[Comorbidities in rheumatoid arthritis: analysis of hospital discharge records]. / Comorbidità nell'artrite reumatoide: un'analisi delle schede di immissione ospedaliera.

OBJECTIVE: Arthritis is often associated with comorbidities. For many of them, such as hypertension, cardiovascular disease, chronic pulmonary disease, and upper gastrointestinal disease, arthritis and its treatment may also represent a risk factor. This study is concerned with an evaluation of the frequency of comorbidities in a cohort of patients with rheumatoid arthritis (RA). METHODS: The discharge diagnoses of patients with RA during the period 1 January 1997 to 31 December 2000 were retrieved from the database of the Department of Internal Medicine of the University of Genova, Italy. The diagnosis of RA was made if the patient's discharge record contained the code 714 of the International Classification of Diseases, IX revision, as first 3 numbers. The other diagnoses were also recorded along with demographic data, type and duration of hospital stay, and performed procedures. RESULTS: During the study period, 427 patients with RA were admitted to the hospital for a total number of 761 admissions, which represented 2.2% of total admissions. Ninety-one (21.3%) patients did not have comorbidities, whereas 336 (78.6%) had one or more comorbidities. The most frequently observed comorbidities were cardiovascular diseases (34.6%), including hypertension (14.5%) and angina (3.5%), followed by gastrointestinal (24.5%), genito-urinary (18.7%) and respiratory (17%) diseases. There was a male predominance (p=0.004) within patients with comorbidities, who were significantly older (64.2+/-3.2 years vs. 57.2+/-4.2 years; p<0.001) and required longer periods of hospital stay (22.7 days vs. 12.5 days; p<0.001). CONCLUSIONS: Comorbidities are present in nearly 80% of RA inpatients. Comorbidity is a good predictor of health outcome, health services utilization, and medical costs. Because RA comorbidity can act as confounder, it should be considered in epidemiologic studies and clinical trials.

Use of an artificial neural network to predict Graves' disease outcome within 2 years of drug withdrawal.

BACKGROUND: Graves' disease (GD) is an autoimmune disorder characterized by hyperthyroidism, which can relapse in many patients after antithyroid drug treatment withdrawal. Several studies have been performed to predict the clinical course of GD in patients treated with antithyroid drugs, without conclusive results. The aim of this study was to define a set of easily achievable variables able to predict, as early as possible, the clinical outcome of GD after antithyroid therapy. METHODS: We studied 71 patients with GD treated with methimazole for 18 months: 27 of them achieved stable remission for at least 2 years after methimazole therapy withdrawal, whereas 44 patients relapsed. We used for the first time a perceptron-like artificial neural network (ANN) approach to predict remission or relapse after methimazole withdrawal. Twenty-seven variables obtained at diagnosis or during treatment were considered. RESULTS: Among different combinations, we identified an optimal set of seven variables available at the time of diagnosis, whose combination was useful to efficiently predict the outcome of the disease following therapy withdrawal in approximately 80% of cases. This set consists of the following variables: heart rate, presence of thyroid bruits, psycological symptoms requiring psychotropic drugs, serum TGAb and fT4 levels at presentation, thyroid-ultrasonography findings and cigarette smoking. CONCLUSIONS: This study reveals that perceptron-like ANN is potentially a useful approach for GD-management in choosing the most appropriate therapy schedule at the time of diagnosis.

Oncological research overview in the European Union. A 5-year survey.

