Abstract: BACKGROUND: Tumor necrosis factor alpha (TNFalpha) is a proinflammatory cytokine and an important mediator in the pathophysiology of inflammatory bowel disease (IBD). The effects of TNFalpha are mediated by 2 specific receptors, a 55-kDa protein (TNF-RI) and a 75-kDa receptor (TNF-RII), which are usually bound to the cell surface. Soluble TNF receptors I and II (sTNF-RI + II) are released by proteolytic cleavage of the extracellular domains of these receptors. Soluble TNF-Rs act as TNF antagonists and can inhibit TNFalpha-mediated proinflammatory effects. METHODS: Levels of sTNF-RI + II were measured using commercially available enzyme-linked immunosorbent assays (ELISAs). Serum levels of sTNF-RI + II of 76 healthy volunteers were compared to serum levels of 373 clinically well-characterized patients with Crohn's disease (CD) and 118 patients with ulcerative colitis (UC) with different disease activity from the German IBD competence network serum bank. CD patient subgroups were defined according to the Vienna Classification. RESULTS: The serum levels of sTNF-RI were significantly increased in all groups (active, chronic active, and remission) of CD and UC patients compared to healthy controls. sTNF-RII levels were significantly higher in active CD patients compared to UC patients with no overlap of the 95% confidence interval. Significantly higher values of sTNF-RII compared to controls were also observed in CD patients and UC patients in remission. There was no statistically significant difference in sTNF-RI or sTNF-RII levels when patient subgroups were analyzed according to disease behavior or disease localization. CONCLUSION: sTNF-RI is upregulated in the serum of IBD patients compared to healthy controls and could be used as a marker for disease activity. sTNF-RII levels are significantly more elevated in serum of active CD patients as compared to UC and could be used as an additional parameter to discriminate both diseases.
Abstract: BACKGROUND: Maintenance of remission is a major issue in inflammatory bowel disease. In ulcerative colitis, the evidence for the effectiveness of azathioprine and 6-mercaptopurine for the maintenance of remission is still controversial. OBJECTIVES: To assess the effectiveness and safety of azathioprine and 6-mercaptopurine for maintaining remission of ulcerative colitis. SEARCH STRATEGY: The MEDLINE database was used to search literature from 1966 to 2006. A manual search was also performed using references from these articles as well as review articles, proceedings from major gastrointestinal meetings and data available from the Cochrane Collaboration database. Authors of maintenance trials were asked about unpublished studies. SELECTION CRITERIA: Randomized controlled trials of at least 12 months duration that compared azathioprine or 6-mercaptopurine with placebo or standard maintenance therapy (mesalamine) were included. DATA COLLECTION AND ANALYSIS: Data were extracted by two raters using standard forms. Disagreements were solved by informal consent, including a third rater. Jadad scores were applied to assess study quality. Analyses were performed separately by type of control (placebo, or active comparator). Pooled odds ratios were calculated based on the fixed effects model unless heterogeneity was shown. MAIN RESULTS: Six studies were identified including 286 patients with ulcerative colitis. The study quality was mostly poor. Azathioprine was shown to be superior for the maintenance of remission as compared to placebo based on four trials (failure to maintain remission: OR 0.41; 95% CI 0.24 to 0.70). Two trials that compared 6-mercaptopurine to mesalazine, or azathioprine to sulfasalazine showed significant heterogeneity. Both studies using active comparators were open label. Adverse effects occurred in 11 of 127 patients receiving azathioprine, including acute pancreatitis (3 cases) and significant bone marrow suppression (5 cases). AUTHORS' CONCLUSIONS: Azathioprine may be an effective maintenance therapy for patients who have failed or cannot tolerate mesalazine or sulfasalazine and for patients who require repeated courses of steroids. More research is needed to evaluate superiority over standard maintenance therapy, especially in the light of a potential for adverse events from azathioprine.
