personality factors are important predictors of psychological morbidity in patients with...

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Aprit2000 AGAAllll 757 SMALL BOWEL CANCER IN CROHN'S DISEASE: THE UNIVER- SITY OF cmCAGO EXPERIENCE. David T. Rubin, Bryan McVerry, Stephen B. Hanauer, Univ of Chicago, Chicago, IL. Background: Adenocarcinoma of the small bowel (SBCA) is a rare, but increasingly recognized, complication of Crohn's disease(CD). Pre vious reports have proposed: long duration of unresected disease, surgically excluded small bowel, chronic fisrulae, prolonged immune modulation, occupational carcinogen exposure, jejunal CD, and male gender as risk factors for development of SBCA. Aim: To evaluate risk factors for SBCA in a tertiary CD population. Methods: The University of Chicago Inflam- matory Bowel Disease (IBD) registry was searched for patients with CD and SBCA. Medical records were reviewed to identify potential risk factors of SBCA as well as smoking history and family history of IBD or intestinal cancer. Results: Eight cases of SBCA were identified amongst the 2657 CD registry patients None had surgically excluded bowel or recognized occupational carcinogen exposure. One patient had a family history of IBD (pt #1), and none had a family history of intestinal cancer. The mean duration of disease before the diagnosis of SBCA was 21.5 yrs (range 3-37). Additional characteristic s are listed. Conclusions: The pri- mary risk factor of SBCA in this large, tertiary IBD population was a long duration of unresected disease . SBCA was diagnosed in both the ileum and jejunum in the absence of surgical bypass, fistulizing disease, or prolonged immune modulation. Novel surveillance techniques for SBCA in long- standing small bowel CD will become increasingly important as chronic medical therapy improves. 12-wk study with 60% newly diagnosed patients (Gastroenterology 1998; 114:15), BZ was statistically superior to mesalamine in complete remission and time to complete relief of symptoms. In another 8-wk study with 16% newly diagnosed patients (Gastroenterology 1997;112:A709), BZ was nu- merically though not statistically superior to mesalamine in symptom improvement. The present study compared BZ to mesalamine in an 8-wk study with 42% newly diagnosed patients. Methods: 175 patients with acute mild to moderate UC were randomized to BZ 6.75g ( =2.4g 5-ASA) or mesalamine 2.4g daily. Patients were stratified according to time since diagnosis (new or relapse) and extent of disease (:54Ocm or > 4Ocm). Endpoints: Primary endpoint was symptomatic remission (SR: absence of rectal bleeding and patient functional assessment of normal or mild) at 8 wk. Secondary endpoints were time to SR, proportion of patients with improved sigmoidoscopic score, stool frequency, physician's global as- sessment (PGA), absence of rectal bleeding and incidence of adverse events (AE). Results: At 8 wks both groups were comparable in all endpoints. However, among all patients, BZ patients achieved SR 12 days earlier (median time: BZ 25 days vs mesalamine 37 days patients. p=O .I94). In newly diagnosed patients with :540cm of disease, median time to SR was shorter for BZ (II days) than mesalamine patients (22 days, p=O.035 ). A significantly greater proportion of all BZ patients had im- proved symptoms at 14 days vs all mesalamine patients: sigmoidoscopic score 48% vs 30%, p=0.OO2, bowel frequency score 55% vs 36%, p=0.OO6, absence of rectal bleeding 30% vs 15%, p =0.OO6, PGA 48% vs 33%, p=0.0I3. The incidence of AEs was BZ 54% vs mesalamine 64% (n.s.). More rapid symptom improvement was accompanied by a signifi- cantly greater mean weight gain in BZ patients (+ l.251bs) compared with mesalamine patients (-0.26Ibs, p=0.049). Conclusions: BZ 6.75g/d is well tolerated and is superior to mesalamine in the time to improvement of signs and symptoms of acute, mild to moderate Uc. Improvement in BZ patients is observed 12-14 days ahead of mesalamine patients with the greatest benefit observed in newly diagnosed patients with left-sided disease (:540 em). Funded by Salix Pharmaceuticals, Inc., Palo Alto, CA 94303 USA. 'Duration ofCDprior todiagnos isof S BCA, "6-lIleICaptopu rine>6mos. Age@ D1seue SBCA Tobacco Fistula COdx duration' location 758 PERSONALITY FACTORS ARE IMPORTANT PREDICTORS OF PSYCHOLOGICAL MORBIDITY IN PATIENTS WITH INFLAM- MATORY BOWEL DISEASE. Kather ine M. Sheehan, Christopher Steele, Adrian O'Gara, Anna M. Kelly, Eva Doherty. Steven E. Patchett. Frank E. Murray, Gastroenterology Dept, Beaumont Hosp, Dublin, Ireland; Dept of Psychology, Royal Coli of Surgeons in Ireland, Dublin, Ireland. Background: Although several studies have suggested increased anxiety and depression in patients with inflammatory bowel disease (IBD), the relationship of these features to disease activity is unclear. The aim of this study was to assess I) the level of