Azathioprine Therapy in a Pediatric TPMT-Deficient Patient-Still an Option.

We describe the case of a pediatric patient on azathioprine therapy with previously undiagnosed homozygote thiopurine S-methyltransferase (TPMT) deficiency, resulting in myelotoxic thiopurine metabolite levels. The patient was successfully treated with a very low azathioprine dose of 50 mg once a week (4% of standard dose), guided by frequent thiopurine metabolite measurement and a close clinical surveillance. We demonstrate that azathioprine therapy still might be an effective and safe therapeutic option in pediatric thiopurine S-methyltransferase-deficient IBD patients.

Gastrointestinal symptoms in low-dose aspirin users: a comparison between plain and buffered aspirin.

BACKGROUND: Aspirin is associated with gastrointestinal side effects such as gastric ulcers, gastric bleeding and dyspepsia. High-dose effervescent calcium carbasalate (ECC), a buffered formulation of aspirin, is associated with reduced gastric toxicity compared with plain aspirin in healthy volunteers, but at lower cardiovascular doses no beneficial effects were observed. AIM: To compare the prevalence of self-reported gastrointestinal symptoms between low-dose plain aspirin and ECC. METHODS: A total of 51,869 questionnaires were sent to a representative sample of the Dutch adult general population in December 2008. Questions about demographics, gastrointestinal symptoms in general and specific symptoms, comorbidity, and medication use including bioequivalent doses of ECC (100 mg) and plain aspirin (80 mg) were stated. We investigated the prevalence of self-reported gastrointestinal symptoms on ECC compared with plain aspirin using univariate and multivariate logistic regression analyses. RESULTS: A total of 16,715 questionnaires (32 %) were returned and eligible for analysis. Of these, 911 (5 %) respondents reported the use of plain aspirin, 633 (4 %) ECC and 15,171 reported using neither form of aspirin (91 %). The prevalence of self-reported gastrointestinal symptoms in general was higher in respondents using ECC (27.5 %) compared with plain aspirin (26.3 %), but did not differ significantly with either univariate (OR 1.06, 95 %CI 0.84-1.33), or multivariate analysis (aOR 1.08, 95 %CI 0.83-1.41). Also, none of the specific types of symptoms differed between the two aspirin formulations. CONCLUSIONS: In this large cohort representative of the general Dutch population, low-dose ECC is not associated with a reduction in self-reported gastrointestinal symptoms compared with plain aspirin.

Gastrointestinal symptoms in NSAID users in an 'average risk population': results of a large population-based study in randomly selected Dutch inhabitants.

AIM: Non-steroidal anti-inflammatory drug (NSAID) use is widespread and associated with gastrointestinal symptoms and complications. The aims of this study were to assess (i) gastrointestinal symptoms in users of prescribed and over-the-counter (OTC) NSAIDs and (ii) proton pump inhibitor (PPI) co-prescription rates in NSAID users at increased risk for gastrointestinal complications. METHODS: Surveys were sent to a randomly selected sample of the adult Dutch general population in December 2008. Questions included demographics, gastrointestinal symptoms, medication use and comorbidity. Main outcome measure was presence of gastrointestinal symptoms. RESULTS: A total of 18,317 surveys were returned (response rate 35%), of which 16,758 surveys were eligible for analysis. Of these, 3233 participants (19%) reported NSAID use. NSAID users more frequently reported gastrointestinal symptoms than persons not using NSAIDs (33% vs. 24%, p < 0.01). Respondents who specified on prescription NSAID use (n = 683) were older, reported more comorbidity, and experienced more gastrointestinal symptoms (41%) compared with OTC users (n = 894, 33%, p < 0.01). This difference was not statistically significant after adjustment for confounders (0.99, 95% CI 0.71-1.37). In respondents with an increased gastrointestinal risk profile, PPI co-prescription rates were 51% for on prescription users and 25% for OTC users. CONCLUSIONS: Prevalence of gastrointestinal symptoms was high in both prescribed and OTC NSAID users, emphasising the side effects of both types of NSAIDs. PPI co-prescription rates in NSAID users at risk for gastrointestinal complication were low.

