On rising reflux and other matters.
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Gastroesophageal Reflux↗
Biomedical subjects
F Pace
Publications and source records attributed to F Pace.
Pretreatment endoscopy--pro & contra: endoscopy is needed before treatment in all patients with gastroesophageal reflux disease.
Most current endoscopic guidelines do not recommend the use of routine esophagoscopy in the evaluation of patients with typical symptoms of gastroesophageal reflux disease (GERD), unless alarm features are present. In patients with known reflux esophagitis, esophagoscopy is considered to have no role either in the further management or follow-up. Screening of reflux patients for Barrett's esophagus is not considered to be cost-effective. On the basis of a critical review of the available literature, and of some recent papers in particular, we disagree with these suggestions. We would argue, on the contrary, that a negative esophagoscopy can provide the GERD patient with reassurance, and that esophagoscopy allows targeted therapy to be offered if it is positive for esophagitis. When Barrett's esophagus is diagnosed, it usually leads to a surveillance program being initiated. The potential benefits of endoscopy for the patient's quality of life are probably underestimated when financial issues alone are taken into account. Even if it is true that a large percentage of GERD patients do not have endoscopic abnormalities (those with nonerosive reflux disease), surrogate tests such as the proton-pump inhibitor test or symptom questionnaires do not provide a more accurate diagnosis. We would therefore suggest that, at least in the specialist setting, all patients with suspected GERD should undergo accurate symptom analysis as well as endoscopic evaluation before treatment is started.
Barrett Esophagus↗
Quality of life in acute and maintenance treatment of non-erosive and mild erosive gastro-oesophageal reflux disease.
BACKGROUND: Quality of life has been assessed in a large, multicentre randomized, open label study. AIM: To evaluate the economic and clinical consequences of two different maintenance treatment modalities, administered to 6017 gastro-oesophageal reflux disease patients at 451 gastroenterological centres in Italy. METHODS: Adult gastro-oesophageal reflux disease patients received, at enrolment, an acute treatment of esomeprazole 40 mg/day for 4 weeks and, if successfully treated, were randomized into two maintenance treatment strategies: esomeprazole 20 mg/day or esomeprazole on demand for 6 months. A baseline endoscopy allowed the exclusion of grade II-IV oesophagitis according to Savary-Miller's classification. Burden of gastro-oesophageal reflux disease was measured at baseline by the generic questionnaire Short-Form 36 and by a disease specific instrument, quality of life in reflux and dyspepsia (QOLRAD), also administered at start and conclusion of maintenance period. Investigators were required to collect patient judgement about the degree of satisfaction with treatment effect on heartburn, with a 7-point scale. RESULTS: A comparison between Short-Form 36 scores and the normative source of the Italian general population suggested that symptomatic gastro-oesophageal reflux disease patients experience a worse quality of life than the general population. At the end of the 4-week treatment with esomeprazole 40 mg all (QOLRAD) dimensions showed a statistically significant (P < 0.0001) and clinically meaningful improvement. Satisfaction level towards treatment was reported high in the total enrolled population after acute treatment with esomeprazole 40 mg/day (96.2% satisfied and 64.4% very satisfied). A statistically significant difference in (QOLRAD) scores was registered at the end of maintenance phase in favour of the continuous regimen, nevertheless the size of this difference was very small in all dimensions; similarly, the proportion of patients very satisfied was slightly higher in the continuous treatment arm (64.5%) than in the on-demand arm (59.7%). CONCLUSIONS: Gastro-oesophageal reflux disease can significantly impair health-related quality of life and esomeprazole therapy allows immediate relief in the acute phase of the disease. Quality of life improvement was maintained during the 6-month follow-up with a slight difference in term of quality of life in reflux and dyspepsia scores and patients' satisfaction in favour of the continuous treatment strategy.
Acute Disease↗
Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole.