This study evaluates the distribution of papers published by European Union (EU) authors in oncological journals from 1996 to 2000, and compares the results with those of a previous study carried out in 1995. The impact of oncological research in the EU is compared with that of the United States (US) and the world, and research trends are highlighted through an analysis of keywords. Data on articles published in oncological journals (ISI Subject Category=ONCOLOGY) selected from Current Contents/Life Science and Current Contents/Clinical Medicine (1996-2000) on the weekly diskette version were downloaded. Mean Impact Factor (IF), source country population and gross domestic product (GDP) were analysed. A special-purpose software to determine the most commonly used keywords was utilised. From 1996 to 2000, 66021 papers were published in the world in oncological journals: 35.5% came from the EU (UK, Italy, Germany, France and The Netherlands ranking the highest) and 38.8% from the US. The total number of EU papers increased from 4063 in 1995 to 4843 in 2000. Compared with the previous study, no important changes were seen, with the top five countries in 1995 maintaining their ranking in 2000. However, some small countries (Denmark, Norway and Ireland) fared worse in 2000, while others (France, Germany and Greece) improved their position. The mean IF for the EU papers was 2.9 compared with 4.0 in the US. The mean IF increased for all of the nations. In particular, while France and Germany showed a very positive performance trend in their respective IFs, countries such as Norway, Denmark and Italy showed less improvement. The analysis of keywords appearing in articles written in 2000 showed that the leading fields of research were breast cancer in the diseases category of keywords, cisplatin and platinum compounds in the drugs category, radiotherapy in the treatment category and apoptosis in the experimental studies category. Variety in the use of keywords should be avoided, and journal editors should encourage their standardisation.

Radiological research in Europe: a bibliometric study.

We performed a bibliometric search to evaluate number and scientific "weight" of papers written by European radiologists, as compared with colleagues from other countries, to measure the contribution of European researchers to radiology journals, and to correlate bibliometric parameters with some socio-economic factors of the different European nations. We considered all peer-reviewed articles published by radiologists in biomedical journals quoted by ISI over the 1995-2000 period. To identify authors as radiologists, the string "radiol" had to appear in the address of the corresponding author, and his country was considered as the country of origin of the paper. The definition of Europe included the 15 countries of the European Union, plus Norway and Switzerland. The scientific "weight" of the paper was assumed to be the impact factor of the journal of the publication in that given year. Then, we considered the annual indexes number of papers/population and number of papers/Gross Domestic Product (GDP) in each country. Data were retrieved from the Eurostat annual statistic reviews. From these bases, we obtained a comparison of the scientific production among European radiologists, those from the U.S. and those from the rest of the world. European radiological research is responsible of almost 40% of the world scientific production in our field, and Germany, UK and France are the leading publishers in Europe. An increase of the number of papers written by European radiologists was noted in the 1995-2000 period, whereas the production from the U.S. had a slight decrease. The mean concentration indexes papers/inhabitants and papers/GDP were significantly lower in Europe than in the U.S., even if some small European countries had higher values than the U.S. As a mean, European research received a lower impact factor than that from the U.S. The assessment of research output has progressively developed as an important issue for the scientific research community. Although not flawless, and often criticized for a variety of reasons, citation analysis is a commonly used technique in this field, is a frequent means to "weight" the scientific production of researchers and is one of the criteria used to assign research grants. Our study shows that European radiology is growing and its production is increasing over time, thus indicating strong commitment to research from European radiologists; however, European radiological research has not yet reached leadership in the literature, and mean indexes addressing the level of resources allocated to research are lower in Europe than in the U.S. This latter point has notable exceptions, but indicates inadequacy of funding, at least in some nations, and in Europe as a whole. The development of research programs within the framework of the European Union specifically aimed to radiology could lead to further advancement of our discipline.

Circadian pattern of intragastric acidity in patients with non-erosive reflux disease (NERD).

BACKGROUND: Most patients with gastro-oesophageal reflux disease have non-erosive reflux disease. Proton pump inhibitors are less effective than expected in these patients, but no previous study has measured their 24-h gastric pH values. AIMS: To evaluate whether there are differences in 24-h intragastric acidity between reflux patients with and without oesophagitis and controls. The influence of Helicobacter pylori on the gastric pH of reflux patients was also assessed. METHODS: Sixty-three consecutive patients with gastro-oesophageal reflux disease symptoms who agreed to undergo endoscopy and 24-h pH-metry were recruited. Twenty-five (39%) had erosive oesophagitis and 38 (61%) did not. H. pylori was diagnosed by CLO test, histology and 13C-urea breath test. Gastric pH was also measured in 30 controls without digestive symptoms. RESULTS: H. pylori was found in seven of the 25 (28%) patients with oesophagitis and 14 of the 38 (37%) patients with non-erosive reflux disease. Oesophageal pH-metry was abnormal in 21 of the 25 (84%) patients with oesophagitis and in 32 of the 38 (84%) patients with non-erosive reflux disease. The median gastric pH did not differ between patients with and without oesophagitis or between them and controls during the 24 h (P = 0.8) and other time intervals (P = 0.2-0.4). The gastric pH did not differ between infected and non-infected patients with oesophagitis (P = 0.2-0.4) or non-erosive reflux disease (P = 0.3-0.8). CONCLUSIONS: The circadian pattern of intragastric acidity does not differ between patients with non-erosive reflux disease and oesophagitis. Moreover, the study confirms that H. pylori infection does not affect the gastric pH in either group of reflux patients.