Abstract: BACKGROUND & AIMS: Sexual problems as a result of inflammatory bowel diseases (IBDs) play an important role in patients' worries and concerns. We aimed to evaluate sexual function in men and women with IBD relative to healthy controls. METHODS: A random sample of the national patients organization was surveyed (n = 1000). Age- and sex-matched friends were used as controls; in addition, controls were selected from a large health insurance cohort. Sexual function was evaluated using the Erectile Index of Erectile Function, and the Brief Index of Sexual Function in Women; impaired function was defined as a score less than -1 on a z-normalized scale. The results are reported as age-adjusted odds ratios with 95% confidence intervals based on conditional logistic regression. RESULTS: The response rate was 41% in cases. Overall, 153 male and 181 female matched pairs were available for analysis. The proportion of patients who were married, had a partner, and were sexually active were similar between cases and controls. Depression was the most important determinant of impaired sexual function. Men with IBD in remission or mild activity had similar Erectile Index of Erectile Function scores as compared with controls. Comorbidity and antihypertensive therapy impacted on single subscores. Women with IBD showed impaired function irrespective of disease activity as compared with healthy controls. Results in women varied by type of control. High socioeconomic status was a protective factor for several subscores in women. CONCLUSIONS: Depression is the most important determinant of low sexual function.
Abstract: The German Society for Digestive and Metabolic Diseases (Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten, DGVS) has already published an impressive number of clinical practice guidelines, with more topics currently being under development. The guideline method within the DGVS as well as between medical professional societies varies greatly. In particular, the levels of evidence as well as the grades of recommendations are often applied very differently. Most guidelines in Germany use the grades of the US Agency for Health Care Policy and Research (AHCPR), which were first published in 1992. Some newer guidelines, e. g., the ulcerative colitis guideline of the DGVS or the guidelines of the German Diabetes Association, try to circumvent problems of this method. They adopted variations of the very simple AHCPR grades. Sometimes these new grading methods have serious shortcomings too. They may not be reproducible, ignore important parts of the consensus process, can only be applied to therapeutic interventions, or they do not adequately distinguish between the strength of a recommendation and the quality of evidence. Meanwhile, an enormous number of different and partially contradictory methodologies for the grading of guideline recommendations are being used. In the GRADE working group several renowned clinical epidemiologists came together to develop a uniform grading systematic that avoids the problems of earlier guideline methods. With GRADE first the quality of evidence is assessed in a systematic manner. The quality of each study plays an important role in this process. Hence randomised trials of poor quality can end up with a lower overall quality rating than well performed observational trials. The strength of recommendation is based on the balance between the expected benefit and harm of the intervention in the respective population for which the recommendations of the guideline are made. The quality of evidence is only one factor contributing to the strength of recommendation. The GRADE method can be more cumbersome in its application compared to older methods. Nevertheless, more and more organisations are adopting GRADE for their guidelines and recommendations. Possibly the DGVS guidelines could benefit from this new system too.
Abstract: The Cochrane Library is an important resource for evidence on the effectiveness of interventions in health care. The field of gastroenterology and hepatology is represented within the Cochrane Collaboration by four Cochrane review groups. The most prominent component of the library is the database of systematic reviews, produced by the Cochrane Collaboration. These offer valid information on relevant clinical topics based on comprehensive and skillful identification, evaluation and synthesis of clinical trials. Other components, library access and an introduction into searching the library are presented.
Abstract: Based on a meta-analysis published in 2006 on the prevention of paediatric antibiotic-associated diarrhoea with probiotics a Cochrane review by the same authors has been released within the current edition of the Cochrane Library (Issue 2, 2007). The per protocol analysis showed a relative risk for the incidence of AAD of 0.49 (0.32; 0.74). These findings could not be confirmed by the intention to treat analysis. These data are promising, but future studies will be necessary to clarify the role of probiotics for the prevention of AAD.
