Perceived food intolerance in subjects with irritable bowel syndrome-- etiology, prevalence and consequences.

OBJECTIVES: This study estimates the prevalence of perceived food intolerance and its consequences in subjects with irritable bowel syndrome (IBS), evaluates the utility of common tests for food intolerance, studies the relation between perceived food intolerance and other disorders, and discusses the etiology. DESIGN: Cross-sectional study. SETTING: National health survey. SUBJECTS: A selection of the population (n=11,078) in Oppland county, Norway, was invited to a health screening, and a sample of subjects with IBS were included in the study. INTERVENTIONS: A medical history of food intolerance, musculoskeletal pain, mood disorders and abdominal complaints was taken, and tests were performed for food allergy and malabsorption. A dietician evaluated the dietary habits of the subjects. RESULTS: Out of 4,622 subjects with adequately filled-in questionnaires, 84 were included in the study, 59 (70%) had symptoms related to intake of food, 62% limited or excluded food items from the diet and 12% had an inadequate diet. The mean numbers of food items related to symptoms and the number of foods limited or excluded from the diet were 4.8 and 2.5, respectively. There were no associations between the tests for food allergy and malabsorption and perceived food intolerance. Perceived food intolerance was unrelated to musculoskeletal pain and mood disorders. CONCLUSIONS: Perceived food intolerance is a common problem with significant nutritional consequences in a population with IBS. The uselessness of current antibody tests and tests for malabsorption and the lack of correlation to psychiatric co-morbidity make the etiology obscure.

The value of a general therapeutic approach in subjects with irritable bowel syndrome.

BACKGROUND: The general therapeutic approach is the cornerstone in the management of irritable bowel syndrome, but the effect is poorly documented. AIM: To evaluate the effect of the general therapeutic approach for irritable bowel syndrome. METHODS: Subjects with irritable bowel syndrome identified in a public screening were included. Scores for abdominal symptom (range 0-12), musculoskeletal pain and mood disorders were calculated. After exclusion of other disorders, a doctor presented irritable bowel syndrome as a positive diagnosis, gave information, reassurance and lifestyle advice, but no pharmacotherapy. A dietician gave dietary advice. There was a follow-up after 6 months. RESULTS: Sixty-five persons (females/males: 44/21) with mean age 49 years (range 31-76) were included, 31 (48%) were recommended dietary changes. Twenty subjects (31%) had satisfactory relief of symptoms after 6 months. The scores for abdominal symptom was reduced from 3.1 to 2.2 (P = 0.007), the reduction was 2.2 in the diarrhoea-predominant group given advice compared with 0.4 in the other subjects (P = 0.035). Previous consultations for the complaints, visits for psychiatric disorders, and presence of mood disorders were predictors of persistent complaints. CONCLUSIONS: There was a significant relief of symptoms after 6 months, those with psychological co-morbidity responded less well. The effect of dietary advice was only seen in those with diarrhoea-predominant irritable bowel syndrome.

Comorbidity of irritable bowel syndrome in general practice: a striking feature with clinical implications.

BACKGROUND: Somatic comorbid symptoms might identify irritable bowel syndrome patients with different aetiologies and needs of treatment. AIMS: To measure comorbid symptoms in patients with irritable bowel syndrome in general practice, and to explore characteristics of patients with low, intermediate and high somatic comorbidity. METHODS: Prospective study of 208 of 278 consecutive patients with irritable bowel syndrome (Rome II) in nine general practices. Questionnaires assessed 22 comorbid symptoms (subjective health complaint inventory), psychosocial factors including psychological distress (Symptom Check list-10) and quality of life (Short form-12). Subjective health complaint data from 1240 adults (controls) constituted a reference material. Patients with low, intermediate and high somatic comorbidity were identified by a somatic comorbidity score (17 subjective health complaint items). Health care seeking was assessed after 6-9 months. RESULTS: Patients with irritable bowel syndrome (67% females, mean age 50, s.d. 16) reported 20 of 22 comorbid symptoms significantly more frequent than controls (odds ratios = 2-7, P < 0.001). The somatic comorbidity score correlated with psychological distress (R = 0.46, P < 0.001). Patients with high somatic comorbidity reported higher levels of mood disorder, health anxiety, neuroticism, adverse life events and reduced quality of life and increased health care seeking when compared to those with low and intermediate somatic comorbidity (P-values < 0.05). CONCLUSIONS: Our findings support the hypothesis that structured assessment of comorbid somatic symptoms might identify subgroups with different aetiology and needs of treatment.