psychological distress in IBD patients and 2) whether it was related to disease activity, or personality variables, such as a patients self efficacy (belief in one s ability to control outcome) and acceptance of illness. Patients and Methods: 57 patients were evaluated (36 Crohns, 21 Ulcerative Colitis). Median age was 34 yrs (range 16-7 \) . The mean duration of illness was 5.8 years. Anxiety and depressive symptoms were measured using the Hospital Anxiety and Depression Scale (HADS). Self Efficacy was scored using the Generalized Self Efficacy Scale (GSES). Adjustment to illness was evaluated using the Acceptance of IIIness Scale (AIS) and disease activity was measured using the Crohns Disease Activity IIIness (COAl) and the Clinical Activity I1l ness for Ulcerative Colitis (CAl) . Levels of pain were also scored using a \Ocm visual analogue scale (VAS). Results: A high level of psychological morbidity was observed in this cohort, 61% of patients demonstrated anxiety levels above the cut-off point while 24% of patients reported depression levels above the cut-off. Anxiety levels correlated with depres- sive symptoms (p=0 .OO8). Females showed higher depression scores than males (p= 0.03). Age correlated significantly with anxiety (p=O .OI) but not depression. 40% of patients reported pain on the VAS. Multiple regression analyses did not demonstrate a relationship between anxiety or depressive symptoms, and duration of illness, pain or disease activity. On the other hand, poor self efficacy correlated with both anxiety (p=0 .OO03) and depression (p=O.OO4). Low acceptance of illness scores also significantly correlated with both anxiety (p=O.OOO4) and depression (p<O .OOOI ). Con- clusion: This data suggests that psychological morbidity in patients with IBD is not directly related to disease activity. but rather to personality where there is a lower sense of personal control and a patient's lack of acceptance of illness. 759 PSYCHOLOGIGAL WELL-BEING AND GASTROINTESTINAL SYMPTOMS IN INFLAMMATORY BOWEL DISEASE IN REMIS- SION. Magnus Sirnren, lenny Axelsson, Hasse Abrahamsson, lan Svedlund, Einar S. Bjsrnsson, Sahlgrenska Univ Hosp, Gothenburg, Sweden. Patients with inflammatory bowel disease (IBD) demonstrate reduced health-related quality of life. We wanted to explore if this is true also when the lBO-patients are in remission, by assessing the psychological general well-being and subjective gastrointestinal (GI) symptoms. Methods: 83 patients with IBD (43 ulcerative colitis (UC), 40 Crohn's disease (CD); 36 males, 47 females; age 21-80 years) completed the following self-admin- istered questionnaires: the Psychological General Well-being Index (PGWB) and the Gastrointestinal Symptom Rating Scale (GSRS). Patients were in clinical, biochemical and endoscopical remission for at least 10 months when participating in the study. The results were compared be- tween UC and CD and with reference values from the general population (Dimenas et al; Scand J Gastroenterol 1996; 31 Suppl 221:8-13). Results: The PGWB index in the IBD patients (103.1. 95% CI 99.4-106.8) were similar to that in the general population (102.9 (102.1-103.8)). However, the psychological general well-being was better in UC (107.4 (l03 .2- 106.8)) than in CD (98.5 (92.5-104.6») (p= O.04). Vitality was lower in CD (15.5 (14.1- 16.9)) compared both to the reference values (17.2 (17.0-17.4)) (p = O.02) and 10 UC (17.8 (16.8-18.9)) (p= 0.02). CD also had less positive well-being (p= O.OO4) and self-control (p= O.OI) than Uc. Subjective gas- trointestinal symptoms were higher in IBD patients (GSRS total score 2.92 (2.74-3.10)) than in the general population (1.53 (1.50-1.55). CD rated their subjective GI symptoms higher than UC (p= O.004), especially ab- dominal pain (p= O. OO4), diarrhea (p<O. OOO I) and eating dysfunction (p=0.OO5) . A strong negative correlation between total scores on GSRS and PGWB in UC was observed (r, = -0.63; p<O.OOOI ). This correlation was less pronounced in CD (r,=-0.38 ; p=0.02). Conclusion: Patients with Crohn's disease in clinical remission have more subjective GI symptoms than UC. The psychological general well-being is comparable to the general population in patients with mD in clinical remission, but lower in CD than in Uc. Subjective gastrointestinal symptoms and psychological well-being are inversely correlated in IBD in remission, especially in Uc. 6·MP" jejunum ileum jejunum ileum ileum jejunum ileum jejunum 22 31 10 22 27 20 3 37 11 15 33 22 17 26 48 12 M F F M M M M F Sex # 1 2 3 4 5 6 7 8

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Page 1: Personality factors are important predictors of psychological morbidity in patients with inflammatory bowel disease

Aprit2000 AGAAllll

757

SMALL BOWEL CANCER IN CROHN'S DISEASE: THE UNIVER­SITY OF cmCAGO EXPERIENCE.David T. Rubin, Bryan McVerry, Stephen B. Hanauer, Univ of Chicago,Chicago, IL.