[Methodology of an epidemiologic prevalence study in rheumatology: the Chiavari study]. / Metodologia di uno studio epidemiologico di prevalenza in reumatologia: lo studio di Chiavari.

OBJECTIVES: Goals of epidemiological studies are the description of the measures of frequency of diseases, the attempt to clarify possible etiopathogenic mechanisms, and the provision of data to support health policy decisions. To increase the familiarity of rheumatologists toward epidemiology, we describe the methodology used in a prevalence study of musculoskeletal complaints performed in Chiavari, Italy. METHODS: A questionnaire, originally developed by the Epidemiology Unit of the Arthitis Research Council in Manchester, UK, to investigate the prevalence of rheumatoid arthritis, was used after translation and validation. 4456 subjects aged 16 years or more listed in four general practices were invited to participate in the study and to fill the ARC questionnaire. The 3294 responders reported a) any past occurrence of joint swelling lasting more than four weeks and the distribution of the swollen joints on a mannequin; b) any joint pain lasting more than four weeks; c) current joint pain or swelling; d) morning stiffness; e) whether they had been previously told by a doctor they had arthritis. RESULTS: Four steps were necessary to obtain a 74% response, i.e. direct contact, two mailings and a phone interview. The performance of the different questions was good. The prevalence of the most common conditions among patients answering positively to the questions regarding morning stiffness and symmetrical swelling of joints was as follows: osteoarthritis 2.60%, fibromyalgia 1.30%, carpal tunnel syndrome 1.14%, rheumatoid arthritis 0.31%, and psoriatic arthritis 0.10%. CONCLUSIONS: Methodological issues regarding the selection of the population and sample to study, the development of a questionnaire, and the problems in obtaining valid informations are discussed.

Assessing oncological productivity. is one method sufficient?

This work analyses the distribution of oncological papers published in 1995 by authors from the European Union (EU) in any journal of all the Subject Categories of the Science Citation Index compiled by ISI (Institute for Scientific Information, Philadelphia, USA) and is based on the country of origin of all of the contributors. The study compares the results with those of a previous study dealing with publications in journals of the ISI Oncology Category based on the country of origin of the corresponding author. The aim of the study was to compare two different methods used to evaluate research productivity in order to understand the extent to which the results are influenced by the methodology adopted. Data on the number of published papers for each country, ratio between the number of occurrences of papers and country population and gross domestic product (GDP), and mean Impact Factors (IF ) were compared. While findings on the number of published papers (United Kingdom (UK), Germany and France ranking best), source country population (Sweden, Denmark and the Netherlands ranking best) and gross domestic product (Sweden, Finland and the Netherlands ranking best) showed no important changes, the mean IF value result was, for some countries, very different from the previous study. In particular, while Germany, Belgium, Portugal and France fared well, Norway, Sweden, Austria and Spain showed poorer results. Some hypotheses are advanced, and care in the scientometric interpretation of data is urged. An analysis of the journals in which EU authors published their articles was also carried out and the main SCI categories to which the journals belong are reported. As was expected, many categories other than oncology were represented (biochemistry, haematology, pathology, etc.).

Noninvasive prediction of sudden death and sustained ventricular tachycardia after acute myocardial infarction using a neural network algorithm.