Lactose malabsorption in a population with irritable bowel syndrome: prevalence and symptoms. A case-control study.

BACKGROUND: Symptoms after intake of milk are common in persons with irritable bowel syndrome (IBS). The aims of this study were to compare the prevalence of lactose malabsorption (LM) and symptoms related to intake of milk and lactose in subjects with IBS with that of healthy volunteers, and to search for symptoms that are characteristic of LM. METHODS: A case-control study in a Norwegian population was initiated. Subjects with IBS were asked for symptoms related to intake of milk and lactose, tested for LM, and compared with a group of healthy volunteers. RESULTS: The study comprised a total of 187 persons (82 with IBS and 105 volunteers), females/males: 138/49, mean age 47 years. In subjects with IBS and in healthy volunteers, LM was present in 3/74 (4.1%) and 4/105 (3.8%), respectively (ns), milk-related symptoms in 32/79 (40%) and 13/105 (12%), respectively (P < 0.001) and symptoms after intake of lactose in 28/74 (38%) and 21/104 (20%), respectively (P=0.01). Borborygmi starting within 5 h after intake of lactose and lasting for more than 2 h indicated LM (OR 61 (95% CI: 8-475), P < 0.001). CONCLUSIONS: IBS and LM are unrelated disorders in a Norwegian population. Milk-related symptoms and symptoms after intake of lactose are unreliable predictors for LM. Precise symptom-based criteria might enhance the diagnostic accuracy for LM.

Diagnosing irritable bowel syndrome: poor agreement between general practitioners and the Rome II criteria.

BACKGROUND: The new guidelines for diagnosing irritable bowel syndrome (IBS) in clinical practice recommend the use of the Rome II criteria. In this study the agreement between general practitioners (GPs) and the Rome II criteria for diagnosing of IBS and functional bowel disorders (FBD) is examined. METHODS: Consecutive patients in general practice were asked to report on abdominal complaints, for which they had consulted or wanted to consult a GP. Patients with such complaints completed a questionnaire based on the Rome II criteria for FBD. After consultations, the GPs reported their diagnoses on the abdominal complaints. RESULTS: Of 3097 screened patients, 553 patients were diagnosed by their GP and had complete data in the questionnaire. Of these patients, 107 had IBS according to the GPs and 209 had IBS according to the Rome II criteria (agreement 58%, kappa 0.01 (CI: -0.06; 0.09)). Agreement on IBS and FBD in patients without organic disease, without reflux or dyspepsia and in patients with a verified diagnosis was 45%-58%, with kappa values from -0.02 to 0.13. IBS and FBD cases were diagnosed by the Rome II criteria more often than by the GPs in all these groups of patients (P < 0.001). In patients with diagnostic discrepancies concerning IBS, 'stress-related symptoms' was predictive of a diagnosis of IBS made by the GPs only (OR 2.17 (CI: 1.1; 4.2)). CONCLUSIONS: This study shows poor agreement in the diagnosis of IBS between GPs and the Rome II criteria. Therefore, current knowledge about IBS based on strict criteria is not necessarily transferable to patients with IBS in general practice.

Comparison of three triple regimens with omeprazole or ranitidine bismuth citrate for Helicobacter pylori eradication.

BACKGROUND: Regimens with ranitidine bismuth citrate (RBC) or omeprazole (O) are effective in eradicating Helicobacter pylori. This randomized, open, multicentre trial compares three different regimens with these drugs. METHODS: Consecutive H. pylori +ve outpatients were included. The alternative regimens were: 1) O 20 mg, clarithromycin (C) 250 mg and metronidazole (M) 500 mg (O.C.M), 2) RBC 400 mg, C 250 mg and M 500 mg (RBC.C.M), 3) RBC 400 mg, tetracycline (T) 1000 mg and M 500 mg [RBC.T.M]. All drugs were given twice daily for 7 days. H. pylori infection was assessed with H. pylori urea breath tests. RESULTS: 426 H. pylori +ve patients were included (mean age 58 years [range 18-88], male/female: 244/182). The eradication rates (intention to treat) in the O.C.M, RBC.C.M and RBC.T.M groups were 117/137 (85%), 141/146 (97%) and 117/143 (82%), respectively (P < 0.001, overall assessment). There were no significant differences in side effects between the alternatives. CONCLUSION: In this trial, RBC.C.M was the most effective one, it was well tolerated and compliance was satisfactory. RBC.T.M is an alternative to regimens with clarithromycin.

