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Biomedical subjects

P Bytzer

Publications and source records attributed to P Bytzer.

At least 19 recordsLinked to original sources
PubMed2006

Irritable bowel syndrome: the burden and unmet needs in Europe.

Irritable bowel syndrome affects approximately 10-15% of the European population, although prevalence rates vary depending on the classification used and the country surveyed. This may be due to differences in patterns of medical care and diagnosis of the condition. Up to 70% of individuals with irritable bowel syndrome may not have been formally diagnosed. The disorder affects 1.5-3 times as many women as men and poses a significant economic burden in Europe, estimated at euro 700-euro 1600 per person per year. It also reduces quality of life and is associated with psychological distress, disturbed work and sleep, and sexual dysfunction. It is a chronic disorder, which affects many individuals for more than 10 years. Most patients are managed in primary care, although some are referred to gastroenterologists and other specialists. Patients with irritable bowel syndrome undergo more abdomino-pelvic surgery than the general population. We propose that a positive diagnosis of the condition may avoid the delay in diagnosis many patients experience. We conclude that, in Europe, there are significant unmet needs including lack of familiarity with irritable bowel syndrome, difficulties in diagnosis and lack of effective treatments for the multiple symptoms of the disorder. The development of pan-European guidelines for irritable bowel syndrome will benefit patients with this condition in Europe.

Cost of Illness↗
PubMed2006

Prescribing of acid suppressive therapy: interactions between hospital and primary care.

BACKGROUND: Overuse of acid suppressive therapy in the hospital setting and in primary care is well documented. AIM: To describe interactions between prescriptions of acid suppressive therapy in hospital and in primary care. METHODS: All patients admitted to hospital over a 24-month period were identified. Details about prescription of acid suppressive therapy were retrieved. All prescriptions of acid suppressive therapy redeemed by these patients 12 months before and after discharge were retrieved from a prescription database. RESULTS: A total of 549 of 4477 patients (12.3%) were treated with acid suppressive therapy while in hospital, but acid suppressive therapy was prescribed de novo in only 192 (35%) of these cases. Information about indication for acid suppressive therapy and planned duration of therapy were given in the discharge letter in only 25% and 17% of the cases, respectively. Among patients treated with acid suppressive therapy during admission, prescriptions on acid suppressive therapy were redeemed by 67% in the year before admission and by 74% in the year after discharge. Among patients who had the acid suppressive therapy discontinued during admission (n = 67), 48% resumed acid suppressive therapy within the following 12 months. Of all subjects treated with acid suppressive therapy in the hospital catchment area, 7.8% were seen in our department. CONCLUSIONS: Decisions about acid suppressive therapy prescribing in hospital has little influence on prescribing in primary care.

Aged↗
PubMed2005

A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation.

BACKGROUND: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. AIMS: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. PATIENTS: Women (> or = 18 years of age) with IBS-C according to the Rome II criteria. METHODS: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. RESULTS: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p < 0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p < 0.05). CONCLUSION: Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.

Adolescent↗
PubMed2005

Hepatic transit time of ultrasound contrast in biopsy characterized liver disease.

PURPOSE: To study the hepatic transit time of an ultrasound contrast agent in patients with liver disease, and to evaluate the mechanism(s) of the well-established shorter cubital vein to hepatic vein transit time in cirrhosis. MATERIAL AND METHODS: Thirty-four patients scheduled for Menghini liver biopsy were studied by ultrasound after injection of 2.5 g Levovist (Schering, Berlin, Germany) into an arm vein. The time from injection until the first appearance of contrast echoes in the hepatic artery and hepatic veins was registered. Hepatic transit time was the difference between the two. RESULTS: Biopsy showed cirrhosis in 9 patients, other diffuse hepatic pathology in 23 patients, and normal liver in 2 patients. Mean hepatic vein arrival time was earlier in cirrhosis than in other liver disease (19.4 s versus 26.0 s; P = 0.013), and hepatic transit time was shorter (6.6 s versus 11.6 s; P = 0.024). A hepatic transit time <10 s was found in all patients with cirrhosis, but also in 10 of 23 patients with other liver pathology. CONCLUSION: Hepatic transit time measurement could not be used to distinguish between cirrhosis and other hepatic pathology, but a transit time = 10 s excluded cirrhosis. The earlier hepatic vein arrival time in cirrhosis is apparently mainly caused by intrahepatic shunting rather than by early arrival of contrast to the liver.

Biopsy↗
PubMed2005

Abnormal hepatic vein Doppler waveform in patients without liver disease.