Adding familial risk assessment to faecal occult blood test can increase the effectiveness of population-based colorectal cancer screening.

BACKGROUND: The Dutch Health Council recently recommended the introduction of a colorectal cancer (CRC) screening programme by faecal occult blood testing (FOBT) for individuals aged 55-75 at population risk of CRC. Individuals at an increased familial CRC risk (≥ 2 times population risk) should be identified at a younger age, so they and their relatives can receive earlier, more intensive surveillance instead of FOBT. AIMS: To determine the percentage of participants with a positive FOBT in a CRC screening programme with an increased familial CRC risk. METHODS: In a population-based study, 10,569 individuals aged 50-75 received an FOBT. Individuals with a positive FOBT were invited for colonoscopy and familial risk assessment. Participants with an average familial CRC risk were compared to those with an increased risk. Increased familial CRC risk was defined as a cumulative lifetime risk of CRC of at least 10%. RESULTS: Of 6001 participants, 430 had a positive FOBT, of whom 324 (63% males; mean age 63 years) completed colonoscopy and familial risk assessment. CRC (n=22) and/or advanced adenomas (n=122) were found in 133 participants. Familial CRC risk was increased in 6% of participants with a positive FOBT. No significant differences were found between participants with an average versus an increased familial CRC risk. CONCLUSION: Six percent of participants with a positive FOBT had an increased familial CRC risk. Identifying at-risk participants enables them and their relatives to undergo regular colonoscopies. Adding familial risk assessment to FOBT screening may thus prevent a substantial number of CRCs.

[Nationwide colorectal cancer screening]. / Bevolkingsonderzoek naar darmkanker.

Usually, colorectal cancer presents with complaints in a late stage, but can be detected in an earlier stage, with better prognosis, by colonoscopy. Using colonoscopy, also precancerous tumours, adenomas, can be detected and excised, but only in a national screening programme. However primary screening with colonoscopy is too burdensome and expensive. Out of all the screening alternatives, only of the faecal occult blood tests (faeces tests) a decreased colorectal cancer mortality has been proven. It stands to reason that the new generation immunochemical faeces tests, can reduce colorectal cancer mortality more effectively, and these tests have, more than the alternatives, a good balance between efficiency, straightforwardness and costs. Recently, the Dutch National Health Council recommended to introduce nationwide colorectal cancer screening, using an immunochemical faecal occult blood test.

Cutoff value determines the performance of a semi-quantitative immunochemical faecal occult blood test in a colorectal cancer screening programme.

BACKGROUND: The cutoff of semi-quantitative immunochemical faecal occult blood tests (iFOBTs) influences colonoscopy referrals and detection rates. We studied the performance of an iFOBT (OC-Sensor) in colorectal cancer (CRC) screening at different cutoffs. METHODS: Dutch screening participants, 50-75 years of age, with average CRC risk and an iFOBT value >or=50 ng ml(-1) were offered colonoscopy. The detection rate was the percentage of participants with CRC or advanced adenomas (>or=10 mm, >or=20% villous, high-grade dysplasia). The number needed to scope (NNTScope) was the number of colonoscopies to be carried out to find one person with CRC or advanced adenomas. RESULTS: iFOBT values >or=50 ng ml(-1) were detected in 526 of 6157 participants (8.5%) and 428 (81%) underwent colonoscopy. The detection rate for advanced lesions (28 CRC and 161 with advanced adenomas) was 3.1% (95% confidence interval: 2.6-3.5%) and the NNTScope was 2.3. At 75 ng ml(-1), the detection rate was 2.7%, the NNTScope was 2.0 and the CRC miss rate compared with 50 ng ml(-1) was <5% (N=1). At 100 ng ml(-1), the detection rate was 2.4% and the NNTScope was <2. Compared with 50 ng ml(-1), up to 200 ng ml(-1) CRC miss rates remained at 16% (N=4). CONCLUSIONS: Cutoffs below the standard 100 ng ml(-1) resulted in not only higher detection rates of advanced lesions but also more colonoscopies. With sufficient capacity, 75 ng ml(-1) might be advised; if not, up to 200 ng ml(-1) CRC miss rates are acceptable compared with the decrease in performed colonoscopies.

