A randomised controlled trial of propofol vs. thiopentone and desflurane for fatigue after laparoscopic cholecystectomy.

Fatigue may delay functional recovery after day surgery and may be more common after propofol anaesthesia. We randomly allocated 123 participants scheduled for ambulatory laparoscopic cholecystectomy to induction and maintenance of general anaesthesia with propofol or thiopentone and desflurane. Postoperative fatigue was unaffected by the allocated anaesthetic. The combined mean (SD) Identity-Consequences Fatigue Scale of 34.3 (15.1) before surgery increased in the first postoperative week: to 60.4 (21.1) on day 1, p < 0.001; to 51.1 (17.2) on day 2, p < 0.001; and to 37.5 (16.3) on day 6, p = 0.028. The mean (SD) fatigue reduced at one postoperative month to 22.4 (12.6), 35% less than the combined pre-operative level, p < 0.001. Rates of nausea, vomiting and rescue antie-mesis during the first week after propofol, compared with thiopentone and desflurane, were: 23/63 vs. 32/60, p = 0.27; 8/63 vs. 9/60, p = 0.71; and 12/63 vs. 28/60, p = 0.001, respectively. There were no differences in postoperative pain. In conclusion, fatigue after scheduled laparoscopic cholecystectomy was unaffected by anaesthesia with propofol vs. thiopentone and desflurane.

Patient compliance with intensive antacid treatment. A multi-centre study.

Patient compliance with respect to a liquid antacid (Novaluzid) was examined in an open multicentre study. The study included 186 patients with various upper gastrointestinal conditions. The patients were randomly assigned to either 2 or 4 weeks' treatment with 10 ml Novaluzid 1 and 3 hours after each meal and at bedtime. They were not informed that they were taking part in a study. The compliance was high, with no difference between the two groups; 82% and 79%, respectively, and showed no dependency on patient age, diagnosis or previous use of antacids.

Heartburn treatment in primary care: randomised, double blind study for 8 weeks.

OBJECTIVE: To compare the effects and tolerability of omeprazole and cisapride with that of placebo for control of heartburn in primary care patients. DESIGN: Randomised, double blind, placebo controlled study. SETTING: 65 primary care practices in Norway. PARTICIPANTS: 483 untreated patients with complaints of heartburn >/=3 days a week, with at most grade 1 reflux oesophagitis. INTERVENTIONS: Omeprazole 20 mg once daily, cisapride 20 mg twice daily, or placebo for 8 weeks. MAIN OUTCOME MEASURES: Adequate control of heartburn, defined as

Chronic fatigue is associated with impaired health-related quality of life in inflammatory bowel disease.

BACKGROUND: Fatigue is reported to reduce health-related quality of life (HRQOL) in chronic diseases. Studies on the importance of fatigue and its implications for the patient's HRQOL in inflammatory bowel disease (IBD) remain scarce and need to be explored. AIM: To investigate the influence of chronic fatigue on both generic and disease-specific HRQOL in IBD. METHODS: Patients in remission, with mild and moderate IBD completed the Fatigue Questionnaire, the Short-Form 36 (SF-36) and the Norwegian version of the Inflammatory Bowel Disease Questionnaire (N-IBDQ). In addition, demographic and clinical variables were obtained. RESULTS: In total, 140 patients were included; the mean age of patients with chronic fatigue was 44.2 years (s.d. = 15.8), that of nonfatigued was 44.7 years (s.d. = 16.0). Ulcerative colitis (UC)/Crohn's disease (CD) = 92/48. Chronic fatigue was associated, after controlling for covariates, with a reduction of HRQOL scores in 6/8 SF-36 dimensions in UC and 5/8 dimensions in CD. In N-IBDQ, chronic fatigue was associated with a reduction of HRQOL in four subdimensions and total score in CD and all dimensions in UC. CONCLUSIONS: Fatigue is associated with reduction of HRQOL scores in IBD. The physical HRQOL domains are particularly affected. The impact of fatigue on disability, sick leave, school and work attendance has to be studied further.

Clinical and economic outcomes in a population-based European cohort of 948 ulcerative colitis and Crohn's disease patients by Markov analysis.