BACKGROUND: The early and accurate noninvasive identification of postinfarction patients at risk of sudden death and sustained ventricular tachycardia (arrhythmic events) still remains an unsolved problem. The aim of the present study was to identify the combination of clinical and laboratory noninvasive variables, easy to obtain in most patients, that best predicts the occurrence of arrhythmic events after an acute myocardial infarction. METHODS: Four hundred and four consecutive patients with acute myocardial infarction were enrolled and followed for a median period of 21.4 months. In each patient, 61 clinical and laboratory noninvasive variables were collected before hospital discharge and used for the prediction of arrhythmic events using an artificial neural network. RESULTS: During follow-up, 13 (3.2%) patients died suddenly and 11(2.5%) had sustained ventricular tachycardia. The neural network showed that the combination best predicting arrhythmic events included: left ventricular failure during coronary care stay, ventricular dyskinesis, late potentials, number of ventricular premature depolarizations/hour, nonsustained ventricular tachycardia, left ventricular ejection fraction, bundle branch block and digoxin therapy at discharge. The neural network algorithm allowed identification of a small high-risk patient subgroup (12% of the study population) with an arrhythmic event rate of 46%. The sensitivity and specificity of the test were 96 and 93% respectively. CONCLUSIONS: These results suggest that, in postinfarction patients, it is possible to predict early and accurately arrhythmic events by noninvasive variables easily obtainable in most patients. Patients identified as being at risk are candidates for prophylactic antiarrhythmic therapy.

Prevalence of self-reported peripheral joint pain and swelling in an Italian population: the Chiavari study.

OBJECTIVE: To evaluate the prevalence of self-reported joint pain and swelling in the peripheral joints of subjects from an Italian general population. To correlate the result with demographic data and physical activity. METHODS: A total of 4,456 subjects aged 16 years or more listed in four general practices were invited to participate in the study and to fill out the ARC questionnaire. The 3,294 responders were asked to report: (a) any past occurrence of joint swelling lasting more than 4 weeks and the distribution of the swollen joints on a mannequin; (b) any joint pain lasting more than 4 weeks; (c) current joint pain or swelling; (d) morning stiffness; (e) whether they had been previously told by a doctor they had arthritis; and (f) their physical activity according to a three-class scale. RESULTS: Joint pain was reported by 889 (27%) subjects and joint swelling was reported by 463 (14%) subjects. Women reported joint pain and swelling more frequently than men, except for the younger age classes. The prevalence of joint pain and swelling increased with age in both sexes until age 55-64, when a plateau was observed. Age was involved in the determination of joint pain and swelling. Physical activity was involved only marginally. CONCLUSIONS: We found high levels of prevalence of pain and swelling in the peripheral joints in a general Italian population. Prevalence was higher in Italian subjects than in subjects from China and Pakistan studied using the same questionnaire. These differences may reflect cultural and social diversity in the perception of disease, as well as true differences in the prevalence of rheumatic symptoms across the world.

Decreased nocturnal urinary antidiuretic hormone excretion in enuresis is increased by imipramine.

OBJECTIVE: To assess the role of integrated nocturnal antidiuretic hormone (ADH) secretion in children with enuresis, and possible modifications induced by treatment with imipramine. PATIENTS AND METHODS: The morning plasma ADH and nocturnal urinary ADH integrated concentrations were measured in 18 consecutive enuretic children (patients) and 21 age- and sex-matched controls admitted for minor treatment. Diurnal and nocturnal urine production, and plasma and urinary osmolality were also determined; lumbosacral radiography and uroflowmetry were undertaken in the patients. The assessments were repeated after 14 days of treatment with imipramine hydrochloride (orally, 20 mg/night). RESULTS: Half the patients had occult spinal malformations but the uroflowmetry results were all within the normal range. The median (95% confidence interval, CI) urinary ADH integrated concentrations were markedly lower in patients, at 29.7 (22.1-37.3) vs 63.0 (35.1-90.8) pg/mL/h (P = 0.03) than in controls. Plasma ADH levels were significantly increased by imipramine (0.64 to 1.47 pg/mL, 95% CI, 0.40-0.89 vs -0.26-3.2; P < 0.001), as were nocturnal urinary ADH integrated concentrations, at 29.7 (22.1-37.3) vs 59.0 (37.3-80.6) pg/mL/h (P < 0.001), and morning plasma osmolality decreased, from 298.5 (294.5-302.5) to 294.9 (292.4-297.3) mosmol/kg (P = 0.003), as was the 24-h fluid intake, from 983 (721-1245) to 666 (435-897) mL (P = 0.004). CONCLUSIONS: We conclude that enuretic children have a lower nocturnal ADH excretion; imipramine restores nocturnal ADH excretion, increases morning plasma ADH levels, and causes consistent changes in other biochemical variables.