Earlier stages of colorectal cancer detected with immunochemical faecal occult blood tests.

BACKGROUND: The aim of colorectal cancer screening is to improve prognosis by the detection of early cancer and precursor stages. We compared the stage distribution of asymptomatic colorectal cancer patients detected by a positive immunochemical or guaiac-based faecal occult blood test (FOBT) with symptomatic colorectal cancer patients. METHODS: In a longitudinal cohort study tumour stages were assessed in 144 symptomatic (mean age 69.3 years, 56% male) and 41 asymptomatic colorectal cancer patients (mean age 64.9 years, 56% male) of which 11 were detected with guaiac FOBT s (G-FOBT, Hemoccult-II) and 30 with immunochemical FOBTs (I-FOBT, OCSensor). Stage distributions were used to calculate average stage specific predicted five-year survival rates and to analyse group differences with Wilcoxon log-rank test. RESULTS: Colorectal cancer was detected in significantly earlier stages in symptomatic compared with asymptomatic patients patients (p<0.0001). Average stage specific predicted five-year survival was 59.1% in symptomatic and 76.6% in asymptomatic patients. Compared with the symptomatic patients the stage distribution for colorectal cancer patients detected with Hemoccult-II was not significantly different(p=0.29), whereas colorectal cancer was detected at significantly earlier stages with the OCSensor (p<0.0001).Treatment could be confined to colonoscopy in 27% of the asymptomatic patients compared with 3% of the symptomatic patients (p<0.0001). Cancer distribution over the colon was comparable between symptomatic and asymptomatic patients (p=0.3). CONCLUSIONS: Compared with symptomatic patients,patients detected by FOBT and especially immunochemical FOBT , presented significantly more often at earlier stages suggesting increased survival. Additionally treatment could more often be confined to colonoscopy.

Getting adequate information across to colorectal cancer screening subjects can be difficult.

OBJECTIVES: Participation in screening should be the outcome of an informed decision. We evaluated whether invitees in the first Dutch colorectal cancer (CRC) screening programme were adequately informed after having received a detailed information leaflet. METHODS: A total of 20,623 subjects aged 50-75 years were invited to the fecal occult blood test (FOBT) screening programme. All received a detailed information leaflet by mail between May 2006 and January 2007. After two weeks, a reminder letter was sent to all invitees, accompanied by a survey on CRC and screening. RESULTS: The survey was completed by 9594 invitees (47%). Almost all responders (99%) found the leaflet clear and readable. Almost all indicated that CRC can be treated better if found early (99%). Only 20% of the responders answered all knowledge-related answers correctly. Almost half of the responders (47%) believed that a negative FOBT excludes the presence of CRC. Older age and having a positive family member for CRC were correctly identified as risk factors by 80%. CONCLUSION: This study demonstrates that although an information leaflet was reported as being clear and readable, the information provided in it was not always understood well. This suggests that other educational options should be investigated in order to improve general knowledge of CRC in screening invitees.

Low priority main reason not to participate in a colorectal cancer screening program with a faecal occult blood test.

BACKGROUND: Compared with screening programs for breast and cervical cancer, reported participation rates for colorectal cancer (CRC) screening are low. The effectiveness of a screening program is strongly influenced by the participation rate. The aim of this study was to investigate the main reasons not to participate in a population-based, invitational CRC screening program. METHODS: In the Dutch study program for CRC screening, a random selection of 20 623 persons were invited received a faecal occult blood test. Of the non-participants, 500 were randomly selected and contacted for a standardized telephone interview from November 2006 to May 2007 to document the main reason not to participate. RESULTS: In total, 312 (62%) non-participants could be included for analysis. Most frequently, reported reasons for non-participation were time-related or priority-related (36%), including 'did not notice test in mailbox' (13%) and 'forgot' (8%). Other reasons were health-related issues, such as 'severe illness' (9%), or emotional reasons, such as 'family circumstances' (7%). CONCLUSIONS: The majority of the reported reasons not to participate reflect low priority for screening. Adding extra instructions and information, and addressing specific concerns through additional interventions should be considered to improve individual decision-making about participation in future CRC population-based screening programs.