Abstract: OBJECTIVES: To identify risk factors of carcinoma of the extrahepatic biliary tract in men. METHODS: Newly diagnosed and histologically confirmed patients, 35-70 years old, were interviewed between 1995 and 1997 in Denmark, Sweden, France, Germany and Italy. Population controls were frequency-matched by age and region. Adjusted odds ratios and 95%-confidence intervals were estimated by logistic regression. RESULTS: The analysis included 153 patients and 1421 controls. The participation proportion was 71% for patients and 61% for controls. Gallstone disease was corroborated as a risk factor for extrahepatic biliary tract carcinoma in men (odds ratio 2.49; 95% confidence interval 1.32-4.70), particularly for gall bladder tumors (odds ratio 4.68; 95% confidence interval 1.85-11.84). For a body mass index [height (m) divided by squared weight (kg2)] >30 at age 35 years, an excess risk was observed (odds ratio 2.58; 95% confidence interval 1.07-6.23, reference: body mass index 18.5-25) that was even stronger if the body mass index was >30 for the lowest weight in adulthood (odds ratio 4.68; 95% confidence interval 1.13-19.40). Infection of the gall bladder, chronic inflammatory bowel disease, hepatitis or smoking showed no clear association, whereas some increase in risk was suggested for consumption of 40-80 g alcohol per day and more. CONCLUSIONS: Our study corroborates gallstones as a risk indicator in extrahepatic biliary tract carcinoma. Permanent overweight and obesity in adult life was identified as a strong risk factor for extrahepatic biliary tract carcinoma, whereas we did not find any strong lifestyle-associated risk factors. Inconsistent results across studies concerning the association of extrahepatic biliary tract carcinoma with overweight and obesity may be explained by the different approaches to assess this variable.
Abstract: Background: Problems with intimacy and sexual performance are among the major concerns of patients with inflammatory bowel disease (IBD). This study was performed to identify disease-related factors associated with low sexual function in men.Methods: Consecutive patients were surveyed using a standardized questionnaire. A random sample from the national patients' organization was also included. Low sexual function was defined as a score < -1 on a z-normalized scale of the International Index of Erectile Function. Results are presented as adjusted odds ratios (ORs) with 95% confidence interval (CI) based on multiple logistic regression.Results: 280 questionnaires were available for analysis. Scores were similar between the groups and compared with general population means, with the exception of sexual desire. Of the clinical group, 44% felt severely compromised sexually due to their IBD. Erectile function was particularly sensitive to somatic problems (disease activity, OR 2.5, 95% CI: 1.3-4.9; diabetes, OR 7.0, 95% CI: 1.4-35.0). The influence of depressive mood was restricted to aspects of satisfaction (sexual satisfaction, OR 2.3, 95% CI 1.1-4.9; overall satisfaction OR 3.7, 95% CI: 1.7-8.3).Conclusions: Sexual function was relatively better with longer disease duration and was not affected by the long-term severity of the disease.(Inflamm Bowel Dis 2007).
Abstract: OBJECTIVES: Data on the clinical presentation, effects of therapy and prognosis of patients with Crohn's disease are often based on patients from specialized referral centers. We assessed the extent of the selection based on the clinical and demographic characteristics. METHODS: All patients with Crohn's disease presenting to the University Hospital of Regensburg (Medical Department) were analyzed retrospectively with respect to demographic and disease specific characteristics. Only patients diagnosed <2 years before presentation were included in the main analysis. The original data from a population-based, prospectively assembled incidence cohort were available for comparison (EC-IBD, northern centers only, n=475). Age at diagnosis, disease location and behavior were categorized according to the Vienna classification. Differences were examined using chi-square tests. MAIN RESULTS: At the referral center, 394 patients were treated within a 5-year period. Of these, 116 patients fulfilled the inclusion criteria for the comparative analysis. Sixteen percent of the referral patients were diagnosed at age 40 or older, as compared with 32% in the population-based group (P<0.004). The distribution of disease location, sex, smoking behavior and positive family history was similar in both groups. Among the referral patients, more had fistulas (39% versus 20%, P<0.001). Also, more patients were receiving steroids (49% versus 27%) or other immunosuppressive therapy (12% versus 4%). The selection effects increase with duration of disease. CONCLUSIONS: Patients with late onset of disease, inflammatory only disease behavior and no need for immunosuppression are under-represented at a tertiary referral center.