In patients with liver cirrhosis Doppler ultrasound often detects absence of the retrograde (hepatopetal) flow phase in the hepatic vein, suggestive of an increased stiffness of the liver parenchyma around the vein. This is rarely or never reported in healthy control persons. We examined the frequency of absent retrograde flow in a consecutive series of 139 patients referred for abdominal ultrasound. We used state-of-the-art ultrasound scanners, and placed the Doppler gate so that in non-forced end-expiration it would sample the right hepatic vein 4-6 cm from the vena cava. There was no association between the hepatic vein flow pattern and age, sex or body mass index. 43 of 139 studied patients showed absent retrograde flow. Review of the case records revealed liver disease in 26 patients and no sign of liver disease in 17 patients. We suggest that absent retrograde flow in the hepatic veins may be seen not only in patients with overt liver disease but also in apparently liver-healthy patients.

Adult↗
PubMed2004

Identifying response to acid suppressive therapy in functional dyspepsia using a random starting day trial--is gastro-oesophageal reflux important?

BACKGROUND: Single subject trials offer an alternative approach to identify and characterize responders to a specific treatment. AIM: To test a new single subject trials design, called random starting day trial, to identify acid-related symptoms in dyspepsia. METHODS: A total of 119 patients with functional dyspepsia entered a 12-day, double-blind random starting day trial. All patients started on placebo and switched to omeprazole 80 mg/day at a randomized and blinded day between day 5 and day 9, with active treatment continuing for the rest of the trial. Based on changes of a daily symptom score, response was defined as a sustained > or =50% reduction of symptoms within 3 days of active treatment. RESULTS: Thirteen of 119 patients (11%) were classified as spontaneous responders because of complete symptom relief before switching to omeprazole. Of the remaining 106 patients, 15 (15.6%) were classified as responders. Five of six (83%) responders compared with 28 of 53 (53%) non-responders had pathological reflux. Multivariate testing identified symptoms suggestive of gastro-oesophageal reflux predictive of response. CONCLUSIONS: The random starting day trial design could identify a subset of dyspeptic patients with a uniform symptomatic response to acid-suppressive therapy. Response seems to be associated with gastro-oesophageal reflux. The random starting day trial needs to be further validated to be considered as a reliable instrument in clinical research.

Anti-Ulcer Agents↗
PubMed2004

Personal view: rationale and proposed algorithms for symptom-based proton pump inhibitor therapy for gastro-oesophageal reflux disease.

Gastro-oesophageal reflux disease and non-erosive reflux disease are chronic, highly prevalent conditions requiring long-term treatment that is both effective and practical. On-demand therapy with a proton pump inhibitor may meet that need. It is becoming a mainstay of long-term treatment because it reduces the risk of over- and under-treatment, is cost-effective and user friendly. Epidemiological and clinical observations speak also in its favour. However, for the anticipated benefits of on-demand therapy to accrue in clinical practice, on-demand treatment algorithms are required. These algorithms must specify the initial evaluation and treatment of candidates, and follow-up protocols for an on-demand strategy. Our group has developed such algorithms, which are presented here.

Algorithms↗
PubMed2004

Reproducibility of a symptom response to omeprazole therapy in functional dyspepsia evaluated by a random-starting-day trial design.

BACKGROUND: Satisfactory treatment options for functional dyspepsia are lacking. Single subject trial designs may identify subgroups of patients with a uniform response to therapy. AIM: To test reproducibility of response in a new random-starting-day trial design developed to identify acid-related symptoms in functional dyspepsia. METHODS: One hundred and nineteen patients with functional dyspepsia completed a 12-day, double-blind random-starting-day trial with an initial placebo run-in followed by switch to omeprazole on a randomized and blinded day (between days 5 and 9) with active treatment continuing for the rest of the trial. Response was defined as a sustained > or =50% reduction of a daily symptom-score within 3 days of active treatment. Fifty-nine patients repeated the random-starting-day trial at relapse of symptoms. RESULTS: After exclusion of placebo responders, 14% (15 of 106) were classified as responders in the first and 20% (10 of 50) in the subsequent random-starting-day trial series. Sixty-eight per cent (40 of 59) of the patients reproduced their initial response with a chance-corrected agreement of 0.29. Comparing response patterns using different symptom rating-scales showed good correlation (kappa 0.60). CONCLUSION: Reproducibility of response in a random-starting-day trial was imperfect, mainly because of the low response rates and strict response criteria. Lack of symptom stability impairs the value of the random-starting-day trial and only patients with frequent and stable symptoms should be evaluated in this design.

Anti-Ulcer Agents↗
PubMed2004

Six-month trial of on-demand rabeprazole 10 mg maintains symptom relief in patients with non-erosive reflux disease.