Is there any association between referral indications for open-access upper gastrointestinal endoscopy and endoscopic findings?

BACKGROUND AND STUDY AIM: The total number of upper gastrointestinal endoscopies is increasing, and despite guidelines for endoscopy referral for general practitioners, the proportion of patients found to have no endoscopic abnormalities is still up to 60% (and increasing). The aim of this study was to assess the association between general practitioners' referral indications and endoscopic findings. PATIENTS AND METHODS: General practitioners of patients referred for an open-access endoscopy between January 2002 and December 2004 were asked to specify the reason for referral on a specially designed form. The relative frequency of patients actually having an endoscopic abnormality was assessed for each referral indication. RESULTS: A total of 1298 people were included in the study. A relevant endoscopic abnormality was found in 48% of patients. Patients with an endoscopic abnormality were not more often referred with "alarm" symptoms or failure of empirical treatment than patients without an abnormal endoscopic finding (31% with an endoscopic abnormality vs. 30% without an endoscopic abnormality had alarm symptoms; 57% of people in both groups experienced failure of empirical treatment). Referral with alarm symptoms had a positive predictive value of 4% for cancer (prevalence 2%; P < 0.01), and referral with reflux-like symptoms had a positive predictive value of 33% for finding reflux esophagitis (prevalence 22%; P < 0.01). CONCLUSIONS: General practitioners' referral indications for open-access endoscopy did not add any relevant predictive value for endoscopic findings in comparison with what might have been expected from overall prevalence. Only alarm symptoms slightly increased the probability of finding cancer and only reflux-like symptoms slightly increased the probability of finding reflux esophagitis.

Upper gastrointestinal endoscopy does not reassure patients with functional dyspepsia.

BACKGROUND AND STUDY AIMS: Upper gastrointestinal endoscopy in patients with functional dyspepsia is often carried out merely to reassure patients that symptoms are not due to serious pathology. The aim of this study was to compare anxiety, depression, and health-related quality of life as proxy values for reassurance in patients with functional dyspepsia before and after upper gastrointestinal endoscopy. PATIENTS AND METHODS: Consecutive patients referred for endoscopy between February 2002 and February 2004 were included in the study. They were asked to score anxiety and depression using the Hospital Anxiety and Depression Scale, health-related quality of life using the EuroQol-5D questionnaire, and their impression of their own general health using a visual analogue scale, 2 weeks before endoscopy and again 1 month afterwards. RESULTS: A total of 420 patients were included, 42 % of whom were found to have an organic abnormality of some sort during upper gastrointestinal endoscopy. Neither the anxiety nor the depression frequencies differed significantly before and after endoscopy, either in patients with organic abnormalities at endoscopy or in those without. The general impression of health did not change after endoscopy either: organic abnormalities 62.7 +/- 27.4 vs. 64.9 +/- 24.2, P = 0.28; functional dyspepsia 61.0 +/- 27.9 vs. 62.8 +/- 27.2, P = 0.39. Only patients who had organic abnormalities reported a slightly improved quality of life 1 month after endoscopy: 0.74 +/- 0.15 vs. 0.78 +/- 0.12, P < 0.01. CONCLUSION: In patients with functional dyspepsia, upper gastrointestinal endoscopy does not improve psychological well-being or health-related quality of life. In view of the invasiveness, cost, and potential harm associated with endoscopy, careful consideration should be given to whether this procedure should be carried out merely for the sake of the patient's "peace of mind".

Evaluation of a gastrointestinal symptoms questionnaire.