BACKGROUND: Previous studies have shown similar effects of rabeprazole and omeprazole, when used at the same dose in the treatment of reflux oesophagitis. However, such studies have been conducted as superiority studies but interpreted as equivalence ones. AIM: To properly assess the comparative efficacy of rabeprazole and omeprazole in inducing complete endoscopic healing and symptom relief in patients with reflux oesophagitis. METHODS: Patients (n=560) with Savary-Miller grade I-III reflux oesophagitis were randomised in a double-blind, double-dummy fashion to rabeprazole or omeprazole 20 mg once daily for 4-8 weeks. Then, patients endoscopically healed and symptomatically relieved were openly maintained with rabeprazole 10 mg or 2x10 mg once daily (in the event of clinical and/or endoscopic relapse) for a maximum of 48 weeks. RESULTS: After 4-8 weeks of treatment, healing (primary end-point) was observed in 228/233 (97.9%) patients in the rabeprazole group and in 231/237 (97.5%) in the omeprazole one (equivalence effect demonstrated by p<0.0001 at Blackwelder test and an upper confidence limit at 97.5% of 0.023). However, rabeprazole was faster in inducing heartburn relief than omeprazole (2.8+/-0.2 versus 4.7+/-0.5 days of therapy to reach the first day with satisfactory heartburn relief, p=0.0045 at log-rank test). In the maintenance phase, 15.2% of patients had an endoscopic and/or clinical relapse. CONCLUSION: Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.
2-Pyridinylmethylsulfinylbenzimidazoles↗
Endoscopic treatment of gastroesophageal reflux disease.
Gastroesophageal reflux disease is a common chronic disorder which has a severe effect on the patient's quality of life. In view of the high cost of medical therapy and the limitations of surgery, a variety of endoscopic techniques have been developed for the treatment of this condition, and these have shown apparently encouraging results, at least in the short term. However, promising results have been obtained in only around two-thirds of patients over a short-term follow-up period of about 6 months. Moreover, several inconsistencies have emerged between the efficacy of this form of treatment in improving symptoms and quality of life and a lack of improvement of objective parameters, such as lower esophageal sphincter pressure and esophageal acid exposure. The authors strongly endorse the need for comprehensive evaluation of clinical evidence on this topic. After an extensive evaluation of existing literature, we suggest that controlled studies are urgently needed in order to clarify the potential of endoscopic therapy, either in terms of cost-effectiveness or in comparison with standard therapy. Meanwhile, with regard to current practice, the use of endoscopic treatment should be limited to clinical trials, which should incorporate the provision of comprehensive and unbiased information to study patients.
Catheter Ablation↗
Technologies in the evaluation of irritable bowel syndrome.
During a meeting in The Hague, The Netherlands, the IBiS Club evaluated the most important techniques that can be used in the investigation of irritable bowel syndrome, either in the context of scientific research or as a clinical diagnostic tool. In each of these, the relevance of findings made in irritable bowel syndrome was balanced against the applicability of the technique. The discussion of the group is summarized in this paper.
Anal Canal↗
Natural history of gastro-oesophageal reflux disease without oesophagitis (NERD)--a reappraisal 10 years on.