BACKGROUND: Forecasting clinical and economic outcomes in ulcerative colitis (UC) and Crohn's disease (CD) patients is complex, but necessary. AIMS: To determine: the frequency of treatment-classified clinical states; the probability of transition between states; and the economic outcomes. METHODS: Newly diagnosed UC and CD patients, allocated into seven clinical states by medical and surgical treatments recorded in serial 3-month cycles, underwent Markov analysis. RESULTS: Over 10 years, 630 UC and 318 CD patients had 22,823 and 11,871 cycles. The most frequent clinical outcomes were medical/surgical remission (medication-free) and mild disease (on 5-aminosalicylates, antibiotics, topical corticosteroids), comprising 28% and 62% of UC cycles and 24% and 51% of CD cycles respectively. The probability of drug-response in patients receiving systemic corticosteroids/immunomodulators was 0.74 in UC, 0.66 in CD. Both diseases had similar likelihood of persistent drug-dependency or drug-refractoriness. Surgery was more probable in CD, 0.20, than UC, 0.08. In terms of economic outcomes, surgery was costlier in UC per cycle, but the outlay over 10 years was greater in CD. Drug-refractory UC and CD cases engendered high costs in the cohort. CONCLUSIONS: Most patients on 5-aminosalicylates, corticosteroids and immunomodulators had favourable clinical and economic outcomes over 10 years. Drug-refractory and surgical patients exhibited greater long-term expenses.

Phenotype at diagnosis predicts recurrence rates in Crohn's disease.

BACKGROUND: In Crohn's disease (CD), studies associating phenotype at diagnosis and subsequent disease activity are important for patient counselling and health care planning. AIMS: To calculate disease recurrence rates and to correlate these with phenotypic traits at diagnosis. METHODS: A prospectively assembled uniformly diagnosed European population based inception cohort of CD patients was classified according to the Vienna classification for disease phenotype at diagnosis. Surgical and non-surgical recurrence rates throughout a 10 year follow up period were calculated. Multivariate analysis was performed to classify risk factors present at diagnosis for recurrent disease. RESULTS: A total of 358 were classified for phenotype at diagnosis, of whom 262 (73.2%) had a first recurrence and 113 patients (31.6%) a first surgical recurrence during the first 10 years after diagnosis. Patients with upper gastrointestinal disease at diagnosis had an excess risk of recurrence (hazard ratio 1.54 (95% confidence interval (CI) 1.13-2.10)) whereas age >/=40 years at diagnosis was protective (hazard ratio 0.82 (95% CI 0.70-0.97)). Colonic disease was a protective characteristic for resective surgery (hazard ratio 0.38 (95% CI 0.21-0.69)). More frequent resective surgical recurrences were reported from Copenhagen (hazard ratio 3.23 (95% CI 1.32-7.89)). CONCLUSIONS: A mild course of disease in terms of disease recurrence was observed in this European cohort. Phenotype at diagnosis had predictive value for disease recurrence with upper gastrointestinal disease being the most important positive predictor. A phenotypic North-South gradient in CD may be present, illustrated by higher surgery risks in some of the Northern European centres.

Quality of life in patients with inflammatory bowel disease: translation, data quality, scaling assumptions, validity, reliability and sensitivity to change of the Norwegian version of IBDQ.

BACKGROUND: The use of quality of life (QoL) questionnaires in clinical medicine must be based on instruments that are reliable and valid. The aim of this study was to describe the translation of the Inflammatory Bowel Disease Questionnaire (IBDQ) into Norwegian, its scaling assumptions and the psychometric properties of the translated questionnaire. METHOD: All patients included were recruited from an ongoing epidemiological study started in 1990 (the IBSEN trial), based on the registration of undiagnosed cases of Crohn disease (CD) or ulcerative colitis (UC) in subjects permanently residing in the study area the year before registration. At the 5-year follow-up visit in the hospital, all patients between 18 and 75 years of age were invited to participate in this QoL study, and those willing were interviewed and asked to complete the two QoL questionnaires, IBDQ and SF-36, on two different occasions separated by 6 months. The IBDQ was tested for validity, reliability and responsiveness. RESULTS: In total, 497 patients (93%) completed the IBDQ questionnaire at visit 1, and 493 (92%) completed SF-36. The mean age was 43.3 years, 48% were female. We found that the Norwegian version of the IBDQ (N-IBDQ) consists of five underlying dimensions in contrast to the four dimensions previously reported. Psychometric testing of the N-IBDQ indicates that the questionnaire is valid, reliable, has a high degree of responsiveness and that the results are comparable to those reported from other groups, even though our findings are based on a different factorial structure than the original McMaster version. CONCLUSION: The N-IBDQ consists of five different dimensions in contrast to the four dimensions previously reported. Good item internal consistency, validity, reliability and responsiveness were demonstrated.

A double-blind placebo-controlled trial with loperamide in irritable bowel syndrome.