Questionnaires are widely used instruments to monitor gastrointestinal (GI) symptoms. However, few of these questionnaires have been formally evaluated. We sought to evaluate our GI symptoms questionnaire in terms of clarity and reproducibility. Primary care patients referred for open access Helicobacter pylori urea breath testing reported GI symptoms (type+severity) and demographic information by written questionnaire. In an interview, patients gave a personal description of the meaning of the GI symptoms on the questionnaire. Patients' descriptions of GI symptoms were compared with current definitions. Symptom severity scores were compared before and after, interview versus questionnaire. Of the 45 patients included, 19 (42%) described all symptoms correctly, whereas 17 (38%) described one symptom incorrectly. None of the patients made more than three mistakes. Regurgitation was the most common incorrectly described symptom (16 patients [36%]), whereas the other individual symptoms were well explained. Symptom severities before the interview, after the interview and reported by questionnaire (mean value+/-SEM) were 2.1 +/- 0.2, 2.1 +/- 0.2, and 1.5 +/- 0.2 points on a 7-point Likert scale (0-6), respectively. Mean severity reported by interview (95% CI) was 1.4 (1.3-1.5) times higher than reported by questionnaire (P < .05). In conclusion, the GI symptom questionnaire is understandable and has good reproducibility for measuring the presence of GI symptoms, although symptom severity is consistently rated higher when reported by interview.

Gastrointestinal disorders and symptoms: does body mass index matter?

BACKGROUND: Recent studies have shown inconsistent results about the association between body mass index (BMI) and gastrointestinal disorders. The aim of this study was to assess the association between BMI and gastrointestinal disorders in patients referred for endoscopy. METHODS: Consecutive patients received a questionnaire about gastrointestinal symptoms prior to upper gastrointestinal endoscopy. The association between BMI and gastrointestinal disease and related symptoms was determined by adjusted logistic regression analyses. RESULTS: A total of 1023 subjects were included, 303 (35%) subjects were overweight (BMI 25 to 30 kg/m2), an additional 118 (14%) subjects were obese (BMI >30 kg/m2). Overall, 42% of the patients experienced symptoms of gastro-oesophageal reflux disease (GERD ), 70% dyspepsia and 55% lower abdominal symptoms. In obese patients the prevalence of GERD was higher (52%) compared with normal weight (44%) and overweight (44%) (ns). Reflux oesophagitis was found in 13, 17 and 19% for normal weight, overweight and obese, hiatus hernia in 7, 9 and 11% and Barrett's oesophagus in 6, 7 and 8%, respectively. CONCLUSION: More than half the patients undergoing upper gastrointestinal (GI ) endoscopy were overweight or obese. In this patient population, no relation between BMI and GI disorders and symptoms was found. However, a small but statistically insignificant trend was observed toward obesity for patients with GERD-associated symptoms.

Anxiety, depression and psychotropic medication use in patients with persistent upper and lower gastrointestinal symptoms.

BACKGROUND: Limited information is available about anxiety, depression and psychotropic medication use in patients referred for gastrointestinal endoscopy. AIM: To determine anxiety and depression and its association with endoscopic findings in a representative sample of patients with persistent gastrointestinal symptoms prior to endoscopy. METHODS: Patients referred to the hospital for endoscopy between February 2002 and February 2004 were asked to score anxiety and depression on the Hospital Anxiety and Depression Scale 2 weeks prior to endoscopy. Information about endoscopic diagnoses was obtained from medical files. RESULTS: A total of 1298 subjects was studied (600 upper gastrointestinal endoscopies and 698 lower gastrointestinal endoscopies). Patients referred for upper gastrointestinal endoscopy used most psychotropic agents (24%; odds ratio = 3.1; 95% confidence interval = 2.3-4.2), especially patients with an organic abnormality when compared with patients without an organic abnormality (42% versus 8%; odds ratio = 8.6; 95% confidence interval = 5.4-14.0). Patients with colonic polyps were more anxious (odds ratio = 1.7; 95% confidence interval = 1.0-2.9) and depressed (odds ratio = 1.8; 95% confidence interval = 1.1-3.1) than other patients referred for lower gastrointestinal endoscopy. CONCLUSIONS: There is no difference in anxiety nor depression between patients with and without organic abnormalities at endoscopy. Patients with colonic polyps are more anxious and depressed than other patients referred for lower gastrointestinal endoscopy. Psychotropic medication use is highest among patients with an organic abnormality in the proximal gastrointestinal tract.