Effect of Helicobacter pylori eradication on 24-hour gastric pH and duodenal gastric metaplasia.

Published data on the regression of the extent of duodenal gastric metaplasia (DGM) after the eradication of Helicobacter pylori infection and the normalization of the organism-induced alterations in gastric physiology are scanty and controversial. Therefore, we decided to assess the circadian pattern of gastric acidity and the degree of DGM before and one year after H. pylori eradication in a group of duodenal ulcer patients. Fifteen consecutive H. pylori-positive patients with endoscopically proven duodenal ulcer were recruited for this study. The diagnosis of H. pylori infection was based on CLO-test and histology, and DGM was assessed on four bulb biopsies taken before and one year after H. pylori eradication. At the same time, gastric pH was measured by 24-hr continuous intraluminal recording. H. pylori eradication was ascertained by means of concomitant negative CLO-test and histology performed both four weeks after the end of the eradicating treatment and at the one-year endoscopic control. After successful cure, all patients discontinued any antiulcer medication. The mean 24-hr gastric pH was 1.7 +/- 0.4 before and 1.6 +/- 0.4 after one year of H. pylori eradication (P = 0.75). DGM improved in three cases, worsened in four cases, and was unchanged in eight cases at the one-year control (P = 0.87). No correlation was found between 24-hr gastric pH and DGM (P = NS) both at baseline and one year after eradication. Our results show that neither circadian gastric acidity nor DGM change significantly one year after H. pylori eradication in duodenal ulcer patients. Thus, the disappearance of H. pylori infection does not determine any increase in gastric pH and any reversal of gastric-type epithelium in the duodenum.

Circadian gastric acidity and Helicobacter pylori infection in patients with chronic pancreatitis.

A high prevalence of duodenal ulcer has been reported in patients with chronic pancreatitis. Data from previous studies on gastric acid secretion in these patients have provided conflicting results, and the potential role of H. pylori infection has been poorly investigated. The aim of this study was to assess the circadian pattern of gastric acidity and the prevalence of H. pylori infection in a group of patients suffering from this disease. Thirty-five patients with chronic pancreatitis ascertained by means of pancreatic calcifications or ductal alterations revealed by ERCP were recruited for this prospective study. They underwent 24-hr gastric pH-metry with glass minielectrodes positioned in the gastric corpus, and their profile of gastric acidity was compared with that of 35 healthy subjects, matched for age and sex. H. pylori infection was diagnosed by means of serology. There was no statistical difference (P = NS) in gastric pH of circadian, nocturnal, daytime, and postprandial periods between healthy subjects and patients with chronic pancreatitis. The prevalence of H. pylori infection was rather low (31%) in our patients and similar to that of a comparable control population (37%) in our geographical area. In conclusion, our study shows that patients with chronic pancreatitis have a circadian pattern of gastric acidity similar to that of normal subjects. Moreover, the prevalence of H. pylori infection is low in this population. These findings greatly differentiate the ulcer diathesis in chronic pancreatitis from that of patients with ordinary duodenal ulcer and suggest that other factors are implicated in the ulcerogenic process.

Comparative effects of three cytokine regimens after high-dose cyclophosphamide: granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor (GM-CSF), and sequential interleukin-3 and GM-CSF.

PURPOSE: To compare the toxicity and effects on hematologic recovery and circulating progenitor cell mobilization of three cytokine regimens administered after high-dose cyclophosphamide (HD-CTX; 6 g/m(2)), given as the first step of a high-dose sequential chemotherapy. PATIENTS AND METHODS: Forty-eight patients with breast cancer or non-Hodgkin's lymphoma were randomized to receive granulocyte colony-stimulating factor (G-CSF) alone (arm 1), granulocyte-macrophage colony-stimulating factor (GM-CSF) alone (arm 2), or sequential interleukin-3 (IL-3) and GM-CSF (arm 3). Cytokines were administered as a single daily subcutaneous injection at a dose of 5 to 6 microg/kg/d. Progenitor cells were evaluated in peripheral blood as well as in apheretic product as both CD34(+) cells and granulocyte-macrophage colony-forming units (CFU-GM). RESULTS: Neutrophil recovery was faster in arm 1 as compared with arms 2 and 3 (P <.0001); no significant differences were observed between arms 2 and 3. In arm 3, a moderate acceleration of platelet recovery was observed, but it was statistically significant only as compared with arm 1 (P =.028). The peak of CD34(+) cells was hastened in a median of 2 days in arm 1 compared with arms 2 and 3 (P =.0002), whereas the median peak value of CD34(+) cells and CFU-GM was similar in the three patient groups. Administration of IL-3 and GM-CSF resulted in more significant toxicity requiring pharmacologic treatment in 90% of patients. CONCLUSION: The three cytokine regimens administered after HD-CTX are comparably effective in reducing hematologic toxicity and mobilizing the hematopoietic progenitor cells. G-CSF accelerates leukocyte recovery and progenitor mobilization. Although G-CSF-treated patients have somewhat slower platelet recovery, they definitely have fewer side effects.