Collaboration by use of the Internet yields data of high quality and detects non-uniform management of patients with Helicobacter pylori infection.

BACKGROUND: The benefits of new technology steadily being introduced in medicine should be documented. In this study, remote entry of a set of data from the daily routine was submitted via the Internet to a common database. The usefulness and quality of the information are evaluated. METHODS: Fourteen hospitals reported a common data set on consecutive Hp+ve patients handled in accordance with daily practice. Participants submitted their data via the Internet to a database. There was no monitoring or other surveillance. No audit was planned or expected, but was nevertheless possible. Doctor compliance with the common agreement was checked, differences in medical practice were noted and quality was assessed comparing the most important source data with the data in the final database. RESULTS: Four-hundred-and-forty patients were included. The quality of the reported data was high, only 1.3% showing a discrepancy between source data and the database. Overall treatment success was 89%, with no significant differences between hospitals. There were significant differences in clinical practice between the centres, the proportion of patients treated for ulcer disease varying from 36% to 96% (P < 0.001). Doctor compliance with the agreed collaboration varied significantly (P < 0.001). CONCLUSION: Internet collaboration through remote data entry in a common database yields data of high quality without monitoring, and is a powerful and resource economic tool for clinical multicentre trials and quality assurance.

Does short-term treatment with proton pump inhibitors cause rebound aggravation of symptoms?

BACKGROUND: Rebound acid hypersecretion might occur after treatment with proton pump inhibitors. This study looks for a rebound aggravation of symptoms after short-term treatment with lansoprazole. STUDY: Sixty-two patients (19 men and 43 women; mean age, 54 years; range, 32-77 years) with heartburn and regurgitation and normal upper endoscopy findings were studied in a randomized, double-blind, placebo-controlled trial with a crossover design. There were two 5-day treatment periods with lansoprazole 60 mg once daily or placebo in random order, separated by a 9-day washout period. Reflux, total, and antacid scores were calculated for each of the treatment periods. Higher scores during the placebo period in the group given lansoprazole first than in the group given placebo first indicated a rebound aggravation of symptoms. RESULTS: The mean symptom scores during the placebo period in the groups given lansoprazole first and placebo first were as follows: reflux score, 21.5 and 17.6, respectively (not significant); total score, 11.2 and 10.3, respectively (not significant); and antacid score, 8.2 and 7.2, respectively (not significant). CONCLUSIONS: There is no indication of a rebound aggravation of symptoms 12 to 14 days after a 5-day treatment with lansoprazole 60 mg once daily in patients with reflux symptoms.

Mesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitis.

BACKGROUND: High doses of mesalazine usually result in an inconvenient dosage schedule and reduced compliance. The goal of this trial was to compare the effects of mesalazine 4 g daily given as prolonged-release granules in packets of 1 g with that of prolonged-release tablets of 0.5 g. METHODS: Two hundred twenty-seven patients with mild-to-moderate ulcerative colitis were randomized to treatment with two packets twice daily (Gr-b.i.d.), 1 packet four times daily (Gr-q.i.d.) or 2 tablets four times daily (Ta-q.i.d.) for 8 weeks. A disease activity index (ulcerative colitis disease activity index: UC-DAI) was calculated, and the granules were defined as noninferior to the tablets if the lower limit of the 95% CI for the differences was more than -1 UC-DAI score unit. RESULTS: Noninferiority of the granules compared with the tablets was demonstrated. The mean improvement in the UC-DAI in the treatment groups Gr-b.i.d., Gr-q.i.d., and Ta-q.i.d. were 3.2, 2.9, and 2.4, respectively; the proportion of complete responders in the three groups 39%, 37%, and 31%, respectively. There were no differences in side effects. CONCLUSION: Mesalazine 4 g daily given as prolonged-release granules twice and four times daily is at least as effective as prolonged-release tablets four times daily in patients with mild to moderate ulcerative colitis. The patients preferred the twice daily dosing.