Health-related quality of life in patients with cardiovascular disease--the effect of upper gastrointestinal symptom treatment.

BACKGROUND: Upper gastrointestinal discomfort decreases the already impaired health status of patients with cardiovascular disease. AIM: To evaluate whether acid suppressive therapy improves health-related quality of life in patients who developed upper gastrointestinal symptoms after starting low-dose acetylsalicylic acid. METHODS: In a double-blind, placebo-controlled randomized trail, cardiac patients using low-dose (80 mg) acetylsalicylic acid with (n = 142) and without (n = 90) upper gastrointestinal symptoms were included. Patients with symptoms were treated with rabeprazole or placebo for 4 weeks. At baseline and 4 weeks information about gastrointestinal symptoms and health-related quality of life was assessed. RESULTS: The 73 patients assigned to rabeprazole when compared with 69 patients given placebo reported the same quality of life scores 4 weeks after randomization. The differences in quality of life scores between patients with and without symptoms at baseline remained after 4 weeks. Patients in whom treatment led to complete symptom relief or those who remained symptom-free reported significantly higher scores for Physical Component Summary (P < 0.01) and Mental Component Summary (P < 0.01), when compared to those with persistent symptoms or new onset symptoms. CONCLUSION: Proton-pump inhibitor therapy did not improve quality of life. Upper gastrointestinal symptom relief in itself considerably increased quality of life.

Empirical treatment followed by a test-and-treat strategy is more cost-effective in comparison with prompt endoscopy or radiography in patients with dyspeptic symptoms: a randomized trial in a primary care setting.

OBJECTIVE: Management of patients with dyspepsia remains controversial. No consensus has yet been reached concerning diagnostic and medical strategies. We conducted a randomized trial to assess the effectiveness of three management strategies for patients with uninvestigated persistent dyspeptic symptoms. METHODS: A total of 199 patients presenting in primary care with dyspeptic symptoms (age 18-65 years, no alarming symptoms) were randomized to either empirical treatment with omeprazole and, in the case of symptomatic relapse, serological Helicobacter pylori infection testing plus eradication therapy (treat-and-test group), prompt upper gastrointestinal endoscopy (endoscopy group) or prompt upper gastrointestinal radiography (radiography group) followed by directed medical treatment. Symptoms, patients' satisfaction and use of resources were recorded during 6 months of follow-up. RESULTS: Sixty-nine patients were assigned to the treat-and-test group, 64 to the radiography group and 66 to the endoscopy group. The median age was 44 years; 104 patients were male and 37% were H.pylori infected. A total of 170 patients (85%) returned the 6 months questionnaire. The numbers of patients with complete symptom relief in the treat-and-test group, endoscopy group and radiography group were 21, 16 and 15, respectively, at 3 months (P = 0.59), and 23, 13 and 12, respectively, at 6 months (P = 0.05). Twenty-two patients in the treat-and-test group underwent endoscopy or radiography. Two patients in the endoscopy group and four patients in the radiography group underwent more than one diagnostic test. The average medical cost per patient for the treat-and-test group was euro 276, for the endoscopy group euro 426 and for the radiography group euro 321, respectively. CONCLUSION: Empirical treatment followed by a test-and-eradicate strategy resulted in fewer diagnostic tests, more symptom relief and lower medical costs compared with prompt upper gastrointestinal radiography or endoscopy in the management of uninvestigated patients with persistent dyspeptic symptoms.

Longitudinal study of bone mineral density in patients with Crohn's disease.