BACKGROUND AND AIM: Ten years ago we published a study describing the 6-month outcome of 33 outpatients with typical gastro-oesophageal reflux disease symptoms and pH-metry proven excess gastro-oesophageal reflux but without endoscopical evidence of oesophagitis, currently referred to as patients with gastro-oesophageal reflux disease without oesophagitis. We now present an update of that report concerning morbidity, drug consumption and quality of life of the original patients 10 years after the initial diagnosis. METHODS: The study consisted of the retrieval and revision of all clinical and instrumental records concerning the cohort of 33 above-mentioned patients. Data are available regarding annual intervals within the first 5 years from original diagnosis and, subsequently, with a follow-up ranging from 7 to 14 years (median 10 years). The records of these 33 patients were reviewed, including the results of clinical visits at the outpatients department, of oesophagogastroduodenoscopies and pH- metries. Finally, a telephonic interview was conducted by means of a structured questionnaire, aiming at evaluating present symptoms, actual therapy if any, health-related quality of life and other information regarding any gastro-oesophageal reflux disease symptoms. RESULTS: Of the original 33 patients, 31 are still alive and 2 were lost to follow-up. Of the 29 remaining, only 1 is definitively not complaining of any gastro-oesophageal reflux disease-related symptoms. Within 5 years of the first diagnosis, oesophagitis was found in all but one of the 18 subjects who underwent repeated endoscopy. At the latest follow-up check, after a median of 10 years, out of the 28 still complaining of gastro-oesophageal reflux disease symptoms, 21 (75%) were presently taking antisecretory drugs (proton pump inhibitors and H-2 receptor antagonists) because of gastro-oesophageal reflux disease symptoms/lesions, 12 of whom intermittently or on demand and the remaining 9 continuously. Two patients (2/28) underwent antireflux surgery, but despite this were still taking antisecretory drugs (in one case H2-RA; in the other proton pump inhibitor). The health-related quality of life, self-evaluated by the patient by means of a VAS scoring from 0 (worst possible) to 10 (best possible) increased significantly from 3.2 to 6.5 from baseline (before therapy) to present time, possibly due to the positive effect of present therapy. CONCLUSIONS: Our study conducted on a cohort of endoscopy-negative patients with pH-metry-confirmed reflux disease has shown that after a median time of 10 years following the original diagnosis, the majority of patients have, in fact, developed reflux oesophagitis and are on prolonged antisecretory therapy because of recurrent gastro-oesophageal reflux disease symptoms/lesions. The study confirms that gastro-oesophageal reflux disease without oesophagitis, as well as gastro-oesophageal reflux disease at large, is a chronic disease characterised by increasing severity with time, which requires protracted medical therapy in a vast proportion of patients. Absence of endoscopic oesophagitis at presentation does not represent a positive prognostic factor.
Cohort Studies↗
The Italian version of the Fibrofatigue Scale, a reliable tool for the evaluation of fibromyalgia symptoms.
OBJECTIVE: To validate a translated Italian version of the Fibrofatigue Scale (FFS). METHODS: The Italian version of FFS was administered to 60 patients affected by fibromyalgia (FM) (57 patients were interviewed again 10 days later) together with the Italian version of the Fibromyalgia Impact Questionnaire (FIQ), the Stanford Health Assessment Questionnaire (HAQ) and the Medical Outcome Survey Short Form-36 (SF-36). All patients were asked about the severity of pain today (10-cm visual analogue scale) and the duration of symptoms. Test-retest reliability was assessed using Spearman correlations. Internal consistency was evaluated with Cronbach's alpha of reliability. Construct validity of the FFS was evaluated by correlations among the FFS, the FIQ and the subscales of the SF-36. RESULTS: Mean duration of symptoms was 7.6 years, and mean age of participants was 56.3 years. Test-retest reliability was between 0.70 and 0.95 for the single items as well as for the total FFS and other components. Internal consistency was 0.90 for the overall FFS. Significant correlations were obtained between the FFS items and the SF-36. CONCLUSIONS: The Italian FFS is a reliable and valid instrument for detecting and measuring functional disability and symptoms severity in Italian patients with FM.
Adult↗
Gastroesophageal reflux disease: a typical spectrum disease (a new conceptual framework is not needed).