Background: Adenocarcinoma of the small bowel (SBCA) is a rare, butincreasingly recognized, complication of Crohn' s disease(CD). Previousreports have proposed: long duration of unresected disease, surgicallyexcluded small bowel, chronic fisrulae, prolonged immune modulation,occupational carcinogen exposure, jejunal CD, and male gender as riskfactors for development of SBCA. Aim: To evaluate risk factors for SBCAin a tertiary CD population. Methods: The University of Chicago Inflam­matory Bowel Disease (IBD) registry was searched for patients with CDand SBCA. Medical records were reviewed to identify potential risk factorsof SBCA as well as smoking history and family history of IBD or intestinalcancer. Results: Eight cases of SBCA were identified amongst the 2657 CDregistry patients (~30l/1 00000) . None had surgically excluded bowel orrecognized occupational carcinogen exposure. One patient had a familyhistory of IBD (pt #1), and none had a family history of intestinal cancer.The mean duration of disease before the diagnosis of SBCA was 21.5 yrs(range 3-37). Additional characteristic s are listed. Conclusions: The pri­mary risk factor of SBCA in this large, tertiary IBD population was a longduration of unresected disease . SBCA was diagnosed in both the ileum andjejunum in the absence of surgical bypass, fistulizing disease, or prolongedimmune modulation. Novel surveillance techniques for SBCA in long­standing small bowel CD will become increasingly important as chronicmedical therapy improves.

12-wk study with 60% newly diagnosed patients (Gastroenterology 1998;114:15), BZ was statistically superior to mesalamine in complete remissionand time to complete relief of symptoms. In another 8-wk study with 16%newly diagnosed patients (Gastroenterology 1997;112:A709), BZ was nu­merically though not statistically superior to mesalamine in symptomimprovement. The present study compared BZ to mesalamine in an 8-wkstudy with 42% newly diagnosed patients. Methods: 175 patients withacute mild to moderate UC were randomized to BZ 6.75g (=2.4g 5-ASA)or mesalamine 2.4g daily. Patients were stratified according to time sincediagnosis (new or relapse) and extent of disease (:54Ocm or > 4Ocm).Endpoints: Primary endpoint was symptomatic remission (SR: absence ofrectal bleeding and patient functional assessment of normal or mild) at 8wk. Secondary endpoints were time to SR, proportion of patients withimproved sigmoidoscopic score, stool frequency, physician's global as­sessment (PGA), absence of rectal bleeding and incidence of adverseevents (AE). Results: At 8 wks both groups were comparable in allendpoints. However, among all patients, BZ patients achieved SR 12 daysearlier (median time: BZ 25 days vs mesalamine 37 days patients.p=O.I94). In newly diagnosed patients with :540cm of disease, mediantime to SR was shorter for BZ ( I I days) than mesalamine patients (22 days,p=O.035 ). A significantly greater proportion of all BZ patients had im­proved symptoms at 14 days vs all mesalamine patients: sigmoidoscopicscore 48% vs 30%, p=0.OO2, bowel frequency score 55% vs 36%,p=0.OO6, absence of rectal bleeding 30% vs 15%, p=0.OO6, PGA 48% vs33%, p=0.0I3. The incidence of AEs was BZ 54% vs mesalamine 64%(n.s.). More rapid symptom improvement was accompanied by a signifi­cantly greater mean weight gain in BZ patients (+ l.251bs) compared withmesalamine patients (-0.26Ibs, p=0.049). Conclusions: BZ 6.75g/d is welltolerated and is superior to mesalamine in the time to improvement of signsand symptoms of acute, mild to moderate Uc. Improvement in BZ patientsis observed 12-14 days ahead of mesalamine patients with the greatestbenefit observed in newly diagnosed patients with left-sided disease (:540em). Funded by Salix Pharmaceuticals, Inc., Palo Alto, CA 94303 USA.

'DurationofCDprior todiagnosisof SBCA, "6-lIleICaptopurine>6mos.

Age@ D1seue SBCA Tobacco FistulaCOdx duration' location

758

PERSONALITY FACTORS ARE IMPORTANT PREDICTORS OFPSYCHOLOGICAL MORBIDITY IN PATIENTS WITH INFLAM­MATORY BOWEL DISEASE.Katherine M. Sheehan, Christopher Steele, Adrian O'Gara, Anna M. Kelly,Eva Doherty. Steven E. Patchett. Frank E. Murray, Gastroenterology Dept,Beaumont Hosp, Dublin, Ireland; Dept of Psychology, Royal Coli ofSurgeons in Ireland, Dublin, Ireland.