Intercellular adhesion molecule-1 (ICAM-1) and granulocyte-macrophage colony stimulating factor (GM-CSF) co-expression in cutaneous malignant melanoma lesions.

The expression of intercellular adhesion molecule-1 (ICAM-1) and granulocyte-macrophage colony stimulating factor (GM-CSF) was investigated in 25 melanoma patients by evaluating 34 fresh biopsy specimens. ICAM-1 in situ hybridization and immunochemistry for ICAM-1 and GM-CSF were performed. Most of the metastatic melanoma samples (12 out of 18) and a few of the primary melanoma lesions (three out of 16) showed ICAM-1 expression. The expression of ICAM-1 was significantly (P < 0.01) higher in metastatic lesions than in primary tumours. GM-CSF mRNA and protein were detected in 10 of the 18 metastatic samples and in two of the 15 primary lesions. A significantly high degree (P < 0.0002) of concordance between ICAM-1 and GM-CSF expression was observed: the samples that were negative or positive for ICAM-1 expression were correspondingly negative or positive for GM-CSF. Correlation with clinical and histological parameters was examined. The expression of both molecules in metastatic samples was found to be significantly (P < 0.001) associated with a shorter recurrence-free period. These findings, if confirmed by a wider number of patients, could suggest the prognostic value of the simultaneous, and probably co-ordinated, expression of ICAM-1 and GM-CSF. They also highlight the importance of preventive molecular and biochemical characterization of neoplastic cell cytokine receptors, specifically focusing on the particular cytokine to be used as anticancer therapy and/or as adjunct to chemotherapy.

Comparison of isotope ratio mass spectrometry and nondispersive isotope-selective infrared spectroscopy for 13C-urea breath test.

OBJECTIVES: The 13C-urea breath test (UBT) is a sensitive and noninvasive method to diagnose Helicobacter pylori infection, but mass spectrometry (IRMS) is very expensive. The aims of this study were to compare the new low-priced infrared spectroscopy with IRMS in detecting the infection and to assess the influence of feeding on test accuracy. METHODS: One hundred thirty-four patients with dyspeptic symptoms were recruited. Of these, 74 were infected and 60 uninfected on the basis of both CLO-test and histology. A subgroup of 37 patients (22 H. pylori-positive and 15 H. pylori-negative) was studied under fasting and nonfasting conditions on two different days. Duplicate breath samples were analyzed with two IRMS systems (Breath Mat and ABCA) and an infrared spectrometer (IRIS) before, 15 min, and 30 min after ingestion of 75 mg 13C-urea with citric acid. In 37 patients the test was repeated the day after the fasted one and was performed 60 min after a meal of 800 Kcal. RESULTS: There was a close correlation between IRIS and Breath Mat (r = 0.969 at 15 min and r = 0.977 at 30 min; p < 0.0001), IRIS and ABCA (r = 0.963 at 15 min and r = 0.985 at 30 min; p < 0.0001), and Breath Mat and ABCA (r = 0.987 at 15 min and r = 0.981 at 30 min; p = 0.0001). The sensitivity ranged from 97-100% at both times with all devices, although the specificity was slightly inferior with the infrared system than with the two IRMS machines (95% vs 98-100% at 30 min), but the difference was not significant (p = NS). Food intake produced three false negative results in all three machines and a systematic shift to lower 6 values in infected patients. CONCLUSIONS: Infrared spectroscopy can be considered a valid alternative to mass spectroscopy for the diagnosis of H. pylori infection. Fasting is required to guarantee an accurate test.