Gastroesophageal reflux disease (GERD) is a common GI disorder, particularly frequent in the primary care setting, with a high direct and indirect economic burden on society. Despite the high prevalence and costs of the disease, the epidemiology and natural history of GERD have not been fully elucidated. It has recently been suggested to abandon the current model of GERD as a "spectrum" disease and to adopt a new conceptual framework, e.g., categorizing GERD into three unique groups of patients: nonerosive reflux disease, erosive esophagitis, and Barrett's esophagus. In the present review we present arguments against this proposal, and argue that the concept of a single disease, potentially progressing from mild nonerosive forms toward metaplasia and neoplasia (adenocarcinoma), still holds true and may in fact help us in planning the diagnostic and therapeutic approach as well as in allocating financial resources much better than the proposed model of a "tripartited" disease. Independently from the conceptual model adopted, however, more data on the natural history of patients with GERD are eagerly needed.
Barrett Esophagus↗
Inflammatory bowel disease versus irritable bowel syndrome: a hospital-based, case-control study of disease impact on quality of life.
BACKGROUND: Inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) are intestinal diseases perceived differently by patients and doctors: the former is considered essentially as an 'organic' disease (i.e. an illness in which the role of stress or psychological factors is at best secondary to the disease itself), whereas the latter is acknowledged as a 'functional' disorder (i.e. illness thought to be more in the 'mind' than in the body of the patient). Accordingly, the respective impact of the two diseases on patients' health-related quality of life (HRQOL) is perceived to be very different. We aimed to compare the relative impact of the disease on HRQOL, psychological profile and perceived burden of stressful life events in two groups of outpatients suffering from IBS and IBD and attending our outpatient department at an Italian university hospital. Eighty patients with IBD (26 with ulcerative colitis and 54 with Crohn disease) and 85 controls with IBS formed the patient samples of the study. METHODS: Three questionnaires were given to the patients while they were attending the outpatient department because of their previously diagnosed disease, namely the SF-36 (a generic well-validated tool for measuring HRQOL), the SCL-90 (for assessing the psychological profile of patients), and the Holmes & Rahe schedule (for the assessment of stressful life experiences). The results were then compared by means of analysis of variance (ANOVA) and Bonferroni-adjusted t test, when appropriate. RESULTS: HRQOL appeared to be similarly reduced in both disease groups (SF-36 overall mean value: 58.2 +/- 16.1 in IBS patients versus 56.4 +/- 22.3 in IBD patients: P > 0.05) in comparison with normative Italian data. Furthermore, the overall severity of psychological symptoms was not statistically different between patients suffering from IBD versus IBS, as shown by SCL-90 mean scores of 0.89 + 0.45 versus 0.83 +/- 0.48, respectively (P > 0.05). On the contrary, the severity of recent stressful life experiences was perceived to be higher by IBS than by IBD patients (mean SRE score: 110.8 = 110.2 versus 61.6 +/- 78.8; P < 0.05). CONCLUSION: Our study supports the notion that, at least in referral centres, patients with IBS show health-related quality of life, psychological distress and recent occurrence of stressful life events of severity at least comparable with age-matched IBD patients.
Adult↗
Role of alimentation in irritable bowel syndrome.
BACKGROUND: Different food items are made responsible for irritable bowel syndrome (IBS) symptoms, but the physiopathology of IBS remains unclear. AIMS: During a meeting in Nice, France, experts of the European Working Team of the IBiS Club discussed selected data regarding the relationships between alimentation, food items (including fibers) and IBS symptoms. METHODS/RESULTS: Food allergy remains a difficult diagnosis, but medical and general history, presence of general symptoms such as skin rash, and hypersensitivity tests may help in achieving a positive diagnosis. On the other hand, food intolerance is more confusing because of the subjectivity of the relationship between ingestion of certain foods and the appearance of clinical symptoms. Different food items which are commonly implicated in adverse reactions mimicking IBS were found to be stimulants for the gut, suggesting that patients with predominant diarrhea IBS have to be carefully questioned about consumption of different kinds of food (i.e., coffee, alcohol, chewing gum, soft drinks) and not only on lactose ingestion. Gas production is discussed on the basis of retention of intestinal gas as well as on malabsorption of fermentable substrates. The role of a large amount of this kind of substrate reaching the colon is suggested as a potential mechanism of IBS-type symptoms in overeating patients. Regarding the role of fiber in IBS, the expert group concluded that fibers are not inert substances and that they could trigger pain or bloating in some IBS patients. CONCLUSION: Despite numerous reviews on this subject, it is very difficult to give general dietary advice to IBS patients, but dieteticians may have a positive role in managing such patients.