Osteoporosis is frequent in Crohn's disease. The aim of the study was to assess the rate of bone loss over time retrospectively and the influence of disease-related factors on bone loss. Twenty-nine patients (8 male), admitted for repeated bone mineral density assessments (BMD) were enrolled. BMD measured by dual energy x-ray absoptiometry was expressed in grams per square centimeter, and as sex- and age-matched Z score. The mean interval between BMD assessments was 41 months, during which period 27 patients used corticosteroids (mean dose 8.6 g) and 21 patients some form of bone protective medication. Initial Z scores at a mean age of 41 years were significantly below zero (spine -1.6 +/- 1.4; femur -1.4 +/- 1.4). Over time, no change in absolute BMD was observed accompanied by an improvement in Z scores. At the same time, an increase in body weight and a decrease in erythrocyte sedimentation rate (ESR) was observed. Multilinear regression analysis demonstrated change in ESR as independent predictor for change in femoral Z score. In conclusion, low BMD is frequent in Crohn's disease, but decline of BMD over time was not found, despite ongoing use of corticosteroids.

Proton-pump inhibitor therapy for acetylsalicylic acid associated upper gastrointestinal symptoms: a randomized placebo-controlled trial.

OBJECTIVE: Patients using acetylsalicylic acid (aspirin) have an increased risk of upper gastrointestinal discomfort. The aim of this study was to assess whether gastric acid suppression improves upper gastrointestinal symptoms in patients using low-dose aspirin for cardiovascular disease. METHODS: In a double-blind, placebo-controlled randomised trial, 150 patients using low-dose (80 mg) acetylsalicylic acid with upper gastrointestinal symptoms who had been admitted at the Coronary Care Unit of the University Medical Center Nijmegen were assigned to treatment with rabeprazole (20 mg once daily) or placebo for 4 weeks. Treatment success, defined as complete upper gastrointestinal symptom relief, could be evaluated in 143 patients. RESULTS: At 4 weeks after randomization, 34 of the 73 patients assigned to rabeprazole therapy (47%) as compared with 30 of the 70 patients given placebo (43%) reported complete upper gastrointestinal symptom relief (P = 0.54). Rabeprazole therapy did lead to a 52% improvement of heartburn symptoms [25% vs. 16%; odds ratio (OR) 0.48, 95% confidence interval (CI): 0.24-0.97]. Epigastric pain, regurgitation, bloating and nausea symptoms did not statistically change after treatment. Patients with a history of dyspepsia more often reported treatment success in comparison to those without (75% vs. 40%; OR 0.25, 95% CI: 0.09-0.70). CONCLUSIONS: Proton-pump inhibitor therapy significantly reduced heartburn, but not other acetylsalicylic acid associated symptoms.

The impact of gastrointestinal symptoms on health status in patients with cardiovascular disease.

BACKGROUND: Drugs for the management of cardiovascular disease may provoke gastrointestinal discomfort and complications. AIM: To evaluate whether upper gastrointestinal symptoms affect the health status of patients with cardiovascular disease. METHODS: Two weeks after discharge, 958 consecutive patients, who had been admitted to the Coronary Care Unit of the University Hospital Nijmegen between January and September 2001, were sent a questionnaire for the evaluation of gastrointestinal symptoms and health status. RESULTS: The questionnaire was returned by 632 patients (66%), with 334 patients (53%) reporting gastrointestinal symptoms. The self-rated health status (mean and 95% confidence interval), evaluated by visual analogue scale, was 70 (68-72) for patients without and 61 (59-63) for patients with gastrointestinal symptoms (P = 0.001). Patients with gastrointestinal symptoms reported significantly higher rates of problems with mobility (50% vs. 37%), self-care (19% vs. 10%), usual activities (70% vs. 52%), pain/discomfort (96% vs. 38%) and anxiety/depression (41% vs. 20%) when compared with those without gastrointestinal symptoms. CONCLUSION: Upper gastrointestinal symptoms strongly impaired the health status of patients with cardiovascular disease.