOD Sixty-four primary -care patients meeting Rome criteria for IBS were r and omized into either self-management plus treatment as usual ( TAU ) ( n=31 ) or a TAU control condition ( n=33 ) . The self-management condition included a structured 7-week manualized programme that was self-administered in conjunction with a 1-hour face-to-face therapy session and two 1-hour telephone sessions . The primary outcome measures were the Subject 's Global Assessment ( SGA ) of Relief and the Irritable Bowel Syndrome Severity Scoring System ( IBS-SSS ) assessed at baseline , end of treatment ( 2 months ) , and 3 and 6 months post-treatment . RESULTS Analysis was by intention-to-treat . Twenty-three ( 76.7 % ) of the self-management group rated themselves as experiencing symptom relief across all three time periods compared to seven ( 21.2 % ) of the TAU controls [ odds ratio ( OR ) 12.2 , 95 % confidence interval ( CI ) 3.72 - 40.1 ] . At 8 months , 25 ( 83 % ) of the self-management group showed a clinical ly significant change on the IBS-SSS compared to 16 ( 49 % ) of the control group ( OR 5.3 , 95 % CI 1.64 - 17.26 ) . CONCLUSIONS This study provides preliminary evidence that CBT-based self-management in the form of a structured manual and minimal therapist contact is an effective and acceptable form of treatment for primary -care IBS patients OBJECTIVES : Gut-directed hypnotherapy has been found to be effective in  irritable bowel syndrome ( IBS ) .  However , r and omized , controlled studies are rare and few have been performed outside highly specialized research centers . The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical setting s outside the traditional research units . METHODS : The study population included IBS patients refractory to st and ard management . In study 1 , patients were r and omized to receive  gut-directed hypnotherapy  ( 12 sessions , 1 h/week ) in psychology private practice s or supportive therapy , whereas patients were r and omized to receive gut-directed hypnotherapy  in a small county hospital or to serve as waiting list controls in study 2 . Gastrointestinal symptom severity and quality of life were evaluated at baseline , at 3 months follow-up and after 1 year . RESULTS : We r and omized 138 IBS patients refractory to st and ard management , 90 in study 1 and 48 in study 2 . In both the studies , IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups ( P<0.05 ) , but not in the control groups ( ns ) . In study 1 , a significantly greater improvement of IBS-related symptom severity could be detected in the gut-directed hypnotherapy group than in the control group ( P<0.05 ) , and a trend in the same direction was seen in study 2 ( P=0.17 ) . The results seen at 3 months were sustained up to 1 year . CONCLUSIONS : Gut-directed hypnotherapy is an effective treatment alternative for patients with refractory IBS , but the effectiveness is lower when the therapy is given outside the highly specialized research centers Background Irritable bowel syndrome is the most common disorder diagnosed by gastroenterologists . Although several r and omized‐controlled trials have assessed the therapeutic role of antidepressant drugs , there is insufficient evidence to support their use One hundred two patients with irritable bowel syndrome were studied in a controlled trial of psychological treatment involving psychotherapy , relaxation , and st and ard medical treatment compared with st and ard medical treatment alone .  Patients were only selected if their symptoms had not improved with st and ard medical treatment over the previous 6 months 
    Output:
    
Cognitive behavioral therapy , relaxation therapy , multi-component psychological therapy , hypnotherapy , and dynamic psychotherapy were all beneficial when data from two or more RCTs were pooled .
: Antidepressants are efficacious in reducing symptoms in IBS patients .