BACKGROUND: Compliance studies have shown that patients with reflux symptoms generally take their medication only when experiencing these symptoms. AIM: To evaluate the efficacy of on-demand rabeprazole maintenance therapy in patients with non-erosive reflux disease. METHODS: This multicentre, randomized, double-blind, placebo-controlled, withdrawal study compared 6 months of on-demand treatment with rabeprazole 10 mg vs. placebo. Adults with a history of reflux symptoms, a negative endoscopy, and > or = 3 days of moderate to very severe heartburn in the 7 days before enrollment (N = 535) entered 4 weeks of open-label, acute treatment with rabeprazole 10 mg once daily. Patients with complete symptom relief then entered the on-demand phase. The primary end-point was discontinuation due to lack of heartburn control during the on-demand phase. RESULTS: Eighty-three percent (432 of 523) of patients reported complete symptom relief at the end of the acute phase. During on-demand treatment, rates of discontinuation because of inadequate heartburn control were 20% (28 of 139) for placebo vs. 6% (16 of 279) for rabeprazole (P < 0.00001). Antacid use was twofold higher in the placebo group vs. the rabeprazole group (P = 0.0009). CONCLUSIONS: Rabeprazole 10 mg once daily is highly effective in acute symptom relief and as on-demand long-term maintenance therapy in non-erosive reflux disease patients.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2004

Assessment of reflux symptom severity: methodological options and their attributes.

Despite major advances in our understanding of reflux disease, the management of this disorder still presents many challenges. Reduction of heartburn is the most readily apparent objective for the patient with reflux disease. Thus the ability to measure heartburn accurately is of fundamental importance to clinical research in reflux disease. Here, the available data on the assessment of reflux symptoms--predominantly heartburn--in clinical trials of symptomatic reflux disease are examined.

Chronic Disease↗
PubMed2003

Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome.

Appropriate guidelines for clinical trials in irritable bowel syndrome are needed because of the inadequacy of previously performed trials, the use of new and more adequate patient definition, new emerging pathophysiological models and the unique requirements related to the assessment of treatment outcome that, in the absence of a biological marker, can rely only on the evaluation of clinical manifestations. This consensus report highlights the following points. (a) A 4-week period is considered to be adequate to assess drug efficacy for the control of symptoms. (b) For the cyclic and non-life-threatening nature of the disease, a long-term study of 4-6 months or more of active treatment to establish efficacy is considered to be inappropriate in the large majority of patients. (c) In the initial assessment phase of drug efficacy, the withdrawal effect of treatment can be ascertained during a follow-up period prolonged for a sufficient time (4-8 weeks) after stopping treatment. Subsequent trials with proper withdrawal phase design and duration can then ascertain the drug post-treatment benefit. (d) Considering the intermittent clinical manifestations of irritable bowel syndrome, designing trials with on-demand or repeated cycles of treatment could be envisaged. However, the lack of a definition of what constitutes an exacerbation is a major obstacle to the design of such trials. In the absence of an established gold standard, appropriately justified novel trial designs are welcome. (e) Patients eligible for inclusion should comply with the Rome II diagnostic criteria for irritable bowel syndrome. (f) The main efficacy outcome of the treatment should be based on one primary end-point. (g) The primary efficacy end-point could combine, in a global assessment, the key symptoms (abdominal pain, abdominal discomfort, bowel alterations) of irritable bowel syndrome or rate any single symptom for drugs considered to target specific symptoms. (h) A 50% improvement in the primary efficacy end-point seems to be a reasonable definition of a responder.

Clinical Trials as Topic↗
PubMed2002

A randomized, double-blind, comparative study of standard-dose rabeprazole and high-dose omeprazole in gastro-oesophageal reflux disease.

BACKGROUND: Rabeprazole has a faster onset of antisecretory action than omeprazole, and it is of interest to determine whether this translates into faster symptom relief in patients with gastro-oesophageal reflux disease. AIMS: To assess the relief from heartburn after 3 days of treatment with standard-dose rabeprazole or high-dose omeprazole (primary end-point). Secondary end-points included the decrease in score for other symptoms of gastro-oesophageal reflux disease, healing rates and quantification of antacid use. METHODS: Patients with endoscopically confirmed erosive oesophagitis were randomized to receive 4 weeks of double-blind treatment with rabeprazole (20 mg) or omeprazole (40 mg). Patients who were not healed after 4 weeks received a further 4 weeks of treatment. RESULTS: Two hundred and seventy-four patients were screened, 251 patients were randomized and 230 patients completed the trial. The numbers of patients with relief from heartburn on day 4 were similar in the two groups (84% for rabeprazole; 95% confidence interval, 76-90%; 83% for omeprazole; 95% confidence interval, 75-89%). There were no significant differences between the treatments in the relief from other gastro-oesophageal reflux disease symptoms or in healing rates. The number of reports of severe heartburn during the first 3 days was higher in the omeprazole group (daytime heartburn: 4.7% for rabeprazole vs. 10.3% for omeprazole, P=0.005; night-time heartburn: 4.7% for rabeprazole vs. 9.8% for omeprazole, P=0.01; statistical comparisons defined post hoc). CONCLUSIONS: Standard-dose rabeprazole was as effective as high-dose omeprazole in relieving symptoms by day 4 of treatment and in healing oesophageal lesions, but had a faster onset of action in patients with severe heartburn. This suggests that the improved pharmacological properties of rabeprazole translate into a clinically relevant advantage.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2001

[Prevention of NSAID induced gastroduodenal ulcers].