Patients with functional dyspepsia responding to omeprazole have a characteristic gastro-oesophageal reflux pattern.

BACKGROUND: The effect of acid secretion inhibitors in patients with functional dyspepsia (FD) is equivocal. One previous trial showed an effect in patients with a characteristic gastro-oesophageal reflux pattern. This double-blind trial compares the number of reflux episodes in responders and non-responders to omeprazole. METHODS: Twenty-four patients (men/women, 11:13; mean age, 49 years) with FD were included; those with reflux as the main symptom were excluded. An upper endoscopy and a 24-h oesophageal pH measurement were performed before randomization to treatment with 10-20 mg omeprazole or placebo for 4 weeks. Patients who at questioning considered themselves to have achieved sufficient relief of dyspeptic symptoms after 4 weeks were characterized as responders. RESULTS: The number of responders in the omeprazole and placebo groups was 8 of 14 (57%) and 2 of 10 (20%), respectively (P = 0.07). The mean number of reflux episodes at the 24-h oesophageal pH measurement in responders and non-responders to omeprazole was 57 and 25, respectively (P < 0.003). In the omeprazole group the number of responders was 0 of 5 (0%) in those with < 32 reflux episodes and 8 of 9 (89%) in those with > 32 reflux episodes (P < 0.003). CONCLUSION: Patients with FD responding to omeprazole were characterized by many reflux episodes.

The natural restricturing process after dilatation of peptic esophageal strictures.

The study analyzes the natural esophageal restricturing process after dilatation of peptic esophageal strictures. Fifty patients (male/female: 30/20) with median age 71 years (range 20-87) with peptic esophageal strictures were dilated with hydrostatic balloons to 20 mm and followed up for 12 months. Stricture size was measured with a 'balloon pull-through' technique before the dilatations, and at follow-ups after 6 and 12 months. The restricturing rate was defined as the difference in stricture diameter at two measurements divided by the time interval. The mean restricturing rate during the first and last 6 month periods were 0.99 and 0.02 mm/month respectively (P < 0.001), and during the first 6 months the restricturing rates were 1.98 and 0.69 mm/month in patients redilated and not redilated respectively (P < 0.001). A tight stricture at the initial dilatation, a long history of reflux symptoms and a short history of dysphagia were all significantly related to a high restricturing during the first 6 months (P < 0.001).

The symptomatic effect of cisapride in patients with irritable bowel syndrome and constipation.

BACKGROUND: Cisapride improves symptoms in patients with idiopathic constipation. This trial compares the effect of cisapride with that of placebo in patients with irritable bowel syndrome (IBS) and constipation. METHODS: Seventy patients were randomized to 12 weeks' treatment with 5 mg cisapride three times daily or placebo in a double-blind trial. The dose could be doubled after 4 weeks in patients without satisfactory improvement. The patients scored their symptoms on a 100-mm visual analogue scale (VAS) (0 = best, 100 = worst), and the investigators evaluated the symptomatic effect. RESULTS: The dose was doubled in 17 and 23 patients in the cisapride and placebo groups, respectively, after 4 weeks. The patients' mean VAS score for global evaluation of IBS symptoms in the cisapride and placebo groups was 73 and 71 mm, respectively, at the start of treatment and 47 and 41 mm at the end. The difference between cisapride and placebo at the end was 6 mm in favour of placebo (95% confidence interval (CI), -6, 18) (NS). The investigators evaluated the effect as good or excellent in 39.2% and 58.8% in the cisapride and placebo groups, respectively. The difference in favour of placebo was 19.5% (95% CI, -5, 44) (NS). Nor were any statistically significant differences seen between cisapride and placebo in the other effect factors. CONCLUSIONS: The trial seems to exclude a clinically significant effect of 15-30 mg cisapride daily in patients with IBS and constipation during a 12-week treatment period.

[Treatment of Helicobacter pylori infection]. / Behandling av Helicobacter pylori.