BACKGROUND: Loperamide has a relaxing effect on localized and segmental large-bowel spasms. On the basis of previously observed effects on pain and stool habits in patients with diarrhoea, the present trial intended to examine the regulating effect in an unselected cohort of patients with the irritable bowel syndrome (IBS). The symptoms in IBS are dependent on variations in motility initiated by different mechanisms. Therefore, when examining the effect of treatment, characterization of the patient material is important. METHODS: Ninety patients were included in this prospective double-blind trial comparing loperamide with placebo over 5 weeks. The two groups were characterized and compared with healthy controls (n = 33), matched by age and sex. Demographic, clinical, and biochemical data were recorded. RESULTS: Clinical variables and social and personal relationships were similar for the loperamide group (n = 35), the placebo group ( n = 34), the dropouts (n = 21), and controls. Somatic diseases and mental disturbances were increased in the patients compared with the controls. Throughout the 5 weeks of treatment an improved stool consistency (32%), reduced defecation frequency (36%), and reduced intensity of pain (30%) were found in the loperamide group. An increase in nightly pain was observed in the loperamide group. CONCLUSIONS: This trial lends support to a multifactorial aetiology in IBS. Treatment must be individualized with regard to both the effect and the risk of constipation and abdominal pain. The trial shows a benefit of loperamide in an unselected cohort of IBS patients with regard to stool frequency, stool consistency, and the overall pain intensity, but with increased abdominal pain during the night. It should be recommended that the patients take the medication in divided daily doses.

Duodenal ulcer treated with omeprazole: healing and relapse rates. Does treatment duration influence subsequent remission?

One hundred and twenty-nine patients were studied with regard to healing of duodenal ulcers with 30 mg omeprazole once daily, recurrence rates after 2 and 4 weeks' treatment in patients with ulcers healed after 2 weeks, and recurrences in rapid and slow healers. Cumulative healing rates were 77% and 98% after 2 and 4 weeks, respectively. Eighty-one patients (65%) were without ulcer symptoms after 2 weeks, and 43 (34%) were improved. Seven of 45 patients (16%; 95% confidence limits, 6-30%) with ulcers healed after 2 weeks had relapsed after another 2 weeks of placebo; 3 were asymptomatic. The overall relapse rate after 6 months was 62%. There were no statistically significant differences in relapse rates between 2 and 4 weeks' treatment of patients with ulcers healed after 2 weeks or between rapid and slow healers. Ulcer size, smoking habits, and alcohol consumption were not significantly related to healing or relapse.

The rate of healing of duodenal ulcers during omeprazole treatment.

We have studied the rate of healing of duodenal ulcers in 44 patients treated with omeprazole, 40 mg once daily for 4 weeks, with or without an 80-mg loading dose on day 1. Fourteen patients (32%) had healed by the end of the 1st week's treatment and a further 27 after a further week (giving a cumulative total of 93%). All patients (100%) had healed by the end of the treatment period. There was no significant difference in healing rate between the two treatment groups. Ulcer symptoms were relieved rapidly, and the drug was well tolerated.

Health-related quality of life in patients with inflammatory bowel disease five years after the initial diagnosis.

BACKGROUND: Health-related quality of life (HRQOL) has become an important tool in evaluating patient satisfaction in inflammatory bowel disease (IBD). So far, few prospective follow-up studies have been done to identify variables that influence HRQOL. We aimed to identify demographic and clinical variables that influence HRQOL 5 years after diagnosis in patients with ulcerative colitis (UC) or Crohn disease (CD) included in a prospective follow-up study from 1990 to 1994 (the IBSEN study). METHODS: All patients completed the Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific quality-of-life questionnaire translated into Norwegian and validated. We present data from 497 patients (328 UC patients and 169 CD patients, mean age 43.3 years, 48% female). The impact of age, gender, smoking, symptom severity, disease distribution, rheumatic symptoms and surgery on IBD patients' HRQOL was analysed. RESULTS: Women had a reduction in IBDQ total score of 10 points compared to men, CD patients had a reduction of 7.5 compared to UC patients. The patients with moderate/severe symptoms had a 50 points lower score than the patients without symptoms. The patients with rheumatic symptoms had a 10 points lower total score than the patients without these symptoms. All differences were statistically significant. The multiple regression analysis showed that symptom severity, rheumatic symptoms and female gender were the strongest predictors of reduction in HRQOL for both diagnosis groups. CONCLUSION: IBD symptoms, rheumatic symptoms and female gender have a significant influence on patients' HRQOL as measured by IBDQ. This was confirmed by the regression analysis.