Colon↗
Delayed presentation of congenital diaphragmatic Bochdalek hernia. Case report.
The authors describe the case of a 1-month-old patient admitted for crisis of paleness, accompanied by hyporeactivity, tachycardia and polypnea; the symptoms, attenuated after detension of the abdomen, grew worse, with compromise of general conditions and respiratory failure. Chest X-ray shows the herniation of intestinal loops in the thoracic cavity. After the first emergency care, it became necessary to submit the baby to HFO and cardiovascular drugs for some hours before getting oxygenation index (OI) and circulation stabilization. Late presenting congenital diaphragmatic hernia (LCDH) is a condition that can occur during first or second infancy with respiratory or abdominal symptoms, quickly worsening or intermittent. The prognosis is good if diagnosis is timely. Patient stabilization before surgical intervention must be valued not only by O.I. but also by circulation conditions.
Age Factors↗
On-demand proton pump inhibitor therapy in patients with gastro-oesophageal reflux disease.
On-demand therapy is an established modality in long-term therapy with histamine-2-receptor antagonists, in cases of mild non-erosive gastro-oesophageal reflux disease. In the literature, only a few studies have specifically addressed the problem of proton pump inhibitors on-demand treatment. The evidence, so far, available suggests that this might be an effective modality of long-term treatment in the majority of patients with non-erosive gastro-oesophageal reflux disease. This treatment modality appears to be the most cost-effective and the best tolerated medical regimen for gastro-oesophageal reflux disease. It also seems to be able to restore the impairment of health-related quality of life due to gastro-oesophageal reflux disease symptoms. Although the current standard of care for patients with non-erosive gastro-oesophageal reflux disease is maintenance therapy with daily administration of a proton pump inhibitor agent, on-demand therapy, with the same drug, may be a reasonable long-term choice. The ideal proton pump inhibitors for such treatment will be those with a more rapid onset of action, more profound acid inhibition, more predictable therapeutic effect and less drug-drug interactions. Newer proton pump inhibitors, like esomeprazole, the S-chiral isomer of omeprazole, are promising drugs for on-demand treatment of gastro-oesophageal reflux disease.
Esomeprazole↗
The rectum: a window to irritable bowel syndrome?
This report summarizes current concepts and information gathered to date about the rectum in the irritable bowel syndrome (IBS) that were presented at the 10th meeting of IBiS Club held in Leuven, Belgium. A working group of experts in the field of IBS discussed whether the rectum or the whole colon is the better site to test in IBS patients and provided suggestions for a number of areas where further advances are required.
Biopsy↗
Tegaserod, a 5-HT(4) receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation.
AIM: To investigate the efficacy and safety of tegaserod, a novel 5-HT(4) receptor partial agonist, in a randomized, double-blind, placebo-controlled, 12-week treatment, multicentre study. METHODS: Eight hundred and eighty-one patients with irritable bowel syndrome, characterized by abdominal pain, bloating and constipation, received tegaserod, 2 mg b.d. or 6 mg b.d., or placebo for 12 weeks. RESULTS: Tegaserod, 2 mg b.d. and 6 mg b.d., showed a statistically significant relief of overall irritable bowel syndrome symptoms, measured by a weekly, self-administered questionnaire. At end-point, treatment differences from placebo were 12.7% and 11.8% for 2 mg b.d. and 6 mg b.d., respectively. The effect of tegaserod was noted as early as week 1, and was sustained over the 12-week treatment period. Individual irritable bowel syndrome symptoms assessed daily also showed a statistically significant improvement of abdominal discomfort/pain, number of bowel movements and stool consistency, and a favourable trend for reducing days with significant bloating. Adverse events were similar in all groups, with transient diarrhoea being the only adverse event seen more frequently with tegaserod than placebo. CONCLUSIONS: Based upon the results of this study, tegaserod offers rapid and sustained relief of the abdominal pain and constipation associated with irritable bowel syndrome. Tegaserod is also well tolerated.