Head-to-head comparison of 1-week triple regimens combining ranitidine or omeprazole with two antibiotics to eradicate Helicobacter pylori.

BACKGROUND: Triple therapies containing omeprazole and ranitidine have been shown to be equivalent in eradicating H. pylori infection, but have been assessed either separately or head-to-head, only in small trials. AIM: To carry out a large randomized controlled study comparing omeprazole and ranitidine combined with two antibiotic combinations for 1 week. METHODS: Three hundred and twenty H. pylori-positive patients were randomly subdivided into four equal-sized groups and received one of the following treatments: OAM = omeprazole 20 mg b.d. + amoxycillin 1 g b.d. + metronidazole 500 mg b.d.; RAM = ranitidine 300 mg b.d. + amoxycillin 1 g b.d. + metronidazole 500 mg b.d.; OAC = omeprazole 20 mg b.d. + amoxycillin 1 g b.d. + clarithromycin 250 mg t.d.s.; RAC = ranitidine 300 mg b.d. + amoxycillin 1 g b.d. + clarithromycin 250 mg t.d.s. The assessment of H. pylori status was performed before and 4 weeks after the end of therapy by means of CLO-test and histology. H. pylori infection was considered to be eradicated when both tests were negative. RESULTS: OAM and RAM eradicated H. pylori in 89% and 85% of cases on per protocol (P = 0.48) and in 77% and 75% of cases on intention-to-treat analyses (P = 0.71). OAC and RAC eradicated H. pylori in 67% and 70% of cases on per protocol (P = 0.68) and in 57% and 64% of cases on intention-to-treat analyses (P = 0.41). In contrast, there was significant difference between OAM and OAC (P<0.01) and between RAM and RAC (P<0.05). Side-effects occurred in 15%, 10%, 17% and 16% of patients with respect to the above four subgroups. CONCLUSIONS: Omeprazole and ranitidine combined with two antibiotics for 1 week are equally effective in the eradication of H. pylori infection, and these results question the role of profound acid suppression in the eradication of the bacterium.

Histological and functional recovery in patients with multifocal atrophic gastritis after eradication of Helicobacter pylori infection.

BACKGROUND/AIMS: To assess the effect of Helicobacter pylori eradication on gastric histology and physiology in patients with multifocal atrophic gastritis over 1-year period. PATIENTS: Fourteen consecutive patients with histological evidence of chronic gastritis and Helicobacter pylori infection diagnosed by histology and serology entered this study. Patients with pernicious anaemia, gastric ulcer or carcinoma, duodenal ulcer, reflux oesophagitis and regular intake of nonsteroidal anti-inflammatory drugs were excluded. METHODS: Patients underwent triple anti-Helicobacter treatment for one week, which resulted successful in all subjects on the basis of negative CLO test and histology as well as 50% decrease in IgG antibodies after 4 weeks and 6 months of treatment, respectively. Histological and functional investigations were performed at baseline, 6 and 12 months after Helicobacter pylori eradication. Histological assessment of inflammatory cell infiltrates was performed on multiple biopsy specimens of the corpus and fundus. Functional tests were 24-hour continuous gastric pH-metry, fasting serum gastrin assay and pepsinogen I levels. RESULTS: There was a progressive significant improvement (p < 0.01-0.001) in acute and chronic inflammatory cell infiltrates in the gastric mucosa throughout the 12-month period. Functional recovery with increase in gastric acidity (p < 0.01) and decrease in gastrin and pepsinogen I levels (p < 0.001) was more evident at the 6-month than at the 12-month checkpoint after Helicobacter pylori eradication (p = NS for gastric pH and p < 0.02 for the other two variables) between 6 and 12 months. CONCLUSIONS: Eradication of Helicobacter pylori infection significantly improves the inflammatory status of oxyntic mucosa and this promotes an almost complete functional recovery. However, the non-parallel behaviour of gastric acidity, which was maximal at 6-month checkpoint, and histological parameters which continued to improve throughout the entire 12-month observation period, seems to indicate that removal of acid-inhibitory substances induced by Helicobacter pylori infection was also responsible for the more rapid recovery of gastric secretory function.