Background: Although several studies have suggested increased anxietyand depression in patients with inflammatory bowel disease (IBD), therelationship of these features to disease activity is unclear . The aim of thisstudy was to assess I) the level of psychological distress in IBD patientsand 2) whether it was related to disease activity, or personality variables,such as a patients self efficacy (belief in one s ability to control outcome)and acceptance of illness. Patients and Methods: 57 patients were evaluated(36 Crohns, 21 Ulcerative Colitis). Median age was 34 yrs (range 16-7 \) .The mean duration of illness was 5.8 years. Anxiety and depressivesymptoms were measured using the Hospital Anxiety and Depression Scale(HADS). Self Efficacy was scored using the Generalized Self EfficacyScale (GSES). Adjustment to illness was evaluated using the Acceptance ofIIIness Scale (AIS) and disease activity was measured using the CrohnsDisease Activity IIIness (COAl) and the Clinical Activity I1lness forUlcerative Colitis (CAl) . Levels of pain were also scored using a \Ocmvisual analogue scale (VAS). Results: A high level of psychologicalmorbidity was observed in this cohort, 61% of patients demonstratedanxiety levels above the cut-off point while 24% of patients reporteddepression levels above the cut-off. Anxiety levels correlated with depres­sive symptoms (p=0.OO8). Females showed higher depression scores thanmales (p=0.03). Age correlated significantly with anxiety (p=O.OI) but notdepression. 40% of patients reported pain on the VAS. Multiple regressionanalyses did not demonstrate a relationship between anxiety or depressivesymptoms, and duration of illness, pain or disease activity. On the otherhand, poor self efficacy correlated with both anxiety (p=0.OO03) anddepression (p=O.OO4). Low acceptance of illness scores also significantlycorrelated with both anxiety (p=O.OOO4) and depression (p<O.OOOI). Con­clusion: This data suggests that psychological morbidity in patients withIBD is not directly related to disease activity. but rather to personalitywhere there is a lower sense of personal control and a patient 's lack ofacceptance of illness.

759

PSYCHOLOGIGAL WELL-BEING AND GASTROINTESTINALSYMPTOMS IN INFLAMMATORY BOWEL DISEASE IN REMIS­SION.Magnus Sirnren, lenny Axelsson, Hasse Abrahamsson, lan Svedlund,Einar S. Bjsrnsson, Sahlgrenska Univ Hosp, Gothenburg, Sweden.

Patients with inflammatory bowel disease (IBD) demonstrate reducedhealth-related quality of life. We wanted to explore if this is true also whenthe lBO-patients are in remission, by assessing the psychological generalwell-being and subjective gastrointestinal (GI) symptoms. Methods: 83patients with IBD (43 ulcerative colitis (UC), 40 Crohn's disease (CD); 36males, 47 females; age 21-80 years) completed the following self-admin­istered questionnaires: the Psychological General Well-being Index(PGWB) and the Gastrointestinal Symptom Rating Scale (GSRS). Patientswere in clinical, biochemical and endoscopical remission for at least 10months when participating in the study. The results were compared be­tween UC and CD and with reference values from the general population(Dimenas et al; Scand J Gastroenterol 1996; 31 Suppl 221:8-13). Results:The PGWB index in the IBD patients (103.1. 95% CI 99.4-106.8) weresimilar to that in the general population (102.9 (102.1-103.8)). However,the psychological general well-being was better in UC (107.4 (l03.2­106.8)) than in CD (98.5 (92.5-104.6») (p= O.04). Vitality was lower in CD(15.5 (14.1- 16.9)) compared both to the reference values (17.2 (17.0-17.4))(p= O.02) and 10 UC (17.8 (16.8-18.9)) (p=0.02) . CD also had less positivewell-being (p=O.OO4) and self-control (p=O.OI) than Uc. Subjective gas­trointestinal symptoms were higher in IBD patients (GSRS total score 2.92(2.74-3.10)) than in the general population (1.53 (1.50-1.55). CD ratedtheir subjective GI symptoms higher than UC (p= O.004), especially ab­dominal pain (p= O.OO4), diarrhea (p<O.OOOI) and eating dysfunction(p=0.OO5). A strong negative correlation between total scores on GSRSand PGWB in UC was observed (r, = -0.63; p<O.OOOI ). This correlationwas less pronounced in CD (r,=-0.38; p=0.02). Conclusion: Patients withCrohn' s disease in clinical remission have more subjective GI symptomsthan UC. The psychological general well-being is comparable to thegeneral population in patients with mD in clinical remission, but lower inCD than in Uc. Subjective gastrointestinal symptoms and psychologicalwell-being are inversely correlated in IBD in remission, especially in Uc.

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