Abdominal Pain↗
Epidemiological aspects of irritable bowel syndrome in Europe and North America.
The epidemiology of irritable bowel syndrome (IBS) in Europe and North America was analyzed from published material. The percentage of the population of Western civilisation with IBS symptoms is between 10 and 15% in most studies. The proportion of a Western population visiting a doctor for IBS symptoms is around 5%. The prevalence of IBS and the proportion of consulters do not seem to depend on age in an adult population. The female-to-male ratio of IBS in the population is close to 2. It is higher in IBS consulters in primary care and may be as high as 3 or 4 in tertiary referral centers. At least in patients from these centers, the number of physician visits and colonoscopies is considerable. Most of the consulters get a drug prescription.
Colonic Diseases, Functional↗
Idiopathic AL amyloidosis and biclonal paraproteinemia: a case report and review of the literature.
A case of 79 year-old man suffering from nephrotic syndrome, infiltrative cardiomyopathy and sensitive neuropathy of the lower limbs, associated with biclonal gammopathy (IgG K and IgA A), is described. There was a history of non-insulin dependent diabetes mellitus and of two lung nodules considered as benign lesions on the basis of cytologic, hematologic and instrumental examination. A rectal biopsy positive for amyloid deposition (Congo red histology and immunofluorescence study) led to the diagnosis of AL amyloidosis. Considering that the patient did not fulfill diagnostic criteria for lymphoproliferative diaseases (myeloma, lymphoma or Waldenström's macroglubulinemia), nor for secondary malignant paraproteinemia, a diagnosis of idiopathic AL amyloidosis with biclonal gammopathy was made. Very few cases of idiopathic AL amyloidosis with double component are reported in the literature. Our review suggests that idiopathic AL amyloidosis with biclonal gammopathy is similar to idiopathic AL amyloidosis with monoclonal paraproteinemia in terms of clinical features, response to therapy and prognosis. Further studies, however, are necessary to clarify the true incidence and the clinical features of idopathic AL amyloidosis associated with biclonal gammopathy.
Aged↗
Ambulatory oesophageal pH-metry. Position paper of the Working Team on Oesophageal pH-metry by the GISMAD (Gruppo Italiano di Studio sulla Motilità dell'Apparato Digerente).
In the last three decades, oesophageal pH monitoring has progressed from a physiological research tool to a routine outpatient clinical investigation in patients with suspected gastro-oesophageal reflux disease, one of the most common gastrointestinal disorders. Technological progress has considerably simplified both the procedure and the interpretation of data obtained, and there is currently reasonable consensus as to the parameters that best discriminate between physiological and pathological reflux. There remains a need for internationally agreed definitions and standards with regard to indexes to quantitate the extent and the significance of the relationship between occurrence of symptoms and reflux episodes during the examination. It is felt that national or local normal values are to be used to circumvent different eating habits and other socio-cultural differences which may influence gastro-oesophageal reflux. The reproducibility of the test appears, at present, to be at least good enough to allow classification of the patient as a pathological or physiological refluxer, albeit wide day-to-day variations seem to exist as far as concerns the extent of gastro-oesophageal reflux. Clinical applications of the technique have increased with better knowledge of the protean clinical manifestations of gastro-oesophageal reflux disease, and include the evaluation of "typical" gastro-oesophageal reflux disease patients with negative endoscopy or refractory oesophagitis, the "atypical" manifestations of gastro-oesophageal reflux disease and the pre- and post-operative evaluation of patients undergoing antireflux surgery.
Calibration↗