The article presents information gained from a survey among Norwegian hospitals in March 1997 concerning their treatment of infections with Helicobacter pylori. Altogether 52 hospitals answered the questionnaire. A combination of proton pump inhibitors, metronidazole and clarithromycin was used by 59% as first choice and urea quick test (94%) and urea breath test (42%) as the primary diagnostic procedures, whereas serology was in little use (17%). Besides ordinary ulcer disease, indications for treatment were: ulcer induced by non-steroid anti-inflammatory drugs (79%), gastrooesophageal reflux (37%), non-ulcer dyspepsia (14%) and cancer prophylaxis (14%). The gastro group at the Department of Pharmacotherapeutics at the University of Oslo invited specialists from all health regions to discuss indications for treatment of H pylori, the diagnosis and the role of general practitioners. The extensive use of clarithromycin might be doubtful due to development of resistance. Indications for treatment of H pylori other than ulcer disease and mucosa associated lymphoid tissue lymphoma are still uncertain. Uncritical use of serological tests in primary care should be discouraged. At present there is no uniform strategy for the diagnosis and treatment of H pylori infection, and a coordinated strategy between general practitioners and specialists is needed.

Ranitidine effectively relieves symptoms in a subset of patients with functional dyspepsia.

BACKGROUND: Acid secretion inhibitors are of dubious value to most patients with functional dyspepsia but might be effective in a subset. The aims of the trial were to compare the effect of ranitidine with that of placebo in selected subsets of patients. METHODS: Two hundred and twenty-six patients with functional dyspepsia were included in a double-blind multi-crossover (MCO) trial. After 6 weeks an effect score (Xs) with a range of 0-5 was calculated. They were then stratified in accordance with their score and randomized to 4 weeks' double-blind treatment with ranitidine or placebo. Overall symptoms were scored on a 100-mm visual analogue scale, and the change in score (measured in millimetres) was the primary effect measure. RESULTS: Two hundred and six patients completed the study. The effect of ranitidine and placebo in the 'responders' (76 patients with Xs of 4-5 after the MCO period) was 28 mm and 5 mm, respectively (P < 0.001), and in all patients 19 mm and 12 mm, respectively (P < 0.03). No effect was seen in 'nonresponders' (130 patients with Xs of 0-3 after the MCO period). The clinical improvement, as judged by the patients given ranitidine during the last 4-week period was statistically significantly different in favour of responders compared with nonresponders. We were unable to characterize the responders on the basis of demographics, symptoms, and signs. CONCLUSIONS: Ranitidine has a good and clinically significant effect in a subset of patients with functional dyspepsia.

Highly effective twice-daily triple therapies for Helicobacter pylori infection and peptic ulcer disease: does in vitro metronidazole resistance have any clinical relevance?

OBJECTIVES: To compare cure rates of Helicobacter pylori (H. pylori) infection, ulcer healing, and side effects of three simplified regimens of triple therapy in patients with peptic ulcer disease. METHODS: Two hundred thirty-one patients were prospectively randomized to receive either regimen OAM (omeprazole 20 mg b.i.d., amoxicillin 750 mg b.i.d., and metronidazole 400 g b.i.d.), OCM (omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d., and metronidazole 400 mg b.i.d.), or BCM (bismuth subcitrate 240 mg b.i.d., clarithromycin 250 mg b.i.d., and metronidazole 400 mg b.i.d.), all for 10 days. Side effects were reported immediately afterward in a self-administered questionnaire. Upper endoscopy was carried out before treatment and 2 months after treatment. Three antral and three corpus biopsy specimens were analyzed microbiologically and with rapid urease test to determine the presence of H. pylori. Altogether 143 patients (62%) had an active ulcer at start of treatment. Metronidazole resistant (M-R) H. pylori strains were found in 30% of patients, while none had clarithromycin resistant (C-R) strains. RESULTS: According to intention-to-treat analysis, H. pylori cure rates were 91, 95, and 95% with OAM, OCM, and BCM, respectively (p = 0.63). In patients with metronidazole-sensitive (M-S) strains versus M-R strains, the cure rates were 96 versus 77% with OAM (p = 0.025), 94 versus 94% with OCM, and 94 versus 96% with BCM. Ulcer healing rates were 95, 94, and 92%, respectively (p = 0.91). There were no significant differences in side effects between the regimens, and only five patients (2%) had to stop the treatment prematurely. CONCLUSIONS: All treatment regimens were highly effective for cure of H. pylori infection and for ulcer healing. Metronidazole resistance reduced the efficacy of OAM, but was of no importance for the efficacy of OCM or BCM. Side effects were of minor importance.