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are important agents in the management of arthritic and inflammatory conditions, and are among the most frequently prescribed medications in North America and Europe. However, there is overwhelming evidence linking these agents to a variety of gastrointestinal (GI) toxicities. OBJECTIVES: To review the effectiveness of common interventions for the prevention of NSAID induced upper GI toxicity. SEARCH STRATEGY: A literature search was conducted, according to the Cochrane methodology for identification of randomized controlled trials in electronic databases, including MEDLINE from 1966 to January 2000, Current Contents for 6 months prior to January 2000, Embase to February 1999, and a search of the Cochrane Controlled Trials Register from 1973 to 1999. Recent conference proceedings were reviewed and content experts and companies were contacted. SELECTION CRITERIA: Randomized controlled clinical trials (RCTs) of prostaglandin analogues (PA), H2-receptor antagonists (H2RA) or proton pump inhibitors (PPI) for the prevention of chronic NSAID induced upper Gl toxicity were included. DATA COLLECTION AND ANALYSIS: Two independent reviewers extracted data regarding population characteristics, study design, methodological quality and number of patients with endoscopic ulcers, ulcer complications, symptoms, overall drop-outs, drop-outs due to symptoms. Dichotomous data was pooled using Revman V3.1. Heterogeneity was evaluated using a chi square test. MAIN RESULTS: Thirty-three RCTs met the inclusion criteria. All doses of misoprostol significantly reduced the risk of endoscopic ulcers. Misoprostol 800 micrograms/day was superior to 400 micrograms/day for the prevention of endoscopic gastric ulcers (RR = 0.18, and RR = 0.38 respectively, p = 0.0055). A dose response relationship was not seen with duodenal ulcers. Misoprostol caused diarrhea at all doses, although significantly more at 800 micrograms/day than 400 micrograms/day (p = 0.0012). Misoprostol was the only prophylactic agent documented to reduce ulcer complications. Standard doses of H2RAs were effective at reducing the risk of endoscopic duodenal (RR = 0.24; 95%, CI: 0.10-0.57) but not gastric ulcers (RR = 0.73; 95% CI: 0.50-1.09). Both double dose H2RAs and PPIs were effective at reducing the risk of endoscopic duodenal and gastric ulcers (RR = 0.44; 95% CI: 0.26-0.74 and RR = 0.37; 95% CI: 27-0.51 respectively for gastric ulcer), and were better tolerated than misoprostol. REVIEWERS' CONCLUSIONS: Misoprostol, PPIs, and double dose H2RAs are effective at preventing chronic NSAID related endoscopic gastric and duodenal ulcers. Lower doses of misoprostol are less effective and are still associated with diarrhea. Only misoprostol 800 micrograms/day has been directly shown to reduce the risk of ulcer complications.

Antacids↗
PubMed2001

Prevalence of gastrointestinal symptoms associated with diabetes mellitus: a population-based survey of 15,000 adults.

BACKGROUND: Gastrointestinal symptoms are reportedly common in diabetes, but a causal link is controversial and adequate population control data are lacking. OBJECTIVE: To determine whether gastrointestinal symptoms are more frequent in persons with diabetes, particularly in those with poor glycemic control. METHODS: Fifteen thousand adults were mailed a questionnaire (response rate, 60.0%) containing validated questions on the frequency of troublesome gastrointestinal symptoms within the past 3 months, diabetic status, and self-reported glycemic control. The prevalence of 16 symptoms and 5 symptom complexes, reported to occur often or very often, was compared using logistic regression analysis, adjusting for age and sex. RESULTS: Overall, 8657 eligible subjects responded; 423 (4.9%) reported having diabetes. Most (94.8%) had type 2 diabetes mellitus. Adjusting for age and sex, all 16 symptoms and the 5 symptom complexes were significantly more frequent in subjects with diabetes compared with controls. An increased prevalence rate of symptoms was significantly associated with poorer levels of glycemic control but not with duration of diabetes or type of diabetic treatment. CONCLUSIONS: Diabetes mellitus is associated with an increased prevalence of upper and lower gastrointestinal symptoms. This effect may be linked to poor glycemic control but not to duration of diabetes or type of treatment.

Abdominal Pain↗