Abstract: BACKGROUND: Magnetic resonance enteroclysis (MRE) is a recently introduced imaging technique that assesses the small bowel with similar sensitivity and specificity as the fluoroscopically performed conventional enteroclysis. Magnetic resonance imaging colonography (MRC) seems to be a promising technique for polyp assessment in the colon. In this feasibility study, we evaluated the combination of small bowel MRI with unprepared MRC as an integrative diagnostic approach of the whole bowel in patients with Crohn's disease. METHODS: Thirty patients with known Crohn's disease were prospectively examined. No particular colonic preparation was applied. Applying the dark lumen technique in all patients, MRE and MRC were performed within 1 session using an integrative examination protocol. T2-weighted and contrast-enhanced T1-weighted sequences were acquired. Inflammation assessment (grades 0 to 2) of the colon was compared with conventional colonoscopy in 29 patient and with surgery in 1 patient. The entire colon was graded fair to good distended in all patients. In 11 of 210 evaluated colonic segments, feces hindered an adequate intraluminal bowel assessment. Twenty-three of 30 patients had complete colonoscopy as the gold standard. In 7 patients, complete colonoscopy could not be performed because of an inflamed stenosis. RESULTS: Correct grading of colonic inflammation was performed with 55.1% sensitivity and 98.2% specificity in all segments. Considering only more extensive inflammation (grade 2), the sensitivity of MRC increased to 70.2% with a specificity of 99.2%. CONCLUSIONS: The combination of MRE and MRC could improve the diagnostic value of abdominal MRI evaluation in patients with Crohn's disease. However, MRC can not replace conventional colonoscopy in subtle inflammation assessment.
Abstract: BACKGROUND: The Savary-Miller, the Los Angeles, and the MUSE (metaplasia, ulcer, stricture, erosion) scoring systems have been developed to assess esophageal lesions related to GERD. Interobserver agreement for these systems was compared, with particular reference to the experience of the endoscopist. METHODS: By using videoendoscopes, videotapes were made of the gastroesophageal junction of 60 patients who presented with symptoms suggestive of GERD. The Savary-Miller, the Los Angeles, and the MUSE systems were used to score all video clips by 9 endoscopists who were subgrouped by level of experience (3 levels, 3 endoscopists per level). Agreement was assessed by using weighted kappa statistics (kappa). RESULTS: The Savary-Miller scoring system revealed moderate agreement for the experienced group (kappa=0.41) but performed poorly when applied by inexperienced raters (kappa=0.16). The Los Angeles system was most reproducible in all subgroups, irrespective of the level of experience (kappa=0.49 to 0.65). The MUSE scoring system was highly similar to the Los Angeles scoring system with respect to erosions and, in addition, allowed assessment of complications of GERD. CONCLUSIONS: The Los Angeles and the MUSE scoring systems are most reliable for the assessment of erosions caused by GERD. Because of low reliability, use of the Savary-Miller scoring system is not recommended. For all scoring systems, interobserver agreement varies with the level of experience in the performance of upper endoscopy.
Abstract: BACKGROUND: Experimental studies have shown that luminal antigens are involved in chronic intestinal inflammatory disorders such as Crohn's disease and ulcerative colitis. Alteration of the intestinal microflora by antibiotic or probiotic therapy may induce and maintain remission. The aim of this randomized, placebo-controlled trial was to determine the effect of oral Lactobacillus GG (L. GG) to induce or maintain medically induced remission. METHODS: Eleven patients with moderate to active Crohn's disease were enrolled in this trial to receive either L. GG (2 x 10(9) CFU/day) or placebo for six months. All patients were started on a tapering steroid regime and received antibiotics for the week before the probiotic/placebo medication was initiated. The primary end point was sustained remission, defined as freedom from relapse at the 6 months follow-up visit. Relapse was defined as an increase in CDAI of >100 points. RESULTS: 5/11 patients finished the study, with 2 patients in each group in sustained remission. The median time to relapse was 16 +/- 4 weeks in the L. GG group and 12 +/- 4.3 weeks in the placebo group (p = 0.5). CONCLUSION: In this study we could not demonstrate a benefit of L. GG in inducing or maintaining medically induced remission in CD.
Abstract: BACKGROUND: The evaluation of abstracts for scientific meetings has been shown to suffer from poor inter observer reliability. A measure was developed to assess the formal quality of abstract submissions in a standardized way. METHODS: Item selection was based on scoring systems for full reports, taking into account published guidelines for structured abstracts. Interrater agreement was examined using a random sample of submissions to the American Gastroenterological Association, stratified for research type (n = 100, 1992-1995). For construct validity, the association of formal quality with acceptance for presentation was examined. A questionnaire to expert reviewers evaluated sensibility items, such as ease of use and comprehensiveness. RESULTS: The index comprised 19 items. The summary quality scores showed good interrater agreement (intra class coefficient 0.60 - 0.81). Good abstract quality was associated with abstract acceptance for presentation at the meeting. The instrument was found to be acceptable by expert reviewers. CONCLUSION: A quality index was developed for the evaluation of scientific meeting abstracts which was shown to be reliable, valid and useful.
Abstract: Environmental factors play an important role in the disease manifestation, course and prognosis of inflammatory bowel disease. Observations on temporal trends and geographical distribution point at risk factors associated with a Western lifestyle. A large number of studies have been performed on various factors such as diet, smoking, and several infectious agents. Childhood exposures modifying immune responses in later life form a particularly interesting field. However, so far, only smoking in Crohn's disease, and smoking cessation in ulcerative colitis can be considered established as risk factors for the manifestation of the disease. Smoking is also associated with a poor prognosis in Crohn's disease. A strong negative association of appendectomy with ulcerative colitis has been very consistent across many studies; however, the implications of this finding are still obscure.
Abstract: BACKGROUND AND PURPOSE: The growing relevance of continuous medical education is evident. Also information retrieval helping to solve clinical problems yet at the patient's bedside becomes more and more important. This study challenges common and coming methods of information retrieval applied by German physicians. It helps answering the question which advantage or disadvantage due to the chosen method of information acquisition may arise. It also shows which practical relevance and which grade of quality the information seeking doctor may anticipate. METHODS: A questionnaire was sent out to all registered clinicians in hospital and practice in Germany. Not only traditional means of information retrieval were analyzed. Also, a lot of the questions posed focused on the acceptance and use of new media in the professional context. About 16,000 colleagues answered by filling in the complete form therewith allowing a deep insight into their informational needs and habits. RESULTS: While traditional media like books and scientific papers enjoy wide public confidence, the acceptance and estimated reliability of virtual sources of information today still remain restrained. The lack of transparency of the virtual sources and ways of information within the web according to often imprecise rules for quality assurance lead to major complaint. Information offered directly by the industry has a very low rate of acceptance. CONCLUSION: To gain higher confidence in electronic media presenting professional knowledge and advanced medical training, the development of technological advantages today seems to be less relevant. Work on the transparency of the informational structures including clear definition of resources and clear indication of possible conflicts of interest are just as important as a comprehensible quality of forthcoming medical content.
Abstract: BACKGROUND: The aim of this study was to examine the determinants of publication and whether publication bias occurred in gastroenterological research. METHODS: A random sample of abstracts submitted to DDW, the major GI meeting (1992-1995) was evaluated. The publication status was determined by database searches, complemented by a mailed survey to abstract authors. Determinants of publication were examined by Cox proportional hazards model and multiple logistic regression. RESULTS: The sample included abstracts on 326 controlled clinical trials (CCT), 336 other clinical research reports (OCR), and 174 basic science studies (BSS). 392 abstracts (47%) were published as full papers. Acceptance for presentation at the meeting was a strong predictor of subsequent publication for all research types (overall, 54% vs. 34%, OR 2.3, 95% CI 1.7 to 3.1). In the multivariate analysis, multi-center status was found to predict publication (OR 2.8, 95% CI 1.6-4.9). There was no significant association between direction of study results and subsequent publication. Studies were less likely to be published in high impact journals if the results were not statistically significant (OR 0.5, 95 CI 95% 0.3-0.6). The author survey identified lack of time or interest as the main reason for failure to publish. CONCLUSIONS: Abstracts which were selected for presentation at the DDW are more likely to be followed by full publications. The statistical significance of the study results was not found to be a predictor of publication but influences the chances for high impact publication.
Abstract: BACKGROUND: The Digestive Diseases Week (DDW) is the major meeting for presentation of research in gastroenterology. The acceptance of an abstract for presentation at this meeting is the most important determinant of subsequent full publication. We wished to examine the determinants of abstract acceptance for this meeting. METHODS: A cross-sectional study was performed, based on abstracts submitted to the DDW. All 17,205 abstracts submitted from 1992 to 1995 were reviewed for acceptance, country of origin and research type (controlled clinical trials (CCT), other clinical research (OCR), basic science (BSS)). A random sub-sample (n = 1,000) was further evaluated for formal abstract quality, statistical significance of study results and sample size. RESULTS: 326 CCT, 455 OCR and 219 BSS abstracts were evaluated in detail. Abstracts from N/W Europe (OR 0.4, 95% CI 0.3-0.6), S/E Europe (OR 0.4, 95% CI 0.2-0.6) and non-Western countries (OR 0.3, 95% CI 0.2-0.5) were less likely to be accepted than North-American contributions when controlling for research type. In addition, the OR for the acceptance for studies with negative results as compared to those with positive results was 0.4 (95% CI 0.3-0.7). A high abstract quality score was also weakly associated with acceptance rates (OR 1.4, 95% CI 1.0-2.0). CONCLUSIONS: North-American contributions and reports with statistically positive results have higher acceptance rates at the AGA. Formal abstract quality was also predictive for acceptance.
Abstract: Publication rates and determinants of publication were studied based on abstracts presented at pancreatic meetings. All abstracts presented at the 1994 and 1995 annual meetings of the European Pancreatic Club (EPC) and the American Pancreatic Association (APA) were followed up by searching MEDLINE. Publication rates were compared using log-rank tests and multiple logistic regression. The prestige of the publishing journals was compared using Kruskal-Wallis tests on scientific impact factors (SIF). Overall, 340 abstracts were presented at the EPC, and 254 were presented at the APA. Of these, 203 (59.7%, EPC) and 138 (54.3%, APA) were later published in peer-reviewed journals. Publication rates did not differ by study type or country region of origin. In addition, median SIFs were similar by conference (APA vs. EPC) and research type (basic science vs. clinical studies) (overall, 1.7). However, North American and North/West European articles were published in higher impact journals as compared with those from other countries. Publication rates and median journal SIFs in pancreas research are similar to those reported from other medical specialty meetings. There is no difference by conference, type of research, or origin (North American vs. European).
Abstract: Smoking is not only a risk factor for Crohn's disease, but ongoing smoking is associated with a poorer disease course. Therefore, smoking cessation should be an important treatment strategy for Crohn's disease patients who smoke tobacco. Recent improvements in understanding how people quit smoking and the development of pharmacological interventions, such as nicotine patches and bupropion, have improved cessation rates. In this article, we first briefly review the evidence supporting the adverse effects of smoking on the disease course. We next review the current understanding of how people change addictive behaviors, such as smoking. We then describe how the gastroenterologist can aid the patient with Crohn's disease to quit smoking, including appropriate and brief counseling strategies and the use of adjunctive treatments. Given the improvements in smoking cessation strategies, all patients with Crohn's disease should be strongly advised to quit smoking and be aided in doing so.
Abstract: STUDY OBJECTIVE: The prevalence of gallstone disease, time trends in the frequency of cholecystectomies and risk factors for the occurrence of cholelithiasis were examined in a cross-sectional population study. METHODS: The survey was based on a random sample from the populations of 4 regions in Germany, stratified by region, age and sex. Information on the frequency of gallstone disease and on potential risk factors were collected by standardized interviews. For the statistical analysis, multiple logistic regression was used. RESULTS: Overall, 1,085 persons were interviewed. The age-standardized prevalence of known gallstones was 4.2% for men and 14.5% for women. The frequency of cholecystectomy almost tripled in women from 1985 to 1994 as compared to 1975 to 1984 despite a decreasing trend in gallstone diagnoses in the same time period. No such trend was apparent in men. In men, age, body weight, changes in body weight, diabetes and use of corticosteroids were identified as risk factors for gallstone disease. In women, gallstone disease was also associated with body weight, changes in body weight and age, and, in addition, the number of births. An inverse association with gallstone disease was found for use of oral contraceptives and level of education in women.
Abstract: A prospective, population-based study was carried out from 1980 to 1984 and again from 1991 to 1995 to determine the incidence of ulcerative colitis in an urban area in Germany. Patients with proctitis were excluded from this analysis. 74 (1980-84) and 76 (1991-95) patients newly diagnosed with ulcerative colitis were identified. A slight rise in the age- and sex-standardized incidence rate from 2.4/10(5) in 1980-84 (95% CI 1.8/10(5) to 3.0/10(5)) to 3.0 (95% CI 2.4/10(5) to 3.7/10(5)) in 1991-95 was primarily due to a significant increase of the disease in young woman. A male preponderance in the earlier time period was hereby leveled out. There were no differences in the extent of the disease and the severity of symptoms. However, the time from onset of symptoms to diagnosis was reduced from a median of nine months in the 1980s to two months in the more recent period.
Abstract: To determine the incidence and clinical pattern of Crohn's Disease in a defined area in Germany, a prospective, population-based study was carried out from 1980 to 1984 and again from 1991 to 1995. All patients newly diagnosed with Crohn's disease within the respective study period who were resident in the study area were included in the study. The results from both study periods were then compared to detect time trends. Altogether 288 (156 and 132, respectively) incident cases were identified yielding an almost unchanged incidence over the years (1980-84: 4.9/10(5); 1991-95 5.2/10(5)). While the peak of incidence is still in the 15-24-year-old group, 1 out of 5 incident patients is now age 50 years and older. Median age at onset of symptoms increased to 30 years (20 years in the former period). Time from onset of symptoms was reduced from a median of 20 months in the 1980s to 5 months. Symptoms did not change significantly, although there seems to be less complicated disease recently. Distal migration of the inflammation in the intestinal tract was observed with significantly more involvement of the sigmoid and rectum in the recent period.
Abstract: BACKGROUND & AIMS: Lifestyle factors have been shown to influence prognosis in Crohn's disease. The purpose of this study was to prospectively assess the effects of smoking and oral contraceptive use on clinical relapse rates. METHODS: Placebo-treated patients formed a prospective cohort, followed up for 48 weeks or until relapse. The influence of smoking and the use of oral contraceptives on relapse risk was examined by life-table analysis (log rank tests) and Cox proportional hazards modeling, taking into account demographic and disease characteristics. RESULTS: Of 152 patients, 61 (40%) had a relapse. Univariate analysis showed unfavorable outcomes for women (P = 0.05), current smokers (P = 0.005), and use of oral contraceptives (P = 0.001). Recent surgery was associated with a decreased risk of relapse (P = 0.02). The Cox model retained current smoking vs. never smoking (hazard ratio, 2.1; 95% confidence interval, 1.1-4.2), oral contraceptive use (hazard ratio, 3.0; 95% confidence interval, 1.5-5.9), and medical compared with surgical induction of remission (hazard ratio, 2.1; 95% confidence interval, 1.0-4.2) as predictors of relapse. Ex-smokers did not have an increased risk. Finally, sex, age, time in remission, disease location, and disease duration were not significant predictors. CONCLUSIONS: Oral contraceptive use and smoking are associated with an increased risk of relapse in patients with Crohn's disease.
